Abstract
Background
Subcutaneous injection of erythropoiesis-stimulating agents for the correction of
anemia associated with chronic kidney disease is well recognized. Different delivery
devices are available, although their impact on patient-reported outcomes is limited.
Objectives
Subcutaneous delivery of darbepoetin alfa via an autoinjector prefilled pen (PFP)
and prefilled syringe (PFS) were compared and assessed according to patient-rated
preferences and perceptions.
Methods
In this single-center, randomized, open-label, double-crossover study, patients continued
using the PFS for 4 injections or were switched to the PFP for the same number of
injections, after which they were switched to the alternative device. Following further
4 injections using the new device, patients were switched back to the initial device.
Questionnaires were administered at the end of each series of injections for each
device and at the start and end of the study.
Results
For overall device preference, the majority (62%) of patients responded with PFP,
whereas 32% preferred the PFS mode of delivery. This preference for PFP was driven
by a perception of increased convenience and ease of use compared with PFS. No significant
differences in pain scores were noted between the 2 devices. Most patients rated both
devices as being “easy” or “extremely easy” to use and were either “satisfied” or
“extremely satisfied.”
Conclusion
When given the choice, most patients preferred the PFP mode of administration compared
with PFS due to convenience and ease of use. ClinicalTrials.gov identifier: ACTRN12611000839909.
Key words
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical TherapeuticsAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Erythropoiesis-stimulating agents: past and future.Kidney Int Suppl. 2007; : S1-S3
- Health-related quality of life outcomes in chronic kidney disease.Curr Opin Nephrol Hypertens. 2010; 19: 153-159
- Prevalence, etiology, and consequences of anemia and clinical and economic benefits of anemia correction in patients with chronic kidney disease: an overview.Am J Health Syst Pharm. 2007; 64: S3-S7
- Health-related quality of life and hemoglobin levels in chronic kidney disease patients.Clin J Am Soc Nephrol. 2009; 4: 33-88
- Does epoetin alfa improve health-related quality of life in chronically ill patients with anemia?.Value Health. 2008; 11: 57-75
- HUMIRA pen: a novel autoinjection device for subcutaneous injection of the fully human monoclonal antibody adalimumab.Expert Rev Med Devices. 2007; 4: 109-116
Clinical guidelines. Anaemia management in chronic kidney disease: (CG39). Issued September. 2006. National Institute for Health and Clinical Excellence.
- Use of darbepoetin alfa in the treatment of anaemia of chronic kidney disease: clinical and pharmacoeconomic considerations.NDT Plus. 2009; 2: i9-i17
- Psychosocial predictors of non-compliance in haemodialysis and peritoneal dialysis patients.Nephrol Dial Transplant. 2002; 17: 93-99
- Renal anaemia—the patient experience.EDTNA ERCA J. 2004; 30: 34-37
- Compliance with subcutaneous erythropoietin in peritoneal dialysis patients.Adv Perit Dial. 2000; 16: 90-92
- Factors influencing erythropoietin compliance in peritoneal dialysis patients.Am J Kidney Dis. 2002; 40: 623-628
- Preference for monthly darbepoetin alfa dosing in patients with chronic kidney disease not receiving dialysis.Curr Med Res Opin. 2006; 22: 2023-2030
- Darbepoetin alfa administered every other week maintains haemoglobin levels over 52 weeks in patients with chronic kidney disease converting from once-weekly recombinant human erythropoietin: results from Simplify the Treatment of Anemia with Aranesp (STAAR).Am J Nephrol. 2006; 26: 149-156
- Darbepoetin alfa administration to achieve and maintain target haemoglobin levels for 1 year in patients with chronic kidney disease.Mayo Clin Proc. 2006; 81: 1188-1194
- Darbepoetin alfa effectively treats anemia in patients with chronic kidney disease with de novo every-other-week administration.Am J Nephrol. 2004; 24: 453-460
- Darbepoetin alfa administered once monthly maintains haemoglobin concentrations in patients with chronic kidney disease.Clin Nephrol. 2005; 63: 327-334
- Once-monthly darbepoetin alfa for maintaining hemoglobin levels in older patients with chronic kidney disease.J Am Med Dir Assoc. 2007; 8: 83-90
- An open-label study of darbepoetin alfa administered once monthly for the maintenance of haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis.J Int Med. 2006; 260: 577-585
- Darbepoetin alfa administered monthly maintains haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis: a multicentre, open-label, Australian study.Nephrology. 2007; 12: 95-101
- Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis.Nefrologia. 2003; 23: 114-124
- Italian study on the treatment of anaemia in chronic dialysis patients switched over to less frequent doses of darbepoetin from human recombinant erythropoietin (rHuEPO).G Ital Nefrol. 2004; 21: 259-266
- Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients.Kidney Int. 2002; 62: 2167-2175
- The efficacy of intravenous darbepoetin alfa administered once every 2 weeks in chronic kidney disease patients on haemodialysis.Nephrol Dial Transplant. 2006; 21: 2846-2850
- Darbepoetin alfa once every 2 weeks for treatment of anemia in dialysis patients: a combined analysis of eight multicenter trials.Clin Nephrol. 2007; 67: 140-148
- A randomized, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease.Curr Med Res Opin. 2008; 24: 2181-2187
- Increased injection pain with darbepoetin- compared to epoetin-ß in paediatric dialysis patients.Nephrol Dial Transplant. 2006; 21: 3520-3524
- Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial.Clin Ther. 2006; 28: 1619-1629
- A multicenter, open-label, randomized, two-period crossover trial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge × 6 mm needle versus a 29 gauge × 12.7 mm needle in obese patients with diabetes mellitus.Clin Ther. 2004; 26: 1663-1678
- A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus.Clin Ther. 2003; 25: 2836-2848
- Usability, participant acceptance, and safety of a prefilled insulin injection device in a 3-month observational survey in everyday clinical practice in Australia.J Diabetes Sci Technol. 2009; 3: 1425-1438
- Understanding and meeting injection device needs in multiple sclerosis: a survey of patient attitudes and practices.Patient Prefer Adherence. 2011; 5: 173-180
- Pharmacist's role in managing anemia in patients with chronic kidney disease: potential clinical and economic benefits.Am J Health Syst Pharm. 2007; 64: S15-S22
Article info
Publication history
Published online: August 17, 2012
Accepted:
August 1,
2012
Identification
Copyright
© 2012 Elsevier HS Journals, Inc. Published by Elsevier Inc. All rights reserved.