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- W4283522294 abstract "Prolyl hydroxylase inhibitors (PHIs) are oral agents that might increase availability of anemia treatment options for patients with chronic kidney disease (CKD). The 36-Item Short Form (SF-36) Vitality score is a patient-reported measure of energy/fatigue – common and important outcomes in patients with CKD. Direct comparative evidence on health-related quality of life from randomized controlled trials (RCTs) between PHIs has not been identified. We conducted an indirect treatment comparison (ITC) of changes in SF-36 Vitality score observed in placebo-controlled RCTs of daprodustat and roxadustat. Four pivotal Phase III, double-blind, placebo-controlled RCTs evaluating either daprodustat (ASCEND-NHQ [submitted for publication]) or roxadustat (ALPS, ANDES, OLYMPUS) in anemic non-dialysis CKD patients were identified. Aggregate data for pre-specified SF-36 Vitality score endpoints – change from baseline to week 28 in ASCEND-NHQ, and from baseline to the average across weeks 12 to 28 for the three roxadustat RCTs – were used in our analyses. Posterior probability distribution estimates and pairwise comparisons were generated using Bayesian Markov Chain Monte Carlo methods with non-informative priors. A 95% credible interval (CrI) for mean least squares mean (LSM) difference in change in SF-36 Vitality score between treatments above zero demonstrated superiority. In pairwise comparisons, respective posterior mean LSM differences for daprodustat (5.37, 95% CrI 0.78, 9.93) and roxadustat (0.67, 95% CrI 0.02, 1.32) demonstrated significantly improved SF-36 Vitality score relative to placebo, and daprodustat demonstrated a significantly improved SF-36 Vitality score relative to roxadustat (4.70, 95% CrI 0.08, 9.31). Our analyses suggest superiority of daprodustat compared with roxadustat for the SF-36 Vitality score, which could be important to patients with anemia of CKD. A potential limitation of this ITC is the differences in timepoints of SF-36 Vitality endpoints across studies; however, our analyses used pre-specified endpoints that considered dosing algorithms and expected hemoglobin rate of rise from PHIs." @default.
- W4283522294 created "2022-06-27" @default.
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- W4283522294 date "2022-07-01" @default.
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- W4283522294 title "CO2 Indirect Treatment Comparison between Daprodustat and Roxadustat in Non-Dialysis Patients with Anemia Associated with Chronic Kidney Disease: An Analysis of Energy/Fatigue as Measured by the SF-36 Vitality Score" @default.
- W4283522294 doi "https://doi.org/10.1016/j.jval.2022.04.100" @default.
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