Oral drug trials show efficacy and safety for treating anemia associated with kidney disease – sciencedaily
The pooled results of recent clinical trials indicate that an oral drug called roxadustat is an effective treatment for anemia in patients with chronic kidney disease. The results are published in an upcoming issue of CJASN.
Many people with kidney dysfunction develop anemia or a shortage of healthy red blood cells that carry oxygen to tissues in the body. Some treatments for anemia are linked to serious cardiovascular side effects, but a new class of oral drugs called hypoxia-inducible factor prolyl hydroxylase inhibitors may be comparable to placebo in these trials. These drugs work on the pathway involved in the production of erythropoietin which stimulates the formation of red blood cells.
To assess the efficacy and cardiovascular safety of one of these inhibitors, called roxadustat, Robert Provenzano, MD (Wayne State University School of Medicine) and colleagues analyzed pooled data from three Phase 3 studies of roxadustat in patients. patients with chronic renal failure and anemia. .
A total of 2391 patients received roxadustat and 1886 received placebo. Treatment with roxadustat increased hemoglobin levels (the protein in red blood cells responsible for transporting oxygen): patients treated with roxadustat compared to placebo had an average change in hemoglobin levels over the weeks 28 to 52 of 1.9 against 0.1 g / dL. Roxadustat also reduced the need for red blood cell transfusions in the first 52 weeks, and there was no increased risk of drug-related death, heart attack, stroke.
“Roxadustat has been shown to be effective, with an acceptable safety profile,” said Dr Provenzano. “As an oral agent, roxadustat addresses a significant unmet need for the treatment of anemia in patients with renal impairment. “
Study co-authors include Lynda Szczech, MD, Robert Leong, MD, Khalil Saikali, MD, Ming Zhong, PhD, Tyson T. Lee, PhD, Dustin J. Little, MD, Mark T, Houser, MD, Lars Frison, PhD, John Houghton and Thomas B. Neff, MD.
Disclosures: RP serves as a consultant for AstraZeneca, DaVita and FibroGen. LS, RL, KGS, MZ, TTL are employees of FibroGen and hold shares and / or stock options of FibroGen. MTH, LF, DJL and JH are employees of AstraZeneca and hold shares and / or stock options of AstraZeneca.
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Material provided by American Society of Nephrology. Note: Content can be changed for style and length.