By Kristina Rebelo
SAN DIEGO -- November 4, 2009 -- An analysis of patients with chronic kidney disease (CKD) who were not on dialysis (NOD) found that they could successfully maintain haemoglobin (Hb) levels with the subcutaneous (SC) erythropoiesis-stimulating agent (ESA) darbepoetin alfa (DA) just once monthly (QM) at slightly higher doses, according to a study presented here at the American Society of Nephrology (ASN) Renal Week 2009.
EXTEND is an ongoing observational study designed to assess the use of extended dosing (every 2 weeks/QM) of SC DA in a large cohort of CKD patients NOD.
This cohort project examined the use of DA QM in CKD (stages 3-5) adult patients (aged >18 years) NOD who were either naïve to ESAs or had previously received other ESA regimens (stratified; ESA prior). The study group included post-renal-transplant patients. This was an interim subanalysis with data available on 305 patients (of 2,465) who were given DA QM and were the subject of observational data for 6 months before and 12 months after the protocol. Data were summarised every 3 months for Hb levels and monthly for ESA dosage.
"Although the introduction of ESAs has transformed the treatment of chronic kidney disease, current regimens can be labour intensive and inconvenient," said Gerhard H. Wirnsberger, MD, Medizinische Universität, Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse, Graz, Austria, on October 29.
"Extended dosing schedules with ESAs have a number of potential benefits, including improved convenience for patients, decreased workload, and potentially, reductions in healthcare system costs," Dr. Wirnsberger continued.
The study reported that 144 men and 161 women, mean age 65.8 years, of whom 82% were white, were given DA QM (n = 149 ESA naïve and 156 ESA prior).
"Mean Hb levels at DA QM commencement were 10.5 and 12.1 g/dL for ESA-naïve and ESA-prior patients, respectively, and geometric mean dose at DA QM commencement for ESA-naïve patients was 10.6 mcg/wk and in ESA-prior patients was 9.7 mcg/wk."
The researchers reported an initial increase in mean Hb 3 months after initiation of DA; mean Hb >11g/dL was maintained at month 12 in the ESA-naïve patients, with a slight increase in dose over time (10.56 mcg/wk at initiation, 14.06 mcg/wk at month 12) compared with the beginning dose.
ESA-prior patients switched from other ESAs or ESA regimens showed a slight decrease in Hb levels before and after the start of treatment with DA, which was followed by stabilisation. The dose of DA decreased on initiation of the protocol and remained stable during the 12-month follow-up (14.70 mcg/wk immediately before, 9.69 mcg/wk at commencement, 11.70 mcg/wk at month 12).
"This interim analysis of the EXTEND study indicates that patients with CKD not on dialysis can be successfully treated with DA SC QM, and the data suggest that a QM dosing schedule of DA is feasible and effective in these patients," said Dr. Wirnsberger.
[Presentation title: Once Monthly (QM) Dosing With Darbepoetin Alfa in Patients With Chronic Kidney Disease Not on Dialysis. Abstract F-PO1090]
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