Medicure Inc. (TSX: MPH)(AMEX: MCU), a cardiovascular-focused biopharmaceutical company, today commented on the positive results of two large AGGRASTAT® (tirofiban) studies, MULTI-STRATEGY 2 and ON-TIME 2, that were presented at the Late Breaking Sessions of the American College of Cardiology 57th Annual Scientific Session.
The 745-patient MULTI-STRATEGY 2 study demonstrated that high-dose tirofiban is non-inferior to REOPRO® (abciximab) during primary percutaneous coronary intervention (PCI) for acute myocardial infarction. The incidence of death/MI at 8 months was 5.9% vs. 7.5% (p equals 0.55) between tirofiban and abciximab.
The 984-patient ON-TIME 2 study showed that treatment with tirofiban in addition to aspirin, heparin and clopidogrel, significantly reduced the incidence of residual ST-segment deviation after PCI in STEMI patients versus placebo (patients treated with aspirin, unfractioned heparin and clopidogrel).
"We are very pleased with the positive data presented on AGGRASTAT® at ACC," commented Medicure's President and CEO, Albert D. Friesen, PhD. "Although, our marketing efforts have been focused on the substantial upstream opportunity for the use of AGGRASTAT® in patients with non-ST-segment elevation acute coronary syndromes, the results from MULTI-STRATEGY 2 and ON-TIME 2 demonstrate the potential for AGGRASTAT® in acute MI patients, while also confirming that earlier, upstream administration of AGGRASTAT® improves outcomes compared to later administration, at the time of PCI."
AGGRASTAT® is not currently approved for use in STEMI patients or as adjunctive therapy in patients undergoing PCI.
About MULTI-STRATEGY 2
The purpose of this 2x2 factorial study was to evaluate the risks and benefits of administering tirofiban at high-bolus dose (25 ug/Kg bolus) followed by a standard infusion rate vs abciximab, and to assess the efficacy of drug-eluting stents in the setting of ST-elevation MI. With respect to the comparison of tirofiban and abciximab, the primary endpoint was the incidence of a equals 50% resolution in ST-segment elevation following percutaneous coronary intervention.
The investigators found no significant difference in % ST segment resolution between the tirofiban and the abciximab groups (n equals 722, 85.3% vs. 83.6%, (95% CI, 0.958-1.086)) following percutaneous coronary intervention. Furthermore, there was no significant difference in the incidence of MACE (p equals 0.85), death/MI (p equals 0.98), urgent target vessel revascularization (uTVR) (p equals 0.59), and stent thrombosis (definite, p equals 0.56) at 30 days. The incidence of death/MI at 8 months was 5.9% vs. 7.5% (p equals 0.55) between tirofiban and abciximab (MACE 9.9% vs. 12.4%, p equals 0.3).
