The results of the largest study of clot-busters ever conductedare now in print.
Today's issue of the New England Journal of Medicine carries asits lead article "An International Randomized Trial ComparingFour Thrombolytic Strategies for Acute Myocardial Infarction"-- the famed GUSTO trial.
The two-year study, called the Global Utilization ofStreptokinase and t-PA for Occluded Coronary Arteries Trial,was the largest of confirmed myocardial infarction everconducted. It included 41,000 heart attack patients -- 23,000of them Americans -- in 1,100 sites in 15 countries.
Above all, the trial results showed that Genentech Inc.'s tissueplasminogen activator (t-PA), given in combination withheparin, statistically saved one more heart attack patient per100 than the much less expensive streptokinase.
A variety of earlier studies had found no advantage for eitherdrug despite a compelling scientific rationale as to why t-PAshould be superior.
The GUSTO trial results were released April 30 at the ClinicalResearch Meeting (of the American Federation for ClinicalResearch, the American Society for Clinical Investigation andthe Association of American Physicians) in Washington, D.C.
Eric Topol, who chaired the GUSTO study and is chairman of theDepartment of Cardiology at the Cleveland Clinic HealthSciences Center, and Robert Califf, the director of the GUSTOCoordinating Center and an associate professor of medicine atDuke University Medical School, presented the data. Topol alsopresented the data Tuesday at the European Society ofCardiology meeting in Nice, France.
Genentech (NYSE:GNE) heralded the GUSTO study as finallyproving once and for all the superiority of t-PA (Activase) fortreating myocardial infarcts. And since the April meetings, theSouth San Francisco, Calif., company's sales of Activase haveincreased; in fact, they were up by 14 percent in one quarter,from $49.2 million to $55.8 million.
Still, because the differences demonstrated between t-PA andstreptokinase were so small (about 1 percent) and thedifference in cost of the treatments so vast ($2,000 per patientvs. $200), a number of physicians, clinicians, researchers andother interested parties have reserved final judgment on t-PAuse until they can see the data in black and white.
-- Jennifer Van Brunt Senior Editor
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