Pooled data show roxadustat versus placebo increases hemoglobin levels with an acceptable profile for cardiovascular safety<\/p>\n<\/h3>\n
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MONDAY, Aug. 23, 2021 (HealthDay News) — For patients with non-dialysis-dependent chronic kidney disease (CKD) and CKD-related anemia, roxadustat increases hemoglobin levels and reduces the need for red blood cell transfusions, according to a study published in the August issue of the Clinical Journal of the American Society of Nephrology<\/em>.<\/p>\n Robert Provenzano, M.D., from Wayne State University in Detroit, and colleagues examined the efficacy and cardiovascular safety of roxadustat versus placebo using data from three phase 3, double-blind studies in patients with non-dialysis-dependent CKD and CKD-related anemia. Overall, 4,277 patients were randomly assigned as follows: 2,391 to roxadustat and 1,886 to placebo.<\/p>\n The researchers found that regardless of rescue therapy, patients treated with roxadustat versus placebo had a mean change from baseline in hemoglobin of 1.9 versus 0.2 g\/dL, averaged over weeks 28 to 52. In the first 52 weeks, roxadustat reduced the need for red blood cell transfusion (6.1 versus 20.4 per 100 patient-exposure years, respectively; hazard ratio, 0.26). In patients treated with roxadustat versus placebo, there were no increased risks for a composite outcome of major adverse cardiovascular events (MACE), including all-cause mortality, myocardial infarction, and stroke; MACE+ (MACE plus unstable angina and heart failure requiring hospitalization); all-cause mortality; or individual MACE+ components.<\/p>\n “Roxadustat was shown to be effective, with an acceptable safety profile,” Provenzano said in a statement. “As an oral agent, roxadustat addresses the significant unmet need in treating anemia in patients with kidney disease.”<\/p>\n Several authors disclosed financial ties to biopharmaceutical companies, including FibroGen, AstraZeneca, and Astellas, which sponsored the studies.<\/p>\n