Results of LIPID Study Which Demonstrate Benefits of Pravachol in Reducing Risk of Stroke Presented at the American College of Cardiology Annual Meeting

News Follows Last Week's FDA Clearance of Pravachol to Reduce Risk of Stroke

and Recurrent Heart Attack In Patients With Normal Cholesterol Levels

Apr 01, 1998, 00:00 ET from Bristol-Myers Squibb

    PRINCETON, N.J., April 1 /PRNewswire/ -- Results from the Long-Term
 Intervention with Pravastatin in Ischaemic Disease (LIPID) study,
 demonstrating the benefits of Pravachol(R) (pravastatin sodium) in reducing
 the risk of stroke among people with a history of heart disease were presented
 at the 47th Annual Scientific Sessions of the American College of Cardiology
 in Atlanta, Georgia.  The presentation of the LIPID results offers an
 additional demonstration of the benefits of Pravachol in reducing the risk of
 a stroke in this patient population.
     The presentation of the LIPID results follows last week's clearance by the
 U.S. Food and Drug Administration of Pravachol for an important new
 indication:  for use in reducing the risk of a stroke or a transient ischemic
 attack (TIA), otherwise known as a "miniature" stroke, in patients who have
 had a heart attack and have normal cholesterol levels (less than 240 mg/dl
 total cholesterol) and to reduce the risk of a recurrent heart attack and
 death from heart disease in this patient population.  These patients represent
 the majority of people who had a heart attack.  The new indication is based on
 the results of another landmark study, the Cholesterol and Recurrent Events
 (CARE) trial.  The indication is even more compelling because the majority of
 patients in the CARE trial were already taking aspirin, which is known to have
 a beneficial impact on the reduction of stroke.
     "In population studies, there appears to be a weak relationship between
 cholesterol levels and risk of non-hemorrhagic stroke, which is the major
 cause of stroke," said Dr. Andrew Tonkin, Principal Investigator of LIPID and
 Director of Health, Medical and Scientific Affairs with the National Heart
 Foundation of Australia.  "We know that the risk of stroke in LIPID and CARE
 was significantly reduced in patients with what would be considered to be
 relatively normal cholesterol levels.  The mechanisms underlying this risk
 reduction are not exactly clear.  However, what we do know is that pravastatin
 works to reduce stroke."
     Pravachol, which is a member of the HMG-CoA reductase inhibitor class of
 drugs, is the first drug of its kind to receive FDA clearance for the
 indication to reduce the risk of a stroke or a TIA in patients who have had a
 heart attack and have normal cholesterol levels.  In addition, Pravachol is
 the first and only drug of its kind to receive FDA clearance for use in
 reducing the risk of a recurrent heart attack and death from heart disease in
 patients with normal cholesterol levels.
     "Pravachol appears to be especially effective in its ability to decrease
 stroke risk," said Eric Raps, M.D., Director of Comprehensive Stroke Center,
 University of Pennsylvania Medical Center.  "It is important to note that the
 relationship between cholesterol and the risk of stroke is weak and the
 evidence suggests that Pravachol reduces the risk of stroke through mechanisms
 beyond its effect on cholesterol."
     More than 4 million people worldwide are believed to suffer a stroke each
 year.  Stroke is the third-leading cause of death and the leading cause of
 disability.  Approximately two-thirds of the people who suffer a stroke will
 experience severe disabilities including paralysis, loss of speech and lapses
 of memory.  In the United States, the cost of care and rehabilitation of
 stroke exceeds $30 billion per year.
     The LIPID study was a five-year, double-blind placebo-controlled study of
 9,014 male and female patients who had either suffered a heart attack or had a
 history of unstable angina and had normal or slightly elevated cholesterol
 levels.  The LIPID study was conducted by an independent group of researchers
 under the auspices of the Heart Foundation of Australia and coordinated by the
 National Health and Medical Research Council's Clinical Trials Centre at the
 University of Sydney.
     The CARE study was a five-year, double-blind placebo-controlled study that
 enrolled 4,159 men and women who had suffered a heart attack in the two years
 prior to enrollment.  Patients in CARE had an average total cholesterol level
 of 209 mg/dl, a level that is similar to that of the U.S. population and
 Canada.  In the CARE study patients who received Pravachol reduced their risk
 of a stroke or TIA by 26 percent, and reduced their risk of recurrent heart
 attack and death from heart disease by 24 percent.
     Pravachol therapy is well tolerated by most patients.  The most common
 side effects include mild skin irritation and transient rash and
 gastrointestinal upset.  Pravachol should not be used by people with active
 liver disease or liver problems, in women who are pregnant or nursing or
 people who are allergic to any component of the medication.  Muscle pain or
 weakness could be a sign of a rare but serious side effect and should be
 reported to your doctor.
     Bristol-Myers Squibb licensed Pravachol from its discoverer, Sankyo
 Company, Inc., of Japan.
     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
     Visit Bristol-Myers Squibb on the World Wide Web at
     For full Pravachol(R) (pravastatin sodium) prescribing information, call
 Bonnie Jacobs of Bristol-Myers Squibb at 609-252-4213.

SOURCE Bristol-Myers Squibb