72530
document
Effect of Ezetimibe on LDL-C Lowering and Atherogenic Lipoprotein Profiles in Type 2 Diabetic Patients Poorly Controlled by Statins . BACKGROUND There exists a subpopulation of T2DM in whom first-line doses of statin are insufficient for optimally reducing LDL-C , representing a major risk of CVD . The RESEARCH study focuses on LDL-C reduction in this population along with modifications of the lipid profiles leading to residual risks . METHODS Lipid changes were assessed in a randomized , multicenter , 12-week , open-label study comparing a high-potency statin ( 10mg of atorvastatin or 1mg of pitavastatin ) plus ezetimibe ( EAT : n = 53 ) with a double dose of statin ( 20mg of atorvastatin or 2mg of pitavastatin ) ( DST : n = 56 ) in DM subjects who had failed to achieve the optimal LDL-C targets . Lipid variables were compared with a primary focus on LDL-C and with secondary focuses on the percentage of patients who reached the LDL-C targets and changes in the levels of RLP-C ( remnant like particle cholesterol ) and sd-LDL-C , two characteristic atherogenic risks of DM . RESULTS The reduction of LDL-C ( % ) , the primary endpoint , differed significantly between the two groups ( -24.6 in EAT vs. -10.9 in DST ) . In the analyses of the secondary endpoints , EAT treatment brought about significantly larger reductions in sd-LDL-C ( -20.5 vs. -3.7 ) and RLP-C ( -19.7 vs. +5.5 ) . In total , 89.4 % of the patients receiving EAT reached the optimized treatment goal compared to 51.0 % of the patients receiving DST . The changes in TC ( -16.3 vs. -6.3 ) and non-HDL-C ( -20.7 vs. -8.3 ) differed significantly between the two groups . CONCLUSION Ezetimibe added to high-potency statin ( 10 mg of atorvastatin or 1 mg of pitavastatin ) was more effective than the intensified-dose statin ( 20 mg of atorvastatin or 2 mg of pitavastatin ) treatment not only in helping T2DM patients attain more LDL-C reduction , but also in improving their atherogenic lipid profiles , including their levels of sd-LDL-C and RLP-C. We thus recommend the addition of ezetimibe to high-potency statin as a first line strategy for T2DM patients with insufficient statin response . TRIAL REGISTRATION The UMIN Clinical Trials Registry UMIN000002593 .
72531
Intervention_Pharmacological
Ezetimibe
72532
Intervention_Pharmacological
high-potency statin ( 10mg of atorvastatin or 1mg of pitavastatin )
72533
Intervention_Pharmacological
ezetimibe
72534
Intervention_Pharmacological
statin
72535
Intervention_Pharmacological
atorvastatin
72536
Intervention_Pharmacological
pitavastatin
72537
Intervention_Pharmacological
DST
72538
Intervention_Pharmacological
Ezetimibe
72539
Intervention_Pharmacological
statin
72540
Intervention_Pharmacological
atorvastatin
72541
Intervention_Pharmacological
pitavastatin
72542
Intervention_Pharmacological
statin
72543
Intervention_Pharmacological
atorvastatin
72544
Intervention_Pharmacological
pitavastatin
72545
Outcome_Physical
LDL-C Lowering
72546
Outcome_Physical
Atherogenic Lipoprotein Profiles
72547
Outcome_Physical
LDL-C
72548
Outcome_Physical
LDL-C
72549
Outcome_Physical
Lipid changes
72550
Outcome_Physical
Lipid variables
72551
Outcome_Physical
LDL-C
72552
Outcome_Physical
LDL-C
72553
Outcome_Physical
levels of RLP-C
72554
Outcome_Physical
sd-LDL-C
72555
Outcome_Physical
reduction of LDL-C
72556
Outcome_Physical
sd-LDL-C
72557
Outcome_Physical
RLP-C
72558
Outcome_Physical
TC
72559
Outcome_Physical
non-HDL-C
72560
Outcome_Physical
LDL-C reduction
72561
Outcome_Physical
atherogenic lipid profiles
72562
Outcome_Physical
sd-LDL-C
72563
Outcome_Physical
RLP-C.
72564
Participant_Condition
Diabetic
72565
Participant_Condition
DM subjects who had failed to achieve the optimal LDL-C targets
72566
Participant_Condition
T2DM patients with insufficient statin response .