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@article{1307912,
author = {Magnani, Giulia and Bonaca, Marc P. and Braunwald, Eugene and Dalby, Anthony J. and Fox, Keith A.A. and Murphy, Sabina A. and Nicolau, José Carlos and Ophuis, Ton Oude and Scirica, Benjamin M. and Špinar, Jindřich and Theroux, Pierre and Morrow, David A.},
article_location = {Hoboken},
article_number = {3},
doi = {http://dx.doi.org/10.1161/JAHA.114.001505},
keywords = {antiplatelet therapy; atherosclerosis; myocardial infarction; peripheral arterial disease; secondary prevention; vorapaxar},
language = {eng},
issn = {2047-9980},
journal = {Journal of the American Heart Association},
title = {Efficacy and Safety of Vorapaxar as Approved for Clinical Use in the United States},
volume = {4},
year = {2015}
}
TY - JOUR
ID - 1307912
AU - Magnani, Giulia - Bonaca, Marc P. - Braunwald, Eugene - Dalby, Anthony J. - Fox, Keith A.A. - Murphy, Sabina A. - Nicolau, José Carlos - Ophuis, Ton Oude - Scirica, Benjamin M. - Špinar, Jindřich - Theroux, Pierre - Morrow, David A.
PY - 2015
TI - Efficacy and Safety of Vorapaxar as Approved for Clinical Use in the United States
JF - Journal of the American Heart Association
VL - 4
IS - 3
SP - "e001505"
EP - "e001505"
PB - Wiley-Blackwell
SN - 20479980
KW - antiplatelet therapy
KW - atherosclerosis
KW - myocardial infarction
KW - peripheral arterial disease
KW - secondary prevention
KW - vorapaxar
N2 - 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.
ER -
MAGNANI, Giulia, Marc P. BONACA, Eugene BRAUNWALD, Anthony J. DALBY, Keith A.A. FOX, Sabina A. MURPHY, José Carlos NICOLAU, Ton Oude OPHUIS, Benjamin M. SCIRICA, Jindřich ŠPINAR, Pierre THEROUX a David A. MORROW. Efficacy and Safety of Vorapaxar as Approved for Clinical Use in the United States. \textit{Journal of the American Heart Association}. Hoboken: Wiley-Blackwell, roč.~4, č.~3, s.~''e001505'', 9 s. ISSN~2047-9980. doi:10.1161/JAHA.114.001505. 2015.
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