Pravachol (pravastatin sodium)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 1996

Specific Treatments:

heart disease

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General Information

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.

Clinical Results

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 today.

Side Effects

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.

Literature References

"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.