29034
document
[ Efficacy and safety of extended-release niacin alone or with atorvastatin for lipid profile modification ] . OBJECTIVE To evaluate the efficacy and safety of extended-release niacin ( niacin ER ) either alone or in combination with atorvastatin for the lipid profile modification in the patients with coronary heart disease ( CHD ) and its equivalents . METHODS One hundred and ten patients with CHD and its equivalents with serum total cholesterol ( TC ) > or = 3.5 mmol/L were randomly assigned into three treatment groups : ( 1 ) atorvastatin group ( n = 38 ) , receiving atorvastatin 10 mg/d for 8 weeks ; ( 2 ) niacin ER group ( n = 38 ) , given niacin ER 500 mg/d for 4 weeks and then 1000 mg/d for 4 weeks ; ( 3 ) combination treatment group ( n = 34 ) , treated with atorvastatin ( 10 mg/d ) plus niacin ER , with the dose initiating from 500 mg/d , and increasing to 1000 mg/d after 4 weeks , for 8 weeks . The serums lipid profiles and adverse effects were assessed in all the patients before treatment , and 4 and 8 weeks after treatment . RESULTS ( 1 ) After 8 weeks of treatment , the serum level of triglyceride ( TG ) and high-density lipoprotein cholesterol ( HDL-C ) were reduced by 30 % and 16 % respectively in the niacin ER group compared with the baseline values ( both P < 0.05 ) . After 8 weeks , the TC , low-density lipoprotein cholesterol ( LDL-C ) , and TG in the atorvastatin group decreased by 19 % , 26 % , and 17 % respectively compared with the baseline values ( all P < 0.05 ) . Combination treatment decreased the TC , LDL-C , and TG levels by 28 % , 38 % , and 39 % respectively , and increased the HDL-C level by 23 % ( all P < 0.05 ) . The improvement in TC and LDL-C achieved by combination treatment was superior to treatment of atorvastatin alone and treatment of niacin ER alone ( all P < 0.05 ) . ( 2 ) The rate of achieving the LDL-C goal of The National Cholesterol Education Program ( NCEP ) in Adult Treatment Panel III ( ATP III ) in the combination therapy group was 73.5 % , significantly higher than those of the atorvastatin and niacin groups ( 47.7 % and 42.1 % respectively , both P < 0.05 ) . ( 3 ) Adverse effect , such as flushing ( 15.8 % ) and gastrointestinal symptoms ( 23.7 % ) were found in the niacin ER group , however , no more adverse effects were found in the combination therapy group . There were no serious adverse events in all groups . CONCLUSION Niacin ER has a favorable effect in modulating the blood lipid profile , especially in reducing TG and elevating HDL-C . Combined statin with niacin may produce a more global and effective improvement in lipid blood levels than monotherapy and is generally safe and well tolerable .
29035
Intervention_Pharmacological
niacin alone
29036
Intervention_Pharmacological
atorvastatin
29037
Intervention_Pharmacological
extended-release niacin ( niacin ER )
29038
Intervention_Pharmacological
atorvastatin
29039
Intervention_Pharmacological
atorvastatin
29040
Intervention_Pharmacological
atorvastatin
29041
Intervention_Pharmacological
niacin ER
29042
Intervention_Pharmacological
niacin ER
29043
Intervention_Control
combination treatment
29044
Intervention_Pharmacological
atorvastatin ( 10 mg/d )
29045
Intervention_Pharmacological
niacin ER
29046
Outcome_Other
Efficacy
29047
Outcome_Other
safety
29048
Outcome_Other
efficacy
29049
Outcome_Other
safety
29050
Outcome_Physical
serums lipid profiles
29051
Outcome_Adverse-effects
adverse effects
29052
Outcome_Physical
serum level of triglyceride ( TG )
29053
Outcome_Physical
high-density lipoprotein cholesterol ( HDL-C )
29054
Outcome_Physical
TC
29055
Outcome_Physical
low-density lipoprotein cholesterol ( LDL-C )
29056
Outcome_Physical
TG
29057
Outcome_Other
atorvastatin
29058
Outcome_Physical
TC
29059
Outcome_Physical
LDL-C
29060
Outcome_Physical
TG levels
29061
Outcome_Physical
HDL-C level
29062
Outcome_Physical
TC
29063
Outcome_Physical
LDL-C
29064
Outcome_Physical
LDL-C
29065
Outcome_Adverse-effects
flushing
29066
Outcome_Adverse-effects
gastrointestinal symptoms
29067
Outcome_Other
reducing
29068
Outcome_Physical
TG
29069
Outcome_Other
elevating
29070
Outcome_Physical
HDL-C
29071
Outcome_Other
global and effective improvement in lipid blood levels
29072
Outcome_Other
safe
29073
Outcome_Other
well tolerable