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- Comparative Effectiveness of Lipid-Modifying Agents
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- Research Review Sept. 1, 2009
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Executive Summary – Sept. 1, 2009
Comparative Effectiveness of Lipid-Modifying Agents
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Archived: This report was assessed in December 2011 and some conclusions were considered out of date. This report has been updated.
Table of Contents
Executive Summary
The Effective Health Care Program was initiated in 2005 to provide valid evidence about the comparative effectiveness of different medical interventions. The object is to help consumers, health care providers, and others in making informed choices among treatment alternatives. Through its Comparative Effectiveness Reviews, the program supports systematic appraisals of existing scientific evidence regarding treatments for high-priority health conditions. It also promotes and generates new scientific evidence by identifying gaps in existing scientific evidence and supporting new research. The program puts special emphasis on translating findings into a variety of useful formats for different stakeholders, including consumers.
Over 28 million Americans have some form of cardiovascular disease (CVD), which causes more deaths than cancer, diabetes, accidents, and chronic lung diseases combined. Estimated direct medical expenditures and lost productivity from CVD amounted to $431.8 billion in the United States in 2007.
A large amount of observational data, as well as clinical trials, support a significant, modifiable role of blood lipids in the production of disease. Cholesterol is transported in the blood in the form of particles containing lipids and proteins, called lipoproteins. Levels of low-density lipoprotein cholesterol (LDL-c) correlate with the development of CVD, while levels of high-density lipoprotein (HDL) are associated with a lower risk of disease.
Cholesterol is a normal part of cell membranes, hormones, and bile acids that are involved in the absorption of some vitamins. Levels of cholesterol are influenced by its production in the liver and the ingestion of dietary fats. Bile acids are released into the intestine, aid in digestion, and then are mostly reabsorbed.
Evidence suggests that lowering LDL-c reduces coronary heart disease (CHD) and ischemic stroke, making LDL-c a primary target of therapy. The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) recommendations provide guidance on the initiation of treatment aimed at lowering lipid levels based on individual patient characteristics. Three levels of risk have been established, with the highest risk individuals being those with CHD, diabetes, clinical atherosclerotic disease in other vascular beds, or multiple risk factors, resulting in a 10-year risk of developing CHD of more than 20 percent. LDL-c levels are indications for the initiation of treatment and represent therapeutic targets, but these targets are achieved by only one-third of all patients, and even fewer of those with established CHD. Low-density lipoprotein (LDL) levels are the primary target of treatment, with HDL and triglyceride levels forming secondary goals in these guidelines. For individuals with elevated triglycerides, the primary goal remains achieving the appropriate LDL target. The ATP III recommendations do not specify a target for HDL increment due to insufficient evidence regarding the proper level.
Medications available for lipid-lowering therapy have various mechanisms of action and pharmacokinetic properties. The most widely prescribed are the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. Known as statins, these agents reduce the production of cholesterol in the liver by binding with the enzyme responsible for its production. In contrast, fibrates do not influence lipid synthesis but rather reduce the levels of fatty acids in the blood. Ezetimibe is an agent that inhibits intestinal absorption by acting on the sterol transporter NPC1L1. Niacin (nicotinic acid) reduces LDL-c and increases high-density lipoprotein cholesterol (HDL-c) via a mechanism yet to be fully elucidated, although it is suspected to be involved in the synthesis and metabolism of apolipoproteins. Bile acid sequestrants (BAS) bind bile acids in the bowel, thereby preventing reabsorption of bile from the intestine. Omega-3 fatty acids have been postulated to lower postprandial triglycerides and have antithrombotic and blood-pressure-reducing effects.
Statins are the most studied and prescribed group of lipid-lowering medications and may be used alone or in combination with a medication of another type. Treatment options for individuals requiring intensive lipid-modifying therapy include increasing the dose of a statin or using a statin in combination with a lipid-modifying agent of another class. It is unclear which of these strategies is superior with respect to clinical outcomes or the attainment of treatment targets. Combining different types of medications may appear attractive but could result in more harms, be less tolerable, or be less effective than statin therapy alone. This systematic review compares the benefits and risks of these two options in terms of clinical events (e.g., myocardial infarction, stroke, or death), surrogate measures (e.g., levels of LDL-c), tolerability, and adherence.
This evidence report was commissioned by the Agency for Healthcare Research and Quality (AHRQ) to address the following key questions:
Key Question 1. For patients who require intensive lipid-modifying therapy, what are the comparative long-term benefits and rates of serious adverse events of co-administration of different lipid-modifying agents (i.e., a statin plus another lipid-modifying agent) compared with higher dose statin monotherapy?
Key Question 2. Do these regimens differ in reaching LDL targets (or other surrogate markers), short-term side effects, tolerability, and/or adherence?
Key Question 3. Compared with higher dose statins and to one another, do combination regimens differ in benefits and harms within subgroups of patients?
Search strategy
MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched from inception to August 2008, and Scopus was searched for references citing eight expert-nominated articles. Additional searches included statistical and medical reviews of drug applications posted by the U.S. Food and Drug Administration (FDA), information packages submitted by the pharmaceutical companies marketing lipid-modifying drugs, and the Internet.
Study selection
Studies employing therapeutic doses of drugs were included. Relevant nonstatin hypolipidemic drugs included ezetimibe, fibrates, niacin, BAS, and omega-3 fatty acids. Randomized controlled trials for all outcomes and nonrandomized comparative studies of 24 weeks or more in duration for clinical outcomes, serious adverse events (SAE), and cancer were eligible.
Screening and data extraction
One reviewer screened abstracts to include studies, and exclusions were verified by another reviewer. Two reviewers independently screened full-text reports, with conflicts resolved by consensus or third party adjudication. Data were extracted in standardized forms.
Evidence synthesis
Primary outcomes were all-cause mortality and vascular death. Secondary outcomes were myocardial infarction (fatal, nonfatal, or unspecified MI), acute coronary syndrome, stroke (hemorrhagic, ischemic, or unspecified), transient ischemic attack, unspecified cerebrovascular event, and revascularization procedures. Surrogate outcomes included attainment of NCEP ATPl III LDL-c goals, LDL-c, HDL-c, total cholesterol (TC):HDL-c ratio, non-HDL-c and triglycerides in the subgroup with diabetes mellitus, and measures of carotid or coronary atherosclerosis. Harms were SAE, cancer, treatment adherence, withdrawal due to adverse events, participants with at least one adverse event, elevated serum aspartate transaminase (AST) and/or alanine transaminase (ALT) above 3 times the upper limit of normal and/or hepatitis, myalgia, creatinine phosphokinase (CPK) above 10 times the upper limit of normal, and rhabdomyolysis.
Populations requiring intensive therapy included participants with a 10-year CHD risk above 20 percent and/or mean baseline LDL-c of at least 190 mg/dL.
Statin plus another hypolipidemic drug combination therapy was compared with statin monotherapy. Synthesis of evidence was specific to combinations employing different nonstatin hypolipidemic drugs. Evidence from nonrandomized studies was synthesized qualitatively only. Anticipating a dearth of available evidence in answering the key questions, analyses were broadened to the following categories:
Dose and statin-specific analyses comparing lower dose of a specific statin plus any dose of a nonstatin lipid-lowering drug vs. higher dose of the same statin monotherapy in:
- All trial populations (or mixed populations)
- Population in need of intensive lipid lowering
- Subgroups.
Analyses of various statins and doses comparing any dose and subtype of statin plus any dose of a nonstatin lipid-lowering drug vs. any dose and subtype of statin monotherapy in:
- All trial populations.
- Population in need of intensive lipid lowering.
- Subgroups .
Lower and higher doses of statins were defined as shown in Table A.
|Lower dose (mg/day)
|5 and/or
10 and/or
|5 and/or
10 and/or
|5 and/or
|5 and/or
10 and/or
20 and/or
|5 and/or
10 and/or
20 and/or
|5 and/or
10 and/or
20 and/or
|Higher dose (mg/day)
|40 and/or
|40 and/or
|20 and/or
40 and/or
All-cause mortality, vascular death, and surrogate efficacy outcomes were examined for all trial populations, populations in need of intensive lipid-lowering, and subgroups. However, anticipating insufficient evidence pertaining to specific populations, syntheses of evidence on harms and clinical outcomes, other than the primary outcomes of all-cause mortality and vascular death, were undertaken irrespective of population characteristics (i.e., across all available trial populations) for each combination vs. monotherapy comparison.
Data were synthesized qualitatively when heterogeneity was substantial (I2 greater than 50 percent). Trials of greater than 24 weeks duration were defined as long term, while those less 24 weeks were considered short term. A systematic procedure was employed to avoid double counting treatment group data when trials presented multiple unequal numbers of combination and monotherapy arms (unit-of-analysis error). Details of the procedure are provided in the full report.
The DerSimonian and Laird approach was used for all meta-analyses, except for rare events (less than 1 percent of participants), when fixed Peto Odds Ratios were calculated.
Methodological quality assessment
Study quality of RCTs was assessed with the Jadad scale, and of nonrandomized studies with the Downs and Black criteria. Reporting of adequacy of allocation concealment was also assessed and considered in the sensitivity analyses.
Rating the quality of evidence synthesized
Using GRADE (Grading of Recommendations Assessment, Development and Evaluation), evidence was rated for the primary outcomes, ATP III goal attainment, and SAE. The GRADEpro software was used.
Table B is a summary table that presents the main conclusions of this report. Conclusions pertaining to the key questions, as well as additional analyses in mixed populations, are summarized below. Ninety-seven unique randomized controlled trials (RCTs) and four controlled clinical trials (CCTs) were included.
Key Question 1. Long-term benefits and serious adverse events
There are several important limitations in the evidence regarding long-term clinical outcomes. Most of the evidence originates from short-term studies aimed at biochemical measures and therefore is insufficient for the clinical events of interest, including the occurrence of MI, stroke, or death. In trials of combination therapy, the monotherapy comparator arms rarely explored higher-dose statins or were not performed in individuals requiring intensive lipid lowering. Due to these limitations in the available data, we present first our results based on the available evidence for the group requiring intensive lipid lowering when combination treatment is compared to a higher dose of a statin, and then provide a broader perspective using available data in all risk groups comparing combination therapy to any monotherapy statin dose.
All-cause mortality
The quality of evidence was very low for all available comparisons of combinations and monotherapy reported below.
For individuals requiring intensive therapy, limited evidence was available for statin combinations with ezetimibe and fibrates compared to higher doses of statins. In the two statin-ezetimibe combination trials, no deaths occurred in either the combination or the statin monotherapy group, precluding a comparative analysis of mortality. A single trial with a statin-fibrate combination showed no difference in mortality compared with a higher dose statin.
Trials comparing combination therapy with stain monotherapy that were not limited to individuals requiring intensive lipid lowering and did not necessarily compare combination therapy with a higher dose of statin monotherapy were examined for an effect on mortality. No significant differences between treatments were observed across any combination, including statin-omega-3 combination, which was studied in three trials, one of which was a large trial lasting 5 years of 18,645 Asians.
Vascular death
Treatments aimed at modifying lipids might be expected to lower the rates of death due to vascular diseases such as heart disease and stroke. However, no trials examined this outcome in a high-risk population and compared the combination to a higher statin dose. Across all available trial populations, two trials each of statin-ezetimibe and statin-niacin combinations did not demonstrate a difference in the occurrence of rare vascular deaths. The quality of evidence was very low for evidence pertaining to both combinations.
Other clinical outcomes
For the outcomes of reduction of MI or stroke or avoidance of revascularization procedures on the carotid or coronary vessels, no evidence comparing combination therapy with a higher dose of statin was available. Evidence comparing various doses of statin-ezetimibe, statin-fibrate, statin-niacin, and statin-BAS combinations with statin monotherapy was available from few trials registering rare events, and no significant difference was detected. One large statin-omega-3 trial of18,645 Asians demonstrated no significant difference between treatments for the outcomes of nonfatal MI, hemorrhagic stroke, ischemic stroke, and all stroke over a period of 5 years.
Serious adverse events
The quality of evidence was very low for all available combination and monotherapy comparisons.
Evidence pertained to all available trial populations and not specifically those in need of intensive treatment. Evidence comparing a combination with a higher dose of statin monotherapy was available only for the statin-ezetimibe combination. Three trials with a maximum duration of 24 weeks demonstrated no difference in the rate of serious adverse events. Overall, 5 percent of participants reported an event. When various doses and statin types in combinations were compared with statin monotherapy, no significant differences were noted across all combinations, including evidence that combined 27 statin-ezetimibe trials with over 13,000 participants. Absolute rates of serious adverse events varied between 2 and 4 percent. Even across all combinations, no differences were detected when analyses were restricted to the few long-term trials of 24 to 52 weeks duration.
Evidence pertained to all available trial populations and not only those in need of intensive treatment. Some data were available for individuals at any risk level and statin dose. One 5-year omega-3 trial of 18,645 participants demonstrated no significant difference in the incidence of cancer, with an overall rate of 3 percent. With two 24-48-week statin-ezetimibe trials of 971 participants, the rate of incident cancer was 1 percent, with no significant difference between treatments. Cancer was too rare in a single small statin-niacin trial to permit any conclusion. No evidence was available for statin-fibrate and statin-BAS combinations. While the available data do not suggest an increased incidence of cancer with ezetimibe or omega-3 combinations, the power to detect small differences in the rates of conditions, such as cancer which may have a long latency prior to presentation, is limited given the current data.
Key Question 2. LDL-targets, short-term side effects, tolerability, and adherence
Surrogate markers are biological markers that are linked to the occurrence of disease and used as targets for therapy. The NCEP ATP report sets treatment goals for various risk categories. In this report, we examine the proportion of individuals attaining the LDL-c goals set by the ATP III panel, the effect on LDL-c and HDL-c levels, the total cholesterol: HDL-c ratio, and markers of atherosclerosis.
Participants attaining ATP III LDL-c goals
The available evidence is of very low quality for all comparisons of combination with monotherapy.
For individuals requiring intensive therapy, two trials employing fixed dose or titrations could be statistically combined. Compared with a higher dose statin alone, statin-ezetimibe combination demonstrated a greater probability of reaching treatment goals. A single trial using a statin-fibrate combination demonstrated no significant difference in the number of participants reaching goals compared to a higher dose statin. No evidence comparing higher dose statin monotherapy with any combination was available for participants requiring intensive treatment.
Substantially more information was available for statin-ezetimibe combination therapy in which the treatment comparison was not necessarily a higher dose of statin. In 88 percent of 18 trials conducted in a population in need of intensive treatment, combination therapy was more likely than statin monotherapy to help participants reach LDL-c targets. Likewise, 96 percent of 23 trials favored the statin-ezetimibe combination when all trial populations using various statins as the two treatments were included.
No evidence was available for the statin-omega-3 combination. Sparse evidence precluding meaningful conclusions was identified for statin-fibrate (two trials), statin-niacin (one trial), and statin-BAS (one trial) combinations across various doses and populations.
When comparing a specific statin in combination with a higher dose statin in populations requiring intensive treatment, evidence was either insufficient or absent for statin-fibrate, statin-niacin, statin-BAS, and statin-omega-3 combinations. Scant evidence from two statin-ezetimibe trials was not statistically combined because of heterogeneity, but both trials indicated significant additional reductions of 10 to 20 percent favoring statin-ezetimibe combination therapy over monotherapy.
More data were observed for individuals requiring intensive therapy when combinations were compared with any dose of statin. Substantial heterogeneity precluded statistical analysis of 18 statin-ezetimibe and 4 statin-BAS trials. However, all statin-ezetimibe trials favored combination treatment, with mean additional reductions of 4 to 27 percent. Inconsistent results were found for statin-BAS trials, while evidence was insufficient for statin-niacin, statin-BAS, and statin-omega-3 combinations.
Across all trial populations, when lower doses of statins in combination were compared with higher doses of the same statin monotherapy, significant additional LDL-c reductions of 3 to 20 percent were observed with statin-ezetimibe combinations (six trials); however, heterogeneity precluded a statistical estimate. Evidence was insufficient or absent for each of the remaining combinations.
Across various doses of statins in combination and as monotherapy in all trial populations, significant LDL-c reductions were found with statin-ezetimibe combination (35 trials, of which 94 percent showed 4 to 27 percent additional reduction in LDL-c) and statin-BAS (11 trials, of which 8 trials employing similar doses showed significant, 8 to16 percent, additional reductions favoring combination). With two statin-omega-3 trials, monotherapy was superior. Indeterminate efficacy was noted for the few statin-fibrate and statin-niacin trials.
There is lack of evidence permitting meaningful conclusions from trials comparing a combination with higher dose of statin monotherapy in populations requiring intensive treatment.
In trials comparing various statins and doses in combination with various statin monotherapies in populations requiring intensive treatment, there was evidence of 1.5 percent increment in HDL-c favoring statin-ezetimibe (15 trials) and statin-fibrate combination therapy, and of no significant difference between monotherapy and statin-BAS combination (four trials). Insufficient evidence compared statin-niacin and statin-omega-3 combination with monotherapy in this population.
When trials were not restricted to populations in need of intensive treatment, no significant difference in change in HDL-c was noted for simvastatin in combination with ezetimibe vs. higher doses of simvastatin alone (five trials). Evidence from a single trial favored statin-niacin combination, and showed no difference between statin-fibrate and monotherapy.
No consistent effect was noted for the statin-ezetimibe combination across diverse trial populations employing various statins and doses. However, across various statins and doses in all populations, significant advantages of the statin-omega-3 and statin-fibrate combinations were noted for HDL-c increment when compared with monotherapy (three trials each), while no significant difference was noted for the statin-BAS combination (nine trials). Five of the six statin-niacin trials favored combination, the exception being the one trial that employed high dose rosuvastatin in both treatments.
Total cholesterol: HDL-c ratio
When comparing a specific statin in combination with a higher dose statin in populations requiring intensive treatment, evidence was either absent or based on single-trial data, precluding robust conclusions across one of each combination therapy. A single ezetimibe trial compared lower dose simvastatin in combination vs. higher dose of simvastatin monotherapy in participants requiring intensive lipid-lowering therapy; results favored the combination therapy, demonstrating 14 percent additional reduction.
When comparing various statins and doses in combination with various statin monotherapies in populations requiring intensive treatment, additional data were available. Significant additional reductions of 3 to 20 percent favoring statin-ezetimibe combination therapy were noted in all 10 trials, with substantial heterogeneity precluding meta-analysis. Evidence was neutral for the statin-fibrate combination (two trials). For other combinations, evidence was either insufficient or absent.
Across all available populations, evidence comparing a lower statin dose in combination with a higher dose as monotherapy demonstrated no significant difference between statin-ezetimibe combination and monotherapy. Evidence was insufficient for statin-fibrate combination.
Across various statins and doses in all trial populations, 20 statin-ezetimibe trials were not meta-analyzed because of substantial heterogeneity; however, combination treatment was significantly favored in all but one trial. Evidence favored statin-omega combination, did not show a difference for statin-fibrate, was insufficient for statin-niacin, and was totally absent for statin-BAS.
Measures of atherosclerosis
Carotid intimal media thickness (IMT) can be measured by ultrasound and correlates with the presence of atherosclerotic plaque and vascular risk factors. Previous research has shown that statin treatment reduces the progression of this marker. Two trials were available that compared mean change from baseline in the IMT with combination therapy compared to statin monotherapy. One trial of 642 evaluable participants requiring intensive lipid lowering compared simvastatin plus ezetimibe with identical-dose simvastatin monotherapy and yielded indeterminate results. Another trial of 149 evaluable participants requiring intensive lipid-lowering therapy and using mixed statins with niacin and as monotherapy also demonstrated indeterminate results.
Adherence and harm
For the comparison of a specific statin in combination with a higher dose of its monotherapy across all trial populations, insufficient evidence was available for any any combination except statin-ezetimibe, which showed no significant differences between treatments for the outcomes of withdrawal due to adverse events and liver toxicity (defined as AST/ALT above three times the upper limit of normal). Most trials had a short duration of treatment and followup.
Conclusions summarized below pertain to the comparisons of various statins and doses in combination with various statin monotherapies in all trial populations.
Early withdrawal due to adverse events was more likely for the combination of statin plus niacin than for statin therapy alone (10 trials with an average duration of 24 weeks). No significant difference was noted for other combinations.
Compared with statin monotherapy, more participants developed at least one adverse event with statin-BAS combination (four trials). Inconsistent results were obtained when statin-niacin combination was compared with statin monotherapy. However, three of six trials showed significantly more participants experiencing adverse events with combination than with monotherapy.
Available evidence did not indicate significant differences between participants developing AST/ALT above three times the upper limit of normal and/or hepatitis, CPK above 10 times the upper limit of normal, or myalgia for a comparison of any combination with statin monotherapy. In addition, no participant developed rhabdomyolysis in any of the 27 RCTs investigating the five statin combination therapies, 85 percent of which were short term.
No significant difference in treatment adherence was noted for statin-ezetimibe and statin-niacin combinations compared to monotherapy. The statin-BAS trials could not be meta-analyzed due to inconsistent and unexplained direction and magnitude of effects on adherence across five trials.
Key Question 3. Benefits and harms within subgroups of patients
Evidence in subgroups
Participants with diabetes mellitus. Absent or insufficient evidence of very low quality precluded meaningful conclusions regarding comparisons of a lower dose of a statin in any of the five combination therapies with a higher dose of statin monotherapy for any relevant outcomes.
Across various statin doses in combination and monotherapy, no evidence was available for statin-niacin, statin-BAS, and statin-omega-3 combinations. Compared with statin monotherapy, the statin-ezetimibe combination allowed more participants with diabetes to reach ATP III LDL-c goals when monotherapy was of similar statin dose and potency to combination statin (very low quality of evidence) and allowed greater additional reductions in LDL-c, ranging from 4 to 26 percent; TC:HDL-c ratio, 3 to 17 percent; and non-HDL-c, 4 to 24 percent. There was inconsistent evidence for a change in HDL-c between combination and monotherapy treatments.
Meta-analysis of two statin-fibrate trials demonstrated no significant difference between treatments for LDL-c reduction, but a significant increase in HDL-c of 5 percent favored the combination. There was insufficient evidence on statin-fibrate combination for other outcomes in participants with diabetes mellitus, including one trial that examined mean percentage reduction in triglyceride in 164 participants, with additional mean reduction of 14 percent favoring combination therapy. Due to the rarity of events, evidence was indeterminate and of very low quality for a difference in all-cause mortality with six statin-ezetimibe and one statin-fibrate trial, and evidence for vascular death was absent across all combinations using various statin doses.
Participants with established vascular disease. Absent or insufficient evidence of very low quality precluded meaningful conclusions regarding comparisons of a lower dose of a statin in any of the five combination therapies with higher dose statin monotherapy for any relevant outcomes in individuals with pre-existing vascular disease.
Across various statin doses in combination and monotherapy, there was insufficient evidence examining the statin-fibrate, statin-niacin, statin-BAS, and statin-omega-3 combinations with respect to statin monotherapy. Compared with statin monotherapy, statin-ezetimibe combination therapy allowed more participants to reach ATP III LDL-c goals and to reach 9 to 27 percent additional reduction in LDL-c. No significant difference was noted for change in HDL-c for this combination, and evidence was insufficient for
TC:HDL-c ratio.
Due to the rarity of events, evidence was indeterminate and of very low quality for a difference in all-cause mortality with six statin-ezetimibe and one statin-fibrate trial, and not estimable for vascular death from one short-term statin-niacin trial registering no event.
Participants with baseline LDL-c of 190 mg/dL or above. Absent or insufficient evidence of very low quality precluded meaningful conclusions regarding comparisons of a lower dose of a statin in any of the five combination therapies with higher dose statin monotherapy for any relevant outcomes.
Across various statin doses in combination and monotherapy, no evidence examined the statin-fibrate, statin-niacin, and statin-omega-3 combinations. Compared with statin monotherapy, the statin-ezetimibe combination allowed 17 percent additional reductions in LDL-c. Insufficient evidence for this combination was available for other outcomes.
No significant difference was noted for change in HDL-c with statin-BAS combination, and evidence was inconsistent for a reduction in LDL-c. Insufficient evidence for this combination was available for other outcomes.
Participants with cerebrovascular disease, females, participants of 80 years of age or older, participants of African descent, participants of Asian descent, and Hispanics. No evidence was available for participants with cerebrovascular disease and those age 80 years and over. Sparse evidence of very low quality, precluding meaningful conclusions, was available in subgroups of participants of different ethnic origins and females. However, one large 5-year trial investigating various statins in both treatments among 18,645 Asians resulted in low-quality evidence that there was no significant difference between statin-omega-3 combination and statin monotherapy for the outcome of all-cause mortality.
Applicability of the Body of Evidence
Available evidence
Population. In general, studies excluded participants with statin-associated myopathy, deranged liver enzymes, high triglycerides, recent vascular events, uncontrolled hypertension, and diabetes mellitus and also excluded the frail elderly over 80 years of age. Most trials were in mixed CHD risk populations, employed a prerandomization run-in phase to minimize nonadherence, and conducted frequent laboratory monitoring for liver and muscle enzyme elevations to withdraw participants with deranged levels.
Intervention and comparators. Studies generally employed therapeutic doses of interventions, but few compared the addition of another nonstatin lipid-lowering drug to a statin with the alternative of statin dose escalation.
Outcomes. Clinical outcomes other than evident all-cause mortality were infrequently assessed. Nevertheless, all-cause mortality was a rare event across most trials.
Followup duration. Most trials were of less than 6 months duration.
There is a dearth of evidence directly examining the comparative effectiveness of treatments. Available evidence mostly compared statin combination therapy with similar or equipotent doses of statin monotherapy and examined relative efficacy using surrogate outcomes over a short-term period. Only one large statin-omega-3 trial can be considered an effectiveness trial; however, this trial examined various statins in various doses in combination and as monotherapy. Direct comparative evidence of clinical effectiveness was also lacking from long-term observational studies
Remaining Issues
This review has identified a number of areas requiring future research. Our recommendations address research methodologies in general and specific needs for research to address the key questions.
All trials must clearly report adequate allocation concealment and intention-to-treat analysis. Blinding and endpoint adjudication should be employed to minimize bias. Failure to comply with these standards has adversely affected the quality of trials in this therapeutic area.
Pragmatic trials are required in order to provide relevant guidance to practitioners and patients. In trials of this type, oversampling of populations of interest, including women, ethnic groups, elderly Americans, and persons with diabetes,would help define the relative applicability of the results. Ample evidence supports the role of LDL-c as a determinant of risk as well as a target for therapy. The current data would support investigation of statin-ezetimibe combinations in this regard. Statin-BAS combinations would also be of some interest, although the potential for BAS to interact with other medications by limiting absorption would limit the broad application of these findings. Further research is required to establish the relevance of therapy directed at triglycerides and HDL-c with respect to clinical outcomes. Trials of statin-niacin combination in individuals with low HDL-c in spite of statin therapy and in individuals on maximal statin therapy would serve to define the clinical relevance of these combinations and, at this time, seem more likely to produce relevant data than more broadly inclusive trials for this combination. Similarly, trials of statin-fibrate therapy in individuals with elevated triglycerides are recommended. Omega-3 preparations are variable in content and source, with no clear accepted formulation for individuals requiring intensive lipid lowering. While a number of benefits have been suggested, it is unclear that statin-omega-3 combination preparations have any benefits over higher dose statins in this population based on the negative data to date. Further investigation of these combinations should focus on optimizing the formulations and establishing added clinical benefit when used in maximally treated populations. The following points apply to the proposed trials of combination therapy and serve to amplify these comments in the context of the key questions.
Key Question 1. Long-term benefits and serious adverse events
- The comparator for trials of combination therapy in which LDL-c reduction or clinical events are a major outcome should be a higher dose statin. The bulk of the clinical evidence for this endpoint, as well as clinical endpoints, exists for statin monotherapy. Until a compelling case can be made for a particular combination therapy, comparisons with similar doses of statin monotherapy are unhelpful in resolving the issue.
- Studies of combination therapy should be conducted over longer time periods and be powered for clinical endpoints. Since the lipid-lowering treatment is usually required for life, both trial treatment and observation duration should be of longer duration. The current evidence base lacks trials of this type, significantly limiting the conclusions that can be drawn. The specific duration will be determined by the endpoints and the risk profile of the population studied but, in general, studies of less than 2 years are unlikely to add significantly to the evidence base on clinical outcomes.
- Harms should be prospectively collected and comprehensively reported. Short-duration trials are unlikely to accrue sufficient adverse events, particularly those with longer latency periods, such as cancer.
- As the possibility of harm cannot be excluded for some individuals with symptomatic cerebrovascular disease due to the unique risk for cerebral hemorrhage in these individuals, this population should be specifically studied in order to better define the parameters for those in whom intensive combination therapy is recommended.
- Concomitant and antecedent therapy should be explicitly stated, as both of these factors may influence outcomes. In studies employing a mixture of statin medications and/or doses, results should be reported by medication and dose in order to allow pooling across studies.
- Studies investigating HDL-c and non-HDL-c targets in a population with LDL-c at target are recommended. The absence of such evidence limits the ability to assess the role of combination therapies that raise HDL-c levels.
Key Question 2. LDL-targets, short-term side effects, tolerability, and adherence
- The comparator for trials of combination therapy, with LDL-c reduction as a primary outcome, should be a higher dose statin, as noted above.
- Studies to correlate LDL-c with carotid IMT and clinical outcomes should be conducted in different populations (e.g., participants with diabetes mellitus, CHD, and multiple risk factors as defined by ATP III), with reporting of antecedent therapy, as this may be a determinant of outcome. Such work would help further validate carotid IMT as a suitable surrogate marker for future trials.
- As medication adherence and persistence are important determinants of outcome and are correlated with the complexity of the treatment regimen, studies should be undertaken to compare combinations delivered as a single pill as opposed to two separate ones.
- Measures of adherence and persistence are affected by the duration of the study period, and thus longer term trials are required for combination therapies of lipid-modifying agents. Trial durations of greater than 6 months and preferably 1 year are recommended.
Key Question 3. Benefits and harms within subgroups of patients
- Trials should be conducted in, or oversample, specific subgroups in order to determine relative benefits and harms of a statin combination compared with statin monotherapy. These groups include women, older individuals more susceptible to harms of drug therapy, participants with diabetes mellitus and multiple risk factors, and those of African, Hispanic, and Asian descent.
- Trials including women and the groups identified above should report results in a manner amenable to extraction and pooling in order to permit the early identification of a differential effect in specific subgroups. Specifically, whenever possible, results should be reported by subgroups in trial publications.
We updated the evidence report by rerunning the previous literature search strategy but limiting the search to MEDLINE and EMBASE databases and excluding CENTRAL. Previously, the CENTRAL database identified only 7 percent of retrieved records, none of them unique to CENTRAL. We searched Ovid MEDLINE® from August Week 1, 2008, to May Week 5, 2009, and EMBASE from Week 30, 2008, to Week 23, 2009. While updating the evidence report, we restricted our focus to studies having 24 weeks or longer followup that reported clinical efficacy outcomes, incidence of serious adverse events, and cancer.
Of a total of 1,271 newly identified records, 25 met the original inclusion criteria. (An updated search flow chart is shown in Appendix K of the full report.) Of these, 20 records were further excluded, as they either did not report clinical outcomes or had durations of followup shorter than 24 weeks. Furthermore, two more studies, one that employed a statin not marketed in the United States and another that failed to report relevant outcomes by treatment groups, were also excluded.
Finally, the three remaining studies were included for evidence update (Appendix K of full report). These were randomized controlled trial reports, two of which were companion reports of previously included reports, contributing no new relevant data. Thus, only one trial provided evidence on a clinical outcome of interest over a minimum period of 24 weeks. In this 56-week trial of 100 participants of mostly European descent with established carotid artery stenosis, one individual in the 80 mg/day simvastatin monotherapy group experienced an acute coronary event, as opposed to none in the 20 mg/day simvastatin monotherapy and 20 mg/day simvastatin plus 2 g/day niacin extended-release combination groups.
Overall, the update of this review did not add new meaningful evidence on longer term clinical outcomes, serious adverse events, or cancer to the report.
|Key Question
|Strength of Evidence (GRADE)
1 Because of scant evidence for those in need of intensive lipid lowering, SAE was examined across all trial populations
Abbreviations: ATP III=Adult Treatment Panel III (of the National Cholesterol Education Program); GRADE=Grading of Recommendations Assessment, Develop ment and Evaluation; LDL-c=low-density lipoprotein cholesterol; SAE=serious adverse events.
|Key Question 1. For patients who require intensive lipid-modifying therapy, what are the comparative long-term benefits and rates of serious adverse events of co-administration of different lipid-modifying agents (i.e., a statin plus another lipid-modifying agent) compared with higher dose statin monotherapy?
|All-cause mortality
|Very low
|Vascular death
|No evidence was available for any statin combination vs. higher dose statin monotherapy.
|Serious1 adverse events
|Very low
|Up to a maximum followup of 24 weeks, no intervention was significantly safer when statin-ezetimibe combination was compared with higher dose statin monotherapy. No evidence was available for other combinations.
|Key Question 2. Do these regimens differ in reaching LDL targets (or other surrogate markers), short-term side effects, tolerability, and/or adherence?
|Attainment of ATP III LDL-c goals
|Very low
|Key Question 3. Compared with higher dose statins and to one another, do combination regimens differ in benefits and harms within subgroups of patients?
|All-cause mortality, vascular death, and attainment of ATP III LDL-c goals
|Very low
|There is insufficient evidence to draw any meaningful conclusions in subgroups for any combination.
|Serious adverse events
|Since absent to scant subgroup evidence was anticipated, SAE was examined across all trial populations (see above).
|Inter-combination, indirect comparison of syntheses
|We are unable to confirm a difference in benefits or harms between combinations due to the lack of evidence.


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GUEST ARTIST – JON MULVEY (Guitars, Recording Engineer, Producer)
Jon Mulvey hails from Los Angeles, California, where he picked up his first guitar when he was just seven years old. Formal Jazz guitar training started at age 11 and he began touring internationally at 15 with top acts. He earned a music composition degree in the Bay Area and then studied under guitar great Joe Satriani. After vaulting onto the world stage, Jon directed his expertise to the studio, where he has participated in over 1500 recordings. But playing guitar, bass, or keys, as well as engineering, producing, and mastering albums in the studio, are only a few of his talents.
For ten years he was a member of Mingus, with Dorian Mingus (son of legendary Jazz Bassist/Composer Charles Mingus). Mingus recorded Jon's music on the Mingus label Debut Records. Now, Jon combines his formidable training with innate talent to help shape his projects' unique sounds, which include world fusion band Vortex Tribe, acoustic world Due Cuori, rock'n Jon Mulvey's Rockethouse and his other solo projects. Jon has recently joined Davey Pattison (vocalist for Robin Trower and Gamma) as lead guitarist. He is also a sponsored clinician for EMG Pickups and Ibanez Guitars.

subset: commoncrawl


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FRITZ!Box 7340 – Service - Knowledge Base
AVM Content
Registering FRITZ!DECT with the FRITZ!Box
The switchable socket FRITZ!DECT is integrated into your home network via an encrypted DECT connection. Once it is registered, you can configure and operate FRITZ!DECT under "Home Network > Smart Home" in the FRITZ!Box user interface.
Requirements / Restrictions
- A maximum of ten switchable sockets can be registered with the FRITZ!Box.
1 Registering FRITZ!DECT
In order for automatic registration to work, you must set the PIN to "0000" under "DECT > Base Station" in the FRITZ!Box user interface:
- Plug FRITZ!DECT into an outlet near the FRITZ!Box.
- The "DECT" LED begins to flash steadily.
- Now push the "DECT" button on the FRITZ!Box within 2 minutes. Hold down the button for at least 6 seconds until the "DECT" or "Info" LED on the FRITZ!Box begins to flash.
Now FRITZ!DECT automatically registers itself with the FRITZ!Box. The "DECT" LED on FRITZ!DECT remains lit as soon as the DECT connection has been established. After the connection is established, the FRITZ!Box checks whether new firmware is available for FRITZ!DECT. If a new version of the firmware is found, it is updated immediately. The update procedure is completed as soon as the LEDs on FRITZ!DECT stop flashing. This process may take several minutes.


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Posted by Chris Mines on April 26, 2011
Not that there's anything wrong with that. We have long maintained that IT organizations and the CIOs that lead them will increasingly be the owner and operator of environmental systems of record, just as they are for financial, HR, and customer data systems, among others. But, ITfS suppliers will want to develop multiple pathways into customer organizations. For most, decision-making around sustainability processes and technologies is diffuse, spread across IT, facilities, operations and CSR. Finding the buyer for sustainability is oft-times the proverbial needle in the haystack.
Posted by Chris Mines on April 8, 2011
Both are prominently featuring "energy" in their messaging in keeping with the current customer focus on that side of the consumption/emissions coupling. And both are emphasizing a combination of software products and consulting services, the two segments of the market that we at Forrester have been tracking for some time now, as regular readers of this blog know by now.
But under the surface there are more differences than similarities in the approach that these two suppliers are taking to ITfS; differences that illuminate divergent strategies, philosophies, and experiences between them. Let's take a closer look.
HP is going broad; IBM is narrowing its focus. With its initial "Energy and Sustainability Management Services" entry, HP is leveraging its data center design and implementation expertise into buildings and other assets across the enterprise. It is stressing a holistic, top-down approach, starting with assessment workshops and other methods to help customers get their arms around the size and shape of the energy/carbon/resource issues.


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Volume VII, No. 7
What's inside...
What's New
- From the U.S. Department of Education
- From the Office of Innovation and Improvement
- American Recovery and Reinvestment Act
- American History
- Arts Education
- Charter Schools/Choice
- Closing the Achievement Gap
- Leadership
- Teacher Quality and Development
- Charter Schools/Choice
- Raising Student Achievement
- School Improvement
- Teacher Quality and Development
- Technology in Education
Hopes for the i3 Fund and OII: A Conversation with OII's New Assistant Deputy Secretary
James H. Shelton III became deputy assistant secretary of the Office of Innovation and Improvement (OII) this past March, where he manages a portfolio that includes most of the Department's competitive teacher quality, school choice, and learning technology programs, as well as programs in the arts, American history, and parental involvement. Shelton was previously a program director for the education division of the Bill & Melinda Gates Foundation, where he managed the Foundation's national programs and work in the northeast region of the United States. He has also been a partner in the NewSchools Venture Fund and co-founded LearnNow, a school management company that later was acquired by Edison Schools. Shelton holds a bachelor's degree in computer science from Atlanta's Morehouse College as well as master's degrees in business and education from Stanford University.
The Office of Innovation and Improvement (OII) is the home for the Department's Investing in Innovation initiative, known more commonly as i3, a $650 million fund authorized under the American Recovery and Reinvestment Act (ARRA). This initiative will award grants in 2010 to local education agencies and nonprofit organizations, and is intended, in the words of Secretary Arne Duncan, to "create robust incentives to expand what works, invest in promising practices, and boldly innovate."
In the interview that follows, Jim Shelton discusses the key tenets of the new i3 fund and shares his perspective on the role of innovation in schools and the role of OII in fostering and supporting innovation.
Innovator: Secretary Duncan, in his speech, "From Compliance to Innovation," last month said the i3 program will help to build a framework for innovation for the future and help us to realize the once-in-a-lifetime opportunity we have to accomplish real reform in education. How specifically will i3 accomplish that?
Shelton: It will do it in two ways. First, by the original name that it was given it in the legislation, "Invest in What Works and Innovation," i3 grantees will be working simultaneously at several points on an innovation continuum. In the competition and the awards we make, we'll create space for things that have really strong evidence of success and are ready for replication or adaptation elsewhere. There will also be support for programs in need of more evidence or perhaps the capacity of the innovator to take it to scale. And, finally, there'll also be space for new ideas, ones that need greater substantiation of their outcomes, to be tried. Specifically, the three levels are:
- The smallest grants of up to about $5 million dollars will be for promising ideas that should be tried.
- Medium-size grants of up to roughly $30 million will help programs that need to build a research base or organizational capacity to succeed at a larger scale.
- The largest grants that will go as high as $50 million for proven programs that are ready to grow and expand.
Second, we'll ask applicants to think differently about how they scale their impact. We are going to be pushing people by asking, "How can you take what you have and figure out how it could impact hundreds of thousands, even millions, of children, as opposed to the thousands it may be touching right now?"
Innovator: What deliverables do you see from the investments that the i3 program will make in innovation?
Shelton: We envision as many as five, ranging from demonstrating, validating, and codifying promising, evidence-supported models to expanding proven and scalable models both regionally and nationally, depending on the individual work of the grantees in the three-tiered structure of the program.
Innovator: Do you then foresee innovations going to scale not just within a single district but across districts and other jurisdictional lines?
Shelton: Absolutely. Whether it's a 200,000-student district or one with just 2,000 students, the most important thing for them to consider is, "How will what I am doing here today, if effective, really impact the broader field?" In fact, the 2,000-student district may even have an advantage in this circumstance because there are a lot more 2,000-student districts than there are 200,000-student districts. But it means they have to really think, "What are we doing that's going to produce knowledge or tools and resources that can have a broad impact on the field?"
Innovator: It's also the case that the i3 program will put a premium on partnerships between the public and private sectors, and bring in strategic investments of resources from foundations alongside the federal, state, and local education funds behind these new projects. Having come from the nonprofit foundation realm, you must have thoughts on how schools and districts can successfully search out private-sector partners.
Shelton: I do and, in fact, am working with some of the OII staff to create a virtual space where the public can submit and comment on ideas to improve education and also look for potential partners from the public and private sectors. The ideas and search for partners can certainly be focused on plans to apply to the i3 fund, but we intend for the site to serve the broader, longer-term purpose of catalyzing innovation whether or not direct federal support is involved.
Innovator: What role will the four assurances, the core reforms embedded in ARRA, play in the i3 fund?
Shelton: We will be looking, although not exclusively, for projects that will advance the four core reforms. We also plan, however, for the i3 program to bolster efforts in other important areas of the President's education agenda, most notably improvement in early learning, college readiness, and better serving schools and students in rural districts. We also hope to see expanded efforts to make better use of the school day and year.
Innovator: Like Race to the Top (RTT), the public can weigh in on the i3 guidelines before they are finalized and applications are solicited. How will that work?
Shelton: A notice of proposed priorities, requirements, definitions, and selection criteria for i3 will be published in the Federal Register in the coming weeks and, as it was with RTT, the public has 30 days to provide the Department with comments. We really want to hear from folks who are involved with education innovation from the school and district levels, researchers and program evaluators, private foundations and nonprofits involved in preK-12 education, and other stakeholders. We want to get this right, but because the i3 grants need to be announced next year, we apologize for the relatively short comment period.
Innovator: Beyond the impact that you hope i3 will have in the next five years, what do you think needs to happen in education innovation that will enable the transformational change that Secretary Duncan has called for in K-12 education?
Shelton: I have to go back to the Secretary's metaphor when he spoke about this at the America's Choice Superintendent's Symposium. He likened this time of extraordinary opportunity created by ARRA to education reform's moon shot – the one chance in a lifetime to make fundamental changes throughout the K-12, actually pre-K to 16, system nationwide.
I'm encouraging all the districts and states to forget about the i3 and Race to the Top funds for a second and think about several essential questions: How do we leverage the core stimulus dollars as investment dollars for transformation? What kind of systems are we going to need four years from now to meet the new expectations that come with educating children and youth in the 21st century, as well as the ones that have bedeviled us for far too long, such as high dropout and lagging achievement levels and declining graduation rates? And, to complicate the challenge even more, how can we achieve this transformation with even fewer resources? I say that because state and district leaders in many instances are looking ahead and not seeing dramatic increases in revenues; in some cases, what they foresee are continued declines in budgets. That's why we all have to strategically use the stimulus dollars as a one-time investment for transformation. If not, we run the risk of putting ourselves, not even four years from now, at the edge of a cliff, finding that we need to do transformative work and having no money to do it.
Innovator: While i3 is rightfully getting lots of attention presently, you're now managing an important collection of competitive grant programs that constitute OII. What's your perspective on these programs and your hopes for OII?
Shelton: OII has a really broad mandate. I would define our objectives in two categories. One is that we want to invest in the creation of breakthrough models that are going to change outcomes for students, teachers, and productivity. And we'll do that through all the funding instruments that we have, from the new work supported by i3, to pushing on the charter front to get more innovation in that growing part of the field, to teacher quality and teacher recruitment grants. I also see us looking to our arts and financial-literary programs for opportunities to push the envelope and really craft solutions that drive a different level of academic achievement and school performance. The second major objective is to make systemic changes to foster innovation in education. We want to lead, along with our partners at the Institute for Education Sciences and the rest of the department, and also work in partnership with folks on the outside, to transform the education ecosystem in order to foster, in a short period of time, a systemic approach to innovation.
Innovator: Your professional background combines several areas that are strategically linked to the things you see that need to be done and also to stakeholders in both the public and private sectors you think need to be partners in getting the work accomplished. How do you see your past experiences informing your new role in OII?
Shelton: I'm feeling fortunate that a lot of things I've done are coming together nicely to support the work I'm doing now. Much of my current work is about best practices, new processes, and making tradeoffs as well as difficult decisions in changing environments. My work in both nonprofit and for-profit investing, in consulting with both public education and private enterprise, and even the computer systems development work I did at the beginning of my career – I find that I'm using all of it.
But what's so different is the combination of the potential to make a difference at a national level and the tremendous responsibility I feel in helping OII and the agency to realize that potential. On one of my first days on the job, someone had just talked to me about Idaho and Montana, and I realized that the future of all the kids in the United Sates and its territories are the concern of me, the OII staff, and all of us at the department. My job has gone from trying to have influence on this federal entity that's supposed to serve all these folks to being responsible for what can and should be a cutting-edge part of that entity. It's a weighty responsibility and a great challenge for me and the OII team. I feel really honored to be in this role.
What's New
From the U.S. Department of Education
On September 8, President Barack Obama delivered a national address to the students of America. During the special address, the president spoke directly to the nation's children and youth about persisting and succeeding in school. The president challenged students to work hard, set educational goals, and take responsibility for their learning. The Department of Education's Web site offers educators ideas for classroom activities for grades preK-6 and 7-12 created by its teachers-in-residence, the Teaching Ambassador Fellows, to help stimulate classroom discussion about the importance of education. (Sept. 2009)
The Department also launched the "I Am What I Learn" video contest. Students can respond to the President's challenge by creating videos describing the steps they will take to improve their education and the role education will play in fulfilling their dreams. All students age 13 and older are asked to create and upload their videos to YouTube by October 8; entries may be in the form of video blogs, public service announcements, music videos, or documentaries. The general public will then vote on their favorites to determine the top 20 finalists. These 20 videos will be reviewed by a panel of judges, including Secretary of Education Arne Duncan. The panel will select three winners, each of whom will receive a $1,000 prize. (Sept. 2009)
President Obama released his Strategy for American Innovation, which calls for investment in building blocks that will ensure the American economy has all the necessary tools for successful innovation. Among them is reforming public schools to deliver a complete and competitive education. (Sept. 2009)
Secretary of Education Arne Duncan and Jim Shelton, Assistant Deputy Secretary for Innovation and Improvement, addressed district superintendents and nonprofit leaders on August 20 about the importance of innovation in education. The Secretary discussed the historic role of innovation and the need for new ideas to support the Department's moon shot goal – producing the highest proportion of college graduates in the world by the end of the next decade. (August 2009)
Secretary Duncan will be joined by former House Speaker Newt Gingrich and civil rights leader Rev. Al Sharpton on a four-city tour to highlight the Obama administration's efforts to reform public education, spur innovation, and discuss challenges facing America's school systems. An outgrowth of their meeting with President Obama last spring, the tour will include school visits, stakeholder meetings, and media briefings, and is expected to stimulate discussion and community engagement around issues of education reform. Tour sites include Philadelphia on Sept. 29, New Orleans on Nov. 3, and Baltimore on Nov. 13. More stops, including a rural site, will be added as the tour progresses. (August 2009)
The latest release of the International Assessments of Student Achievement, the Programme for International Student Assessment (PISA), results are "another wake-up call that our students are treading the waters of academic achievement while other countries' students are swimming faster and farther," according to Secretary Arne Duncan. "Our students have stagnated educationally, putting our long-term economic security at risk." In his statement, the Secretary specifically pointed to the fact that math scores of America's 15-year-olds now lag behind those of 31 countries, and that American eighth graders' science scores are now trailing those of their peers in eight countries. "We've never settled for second best," Secretary Duncan observed, "and now we're in another race of sorts – a race to the top tier of the world's students whose academic achievement is the best and the brightest." (August 2009)
Despite busy schedules and summer heat, many Cabinet members and senior administration officials joined Secretary Duncan for "Read to the Top!." the Department's weekly reading initiative, during June, July, and August. For 12 weeks, Secretary Duncan and 15 Cabinet members and other senior administration officials brought books to life for the more than 1,200 children who gathered under shady trees on the Department's plaza to listen to the stories and ask questions. Even the "First Grandmother" of the United States, Marian Robinson, stopped by to read to the children who had many questions for her.(August 2009)
On August 18, Secretary Duncan addressed several thousand arts education advocates via a teleconference that focused on the role of the arts in a complete education. The Secretary expressed his concerns about access to arts education in U.S. public schools and noted several ways that K-12 arts programs can be supported in the future. The nationwide call followed the release of a letter PDF-[3.84KB] to school and education community leaders about the arts in schools. "The Elementary and Secondary Education Act (ESEA) defines the arts as a core subject," the Secretary wrote, "and the arts play a significant role in children's development and learning process." (August 2009)
Secretary Duncan continued his "Listening and Learning" tour on September 15 with a special town hall meeting to begin the new season of the Department's "Education News Parents Can Use" television broadcast. In this "America Goes Back to School" edition of the show, Secretary Duncan engaged parents from across the nation in a live, interactive discussion via telephone, e-mail, and video. The Secretary has visited more than half of the states to date, meeting with hundreds of students, parents, teachers, principals, education support staff, superintendents, professors, higher education administrators, and community leaders, and has engaged them in a conversation about federal education policy in anticipation of the reauthorization of the No Child Left Behind Act. To watch the archived broadcast, go to http://www.connectlive.com/events/ednews. (Sept. 2009)
The National Center for Education Statistics' Back to School Forecast notes more students are entering and returning to America's schools and colleges than ever before. In fall 2009, a record of nearly 49.8 million students will attend public elementary and secondary schools. Of these, almost 35 million will be in prekindergarten through 8th grade and 14.8 million in grades 9 through 12.(Sept. 2009)
From the Office of Innovation and Improvement
And the winner is…children's literacy by way of innovative television programs supported by OII's Ready To Learn Partnership. Between the Lions, a multimedia educational initiative for children ages three to seven, and WordWorld PDF-[25.6KB], which empowers preschoolers to read, won a combined four top awards at the 36th Annual Daytime Emmy Awards ceremony. Now in its ninth season, Between the Lions won Emmys for both Outstanding Pre-School Children's Series and Outstanding Writing in a Children's Series. WordWorld, launched in July 2007, was honored for both Outstanding Children's Animated Program and Outstanding Writing in Animation. Sesame Street received a Lifetime Achievement Award as well as four other Emmys, including one for New Approaches in the Daytime Children's category that recognizes the use of new media such as Web sites and interactivity. Cookie Monster, helping to accept the Lifetime Achievement Award, declared it both an honor and delicious as he devoured the golden statue. (August 2009)
American Recovery and Reinvestment Act
Secretary of Education Arne Duncan called on the nation to turn around thousands of underperforming schools. In announcing draft requirements for $3.5 billion in Title I School Improvement grants, the Secretary joined U.S. Senator Harry Reid at Harley Harmon Elementary School in Las Vegas. "If we are to put an end to stubborn cycles of poverty and social failure…" according to Secretary Duncan, "we must address the needs of children who have long been ignored and marginalized in chronically low-achieving schools." (August 2009)
In early August, Secretary Duncan announced the availability to states of $11.37 billion in Title I, IDEA, and Vocational Rehabilitation (VR) funding as part of ARRA, which was 30 days ahead of schedule and in response to President Obama's direction to Cabinet members to pick up the pace of the Recovery Act implementation. (August 3, 2009)
The Council of Chief State School Officers, on behalf of the National Center for Education Statistics, is hosting a series of WebEx information sessions PDF-[74.8KB] for states planning to apply for Statewide Longitudinal Data System (SLDS) grants. The last of the series of three sessions is scheduled for October 5, 2009, from 12:00-1:30 p.m. (EST). Participants will receive an overview of the FY09 SLDS competition and opportunity for questions and answers. (August 2009)
American History
The Advisory Council on Historic Preservation presented its Award for Federal Preserve America Accomplishment PDF-[332KB] to the National Park Service for its integral role in the service learning project, Of the Student, By the Student, For the Student, at Harpers Ferry National Historical Park. The Park Service combined efforts with the Journey Through Hallowed Ground Partnership and the Harpers Ferry Middle School to help students to create six vodcasts that provide a middle-school perspective on the John Brown Raid. Walking in the footsteps of the raiders, and using the places where the raid occurred and primary historic documents, students interpreted the significance of the John Brown Raid to their peers. The vodcasts will be seen by visitors to Harpers Ferry National Historical Park. (August 2009)
Arts Education
MusicianCorps, a domestic "musical Peace Corps," sponsored by the nonprofit Music National Service, is up and running in four cities. Talented musicians are recruited, trained, and placed in under-resourced schools, low-income communities, and health care settings, where they will provide music learning and mentoring experiences for at-risk youth. The inaugural cities are New Orleans, the San Francisco Bay area, Seattle and Chicago. Musician Corps Fellows receive a modest living stipend, professional development, and health care in return for their full-time service commitment. (August 2009)
The Kennedy Center's Education Department launched Any Given Child to assist communities nationwide in strengthening and expanding arts education opportunities for students. The goal is to ensure that all young people in the community have access to a complete, affordable arts education. Participating communities will begin by assessing existing arts resources in the schools as well as programs offered by local organizations and then develop long-range plans for arts education in each community. The Center plans to bring its staff and consultants to work with community leaders and school administrators.
Charter Schools/Choice
Nearly two-thirds of Americans favor charter schools, according to the latest Phi Delta Kappa/Gallup Poll, which sampled more than 1,000 adults on a wide range of education topics that included both their support for public charters and their understanding of several specific characteristics of charter schools. A majority of respondents, for instance, wrongly assumed that charter schools charge tuition and 71 percent didn't know that charters have open enrollment policies. Other topics addressed in the annual survey include early childhood education, teacher pay, and high school dropouts. (Sept. 2009)
Public School Choice News provides links to research, policy, and tools for the implementation and improvement of public school choice. The e-newsletter, developed through BuildingChoice.org, a Web site funded by OII, features news and information related to ARRA as well as a wide range of public school choice resources. To subscribe, visit the Public School Choice News subscription page. (August 2009)
Closing the Achievement Gap
The Aldine Independent School District(AISD) outside Houston won the 2009 Broad Prize for Urban Education PDF-[178KB], the largest education award in the country, and as a result will receive $1 million in college scholarships from The Eli and Edythe Broad Foundation. Aldine, where a majority of students qualify for free and reduced-price meals, has "shown some of the most consistent student achievement gains nationally in the last decade and has been recognized as one of the top five most improved urban American school systems in four of the last six years." Other finalist districts for the 2009 prize were Broward County Public Schools in Florida; Gwinnett County Public Schools outside Atlanta (see "Innovations in the News."); the Long Beach Unified School District in California; and Socorro Independent School District in Texas. (Sept. 2009)
A combination of educational and social barriers, including family care-taking responsibilities, poor academic preparation, and gender stereotyping, are causing Latina students to drop out of high school, according to a new study by the National Women's Law Center and the Mexican American Legal Defense and Educational Fund. The two organizations used surveys, interviews, and focus groups to concentrate on high school issues encountered by Latinas. The study was prompted in part by an earlier law center report concerning girls' graduation rates that revealed disproportionally high dropout rates for Latinas. Researchers reported a substantial gap between Latinas' educational goals and their personal expectations about reaching those goals. (August 2009)
More than 1.5 million students in the class of 2009 took the SAT, the most college-bound students of any graduating class and the most diverse annual group of students to take the college admission exam, according to the College Board. Forty percent of the 2009 SAT takers were minority students, a more than 10 percent increase in that group since 1999, when minority students constituted only 29 percent of the test takers. (August 2009)
A study PDF-[1.37MB] by New York University's Institute for Education and Social Policy indicates that students in elementary and middle schools led by graduates of the city's Aspiring Principals Program made gains in English-language arts at a faster pace than students in schools headed by new principals who did not attend the program. Run by the New York City Leadership Academy, the program teaches turnaround strategies and has trained about 15 percent of the city's principal corps. (August 2009)
Teacher Quality and Development
The talents of great teachers appear to have a positive effect on their peers, according to a study in which researchers reviewed 11 years of North Carolina school data and found results suggesting that high-performing teachers' abilities not only resulted in better student performance in their classrooms, but in other classrooms at the same grade level. "If it's true that teachers are learning from their peers, and the effects are not small, then we want to make sure that any incentive system we put in place is going to be fostering that and not preventing it," said C. Kirabo Jackson of Cornell University, a co-author of the study. (Sept. 2009)
Innovations in the News
Charter Schools/Choice
The mayor of St. Louis is looking for a few good schools that will address the unmet needs of students whose present schools are performing poorly. Based on the results of a recent study that compared performance of both district and charter schools by ZIP code, Mayor Francis Slay wants to strategically locate new charter schools in neighborhoods with the least access to good public schools. The mayor's office plans to invite local and national charter groups to propose new schools in six neighborhoods targeted by the study. [More—The St. Louis Post-Dispatch] (Sept. 1)
Nineteen organizations are proposing to open as many as 23 new public charter schools in Louisiana in the 2010-2011 school year. Twenty of the applications submitted last month to the Louisiana Department of Education are for traditional brick-and-mortar buildings and three are for virtual schools. The National Association of Charter School Authorizers will screen the applicants and make recommendations to the state Board of Elementary and Secondary Education later this fall. [More—The Advocate (Baton Rouge, La.)] (August 31)
Raising Student Achievement
A committee of the National Science Board has convened to consider ways for schools to produce students with the ability to innovate in science, technology, engineering, and mathematics. "Innovators are a bit of a different breed," according to Camilla P. Benbow, a science-board member, who said the committee will consider what the needs of innovators are, and how schools can address those needs. [More—Education Week] (September 2) (paid subscription required)
Urban Academy, one of five new alternative high schools in Newark, is offering potential dropouts a set of possibilities for achieving their diplomas, including online courses, evening classes, and internships. The Academy is part of a network, the Alternative High School Initiative, which began six years ago with support from the Bill & Melinda Gates Foundation and the National League of Cities, and is also operating in Nashville and Indianapolis. The Urban Academy's new comprehensive program replaces the district's former Twilight program, which only provided night courses for dropouts. [More—The Star-Ledger (Newark, N.J.)] (Sept. 1)
Students attending the new City Polytechnic High School of Engineering, Architecture, and Technology in Brooklyn will be able to earn both their high school diplomas and college associate degrees in five years. The school, the first of its kind in New York City, operates on a trimester schedule and blends a career and technical education curriculum with advanced coursework that permits students to complete high school graduation requirements in three years. [More—The Brooklyn (NY) Daily Eagle] (August 31)
In Baltimore, students at risk of dropping out of high school now have a new option – the accelerator school, which provides a concentrated version of high school in two years. Students ages 14 to 21 are eligible to attend, but must participate in a lengthy interview process and agree to abide by a set of strict rules that include a ban on cell phones in school. The Open Society Institute provided a grant to help the new schools get underway. [More—The Baltimore Sun] (August 31)
Schools in Arizona and Florida's Brevard County have adopted two similar approaches to ensuring that students in as early as elementary school are setting their sights on and preparing for college. At the Kyrene de los Niños Elementary School in Tempe, Arizona, the college-prep culture is evident from the pennants that adorn the school's lobby to the visits by college students who share their experiences and advice on degrees and paying for college. Niños is part of the No Excuses University Network, which is based in California. Nine schools in Brevard County are part of AVID, Advancement Via Individual Determination, which focuses on seventh through 12th grades and includes courses at each grade level in college-success skills. Participating students are recruited in sixth grade and, with their parents, sign contracts that address expectations for their GPAs and homework. [More—The Arizona Republic and Florida Today (Melbourne)] (Sept.1 and August 26)
Advanced Placement scores of students participating in the Massachusetts Math and Science Initiative (MMSI) increased by 39 percent, 11 times greater than non-participants. The program is supported by a national math and science coalition that includes ExxonMobil, the Bill & Melinda Gates Foundation, and the Dell Foundation. Twelve additional high schools in the state will join MMSI this school year, and the program is expected to involve nearly 100 schools and more than 37,000 students by 2013. [More—The State House News Service (MA)] (August 28)
Report cards for Miles Elementary School students in Kentucky will be dramatically different this year; A's and B's will be replaced by standards that are set by teachers and students. An example for second graders: In the first quarter of the year, students will be able to identify whether two- and three-digit numbers are odd and even. Students' performance will be rated in five categories, ranging from no progress to above standards, and teachers will judge progress and achievement using rubrics they developed as part of a professional development phase of preparing for the new countywide grading system. Parents have also been involved in the system's development. [More—The Cincinnati Enquirer] (August 24)
School Improvement
Researchers at the University of Illinois studied data from the National Educational Longitudinal Study concerning tenth graders at nearly 700 U.S. high schools, and found that "classroom disruptions and psychologically hostile school environments can contribute to a climate in which good students have difficulty learning and students who are behind have trouble catching up."Students' fear for their physical safety was relatively low, according to the researchers, but 70 percent of the students reported being negatively affected by classroom disruptions, and 20 percent reported being put down by peers. School environments that protect students from physical harm cannot be assumed to also protect them from emotional harm, the researchers reported. [More—Science Daily] (Sept. 2)
Cleveland's "innovation" schools are celebrating a successful year in which, as a group, the eight schools earned impressive grades on their school report cards. The schools have either no or flexible admission requirements, and differ from other schools in Cleveland by virtue of their small size, autonomy to shape their curriculum and extend the school day, the ability of principals to hire from outside the city and ignore seniority, and agreements with the Cleveland Teachers Union that give the schools what the union calls management rights. [More—The Plain Dealer (OH)] (Sept. 1)
Wisconsin is replacing its longstanding statewide test with a system that will combine assessments at the state, district, and classroom levels, according to state superintendent Tony Evers. The move is applauded by the state's associations of school districts and local school boards as well as the largest teachers union in the state. Recommended by a task force that studied statewide tests, the new set of tests will be computer-based and will provide multiple opportunities for gauging student progress throughout the year. [More—The AP] (August 27)
"Staying true to one program and giving it time to take root is the key," according to Valarie Lewis, assistant principal at New York City's Osmond A. Church School, which received a three-year, $784,000 grant 10 years ago and used it to develop and carry out a comprehensive reform plan. Since that initial investment, the consistent use of a portion of Title I funds to support the school's choice of Core Knowledge as the center of its reform, as well as avoiding fads and quick fixes, has led to success, including a national award from the Education Trust. [More—The Christian Science Monitor] (August 26)
Gwinnett Schools, Georgia's largest school district, has used the flexibility given to it by the state in exchange for greater accountability to earn a finalist spot for the coveted Broad Prize (see "What's New"), which recognizes urban school systems that demonstrate marked gains in student performance and reduction in the achievement gap among low-income and minority students. While Gwinnett school officials await word from the Broad Foundation, the district was named as a potential stop on a new national tour (see "What's New") by former U.S. House Speaker Newt Gingrich and the Rev. Al Sharpton to showcase districts that are showing promise in school reform. [More—The Atlanta Journal-Constitution] (August 25)
Teacher Quality and Development
New teachers in Bridgewater, Mass., are feeling confident about their assignments thanks to the Teachers for a New Era Partnership that included a new teacher workshop led by veteran teachers and will be followed by seven two-hour mentoring opportunities during the school year. Bridgewater State College and Boston College, with support from the Carnegie Foundation, sponsor the Partnership, which also provides a graduate course for veteran teachers to help them become more effective mentors to new teachers. [More—The Boston Globe] (August 30)
In Washington, DC, teachers started the new school year with a detailed set of guidelines and strategies, the "DCPS Teaching and Learning Framework," that specifies the expectations for highly skilled teachers. For example, a highly skilled teacher should, within 30 minutes of class time, respond to students' correct answers by "probing for higher-level understanding" of the idea under discussion. A corps of "master teachers" will assist principals in assessing their teachers based on the new framework. [More—The Washington Post] (August 23)
Technology in Education
South Dakota, Maine, and Wyoming lead the nation in the percentages of their students that have one-to-one, or ubiquitous, computing programs in their schools, according to Project RED: Revolutionizing Education, led by a group of education technology researchers and market analysts. The national database compiled by Project RED reveals a national average of just over five percent of the nation's schools with ubiquitous technology programs, affecting approximately four percent of American students. [More—eSchool News] (Sept. 1)
Students at Chesapeake High School in Maryland can now bring real-world situations in environmental science and geometry into the classroom using 3-D simulations. The Johns Hopkins University's Center for Technology in Education, Lockheed Martin, and Northrop Grumman are partnering with the county schools in the creation of the $2 million virtual laboratory. The laboratory is modeled in part on the Hopkins' Applied Physics Laboratory and students can communicate remotely with Lockheed and Northrop engineers. [More—The Baltimore Sun] (Sept. 2)
Despite the current economic climate and resulting school budget shortages, schools in Maine are expanding the state's commitment to providing laptops for every student. Begun in 2002, the Maine Learning Technology Initiative (MLTI) initially targeted 7th and 8th graders. Now MLTI is expanding the effort to high schools, with state funding to install wireless-network infrastructures and school-level purchases of laptops. Half of the state's high schools are expected to participate in the first year of the MLTI expansion. [More—Education Week] (Sept. 2) (premium article access compliments of EdWeek.org)
School leaders in Trussville, Ala., believe that more is better when it comes to students accessing the Internet, including the use of online social networking sites that most other districts declare off-limits for classrooms. "We know kids use these tools, so we really feel obligated to help kids use them right and prepare them for what they face in the world every day," said Trussville superintendent Suzanne Freeman. Access is incrementally expanded as students move through the grade levels and encounter the need for increasingly complex educational content. The approach is in line with advice from media experts and guidance from the American Library Association's Center for Intellectual Freedom. [More—Education Week] (Sept. 2) (paid subscription required)
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The Spencer County High School Boys' Basketball Team could possibly be a contender for the 8th region crown this season. What are your thoughts? Have you seen the team in action? What are some of the team's strengths and weaknesses?


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Coffee Bean International® Launches Redesigned Website
Coffee Bean International today announced the launch of its newly designed website at www.coffeebeanintl.com. The improved and expanded site features more robust content and additional resources that demonstrate the quality, innovation and services offered by one of the nation's leading private brand specialty coffee roasters.
Features include a behind-the-scenes video tour of Coffee Bean International's state-of-the-art LEED® Silver certified facility. Viewers witness the Portland-based company's use of small-batch roasting and the latest packaging technology to produce authentic specialty coffee. They see the well-engineered process of moving green coffee from burlap sacks to freshly roasted beans, packed and ready to ship to customers of all sizes. This video and other content was developed to better communicate the company's expertise in coffee sourcing, artisan roasting, and helping clients build and grow their businesses into top specialty coffee destinations.
"Our site now offers customers and partners a view into our roastery, as well as a more complete picture of our capabilities as a full-service partner across the three distinct channels we operate in," said Joe Prewett, Vice President of Marketing at Coffee Bean International.
The new website features are organized to provide quick and direct access to resources for private label retail buyers, restaurant coffee buyers and coffee house owner/operators.
- For grocery buyers, restaurateurs and coffeehouse owners, the site articulates Coffee Bean International's expertise at developing turnkey private brand or branded coffee programs, including their process of developing a dynamic and profitable presence on the shelf or menu.
- Viewers discover how Coffee Bean International's partnership approach can translate their brand into a custom coffee program that complements their concept, enhances margins, and offers an exciting line-up of award-winning specialty certified organic, fair trade and direct trade coffees.
- A company blog "Coffee's On!" offers news and stories from abroad, and industry insight from the company's team of experts, including Roastmaster Paul Thornton, Product Innovation Manager Sarah Beaubien, Vice President of Marketing Joe Prewett, and Vice President of Coffee Culture Bruce Mullins, among others.
About Coffee Bean International, Inc.
Founded in 1972, Coffee Bean International is a visionary coffee company in the heart of the Pacific Northwest. As one of North America's first roasters of specialty coffee, its unwavering commitment to handcrafted quality and sustainable business practices has earned it respect and a place among the coffee industry's premier roaster/wholesalers. Coffee Bean International serves more than 2,000 active customers, including many independent specialty coffee retailers and prestigious larger, quality-oriented chains. Coffee Bean International operates out of a LEED® Silver certified roasting facility and invests in partnerships, direct trade and certification programs which support improving coffee quality and coffee growers' lives and communities world-wide. For more information, visit us online at coffeebeanintl.com.


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WALNUT CREEK, Calif. — Central Garden & Pet Company has named John R. Ranelli as its new president and CEO, effective February 11.
Central Garden & Pet is a leading supplier of branded products for the lawn and garden and pet supplies markets. Ranelli has been a member of its board and a member of the board's audit committee since 2010. He will remain on Central's board and current chairman and CEO Bill Brown will remain chairman.
"Over the last two years, John has become a leader on our board and a trusted partner. His close to 40 years of experience in building consumer products companies will be invaluable as we position Central for the next phase of growth and continue our transition to an integrated branded consumer products company," said Brown. "While we have considerable work yet to do, Central is a different company today than it was a year ago. We are transforming Central from what was essentially a collection of more than 20 operating companies into an integrated organization. We are focused on building our brands and introducing innovative new products to the marketplace. We are eliminating redundant costs and pursuing a plan to achieve significant savings over the next few years. As we begin the next phase of our transformation, John Ranelli is the right person to build on this progress and to drive the company forward so that it can meet the expectations of our customers and shareholders."
Ranelli has extensive experience in leading mid- to large-size consumer products companies, driving shareholder value through transformation initiatives and revenue and profitability growth. He has served as CEO of Mikasa Inc., a global dinnerware, crystal and home accessories company, of FGX International (FosterGrant), a global optical company and, most recently, of Woolrich Inc., an outdoor clothing company. He has served as an advisor to companies and private equity firms since leaving Mikasa Inc. when it was sold in 2008. Previously, he served in senior executive capacities with the Timberland Company, Stride Rite Corporation, Deckers Outdoor Corporation and TLC Beatrice. He has served on the boards of GNC, Deckers Outdoor Corp, Party City and Woolrich. Mr. Ranelli will continue to serve on the Woolrich board as non-executive chairman.
"We have a great opportunity to build our brands by continuing to invest in marketing and new product innovation. I am confident that as we strengthen our customer relationships, develop stronger ties with the consumer and continue to improve our execution, we will deliver the sustainable, profitable growth that we expect of our company and create meaningful value for our shareholders. I look forward to working with the Central team to achieve these goals."
Central Garden & Pet Company names new CEO
WALNUT CREEK, Calif. — Central Garden & Pet Company has named John R. Ranelli as its new president and CEO, effective February 11.


text: I just purchased a 2008 GMC Sierra Denali. I have to Bose premium audio system, but it doesn't have the dvd system in the back. What would be the best system that would still work the the Bose system? Looking for a flip down one. Sorry just realized I posted this in the wrong forum. Maybe if a admin could move it for me...thanks


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I had quite a large quantity of bees flying outside the hive late last week. The temps here were around 50 degrees. I looked into the hive and a large quantity of dead bees had been blocking the entrance reducer. I swept many of these out. Does it sound like all is well in this hive?
Any tips on what I should be doing to prepare for the spring? This is the second season for this hive.


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Advice for soon to be graduate
Hello all,
I am getting ready to graduate this spring and am looking for some career advice. I will be graduating with two bachelors, Computer Science and Information assurance. I currently work two jobs, one as an intern in the Information Assurance group at a larger company, and the other as a security guard for a smaller IT company. I have obtained my Security+ certification and am looking to add a few more certifications before graduation.
I would like to find a job that would let me interact with multiple areas of the IT security profession and not limit myself to one particular technology, i.e. firewall engineer. I enjoy completing forensic and penetration challenges that I find online, but from my research there are not many entry level positions out there for either of those fields. From my job hunt so far, the job title of "Security Engineer" seems to be as close as I can get to my desired profession. Does anyone have any opinions on similar jobs I should search for or know of opportunities to lead me into a career in either forensics or penetration testing? As a side note, there is the possibility of a job offer from the company I currently have an internship with, but the team is geared more toward security product support. It might be a decent opportunity for me to acquire some experience in the field, but I feel like I would be limiting my career growth if all I did was focus on product support. I want a job where I am challenged and have the chance to learn more about the security field, not spend my days figuring out why product xyz isn't working.
The next question is the dreaded certification question! I understand that certifications don't replace experience, but it would seem that it makes getting your foot in the door that much easier (especially a bonus with my limited experience). One of my teachers conducts a CISSP training course every spring and lets students sit in for free. He claims that every student with an IA degree that has taken his course has passed, but I don't know how much backbone the certification has without the required experience? The other issue I have run into with certifications are finding ones that will give me the most return on investment. Is getting a C|EH or GPEN certification worth it if the likelihood of me finding a penetration testing job right of college is low? I understand the benefits of displaying work ethic and ability to conduct self-study, but is investing $1000+ worth it at the beginning of your career?
Any input would be appreciated on my questions or just suggestions for a young security professional starting out in their career.
Thanks EH!