Year: 2010
Type: book-review
Abstract: Extended abstractCitationCorwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, and Corwin MJ, for the EPO Critical Care Trials Group: Efficacy and Safety of Epoetin Alfa in Critically Ill Patients N Engl J Med 2007;357:965-76BackgroundAnemia, which is common in the critically ill, is often treated with red-cell transfusions which are associated with poor clinical outcomes. We hypothesized that therapy with recombinant human erythropoietin (epoetin alfa) might reduce the need for red-cell transfusions.MethodsObjectiveEvaluate the efficacy of epoetin alfa in reducing the packed red blood cell transfusion requirement in critically ill patients.DesignProspective, randomized, double blind, placebo controlled, multi-center trialSetting115 medical centers throughout the United States. Subjects: 1460 patients that had been admitted to medical, surgical, or trauma intensive care units. Inclusion criteria included age 18 years or greater, patients remained in the ICU for two days, and hemoglobin level less than 12 gm/dl. Statistical analysis was performed for the entire group, as well as subgroup analysis according to the type of ICU to which the patient was admitted (the subgroup analysis was included in the initial study design).InterventionAfter enrollment, patients randomized to the study group received epoetin alfa 40,000 units SQ on study day 1, 8, and 15. The drug was withheld if the hemoglobin level was greater than 12 gm/dl at the time of scheduled administration. Patients randomized to the placebo group received a placebo injection according to the same schedule. All patients enrolled received supplemental iron. Patients were given packed red blood cell transfusions at the discretion of the treating physician. The investigators recommended goal hemoglobin concentration of 7 to 9 gm/dl, and not to transfuse for a hemoglobin concentration of greater than 9 gm/dl unless a specific indication was present.OutcomesThe primary endpoint was percentage of patients requiring blood transfusion. Secondary endpoints included number of units transfused, mortality, and the change in hemoglobin concentration from baseline.ResultsAs compared with the use of placebo, epoetin alfa therapy did not result in a decrease in either the number of patients who received a red-cell transfusion (relative risk for the epoetin alfa group vs. the placebo group, 0.95; 95% confidence interval [CI], 0.85 to 1.06) or the mean (± SD) number of red-cell units transfused (4.5 ± 4.6 units in the epoetin alfa group and 4.3 ± 4.8 units in the placebo group, P = 0.42). However, the hemoglobin concentration at day 29 increased more in the epoetin alfa group than in the placebo group (1.6 ± 2.0 g per deciliter vs. 1.2 ± 1.8 g per deciliter, P < 0.001). Mortality tended to be lower at day 29 among patients receiving epoetin alfa (adjusted hazard ratio, 0.79; 95% CI, 0.56 to 1.10); this effect was also seen in pre-specified analyses in those with a diagnosis of trauma (adjusted hazard ratio, 0.37; 95% CI, 0.19 to 0.72). A similar pattern was seen at day 140 (adjusted hazard ratio, 0.86; 95% CI, 0.65 to 1.13), particularly in those with trauma (adjusted hazard ratio, 0.40; 95% CI, 0.23 to 0.69). As compared with placebo, epoetin alfa was associated with a significant increase in the incidence of thrombotic events (hazard ratio, 1.41; 95% CI, 1.06 to 1.86).ConclusionsThe use of epoetin alfa does not reduce the incidence of red-cell transfusion among critically ill patients, but it may reduce mortality in patients with trauma. Treatment with epoetin alfa is associated with an increase in the incidence of thrombotic events. (ClinicalTrials.gov number, NCT00091910.)
Source: Critical Care
DOI: 10.1186/cc9370
Authors: David Hecht, Arthur Boujoukos
Institution: University of Pittsburgh
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,190
OpenAlex ID: W1970986093