This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Introduction Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism. We assessed the efficacy and tolerability of roxadustat in patients with chronic kidney disease (CKD)-related anemia not on dialysis. Methods ANDES was a global Phase 3 randomized study in which adults with stage 3–5 CKD not on dialysis received roxadustat or placebo. Patients were initially dosed thrice weekly; dose was titrated to achieve a hemoglobin level ≥11.0 g/dl, followed by titration for maintenance. The primary endpoints were change in hemoglobin (weeks 28–52) and proportion of patients achieving a hemoglobin response (hemoglobin ≥11.0 g/dl and increase ≥1.0 g/dl [baseline >8.0 g/dl], or increase ≥2.0 g/dl [baseline ≤8.0 g/dl]) (week 24). Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were recorded. Results In roxadustat (n = 616) and placebo (n = 306) groups, hemoglobin mean (SD) change from baseline over weeks 28–52 was significantly larger for roxadustat (2.00 [0.95]) versus placebo (0.16 [0.90]), corresponding to least-squares mean difference of 1.85 g/dl (95% confidence interval [CI] 1.74–1.97; P < 0.0001). The proportion of patients achieving a response at week 24 was larger for roxadustat (86.0%; 95% CI 83.0%–88.7%) versus placebo (6.6%; 95% CI 4.1%–9.9%; P < 0.0001). The proportion of patients receiving rescue therapy at week 52 was smaller for roxadustat (8.9%) versus placebo (28.9%); hazard ratio, 0.19 (95% CI 0.14–0.28; P < .0001). The incidences of TEAEs and TESAEs were comparable. Conclusion This study showed that roxadustat corrected and maintained hemoglobin and was well tolerated in patients with CKD-related anemia not on dialysis ( ClinicalTrials.gov NCT01750190).

The aim of this study was to compare postoperative outcomes in patients undergoing aortic valve replacement through a ministernotomy or conventional sternotomy. Sixty patients were randomized into 2 groups of 30 each: group 1 had a full sternotomy and group 2 had a ministernotomy. Pain was evaluated on a daily basis, pulmonary function tests were performed perioperatively. The skin incision was shorter in group 2 (7.17 vs 24.50 cm in group 1). There was significantly less mediastinal drainage in group 2 (233 vs 590 mL in 24 hours in group 1). Group 1 patients had more blood transfusions and longer ventilation time. In group 1, 96.7% experienced severe pain, whereas 93.3% in group 2 reported minimal pain. Hospital stay was 17.7 days in group 1 and 8.0 days in group 2. The ministernotomy had a cosmetic advantage, less blood loss and transfusion requirement, greater sternal stability, better respiratory function, and earlier extubation and hospital discharge.

No abstract

PACTR201602001476292.