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Study shows no benefit for lower cholesterol by drugs { August 31 2004 }

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Study of high-dose Zocor deals blow to Merck
Tuesday, August 31, 2004

A high-dose regimen of Merck's cholesterol drug Zocor offered no conclusive benefits over a low-cholesterol diet and a lower dose of Zocor in preventing a recurrence of cardiac events in patients who'd already had heart attacks, a study indicated yesterday.

The results of the study, announced at a medical meeting in Munich and in the new issue of the Journal of the American Medical Association, or JAMA, delivered a blow to Merck, the Whitehouse Station pharmaceuticals maker that financed the 4,500-patient study to bolster sales of its drug.

In the study, half of the patients were given daily dose of 40 milligrams of simvastatin, which the company sells under the brand name Zocor, for 30 days and then raised to 80 milligrams daily. The drug was given within about four days of the initial heart "event."

The other patients were given a placebo for four months, then put on a 20-milligram dose of simvastatin.

While cholesterol levels dropped more sharply in the first group, the risks of suffering another heart attack, stroke, readmission to the hospital or heart-related death were comparable in the two groups.

Among those who went on the drug regimen right away, 14 percent suffered another heart event, compared with 17 percent taking a placebo initially -- a difference that was not seen as statistically significant. Patients were followed for between six months and two years.

In addition, 0.4 percent of those on the heavier dose of simvastatin suffered from myopathy, a type of muscle pain and weakness, and statins can cause liver problems in a few cases.

Adding to Merck's woes, nine of the patients studied taking the highest dose of Zocor -- 80 milligram -- experienced muscle weakening. None of the patients taking lower doses experienced this, but one person in the placebo group did.

Merck spokesman Tony Plohoros said overall, the incidence of the side effect during the trial was 0.4 percent and is consistent with safety data already mentioned in the label.

Zocor is the second of Merck's top-selling drugs that has shown side effects at the highest doses. Concerns are growing that its arthritis pain drug Vioxx has cardiovascular side effects when it is taken in doses over 50 milligram.

Any kind of side effect for a statin is a serious matter in the highly competitive market for cholesterol drugs, the top-selling medicines in the world.

Zocor is Merck's best-selling drug and had sales of $2.7 billion worldwide in the first six months of this year.

Merck's patent on Zocor expires in 2006.

Reuters contributed to this report.

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