Once Monthly C.E.R.A. Found Beneficial
Jean-Philippe Ryckelynck, MD, of CHU Clemenceau, Caen, France, told delegates that MAXIMA and PROTOS—two concurrent phase III studies—demonstrated that IV and subcutaneous (SC) C.E.R.A. given either once every two or four weeks maintained stable hemoglobin levels in dialysis patients who were switched to this drug from epoetin (EPO) administered once to three times a week. He and his colleagues analyzed pooled data from both studies.
Mean baseline hemoglobin levels were 11.7 g/dL for patients over age 65 and those aged 65 years and younger and 11.8 g/dL for men and women. Between weeks 29 and 36, when the treatment effect of the two strategies was being evaluated, Dr. Ryckelynck and colleagues found that C.E.R.A. given once every four weeks had virtually identical effects on hemoglobin in men and women over age 65 and age 65 years and under.
For women over 65, the mean within-patient standard deviation in hemoglobin from baseline was 0.60 g/dL in the C.E.R.A. cohort and 0.55 in the EPO group. For men over 65, the mean within-patient standard deviation in hemoglobin from baseline was 0.52 g/dL in the C.E.R.A. group and 0.50 g/dL in the EPO group.
For women and men 65 years of age and under, the corresponding within-patient standard deviation from baseline in hemoglobin was 0.56 g/dL for women receiving C.E.R.A., and 0.57 g/dL for women on EPO, while for men, changes in hemoglobin from baseline were similarly modest at 0.58 g/dL for C.E.R.A. recipients and 0.59 g/dL for EPO.
C.E.R.A. is as effective as EPO in maintaining anemia control in patients converted directly from EPO, and both treatments are definitively associated with an important stability of hemoglobin over time, Dr. Ryckelynck concluded.
Comparing another subgroup of patients involved in the same phase III trials but who this time
had either diabetes or coronary artery disease (CAD) on study entry, Johannes Mann, MD, of Munich General Hospitals in
Mean baseline hemoglobin levels were com-parable in patients with and without diabetes and with and without CAD at 11.7 to 11.8 g/dL, respectively, according to the study.