_____From The Post_____   • Reports to Broaden Statin Use (The Washington Post, Jul 9, 2002) • Lower Cost, Yes. Lower Cholesterol, Maybe (The Washington Post, Mar 12, 2002) • More People Could Benefit From Statins, Study Finds (The Washington Post, Nov 14, 2001) • New Warnings on Cholesterol Drugs Sought (The Washington Post, Aug 21, 2001) • Need to Know (The Washington Post, Aug 14, 2001) • Cholesterol Drug Taken Off Market (The Washington Post, Aug 9, 2001) • Statins, at the Heart of a New Cholesterol Campaign (The Washington Post, Jul 31, 2001) • Blood Test May Help Spot Hearts at Risk, Scientists Say (The Washington Post, Jun 28, 2001) • A Heart Drug Far Surpasses Expectations (The Washington Post, May 19, 2001)   _____More on Statins_____   • Should You Take Statins? • On the Web: American Family Physician on Statins • On the Web: Can Statins Prevent Strokes?   _____  Lean Plate Club E-mail _____ Get healthy eating tips weekly from columnist Sally Squires. • Sample • Subscribe     _____Full Coverage_____   • More Health News   _____From Our Advertisers_____   • Find health and fitness experts in the Washington area.   E-Mail This Article   Printer-Friendly Version   Subscribe to The Post

By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, September 3, 2002; Page HE01

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 -- about 9 percent of that country's population -- 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 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."

It is not known how statins cause nerve damage, which is sometimes reversible. Golomb said reversibility depends on several factors, including the length of time someone took the drug and the size of the dose. People who took large doses for a long time may be left with permanent nerve damage even after they stop taking the drug.

Gaist, a neurologist at Denmark's Odense University Hospital, first noticed that seven patients who were taking statins in the mid-1990s developed nerve damage for which there was no other apparent explanation. The most common causes of neuropathy are diabetes, thyroid problems and alcohol abuse, which were ruled out in these patients.

He and his colleagues then launched a population-based study made possible by the large health registries maintained by the governments of Scandinavian countries.

Gaist and his colleagues matched 166 first-time neuropathy patients whose symptoms had no apparent causes other than statin use with a matched control group of people with no nerve damage. After excluding patients with diabetes or other conditions or medications known to cause nerve problems, they determined which patients had taken statins. Of the 166 people with neuropathy, nine had taken statins for an average of 2.8 years.