Second study shows cardiovascular events and mortality up in patients not undergoing dialysis
WEDNESDAY, Jan. 23 (HealthDay News) -- Peginesatide, a peptide-based erythropoiesis-stimulating agent, is safe and effective in patients with advanced chronic kidney disease and anemia as long as they are undergoing dialysis, according to two studies published in the Jan. 24 issue of The New England Journal of Medicine.
In the first study, Steven Fishbane, M.D., from the Hofstra North Shore-LIJ School of Medicine in Great Neck, N.Y., and colleagues analyzed data from 1,418 patients with advanced chronic kidney disease and anemia undergoing hemodialysis who were treated with peginesatide or epoetin as part of two randomized open-label trials. The researchers found that peginesatide was non-inferior to epoetin in its ability to maintain hemoglobin levels, and the cardiovascular safety was similar in both groups.
In the second study, Iain C. Macdougall, M.D., from King's College Hospital in London, and colleagues analyzed data from 983 patients with advanced chronic kidney disease and anemia not undergoing dialysis who were treated with peginesatide or darbepoetin as part of two randomized open-label trials. The researchers found that peginesatide was non-inferior to darbepoetin in its ability to increase and maintain hemoglobin levels, but cardiovascular events and mortality were higher in patients receiving peginesatide.
"Peginesatide can be used for anemia correction in patients undergoing hemodialysis, in which case its efficacy profile is similar to the profiles of established erythropoiesis-stimulating agents, but concerns remain about its safety in patients not receiving hemodialysis," writes the author of an accompanying editorial.
Several authors from the first study disclosed financial ties to pharmaceutical companies, including Affymax and Takeda, which funded both studies.
Full Text - Fishbane (subscription or payment may be required)
Full Text - Macdougall (subscription or payment may be required)
Editorial (subscription or payment may be required)