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Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study

key information

source: American Society of Hematology

year: 2016

authors: nathan S Fishman, Joseph Kim, Daniel Lichy, Kathleen Vaughan, Stephen Yoon, Niral Sheth, James Ahad, Deepika Darbari, Katherine Chadwick, Hans Ackerman, Alexander M. Gorbach, James G. Taylor

summary/abstract:

Background: Sickle cell anemia (SCA) is characterized by significant phenotypic variability. DOVE1 was a Phase 3, double-blind, randomized, parallel-group, placebo-controlled, multinational study that investigated the efficacy and safety of prasugrel, a P2Y12 adenosine diphosphate receptor antagonist, for reduction of vaso-occlusive crises (VOCs), a composite of painful crisis or acute chest syndrome, in 2- to <18-year-olds with SCA (age cohorts: 2 to <6 years, 6 to <12 years, and 12 to <18 years)

Methods: DOVE was conducted at 51 sites in 13 countries across 4 continents. A total of 341 subjects were randomized (prasugrel, n=171; placebo, n=170) and SCA genotypes (homozygous hemoglobin S; hemoglobin Sβ0 thalassemia) were included. Eligibility required >=2 VOCs in the prior year. Baseline clinical and laboratory characteristics and study endpoints were compared by region. Since no overall treatment effect was found, data provided reflect the combined 341 subjects (Americas, N=57; sub-Saharan Africa [SSA], N=148; North Africa/Middle East, N=110; Europe, N=26).

organization: Evelina London Children's Hospital; Guy's and St Thomas' Hospital NHS Trust, London; Azienda Ospedaliera - Università di Padova; King's College London; Boston Children’s Cancer and Blood Disorders Center; UCSF Benioff Children's Hospital Oakland; Kenya Medical Research Institute; Alexandria University; Eli Lilly and Company, Indianapolis; American University of Beirut Medical Center

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