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This article was originally published in The Gray Sheet

Executive Summary

CENTOCOR's CENTORX REDUCES HEART ATTACKS AND REPEAT ANGIOPLASTY BY 35% when used on an emergency basis following balloon angioplasty, according to results of the Evaluation of 7E3 in Preventing Ischemic Complications (EPIC) trial reported March 16 at the American College of Cardiology annual meeting in Anaheim. The results were presented by Neil Kleinman, MD, Baylor College of Medicine, one of the investigators in the 56-center study. In a press briefing following the presentation, Eric Topol, MD, The Cleveland Clinic, one of the EPIC study directors, called the effects of CentoRx (7E3) a "meaningful and important reduction in the serious events" following percutaneous transluminal coronary angioplasty (PTCA). Compared to aspirin, which causes a 20% reduction in such events, "this is a pretty substantial difference," Topol commented. Centocor issued a same-day press release stating that the company would submit a product license application (PLA) in 1993 for the agent based on the data. Lilly has marketing rights to CentoRx under a $100 mil. 1992 licensing agreement. Centocor received the data from the trial approximately one week before the meeting and is still analyzing the results. In the double-blind, placebo-controlled study, 2,099 patients were enrolled who were considered at high risk for complications during balloon angioplasty. Patients were considered at high risk if they recently had had a myocardial infarction, had unstable angina, were in the acute phase of an infarction or had an angiogram identified as high-risk. Patients were randomized to placebo, a .25 mg/kg bolus injection of CentoRx plus a placebo infusion, or a CentoRx .25 mg/kg bolus dose plus 10 microgram/minute infusion of the drug over 12 hours. The bolus injections were administered 10 minutes prior to balloon angioplasty. All patients received aspirin and heparin. The percentage of patients experiencing death, a myocardial infarction, or emergency repeat angioplasty in the 30 days following PTCA was reduced from 12.8% in the placebo group to 8.3% in the patients treated with the CentoRx bolus dose plus 12-hour infusion. The 11.4% incidence of complications in the patients receiving a CentoRx bolus dose just prior to therapy was not statistically significantly different from placebo. The major side effect of CentoRx therapy, as expected, was a two-fold increase in the incidence in major bleeding over placebo. Fourteen percent of patients treated with the bolus plus infusion dose of CentoRx experienced major bleeds, as defined by a greater than 5 gm/dl decrease in hemoglobin, compared to 7% of placebo-treated patients. Patients treated with the CentoRx bolus dose had an 11% incidence of major bleeds. Because of the bleeding complications, study co-director Robert Califf, MD, Duke University Medical Center, recommended that CentoRx only be used in patients at high risk of reocclusion of blood vessels following angioplasty. The researchers estimate that 10% to 20% of all angioplasty patients are considered high-risk.



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