David H. Henry, MD; Gildon N. Beall, MD; Constance A. Benson, MD; John Carey, MD; Lawrence A. Cone, MD; Lawrence J. Eron, MD; Milan Fiala, MD; Margaret A. Fischl, MD; Stephen J. Gabin, MD; Michael S. Gottlieb, MD; Jeffrey E. Galpin, MD; Jerome E. Groopman, MD; Thomas M. Hooton, MD; Joseph G. Jemsek, MD; Randy L. Levine, MD; Steven A. Miles, MD; John J. Rinehart, MD; Adan Rios, MD; William J. Robbins, MD; John C. Ruckdeschel, MD; Jean A. Smith, MD; Spotswood L. Spruance, MD; Barbara Starrett, MD; John Toney, MD; Ralph Zalusky, MD; Robert I. Abels, MD; Edward C. Bryant, DrPH; Kay M. Larholt, ScD; Allan R. Sampson, PhD; Seth A. Rudnick, MD
▪ Objective: To assess the effect of recombinant human erythropoietin (r-HuEPO) on anemia in patients with the acquired immunodeficiency syndrome (AIDS) who are receiving zidovudine therapy.
▪ Design: Combined analysis of four 12-week, randomized, double-blind, controlled clinical trials.
▪ Setting: Multiple centers in the United States.
▪ Patients: Two hundred and ninety-seven anemic (hematocrit < 30%) patients with AIDS who were receiving zidovudine therapy. Of the 297 patients, 255 were evaluable for efficacy, but all patients were included in analysis of safety.
▪ Intervention: Patients were randomly assigned to receive either r-HuEPO (100 to 200 U/kg body weight) or placebo, intravenously or subcutaneously, three times per week for up to 12 weeks.
▪ Measurements: Changes in mean hematocrit, transfusion requirement, and quality of life.
▪ Results: Sixty-nine percent of patients had endogenous serum erythropoietin levels less than or equal to 500 IU/L, and 31% had erythropoietin levels greater than 500 IU/L. In patients with low erythropoietin levels (≤ 500 IU/L), r-HuEPO therapy decreased the mean number of units of blood transfused per patient when compared with placebo (3.2 units and 5.3 units, respectively; P = 0.003) and increased the mean hematocrit from the baseline level (4.6 percentage points and 0.5 percentage points, respectively; P < 0.001). Overall quality of life improved in patients on r-HuEPO therapy (P= 0.13). Patients with erythropoietin levels greater than 500 IU/L showed no benefit from r-HuEPO in any outcome variable. Placebo and r-HuEPO recipients did not differ in the incidence of adverse effects or opportunistic infections.
▪ Conclusion: Therapy with r-HuEPO can increase the mean hematocrit and decrease the mean transfusion requirement in anemic patients with AIDS who are receiving zidovudine and have endogenous low erythropoietin levels (< 500 IU/L). Such therapy is of no apparent benefit in patients whose endogenous erythropoietin levels are higher than 500 IU/L.
Henry DH, Beall GN, Benson CA, et al. Recombinant Human Erythropoietin in the Treatment of Anemia Associated with Human Immunodeficiency Virus (HIV) Infection and Zidovudine Therapy: Overview of Four Clinical Trials. Ann Intern Med. 1992;117:739–748. doi: 10.7326/0003-4819-117-9-739
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Published: Ann Intern Med. 1992;117(9):739-748.
Hematology/Oncology, Infectious Disease, Red Cell Disorders.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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