THURSDAY, Sept. 16 (HealthDay News) -- Patients with chronic kidney disease (CKD), type 2 diabetes, and anemia treated with an erythropoiesis-stimulating agent (ESA) who have a poor initial response are at higher risk for cardiovascular events and death than better-responding patients, according to a study in the Sept. 16 issue of the New England Journal of Medicine.
Scott D. Solomon, M.D., of Brigham and Women's Hospital in Boston, and colleagues randomized 1,872 patients with type 2 diabetes, CKD, and anemia to receive the ESA darbepoetin alfa or placebo. The researchers evaluated the patients after four weeks, divided them into quartiles by initial response, and compared their responses in subsequent weeks as darbepoetin alfa doses were increased to achieve hemoglobin targets. Study end points included death from any cause, a composite cardiovascular end point of death from any cause or cardiovascular events, and fatal or nonfatal stroke.
The researchers found that, overall, 471 patients responded poorly to the treatment (hemoglobin change under 2 percent), while responding patients had hemoglobin changes ranging from 2 to 15 percent or more. Patients with a poor initial response had a lower average hemoglobin level after 12 weeks than did the patients with a better initial response, even as the poorly responding patients received higher ESA doses. Poorly responding patients also had higher rates of the composite cardiovascular end point (hazard ratio, 1.31) or death (hazard ratio, 1.41).
"Although the mechanism of this differential effect is not known, these findings raise concern about current target-based strategies for treating anemia in patients with CKD," the authors write.
The study was supported by Amgen.
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