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| |  DG DISPATCH - ESC 2000: Researchers Stunned As Abciximab Fails To Aid In Unstable Angina By Ed Susman Special to DG News AMSTERDAM, THE NETHERLANDS -- August 29, 2000 -- Researchers say they were so stunned by the negative results of a trial of abciximab (ReoPro, Centocor) that they haven't yet pulled themselves together enough to look at sug-group analysis to find out what went wrong. In the GUSTO-4 ACS trial (Global Utilization of Strategies To open Occluded coronary arteries in Acute Coronary Syndromes), abciximab was given to patients in two infusions -- one lasting 24 hours; the other 48 hours. In fact, Dr. Maarten Simoons, MD, the president-elect of the ESC, who presented the data in the trial said that abciximab actually performed worse than the placebo treatment, especially in the longer duration therapy. "Quite unexpectedly, abciximab did not reduce death or myocardial infarction (heart attacks)," said Dr. Simoons, professor of cardiology at Erasmus University, Rotterdam. He said that the drug apparently works well in cases in which patients undergo angioplasty to relieve pain associated with unstable angina. But why abciximab failed to show a benefit in patients not undergoing the invasive procedure, mystified researchers. "We don't understand why this was negative," said Dr. Frans van de Werf, MD, professor of cardiology at the University of Leuven, Belgium. "I don't think this drug is going to be used where there is no angioplasty planned for the patient." "On the positive side," Dr. van de Werf said, "the study may save millions" because the expensive drug will be used less. Dr. Simoons estimated that the drug costs between US$1,000 to US$1,500 a dose. Dr. Simoons said doctors in Europe and the United States will have to review new recommendations that suggested use of abciximab in certain patients. "We were convinced that the trial would show it would be useful in these patients, but it did not," he said. Abciximab is one of a class of drugs known as IIA/IIIB inhibitors which are designed to prevent platelets from aggregating and forming clots which could lead to heart attacks. The class has a checkered history, with oral forms of the drug being associated with increased mortality in a number of studies. However, they have proved successful in helping patients who undergo invasive procedures. Dr. Ferenc Follath, MD, professor of medicine at University Hospital, Zurich, Switzerland, said the low incidence of heart attack or death in the study might indicate that current treatments are sufficient for the treatment of patients with unstable angina and there is nothing more to be gained by adding more drugs. "One wonders if anything would have worked better," he said. In the study, the largest done on a this class of drug in an non-interventional setting, 7,800 people were assigned to receive either a 24-hour infusion of abciximab, a 48-hour infusion of the drug, or a placebo treatment. At 30 days -- the designated endpoint of the trial, 8 percent of the patients receiving placebo had suffered a heart attack or died, compared with 8.2 percent of those receiving 24 hours of abciximab and 9.1 percent of those receiving the 48-hour infusion of abciximab. Dr. Simoons said the differences were not statistically significant. Related link: ReoPro.
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