Oral drug Roxadustat safe and effective for anemia treatment in kidney disease patients: Study
Roxadustat was shown to be effective, with an acceptable safety profile. USA: An oral drug called roxadustat is effective for the treatment of anemia in patients with chronic kidney disease, shows pooled results from recent clinical trials. The study results appear in the Clinical Journal of the American Society of Nephrology (CJASN).
Many people with kidney dysfunction develop anemia -- a shortage of healthy red blood cells that carry oxygen to the body's tissues. Some anemia treatments may lead to serious cardiovascular side effects.
To evaluate the efficacy and cardiovascular safety of one such inhibitor -- called roxadustat -- Robert Provenzano, MD (Wayne State University School of Medicine) and his colleagues analyzed data pooled from three phase 3 studies of roxadustat in patients with chronic kidney disease and anemia.
In total, 2,391 patients received roxadustat and 1,886 received a placebo. Roxadustat treatment boosted levels of hemoglobin (the protein in red blood cells responsible for transporting oxygen): roxadustat- vs. placebo-treated patients showed an average change in hemoglobin averaged over weeks 28 to 52 of 1.9 vs. 0.1 g/dL. Roxadustat also reduced the need for red blood cell transfusions in the first 52 weeks, and there were no increased risks of mortality, heart attacks, strokes linked to the drug.
"Roxadustat was shown to be effective, with an acceptable safety profile," said Dr. Provenzano. "As an oral agent, roxadustat addresses the significant unmet need in treating anemia in patients with kidney disease."
Reference:
The study titled, "Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non–Dialysis-Dependent CKD: Pooled Results of Three Randomized Clinical Trials," is published in the journal CJASN.
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