Efficacy and Safety of Vorapaxar as Approved for Clinical Use in the United States

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F15%3A00083509" target="_blank" >RIV/00216224:14110/15:00083509 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/65269705:_____/15:00063156

Výsledek na webu

<a href="http://dx.doi.org/10.1161/JAHA.114.001505" target="_blank" >http://dx.doi.org/10.1161/JAHA.114.001505</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1161/JAHA.114.001505" target="_blank" >10.1161/JAHA.114.001505</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and Safety of Vorapaxar as Approved for Clinical Use in the United States

Popis výsledku v původním jazyce

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 peripheralartery 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. At3 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&lt;0.001).

Název v anglickém jazyce

Efficacy and Safety of Vorapaxar as Approved for Clinical Use in the United States

Popis výsledku anglicky

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 peripheralartery 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. At3 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&lt;0.001).

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FA - Kardiovaskulární nemoci včetně kardiochirurgie

OECD FORD obor

—

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2015

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of the American Heart Association

ISSN

2047-9980

e-ISSN

—

Svazek periodika

4

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

"e001505"

Kód UT WoS článku

000351520300011

EID výsledku v databázi Scopus

—