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DG DISPATCH - AHA: Head-to-head Trial Shows Aggrastat (Tirofiban) Doesn’t Measure Up To ReoPro (Abciximab) By Ed Susman Special to DG News NEW ORLEANS, LA -- November 16, 2000 -- In a study that surprised and perplexed its sponsors, Merck and Company, the IIb/IIIa inhibitor tirofiban (Aggrastat) failed to provide evidence that it was at least as good as abciximab (ReoPro, Centocor) in a face-to-face trial. TARGET (Do Tirofiban and ReoPro Give Similar Efficacy Outcomes Trial) evaluated the relative efficacy and safety of tirofiban in comparison with abciximab when each was administered at the start of coronary interventions in patients with either stable coronary artery disease or unstable angina. "The two treatment regimens were not shown to be comparable in this setting," said Eric Topol, MD, chairman of the department of cardiology and professor of medicine at the Cleveland Clinic. "Treatment with ReoPro led to statistically significantly fewer adverse cardiac outcomes in these patients than did treatment with Aggrastat." Tirofiban is priced significantly lowered than abciximab, generally the treatment of choice when patients with heart disease are undergoing angioplasty procedures. Previous clinical trials had shown that when tirofiban is added to standard therapy for patients diagnosed with acute coronary syndromes the patients receives significant benefit in the prevention of adverse events. Patients in TARGET who were undergoing angioplasty with stent placement were assigned to receive standard medical care-aspirin, herapin and clopidogrel-and either tirofiban or abciximab. The primary endpoint of the double-blind study was the combined incidence at 30 days of death, nonfatal heart attack or the requirement for an urgent repeat revascularization. Topol said the event rate was 7.55 percent for tirofiban and 6.01 for abciximab in the trial which involved 4,812 patients. He said the differences were significant, to the p=0.037 level. Among the secondary endpoints: - There were 12 deaths among the 2,398 patients on tirofiban-a rate of 0.05 percent, compared with 10 deaths among the 2,414 patients on abciximab-a rat of 0.41 percent. That difference, Dr. Topol said, was not significant. - Among tirofiban patients, the nonfatal myocardial infarction rate reached 6.88 percent, compared with 5.43 among abciximab patients, significant to the level of p=0.04, said Dr. Topol. - There were no significant difference in the rate at which patients in either group required urgent repeat cardiac procedures -- 0.80 percent with tirofiban; 0.70 percent with abciximab. Despite the disappointing results, Rick Sax, MD, senior director of clinical research at Merck Research Laboratories, said the company "remains firm in its commitment to the use of Aggrastat when it is initiated in patients presenting in the hospital with acute coronary syndrome, including patients who subsequently go on to have an angioplasty procedure." Related Links: Aggrastat® (tirofiban hydrochloride), Merck & Co., Inc, ReoPro® (abciximab) and Centocor. E-mail this page to a friend or colleague! To print, use this version