Cholesterol Drug Fails Main Goal in Heart Study


22 july 2008--The cholesterol drug Vytorin, which is sold by Merck & Company and Schering-Plough, failed to meet its main goal of improving cardiovascular outcomes for patients with irregular thickening of the main valve to the aorta, according to results of a new study.
No significant difference in the study’s composite goals was seen between the patients who received Vytorin and those who received a placebo, according to data presented on Monday in London by its primary researcher, Dr. Terje Pedersen of Ulleval University Hospital in Oslo, Norway.
There were also slightly more cancer deaths in the drug group — 39 versus 23 on placebo — although the researcher said those could have occurred as a result of chance.
Researchers said much larger studies of Vytorin have not showed increased cancer risk.
The primary composite goals of the study of patients with irregular thickening of the main valve to the aorta were broken into two sets of secondary goals and Vytorin was superior on one of those sets of measures, researchers said.
Vytorin was significantly better than placebo in reducing atherosclerotic events, defined as non-fatal heart attacks, need for coronary artery bypass surgery or artery-clearing procedures, hospitalization due to chest pain and strokes.
The drug was no better than placebo on the other secondary measure of reducing aortic valve disease events — the need for surgical valve replacement, hospitalization because of heart failure and cardiovascular death.
Vytorin did lower bad LDL cholesterol by 61 percent throughout the study.
The trial was designed to determine whether aggressive cholesterol lowering can lessen the need for surgical replacement of aortic valves, reduce cardiac death and reduce cardiovascular events, including heart attacks.