Comparative efficacy of epoetin alfa-epbx and epoetin alfa, evaluated by coprimary efficacy end points of mean weekly hemoglobin level and mean weekly epoetin dose by body weight
| Analysis | Epoetin alfa-epbx | Epoetin alfa |
|---|---|---|
| Primary analysis (ITT population) | n=306 | n=306 |
| Mean weekly hemoglobin level during last 4 wk of treatment, g/dl | ||
| Least squares mean (SEM) | 10.17 (0.05) | 10.28 (0.05) |
| Difference (95% CI)a | −0.12 (−0.25 to 0.01) | |
| Mean weekly epoetin dose by body weight during last 4 wk of treatment, U/kg per weekb | ||
| Least squares mean (SEM) | 90.16 (3.87) | 89.79 (3.88) |
| Difference (95% CI)c | 0.37 (−10.40 to 11.13) | |
| Sensitivity analysis (per protocol population) | n=204 | n=192 |
| Mean weekly hemoglobin during last 4 wk of treatment, g/dl | ||
| Least squares mean (SEM) | 10.19 (0.06) | 10.30 (0.06) |
| Difference (95% CI)a | −0.10 (−0.27 to 0.06) | |
| Mean weekly epoetin dose by body weight during last 4 wk of treatment, U/kg per week | ||
| Least squares mean (SEM) | 85.71 (4.73) | 88.12 (4.88) |
| Difference (95% CI)c | −2.41 (−15.77 to 10.95) | |
ITT, intent to treat; 95% CI, 95% confidence interval.
↵a The 95% CI for the least squares mean of the difference (epoetin alfa-epbx–epoetin alfa) in mean weekly hemoglobin had to reside within the equivalence margin of ±0.5 g/dl for equivalence to be concluded.
↵b One patient in each group did not have dose data reported at baseline. Therefore, primary analysis of mean weekly epoetin dose by body weight during last 4 wk of treatment in the ITT population is on the basis of data for 305 randomized patients in each treatment group.
↵c The 95% CI for the least squares mean of the difference (epoetin alfa-epbx–epoetin alfa) in mean weekly epoetin dose per kilogram of body weight had to reside within the equivalence margin of ±45 U/kg per week for equivalence to be concluded.