Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Cardiology/Vascular Diseases | Family Medicine
View By:YearCompanyConditionsTherapeutic AreasDrug Names
Pravachol (pravastatin sodium)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bristol-Myers Squibb
Approval Status: Approved April 1996
Treatment Area: heart disease
Pravachol has been shown to reduce the risk of heart attack and
slow the build-up of plaque in the arteries of subjects with
elevated cholesterol and heart disease. A new indication for
Pravachol was approved in March of 1998. Pravachol can now be used
in reducing the risk of stroke or transient ischemic attack (TIA)
in subjects who have had a heart attack and have normal cholesterol
levels, and in reducing the risk of recurrent heart attack and
death from heart disease.
The new indication for Pravachol is based on the results of the
Pravastatin Athersclerosis and Myocardial Infarction (MI) Reduction
Program, which included four independent clinical trials, each
conducted for two to three years in 1,891 subjects. In this
analysis, in addition to showing a statistically significant
slowing of coronary atherosclerosis, Pravachol significantly
reduced the risk of fatal and non-fatal heart attacks (event rate
6.4% in the placebo group vs. 2.4% in Pravachol subjects). 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.
Pravachol was also recently shown to reduce the risk of a
subject experiencing a first heart attack (known as primary
prevention). In this trial of 6,595 subjects with elevated
cholesterol, but without evidence of heart disease, Pravachol
reduced the risk of a first heart attack by nearly one-third.
Results of the Cholesterol and Recurrent Events (CARE) study
were recently reported at the American College of Cardiology
Meeting. This study evaluated the benefits of Pravachol in subjects
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
striking because patients in the CARE study represent a large
portion--nearly 75%--of heart attack survivors in the United States
Pravachol therapy is well tolerated by most subjects. The most
common side effects include mild skin irritation and transient rash
and gastrointestinal upset. 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.
"Prevention of Coronary Heart Disease with Pravastatin in
Men with Hypercholesterolemia." New England Journal of
Medicine. November 16, 1995.
"Reduction in Cardiovascular Events During Pravastatin
Therapy." Circulation. November 1, 1995.