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https://observatorio.fm.usp.br/handle/OPI/9730
Title: | Efficacy and Safety of Vorapaxar as Approved for Clinical Use in the United States |
Authors: | MAGNANI, Giulia; BONACA, Marc P.; BRAUNWALD, Eugene; DALBY, Anthony J.; FOX, Keith A. A.; MURPHY, Sabina A.; NICOLAU, Jose Carlos; OPHUIS, Ton Oude; SCIRICA, Benjamin M.; SPINAR, Jindrich; THEROUX, Pierre; MORROW, David A. |
Citation: | JOURNAL OF THE AMERICAN HEART ASSOCIATION, v.4, n.3, article ID e001505, 9p, 2015 |
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 20P-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. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - FM/MCP Artigos e Materiais de Revistas Científicas - HC/InCor Artigos e Materiais de Revistas Científicas - LIM/11 Artigos e Materiais de Revistas Científicas - ODS/03 |
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art_MAGNANI_Efficacy_and_Safety_of_Vorapaxar_as_Approved_for_2015.PDF | publishedVersion (English) | 1.64 MB | Adobe PDF | View/Open |
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