On statins

Seeking a Fuller Picture of Statins

Statins save lives and improve the quality of lives. I am certain of that statement. Especially when used as secondary prevention, this drug class decreases subsequent infarctions and their sequelae. The recent recommendations to lower our goal LDL in secondary prevention has brought the anti-statin lobby out of a closet.

Like every drug class, statins have occasional side effects. All drugs have side effects. In medicine we must always balance the expected benefit with the potential side effects. Clearly statins provide more benefits than side effects.

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.

Some consumer groups have said 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.

Over all, 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.

“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.

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.

“I’m pro-statin, but I don’t want to go beyond what the evidence says,” said Dr. Beatrice A. 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.”

Six statins are currently on the market: Lipitor by Pfizer; Zocor, by Merck; Crestor by AstraZeneca; Pravachol by Bristol-Myers Squibb; Lescol, by Reliant Pharmaceuticals; and Mevacor, also by Merck. The drugs cost $500 to $1,000 or more for a year’s supply, depending on the brand and the dosage. Statins slow the production of cholesterol in the body and increase the liver’s ability to remove L.D.L., the type of cholesterol linked to heart disease, from the blood.

In the vast majority of patients, doctors say, statins appear to produce few or no side effects. But in clinical trials, some patients reported gastrointestinal problems, headaches and nausea. It was unclear if these problems were caused by the medications, because subjects who were taking placebos reported similar side 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. But safety guidelines written in 2002 and posted on the N.I.H. 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-H.I.V. drugs protease inhibitors and some medications used to treat fungal infections.

I would hesitate to go the British route and make statins OTC. Nonetheless, I feel comfortable prescribing statins at high doses to most patients. Like any drug, we (physicians) have the responsibility to monitor for potential side effects with history, physical exam and sometimes laboratory testing.