If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Pravachol Cleared by FDA to Reduce the Risk of Heart Attacks PRINCETON, N.J., April 16, 1996 -- Bristol-Myers Squibb (NYSE: BMY) today announced that its widely prescribed cholesterol-lowering drug Pravachol(R) (pravastatin sodium) has been shown to reduce the risk of heart attack and slow the build-up of plaque in the arteries of patients with elevated cholesterol and heart disease. Pravachol has been cleared for marketing for this new indication by the U.S. Food and Drug Administration (FDA); it is the first and only HMG CoA reductase inhibitor to be granted this indication. The new indication for Pravachol is based on the results of the Pravastatin Atherosclerosis and Myocardial Infarction (MI) Reduction Program, which included four independent clinical trials, each conducted for two to three years in 1,891 patients. In this analysis, in addition to showing a statistically significant slowing of coronary atherosclerosis, Pravachol significantly reduced by 62% the risk of fatal and non-fatal heart attacks (event rate 6.4% in the placebo group vs. 2.4% in Pravachol patients). The researchers suggest that the benefits of Pravachol in reducing the risk of heart attack may be observed early, beginning one year after starting therapy. "Traditionally, with dietary management and other means of lowering cholesterol, it could take as long as two to three years to observe the positive impact that lowering cholesterol could have on reducing cardiovascular events, such as heart attack. However, for patients taking Pravachol, in addition to dietary control, we now have shown reductions in cardiovascular events beginning at one year of therapy," said Bertram Pitt, MD, Professor of Internal Medicine, University of Michigan at Ann Arbor and one of the study investigators. "We are very excited to announce this new indication which confirms the benefits of Pravachol for reducing heart attacks in hypercholesterolemic patients with coronary heart disease. This is especially important since it is estimated that 11 million Americans have elevated cholesterol levels and evidence of heart disease, placing them at increased cardiovascular risk," said Sol Rajfer, MD, Senior Vice President, Worldwide Clinical Research and Development, Bristol-Myers Squibb. "In addition to this new indication for Pravachol, we now have new data from two recently reported landmark clinical trials which show that the benefits of Pravachol can be extended to a broader range of patients, including those with hypercholesterolemia who are at risk for a first heart attack and those who have had a heart attack, but do not have high cholesterol levels," he added. An application to obtain FDA clearance for additional claims has been filed. Pravachol was also recently shown to reduce the risk of a patient experiencing a first heart attack (known as primary prevention). In this trial of 6,595 patients with elevated cholesterol, but without evidence of heart disease, Pravachol reduced the risk of a first heart attack by nearly one-third. The pravastatin primary prevention study was published in the November 16, 1995, issue of The New England Journal of Medicine, in an article entitled "Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia." In addition, at the recent American College of Cardiology meeting, the Cholesterol and Recurrent Events (CARE) study results were reported. This study evaluated the benefits of Pravachol in patients who have survived a first heart attack, but do not have elevated cholesterol levels. Pravachol significantly reduced the risk of dying from heart disease or having another heart attack and the need for bypass surgery or balloon angioplasty. These results are particularly striking because patients in the CARE study represent a large portion nearly 75% of heart attack survivors in the U.S. today. The new indication for reducing heart attack and slowing plaque progression is based on a four study analysis published in the November 1, 1995, edition of the journal Circulation, in an article entitled "Reduction in Cardiovascular Events During Pravastatin Therapy." The analysis included data from four double-blind, placebo-controlled trials, all of which examined the effects of pravastatin on atherosclerosis and coronary events. The four studies were: PLAC I (Pravastatin Limitation of Atherosclerosis in the Coronaries), PLAC II (Pravastatin, Lipids and Carotid Atherosclerosis), REGRESS (Regression Growth Evaluation Statin Study), and KAPS (Kuopio Atherosclerosis Prevention Study). All studies were also published independently in peer-reviewed journals. Bristol-Myers Squibb licensed pravastatin from its discoverer Sankyo Company, Inc., of Japan. Bristol-Myers Squibb has exclusive marketing rights in all major pharmaceutical markets worldwide, with the exception of Japan. Pravachol therapy is well-tolerated by most patients. However, the drug should not be used by people with active liver disease or liver problems, in women who are pregnant or breast feeding, or people who are allergic to any component of the medication. The most common side effects include mild skin irritation and transient rash and gastrointestinal upset. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products.
|
