Thursday, March 18, 2004

Even though some cholesterol is necessary for life, too much can take it away. Almost a decade ago, statins were pronounced miracle drugs for their pronounced ability to reduce levels of “bad cholesterol” in the form of low-density lipoprotein (LDL). While health professionals routinely prescribed statins like Lipitor and Pravachol to their patients to lower their LDL levels to below 100 milligrams per deciliter of blood, they had no evidence of which medication was more effective and only a flimsy factual foundation for the baseline of 100.

Now they do, in what medical experts have called a “sea change” in the treatment of heart disease. It was brought about by publication of the results of two head-to-head trials between Lipitor (atorvastatin) and Pravachol (pravastatin). The first, published earlier this month in the Journal of the American Medical Association (JAMA), showed that Lipitor was better than Pravachol at preventing the progression of coronary atherosclerosis — the thickening of arteries near the heart. The second study, a two-year survey of more than 4,100 heart patients done by a group of researchers at the Harvard Medical School, made the point in even more convincing fashion. To be published in the April 8 issue of the New England Journal of Medicine (NEJM), the study showed that heart patients given high doses of Lipitor, which lowered their LDL levels to the seemingly abnormally low 62 milligrams per deciliter, were 30 percent less likely to die of heart disease than their counterparts on Pravachol.

Researchers are still not sure of the mechanism that makes Lipitor better at preventing heart disease than Pravachol. Statins as a whole are thought to reduce the injurious effects of inflammation, but there is no indication that one drug is better than the other at doing so.

Most researchers had anticipated that the Harvard study would demonstrate that there was no difference between the two medicines. That expectation had led Bristol-Myers Squibb, the maker of Pravachol, to sponsor the study. Before they agreed to do it, the Harvard researchers insisted that the study be published regardless of the results.

While the drug company’s stock price went down when the study was released, patients and clinicians gained long-lasting guidance that should extend many lives. As the accompanying NEJM editorial noted, “These two studies strongly reinforce the need to engage in more head-to-head trials of drugs within the same class … It is well worth the resources and effort to illuminate such therapeutic choices.” It will also be worth the efforts of researchers to secure similar publication agreements from corporate sponsors of scientific studies.

The two studies are likely to save both lives and the expense of unnecessary hospital visits, giving another demonstration of the prescription drug provision included in the recently passed Medicare reform bill. (Lipitor is covered.) Policy-makers and scientists should continue to search for ways to put miracle drugs like statins in the hands of consumers, along with the best possible scientific guidance.

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