Pooled data show roxadustat versus placebo increases hemoglobin levels with an acceptable profile for cardiovascular safety
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.
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.
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.
“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.”
Several authors disclosed financial ties to biopharmaceutical companies, including FibroGen, AstraZeneca, and Astellas, which sponsored the studies.
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