GENERIC NAME: pravastatin

BRAND NAME: Pravachol

DRUG CLASS AND MECHANISM: Pravastatin is an oral drug for lowering cholesterol in the blood. It has been shown to reduce the occurrence of heart attacks, strokes and death caused by coronary heart disease. It belongs to a class of drugs called HMG-CoA reductase Inhibitors, commonly called "statins". Other statins include simvastatin (Zocor), lovastatin (Mevacor), atorvastatin (Lipitor) and fluvastatin (Lescol). Statins reduce cholesterol by inhibiting an enzyme in the liver (HMG-CoA reductase) that is necessary for the production of cholesterol. In the blood, statins lower total and LDL ("bad") cholesterol as well as triglycerides. They also increase HDL ("good") cholesterol. LDL cholesterol is believed to be an important cause of coronary artery disease. Lowering LDL cholesterol levels slows and may even reverse coronary artery disease. Raising HDL cholesterol levels also may slow coronary artery disease.

Scientists have discovered that inflammation of the coronary arteries also may contribute to coronary heart disease. Inflammation is associated with elevated levels of a protein called C-reactive protein. This C-reactive protein in blood can be measured by a test, referred to as the "highly sensitive" C-reactive protein test (Hs-CRP). Elevated levels of Hs-CRP predict the occurrence of heart attacks, strokes and death. In fact, Hs-CRP is a better predictor of heart attacks, strokes and death than cholesterol levels. Pravastatin reduces the levels of Hs-CRP and it has been suggested that pravastatin may reduce coronary artery disease by reducing inflammation rather than, or in addition to, lowering levels of cholesterol. Pravastatin was approved by the FDA in October, 1991.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Tablets: 10, 20, 40, and 80 mg

STORAGE: Pravastatin should be stored at room temperature, between 20-25°C (68-77°F).

PRESCRIBED FOR: Pravastatin is used for the reduction of total and LDL cholesterol as well as triglycerides and to increase HDL cholesterol. Pravastatin reduces the occurrence of heart attacks, strokes and death caused by coronary artery disease.

DOSING: The starting dose for most adults is 40 mg once daily. The maximum dose is 80 mg per day.

DRUG INTERACTIONS: Bile acid sequestrants such as cholestyramine (Questran) may significantly reduce the absorption of pravastatin and therefore reduce its effect. Therefore, pravastatin should be taken 1-4 hours after bile acid sequestrants.

The use of pravastatin with nicotinic acid, gemfibrozil (Lopid) or other drugs that may cause liver or muscle problems may increase the incidence of such side effects.

PREGNANCY: Although there is no data in pregnant women, statins should not be used by pregnant women because there is an increased risk of muscle malformations when statins are given to pregnant animals.

NURSING MOTHERS: A small amount of pravastatin is excreted in breast milk. Because of the risk of toxicity to the infant, nursing mothers should not nurse while taking pravastatin.

SIDE EFFECTS: Like most statins, the most common side effects of pravastatin are headache, nausea, vomiting, diarrhea, muscle pain, and abnormal liver tests. The most serious potential side effects are liver damage and muscle inflammation or breakdown.

Serious liver damage with statins is rare. More often, statins cause abnormalities of liver tests, and, therefore, periodic measurement of liver tests in the blood is recommended for all statins. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test is greater than three times normal, the statin usually is stopped. Liver tests should be measured before therapy is started, whenever the dose of the statin is increased, or if there is a medical concern. Measurement of liver tests is recommended with pravastatin even though in long-term studies abnormalities of liver tests with pravastatin was similar to a sugar pill.

Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. When used alone, statins cause rhabdomyolysis in less than one percent of patients. Rhabdomyolysis causes the release of muscle protein (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. To prevent the development of rhabdomyolysis, patients taking statins, including pravastatin, should contact their healthcare provider immediately if they develop unexplained muscle pain, weakness, or tenderness. Since pravastatin prevents heart attacks, strokes and death, its benefit usually outweighs its serious but rare side effects.