Efficacy and safety of vorapaxar as approved for clinical use in the United States

Journal of the American Heart Association
Giulia MagnaniDavid A Morrow

Abstract

Vorapaxar is a protease-activated receptor-1 antagonist approved by the U.S. Food and Drug Administration (FDA) for the reduction of thrombotic cardiovascular (CV) events in patients with a history of myocardial infarction (MI) and peripheral artery disease (PAD), without a previous stroke or transient ischemic attack (TIA). We examined the efficacy and safety of vorapaxar in the intended use population, considering 20,170 patients randomized in the multinational, double-blinded, placebo-controlled TRA 2°P-TIMI 50 trial. Of these, 16,897 qualified with a history of MI in the prior 2 weeks to 1 year and 3273 with PAD. At baseline 97% of the patients were treated with aspirin, 71% with a thienopyridine, and 93% a statin. At 3 years, the endpoint of CV death, MI, or stroke was significantly reduced with vorapaxar compared with placebo (7.9% versus 9.5%, HR, 0.80; 95% CI 0.73 to 0.89; P<0.001). Vorapaxar also significantly reduced the composite of CV death, MI, stroke, and urgent coronary revascularization (10.1% versus 11.8%, HR, 0.83; 95% CI 0.76 to 0.90; P<0.001), as well as the rate of CV death or MI (P<0.001). The safety endpoint of GUSTO moderate or severe bleeding, was increased in the vorapaxar group (3.7 versus 2.4, HR, 1....Continue Reading

References

Nov 6, 2007·The New England Journal of Medicine·Stephen D WiviottUNKNOWN TRITON-TIMI 38 Investigators
Aug 30, 2008·The New England Journal of Medicine·Ralph L SaccoUNKNOWN PRoFESS Study Group
Sep 1, 2009·Future Cardiology·Marc P Bonaca, David A Morrow
Sep 1, 2009·The New England Journal of Medicine·Lars WallentinMona Thorsén
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
Aug 31, 2012·The New England Journal of Medicine·UNKNOWN SPS3 InvestigatorsLesly A Pearce
Feb 12, 2013·Stroke; a Journal of Cerebral Circulation·David A MorrowUNKNOWN Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events–TIMI 50 Steering Committee and Inve

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Citations

Oct 20, 2015·Expert Opinion on Pharmacotherapy·Amy Wang
Nov 13, 2015·Expert Review of Cardiovascular Therapy·Udaya S TantryPaul A Gurbel
Nov 14, 2015·Expert Review of Neurotherapeutics·Victor L SerebruanyDan F Hanley
Jun 28, 2016·The Canadian Journal of Cardiology·David H FitchettAnatoly Langer
Sep 26, 2015·Future Cardiology·Francesco FranchiDominick J Angiolillo
Sep 24, 2015·Trends in Cardiovascular Medicine·Yongwhi ParkDominick J Angiolillo
Aug 19, 2015·Progress in Cardiovascular Diseases·Francesco FranchiDominick J Angiolillo
Aug 15, 2015·British Dental Journal·S Johnston
Jun 6, 2015·Journal of the American College of Cardiology·Neal S Kleiman, Kumaran Kolandaivelu
Oct 26, 2016·Journal of Vascular Surgery·Rohun U PalekarSamuel A Wickline
Apr 6, 2016·Journal of the American College of Cardiology·Marc P BonacaMarc S Sabatine
Apr 15, 2016·European Heart Journal. Acute Cardiovascular Care·Ethan C KosovaDavid A Morrow
Jun 2, 2017·Journal of Cardiovascular Pharmacology and Therapeutics·Jae Youn MoonDominick J Angiolillo
Jun 13, 2018·Expert Opinion on Pharmacotherapy·José C NicolauRobert P Giugliano
Aug 19, 2017·Arteriosclerosis, Thrombosis, and Vascular Biology·Bart L van den EshofMaartje van den Biggelaar
Oct 1, 2018·Journal of Cellular Biochemistry·Najmeh JaberiSeyed Mahdi Hassanian
Apr 21, 2020·Future Cardiology·Udaya S TantryPaul A Gurbel
Feb 24, 2017·Journal of Thrombosis and Thrombolysis·Homam Ibrahim, Sunil V Rao
Jul 12, 2016·Coronary Artery Disease·Leo UngarKenneth W Mahaffey
Dec 5, 2018·Journal of Thrombosis and Thrombolysis·Simon CorreaMichelle L O'Donoghue
Dec 12, 2018·Journal of the American Heart Association·Leo UngarChiara Melloni
Dec 26, 2018·Expert Opinion on Investigational Drugs·Srikanth YandrapalliWilbert S Aronow
Oct 7, 2020·Expert Review of Cardiovascular Therapy·Leonardo De LucaGiulia Magnani
Oct 21, 2020·Clinical Science·Sarah W Y LokSydney C W Tang
Oct 30, 2020·International Journal of Molecular Sciences·Madhumita ChatterjeeMargitta Elvers
Jun 11, 2021·Circulation Research·Marc P BonacaMark A Creager

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