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Platelet Function: Meloxicam Intravenous in Whole Blood Samples From Healthy Volunteers.
Jahr, Jonathan S; Searle, Shawn; McCallum, Stewart; Mack, Randall; Minger, Kim; Freyer, Alex; Du, Wei; Hobson, Sue.
Afiliación
  • Jahr JS; David Geffen School of Medicine at UCLA, Ronald Reagan UCLA Medical Center/UCLA Health, Los Angeles, California, USA.
  • Searle S; PRA Health Sciences, Salt Lake City, Utah, USA.
  • McCallum S; Baudax Bio (formerly Recro Pharma, Inc.), Malvern, Pennsylvania, USA.
  • Mack R; Baudax Bio (formerly Recro Pharma, Inc.), Malvern, Pennsylvania, USA.
  • Minger K; Baudax Bio (formerly Recro Pharma, Inc.), Malvern, Pennsylvania, USA.
  • Freyer A; Baudax Bio (formerly Recro Pharma, Inc.), Malvern, Pennsylvania, USA.
  • Du W; Clinical Statistics Consulting, Blue Bell, Pennsylvania, USA.
  • Hobson S; Baudax Bio (formerly Recro Pharma, Inc.), Malvern, Pennsylvania, USA.
Clin Pharmacol Drug Dev ; 9(7): 841-848, 2020 10.
Article en En | MEDLINE | ID: mdl-31961516
Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective treatments for pain but may induce bleeding events due to platelet dysfunction associated with inhibition of cyclooxygenase (COX)-1 impairing thromboxane production. An intravenous nanocrystal formulation of meloxicam, a COX-2 preferential nonsteroidal anti-inflammatory drug, is under development for the treatment of moderate to severe pain. This single-center ex vivo study evaluated the effect of meloxicam intravenous and ketorolac on platelet function in whole blood samples from healthy volunteers. Each whole blood sample was aliquoted to allow analysis using a platelet function analyzer under negative control (untreated), positive control (2 therapeutic ketorolac concentrations), and meloxicam intravenous (1 therapeutic, 3 supratherapeutic concentrations) using both collagen with epinephrine and collagen with adenosine diphosphate reagent cartridges. The platelet function analyzer determines closure time by simulating platelet adhesion and aggregation following vascular injury. The final analysis set included data from 8 subjects. The collagen with adenosine diphosphate analysis (sensitive to thrombocytopathies) showed no significant differences in closure time for meloxicam- or ketorolac-treated samples and untreated control. The collagen with epinephrine analysis (sensitive to aspirin-induced platelet abnormalities) produced no significant difference in closure time between any meloxicam concentration and untreated control. Ketorolac was associated with significantly longer closure times vs untreated control at both the 2.5- and 5-µg/mL concentrations (P = .003 and .0257, respectively) and vs meloxicam at several concentrations. Similar results were observed when all analyzed samples were included. Meloxicam intravenous had no significant effect on closure times at therapeutic or supratherapeutic concentrations in this ex vivo study.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Dolor / Agregación Plaquetaria / Antiinflamatorios no Esteroideos / Meloxicam Límite: Adult / Female / Humans / Male Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Dolor / Agregación Plaquetaria / Antiinflamatorios no Esteroideos / Meloxicam Límite: Adult / Female / Humans / Male Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos