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AHA: Pexelizumab Reduces Early and Late Events Following Coronary Artery Bypass Grafting By Peggy Peck ORLANDO, FL -- November 11, 2003 -- Use of the investigational anti-inflammatory agent pexelizumab in patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass with or without valve repair was associated with a significant reduction in both early and late postoperative myocardial infarction (MI). But pexelizumab did not significantly reduce death or MI at 30 days in the CABG-only patients, which was the primary endpoint of the randomized, double-blind, placebo-controlled study, said principal investigator Edward D. Verrier, MD, from the division of cardiovascular surgery, University of Washington, Seattle, United States. Dr. Verrier presented results of the Pexelizumab for the Reduction of Infarction and Mortality in Coronary Artery Bypass Graft surgery (PRIMO-CABG) study here on November 10th at the American Heart Association's Scientific Sessions 2003 late-breaking clinical trials sessions. "Pexelizumab was associated with significant reductions in death and MI in the CABG-only group at day 4, and this reduction was durable at day 180," Dr. Verrier said. Nonetheless, at day 30, 11.8% of the 1,368 patients in the placebo arm and 9.8% of the 1,378 patients in the pexelizumab arm had reached the combined endpoint, and this was non-significant at P = .069. For all patients, pexelizumab significantly reduced mortality and MI at day 4 and at day 30, he said. The Phase 3 study enrolled 3,099 patients (1,546 in the placebo arm; 1,553 in the active treatment arm), with 2,746 patients in the CABG-only group. Two hundred and five centers in North America and Europe participated in the study. Explaining the early benefit, Dr. Verrier said "that is what one would expect to see with an anti-inflammatory: If the drug is going to work, it is going to work early. But we are pleased that this early response carried through to day 180." Pexelizumab was well tolerated, and adverse events were similar in the placebo and treatment arms. The study was funded by Alexion Pharmaceuticals, Cheshire, Connecticut, United States, in conjunction with Proctor & Gamble Pharmaceuticals. E-mail this page to a friend or colleague! To print, use this version