Chronic anemia and fatigue in elderly patients: results of a randomized, double-blind, placebo-controlled, crossover exploratory study with epoetin alfa

J Am Geriatr Soc. 2007 Oct;55(10):1557-65. doi: 10.1111/j.1532-5415.2007.01357.x. Epub 2007 Aug 14.


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 < or =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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anemia / drug therapy*
  • Chicago
  • Comorbidity
  • Cross-Over Studies
  • Double-Blind Method
  • Epoetin Alfa
  • Erythropoietin / therapeutic use*
  • Fatigue / drug therapy*
  • Female
  • Hematinics / therapeutic use*
  • Hemoglobins / drug effects*
  • Humans
  • Male
  • Mobility Limitation
  • Quality of Life
  • Recombinant Proteins
  • Treatment Outcome


  • Hematinics
  • Hemoglobins
  • Recombinant Proteins
  • Erythropoietin
  • Epoetin Alfa