A multinational trial of prasugrel for sickle cell vaso-occlusive events
| Autor: | David C. Rees, Raffaella Colombatti, Miguel R. Abboud, Nancy Robitaille, Hoda Hassab, Catherine I. Segbefia, Chunmei Zhou, Julie Kanter, Tsiri Agbenyega, Patricia B. Brown, Dmitry Zamoryakhin, Videlis Nduba, Janet Oyieko, Bernhards Ogutu, Lori E. Heath, Joseph A. Jakubowski, Matthew M. Heeney, Baba Inusa, Carolyn Hoppe |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Oral
Male medicine.medical_specialty Peripheral Vascular Diseases/etiology Platelet Aggregation Inhibitors/adverse effects Prasugrel Adolescent Anemia Administration Oral Pain Hemorrhage 030204 cardiovascular system & hematology Pain/etiology Placebo 03 medical and health sciences 0302 clinical medicine Double-Blind Method hemic and lymphatic diseases Internal medicine Hemorrhage/chemically induced Acute Chest Syndrome medicine Acute Chest Syndrome/etiology Anemia Sickle Cell Child Child Preschool Female Humans Peripheral Vascular Diseases Platelet Aggregation Inhibitors Prasugrel Hydrochloride Preschool business.industry General Medicine medicine.disease Prasugrel Hydrochloride/adverse effects Sickle cell anemia Acute chest syndrome Surgery Sickle Cell 030220 oncology & carcinogenesis Administration Platelet aggregation inhibitor Anemia Sickle Cell/complications business Vaso-occlusive crisis medicine.drug |
| Zdroj: | Heeney, M M, Hoppe, C C, Abboud, M R, Inusa, B, Kanter, J, Ogutu, B, Brown, P B, Heath, L E, Jakubowski, J A, Zhou, C, Zamoryakhin, D, Agbenyega, T, Colombatti, R, Hassab, H M, Nduba, V N, Oyieko, J N, Robitaille, N & Segbefia, C I & Rees, D C 2016, ' A Multinational Trial of Prasugrel for Sickle Cell Vaso-Occlusive Events ', New England Journal of Medicine, vol. 374, no. 7, pp. 625-635 . https://doi.org/10.1056/NEJMoa1512021 |
| ISSN: | 0179-4000 |
| DOI: | 10.1056/NEJMoa1512021 |
| Popis: | BACKGROUNDSickle cell anemia is an inherited blood disorder that is characterized by painfulvaso-occlusive crises, for which there are few treatment options. Platelets mediate intercellular adhesion and thrombosis during vaso-occlusion in sickle cell anemia, which suggests a role for antiplatelet agents in modifying disease events.METHODSChildren and adolescents 2 through 17 years of age with sickle cell anemia wererandomly assigned to receive oral prasugrel or placebo for 9 to 24 months. The primary end point was the rate of vaso-occlusive crisis, a composite of painful crisis or acute chest syndrome. The secondary end points were the rate of sickle cell–related pain and the intensity of pain, which were assessed daily with the use of pain diaries.RESULTSA total of 341 patients underwent randomization at 51 sites in 13 countries acrossthe Americas, Europe, Asia, and Africa. The rate of vaso-occlusive crisis events per person-year was 2.30 in the prasugrel group and 2.77 in the placebo group (rate ratio, 0.83; 95% confidence interval, 0.66 to 1.05; P=0.12). There were no significant differences between the groups in the secondary end points of diary-reported events. The safety end points, including the frequency of bleeding events requiring medical intervention, of hemorrhagic and nonhemorrhagic adverse events that occurred while patients were taking prasugrel or placebo, and of discontinuations due to prasugrel or placebo, did not differ significantly between the groups.CONCLUSIONSAmong children and adolescents with sickle cell anemia, the rate of vaso-occlusive crisis was not significantly lower among those who received prasugrel than among those who received placebo. There were no significant between-group differences in the safety findings. (Funded by Daiichi Sankyo and Eli Lilly; ClinicalTrials.gov number, NCT01794000.) |
| Databáze: | OpenAIRE |
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