Effect of co-administering ezetimibe with on-going simvastatin treatment on LDL-C goal attainment in hypercholesterolemic patients with coronary heart disease.
OBJECTIVE
To determine whether co-administering ezetimibe with on-going simvastatin treatment was more effective than placebo plus on-going simvastatin in achieving an LDL-C treatment target of < or = 2.60 mmol/l (100 mg/dl) in hypercholesterolemic patients with coronary heart disease (CHD).


METHODS
Men and women (age > or = 18 years) with documented CHD and on a stable dose of simvastatin 10 mg or 20 mg for at least 6 weeks were recruited for this study. After a 4-week simvastatin 10 or 20 mg plus placebo and diet run-in period, patients were eligible for randomization if LDL-C > 2.60 and < or = 4.20 mmol/l and triglycerides (TG) < or = 4.00 mmol/l. Eligible patients were randomized to a double-blind comparative study with ezetimibe 10 mg co-administered with on-going simvastatin 10 mg or 20 mg (n=181) versus placebo to match ezetimibe co-administered with simvastatin 10 mg or 20 mg (n=191) for 6 weeks.


RESULTS
At baseline, mean LDL-C was comparable between the ezetimibe (3.14 mmol/l) and placebo (3.19 mmol/l) groups. With the addition of ezetimibe or placebo to on-going simvastatin therapy, the percentage of patients achieving the LDL-C goal of < or = 2.60 mmol/l after 6 weeks of treatment was significantly (p < or = 0.001) greater in the ezetimibe group (74.3%) than in the placebo group (16.7%). The addition of ezetimibe to on-going simvastatin treatment also resulted in a significantly (p < or = 0.001) larger mean percent reduction in LDL-C from baseline (25.2%) compared with placebo (0.9%). Ezetimibe was generally well tolerated compared to placebo when added to on-going simvastatin treatment.


CONCLUSIONS
Co-administering ezetimibe with on-going simvastatin 10 or 20 mg treatment allowed more hypercholesterolemic patients with CHD to reach the LDL-C treatment target of < or = 2.60 mmol/l.
Farnier
Michel
M
Point Medical, Rond Point de la Nation, 21000 Dijon, France. mfarnier@ipac.fr
Volpe
Massimo
M
Massaad
Rachid
R
Davies
Michael J
MJ
Allen
Christopher
C
D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001055:Apolipoproteins B / Q000097:blood; D001384:Azetidines / Q000008:administration & dosage* / Q000627:therapeutic use; D008078:Cholesterol, LDL / Q000097:blood* / Q000187:drug effects; D003327:Coronary Disease / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012449:Safety; D019821:Simvastatin / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D000924:Anticholesteremic Agents; D001055:Apolipoproteins B; D001384:Azetidines; D008078:Cholesterol, LDL; D014280:Triglycerides; D019821:Simvastatin; D000069438:Ezetimibe