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

Wun, T and Soulieres, D and Frelinger, AL and Krishnamurti, L and Novelli, EM and Kutlar, A and Ataga, KI and Knupp, CL and McMahon, LE and Strouse, JJ and Zhou, C and Heath, LE and Nwachuku, CE and Jakubowski, JA and Riesmeyer, JS and Winters, KJ (2013) A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease. Journal of Hematology and Oncology, 6 (1).

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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. © 2013 Wun et al.; licensee BioMed Central Ltd.

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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Wun, T
Soulieres, D
Frelinger, AL
Krishnamurti, L
Novelli, EMemn3@pitt.eduEMN3
Kutlar, A
Ataga, KI
Knupp, CL
McMahon, LE
Strouse, JJ
Zhou, C
Heath, LE
Nwachuku, CE
Jakubowski, JA
Riesmeyer, JS
Winters, KJ
Date: 19 February 2013
Date Type: Publication
Journal or Publication Title: Journal of Hematology and Oncology
Volume: 6
Number: 1
DOI or Unique Handle: 10.1186/1756-8722-6-17
Schools and Programs: School of Medicine > Medicine
School of Medicine > Pediatrics
Refereed: Yes
Date Deposited: 06 Oct 2016 15:29
Last Modified: 12 Oct 2017 08:57
URI: http://d-scholarship.pitt.edu/id/eprint/29758

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