Dataset Information

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

ABSTRACT:

Background

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).

Methods and results

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, 1.55; 95% CI 1.30 to 1.86, P<0.001). Intracranial bleeding (ICH) was 0.6% versus 0.4%, P=0.10 with vorapaxar versus placebo, with fatal bleeding 0.2% versus 0.2%; P=0.70.

Conclusions

In patients with prior MI or PAD who have not had a previous stroke or TIA, vorapaxar added to standard therapy is effective for long-term secondary prevention of thrombotic CV events, while increasing moderate or severe bleeding.

Clinical trial registration

URL: clinicaltrials.gov Unique Identifier: NCT00526474.

SUBMITTER: Magnani G

PROVIDER: S-EPMC4392433 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Magnani Giulia G Bonaca Marc P MP Braunwald Eugene E Dalby Anthony J AJ Fox Keith A A KA Murphy Sabina A SA Nicolau José Carlos JC Oude Ophuis Ton T Scirica Benjamin M BM Spinar Jindrich J Theroux Pierre P Morrow David A DA

Journal of the American Heart Association 20150319 3

<h4>Background</h4>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).<h4>Methods and results</h4>We examined the efficacy and safety of vorapaxar in the intended use population, considering 20,170 patients randomized in the ...[more]

PMID: 25792124

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Dataset Information

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

Background

Methods and results

Conclusions

Clinical trial registration

Publications

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

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