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FDA Approves Pravachol (Pravastatin) 80 mg for Heart Disease

PRINCETON, NJ -- February 11, 2002 -- Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved Pravachol® (pravastatin sodium) 80 mg, a new dosage strength of one of the leading therapies in the fight against heart disease.

Pravachol is the only member of the statin drug class that is indicated to reduce the risk of first or second heart attack and stroke in patients with elevated cholesterol or coronary heart disease, in addition to diet when diet and exercise are not enough. Pravachol 80 mg was developed to provide physicians with an additional option for treating patients who require higher dose statin therapy.

Pravachol is one of the most extensively studied drugs of its kind, and has been the subject of three landmark studies -- the West of Scotland Coronary Prevention Study (WOSCOPS), the Cholesterol And Recurrent Events (CARE) trial, and the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) trial -- as well as numerous other clinical trials. Based on safety data from these trials, the FDA approved labeling which reduces the recommendation for ongoing liver function testing with Pravachol. Other statin drugs may recommend more frequent liver function testing.

"Coronary heart disease is the number one killer of men and women in the United States," said Richard J. Lane, president, Worldwide Medicines, Bristol-Myers Squibb. "Pravachol, which has been the subject of several landmark clinical trials, is already well-established as an important option in the fight against heart disease. In addition, Bristol-Myers Squibb remains committed to fully exploring the further benefits of Pravachol through the support of additional clinical trials and research."

According to the American Heart Association, approximately 1.1 million Americans suffer a heart attack each year and approximately 40 percent of those heart attacks are fatal. In May 2001, the National Cholesterol Education Program issued new guidelines that suggest that more people should begin taking long-term statin therapy to reduce the alarming death rates caused by heart disease. Based on the new guidelines, the number of Americans who are candidates for statin therapy could increase from 13 to 36 million patients.

Pravachol, a prescription drug, is not for everyone, including women who are pregnant or nursing or may become pregnant, or people with liver problems. Because serious side effects can result, patients should tell their doctor about any unexplained muscle pain or weakness they experience while on Pravachol, and about any other medications they are taking. Doctors may do blood tests to check for liver problems.

It is recommended that liver function tests be performed prior to initiating therapy, prior to increasing the dose, and when otherwise clinically indicated. If a patient develops increased transaminase levels, or signs and symptoms of liver disease, more frequent monitoring may be required, and withdrawal of pravastatin therapy is recommended if an increase in AST or ALT of three times the upper limit of normal or greater persists. Some mild side effects, such as slight rash or stomach upset, occurred in two to four percent of patients.

SOURCE: Bristol-Myers Squibb Company

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