A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease Public Deposited

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Creator
  • Ataga, Kenneth I.
    • Affiliation: School of Medicine
  • Novelli, Enrico M.
    • Other Affiliation: University of Pittsburg Medical Center, Pittsburg, PA, USA
  • Nwachuku, Chuke E.
    • Other Affiliation: Daiichi Sankyo, Inc, Edison, NJ, USA
  • Heath, Lori E.
    • Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
  • McMahon, Lillian E.
    • Other Affiliation: Boston Medical Center, Boston, MA, USA
  • Knupp, Charles L.
    • Other Affiliation: ECU-Brody School of Medicine, Greenville, NC, USA
  • Wun, Ted
    • Other Affiliation: University of California, Davis Cancer Center, 4501 X St., Ste. 3016, Sacramento, CA, 95817, USA
  • Riesmeyer, Jeffrey S.
    • Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
  • Soulieres, Denis
    • Other Affiliation: CHUM-Notre-Dame, Montreal, QC, Canada
  • Jakubowski, Joseph A.
    • Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
  • Strouse, John J.
    • Other Affiliation: The Johns Hopkins University School of Medicine, Baltimore, MD, USA
  • Frelinger, Andrew L.
    • Other Affiliation: Children’s Hospital Boston, Harvard Medical School, Boston, MA, USA
  • Winters, Kenneth J.
    • Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
  • Kutlar, Abdullah
    • Other Affiliation: Medical College of Georgia, Augusta, GA, USA
  • Krishnamurti, Lakshmanan
    • Other Affiliation: Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA
  • Zhou, Chunmei
    • Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
Abstract
  • Abstract: Background: Platelet activation has been implicated in the pathogenesis of sickle cell disease (SCD) suggesting antiplatelet agents may be therapeutic. To evaluate the safety of prasugrel, a thienopyridine antiplatelet agent, in adult patients with SCD, we conducted a double-blind, randomized, placebo-controlled study. Methods: The primary endpoint, safety, was measured by hemorrhagic events requiring medical intervention. Patients were randomized to prasugrel 5 mg daily (n = 41) or placebo (n = 21) for 30 days. Platelet function by VerifyNow® P2Y12 and vasodilator-stimulated phosphoprotein assays at days 10 and 30 were significantly inhibited in prasugrel- compared with placebo-treated SCD patients. Results: There were no hemorrhagic events requiring medical intervention in either study arm. Mean pain rate (percentage of days with pain) and intensity in the prasugrel arm were decreased compared with placebo. However, these decreases did not reach statistical significance. Platelet surface P-selectin and plasma soluble P-selectin, biomarkers of in vivo platelet activation, were significantly reduced in SCD patients receiving prasugrel compared with placebo. In sum, prasugrel was well tolerated and not associated with serious hemorrhagic events. Conclusions: Despite the small size and short duration of this study, there was a decrease in platelet activation biomarkers and a trend toward decreased pain.
Date of publication
Identifier
  • 23414938
  • doi:10.1186/1756-8722-6-17
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • Ted Wun et al.; licensee BioMed Central Ltd.
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Journal title
  • Journal of Hematology & Oncology
Journal volume
  • 6
Journal issue
  • 1
Page start
  • 17
Language
  • English
Is the article or chapter peer-reviewed?
  • Yes
ISSN
  • 1756-8722
Bibliographic citation
  • Journal of Hematology & Oncology. 2013 Feb 17;6(1):17
Access
  • Open Access
Publisher
  • BioMed Central Ltd
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