Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease.
This randomised, double-blind study evaluated the efficacy and safety of ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg tablet compared to doubling the atorvastatin (ATV) dose in hypercholesterolaemic patients with atherosclerotic or coronary heart disease (CHD). The study group included 435 male and female CHD patients (aged >or=18 years) who had not achieved their low-density lipoprotein cholesterol (LDL-C) goal of <2.50 mmol/l while on a stable dose of ATV 10 mg for >or=6 weeks. After a 1-week diet/stabilisation period, patients with LDL-C >or=2.50 mmol/l and <or=4.20 mmol/l were randomised (1:1) to EZE/SIMVA 10/20 mg/day (n = 221) or ATV 20 mg/day (n = 214) for 6 weeks. The primary efficacy objective was to determine the per cent reduction from baseline in LDL-C at week 6. EZE/SIMVA 10/20 mg produced significantly greater mean per cent changes from baseline in LDL-C compared with ATV 20 mg (-32.8 vs. -20.3%; p </= 0.001). A significantly greater proportion of patients achieved an LDL-C goal <2.50 mmol/l with EZE/SIMVA than ATV (77.9 vs. 51.9%; p <or= 0.001). Significant improvements in total cholesterol (-20.3 vs. -13.0%), non-high-density lipoprotein cholesterol (non-HDL-C) (-27.9 vs. -17.0%), apolipoprotein B (-23.4 vs. -14.7%) and HDL-C (1.8 vs. -0.4%) were observed after switching to EZE/SIMVA 10/20 mg for 6 weeks (p < 0.05 for all parameters). EZE/SIMVA 10/20 mg was generally well tolerated, with an overall safety profile similar to that of ATV 20 mg. EZE/SIMVA 10/20 mg produced superior lipid-altering efficacy by dual inhibition of cholesterol synthesis and intestinal absorption compared with doubling the dose of ATV from 10 to 20 mg.
Barrios
V
V
Department of Cardiology, Hospital Ramón y Cajal, Madrid, Spain. vbarrios.hrc@salud.madrid.org
Amabile
N
N
Paganelli
F
F
Chen
J-W
JW
Allen
C
C
Johnson-Levonas
A O
AO
Massaad
R
R
Vandormael
K
K
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000008:administration & dosage*; D001055:Apolipoproteins B / Q000097:blood; D050197:Atherosclerosis / Q000150:complications / Q000188:drug therapy; D000069059:Atorvastatin; D001384:Azetidines / Q000008:administration & dosage*; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003327:Coronary Disease / Q000150:complications / Q000188:drug therapy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005060:Europe; D000069438:Ezetimibe; D005260:Female; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D006937:Hypercholesterolemia / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000008:administration & dosage*; D019821:Simvastatin / Q000008:administration & dosage*; D013624:Taiwan; D016896:Treatment Outcome
D000924:Anticholesteremic Agents; D001055:Apolipoproteins B; D001384:Azetidines; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D011758:Pyrroles; D000069059:Atorvastatin; D019821:Simvastatin; D000069438:Ezetimibe