New study results could dramatically alter the future medical treatment of atherosclerosis. Cleveland Clinic researchers revealed that an investigational drug known as evacetrapib can boost HDL (good) cholesterol and lower LDL (bad) cholesterol far beyond levels achievable by any other medications currently in use. At the highest tested dosage, the levels of HDL more than doubled.
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The study was presented by Cleveland Clinic cardiologist and principal investigator Stephen Nicholls MD PhD, at the American Heart Association’s Scientific Sessions in Orlando, Fla. The results of this Phase II clinical trial were simultaneously published in the Journal of the American Medical Association.
“In this study, evacetrapib was able to show striking increases in HDL while significantly lowering LDL,” said Dr. Nicholls. “The next step will be a large cardiovascular outcome trial to determine if this drug can reduce cardiovascular morbidity and mortality.”
Evacetrapib belongs to a new class of drugs under development known as cholesteryl ester transfer protein (CETP) inhibitors. The first drug in the class, torcetrapib, failed due to unexpected toxicity, but many researchers believe that newer compounds such as evacetrapib may avoid this toxicity. In the current trial, evacetrapib showed none of the adverse effects noted with torcetrapib. Specifically, evacetrapib resulted in no increase in blood pressure or adrenal synthesis of aldosterone or cortisol.
“Keep in mind that this is only a Phase II study,” says Steven Nissen, MD, chair of Cardiovascular Medicine at Cleveland Clinic, and chairman of the study. “It will be several years before it can be considered by the FDA for approval.”
Despite the benefits of statins, cardiovascular disease remains the No. 1 cause of death in both men and women in developed countries. Accordingly, considerable efforts have focused on development of new therapeutic agents designed to address residual cardiovascular risk.