Monday, March 26, 2012

Vorapaxar in Secondary prevention of ACS - Data Published in NEJM

Net Clinical Benefit should help regulatory success, but increased bleeding risks will restrict commercial success
At ACC yesterday, MRK announced the detailed data on Vorapaxar from the TRA-2P trial, which included patients with a history  of MI, PAD or Stroke (2 weeks to 12 months).  Patients with a history of stroke discontinued the study earlier based on the recommendation of the DSMB.

Overall, Vorapaxar showed positive net clinical benefit in patients with no history of stroke. Vorapaxar reduced the number of primary efficacy endpoint events (CV death, MI, Stroke) by 136, while increased the number of GUSTO moderate and severe bleeds by 128. The number of fatal bleeds or ICH were increased by 24.  

The benefit was most robust in patients with history of MI, as Vorapaxar reduced death/stroke/MI events by 140, while the number of GUSTO moderate/severe bleeding increased by 110, and the number of fatal bleeds/ICH by 20.
 
http://www.nejm.org/doi/full/10.1056/NEJMoa1200933?query=featured_home#t=articleMethods

Trial Design at http://clinicaltrials.gov/ct2/show/NCT00526474?term=vorapaxar&rank=5