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Crestor (Rosuvastatin Calcium) Available in US For Treatment of Elevated Cholesterol

WILMINGTON, DE -- September 16, 2003 -- AstraZeneca today announced the availability of CrestorŽ (rosuvastatin calcium), a new, once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia.

Crestor is available in 5 to 40 mg doses in pharmacies nationwide. Therapy with Crestor should be individualized according to therapy goal and response. The recommended usual starting dose is 10 mg once daily in patients with hypercholesterolemia and mixed dyslipidemia.

Crestor is the newest of the statin (HMG-CoA reductase inhibitors) class of drug therapy. In clinical trials, Crestor lowered LDL (low-density lipoprotein) cholesterol or "bad" cholesterol by 45 to 63 percent (7 percent for placebo) and increased HDL (high-density lipoprotein) cholesterol or "good" cholesterol by 8 to 14 percent (3 percent for placebo).

"With the recent FDA approval in the U.S., Crestor has received regulatory approval in 27 countries worldwide," said Adele Gulfo, Vice President, Cardiovascular of AstraZeneca. "Crestor is an extremely effective, new alternative for the millions of patients who need to lower their elevated cholesterol." The clinical development program for Crestor is the largest program ever submitted to initially evaluate a statin. More than 24,000 patients in the U.S. 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.

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 (e.g., LDL apheresis) or if such treatments are unavailable.

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. 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. 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.

Full prescribing and product information for Crestor is available by calling the AstraZeneca Information Center at 1-800-236-9933 or by visiting http://www.crestor.com.

ABOUT CHOLESTEROL

Cholesterol is a soft, waxy substance found among lipids (fats) in the bloodstream and in cells. Cholesterol plays a key role in forming cell membranes, some hormones, and other necessary tissues. The body manufactures cholesterol, but it is also derived from animal products in a person's diet, including meats, poultry, fish, eggs, butter, cheese, and whole milk.

Guidelines issued by the National Cholesterol Education Program's Adult Treatment Panel III continue to identify elevated LDL-cholesterol as the primary target of cholesterol-lowering therapy, establishing an LDL-level of < 100 mg/dL as optimal and raising the cutpoint defining low HDL-cholesterol from 35 to 40 mg/dL. The guidelines have also substantially expanded the number of Americans eligible for drug therapy, including raising the number of people on dietary treatment from about 52 million to 65 million, and increasing the number of patients eligible for cholesterol-lowering drug therapy from approximately 13 million to 36 million. Currently, it is estimated that only about one third of treated patients reach their LDL-cholesterol goal.


SOURCE: AstraZeneca

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