{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["32(12)"],"submitter":["Fenaux P"],"pubmed_abstract":["Erythropoiesis-stimulating agents are first choice for treating anemia in low-risk MDS. This double-blind, placebo-controlled study assessed the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (i.e., low-risk) MDS patients with Hb ≤ 10.0 g/dL, with no or moderate RBC transfusion dependence (≤4 RBC units/8 weeks). Patients were randomized, 2:1, to receive epoetin-α 450 IU/kg/week or placebo for 24 weeks, followed by treatment extension in responders. The primary endpoint was erythroid response (ER) through Week 24. Dose adjustments were driven by weekly Hb-levels and included increases, and dose reductions/discontinuation if Hb > 12 g/dL. An independent Response Review Committee (RRC) blindly reviewed all responses, applying IWG-2006 criteria but also considering dose a"],"journal":["Leukemia"],"pagination":["2648-2658"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6286328"],"repository":["biostudies-literature"],"pubmed_title":["A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS."],"pmcid":["PMC6286328"],"pubmed_authors":["Anagnostopoulos A","Gercheva-Kyuchukova L","Haralampiev H","Wapenaar R","Platzbecker U","Oliva EN","Potamianou A","Symeonidis A","Giagounidis A","Schlag R","Fenaux P","Radinoff A","Gotze KS","Spiriti MAA","Milionis I","Santini V","Berger MH"],"additional_accession":[]},"is_claimable":false,"name":"A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS.","description":"Erythropoiesis-stimulating agents are first choice for treating anemia in low-risk MDS. This double-blind, placebo-controlled study assessed the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (i.e., low-risk) MDS patients with Hb ≤ 10.0 g/dL, with no or moderate RBC transfusion dependence (≤4 RBC units/8 weeks). Patients were randomized, 2:1, to receive epoetin-α 450 IU/kg/week or placebo for 24 weeks, followed by treatment extension in responders. The primary endpoint was erythroid response (ER) through Week 24. Dose adjustments were driven by weekly Hb-levels and included increases, and dose reductions/discontinuation if Hb > 12 g/dL. An independent Response Review Committee (RRC) blindly reviewed all responses, applying IWG-2006 criteria but also considering dose a","dates":{"release":"2018-01-01T00:00:00Z","publication":"2018 Dec","modification":"2026-07-09T11:25:16.446Z","creation":"2019-03-27T00:11:18Z"},"accession":"S-EPMC6286328","cross_references":{"pubmed":["29895954"],"doi":["10.1038/s41375-018-0118-9"]}}