|Higher CV Event Rate Linked to Low Hb in HD Patients - Renal and Urology News|
NATIONAL HARBOR, Md.—Hemodialysis (HD) patients receiving either epoetin or peginesatide who achieve low hemoglobin (Hb) levels have an increased rate of cardiovascular (CV) events, according to new data presented at the National Kidney Foundation 2012 Spring Clinical Meetings.Pablo E. Pergola, MD, PhD, of Renal Associates in San Antonio, Tex., analyzed data from 1,608 subjects who participated in two phase 3 clinical trials comparing peginesatide with epoetin. Peginesatide is an investigational medication under review by the FDA as a treatment for anemia in dialysis patients. The two trials demonstrated that peginesatide was not inferior to epoetin in maintaining Hb levels in HD patients.
The study by Dr. Pergola's group included 542 patients who received epoetin and 1,066 who received peginesatide. The researchers examined the cardiovascular composite safety endpoint (CSE) rate for both groups of patients. CSE included stroke, myocardial infarction, death, congestive heart failure, unstable angina, and arrhythmia.For both epoetin and peginesatide, CSE rates were highest among patients with achieved Hb levels of 10 g/dL or lower: 0.90 and 0.64 CSE events/patient-year, respectively. By comparison, the rates were 0.19 and 0.15, respectively, for achieved Hb levels above 12 g/dL.