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

Background: DOVE (Determining Effects of Platelet Inhibition on Vaso-Occlusive Events) was a Phase 3, randomized, double-blind, placebo-controlled study conducted in children with sickle cell anemia at 51 sites in 13 countries across four continents. Procedure: Data from DOVE were assessed for regio...

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Autores principales: Inusa, Baba Psalm Duniya, Colombatti, Raffaella, Rees, David C., Heeney, Matthew M., Hoppe, Carolyn C., Ogutu, Bernhards, Hassab, Hoda M., Zhou, Chunmei, Yao, Suqin, Brown, Patricia B., Heath, Lori E., Jakubowski, Joseph A., Abboud, Miguel R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6912763/
https://www.ncbi.nlm.nih.gov/pubmed/31744266
http://dx.doi.org/10.3390/jcm8112009
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author Inusa, Baba Psalm Duniya
Colombatti, Raffaella
Rees, David C.
Heeney, Matthew M.
Hoppe, Carolyn C.
Ogutu, Bernhards
Hassab, Hoda M.
Zhou, Chunmei
Yao, Suqin
Brown, Patricia B.
Heath, Lori E.
Jakubowski, Joseph A.
Abboud, Miguel R.
author_facet Inusa, Baba Psalm Duniya
Colombatti, Raffaella
Rees, David C.
Heeney, Matthew M.
Hoppe, Carolyn C.
Ogutu, Bernhards
Hassab, Hoda M.
Zhou, Chunmei
Yao, Suqin
Brown, Patricia B.
Heath, Lori E.
Jakubowski, Joseph A.
Abboud, Miguel R.
author_sort Inusa, Baba Psalm Duniya
collection PubMed
description Background: DOVE (Determining Effects of Platelet Inhibition on Vaso-Occlusive Events) was a Phase 3, randomized, double-blind, placebo-controlled study conducted in children with sickle cell anemia at 51 sites in 13 countries across four continents. Procedure: Data from DOVE were assessed for regional differences in subject phenotype and treatment. Demographics, baseline clinical and laboratory data, hydroxyurea (HU) use, vaso-occlusive crisis (VOCs; composite endpoint of painful crisis or acute chest syndrome (ACS)), serious adverse events (SAEs), hospitalization, and treatments were compared across the Americas, Europe, North Africa/Middle East, and Sub-Saharan Africa (SSA). Results: Race, body mass index, and blood pressures differed by region. Pre-enrollment VOCs were highest in the Americas. For subjects not on HU, baseline hemoglobin was lowest in SSA; reticulocyte count was lowest in the Americas. Within SSA, Kenya subjects presented higher baseline hemolysis. Painful crisis was the most common SAE, followed by ACS in the Americas and infections in other regions. VOC rate and percentage of VOC hospitalizations were highest in Europe. Regardless of region, most VOCs were treated with analgesics; approximately half were treated with intravenous fluids. The proportion of VOC-related transfusions was greatest in Europe. Lengths of hospital stay were similar across regions. Conclusions: Overall differences in SAEs and hospitalization for VOCs may be due to cultural diversities, resource utilization, disease severity, or a combination of factors. These data are of importance for the planning of future trials in SCA in a multinational setting.
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spelling pubmed-69127632020-01-02 Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study Inusa, Baba Psalm Duniya Colombatti, Raffaella Rees, David C. Heeney, Matthew M. Hoppe, Carolyn C. Ogutu, Bernhards Hassab, Hoda M. Zhou, Chunmei Yao, Suqin Brown, Patricia B. Heath, Lori E. Jakubowski, Joseph A. Abboud, Miguel R. J Clin Med Article Background: DOVE (Determining Effects of Platelet Inhibition on Vaso-Occlusive Events) was a Phase 3, randomized, double-blind, placebo-controlled study conducted in children with sickle cell anemia at 51 sites in 13 countries across four continents. Procedure: Data from DOVE were assessed for regional differences in subject phenotype and treatment. Demographics, baseline clinical and laboratory data, hydroxyurea (HU) use, vaso-occlusive crisis (VOCs; composite endpoint of painful crisis or acute chest syndrome (ACS)), serious adverse events (SAEs), hospitalization, and treatments were compared across the Americas, Europe, North Africa/Middle East, and Sub-Saharan Africa (SSA). Results: Race, body mass index, and blood pressures differed by region. Pre-enrollment VOCs were highest in the Americas. For subjects not on HU, baseline hemoglobin was lowest in SSA; reticulocyte count was lowest in the Americas. Within SSA, Kenya subjects presented higher baseline hemolysis. Painful crisis was the most common SAE, followed by ACS in the Americas and infections in other regions. VOC rate and percentage of VOC hospitalizations were highest in Europe. Regardless of region, most VOCs were treated with analgesics; approximately half were treated with intravenous fluids. The proportion of VOC-related transfusions was greatest in Europe. Lengths of hospital stay were similar across regions. Conclusions: Overall differences in SAEs and hospitalization for VOCs may be due to cultural diversities, resource utilization, disease severity, or a combination of factors. These data are of importance for the planning of future trials in SCA in a multinational setting. MDPI 2019-11-17 /pmc/articles/PMC6912763/ /pubmed/31744266 http://dx.doi.org/10.3390/jcm8112009 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Inusa, Baba Psalm Duniya
Colombatti, Raffaella
Rees, David C.
Heeney, Matthew M.
Hoppe, Carolyn C.
Ogutu, Bernhards
Hassab, Hoda M.
Zhou, Chunmei
Yao, Suqin
Brown, Patricia B.
Heath, Lori E.
Jakubowski, Joseph A.
Abboud, Miguel R.
Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study
title Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study
title_full Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study
title_fullStr Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study
title_full_unstemmed Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study
title_short Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE Study
title_sort geographic differences in phenotype and treatment of children with sickle cell anemia from the multinational dove study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6912763/
https://www.ncbi.nlm.nih.gov/pubmed/31744266
http://dx.doi.org/10.3390/jcm8112009
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