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| |  AZD6140 Shows Promise in Acute Coronary Syndrome: Presented at AHA By Jill Stein DALLAS, TX -- November 16, 2005 -- AZD6140 has demonstrated potential as a more effective treatment than clopidogrel in patients with acute coronary syndrome, researchers reported here at the American Heart Association's Scientific Sessions 2005 (AHA). AZD6140 is a new and selective reversible oral platelet ADP P2Y12 receptor antagonist. In his presentation on November 15th, Christopher Cannon, MD, Associate Physician, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, United States, presented early efficacy data in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). Patients were randomized to AZD6140 plus aspirin or clopidogrel plus aspirin as part of the DISPERSE2 trial.* "Treatment with the platelet ADP P2Y12 receptor antagonist clopidogrel reduced cardiovascular events in patients undergoing percutaneous coronary intervention and those with acute coronary syndrome, cardiovascular accident, and coronary artery disease," Dr. Cannon said. Clopidogrel has several limitations, including a low level of inhibition (with one-third of patients displaying resistance), variability in response, and an irreversible effect. In addition, it is a pro-drug requiring metabolic activation, he added. In a prior randomized trial, AZD6140 achieved greater and more consistent levels of platelet inhibition than clopidogrel in patients with stable atherosclerosis. The present trial includes patients with NSTE-ACS within the previous 48 hours documented by ischemic symptoms of lasting at least 10 minutes plus biochemical marker evidence of MI or electrocardiographic (ECG) changes indicative of ischemia. According to the study protocol, 990 patients were treated with aspirin up to 325 mg first dose, increased to 75-100 mg qd, plus heparin/low-molecular-weight heparin and/or glycoprotein (GP) IIb/IIIa inhibition. In addition, patients were randomized to up to 12 weeks of AZD6140 90 or 180 mg bid or to clopidogrel 75 mg qd. Half of patients in each of the AZD6140 arms received a 270 mg loading dose; in the clopidogrel group, treatment-naïve patients received a 300 mg loading dose. Adjudicated total bleeding rates were similar for the AZD6140 90 mg bid, AZD6140 180 mg bid and clopidogrel 75 mg qd groups. There was no evidence of a dose response for major bleeds (e.g., the overall bleeding rates were 7.8%, 6.2%, and 8.0%, respectively). AZD6140 90 mg and 180 mg bid doses were well tolerated over 12 weeks. The percentages of patients who withdrew due to adverse events were low and similar between the groups. Overall, 6%, 7%, and 6% of patients stopped treatment prematurely in the AZD6140 90 mg bid, AZD6140 180 mg bid, and the clopidogrel 75 mg qd groups, respectively. The study was funded by AstraZeneca. * A Double-blind, Double-dummy, Parallel Group Randomized Dose Confirmation and Feasibility Study of AZD614O + Acetyl Salicylic Acid (ASA) Compared with Clopidogrel + ASA in Patients with Non-ST Segment Elevation Acute Coronary Syndromes.
[Presentation title: The DISPERSE2 Trial: Safety, Tolerability, and Preliminary Efficacy of AZD6140, the First Oral, Reversible ADP Receptor Antagonist, Compared with Clopidogrel in Patients with Non-ST Segment Elevation Acute Coronary Syndrome. Abstract 2906]
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