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Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent CKD: Pooled Results of Three Randomized Clinical Trials
CONCLUSIONS: Roxadustat was more effective than placebo at increasing hemoglobin in patients with non-dialysis-dependent CKD and anemia, while decreasing transfusion rate and being noninferior to placebo with respect to risk of MACE.CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: A Study of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not Receiving Dialysis, NCT01750190; Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis (ALPS), NCT01887600; Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not ...
Source: Clinical Journal of the American Society of Nephrology : CJASN - August 7, 2021 Category: Urology & Nephrology Authors: Robert Provenzano Lynda Szczech Robert Leong Khalil G Saikali Ming Zhong Tyson T Lee Dustin J Little Mark T Houser Lars Frison John Houghton Thomas B Neff Source Type: research

Efficacy and Cardiovascular Safety of Roxadustat in Dialysis-Dependent Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies
ConclusionRoxadustat improved hemoglobin similarly to ESA while demonstrating comparable cardiovascular and overall safety profiles in a wide spectrum of dialysis-dependent patients with anemia of CKD. Roxadustat represents an oral alternative to ESAs for achieving a target hemoglobin for anemia of CKD in dialysis-dependent patients.
Source: Advances in Therapy - September 14, 2021 Category: Drugs & Pharmacology Source Type: research

Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease
CONCLUSIONS: HIF stabiliser management of anaemia had uncertain effects on CV death, fatigue, death (any cause), CV outcomes, and kidney failure compared to placebo or ESAs. Compared to placebo or ESAs, HIF stabiliser management of anaemia probably decreased the proportion of patients requiring blood transfusions, and probably increased the proportion of patients reaching the target Hb when compared to placebo.PMID:36005278 | DOI:10.1002/14651858.CD013751.pub2
Source: Cochrane Database of Systematic Reviews - August 25, 2022 Category: General Medicine Authors: Patrizia Natale Suetonia C Palmer Allison Jaure Elisabeth M Hodson Marinella Ruospo Tess E Cooper Deirdre Hahn Valeria M Saglimbene Jonathan C Craig Giovanni Fm Strippoli Source Type: research

Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies
ConclusionThere was no evidence of increased risk of cardiovascular events or mortality with roxadustat compared with ESA in patients with anemia who have NDD or ID-DD CKD. Although TEAEs occurred commonly in both the roxadustat and ESA groups, patients infrequently discontinued the study drug because of an adverse event.Clinical Trial Registration NumbersDOLOMITES, 1517-CL-0610 [NCT02021318]; HIMALAYAS, FGCL-4592-063 [NCT02052310]; SIERRAS, FGCL-4592-064 [NCT02273726]; and ROCKIES, D5740C00002 [NCT02174731].
Source: Advances in Therapy - February 7, 2023 Category: Drugs & Pharmacology Source Type: research

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