波立维Plavix——动脉粥样硬化样疾病—培训课件.pptVIP

Slide 6 CURE – Endpoints The primary endpoint is: the composite of cardiovascular death, MI, or stroke. The second primary endpoint is: the composite of cardiovascular death, MI, stroke, or refractory ischemia. The primary analysis was based on intention to treat. Only the first event was counted. Refractory ischemia was defined differently in-hospital and post-discharge. in-hospital: recurrent chest pain lasting more than 5 minutes with new ischemic ECG changes while on optimal medical therapy (two anti-anginals, one of which should be IV nitrates unless contraindicated) and leading to additional interventions (such as thrombolytic therapy, cardiac catheterization, insertion of intra-aortic balloon pump, coronary revascularization or transfer for cardiac intervention) by midnight of the next calendar day post-discharge: rehospitalization lasting 24 hours for unstable angina, with ischemic ECG changes. Slide 8 CURE – Concomitant Medications After Randomization Patients in CURE were receiving optimal medical management based on current guidelines. During the initial hospitalization, 99% of patients received ASA, ~92% of patients received heparin/LMWH, ~84% beta-blockers, ~49% calcium channel blockers, ~62% ACE inhibitors and ~64% lipid-lowering drugs. No clinically relevant adverse interactions were reported between clopidogrel and these concomitant medications. Reference Sanofi-Synthelabo. Data on file. Slide 9 CURE – Main Efficacy Results Primary endpoint (1) A 20% relative risk reduction (RRR) in the primary composite endpoint of cardiovascular death, MI, or stroke was observed with clopidogrel on top of standard therapy (including ASA) versus standard therapy alone (p=0.00009). The Kaplan-Meier curves began to diverge within hours and continued to diverge over the course of 12 months. Clopidogrel on top of standard therapy (including ASA) demonstrates an early effect (within hours) and sustained long-term benefit throughout the entire trial p