August 30, 2001
BY: WES ALLISON

Despite the Baycol scare, experts say patients put themselves at far greater risk if they stop taking similar cholesterol-lowering drugs.

Dr. Rose Marie Robertson's colleague approached her last week with a frightening problem: Of the 10 patients he had seen one morning, half had quit taking their cholesterol-lowering medication out of fear they would suffer muscle failure and maybe die.

"That's dangerous," said Robertson, a cardiologist and immediate past president of the American Heart Association. "The overall benefit of these cholesterol-lowering drugs is enormous, and the risk is tiny." But many people apparently don't realize that, doctors say. After this month's well-publicized withdrawal from the market of Baycol, which was linked to at least 31 deaths, some patients have quit taking similar cholesterol-lowering medications, which are prescribed for millions of Americans.

That worries cardiologists and family practitioners who say the risk of suffering a stroke or heart attack because of high cholesterol is much, much greater than suffering a serious adverse reaction from one of the half-dozen other medications like Baycol, called statins, still on the market.

The confusion comes just as cardiac experts are advising doctors to prescribe statins for millions more patients than are now on them. Sales of the drugs totaled $ 9-billion in 2000, according to IMS Health.

Nationally, and throughout the Tampa Bay area, doctors say they have been flooded with calls from worried patients. Some quit taking statins, which include Zocor, Lipitor and Pravachol, while others were simply confused.

"We have been inundated. They're concerned about whether or not they should continue taking the medication they're on," said Mary Reis, an advanced registered nurse practitioner who runs the cardiac preventive services clinics at the Heart & Vascular Institute of Florida in Safety Harbor.

"I have assured them that . . . we're practicing evidence-based medicine by putting people on drugs that were well-studied, and the data supporting the benefit is very strong," she said. "Do not stop these medications. The benefits far outweigh the risk."

In May, the National Institutes of Health issued guidelines urging more aggressive treatment of high cholesterol, citing five large national studies proving that reducing cholesterol lowers the risk of cardiovascular disease, including heart attacks and stroke.

Diet and exercise should be encouraged first, but the NIH report recognized that lifestyle changes alone weren't doing enough.

In the past, the government had recommended doctors consider medication for anyone whose bad, or LDL, cholesterol was 160 milligrams or higher. The new guidelines dropped the limit to 130mg.

That bumped the number of Americans who would qualify for statins from 13-million to 36-million.

Statins were introduced in the late 1980s. Researchers have known since then that statins could cause muscle tissue to break down, called called rhabdomyolysis, which could lead to kidney failure and other problems. But it was rare, and rarely fatal.

With Baycol, however, reports of serious rhabdomyolysis were about 10 times as frequent as other statins, according to the Food and Drug Administration. Bayer AG identified 31 deaths linked to the drug when it voluntarily pulled Baycol off the market on Aug. 8.

Robertson, director of the Women's Heart Institute at Vanderbilt University in Nashville, said patients should not be too concerned about rhabdomyolysis with other statins.

"The risk of this muscle failure is predictable," she said. "The person starts to have some muscle pain, and you stop it. It does not sneak up on you."

Dr. Kevin F. Garner, a cardiologist at the St. Petersburg-Suncoast Medical Clinic and assistant clinical professor at the University of South Florida, said his office received numerous calls from patients, and he will not be surprised if more show up for appointments and tell him they quit taking their statins.

Like other local cardiologists, he frequently prescribes these drugs and says they work for patients.