No differences in the pharmacodynamics and pharmacokinetics of the thrombin receptor antagonist vorapaxar between healthy Japanese and Caucasian subjects.

Background: Vorapaxar, a novel antiplatelet agent in advanced clinical development for the prevention and treatment of atherothrombotic disease, is a potent, orally bioavailable thrombin receptor antagonist selective for the protease-activated receptor 1 (PAR-1). Methods: Since race/ethnicity may af...

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Publicado en:European Journal of Clinical Pharmacology Vol. 68; no. 3; pp. 291 - 301
Autores principales: Kosoglou, Teddy, Reyderman, Larisa, Kasserra, Claudia, Jennings, Lisa, Young, Sophia, Xuan, Fengjuan, Pei, Jinglan, Maxwell, Stephen, Schiller, James, Meehan, Alan, Cutler, David
Formato: research tables/charts randomized controlled trial Journal Article
Publicado: Springer Nature Mar2012
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Springer Nature
      place: New York, New York
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        atl: No differences in the pharmacodynamics and pharmacokinetics of the thrombin receptor antagonist vorapaxar between healthy Japanese and Caucasian subjects.
      aug:
        au:
          Kosoglou, Teddy
          Reyderman, Larisa
          Kasserra, Claudia
          Jennings, Lisa
          Young, Sophia
          Xuan, Fengjuan
          Pei, Jinglan
          Maxwell, Stephen
          Schiller, James
          Meehan, Alan
          Cutler, David
        affil: Merck Sharp & Dohme Corp., Whitehouse Station USA
      sug:
        subj:
          Platelet Aggregation Inhibitors Pharmacokinetics
          Platelet Aggregation Inhibitors Pharmacodynamics
          Platelet Aggregation Inhibitors Administration and Dosage
          Human
          Asians
          White Persons
          Randomized Controlled Trials
          Random Assignment
          Male
          Female
          Adolescence
          Adult
          Middle Age
          Descriptive Statistics
          Platelet Aggregation Inhibitors Adverse Effects
          Matched-Pair Analysis
          Confidence Intervals
          Funding Source
          Analysis of Variance
          Coefficient alpha
          Adolescent: 13-18 years
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Male
          Female
      ab: Background: Vorapaxar, a novel antiplatelet agent in advanced clinical development for the prevention and treatment of atherothrombotic disease, is a potent, orally bioavailable thrombin receptor antagonist selective for the protease-activated receptor 1 (PAR-1). Methods: Since race/ethnicity may affect the safety, efficacy and dosage of drugs, this study was conducted to evaluate potential differences in the pharmacodynamics, pharmacokinetics and safety of vorapaxar after single (5, 10, 20, or 40 mg) or multiple (0.5, 1, or 2.5 mg once daily) doses in healthy Japanese and matched (gender, age, height, and weight) Caucasian volunteers. Results: Vorapaxar was well tolerated in both Japanese and Caucasian subjects. Pharmacodynamic and pharmacokinetic profiles of vorapaxar in the two racial/ethnic groups were similar. In both racial groups, complete inhibition of platelet aggregation was achieved most rapidly with vorapaxar 40 mg and was consistently achieved and maintained with a 2.5 mg daily maintenance dose. Conclusion: There were no substantial differences in the safety, pharmacokinetics or pharmacodynamics of vorapaxar between Japanese and Caucasian subjects.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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