The FDA report on vorapaxar in the elderly: A convoluted dilemma

International Journal of Cardiology
Victor L Serebruany, Seth D Fortmann

Abstract

There are consistent data suggesting that elderly patients benefit from less aggressive antiplatelet strategies following acute coronary syndromes. This observation is likely because advanced age is associated with greater bleeding and potentially less efficacy. Oral antiplatelet agents are often prescibed uniformly, without dose adjustments, representing a concerning reality for this patient population. Vorapaxar, a platelet thrombin PAR-1 inhibitor, has been evaluated in the TRA2P and TRACER trials, but drug efficacy and safety, with respect to age, were not discussed in detail. We sought to define the FDA-confirmed age-dependent clinical outcomes after vorapaxar. The mean and median ages in the TRA2P indicated population were about 60 years, with 33.4% greater than 65 years of age and 9.2% greater than 75 years of age. Vorapaxar efficacy was reduced in those aged 72 or older, while bleeding rates gradually increased with age for both arms. For patients aged 75 or older, efficacy numerically favored vorapaxar, but this interaction was not statistically significant (HR=1.18; 95% CI=0.95-1.46; p=0.132). In TRACER, the point estimates by age quintile for the primary endpoint also favored vorapaxar, except for the lowest age quin...Continue Reading

References

Apr 17, 2002·Circulation·S Goya WannametheeLucy Lennon
Jan 22, 2003·Seminars in Thrombosis and Hemostasis·Wade R Wilkerson, David C Sane
Sep 18, 2007·Experimental Gerontology·Daniela MariRita Provenzano
Sep 22, 2011·European Journal of Clinical Pharmacology·Teddy KosoglouDavid L Cutler
Nov 15, 2011·The New England Journal of Medicine·Pierluigi TricociUNKNOWN TRACER Investigators
Mar 27, 2012·The New England Journal of Medicine·David A MorrowUNKNOWN TRA 2P–TIMI 50 Steering Committee and Investigators
Jul 1, 2015·International Journal of Cardiology·Victor L Serebruany

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Citations

Jun 11, 2016·Critical Reviews in Clinical Laboratory Sciences·Xiaohong Ruby XuHeyu Ni
Oct 30, 2020·International Journal of Molecular Sciences·Madhumita ChatterjeeMargitta Elvers

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