دانلودمقاله باموضوع Molidustat برای بیماران ژاپنی با کم خونی کلیوی دیالیز
در قالب pdf و در 13 اسلاید،قابل ویرایش، شامل:
موضوع به انگلیسی:Molidustat for Japanese Patients
With Renal Anemia Receiving Dialysis
بخشی از متن:Introduction: Molidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor for renal anemia treatment,
was evaluated in 5 phase 3 studies (MIYABI program). We report the results of the MIYABI hemodialysis-
maintenance study.
Methods: This 52-week, randomized, double-blinded, double-dummy study compared the efficacy and
safety of molidustat and darbepoetin in Japanese patients receiving hemodialysis and erythropoiesisstimulating
agents. Molidustat (starting dose: 75 mg/day) and darbepoetin were titrated to maintain hemoglobin
(Hb) levels in the target range ($10.0 and <12.0 g/dl). Primary outcomes were mean Hb level
during the evaluation period (weeks 33–36) and its change from baseline. Safety outcomes included
adverse events.
Results: Overall, 229 patients were randomized (molidustat, n ¼ 153; darbepoetin, n ¼ 76). Baseline
characteristics were well balanced. Mean baseline Hb level was 10.8 g/dl. Mean (95% confidence interval
[CI]) for mean Hb levels during the evaluation period were within the target range in both groups (molidustat:
10.63 [10.42–10.84] g/dl; darbepoetin: 10.77 [10.59–10.95] g/dl). Least-squares mean (95% CI)
change in mean Hb level during the evaluation period from baseline was –0.14 (–0.37 to 0.09) g/dl for
molidustat and –0.07 (–0.30 to 0.16) g/dl for darbepoetin; molidustat was noninferior to darbepoetin (leastsquares
mean difference [95% CI] [molidustat–darbepoetin]: –0.13 [–0.46 to 0.19] g/dl), based on a noninferiority
margin of 1.0 g/dl. In line with published literature, and as expected in this patient population,
most participants had $1 treatment-emergent adverse event