AstraZeneca announced that its new cholesterol-lowering medication, Crestor (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.

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.