Premium
Chronic Anemia and Fatigue in Elderly Patients: Results of a Randomized, Double‐Blind, Placebo‐Controlled, Crossover Exploratory Study with Epoetin Alfa
Author(s) -
Agnihotri Parag,
Telfer Margaret,
Butt Zeeshan,
Jella Abhay,
Cella David,
Kozma Chris M.,
Ahuja Mukesh,
Riaz Shahbaz,
Akamah Joseph
Publication year - 2007
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/j.1532-5415.2007.01357.x
Subject(s) - medicine , epoetin alfa , anemia , placebo , crossover study , quality of life (healthcare) , randomized controlled trial , erythropoietin , physical therapy , alternative medicine , nursing , pathology
OBJECTIVES: To evaluate the effect of epoetin alfa treatment on hemoglobin (Hb), fatigue, quality of life (QOL), and mobility in elderly patients with chronic anemia. DESIGN: An exploratory, 32 week, randomized, double‐blind, crossover treatment trial. PARTICIPANTS: Sixty‐two community‐dwelling individuals aged 65 and older with chronic anemia (Hb ≤11.5 g/dL). INTERVENTION: Subcutaneous epoetin alfa or placebo weekly for 16 weeks (Phase I) with crossover to the opposite treatment (Phase II). MEASUREMENTS: Hb and QOL scores from the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Mobility was assessed as a secondary outcome using the Timed Up and Go (TUG) test. RESULTS: Of the 62 subjects enrolled, complete data were analyzed for 58 in Phase I and 54 participants in Phase II. Of those enrolled, most were African American (95%) and female (85%) and had multiple comorbidities and a mean age±standard deviation of 76.1±7.2. Mean baseline Hb was 10.5±0.9 g/dL (7.3–11.5). In Phase I, 67% of those taking epoetin alfa, and in Phase II, 69% of those taking epoetin alfa had an increase in Hb of more than 2 g/dL, significantly more than those taking placebo ( P< .001). Similarly, elderly participants significantly improved on the fatigue and anemia subscales of the FACIT across phases (all P <.05). No significant differences were found between treatment and placebo on TUG scores. Epoetin alfa was well tolerated. CONCLUSION: In this trial involving predominantly older African‐American women with anemia, a direct relationship existed between increases in Hb during epoetin alfa therapy and improvements in fatigue and QOL.