Efficacy and safety of cerivastatin in primary hypercholesterolemia: a long term comparative titration study with simvastatin.
OBJECTIVE
To compare cerivastatin with simvastatin in their long term safety and efficacy in reducing low density lipoprotein cholesterol (LDL-C).


METHODS
Multicentre, randomized, double-blind, parallel group study.


METHODS
Thirteen Canadian centres.


METHODS
A total of 387 patients with primary hypercholesterolemia received treatment with either cerivastatin (0. 05 to 0.3 mg/day) or simvastatin (5 to 40 mg/day) to achieve plasma LDL-C levels below 3.36 mmol/L (130 mg/dL) for an initial 32-week dose-titration phase and a subsequent 72-week extension phase.


RESULTS
Cerivastatin and simvastatin produced clinically significant reductions in LDL-C of 28.4% and 35.4%, respectively, at the end point for the 32-week study, and reductions of 32.8% and 35. 0%, respectively, at the end of the extension phase of the study. Response rates (a greater than 15% drop in LDL-C) were comparable for the two treatments (88.9% cerivastatin versus 93.2% simvastatin) at the 32-week end point. Response rates were 100% for both treatments at the end of the 72-week extension phase. Both treatments also reduced total cholesterol, apolipoprotein B and very low density lipoprotein cholesterol levels. Cerivastatin and simvastatin increased HDL-C levels significantly by 8.8% and 11.0%, respectively, at the end point for the 32-week study, and by 8.6% and 12.1%, respectively, at the end of the extension phase of the study. Treatments were well tolerated, and the incidence of adverse effects was similar in both groups.


CONCLUSIONS
This forced titration study demonstrates that cerivastatin, given once daily at doses up to 0.3 mg/day, is effective and well tolerated. The results of this study support further investigation of higher doses of cerivastatin given the excellent safety profile at doses up to 0.3 mg.
Leiter
L A
LA
University of Toronto, Toronto, Canada. leiter@smh.toronto.on.ca
Hanna
K
K
D000924:Anticholesteremic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D006937:Hypercholesterolemia / Q000188:drug therapy*; D011725:Pyridines / Q000494:pharmacology / Q000627:therapeutic use*; D019821:Simvastatin / Q000494:pharmacology / Q000627:therapeutic use*; D017186:Titrimetry
D000924:Anticholesteremic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011725:Pyridines; D019821:Simvastatin; C086276:cerivastatin