Schering-Plough, Merck's Vytorin misses study goal

Results of a preliminary analysis of the just-completed study showed Vytorin, marketed jointly by Merck & Co. and Schering-Plough Corp., was no better than placebo at lowering the risk of major cardiovascular events--including heart attack, stroke, heart surgery and death--in patients with aortic stenosis.

The sometimes deadly condition, which is becoming increasingly common in elderly people, involves blockage and stiffening of the aortic valve, which sends oxygen-rich blood through the aorta and on throughout the body. More than 5 million Americans have the disease to some extent, and it's the No. 2 cause of heart surgery.

Researchers at 173 sites in Europe were hoping the study, called SEAS, would show Vytorin offers a nonsurgical way to treat aortic stenosis.

That wasn't the case, although Vytorin did cut cholesterol levels about 60 percent.

The findings overshadowed second-quarter results for the two companies, which held up the results from Monday morning until the end of the day to allow researchers involved with SEAS to discuss the findings with reporters and analysts.

Vytorin, which combines Merck's Zocor--now available as a cheap generic--with Schering-Plough's Zetia, didn't protect patients' heart valves and raised fears, apparently unfounded, that it increased risk of cancer.

"You don't help that (valve) disease, but you do help the patients" by protecting other heart blood vessels and reducing heart attacks and the need for bypass surgery or artery-clearing angioplasty, Sir Richard Peto, an Oxford University statistician and cancer expert who analyzed the data, told The Associated Press in an interview.

The study of 1,873 patients aged 45 to 85, just ended in March, did find that secondary benefit, but it's already known that some cholesterol-lowering drugs reduce risk of heart attack and stroke.

The cholesterol-lowering and reduced heart complications are consistent with what's been shown with Zocor alone, said Cleveland Clinic cardiologist Dr. Steven Nissen, who recommends that Vytorin and Zetia not be used as first-line drugs.