Skip to Content for 1997 First Quarter Report Menu for 1997 First Quarter Report About Us Menu Research Menu Development Menu Medicines Menu Investors Menu Media Menu Careers Menu
Banner Image

1997 First Quarter Report

Letter to Stockholders | Business Events | Financial Highlights
Pipeline Profile | Marketed Product News | Business Partner News

GUSTO III Suggests Activase® (Alteplase, recombinant) Remains A Standard in Treatment of Acute Myocardial Infarction


The Wall Street Journal and other media outlets reported that the GUSTO III trial did not demonstrate its primary hypothesis that a new thrombolytic therapy might save more lives in the treatment of acute myocardial infarction than Activase, which remains a standard for heart attack treatment.
In early 1997, Boehringer Mannheim launched a new competitive thrombolytic agent called Retavase™ (Reteplase) for the treatment of acute myocardial infarctions (AMI), or heart attacks. Though the medical community knew Retavase was safe and effective based on the clinical testing conducted to obtain regulatory clearance, no data existed to indicate whether it could save more lives than Genentech's Activase. Activase had become the most widely used thrombolytic therapy for the treatment of heart attack after a comparative study called GUSTO demonstrated in 1993 that it saved significantly more lives than another competitive thrombolytic therapy, streptokinase. A new study called GUSTO III was designed to show whether Retavase could save more lives after a heart attack than Activase.

Results from the GUSTO III study, announced in March, 1997, at the American College of Cardiology annual meeting, demonstrated that Retavase does not save more lives than Activase in the treatment of AMI. Investigators of the GUSTO III group reported that in the trial Retavase did not provide a statistically significant benefit in 30-day mortality as compared to Activase. In the trial, 10,139 patients received Retavase while 4,921 patients were given Activase.

What does this mean for Activase? The GUSTO III investigators established that the primary hypothesis of the trial was to determine if Retavase would save more lives than Activase. Since this primary hypothesis was not met, Genentech believes that Activase remains a standard of care in the management of AMI and that, based on GUSTO III, physicians have no clinical basis for changing their prescribing habits for treating AMI. There was no statistically significant difference in the overall mortality rate, total intracranial hemorrhage rate, or total stroke rate.

For the past 10 years, physicians have used Activase to save the lives of heart attack patients. In 1996, Activase was also the first therapy cleared by the U.S. Food and Drug Administration for the treatment of acute ischemic stroke. Its impact on cardiovascular medicine has been significant, and GUSTO III reinforces the role Activase plays in saving lives every day.