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Cholesterol-Lowering Statin, Crestor (Rosuvastatin Calcium), Receives FDA Approval

Crestor Significantly Lowers LDL Cholesterol by As Much As 63%

WILMINGTON, DE -- August 13, 2003 -- AstraZeneca (NYSE: AZN) announced that its new cholesterol-lowering medication, CrestorŽ (rosuvastatin calcium) has received approval from the U.S. Food and Drug Administration (FDA) as an adjunct to diet for the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia.

Crestor is the newest member of the cholesterol-lowering statin (HMG-CoA reductase inhibitors) class of drug therapy. In a six-week dose-ranging placebo-controlled study using a 5, 10, 20 or 40 mg dose, Crestor lowered LDL- cholesterol by 45 to 63 percent (7 percent for placebo), and increased HDL- cholesterol by 8 to 14 percent (3 percent for placebo). In a comparative clinical trial of more than 2,200 patients, Crestor 10 mg to 40 mg reduced LDL-cholesterol by 46 percent to 55 percent; atorvastatin 10 mg to 80 mg reduced LDL-cholesterol by 37 percent to 51 percent; simvastatin 10 mg to 80 mg reduced LDL-cholesterol by 28 percent to 46 percent; and pravastatin 10 mg to 40 mg reduced LDL-cholesterol by 20 percent to 30 percent.

"We are delighted with the approval of Crestor in the United States, " said Sir Tom McKillop, Chief Executive Officer of AstraZeneca. "We believe that Crestor offers an important new treatment option for millions of patients." The clinical development program for Crestor is the largest program ever submitted to initially evaluate a statin. More than 24,000 patients in the US and worldwide have received Crestor in ongoing clinical trials. A clinical outcomes program that will enroll more than 18,000 patients was initiated in May 2003.

"Despite currently available treatments, a large number of patients are still not reaching their target cholesterol goals," said Christie Ballantyne, MD, Professor of Medicine, Baylor College of Medicine. "Recent data from the National Health and Nutrition Examination Survey (NHANES) suggests that only 35 percent of people with high cholesterol are aware of their condition and only 12 percent are being treated for it."

IMPORTANT INFORMATION ABOUT Crestor

Crestor is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Type IIa and IIb); as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV); and to reduce LDL-C, Total-C, and ApoB in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.

The dose range for Crestor is 5 to 40 mg once daily. Therapy with Crestor should be individualized according to goal of therapy and response. The recommended usual starting dose of Crestor is 10 mg once daily in patients with hypercholesterolemia and mixed dyslipidemia. Initiation of therapy with 5 mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20 mg start dose may be considered. The 40 mg dose should be reserved for those patients who have not achieved goal LDL-C at 20 mg. After initiation and/or upon titration of Crestor, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Crestor is generally well tolerated. Adverse reactions have usually been mild and transient. In clinical trials of 10,275 patients, the most commonly reported treatment-related adverse events were myalgia, constipation, asthenia, abdominal pain and nausea. Crestor is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases and in women who are pregnant or may become pregnant, and in nursing mothers.

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with Crestor and with other drugs in this class. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter.

Crestor should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Crestor therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. The benefit of further alterations in lipid levels by the combined use of Crestor with fibrates or niacin should be carefully weighed against the potential risk of this combination. Combination therapy with Crestor and gemfibrozil should generally be avoided.


SOURCE: AstraZeneca

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