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FDA Talk Paper

August 12, 2003

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FDA Approves New Drug for Lowering Cholesterol

The Food and Drug Administration (FDA) today approved Crestor (rosuvastatin) to lower cholesterol. Lowering cholesterol is a key to reducing the risk of heart disease. Rosuvastatin is in the class of drugs called HMG-CoA reductase inhibitors, also known as statins. These drugs work by partially blocking the synthesis of cholesterol in the liver which leads to increased removal of cholesterol from the blood. Statin drugs should be prescribed along with a low-cholesterol diet and an exercise program. They lower levels of bad cholesterol (LDL-C) and triglycerides (TG) and increase levels of good cholesterol (HDL-C)in the blood. The higher the level of LDL-C in the blood, and the lower the level of HDL-C, the greater the risk for coronary artery disease, or atherosclerosis, which develops because of accumulation of cholesterol in the walls of arteries. In addition, other factors, such as high blood pressure, diabetes, smoking, and a family history of early heart attack also increase the risk of atherosclerosis.

Rosuvastatin was approved based on multiple trials of at least 6 weeks’ duration in which Rosuvastatin treatment was compared to placebo and other marketed statins. In these trials, rosuvastatin reduced total-C, LDL-C, and TG and increased HDL-C with therapeutic response occurring within one week and maximum response seen at four weeks. Approximately 12,000 patients received rosuvastatin at different doses in clinical trials submitted to FDA.

The most frequent side effects seen in patients treated with rosuvastatin included muscle aches, stomach pain, constipation, nausea, and weakness. In rare instances, severe muscle pain and muscle weakness resulting in kidney damage have been associated with statin drugs. If general muscle aches persist, patients should call their physician.

Patients should be monitored for abnormalities of liver function before treatment, at 12 weeks following initial therapy and with any elevation of dose. Monitoring is recommended periodically thereafter.

Rosuvastatin is available in 5, 10, 20, and 40 mg tablets. In the clinical trials, the majority of patients reached target LDL-C levels as recommended by the National Cholesterol Education Program on either the 5 or 10 mg starting dose. The 20 mg dose can be the start dose for patients who have very high cholesterol levels while the 40 mg dose should be reserved only for those individuals who are not adequately treated with the 20 mg dose.

CRESTOR is the brand name for rosuvastatin and is marketed by AstraZeneca.