Thursday, Nov 24, 1994
South San Francisco, Calif. -- November 24, 1994 --The results of the 2,400-patient angiographic substudy of the heart attack mega-trial GUSTO -- published in the November 25 issue of the New England Journal of Medicine (NEJMJ) -- reaffirm that a new accelerated Activase® (Alteplase, recombinant) t-PA regimen combined with i.v. heparin opens more heart arteries faster and saves more lives after a heart attack than the other clot-dissolving regimens studied.
The study -- the largest ever of its kind -- validates the scientific basis for Activase t-PA's benefits, known as the "early open artery hypothesis."
In the NEJM paper, principal author and study chairman, Allan M. Ross, M.D. concluded: "The study supports the hypothesis that more rapid and complete restoration of coronary flow through the infarct-related artery results in improved ventricular performance and lower mortality among patients with myocardial infarction. This would appear to be the mechanism by which accelerated t-PA therapy produced the most favorable outcome in the GUSTO trial."
In an accompanying editorial, Eugene Braunwald, M.D., Chairman, Department of Medicine, Brigham and Women's Hospital, wrote that "the overall results of the GUSTO trial are good news indeed for patients with acute myocardial infarction" for two reasons: First, mortality was reduced to an impressively low 6.3 percent with accelerated t-PA and i.v. heparin, and second, since the GUSTO angiographic substudy resoundingly confirms the open-artery theory, future research in the treatment of heart attack may progress at an accelerated pace to reduce mortality even further.
"Now that the major findings of the GUSTO trial have been rigorously peerreviewed and published in the country's leading medical journal, more medical professionals and group practices have the opportunity to evaluate them," said G. Kirk Raab, president and chief executive officer of Genentech, Inc. "As these findings are accepted and applied, heart attack patients and their families will be the ultimate beneficiaries of the life-saving and quality-of-life-enhancing benefits of Activase."
To date, about two-thirds of heart attack patients receiving clot-dissolving therapy in the United States are receiving Activase t-PA.
On October 15, 1993, Genentech filed an amendment to its Product License Application with the FDA to reflect the accelerated dosing regimen used in the GUSTO study.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco, California and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
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