Trial Fails to Support Earlier Studies That Show Statins Work

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Despite Study, Docs Still Like Statins

Big Trial Fails to Support Earlier Studies That Show Statins Work

By  DeNoon

WebMD Medical News

Reviewed By Brunilda  Nazario, MD

Dec. 17, 2002 -- Whoops. A major study was supposed to prove that cholesterol-lowering statin drugs save lives. It didn't.

The report, in the Dec. 18 issue of the Journal of the American Medical Association, looks at the much-used statin sold as Pravachol. It finds that the drug doesn't reduce either heart disease or death in a cross-section of older people whose high blood pressure is under control and who have moderately high cholesterol levels.

Does this mean statins don't work -- or that Pravachol isn't as good as other statins? No, experts say. Study leader Barry R. , MD, PhD, of the University of Texas-Houston Health Science Center, urges patients with high cholesterol to keep taking their medicine, whether it is Pravachol or another statin.

"The bottom line is that cholesterol-treatment guidelines should remain the same," tells WebMD. "This study says that people who are on statins should remain on them. All studies show statins are good at lowering cholesterol and that it is good to lower cholesterol to avoid heart disease and death."

The study looked at 10,355 people age 55 or older enrolled in a study comparing different kinds of blood-pressure drugs. All had too-high levels of LDL cholesterol -- the "bad" kind of cholesterol. About half the patients got Pravachol while the other half got "usual care." Usual care meant being placed on a specific national guidelines cholesterol-lowering diet.

Pravachol did what it is supposed to do. Patients who took the drug saw their LDL cholesterol levels fall by 28%. But those in the usual-care group had their LDL cholesterol levels drop by 11%. The end result: the Pravachol patients had about the same rate of death and heart disease as the usual-care group after nearly five years.

What happened? When the study began in the early 1990s, "usual care" didn't mean taking statins. That changed over the course of the study. It was an open-label study, in which patients knew what they were and weren't taking. Nearly a third of the usual-care patients started taking the lipid-lowering drugs -- particularly those at highest risk of heart disease. At the same time, many patients getting statins stopped taking their medication.

Accompanying the study in JAMA is an editorial by C. Pasternak, MD, associate professor of medicine at Harvard University and director of preventive cardiology at Massachusetts General Hospital, Boston. Pasternak notes that the open-label study is much closer to real life than a placebo-controlled trial. He says it shows that doctors have to do a better job of making sure their patients take their medicine.

"We have a huge problem -- a compliance epidemic," Pasternak tells WebMD. "People stop taking their statins. It's no one thing; there are a dozen different reasons for different people in different places. Research suggest that in people without active heart disease, half stop taking their stains only six months after their first prescription. After two years, only a third are still taking their pills. That is what we need to focus on."

So what's the bottom line? and Pasternak wholeheartedly agree: If you lower your cholesterol to recommended levels, you'll significantly lower your chances of heart disease and death. Treatment with statins can help many patients reach these lower cholesterol levels.

SOURCES: Journal of the American Medical Association, Dec. 18, 2002 • Barry R. , MD, PhD, of the University of Texas-Houston Health Science Center • C. Pasternak, MD, associate professor of medicine at Harvard University and director of preventive cardiology at Massachusetts General Hospital, Boston.

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