Eighteen studies were included for the review (n=5,421 patients); seven double blind RCTs (n=1,472), seven open-label RCTs (n=1270) and four open-labelled non-randomised trials (n=2,679).
Cancer (nine RCTs, n=1,949 patients): Epoetin α was associated with statistically significant improvements in haemoglobin levels compared with controls in four out of eight trials (p<0.001); significantly fewer patients who received epoetin α needed a transfusion compared with controls (p<0.02). Treatment with epoetin α did not result in significantly different survival rates between the groups in two of the three trials that measured this. Fatigue, as measured by Functional Assessment of Cancer Therapy scale, was significantly improved in patients treated with epoetin α compared to controls (p=0.02 to p<0.0001) in four out of eight trials. Three out of five trials found significant improvements on the Functional Assessment of Cancer Therapy anaemia subscale in patients treated with epoetin α compared with controls (p=0.01 to p<0.0001). Four out of seven trials found significant improvements in energy, ability to perform daily activities, and overall health-related quality of life, as measured by the Linear Analogue Scale Assessment, in patients receiving epoetin α compared with controls at follow-up (p =0.02 to p<0.0007).
HIV/AIDS (six studies, n=1,715 patients): Patients receiving epoetin α showed a significant increase in haemoglobin levels at 16 weeks of follow-up compared with baseline levels (mean change in haemoglobin 2.9g/dL and 2.5g/dL; two studies; p<0.0001). Within-group analyses demonstrated significant improvements in patients receiving epoetin α at follow-up on all domains of the Medical Outcomes Study-HIV subscale (p<0.05 to p<0.0001) in two studies. One study found significant within-group improvements in energy and health distress (p<0.05), but not in physical or role function at follow-up in patients receiving epoetin α. Two out of the three studies using the Linear Analogue Scale Assessment found significant improvements in energy, daily activities and overall health-related quality of life at follow-up compared with baseline levels in patients with HIV/AIDS receiving epoetin α. One RCT found no significant difference between epoetin α and standard care on health-related quality of life as measured by the Medical Outcomes Study physical outcomes subscale and the medical outcomes subscale.
Pre-dialysis chronic kidney disease (three studies, n=1,757): Pre-dialysis chronic kidney disease patients with anaemia showed significant improvements in haemoglobin when receiving epoetin α compared with controls: mean change in haemoglobin 4.7g.dL versus -1.0g/dL in two studies (p<0.0001) and percentage of patients with greater than 6% increase in haemoglobin 57% to 90% versus 10% in one study (p<0.05). One RCT reported significantly improved energy (change in Medical Outcomes Study score 5.8 versus -3.0; p=0.036) and physical function (change in Medical Outcomes Study score 7.8 versus -4.8; p=0.006) in pre-dialysis chronic kidney disease patients receiving epoetin α compared with controls. There were no other significant differences on a range of other health-related quality of life scales used in this trial. One RCT found a significantly improved work capacity in patients treated with epoetin α compared with controls (p<0.05). One within-group study found significant improvements at 16 weeks compared with baseline on all Linear Analogue Scale Assessment scales (p<0.0001) and kidney disease questionnaire domains (p<0.0001).