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Study links statins to nerve damage

Tuesday, September 10, 2002

By Sandra G. Boodman, The Washington Post

Cholesterol-lowering drugs called statins have been hailed as an enormous advance in the treatment of heart disease and stroke, medications so beneficial that some doctors have jokingly suggested putting them in the water supply.

But a recent large study by Danish physicians has cast the drugs taken by 16 million Americans in a less favorable light.

Researchers who studied 500,000 residents of Denmark found that people who took statins were more likely to develop a form of nerve damage called polyneuropathy than those who never took the drugs. Polyneuropathy, also known as peripheral neuropathy, is characterized by weakness, tingling and pain in the hands and feet as well as by difficulty walking.

Taking statins for one year raised the risk of nerve damage by about 15 percent -- about one case for every 2,200 patients. For those who took statins for two or more years, the additional risk rose to 26 percent. The Danish study, published earlier this year in the journal Neurology, is not the first to implicate statins in the development of nerve problems, but as one of the largest statin studies to date it is regarded as significant.

Last year the cholesterol-lowering drug Baycol was withdrawn from the market after it was linked to 31 deaths caused by rhabdomyolysis, a rare and severe breakdown of muscle that can lead to kidney failure and death. No deaths were reported in the Danish study, which involved a number of different statins rather than a single drug.

Several other studies, involving a total of 50,000 patients, have not found nerve damage to be a common side effect of statins, sold under the brand names Lipitor, Zocor and Pravachol, although the problem is mentioned on the labeling of all of these drugs. These studies also have found that statins reduced by 30 percent the risk of stroke and heart disease, the leading causes of death in the United States.

Despite the increased incidence of nerve damage, David Gaist, lead author of the Danish study, said that for many patients the benefits of statins may outweigh the risk of neuropathy, an uncommon side effect. He and other experts advise patients who experience neurological problems while taking a cholesterol-lowering drug to promptly inform their physician.

"This study does raise the awareness that polyneuropathy may occur, but other studies have not found it to be a significant problem," said cardiologist Sidney Smith, a professor of medicine at the University of North Carolina at Chapel Hill.

"The cardiovascular advantage is so substantial that we need to be sure that patients who need statins get them," added Smith, chief scientific officer for the American Heart Association.

Vanessa McGowan, a spokeswoman for Pfizer, which makes Lipitor, the world's best-selling statin, noted that fewer than 2 percent of the 80,000 Lipitor patients enrolled in Pfizer's ongoing study of the drug have reported a neurological symptom. "If there's any question, people should work with their physician," she said.

To Beatrice Golomb, an assistant professor of medicine at the University of California, San Diego, the Danish results underscore the importance of patients' reports of possible statin side effects.

"This is a very important, well-done study," said Golomb, the principal investigator of two large federally funded studies into the effects of statins on non-cardiac functions.

Nerve problems, Golomb said, "are one of the three most common side effects we hear about from patients, but until now there was only a smattering of reports in the case literature."

In many cases, she said, patients told her they had complained to their doctors about neurological problems, only to be told that their symptoms could not be related to cholesterol-lowering medication.

"The benefits of statins get a lot of publicity because there is a multibillion-dollar industry backing them, but there isn't a corresponding interest group" to counter the tidal wave of positive publicity, Golomb said.

Even so, she added, "I'm not sure I would change prescribing practices based on [the Danish study]. But physicians need to be alert to the possibility of problems and to revisit the risk-benefit question if problems arise."

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