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Statins Work, If You Take Them

New study suggests clinical trials may overstate real-world results

TUESDAY, Dec. 17, 2002 (HealthDayNews) -- Statins work as advertised to lower cholesterol.

However, that doesn't automatically translate into a reduction in their risk of heart problems or death compared with conventional therapy to lower blood fat, a new study has found.

Still, experts say the results don't undermine the broad utility of statins, which are among the most widely prescribed drugs on the planet. Rather, the study suggests doctors need to do a better job of keeping patients on the medications if they expect the same performance produced by rigorous clinical trials.

"This is not in any way a blemish on statins or pravastatin [the drug used in the study]," says Dr. Richard C. Pasternak, a Harvard University cardiologist. "It's more a blemish on our ability to maintain best practice."

Pasternak wrote an editorial accompanying the study, which appears in tomorrow's issue of the Journal of the American Medical Association.

Statins have shined in previous studies, leading to marked reductions in total cholesterol and the LDL, or the "bad" form of blood fat. However, those trials have been in tightly controlled settings that don't necessarily reflect the real world. They also typically involved people with high or extremely high cholesterol.

The latest study, called ALLHAT, was the second-largest cholesterol-lowering trial yet conducted, involving 10,355 people treated at 513 clinics in North America. Volunteers had moderately high cholesterol and elevated blood pressure that was under control with medication. They also had at least one risk factor for heart disease, such as Type II diabetes.

Half the patients -- men and women aged 55 and older -- received 40 milligrams a day of pravastatin, sold as Pravachol by Bristol-Myers Squibb. The rest received "usual care," which consisted of lifestyle changes such as a low-fat diet and exercise. Nearly a third of those in this group switched to pravastatin during the eight-year study.

After four years, patients on the statin drug saw their total cholesterol drop by about twice as much as those in the other group, 17 percent versus 8 percent. And in a subset from whose LDL cholesterol was sampled, the drop was even better: 28 percent versus 11 percent.

However, the gap between the two groups for total cholesterol was less than half the average of eight other large studies comparing statins with other therapies.

The number of people in either group who died was essentially identical, with a six-year death rate of about 15 percent. Rates of coronary heart disease -- defined as non-fatal heart attacks and deadly artery trouble -- were also close, at 9.3 percent in the statin group versus 10.4 percent in the usual care group, a difference that wasn't statistically significant.

Even so, Dr. Barry Davis, a co-author of the paper, says the benefits of statins are clear and probably understated in the study.

"Statins are very useful at lowering cholesterol and, in the big picture, at lowering cardiovascular morbidity and mortality, especially from heart attacks," he says.

Davis, who ran the ALLHAT center at the University of Texas-Houston Health Science Center, explains that the benefits of the drug were obscured by patients hopping out of the usual care group into the statin arm of the study. That migration was prompted by new evidence of the drug's ability to prevent cardiovascular deaths made public during the late 1990s. "If none had switched, it's highly likely that we would have seen a difference" in mortality, he says.

"The [clinical] trials provide a compelling case for statin use, but in the real world it doesn't appear that patients are getting the full benefit that the trials suggest," says Joshua S. Benner, director of health economics at Epinomics Research, a Virginia-based consulting firm.

The reason: Only one in four people who start taking the drugs are still on them as intended five years later, according to a study Benner helped conduct while a researcher at Harvard Medical School.

That disappointing compliance rate comes despite the fact that statins are relatively easy to take, with few side effects. And in Benner's study, patients received the drugs for free or paid only a few dollars to fill each prescription.

What To Do

To learn more about high cholesterol and how to keep it in check, visit the American Heart Association. You can also try the Heart Information Network.

SOURCES: Barry Davis, M.D., director, ALLHAT clinical trial center, and professor, biometry, University of Texas-Houston; Joshua S. Benner, Pharm.D., Sc.D., director, health economics, Epinomics Research, Alexandria, Va.; Richard C. Pasternak, M.D., director, preventive cardiology, Massachusetts General Hospital, and associate professor, medicine, Harvard Medical School, Boston; Dec. 18, 2002, Journal of the American Medical Association
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