Time to onset of neuropathic pain reduction: A retrospective analysis of data from nine controlled trials of pregabalin for painful diabetic peripheral neuropathy and postherpetic neuralgia

American Journal of Therapeutics

Volumn 17, Issue 6, 2010, Pages 577-585

  Sharma, Uma ^a   Griesing, Teresa ^b   Emir, Birol ^b   Young Jr , James P ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^b Pfizer Global Pharmaceuticals   (United States)

Author keywords

diabetic peripheral neuropathy; neuropathic pain; polyneuropathy; postherpetic neuralgia; pregabalin

Indexed keywords

PLACEBO; PREGABALIN;

ADULT; AGED; ANALGESIA; ARTICLE; CONTROLLED STUDY; DIABETIC NEUROPATHY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; NEUROPATHIC PAIN; PAIN ASSESSMENT; PERIPHERAL NEUROPATHY; POSTHERPETIC NEURALGIA; PRIORITY JOURNAL; RETROSPECTIVE STUDY; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANALGESICS; DIABETIC NEUROPATHIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; ENDPOINT DETERMINATION; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; MALE; MIDDLE AGED; NEURALGIA, POSTHERPETIC; PAIN MEASUREMENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES;

EID: 78149359581     PISSN: 10752765     EISSN: None     Source Type: Journal    
DOI: 10.1097/MJT.0b013e3181d5e4f3     Document Type: Article

References (55)

1. Rudin NJ. Chronic pain rehabilitation: principles and practice. WMJ. 2001;100:36-43, 66.
2. Schwartzman RJ, Grothusen J, Kiefer TR, et al. Neuro-pathic central pain: epidemiology, etiology, and treatment options. Arch Neurol. 2001;58:1547-1550.
3. Jensen TS, Gottrup H, Sindrup SH, et al. The clinical picture of neuropathic pain. Eur J Pharmacol. 2001;429
4. Woolf CJ. Dissecting out mechanisms responsible for peripheral neuropathic pain: implications for diagnosis and therapy. Life Sci. 2004;74:2605-2610.
5. Chong MS, Hester J. Diabetic painful neuropathy: current and future treatment options. Drugs. 2007;67:569-585.
6. Aring AM, Jones DE, Falko JM. Evaluation and pre-vention of diabetic neuropathy Am Fam Physician. 2005; 71:2123-2128.
7. Vinik A. Clinical review: use of antiepileptic drugs in the treatment of chronic painful diabetic neuropathy J Clin Endocrinol Metab. 2005;90:4936-4945.
8. Dyck PJ, Davies JL, Wilson DM, et al. Risk factors for severity of diabetic polyneuropathy: intensive longitudi-nal assessment of the Rochester Diabetic Neuropathy Study cohort. Diabetes Care. 1999;22:1479-1486.
9. Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy Clin J Pain. 2002;18:350-354.
10. Calcutt NA. Potential mechanisms of neuropathic pain in diabetes. Int Rev Neurobiol. 2002;50:205-228.
11. Nash TP. Treatment options in painful diabetic neurop-athy. Acta Neurol Scand Suppl. 1999;173:36-42.
12. Sadosky A, Mc Dermott 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 Practice. 2008;8: 45-56.
13. Davies M, Brophy S, Williams R, et al. The prevalence, severity, and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care. 2006;29: 1518-1522.
14. Hartsfield CL, Korner EJ, Ellis JL, et al. Painful diabetic peripheral neuropathy in a managed care setting: patient identification, prevalence estimates, and pharmacy utili-zation patterns. Popul Health Manag. 2008;11:317-328.
15. 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 out-patients clinics. Diabetes Metab. 2009;35:206-213.
16. Schmader K. Herpes zoster in older adults. Clin Infect Dis. 2001;32:1481-1486.
17. Kost RG, Straus SE. Postherpetic neuralgia\pathogenesis, treatment, and prevention. N Engl J Med. 1996;335:32-42.
18. Bowsher D. The management of postherpetic neuralgia. Postgrad Med J. 1997;73:623-629.
19. Choo PW, Galil K, Donahue JG, et al. Risk factors for postherpetic neuralgia. Arch Intern Med. 1997;157: 1217-1224.
20. Kanazi GE, Johnson RW, Dworkin RH. Treatment of postherpetic neuralgia: an update. Drugs. 2000;59:1113-1126.
21. Dworkin RH, Portenoy RK. Pain and its persistence in herpes zoster. Pain. 1996;67:241-251.
22. Weaver BA. Herpes zoster overview: natural history and incidence. J Am Osteopath Assoc. 2009;109:S2-S6.
23. Field MJ, Cox PJ, Stott E, et al. Identification of the -δ-1 subunit of voltage-dependent calcium channels as a molecular target for pain mediating the analgesic actions of pregabalin. Proc Natl Acad Sci USA. 2006; 103: 17537-17542.
24. 2δ ligands: novel modulators of neurotransmission. Trends Pharmacol Sci. 2007;28:75-82.
25. 2-delta) subunit as a target for antiepileptic drug discovery. Epilepsy Res. 2007;73:137-150.
26. 3H] pregabalin binding is increased in ipsilateral dorsal horn following chronic constriction injury. Neurosci Lett. 2007;417:187-192.
27. Joshi I, Taylor CP. Pregabalin action at a model synapse: binding to presynaptic calcium channel alpha(2)-delta subunit reduces neurotransmission in mice. Eur J Pharmacol. 2006;553:82-88.
28. Fehrenbacher JC, Taylor CP, Vasko MR. Pregabalin and gabapentin reduce release of substance P and CGRP from rat spinal tissues only after inflammation or activation of protein kinase C. Pain. 2003;105:133-141.
29. 2+ influx by gabapentin and pregabalin in the human neocortex. Neuropharmacology. 2002;42:229-236.
30. 3H]-norepinephrine release from rat neocortical slices. Synapse. 2002;45:171-190.
31. +-evoked release of [H]glu-tamate from rat caudal trigeminal nucleus slices. Pain. 2001;93:191-196.
32. Rosenstock J, Tuchman M, La Moreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neurop-athy: a double-blind, placebo-controlled trial. Pain. 2004; 110:628-638.
33. Lesser H, Sharma U, La Moreaux L, et al. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized clinical trial. Neurology. 2004;63:2104-2110.
34. 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: 253-260.
35. 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;12:203-213.
36. Freynhagen R, Strojek K, Griesing T, et al. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-con-trolled trial of flexible-and fixed-dose regimens. Pain. 2005;115:254-263.
37. Dworkin RH, Corbin AE, Young JP Jr, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology. 2003;60:1274-1283.
38. Sabatowski R, Gálvez R, Cherry DA, et al. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain. 2004;109:26-35.
39. van Seventer R, Feister HA, Young JP Jr, et al. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomised trial. Curr Med Res Opin. 2006;22: 375-384.
40. Dubinsky RM, Kabbani H, El-Chami Z, et al. Practice parameter: treatment of postherpetic neuralgia: an evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2004;63: 959-965.
41. Attal N, Cruccu G, Haanpää M, et al. EFNS Task Force: EFNS guidelines on pharmacological treatment of neu-ropathic pain. Eur J Neurol. 2006;13:1153-1169.
42. 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 Manage. 2007;12:13-21.
43. Pfizer Protocol No.1008-040: A placebo-controlled trial of pregabalin and amitriptyline for treatment of painful diabetic peripheral neuropathy Available at: www. clinicalstudyresults.org/documents/company-study-1952- 0.pdf. Accessed October 21, 2009.
44. Winchell, C. Memorandum re: supervisory medical review of NDA 21-445. In: US Food and Drug Admini-stration. Center for Drug Evaluation and Research Approval Package for Application Number 21-446 Medical Review(s). Available at: http://www.accessdata. fda.gov/drugsatfda-docs/nda/2004/021446-Lyrica%20 Capsules-medr.pdf. Accessed March 8, 2010.
45. Zelman DC, Dukes E, Brandenburg N, et al. Identification of cut-points for mild, moderate and severe pain due to diabetic peripheral neuropathy Pain. 2005;115:29-36.
46. Kashoki, M. Addendum to the Medical Officer Review of the NDA. In: US Food and Drug Administration. Center for Drug Evaluation and Research Approval Package for Application Number 21-446 Medical Review(s). Available at: http://www.accessdata.fda.gov/drugsatfda- docs/nda/2004/021446- Lyrica%20Capsules-medr.pdf. Accessed March 8, 2010.
47. Freynhagen R, Busche P, Konrad C, et al. Effectiveness and time to onset of pregabalin in patients with neuropathic pain [in German]. Schmerz. 2006;20:285-292.
48. Stacey BR, Barrett JA, Whalen E, et al. Pregabalin for postherpetic neuralgia: placebo-controlled trial of fixed and flexible dosing regimens on allodynia and time to onset of pain relief. JPain. 2008;9:1006-1117.
49. Randinitis EJ, Posvar EL, Alvey CW, et al. Pharmacoki-netics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol. 2003;43:277-283.
50. Goldstein DJ, Lu Y, Detke MJ, et al. Duloxetine versus placebo in patients with painful diabetic neuropathy Pain. 2005;116:109-118.
51. Morello CM, Leckband SG, Stoner CP, et al. Randomized double-blind study comparing the efficacy of gabapentin with amitriptyline on diabetic peripheral neuropathy pain. Arch Intern Med. 1999;159:1931-1937.
52. Watson CP, Babul N. Efficacy of oxycodone in neuro-pathic pain: a randomized trial in postherpetic neuralgia. Neurology. 1998;50:1837-1841.
53. Semenchuk MR, Sherman S, Davis B. Double-blind, randomized trial of bupropion SR for the treatment of neuropathic pain. Neurology. 2001;57:1583-1588.
54. Reisner L. Antidepressants for chronic neuropathic pain. Curr Pain Headache Rep. 2003;7:24-33.
55. Wernicke JF, Pritchett YL, D'Souza DN, et al. A random-ized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology. 2006;67:1411-1420.