Video: Statins scrutinized

updated 8/31/2004 5:52:07 PM ET 2004-08-31T21:52:07

Putting patients with heart trouble on a high dosage of statin drugs quickly to lower their blood cholesterol levels offers only a marginal benefit compared to current treatment, a study said Monday.

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 study funded by Merck & Co. Inc., half the 4,500 patients were given a 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 to 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.

Even so, the researchers said the findings favored quick use of statins.

“Until recently, little information was available about the timing of initiating statin drugs after a heart attack,” said researcher Dr. James de Lemos of the University of Texas Southwestern Medical Center, Dallas. “The findings from the ... trial suggest that statins can be initiated earlier and in dosages well above the typical starting dose,” he said, adding patients should be closely monitored for side effects.

An editorial accompanying the study, both of which were published 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.

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

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