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| |  AHA: Pexelizumab Reduces Death/Myocardial Infarction in Some Cardiopulmonary Bypass Patients CHESHIRE, CT -- November 13, 2001 -- At the 2001 Scientific Sessions of the American Heart Association (AHA), investigators presented data from Alexion Pharmaceuticals Inc. Phase IIb Cardiopulmonary Bypass (CPB) pexelizumab trial. The Phase IIb data showed that pexelizumab administration was associated with a reduction in the composite incidence of death or myocardial infarction (MI), the same endpoint to be confirmed in the upcoming Phase III pivotal trial in coronary artery bypass graft (CABG) surgery patients, known as the PRIMO-CABG trial (Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery). On November 12th, 2001, Stanton K. Shernan, M.D., Assistant Professor of Anesthesiology at Harvard Medical School and Director of Cardiac Anesthesia at Brigham and Women's Hospital, presented the data in his poster titled: "Pexelizumab Reduces Death and Myocardial Infarction in CABG Patients Requiring CPB: Results of the 914 Patient Phase II Trial." On November 13th, 2001, Nancy Nussmeier, M.D., Director, Cardiovascular Anesthesiology Research, Texas Heart Institute, will present "C5-Complement Suppression by Pexelizumab in CABG Patients Is Associated with Reduction of Postoperative Myocardial Infarction." The trial was sponsored by Alexion Pharmaceuticals, Inc. and its pexelizumab development partner, Procter & Gamble Pharmaceuticals, Inc. "Postoperative mortality and cardiac morbidity remain significant complications of CABG surgery," stated Dr. Shernan. "The current data presented at the meeting suggest that sustained inhibition of terminal complement with pexelizumab may provide significant reductions in postoperative myocardial injury. Should the PRIMO-CABG trial confirm the results reported at these meetings, pexelizumab may provide benefit to patients undergoing CABG surgery." In the double-blind, randomized, placebo-controlled Phase IIb trial which enrolled 914 patients at 65 medical centers in the United States, patients were stratified into two groups, those undergoing only CABG with CPB or patients undergoing CABG with concomitant valve surgery during CPB. Approximately 90 percent of patients were in the CABG only group. Patients were treated with placebo, pexelizumab 2.0 mg/kg bolus, or pexelizumab 2.0 mg/kg bolus followed by a 24 hour infusion of pexelizumab at 0.05 mg/kg/hr. Patients were followed for safety and efficacy for 30 days. Both regimens appeared to be safe and well-tolerated in CPB patients, with observed serious adverse events comparable to placebo, including atrial fibrillation, infection, right heart failure and hemorrhage. The most common adverse events observed were also comparable to placebo, including atrial fibrillation, nausea and anemia. Of note, an exploratory analysis presented at the scientific sessions showed the impact of pexelizumab on the combined incidence of death or myocardial infarction in the Phase IIb trial, the same endpoint of the upcoming Phase III pivotal CABG trial. In the CABG only group, pexelizumab bolus administration followed by continuous infusion was associated with a 67 percent reduction, as compared to placebo, in the composite incidence of death or myocardial infarction at 30 days, from 9.3 percent in placebo to 3.0 percent with pexelizumab (P=.003). A relative reduction in death of 79 percent occurred from 1.9 percent in placebo to 0.4 percent with pexelizumab (P=.22). Non-Q wave MI decreased 66 percent, from 8.0 percent in placebo to 2.7 percent with pexelizumab (P=.008). Q wave MI decreased 100 percent, from 1.1 percent in placebo to 0 percent with pexelizumab (P=.09). As presented in January, 2001, the initial primary combined endpoint, which included a more modest non-Q wave definition of CK-MB consistent with smaller, more mild post-operative myocardial infarctions, neurologic deficits and left ventricular dysfunction, was not achieved. Additional results presented at the scientific meetings examined whether pexelizumab also limited the incidence of smaller perioperative myocardial infarctions. As presented at the meeting, pexelizumab bolus administration followed by continuous infusion was associated with a 24 percent reduction in infarcts with peak CK-MB levels greater than 60 ng/ml (P=.21), 46 percent reduction in infarcts with peak CK-MB levels greater than 70 ng/ml (P<.02), 47 percent reduction in infarcts with peak CK-MB levels greater than 80 ng/ml (P<.04), 60 percent reduction in infarcts with peak CK-MB levels greater than 90 ng/ml (P<.009), 66 percent reduction in infarcts with peak CK-MB levels greater than 100 ng/ml (P=.008), and 68 percent reduction in infarcts with peak CK-MB levels greater than 120 ng/ml (P<.02). According to the American Heart Association, approximately 550,000 coronary artery bypass graft surgery procedures were performed in the U.S. in 1998. SOURCE: Alexion Pharmaceuticals Inc.
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