Monday, April 13, 1998
The Aggrastat data
WASHINGTON - Friday's vote by the Cardiovascular and Renal Drugs Advisory Committee to recommend approval of Merck & Co. Inc.'s Aggrastat tirofiban platelet inhibitor for treatment of acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), but not for angioplasty, was based on the company's presentation of data from three trials. The PRISM, PRISM-Plus and RESTORE studies involved a total of 7,288 patients.
PRISM was designed to study the safety and efficacy of Aggrastat alone during an initial stabilization period. In the trial, 3,232 patients with unstable angina were randomized to either a loading dose of Aggrastat of 18 µg/kg over 30 minutes followed by an infusion of 0.15 µg/kg/minute for 48 hours or heparin, which served as an active control.