Abstract
Background and Objective
Painful diabetic peripheral neuropathy (pDPN) is a highly prevalent complication of diabetes mellitus, which is associated with substantial costs to society and national health systems. This economic impact varies depending on the therapeutic management provided to patients. The objective of this study was to compare healthcare resource utilization and costs among pDPN patients newly treated with pregabalin or gabapentin in routine medical practice.
Methods
We performed a retrospective medical records study of pDPN patients newly treated with pregabalin or gabapentin as an add-on therapy who are covered by the Badalona Serveis Assistencials (BSA) health plan, a healthcare provider in Spain, from 2006 to 2009. Healthcare resource utilization and days off work were assessed. The societal perspective was used to estimate costs.
Results
Three hundred and ninety-five records were eligible for analysis: 227 (57.5 %) included pregabalin and 168 (42.5 %) gabapentin. Mean (standard deviation) concomitant use of analgesics throughout the study was higher in the gabapentin cohort [3.9 (2.2) vs. 3.1 (2.1); p < 0.05], mainly due to greater use of non-narcotics (78.0 vs. 71.8 %; p < 0.05) and opioids (32.7 vs. 28.6 %; p < 0.05). Healthcare costs accounted for 59.2 % of total costs, of which 71.9 % occurred in primary care, with a mean cost per patient of €2,476 (year 2010 values). Adjusted mean (95 % CI) total costs were significantly lower in pregabalin-treated patients [€2,003 (1,427–2,579)] than in gabapentin-treated patients [€3,127 (2,463–3,790)] (p = 0.013), mainly due to lower healthcare costs [€1,312 (1,192–1,432) vs. €1,675 (1,537–1,814); p < 0.001].
Conclusions
Adding pregabalin to existing pDPN therapy resulted in lower total healthcare costs and lower resource utilization than resulted from adding gabapentin.
Similar content being viewed by others
References
Chen L, Magliano DJ, Zimmet PZ. The worldwide epidemiology of type 2 diabetes mellitus-present and future perspectives. Nat Rev Endocrinol. 2011;8:228–36. doi:10.1038/nrendo.2011.183.
Tousoulis D, Kampoli AM, Stefanadis C. Diabetes mellitus and vascular endothelial dysfunction: current perspectives. Curr Vasc Pharmacol. 2012;10:19–32.
Vincent AM, Callaghan BC, Smith AL, et al. Diabetic neuropathy: cellular mechanisms as therapeutic targets. Nat Rev Neurol. 2011;7:573–83.
Selvarajah D, Wilkinson ID, Davies J, et al. Central nervous system involvement in diabetic neuropathy. Curr Diab Rep. 2011;11:310–22.
Obrosova IG. Diabetic painful and insensate neuropathy: pathogenesis and potential treatments. Neurotherapeutics. 2009;6:638–47.
Boulton AJM. Guidelines for the diagnosis and outpatient management of diabetic peripheral neuropathy. Diabet Med. 1998;15:508–14.
Veves A, Backonja M, Malik RA. Painful diabetic neuropathy: epidemiology, natural history, early diagnosis, and treatment options. Pain Med. 2008;9:660–74.
Hsu WC, Yen AM, Liou HH, et al. Prevalence and risk factors of somatic and autonomic neuropathy in prediabetic and diabetic patients. Neuroepidemiology. 2009;33:344–9.
Tesfaye S, Selvarajah D. Advances in the epidemiology, pathogenesis and management of diabetic peripheral neuropathy. Diabetes Metab Res Rev. 2012;1:8–14.
Sadosky A, McDermott AM, Brandenburg NA, et al. A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions. Pain Pract. 2008;8:45–56.
Dworkin RH, Malone DC, Panarites CJ, et al. Impact of postherpetic neuralgia and painful diabetic peripheral neuropathy on health care costs. J Pain. 2010;11:360–8.
Boulanger L, Zhao Y, Bao Y, et al. A retrospective study on the impact of comorbid depression or anxiety on healthcare resource use and costs among diabetic neuropathy patients. BMC Health Serv Res. 2009;9:111.
Zhao Y, Ye W, Boye KS, et al. Prevalence of other diabetes-associated complications and comorbidities and its impact on health care charges among patients with diabetic neuropathy. J Diabetes Complications. 2010;24:9–19.
Van Acker K, Bouhassira D, De Bacquer D, et al. Prevalence and impact on quality of life of peripheral neuropathy with or without neuropathic pain in type 1 and type 2 diabetic patients attending hospital outpatients clinics. Diabetes Metab. 2009;35:206–13.
Bril V, England J, Franklin GM, et al.; American Academy of Neurology; American Association of Neuromuscular and Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Evidence-based guideline: treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology 2011;76:1758–65.
Samper Bernal D, Monerris Tabasco MM, Homs Riera M, et al. Etiología y manejo de la neuropatía diabética dolorosa. Rev Soc Esp Dolor. 2010;17:286–96.
Mitka M. Group releases new guideline on options for treating painful diabetic neuropathy. JAMA. 2011;305:2507–8.
Hovaguimian A, Gibbons CH. Clinical approach to the treatment of painful diabetic neuropathy. Ther Adv Endocrinol Metab. 2011;2:27–38.
Lesser H, Sharma U, Lamoreaux L, et al. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004;63:2104–10.
Rosenstock J, Tuchman M, Lamoreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110:628–38.
Richter RW, Portenoy R, Sharma U, et al. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005;6:253–60.
Freynhagen R, Grond S, Schüpfer G, et al. Efficacy and safety of pregabalin in treatment refractory patients with various neuropathic pain entities in clinical routine. Ínt J Clin Pract. 2007;61:1989–96.
Arezzo JC, Rosenstock J, Lamoreaux L, et al. Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. BMC Neurol. 2008;8:33.
Hurley RW, Lesley MR, Adams MC, et al. Pregabalin as a treatment for painful diabetic peripheral neuropathy: a meta-analysis. Reg Anesth Pain Med. 2008;33:389–94.
Freeman R, Durso-Decruz E, Emir B. Efficacy, safety, and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses. Diabetes Care. 2008;31:1448–54.
Tölle T, Freynhagen R, Versavel M, et al. Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study. Eur J Pain. 2008;12:203–13.
Satoh J, Yagihashi S, Baba M, et al. Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial. Diabet Med. 2011;28:109–16.
Gálvez R, Marsal C, Vidal J, et al. Cross-sectional evaluation of patient functioning and health-related quality of life in patients with neuropathic pain under standard care conditions. Eur J Pain. 2007;11:244–55.
Navarro A, Saldaña MT, Pérez C, et al. Patient-reported outcomes in subjects with neuropathic pain receiving pregabalin: evidence from medical practice in primary care settings. Pain Med. 2010;11:719–31.
Saldaña MT, Navarro A, Pérez C, et al. Patient-reported-outcomes in subjects with painful lumbar or cervical radiculopathy treated with pregabalin: evidence from medical practice in primary care settings. Rheumatol Int. 2010;30:1005–15.
Pérez C, Navarro A, Saldaña MT, et al. Pregabalin and gabapentin in matched patients with peripheral neuropathic pain in routine medical practice in a primary care setting: findings from a cost-consequences analysis in a nested case-control study. Clin Ther. 2010;32:1357–70.
Sicras-Mainar A, Rejas-Gutiérrez J, Navarro-Artieda R, et al. Cost analysis of adding pregabalin or gabapentin to the management of community-treated patients with peripheral neuropathic pain. J Eval Clin Pract. 2011;18:1170–9. doi:10.1111/j.1365-2753.2011.01752.x.
Udall M, Harnett J, Mardekian J. Costs of pregabalin or gabapentin for painful diabetic peripheral neuropathy. J Med Econ. 2012;15:361–70.
Gore M, Tai KS, Zlateva G, et al. Clinical characteristics, pharmacotherapy, and healthcare resource use among patients with diabetic neuropathy newly prescribed pregabalin or gabapentin. Pain Pract. 2011;11:528–39.
Lamberts H, Wood M, Hofmans-Okkes ÍM, editors. The international classification of primary care in the European community: with a multi-language layer. Oxford: Oxford University Press; 1993.
WHO Collaborating Centre for Drug Statistic Methodology. Norwegian Institute of Public Health. The Anatomical Therapeutic Chemical (ATC) classification system, Oslo; 1991. http://www.whocc.no. Accessed 29 May 2012.
Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–83.
Weiner JP, Starfield BH, Steinwachs DM, et al. Development and application of a population-oriented measure of ambulatory care case-mix. Med Care. 1991;29:452–72.
Gore M, Sadosky A, Tai KS, et al. A retrospective evaluation of the use of gabapentin and pregabalin in patients with post-herpetic neuralgia in usual-care settings. Clin Ther. 2007;29:1655–70.
Consejo General de Colegios Oficiales de Farmacéuticos. Catálogo de Especialidades Farmacéuticas. Madrid: Consejo General de Colegios Oficiales de Farmacéuticos; 2010.
National Institute of Statistics. Encuesta de costes laborales del año 2010, Spain; 2010. http://www.ine.es/infoine. Accessed Feb 2012.
Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ. 2000;320:1197–200.
Navarro A, Saldana MT, Perez C, et al. A cost-consequences analysis of the effect of pregabalin in the treatment of peripheral neuropathic pain in routine medical practice in primary care settings. BMC Neurol. 2011;11:7.
Baron R, Freynhagen R, Tölle TR, et al.; A0081007 Investigators. The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy. Pain 2010;150:420–7.
Backonja M, Glanzman RL. Gabapentin dosing for neuropathic pain: evidence from randomized, placebo-controlled clinical trials. Clin Ther. 2003;25:81–104.
Van Seventer R, Sadosky A, Lucero M, et al. A cross-sectional survey of health state impairment and treatment patterns in patients with post-herpetic neuralgia. Age Ageing. 2006;35:132–7.
Quilici S, Chancellor J, Löthgren M, et al. Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain. BMC Neurol. 2009;9:6.
Vetter TR. The application of economic evaluation methods in the chronic pain medicine literature. Anesth Analg. 2007;105:114–8.
Acknowledgments
We thank the Badalona Serveis Assistencials (BSA) healthcare professionals who aided this study. BSA healthcare professionals were not paid for the development of this manuscript. This study was funded by Pfizer Inc. Javier Rejas is a full employee of Pfizer, S.L.U. Dr. Antoni Sicras is an employee of DataClinics who was a paid consultant to Pfizer for the statistical analysis and for the development of this manuscript. All other authors declare that they have no competing interests. All authors had complete access to the data, participated in the analysis and/or interpretation of results, drafted and approved the content of the manuscript. Antoni Sicras and Javier Rejas participated in the design and idea of the original study and in the interpretation of data and drafting the manuscript. Albert Planas and Ruth Navarro participated in data interpretation, review of the manuscript, and made an important contribution to several parts of the manuscript. All authors were responsible for literature review and extraction of references.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Sicras, A., Rejas, J., Navarro, R. et al. Adding Pregabalin or Gabapentin for the Management of Community-Treated Patients with Painful Diabetic Peripheral Neuropathy: A Comparative Cost Analysis. Clin Drug Investig 33, 825–835 (2013). https://doi.org/10.1007/s40261-013-0131-8
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40261-013-0131-8