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ISA: Study Shows Promising Effects Of New Statin On Lipid Parameters STOCKHOLM, SWEDEN -- June 28, 2000 -- AstraZeneca's investigational lipid-lowering medication, ZD4522, reduced low-density lipoprotein (LDL) cholesterol levels up to 65 percent and increased high-density lipoprotein (HDL) cholesterol levels up to 14 percent, according to Phase II clinical data presented today at the XIIth International Symposium of Atherosclerosis meeting. The Phase II data evaluated the efficacy and tolerability of once-daily doses of ZD4522 over six weeks. Patients ranged in age from 18 to 70 with mild-to-moderate hypercholesterolemia. The dose-ranging program was assessed in two stages. Compared with placebo, all doses of ZD4522 significantly lowered mean LDL-cholesterol (p<0.001) and total cholesterol (p<0.05) in a dose-dependent manner. After six weeks, ZD4522 lowered LDL cholesterol an average of 65 percent at the 80 mg dose. Significant reductions in LDL cholesterol were seen at all doses compared with placebo, with an average reduction of more than 50 percent at a dose as low as 10 mg. Additionally, all doses of ZD4522 lowered triglycerides and raised HDL cholesterol, with the responses ranging from a 10 percent to 35 percent reduction in triglycerides and a 9 percent to 14 percent increase in HDL. Importantly, 90 percent of the reduction in LDL cholesterol with ZD4522 was seen in the first two weeks of treatment. In the first stage of the dosing program, 142 patients were randomized in a double-blind fashion to treatment with one of six different dosages of ZD4522 (1 mg to 40 mg), or placebo. Some patients were randomized to receive open-label atorvastatin (Lipitor®, Parke Davis) to benchmark the responses of the patient population, but no statistical comparisons were made between ZD4522 and atorvastatin. In the second stage, 64 patients were randomized to treatment, including an 80 mg dose of ZD4522. Over the treatment period, ZD4522 was well tolerated across all doses. The most commonly reported adverse events considered to be related to treatment with ZD4522 included gastrointestinal disorders and headache. ZD4522 is in the class of lipid-lowering medications called HMG CoA reductase inhibitors or "statins." ZD4522 was initially developed by the Japanese pharmaceutical company Shionogi and is licensed to AstraZeneca. To date, there are more than 4,000 patients involved in Phase III trials. Direct comparisons between ZD4522 and currently available statins will occur during the Phase III program. High LDL cholesterol is one of the most significant factors contributing to coronary artery disease, in which arteries supplying blood to the heart become blocked by cholesterol-filled plaques. Heart disease is the world's leading cause of death, and large clinical trials using statins have demonstrated the benefits of these drugs in reducing cardiovascular morbidity and mortality. Despite significant advances in the treatment of high cholesterol, lowering LDL cholesterol to target levels recommended by world health authorities still eludes many patients. Related Link: AstraZeneca. E-mail this page to a friend or colleague! To print, use this version