(Circulation. 2000;102:e9026.)
© 2000 American Heart Association, Inc.
Cardiovascular News |
Cardiovascular News
GUSTO IV-ACS Lacks Vigor; COPERNICUS Affirmed
Hotline sessions at the 22nd Annual Congress of the European Society of Cardiology in Amsterdam were meant to be topical, but the results of two studies released August 27 and 28, 2000, made the biggest news for totally opposite reasons. The GUSTO IV-ACS (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes) Phase III trial designed to evaluate the safety and efficacy of abciximab (a glycoprotein IIb/IIIa inhibitor) in patients with acute coronary syndromes showed that the drug—one of a fairly new class of drugs—did not show a statistically significant benefit over the placebo. By contrast, the COPERNICUS (CarvedilOl ProspEctive RaNdomIsed CUmulative Survival) trial demonstrated that patients with heart failure receiving the ß-blocker carvedilol had a 35% lower risk of dying than patients treated with placebo. This confirmed the decision of the study’s data safety and monitoring board in March 2000 to halt the study because the treatment arm showed significant survival advantage.
Maarten Simoons, MD, professor of cardiology at the University of Rotterdam in the Netherlands and a principle investigator of the GUSTO trial expressed surprise at the results. He stated that the drug presented no greater risk than placebo and no greater benefit. When asked about the implications, he said, "Well, in the Netherlands, this saves millions." He stated that the cost of the drug—as much as $1000 per treatment in the Netherlands and between $1200 and $1500 in the United States—had threatened to increase health budgets around the world.
Dr. Simoons hastened to add