Question: In patients with chronic renal failure (CRF) and renal anemia, does recombinant human erythropoietin (rHu EPO) delay the need for dialysis?
Data sources: Studies were identified by searching 13 databases, including MEDLINE (1980 to May 2001), EMBASE/Excerpta Medica (1984 to June 2001), and the Cochrane Controlled Trials Register; hand searching Kidney International; scanning reference lists of relevant articles, reviews, and book chapters; searching the Internet; and contacting experts in the field and at relevant biomedical companies.
Study selection: Studies were selected if they were randomized controlled trials (RCTs) or quasi-RCTs that compared rHu EPO with placebo or no rHu EPO in patients with CRF and renal anemia who had not started dialysis.
Data extraction: 2 investigators independently assessed trials for methodologic quality and subject relevance. Data were extracted on participants, intervention, and outcomes (time to dialysis, glomerular filtration rate [GFR], serum creatinine level, hemoglobin or hematocrit values, blood transfusions, quality-of-life measures, hypertension, other adverse events, and mortality).
Main results: 12 RCTs (232 patients) were included. 9 trials were 8 to 12 weeks in duration; 3 trials ranged from 36 weeks to 1 year. 5 trials reported progression of renal failure; groups did not differ for the proportion of patients starting dialysis (Table). The groups did not differ for GFR (4 trials) (weighted mean difference [WMD] 1.59 mL/min, 95% CI −0.49 to 3.66) or serum creatinine levels (5 trials) (WMD 76.12 µmol/L, CI −7.94 to 160.17). Fewer patients who received rHu EPO required blood transfusions (Table). 1 trial that measured hemoglobin level showed that rHu EPO was beneficial (mean difference 2.3 g/dL, CI 1.37 to 3.23), and 7 trials showed a benefit of rHu EPO in increasing hematocrit levels (WMD 9.92%, CI 8.7% to 11.05%). 2 trials that measured quality of life showed improvement with rHu EPO at 12 and 48 weeks. More patients who received rHu EPO had to start antihypertensive therapy than did control-group patients (Table). Incidences of withdrawal because of adverse effects (4 trials) and mortality (3 trials) were low and did not differ between groups.
Conclusion: In patients with chronic renal failure and renal anemia, recombinant human erythropoietin corrects anemia and reduces the need for blood transfusions but increases blood pressure and does not reduce the need to start dialysis.
Recombinant human erythropoietin (rHu EPO) vs placebo or no rHu EPO (control) for chronic renal failure with renal anemia*
|Outcomes at 8 wk to 1 y||Number of trials||Weighted event rates||RRR (95% CI)||NNT (CI)|
|Dialysis||5||31%||43%||28% (−3 to 50)||Not significant|
|Blood transfusion||3||7.0%||26%||69% (21 to 88)||6 (3 to 23)|
|RRI (CI)||NNH (CI)|
|Antihypertensive therapy||4||47%||33%||42% (0 to 102)||8 (4 to 100)|