Zontivity vorapaxar: Additional Phase III data

Additional data from 3,623 patients with diabetes mellitus and a prior MI and without a history of stroke or transient ischemic attack in the double-blind Phase III TRA 2P-TIMI 50 trial showed that Zontivity vorapaxar plus standard of care (SOC) significantly improved the incidence of CV death, MI, stroke and urgent coronary revascularization at 3 years -- the primary endpoint -- vs. placebo plus SOC (11.4 vs. 14.3%, p=0.002). In patients with diabetes mellitus, Zontivity plus SOC increased the incidence of moderate/severe bleeding classified by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) definition vs. placebo plus SOC (4.4% vs. 2.6%). The net clinical outcome integrating the primary composite endpoint and safety bleeding endpoint was improved with Zontivity plus SOC vs. placebo plus SOC (HR=0.79).

The relative effect of Zontivity on the primary endpoint was similar among patients without diabetes mellitus and without a history of stroke or transient ischemic attack (n=13,273) vs. placebo (HR=0.81, p=0.003). However, since the rate of major CV events was substantially higher in diabetics, Zontivity led to a greater absolute risk reduction in diabetics than non-diabetics (absolute risk difference of 3.5% vs. 1.36%). The calculated number needed to treat to avoid 1 major cardiovascular event over 3 years in the diabetic population was 29 vs. 74 among non-diabetics. Data were published in Circulation. ...