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Bristol-Myers Squibb

Executive Summary

Preliminary study results from the InTIME-II study show lanoteplase (nPA) was equivalent to alteplase (tPA) in reducing 30-day all cause mortality in patients with heart attack, 6.77% vs. 6.6%. The international, 15,078-patient, Phase III study treated acute myocardial infarction patients with single bolus lanoteplase (120,000 units/kg) or front-loaded alteplase (up to 100 mg). Patients treated with lanoteplase vs. alteplase had lower 24-hour mortality (2.39% vs. 2.49%), 30-day recurrent heart attack rate (4.98% vs. 5.54%), and combined death, heart attack, severe heart failure and non-fatal stroke (12.84% vs. 13.28%). Lanoteplase, however, had a higher intracranial hemorrhage rate than alteplase, (1.13% vs. .62%), although the drugs had similar non-fatal stroke rates

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