Effect of darbepoetin alfa administered once monthly on maintaining hemoglobin levels in older patients with chronic kidney disease.

Abstract

BACKGROUND:

The anemia of chronic kidney disease (CKD) is associated with increased hospitalizations, increased cardiovascular morbidity and mortality, and diminished quality of life in the elderly. Darbepoetin alfa is an erythropoiesis-stimulating agent that has been shown to be effective in treating anemia in patients with CKD (but not on dialysis) when administered using extended-dosing regimens.

OBJECTIVE:

The purpose of this post hoc analysis was to examine the efficacy and safety profile of once-monthly (QM) darbepoetin alfa in study patients stratified according to age (ie, <65, 65-74, and > or =75 years).

METHODS:

Patients with CKD but not on dialysis, receiving darbepoetin alfa every other week (Q2W), and with stable hemoglobin (Hb) levels between 11 and 13 g/dL, inclusive, were enrolled in this 33-week, multicenter, open-label, single-arm study. The study was carried out at 36 US centers and consisted of a 24-week QM darbepoetin alfa dose-titration period followed by an 8-week evaluation period. Hb levels were measured Q2W. Study results were stratified according to patient age (<65, 65-74, and > or =75 years).

RESULTS:

A total of 152 patients (79 women, 73 men) were enrolled; 55 patients (36%) were <65 years of age, 46 (30%) were 65 to 74 years of age, and 51 (34%) were > or =75 years of age. In patients who received > or =1 dose of darbepoetin alfa, Hb levels > or =11 g/dL were maintained in 76%, 80%, and 71% of patients aged <65, 65 to 74, and > or =75 years, respectively. For patients who completed the study, the proportions who maintained Hb levels > or =11 g/dL were 83%, 88%, and 85%, respectively, for the 3 age groups. The safety profile of QM darbepoetin alfa in this study was consistent with that expected in patients with CKD not receiving dialysis.

CONCLUSIONS:

Darbepoetin alfa administered QM maintained Hb levels > or =11 g/dL in patients with CKD (not on dialysis) aged <65, 65 to 74, and > or =75 years. This treatment regimen may help optimize anemia management for older community-dwelling and long-term care patients.

• Authors: Marcia R Silver, Anil Agarwal, Michelle Krause, Lei Lei, Catherine Stehman-Breen
• Journal: The American journal of geriatric pharmacotherapy (Am J Geriatr Pharmacother) Vol. 6 Issue 2 Pg. 49-60 (Jun 2008) ISSN: 1543-5946 [Print] United States
• PMID: 18675764 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Hematinics
• Hemoglobins
• Erythropoietin
• Darbepoetin alfa

Topics

• Age Factors
• Aged
• Anemia (drug therapy, etiology)
• Darbepoetin alfa
• Drug Administration Schedule
• Drug Monitoring
• Erythropoietin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Female
• Hematinics (administration & dosage, adverse effects, therapeutic use)
• Hemoglobins (drug effects, metabolism)
• Humans
• Kidney Failure, Chronic (complications)
• Long-Term Care
• Male
• Middle Aged
• Residence Characteristics