Roxastat is not inferior to darbepoetin alfa in the Phase 3 trial of head-to-head treatment of anemia
Last Update: 2020-06-17
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Astedai recently released the results of phase III clinical trial DOLOMITES, which was conducted in adult patients with stage 3 to 5 chronic kidney disease (CKD) non-dialysis dependence (NDD) to assess the efficacy of roxadustat and darpoetbein alfa for anaemiaThe results showed that roxadustat's therapeutic effect in correcting hemoglobin levels was no worse than darbepoetin alfa (89.5% vs 78.0%; 95% CI: 5.66%, 17.36%) during the first 24 weeks of treatment, reaching the main endpoint of the study (95% CI.0)the secondary endpoint of the study was the non-disadvantageandity and superiority of the stratified testThe data show edigate levels of LDL cholesterol (minimum mean variance (LSM) difference of 0.403mmol/L; 95% CI: -0.510, -0.296; 0.01), the first intravenous iron (risk ratio of .45; 95% CI: 0.26, 0.78; p-0.004), roxadustat shows superiorityRoxadustat showed non-de-secrimmage in terms of average arterial pressure (LSM difference- of 0.372 mmHg; 95% CI: -1.587, 0.842) and the time at which hypertension occurred (HR-0.83; 95% CI:0.56, 1.22)safety, there was no significant difference in the overall incidence of adverse events during treatment by roxadustat and darbepoetin alfa (91.6% and 92.5%, respectively)Unconfirmed analysis of severe adverse cardiovascular events (MACE) and MACE plus in-patient unstable angina and inpatient congestive heart failure (MACE plus) showed that the two drugs had an average OF 0.81 (95% CI:0.52, 1.25) and 0.90 (95% CI: 0.61, 1.32), respectivelyrenal anemia is one of the main complications of CKD renal dysfunctionWith the progress of CKD, the prevalence and severity of CKD-related anemia increased graduallyPatients with renal anemia are difficult to correct than conventional anemia, the patients are severely weak and have poor quality of lifeCurrent standard treatments for renal anemia are erythropoietin (EPO hormone) replacement, red blood cell-generating stimulants (ESA) such as alfaibertin and intravenous iron agentsunlike ESA, roxadustat is an oral inhibitor of hypoxic induction factor (HIF) oxalate xylitoxe (PH), which can improve patienthemoglobin levels through different mechanismsAs an HIF-PH inhibitor, roxadustat activates the body's natural protection response to reduced oxygen levels in the bloodThis reaction involves the regulation of complementary processes that promote red blood cell production and increase blood oxygen carrying capacityDiscovered by FibroGen, the drug was developed in partnership with AstraZeneca in the United States, China and other markets, and with Astellas in Japan and the European UnionReference Source: Roxadustat SHS Non-Criterion to Darbepoetin Phase 3 DOLOMITES Study of The Saat in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease
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