 | Healthy Heart | | |
What Does PROVE-IT Prove for Your Heart?
March 12, 2004
Last reviewed by Faculty of Harvard Medical School on May 28, 2008  By Thomas H. Lee, M.D.
Brigham and Women's Hospital The results of the PROVE-IT study were front page news in 2004. The findings may have been forgotten with so many studies confirming how much statin drugs reduce the risk of heart-disease complications. This study, however, remains one that should continue to receive our attention. Its implications may change your heart health care. PROVE-IT stands for Pravastatin or Atorvastatin Evaluation and Infection Therapy, and was led by researchers at Harvard Medical School. The study design was a bold bet by Bristol Myers Squibb, the manufacturer of pravastatin (Pravachol), one of the older statin medications. When the study was conceived, Bristol Myers Squibb believed that pravastatin had greater impact on inflammation in arteries, and therefore would be at least as good, if not better, in reducing future heart attacks, even if it didn't lower LDL cholesterol as much. Two years ago, the new kid on the block that had been grabbing all the patients was atorvastatin (Lipitor). Lipitor lowers LDL cholesterol much more than Pravachol, but Bristol Myers Squibb bet that its statin would work just as well where it counted — to reduce risk of death, repeat heart attack, and the need for angioplasty or bypass surgery. And the company spent many millions of dollars on a trial to "prove it." The company lost the bet — big time. In this trial, 4,162 patients with recent unstable angina or heart attacks were randomly assigned to take either 40 milligrams (mg) of pravastatin or 80 mg of atorvastatin per day. LDL levels fell in both groups – but much more in those taking atorvastatin. The median LDL levels were 95 milligrams per deciliter (mg/dL) versus 62 mg/dL in those taking pravastatin and atorvastatin, respectively. After two years, 26% of those taking pravastatin had a cardiovascular problem, versus 23% of those using atorvastatin. That difference may not sound like much, but it represents a 16% reduction in risk. So what did PROVE-IT prove? Primarily, it showed that 80 mg of atorvastatin is probably a better strategy than 40 mg of pravastatin for people who have had unstable angina or a heart attack — what doctors call acute coronary syndrome or ACS. We don't really know whether the better outcome was due to the lower LDL cholesterol level, or other properties of the drugs that don't have anything to do with LDL cholesterol. Most cardiologists I know are NOT switching patients from one statin to another because of PROVE-IT. However, they are pushing to get the LDL levels of their patients down. In the past, it was "nice" if patients got their LDL below 100. Now physicians and patients aim at getting those levels a bit lower. Despite the benefits, patients should be aware of the potentially serious side effects of statins. As the dosage goes up, LDL goes down — but the risk of muscle and liver damage increases. If you have heart disease, you don't need to call your doctor immediately to add or change medications, but at your next office visit discuss whether the results from PROVE-IT apply to you. You may want to set a new, lower goal for your LDL cholesterol. Thomas H. Lee, M.D., is the chief executive officer for Partners Community HealthCare Inc. He is a professor of medicine at Harvard Medical School. He is an internist and cardiologist at Brigham and Women's Hospital. Dr. Lee is the chairman of the Cardiovascular Measurement Assessment Panel of the National Committee for Quality Assurance.
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