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Statins Deception, Zocor - simvastatin: Big setback for Merck cholesterol drug

Big setback for Merck cholesterol drug
High doses of Zocor provide no benefits in preventing new problems in heart attack patients: study.
August 31, 2004: 6:31 AM EDT
Source: Money

MUNICH (Reuters) - Merck's anti-cholesterol drug Zocor suffered a setback after a major study found high doses of the drug showed no conclusive benefits in preventing fresh cardiac problems in heart attack patients.

The news is a blow for the U.S. pharmaceuticals giant in the $22-billion-a-year market for cholesterol-lowering statin drugs and could play into the hands of Pfizer, (PFE: Research, Estimates) which makes top-seller Lipitor.

Results of the Merck-sponsored study were released at the European Society of Cardiology and published in the new issue of the Journal of the American Medical Association.

The trial, involving 4,497 patients, showed no statistically significant benefit from giving a high dose of Zocor, or simvastatin.

"The early-launch statins like Zocor do look increasingly anaemic in comparison with later drugs like Lipitor, and it's easy to see how Pfizer has mopped up market share," said Paul Diggle, an industry analyst with Code Securities in London.

AstraZeneca Plc has also recently entered the market with another potent new statin called Crestor.

But it may not be all bad news for Merck (MRK: Research, Estimates), since the disappointing Zocor results could reinforce the case for using Vytorin, a new cholesterol-lowering pill that combines Zocor with a different type of cholesterol reducer, which has been developed by Merck and Schering-Plough. (SPG: Research, Estimates)

"This could actually help in selling Vytorin," said a second London-based analyst, who declined to identified.
Risk management

Normally, patients at risk of another heart attack are first stabilized and put on low-cholesterol diets before introducing cholesterol-lowering drugs such as statins.

But in the Zocor study, half the patients were given a daily dose of 40 milligrams 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.

A total of 14.4 percent of those who went on the drug regimen right away suffered another heart event, compared to 16.7 percent taking a placebo initially -- a difference that was within the margin of error.

In addition, 0.4 percent of those on the heavier dose of Zocor suffered from myopathy, a type of muscle pain and weakness.

Michael Blazing, of Duke University Medical Center in Durham, North Carolina, argued that, despite lack of statistical significance in outcomes, the study underlined the message that "lower is better" when it comes to cholesterol control.

The study's findings point to a cautious approach in using the 80-milligram Zocor dose, though the 40-milligram dose appears to be safe and effective, wrote Steven Nissen of the Cleveland Clinic Foundation.

An editorial accompanying the study, in the online version of the Journal of the American Medical Association, commended the researchers for publishing the study findings even though they "did not meet its original objectives" -- in light of recent criticisms that bad news in some company-funded studies have been swept under the rug.

Doctors have been worried about the side effects of statins since Bayer AG's Baycol was withdrawn in August 2001 following incidents of severe muscle weakening. The drug is now linked to over 100 deaths.   

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