LDL-C goal attainment with the addition of ezetimibe to ongoing simvastatin treatment in coronary heart disease patients with hypercholesterolemia.
OBJECTIVE
To evaluate the addition of ezetimibe or placebo to on-going simvastatin treatment on attaining the LDL-C treatment target of </= 2.60 mmol/L (100 mg/dL) in coronary heart disease (CHD) patients with hypercholesterolemia.


METHODS
Patients with documented CHD were recruited if they were on a stable dose of simvastatin 10 mg or 20 mg for at least 6 weeks, had LDL-C > 2.60 mmol/L and </= 4.20 mmol/L (> 100 mg/dL and </= 160 mg/dL), triglycerides </= 4.00 mmol/L (355 mg/dL) and hepatic transaminases and creatine kinase </= 50% above the upper limit of normal. After a 4-week placebo and diet run-in period, eligible patients were randomized to a double-blind, placebo-controlled comparative study with ezetimibe 10mg co-administered with on-going simvastatin 10mg or 20 mg (n = 208) versus placebo to match ezetimibe co-administered with simvastatin 10mg or 20mg for 6 weeks (n = 210).


RESULTS
When ezetimibe was added to on-going simvastatin therapy, a significantly greater percentage of patients attained the LDL-C target of </= 2.60 mmol/L after 6 weeks of treatment compared to placebo added to on-going simvastatin (80.4% vs. 17.4%, respectively;p </= 0.001). When co-administered with on-going simvastatin therapy, mean percentage reduction in LDL-C from baseline was significantly larger in the ezetimibe group compared to placebo (27.1% vs. 4.1%, respectively; p </= 0.001). The co-administration of ezetimibe or placebo to on-going simvastatin treatment was generally well tolerated.


CONCLUSIONS
Ezetimibe co-administered with on-going simvastatin 10 mg or 20 mg treatment enabled more CHD patients with hypercholesterolemia to attain the LDL-C treatment target of </= 2.60 mmol/L.
Brohet
C
C
Saint-Luc Hospital-Catholic University of Louvain, Brussels, Belgium. brohet@card.ucl.ac.be
Banai
S
S
Alings
A M W
AM
Massaad
R
R
Davies
M J
MJ
Allen
C
C
D000284:Administration, Oral; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D001384:Azetidines / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood* / Q000187:drug effects*; D003327:Coronary Disease / Q000150:complications*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D019821:Simvastatin / Q000627:therapeutic use*; D016896:Treatment Outcome
D000924:Anticholesteremic Agents; D001384:Azetidines; D008078:Cholesterol, LDL; D010919:Placebos; D019821:Simvastatin; D000069438:Ezetimibe