Skip to main content
SpringerLink
Log in

Efficacy and Safety of Pregabalin for the Treatment of Neuropathic Pain in Patients Undergoing Hemodialysis

  • Original Research Article
  • Published:
Clinical Drug Investigation Aims and scope Submit manuscript

Abstract

Objective

Pregabalin is a gamma aminobutyric acid derivative administered for neuropathic pain. It binds to α2δ subunits of voltage-dependent calcium channels, and inhibits calcium inflow of synapses and the release of excitatory neurotransmitters. This study investigated the efficacy and safety of pregabalin in patients with peripheral neuropathic pain undergoing maintenance hemodialysis.

Methods

This study was a prospective, open-label, single-arm, multi-center trial. Patients were treated with an initial dose of pregabalin at 25 mg; this was then increased up to a maximum of 150 mg depending on the patient during a 12-week study period. Visual Analog Scale, Eight-Item Short Form Health Survey (SF-8), and laboratory data were collected at baseline and the end of the study.

Results

A total of 45 patients with peripheral neuropathic pain were included, of whom 35 patients were analyzed. The final mean dose of pregabalin was 50.7 mg daily. Mean Visual Analog Scale scores significantly decreased from 52.4 mm at baseline to 34.1 mm at the end of the study (p < 0.0001). Scores for all eight categories of the SF-8 significantly increased compared with baseline (p < 0.05). Both physical and mental component summary scores of the SF-8 also significantly increased (p < 0.05). Ten patients were withdrawn from the study because of drowsiness, dizziness, and invalidity; however, no serious adverse drug reactions were recorded.

Conclusions

If adverse effects are carefully monitored and the administered dosage prudently determined, pregabalin can be an effective treatment for peripheral neuropathic pain in patients undergoing hemodialysis.

Trial Registration: UMIN000023117.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Institute for Clinical Systems Improvement. Health care guideline: assessment and management of chronic pain. 6th ed., November 2013. http://www.icsi.org/_asset/bw798b/ChronicPain.pdf. Accessed 22 Aug 2016.

  2. Merskey H, Bogduk N, editors. IASP Task Force on taxonomy, classification of chronic pain. 2nd ed. Seattle: IASP Press; 1994. p. 209–14.

    Google Scholar 

  3. Breivik H, Borchgrevink PC, Allen SM, et al. Assessment of pain. Br J Anaesth. 2008;101:17–24.

    Article  CAS  PubMed  Google Scholar 

  4. Cruccu G, Anand P, Attal N, et al. EFNS guidelines on neuropathic pain assessment. Eur J Neurol. 2004;11:153–62.

    Article  CAS  PubMed  Google Scholar 

  5. Masakane I, Nakai S, Ogata S, et al. An overview of regular dialysis treatment in Japan (as of 31 December 2013). Ther Apher Dial. 2015;19:540–74.

    Article  CAS  PubMed  Google Scholar 

  6. Abe M, Kalantar-Zadeh K. Haemodialysis-induced hypoglycaemia and glycaemic disarrays. Nat Rev Nephrol. 2015;11:302–13.

    Article  CAS  PubMed  Google Scholar 

  7. Dworkin RH, O’Connor AB, Backonja M, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007;132:237–51.

    Article  CAS  PubMed  Google Scholar 

  8. Moulin DE, Clark AJ, Gilron I, et al. Pharmacological management of chronic neuropathic pain: consensus statement and guidelines from the Canadian Pain Society. Pain Res Manag. 2007;12:13–21.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Attal N, Cruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010;17:1113–23.

    Article  CAS  PubMed  Google Scholar 

  10. Tan T, Barry P, Reken S, Baker M. Pharmacological management of neuropathic pain in non-specialist settings: summary of NICE guidance. BMJ. 2010;340:707–9.

    Article  Google Scholar 

  11. Randinitis EJ, Posvar EL, Alvey CW, et al. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol. 2003;43:277–83.

    Article  CAS  PubMed  Google Scholar 

  12. Ware J, Kosinski M, Dewey J, Gandek B. How to score and interpret single-item health status measures: a manual for users of the SF-8 Health Survey. Boston: QualyMetric; 2001.

    Google Scholar 

  13. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.

    Article  PubMed  Google Scholar 

  14. Dworkin RH, Corbin AE, Young JP Jr, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology. 2003;60:1274–83.

    Article  CAS  PubMed  Google Scholar 

  15. Cappuzzo KA. Treatment of postherpetic neuralgia: focus on pregabalin. Clin Interv Aging. 2009;4:17–23.

    CAS  PubMed  PubMed Central  Google Scholar 

  16. Arezzo JC, Rosenstock J, LaMoreaux L, Pauer L. 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. doi:10.1186/1471-2377-8-33.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Satoh J, Yagihashi S, Baba M, et al. Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial. Diabet Med. 2010;28:109–16.

    Article  Google Scholar 

  18. Satoh J, Yagihashi S, Baba M, et al. Efficacy and safety of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial. J Diabetes Investig. 2011;2:457–563.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. 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.

    Article  PubMed  Google Scholar 

  20. 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. Int J Clin Pract. 2007;61:1989–96.

    Article  CAS  PubMed  Google Scholar 

  21. Agarwal A, Gautam S, Gupta D, et al. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008;101:700–4.

    Article  CAS  PubMed  Google Scholar 

  22. Zhang SS, Wu Z, Zhang LC, et al. Efficacy and safety of pregabalin for treating painful diabetic peripheral neuropathy: a meta-analysis. Acta Anaesthesiol Scand. 2015;59:147–59.

    Article  CAS  PubMed  Google Scholar 

  23. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: systematic review, meta-analysis and updated NeuPSIG recommendations. Lancet Neurol. 2015;14:162–73.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Haanpaa M, Treede RD. Diagnosis and classification of neuropathic pain. Pain Clinical Update. 2010;XVIII, Issue 7.

  25. Kehler H, Jensen TS, Woolf C. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006;367:1618–25.

    Article  Google Scholar 

  26. Kavoussi R. Pregabalin: from molecule to medicine. Eur Neuropsychopharmacol. 2006;16(Suppl 2):S128–33.

    Article  CAS  PubMed  Google Scholar 

  27. Ohishi A, Chisaki Y, Hira D, et al. Opioid analgesics increase incidence of somnolence and dizziness as adverse effects of pregabalin: a retrospective study. J Pharm Health Care Sci. 2015;1:30. doi:10.1186/s40780-015-0032-5.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45(Suppl 6):13–8.

    Article  CAS  PubMed  Google Scholar 

  29. Yue J, Jiao S, Xiao Y, et al. Comparison of pregabalin with ondansetron in treatment of uraemic pruritus in dialysis patients: a prospective, randomized, double-blind study. Int Urol Nephrol. 2015;47:161–7.

    Article  CAS  PubMed  Google Scholar 

  30. Annemans L, Caekelbergh K, Morlion B, et al. A cost-utility analysis of pregabalin in the management of peripheral neuropathic pain. Acta Clin Belg. 2008;63:170–8.

    Article  CAS  PubMed  Google Scholar 

  31. Vranken JH, Dijkgraaf MG, Kruis MR, et al. Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen. Pain. 2008;136:150–7.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, 30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan

    Tomoyasu Otsuki, Kazuyoshi Okada & Masanori Abe

  2. Department of Nephrology, Keiai Hospital, Tokyo, Japan

    Terumi Higuchi, Toshio Yamazaki & Erina Okawa

Authors
  1. Tomoyasu Otsuki
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Terumi Higuchi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Toshio Yamazaki
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Erina Okawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Kazuyoshi Okada
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Masanori Abe
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Masanori Abe.

Ethics declarations

Funding

No sources of funding were received for the preparation of this study.

Conflict of interest

MA has received honoraria from Kyowa Hakko Kirin, Daiichi Sankyo, and Otsuka Pharmaceutical. The other authors declare that they have no relevant financial interests.

Ethical approval

All procedures in this study were in accordance with the 1964 Helsinki Declaration, and the ethical committees of our hospitals approved the study.

Informed consent

Written informed consent was obtained from all patients.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Otsuki, T., Higuchi, T., Yamazaki, T. et al. Efficacy and Safety of Pregabalin for the Treatment of Neuropathic Pain in Patients Undergoing Hemodialysis. Clin Drug Investig 37, 95–102 (2017). https://doi.org/10.1007/s40261-016-0464-1

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40261-016-0464-1

Keywords

Search

Navigation