Pravachol (pravastatin sodium)

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

Approval Status:

Approved July 1996

Specific Treatments:


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General Information

Pravachol, a cholesterol-lowering medication, has been approved to help prevent a first heart attack and reduce death from cardiovascular disease in subjects with elevated cholesterol who are at risk of a first heart attack. Pravachol's new indication also includes reducing the need for balloon angioplasty or coronary bypass surgery.

Pravachol is the only HMG CoA reductase inhibitor indicated to both reduce the risk of heart attack and slow the build-up of plaque in the coronary arteries of subjects with elevated cholesterol who have established symptoms of heart disease. Prevention of recurrent heart attack in subjects with established heart disease is known as "secondary prevention." It is estimated that there are more than four million Americans who have elevated cholesterol levels and heart disease.

Clinical Results

The new Pravachol indication is based on the Pravachol Primary Prevention Study (also known as the West of Scotland study), a landmark clinical trial demonstrating a significant reduction in the risk of a first heart attack in subjects with elevated cholesterol, but no history of heart disease. The results of this study are particularly compelling because 800,000 of the 1.25 million heart attacks that occur each year in the United States are first heart attacks. Up to one third of first heart attacks will be fatal. Prevention of first heart attack is known as "primary prevention."

The Pravachol Primary Prevention Study, evaluated the use of Pravachol in 6,595 subjects over a five-year period, demonstrated that Pravachol reduced the risk of first heart attack by 31%. Death from cardiovascular disease was reduced by 32%, and there was no increase in death from non-cardiovascular causes. In addition, the study showed that Pravachol reduced the need for coronary procedures such as balloon angioplasty and bypass surgery by 37%.

Another major finding from the Pravachol Primary Prevention Study was that Pravachol benefit, in terms of reduction in first heart attacks, begins at about six months after the initiation of therapy.

Side Effects

Pravachol therapy is well tolerated by most subjects. However, 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. The most common side effects include mild skin irritation and transient rash and gastrointestinal upset.

Additional Information

Approximately 17 million Americans with high cholesterol, but with no evidence of heart disease, are considered at risk for a first heart attack.