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ASTRA USA, INC.: GUSTO-1 "NOT A MANDATE" TO CHANGE THROMBOLYTIC THERAPY

 WASHINGTON, April 30 /PRNewswire/ -- The following was released today by Astra USA, Inc.:
 Thrombolytic therapy is a major advance in reducing death due to heart attacks, no matter which thrombolytic agent is used. The importance of thrombolytic therapy was verified again today by the GUSTO-1 trial committee at a media briefing announcing its results. Although the early data suggest small but statically significant differences between streptokinase and tPA (Activase(R), alteplase, Genentech), close scrutiny and peer review are necessary before any reliable clinical conclusions may be drawn.
 ISIS-3 remains the "gold standard" as a thrombolytic study because it was double-blinded and placebo-controlled, which scientists agree is the least biased, most believable way to conduct any trial. Double- blinded studies are especially important when the trial is attempting to establish minute differences in clinical benefit. Indeed, the differences observed between the agents used in GUSTO-1 were very small -- less than one percent for every endpoint examined. Whether such small differences have clinical relevance in "real world" settings remains open to question.
 According to Richard Peto, an internationally renowned epidemiologist and clinical investigator, "when the GUST-1 results are combined with those of GISSI-2 and ISIS-3, there continues to be no significant difference in the mortality rates between the drugs." Perhaps with this in mind, Eric Topol, MD, chairman of the GUSTO-1 coordinating committee, said today at a media briefing that GUSTO-1 "is not, at this point, a clinical practice mandate. It is just a new finding to be put into context with all the other trials and the available data in the field."
 The preliminary GUSTO-1 data raise a number of potentially troubling questions requiring rigorous examination before physicians alter the manner in which they conduct thrombolytic therapy. One question that may obscure the clinical equivalence of streptokinase and tPA was the disproportionate number of patients in the accelerated tPA arm who received coronary bypass surgery. This factor may have inflated the survival rate in the tPA arm.
 Second, mortality differences may have been further exaggerated by critical protocol violations in the streptokinase-plus-subcutaneous- heparin arm. Nearly half of the patients recruited into this arm received intravenous heparin instead. This flaw may unfairly influence side effects and mortality benefits in the streptokinase arm.
 Finally, it is important to reiterate the findings if ISIS-3, the most highly regarded and widely scrutinized megatrial. ISIS-3 concluded that streptokinase was equally effective as tPA (duteplase, Wellcome), had a safe profile, and was exceptionally cost effective. In ISIS-3, tPA (duteplase, Wellcome) also was shown to have a significantly higher rate of cerebral hemorrhage.
 The fact remains that the best strategy for reducing mortality from heart attacks is to use thrombolytic therapy in more patients. In fact, if all eligible patients received a thrombolytic agent, an additional 15,000 lives would be saved in the United States each year. This remains the most important issue in thrombolytic therapy, as opposed to quibbling over minute and possibly clinically irrelevant differences between agents.
 -0- 4/30/93
 /CONTACT: Nigel Rulewski, MB, BS of Astra USA, Inc., 508-366-1100, or home, 617-237-7211, or Cassie Holm of McAdams Public Relations, 202-328-2000 (4/30), or 212-698-1506 (after 4/30), for Astra USA, Inc./


CO: Astra USA, Inc. ST: District of Columbia IN: MTC SU:

LD-TM -- NY099 -- 3479 04/30/93 18:49 EDT
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Date:Apr 30, 1993
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