Cholesterol
Experimental cholesterol drug failed to prevent cardiovascular events
Phase III trial halted early as treatment did not reduce rate of vascular events in patients with high-risk disease.
Source: Shutterstock.com
In a phase III trial, researchers assessed the effect of cholesterol ester transfer protein inhibitor, evacetrapib, on cardiovascular outcomes in 12,092 patients with high-risk cardiovascular disease.
In phase II trials, the cholesterol ester transfer protein inhibitor, evacetrapib, increased high-density lipoprotein (HDL) cholesterol levels by up to 130% and reduced low-density lipoprotein (LDL) cholesterol by up to 35%, but it was unknown if this translated to an effect on cardiovascular outcomes.
In a phase III trial, 12,092 patients with high-risk cardiovascular disease were randomly assigned to 130mg dose of evacetrapib or placebo for two years.
The trial was stopped after a median follow-up of 28 months owing to futility. At this point, the primary endpoint (death from cardiovascular causes, myocardial infarction, stroke, coronary revascularisation, or hospitalisation for unstable angina) had occurred in 12.9% of the evacetrapib group and 12.8% of the placebo group (hazard ratio 1.01; 95% confidence interval 0.91–1.11; P=0.91).
Reporting in The New England Journal of Medicine[1] (online, 18 May 2017), the researchers say the results reinforce the need for adequately powered clinical trials of new agents, even when results have been seen with surrogate endpoints.
Citation: Clinical Pharmacist DOI: 10.1211/CP.2017.20203054
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