A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease
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Wun, Ted, et al. A Double-blind, Randomized, Multicenter Phase 2 Study of Prasugrel Versus Placebo In Adult Patients with Sickle Cell Disease. BioMed Central Ltd, 2013. https://doi.org/10.17615/vmvb-3646APA
Wun, T., Soulieres, D., Frelinger, A., Krishnamurti, L., Novelli, E., Kutlar, A., Ataga, K., Knupp, C., Mc Mahon, L., Strouse, J., Zhou, C., Heath, L., Nwachuku, C., Jakubowski, J., Riesmeyer, J., & Winters, K. (2013). A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease. BioMed Central Ltd. https://doi.org/10.17615/vmvb-3646Chicago
Wun, Ted, Denis Soulieres, Andrew L Frelinger, Lakshmanan Krishnamurti, Enrico M Novelli, Abdullah Kutlar, Kenneth I Ataga et al. 2013. A Double-Blind, Randomized, Multicenter Phase 2 Study of Prasugrel Versus Placebo In Adult Patients with Sickle Cell Disease. BioMed Central Ltd. https://doi.org/10.17615/vmvb-3646- Creator
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Wun, Ted
- Other Affiliation: University of California, Davis Cancer Center, 4501 X St., Ste. 3016, Sacramento, CA, 95817, USA
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Soulieres, Denis
- Other Affiliation: CHUM-Notre-Dame, Montreal, QC, Canada
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Frelinger, Andrew L.
- Other Affiliation: Children’s Hospital Boston, Harvard Medical School, Boston, MA, USA
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Krishnamurti, Lakshmanan
- Other Affiliation: Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA
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Novelli, Enrico M.
- Other Affiliation: University of Pittsburg Medical Center, Pittsburg, PA, USA
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Kutlar, Abdullah
- Other Affiliation: Medical College of Georgia, Augusta, GA, USA
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Ataga, Kenneth I.
- Affiliation: School of Medicine
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Knupp, Charles L.
- Other Affiliation: ECU-Brody School of Medicine, Greenville, NC, USA
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McMahon, Lillian E.
- Other Affiliation: Boston Medical Center, Boston, MA, USA
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Strouse, John J.
- Other Affiliation: The Johns Hopkins University School of Medicine, Baltimore, MD, USA
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Zhou, Chunmei
- Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
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Heath, Lori E.
- Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
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Nwachuku, Chuke E.
- Other Affiliation: Daiichi Sankyo, Inc, Edison, NJ, USA
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Jakubowski, Joseph A.
- Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
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Riesmeyer, Jeffrey S.
- Other Affiliation: Eli Lilly and Company, Indianapolis, IN, USA
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Winters, Kenneth J.
- 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
- February 17, 2013
- DOI
- Identifier
- Resource type
- Article
- Rights statement
- In Copyright
- Rights holder
- Ted Wun et al.; licensee BioMed Central Ltd.
- License
- 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
- Publisher
- BioMed Central Ltd
- Access right
- Open Access
- Date uploaded
- March 1, 2013
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