Chronic Anemia and Fatigue in Elderly Patients: Results of the First Randomized Double-Blind Placebo-Controlled Cross-Over Study with Epoetin Alfa.

Background: Anemia is a common condition among elderly and its prevalence increases with age. Fatigue is well recognized as a prominent feature of chronic anemia and may be especially symptomatic in this population. In order to evaluate the effect of epoetin alfa (EPO) treatment on hemoglobin (Hb), fatigue, and health related quality of life (QOL) in elderly patients (pts) with chronic anemia a 32 week(w) randomized, double-blind, cross-over treatment trial among community-dwelling participants ≥65y was conducted. Pts were ambulatory and had anemia for ≥3 months with inclusion Hb ≤11.5g/dL. Pts with GI bleeding, active cancer, CKD (GFR Results: 62 pts, 85% women, and 95% African American with a mean (SD) age of 76.1y (±7.2). Mean baseline Hb was 10.5±0.9 g/dL (7.3–11.5); 75% had anemia of chronic disease and 25% had unexplained anemia. Common baseline comorbidities included hypertension, CHF, osteoarthritis, and Type 2 diabetes. Seven pts did not complete the study. There was 1 death, 1 stroke and 1 DVT on placebo and 1 death and 1 pulmonary embolus on EPO. None of the serious adverse events or deaths were considered treatment-related. Pts receiving EPO had significantly increased Hb compared to placebo at the end of phases 1 and 2 (p Conclusion: A direct relationship exists between increasing Hb during EPO therapy, fatigue scores and corresponding QOL improvements among elderly persons with anemia. EPO was well tolerated in this trial among anemic elderly pts. Improving fatigue may enhance ability to perform daily activities in the elderly.