NEW YORK — In the latest disappointment for cholesterol pill Vytorin, a major European study in patients with heart valve disease found the drug didn't prevent worsening of the disease or lower the need for valve surgery, sending its makers' stock plunging.
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 a 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 the elderly, involves partial blockage and stiffening of the aortic valve, which sends oxygen-rich blood from the heart to the rest of 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 hospitals and other sites in Europe were hoping the study, called SEAS, would show that Vytorin offered a nonsurgical way to treat the condition by reducing bad cholesterol levels and plaque buildup.
That wasn't the case, although Vytorin did cut cholesterol levels about 60%.
But Vytorin, which combines Merck's Zocor -- now available as an inexpensive generic -- with Schering-Plough's Zetia, didn't do anything to 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, said Richard Peto, an Oxford University statistician and cancer expert who analyzed the data.
The 1,873-patient study, which ended in March, did find that secondary benefit, but it's already well-documented that some cholesterol-lowering drugs reduce the 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.
"We are left with just as many questions about the efficacy of Vytorin [as before], and we have new questions about the safety," he said, referring to the excess cancer cases and deaths in Vytorin users.
