Comparing within-patient standard deviations for hemoglobin levels in patients with and without diabetes and with and without CAD, responses to both strategies were virtually identical from the outset and stayed around 12 g/dL in all groups, Dr. Mann said.
Hypertension was documented in 13% to 16% of patients, but the difference in incidence was similar in patients treated with C.E.R.A. and EPO.
Death and cardiovascular death were more prevalent among patients with CAD than those without but again, there was no difference in the incidence of either of these end points between the two treatment arms.
“Patients [with diabetes and CAD] are notoriously more difficult to treat than those without comorbidities and because of potential side effects, so we felt this was quite an important aspect to look at,” Dr. Mann observed.
In a 52-week study of CKD patients not on dialysis, Rowan Walker, MD, of the Royal Melbourne Hospital in Parkville, Australia, presented results of the ARCTOS phase III study, which showed that CKD patients not yet on dialysis can be effectively converted from twice-monthly to once-monthly C.E.R.A.
In the study, patients were either converted to once-monthly C.E.R.A. or maintained on either a twice-monthly regimen of the drug or once-weekly darbepoetin alfa. Patients were then followed for another 24 weeks. Baseline hemoglobin levels ranged between 8 and 11 g/dL. “Mean hemoglobin levels were almost identical across the three treatment arms throughout the maintenance period,” Dr. Walker noted.
C.E.R.A. dose remained stable during the maintenance phase, but initially was nearly doubled when patients dropped from the twice-monthly to the once-monthly regimen, as treatment was obviously given half as often, he added. The tolerability profile of C.E.R.A. was similar to that of other EPO agents, Dr. Walker said.
For CKD patients not yet on dialysis, subcutaneous C.E.R.A. provides a smooth and steady rise in hemoglobin levels, he concluded. The study shows that once-monthly administration of C.E.R.A. maintains stable hemoglobin levels.