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Erythropoiesis-stimulating Protein (erythropoiesis-stimulating + protein)

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Medical Sciences	100%

Selected Abstracts

Darbepoetin alfa administered monthly maintains haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis: A multicentre, open-label, Australian study

NEPHROLOGY, Issue 1 2007
ALEX DISNEY
SUMMARY: Aim: Darbepoetin alfa, an erythropoiesis-stimulating protein, has a longer serum half-life than recombinant human erythropoietin, allowing less-frequent administration. This study aimed to demonstrate that once-monthly (QM) darbepoetin alfa administration would maintain haemoglobin (Hb) concentrations in subjects with chronic kidney disease (CKD) not receiving dialysis who had previously been administered darbepoetin alfa every 2 weeks (Q2W). Methods: This was a multicentre study in which subjects with CKD receiving stable Q2W darbepoetin alfa doses and with stable Hb (100,130 g/L) were started on QM darbepoetin alfa dosing. The initial QM darbepoetin alfa dose was equivalent to the cumulative darbepoetin alfa dose administered during the month preceding enrolment. Darbepoetin alfa doses were titrated to maintain Hb concentrations between 100 and 130 g/L. The primary endpoint was the proportion of subjects maintaining mean Hb 0e; 100 g/L during the evaluation period (weeks 21,33). Results: Sixty-six subjects were enrolled in the study and all received at least one dose of darbepoetin alfa; 55 (83%) had mean Hb 0e; 100 g/L during evaluation. Mean (SD) Hb concentrations at baseline and during the evaluation period were 119 (8.7) g/L and 114 (9.8) g/L, respectively. The median QM darbepoetin alfa dose at baseline and during the evaluation period was 80 ,g. Darbepoetin alfa was considered to be well-tolerated. Conclusion: Patients with CKD not receiving dialysis who are receiving darbepoetin alfa Q2W can be safely and effectively extended to darbepoetin alfa QM. Dosing QM may simplify anaemia management for patients and health-care providers. [source]

Population pharmacokinetics of darbepoetin alfa in healthy subjects

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 1 2007
Balaji Agoram
Aim To develop and evaluate a population pharmacokinetic (PK) model of the long-acting erythropoiesis-stimulating protein, darbepoetin alfa in healthy subjects. Methods PK profiles were obtained from 140 healthy subjects receiving single intravenous and/or single or multiple subcutaneous doses of darbepoetin alfa (0.75,8.0 µg kg,1, or either 80 or 500 µg). Data were analysed by a nonlinear mixed-effects modelling approach using NONMEM software. Influential covariates were identified by covariate analysis emphasizing parameter estimates and their confidence intervals, rather than stepwise hypothesis testing. The model was evaluated by comparing simulated profiles (obtained using the covariate model) to the observed profiles in a test dataset. Results The population PK model, including first-order absorption, two-compartment disposition and first-order elimination, provided a good description of data. Modelling indicated that for a 70-kg human, the observed nearly twofold disproportionate dose,exposure relationship at the 8.0 µg kg,1 -dose relative to the 0.75 µg kg,1 -dose may reflect changing relative bioavailability, which increased from ,,48% at 0.75 µg kg,1 to 78% at 8.0 µg kg,1. The covariate analysis showed that increasing body weight may be related to increasing clearance and central compartment volume, and that the absorption rate constant decreased with increasing age. The full covariate model performed adequately in a fixed-effects prediction test against an external dataset. Conclusion The developed population PK model describes the inter- and intraindividual variability in darbepoetin alfa PK. The model is a suitable tool for predicting the PK response of darbepoetin alfa using clinically untested dosing regimens. [source]

The Effect of Administering Erythropoiesis-Stimulating Proteins in Patients With Chronic Heart Failure: Results From a Retrospective Study

CONGESTIVE HEART FAILURE, Issue 6 2006
Reynolds M. Delgado MD
Anemia is prevalent in patients with chronic heart failure and is associated with worse symptoms and poor prognosis. The authors reviewed the charts of all patients (N=467) treated at Texas Heart Institute from January 2000 to October 2003, during which time a clinical protocol offered treatment with erythropoiesis-stimulating proteins. Post-treatment, the authors observed a significant increase in mean ± SD hemoglobin, from 9.9±1.1 g/dL to 11.7±1.5 g/dL (P<.0001), improvement of renal function (a decrease in mean levels of creatinine and blood urea nitrogen), and fewer hospital admissions (1.0±1.4 vs 1.8±1.6; P=.0003) without an increase in adverse clinical events, compared with pretreatment and compared with an untreated control group. These results suggest a potential benefit of anemia treatment with recombinant erythropoiesis-stimulating proteins in patients with chronic heart failure. [source]