Merck has reported that anacetrapib, its investigational CETP inhibitor, has met all safety and efficacy endpoints in a Phase III trial involving patients with coronary heart disease (CHD).
The randomised, placebo-controlled and double-blind trial evaluated the lipid-modifying efficacy, safety and tolerability of 100mg of anacetrapib daily, in combination with ongoing statin therapy in patients with CHD or CHD risk equivalents.
The 18-month study enrolled more than 1,600 patients, who were randomised to receive either anacetrapib or placebo.
The primary endpoint was percent change in low-density lipoprotein cholesterol from baseline after 24 weeks of treatment.
Safety and tolerability assessments, including adverse experiences, safety laboratory tests, vital signs and physical exams, were also evaluated over the 76-week treatment period.
The pre-specified cardiovascular endpoints to evaluate safety included cardiovascular death, non-fatal myocardial infarction, stroke and hospitalisation for unstable angina.
At 24 Weeks, anacetrapib decreased low-density lipoprotein cholesterol by 40% compared to the placebo, while raising high-density lipoprotein cholesterol by 138%.
There were no significant differences in the primary safety measures in patients treated with anacetrapib compared to placebo-treated patients.
The pre-specified cardiovascular endpoint occurred in 16 patients treated with anacetrapib, and 21 patients treated with the placebo.