Friday, Apr 30, 1993
South San Francisco, Calif. -- April 30, 1993 --"GUSTO trial results are important to public health as they clearly demonstrate t-PA's life-saving benefit -- opening arteries quickly and keeping them open -- is the key to reducing death from heart-attack," said G. Kirk Raab, president & CEO of Genentech, Inc. "Heart attack patients are the real winners."
GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries) showed that front-loaded Activase® (Alteplase, recombinant) t-PA, combined with IV heparin reduced heart attack patient mortality by nearly 14 percent over other thrombolytic regimens studied in the trial, a statistically significant difference.
Given the current rate of thrombolytic use in the U.S. -- about 170,000 patients -the exclusive use of front-loaded t-PA could potentially save at least an additional 1,700 lives each year. And as the treatment of patients with clot dissolving therapy expands even more lives should be saved.
GUSTO also showed that t-PA reduces life-threatening complications associated with heart attack, such as congestive heart failure, shock, arrhythmias, and severe allergic reactions."Based on the significant life-saving benefit seen in GUSTO, t-PA's cost effectiveness is comparable to that of other widely accepted life-extending standards of care, such as cholesterol-lowering therapy, high-blood pressure therapy, mammography and open heart surgery," said J. Sanford Schwartz, M.D., executive director, Leonard Davis Institute of Heath Economics, University of Pennsylvania.
Genentech remains committed to increasing the use of t-PA and ensuring access to it through its Uninsured Patients Program, which makes the drug available to all people who cannot afford it. Genentech will continue to support the National Registry of Myocardial Infarction, the largest-ever heart attack patient database, already used by nearly 1,000 U.S. hospitals to evaluate heart attack treatment in more than 150,000 patients to date.
When key clinical endpoints measured in the trial were considered in aggregate, the front-loaded t-PA arm of the study proved significantly superior to the other regimens tested.
There was no significant increase in risk of overall stroke with t-PA when compared with streptokinase in GUSTO. A subgroup category of stroke (hemorrhagic stroke) did show an increase with the t-PA arm. However, the slightly increased risk of hemorrhagic stroke with t-PA is more than offset by the ten-fold increase in life-saving benefit shown in GUSTO.
The results of GUSTO, the largest study of its kind ever conducted, have resolved many unanswered questions about emergency heart attack treatment. The study will provide useful information for physicians to further benefit their patients. This information is available because of the quality and dimension of the trial, which demonstrates the dedication and excellence of the 1,100 hospitals that participated in this massive clinical research undertaking."The results of the GUSTO trial are not only definitive proof that t-PA can save thousands of lives, but also confirms the critical medical advances in human healthcare offered by biotechnology. GUSTO provides definitive support for t-PA as the optimal way to save lives and reduce other serious medical problems for people having heart attacks. The results confirm that t-PA fills a need that other pharmacologic therapies don't," stated Raab.
Genentech, Inc., is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant 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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