FDA PANEL RECOMMENDS CAPOTEN(R) FOR POST-HEART ATTACK PATIENTS

    PRINCETON, N.J., Feb. 19 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration's (FDA) Cardio-Renal Advisory Committee has recommended the approval of Capoten(R) (captopril) for an important new use in selected patients following a heart attack to improve survival and reduce hospitalizations for heart failure.
    Capoten, discovered by Bristol-Myers Squibb Company, was the first ACE (angiotensin converting enzyme) inhibitor developed and approved for use in the United States.  Capoten has been used to treat millions of patients for high blood pressure and congestive heart failure.  The panel recommendation can lead to approval for a novel indication of use for Capoten in post-heart attack patients with compromised heart function.
    "We are pleased with the committee's recommendation to approve Capoten for patients following an acute myocardial infarction or heart attack," said Kenneth M. Given, M.D., senior vice president for Worldwide Regulatory Affairs for Bristol-Myers Squibb Pharmaceutical Group.  "Our experience with Capoten demonstrates that we can improve the survival of selected patients following acute myocardial infarction, and decrease hospitalizations for heart failure."
    The decision of the FDA's Cardio-Renal Advisory Committee was based largely on the results of the landmark five-year, multicenter Survival and Ventricular Enlargement (SAVE) trial, in which 2,231 patients were randomized to receive either Capoten or placebo 3-to-16 days after a myocardial infarction.  Patients who were treated did not have overt heart failure, but they had documented damage and impaired function of the left ventricle, the heart's main pumping chamber.  When compared to patients treated with placebo, patients treated with Capoten had a significant reduction (19 percent) in the risk of death from all causes and a reduction in cardiovascular death (21 percent).  Treatment with Capoten also reduced morbidity due to major cardiovascular events, such as the development of severe heart failure requiring hospitalization (22 percent).
    The results of the SAVE trial were published in the Sept. 3, 1992, issue of The New England Journal of Medicine.  The lead investigators, Marc A. Pfeffer, M.D., and Eugene Braunwald, M.D., both of Harvard Medical School and Brigham and Women's Hospital in Boston, presented their findings today to the Cardio-Renal Advisory Committee.
    Commenting on the Advisory Committee recommendation, Given said, "It appears to indicate that there is a role for Capoten at almost every step of the cardiovascular disease process -- from high blood pressure to heart attack and asymptomatic left ventricular dysfunction to overt heart failure."
    Bristol-Myers Squibb is a research-based, diversified health care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices.  It is among the world's leading makers of cardiovascular, anticancer, anti-infective, central nervous system and dermatological drug therapies, diagnostic agents and non-prescription medicines.
    /delval/
    -0-                       2/19/93
    /CONTACT:  Robert F. Laverty of Bristol-Myers Squibb, 609-252-5551/
    (BMY)

CO: Bristol-Myers Squibb Company; U.S. Food and Drug Administration ST: New Jersey IN: MTC SU:

CC-MK -- PH022 -- 8460 02/19/93 14:34 EST