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Reassuring Data On Cholesterol Drug

Heart patients worried about the safety of cholesterol-lowering medicines known as statins should be reassured by new research showing that one of the more established brands is not harmful, experts said Monday.

Heart patients have been nervous since a newer statin, Lipobay — known as Baycol in the United States — was pulled off the market three weeks ago after being linked with deadly muscle destruction. Some patients have stopped taking statins altogether, despite the overwhelming evidence that they save lives.

The latest study, led by doctors at Brigham and Women's Hospital in Boston, examined Pravachol, generically known as pravastatin, the most comprehensively studied of the statin drugs. Results were presented Monday at a meeting of the European Society of Cardiology.

The findings, involving 20,000 patients followed for five years, were based on the safety evidence from three trials combined, so that any adverse effects could be more easily noticed.

The scientists found that there were no more serious side effects among those taking the drugs than among those getting fake pills.

"A study like this is quite significant in terms of reassuring patients that statins that have been used for 10 to 15 years are, in fact, safe and that the concern over a recently developed statin should not be translated to those that have been used for years around the world," said Dr. Sidney Smith, chief science officer of the American Heart Association, who was not connected with the research.

"We probably can never get enough information, and there is always a risk/benefit situation with all drugs," Smith said.

Dr. John Simes, director of the National Health and Medical Research Council Clinical Trials Center at the University of Sydney in Australia, who conducted one of the original Pravachol studies, said the latest findings effectively rule out any problems that could have outweighed the benefits of the medication.

Statins, which dramatically lower cholesterol, have been shown to reduce the risk of heart attack and stroke by 30 percent.

There are four other statins being given to patients — Lipitor, Zocor, Mevacor and Lescol.

Experts say each statin drug should be considered individually because they differ slightly in chemical structure.

Bayer Pharmaceutical recalled Lipobay (and Baycol) Aug. 8, after it was linked to 31 U.S. deaths and at least nine more in other countries.

Baycol was tied to rhabdomyolysis, a life-threatening condition in which muscle cells are destroyed and released into the bloodstream. The condition, which can cause extreme muscle pain, is occasionally so severe that patients develop potentially fatal kidney failure.

Some cases were attributed to incorrect dosage, while others were blamed on mixing the drug with other medications. About one in 30,000 bad reactions could be attributed directly to the tablet, according to Bayer.

"If people stop taking their medicines because of wht they've heard, then this study becomes much more important," said one of the investigators of the latest study, Dr. Marc A. Pfeffer, a cardiologist at Brigham and Women's and a professor of medicine at Harvard Medical School.

The study was not initiated in response to the recent fears over statins, but was planned in 1995. It was funded by the drug's maker, Bristol-Myers Squibb Company.

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