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On statins, a dose of caution

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On statins, a dose of caution
Source: International Herald Tribune
 
David Tuller NYT
Thursday, July 22, 2004

Among cardiologists, it has become a running joke: Maybe the powerful drugs known as statins should be added to the water supply. Not only do statins greatly reduce cholesterol and lower mortality in people at risk for heart attacks, but some studies also suggest that they might help to prevent or treat a wide range of ailments, including Alzheimer's disease, multiple sclerosis, bone fractures, some types of cancer, macular degeneration and glaucoma.
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Millions of people around the world take statins. With U.S. goverment recommendations issued last week, millions more are likely to begin taking the drugs, and many who already take them are likely to have their dosages increased.
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On July 12, the National Institutes of Health, in conjunction with the American Heart Association and the American College of Cardiology, endorsed sharply lowering the desired levels of harmful cholesterol for people at moderate to high risk for heart disease. The recommendations were based on clinical trials involving more than 50,000 people.

Yet some experts say statins are more complex than their status as the latest wonder drugs suggests. Like all drugs, they can have side effects that are in some cases potentially serious.
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Some consumer groups have said that the new recommendations, published in the journal Circulation, are tainted by the influence of drug companies that make statins and finance research on the drugs.
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Overall, experts say, statins have proved to be remarkably safe. A majority also agree that the drugs are proving ever more useful and have saved many lives, particularly among middle-age men at risk for heart disease, the group most widely studied.
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"From everything we're seeing in the clinical trials, the trend is that the statins are being shown to be helpful in many more situations," said Dr. Dana McGlothlin, a cardiologist at the University of California, San Francisco Medical Center.
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But some researchers say side effects occur more frequently than patients and even doctors realize, and they note that whether the drugs produce any long-term toxicity over 20 or 30 years remains unknown.
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"I'm pro-statin, but I don't want to go beyond what the evidence says," said Beatrice Golomb, an associate professor at the University of California, San Diego, and the principal investigator of a large federally financed study of the effect of statin use on cognition, mental state and other noncardiac processes. "There's a multibillion-dollar industry ensuring that you hear all the good things, but no corresponding interest group ensuring that you hear the other side."
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Six statins are on the market: Lipitor (atorvastatin calcium) by Pfizer; Zocor (simvastatin) by Merck; Crestor (rosuvastatin calcium) by AstraZeneca; Pravachol (pravastatin sodium) by Bristol-Myers Squibb; Lescol (fluvastatin sodium) by Reliant Pharmaceuticals; and Mevacor (lovastatin), also by Merck. Statins slow the production of cholesterol in the body and increase the liver's ability to remove LDL, the type of cholesterol linked to heart disease, from the blood.
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In the vast majority of patients, doctors say, statins appear to produce few or no side effects. But in trials, some patients reported gastrointestinal problems, headaches and nausea. It was unclear if these problems were caused by the medications, because subjects taking placebos reported similar effects. About 1 percent of people on the drugs, clinical trials indicate, develop elevated liver enzymes, and one in 1,000 have drug-related muscle pain and other problems, according to a review by the National Institutes of Health.
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But safety guidelines written in 2002 and posted on the institutes' Web site note that it has not been determined whether the raised liver enzymes that statins can produce are in fact linked to liver toxicity. Some studies have found that the side effects of statins can be exacerbated by some other medications, including the anti-HIV drugs protease inhibitors and some medications used to treat fungal infections.
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One statin, Bayer's Baycol, was removed from the market in 2001 after reports that 31 people taking it had died from rhabdomyolysis, a disorder involving muscle-tissue breakdown that can lead to kidney failure.
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Another statin, Crestor, has come under attack by Public Citizen, a Washington consumer group.
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In a letter published in April in The Lancet, Sidney Wolfe, director of Public Citizen's health research group, asserted that Crestor had caused 18 cases of severe muscle deterioration and a dozen cases of kidney damage since it went on the market. The organization has petitioned the Food and Drug Administration to ban Crestor.
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AstraZeneca, Crestor's maker, says that the drug is safe and dismisses the accusations made by Public Citizen as groundless.
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The Food and Drug Administration has not ruled on Public Citizen's petition. But the National Institutes of Health estimated that rhabdomyolysis is extremely rare in patients taking statins now on the market, occurring in fewer than one out of every one million people on the drugs.
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Golomb said she had been documenting cases of adverse events associated with statin use. She said she had collected detailed data on about 500 people who report having experienced muscle aches, memory problems, irritability, neuropathy or other symptoms while taking the drugs. In many cases, Golomb said, the problems resolved after the patients stopped the statin, and came back if they returned to the drug or took another statin.
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One participant in the study, Jane Brunzie, 66, of Vista, California, said she had begun having frequent "senior moments" while on a regimen of 30 milligrams of Lipitor. The problem got so bad, she said, that her daughter refused to let Brunzie baby-sit for her 9-year-old granddaughter and her family began looking into residential facilities for people with dementia. "I was constantly struggling to remember a person, a place, an event, a word," Brunzie said. "It got so bad I couldn't carry on a normal conversation."
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At her son's prompting, Brunzie said, she stopped the medication several months ago and the problem cleared up within a week.
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Researchers say that such case studies do not offer proof that statins are causing the problems; the only way to show that is through randomized clinical trials. And drug makers generally dismiss such concerns as greatly overstated. Large-scale clinical trials and years of real-world use by millions, they say, have provided proof of statins' safety in all but the rarest instances.
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"We have over 70 million patient-years of experience worldwide, so we're able to comment on our efficacy and safety profile with confidence," said Dr. Gary Palmer, a vice president with the cardiovascular medical group at Pfizer, which makes Lipitor.
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The New York Times



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