Merck Posts Topline Results For Heart Drug Vytorin

Merck reported top-line results from the IMPROVE-IT trial investigating its investigational drug Vytorin (ezetimibe/simvastatin) in patients with high-risk patients with acute coronary syndromes.

Vytorin comprises simvastatin and the non-statin Zetia (ezetimibe). The drug is to be paired with dieting to lower total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non–HDL cholesterol, as well as to increase HDL cholesterol in patients with primary hyperlipidemia or mixed hyperlipidemia when a proper diet is not entirely effective.

Launched almost a decade ago, the randomized and double blind IMPROVE-IT study investigated the incidence of major cardiovascular events in patients treated with Vytorin compared with those who were treated with simvastatin alone. The trial met both primary and secondary composite efficacy endpoints. Results show that patients who took Vytorin achieved significantly less major cardiovascular events than those who took simvastatin alone. Thirty-three percent of the patients in the Vytorin arm experienced a heart attack or stroke versus 34.7 percent of those in the simvastatin monotherapy.

Though the two percent difference may seem meager, it is good news to Merck and other companies developing cholesterol drugs, Forbes says. Study co-chairs, Drs. Eugene Braunwald of Harvard Medical School and Robert Califf of Duke University, said, “In IMPROVE-IT, the addition of ezetimibe to a statin resulted in a further reduction in cardiovascular events compared to statin therapy alone, which is the first time this has been directly shown in a study of a non-statin cholesterol-lowering medicine. The IMPROVE-IT data also address an important scientific question about lowering LDL-C to very low levels.” Results of the trial were presented at the American Heart Association 2014 Scientific Sessions.

The company said it will submit the data from the trial to the U.S. Food and Drug Administration (FDA) in mid-2015 to support a new indication application for Vytorin and Zetia in major cardiovascular events.