Pharmacological treatment of diabetic peripheral neuropathy

P and T

Volumn 40, Issue 6, 2015, Pages 372-388

  Cohen, Kenneth ^a   Shinkazh, Nataliya ^a   Frank, Jerry ^b   Israel, Igor ^c   Fellner, Chris ^d  

^a TOURO COLLEGE   (United States)

^b STONY BROOK UNIVERSITY   (United States)

^c Parker Jewish Institute for Health Care and Rehabilitation   (United States)

^d MediMedia Managed Markets   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMITRIPTYLINE; CAPSAICIN; CARBAMAZEPINE; DESIPRAMINE; DEXTROMETHORPHAN; DULOXETINE; GABAPENTIN; HARKOSERIDE; LAMOTRIGINE; LIDOCAINE; MORPHINE SULFATE; OXCARBAZEPINE; OXYCODONE; PREGABALIN; TAPENTADOL; TOPIRAMATE; TRAMADOL; VALPROIC ACID; VENLAFAXINE;

ARTICLE; CLINICAL FEATURE; DIABETIC NEUROPATHY; DISEASE ASSOCIATION; DISEASE CLASSIFICATION; HUMAN; HYPERGLYCEMIA; PERIPHERAL NEUROPATHY; RISK FACTOR; TREATMENT OUTCOME;

EID: 84930740307     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (184)

1. Sinnriech M, Taylor B, Dyck P. Diabetic neuropathies: classification, clinical features, and pathophysiological basis. Neurologist 2005;11:63–79
2. Dyck PJ, Albers JW, Andersen H, et al. Diabetic polyneuropathies: update on research definition, diagnostic criteria, and estimation of severity. Diabetes Metab Res Rev 2011;27:620–628
3. Dyck PJ, Kratz KM, Karnes JL, et al. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology 1993;43:817–824
4. Cameron NE, Eaton SEM, Cotter MA, Tesfaye S. Vascular factors and metabolic interactions in the pathogenesis of diabetic neuropathy. Diabetologia 2001;44:1973–1988
5. Malik RA, Tesfaye S, Thompson SD, et al. Endoneurial localization of microvascular damage in human diabetic neuropathy. Diabetologia 1993;36:454–459
6. Tesfaye S, Malik R, Ward JD. Vascular factors in diabetic neuropathy. Diabetologia 1994;37:847–854
7. Tesfaye S, Vileikyte L, Rayman G, et al. Painful diabetic peripheral neuropathy: consensus recommendations on diagnosis, assessment and management. Diabetes Metab Res Rev 2011;27:629–638
8. Eaton SEM, Harris NK, Ibrahim S, et al. Increased sural nerve epineurial blood flow in human subjects with painful diabetic neuropathy. Diabetologia 2003;46:934–949
9. Baynes JW, Thorpe SR. Role of oxidative stress in diabetic complications: a new perspective on an old paradigm. Diabetes 1999;48:1–9
10. Vlassara H, Striker GE. Advanced glycation endproducts in diabetes and diabetic complications. Endocrinol Metab Clin North Am 2013;42:697–719
11. Vlassara H, Palace MR. Diabetes and advanced glycation endproducts. J Intern Med 2002;251:87–101
12. Papanas N, Vinik AL, Ziegler D. Neuropathy in prediabetes: Does the clock start ticking early? Nat Rev Endocrinol 2011:7:682–690
13. Sumner CJ, Sheth S, Griffin JW, et al. The spectrum of neuropathy in diabetes and impaired glucose tolerance. Neurology 2003;60:108–111
14. Papanas N, Ziegler D. Prediabetic neuropathy: Does it exist? Curr Diabet Rep 2012;12:376–383
15. Smith AG, Singleton JR. Idiopathic neuropathy, prediabetes and the metabolic syndrome. J Neur Sci 2006;242:9–14
16. Smith AG. Impaired glucose tolerance and metabolic syndrome in idiopathic neuropathy. J Peripher Nerv Syst 2012;7(suppl):15–21
17. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, Georgia: U.S. Department of Health and Human Services; 2014. Available at: http://www.cdc.gov/diabetes/pubs/statsreport14/nationaldiabetes-report-web.pdf. Accessed April 3, 2015
18. Vinik AI, Park TS, Stansberry KB, Pittenger GL. Diabetic neuropathies. Diabetologia 2000;43:957–973
19. Bansal V, Kalita J, Misra UK. Diabetic neuropathy. Postgrad Med J 2006;82:95–100
20. Dorsey R, Eberhardt M, Gregg E, Geiss L. Control of risk factors among people with diagnosed diabetes by lower extremity disease status. Prev Chronic Dis 2009;6:1–6
21. Adler A, Boyko E, Ahroni J, et al. Risk factors for diabetic peripheral sensory neuropathy. Diabetes Care 1997;20:1162–1167
22. Perkins B, Greene D, Bril V. Glycemic control is related to the morphological severity of diabetic sensorimotor polyneuropathy. Diabetes Care 2001;24:748–752
23. Tracy JA, Dyck PJB. The spectrum of diabetic neuropathies. Phys Med Rehabil Clin North Am 2008;19:1–26
24. Boyko E, Ahroni J, Stensel V, et al. A prospective study of risk factors for diabetic foot ulcers: the Seattle Diabetic Foot Study. Diabetes Care 1999;22:1036–1042
25. Dyck PJ, Davies JL, Wilson DM, et al. Risk factors for severity of diabetic polyneuropathy: intensive longitudinal assessment of the Rochester Diabetic Neuropathy Study Cohort. Diabetes Care 1999;22:1479–1486
26. Thomas PK. Classification, differential diagnosis, and staging of diabetic peripheral neuropathy. Diabetes 1997;46(suppl 2):S54–S57
27. Ayad H. Diabetic neuropathy: classification, clinical manifestations, diagnosis and management. In: Baba S, et al, eds. Diabetes Mellitus in Asia. Amsterdam, Netherlands: Excerpta Medica; 1997:222–224
28. Tesfaye S, Selvarajah D. Advances in the epidemiology, pathogenesis and management of diabetic peripheral neuropathy. Diabetes Metab Res Rev 2012;28(suppl 1):8–14
29. Smith AG, Singleton JR. Impaired glucose tolerance and neuropathy. Neurologist 2008;14:23–29
30. Singleton JR, Smith AG, Bromberg MB. Increased prevalence of impaired glucose tolerance in patients with painful sensory neuropathy. Diabetes Care 2001;24:1448–1453
31. Davies M, Brophy S, Williams R, Taylor A. The prevalence, severity and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care 2006;29:1518–1522
32. Sadosky A, Schaefer C, Mann R, et al. Burden of illness associated with painful diabetic peripheral neuropathy among adults seeking treatment in the US: results from a retrospective chart review and cross-sectional survey. Diabetes Metab Syndr Obes 2013;6:79–92
33. Cavanagh PR, Derr JA, Ulbrcht JS, et al. Problems with gait and posture in neuropathic patients with insulin-dependent diabetes mellitis. Diabet Med 1992;9:469–474
34. Abbott CA, Carrington AL, Bath AS, et al. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabet Med 2002;19:377–384
35. Boultan AJM, Vileikyte L, Ragnarson-Tennvall G, et al. The global burden of diabetic foot disease. Lancet 2005;366:1719–1724
36. Kuritzky L, Samraj GP. Current treatments in the management of diabetic peripheral neuropathic pain 2009. Pain Med News, September 2009:1–12. Available at: http://www.painmedicinenews.com/download/DPNP_ PMN0809_WM.pdf. Accessed March 4, 2015
37. Dworkin RH, Backonja M, Rowbotham MC, et al. Advances in neuropathic pain: diagnosis, mechanisms, and treatment recommendations. Arch Neurol 2003;60:1524–1534
38. Farrar JT, Young GP Jr, LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149–158
39. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321:405–412
40. Epidemiology of Diabetes Interventions and Complications (EDIC). Design, implementation, and preliminary results of a long-term follow-up of the Diabetes Control and Complications Trial cohort. Diabetes Care 1999;22:99–111
41. Martin CL, Albers J, Herman WH, et al. Neuropathy among the Diabetes Control and Complications Trial cohort 8 years after trial completion. Diabetes Care 2006;20:340–344
42. Morrison S, Colberg SR, Mariano M. Balance training reduces falls risk in older individuals with type 2 diabetes. Diabetes Care 2010;33:748–750
43. Smith AG, Russell J, Feldman EL. Lifestyle intervention for pre-diabetic neuropathy. Diabetes Care 2006;29:1294–1299
44. Bertelsmann FW, Heimans JJ, Van Rooy JC, et al. Peripheral nerve function in patients with painful diabetic neuropathy treated with continuous subcutaneous insulin infusion. J Neurosurg Psychiatry 1987;50:1337–1341
45. Callaghan BC, Little AA, Feldman EL, et al. Enhanced glucose control for preventing and treating diabetic neuropathy. Cochrane Database Syst Rev 2012 June 13;6:CD007543. doi: 10.1002/14651858.CD007543.pub2
46. American Diabetes Association. Standards of medical care in diabetes—2014 (position statement). Diabetes Care 2014;37:S14–S80
47. Handelsman Y, Mechanick JI, Blonde L, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011;17(suppl 2):1–53
48. Albers JW, Herman WH, Pop-Busui R, et al. Effect of prior intensive insulin treatment during the Diabetes Control and Complications Trial (DCCT) on peripheral neuropathy in type 1 diabetes during the Epidemiology of Diabetes Interventions and Complications (EDIC) study. Diabetes Care 2010;33:1090–1096
49. Nathan DM, Cleary PA, Backlund JC, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;535:2643–2653
50. Azad N, Emanuele NV, Abraira C, et al. The effects of intensive glycemic control on neuropathy in the VA Cooperative Study on Type II Diabetes Mellitus (VA CSDM). J Diabetes Complications 1999;13:307–313
51. Ismail-Beigi F, Craven T, Banerji MA, et al. Effect of intensive treatment of hyperglycemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomized trial. Lancet 2010;376:419–430
52. Pop-Busui R, Lu J, Brooks MM, et al. Impact of glycemic control strategies on the progression of diabetic peripheral neuropathy in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) cohort. Diabetes Care 2013;36:3208–3215
53. Bril V, England J, Franklin GM, et al. 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;76:1758–1765
54. Argoff C, Backonja M, Belgrade M, et al. Consensus guidelines: treatment and planning options: diabetic peripheral neuropathic pain. Mayo Clin Proc 2006;81(suppl):S12–S25
55. Tan T, Barry P, Reken S, et al. Pharmacological management of neuropathic pain in non-specialist settings: summary of NICE guidance. BMJ 2010;340:c1079. doi: 10.1136/bmj.c1079
56. Sultan A, Gaskell H, Derry S, Moore RA. Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. BMC Neurol 2008;8:29. doi: 10.1186/1471-2377-8-29
57. Wernicke JF, Pritchett YL, D’Souza DN, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology 2006;67:1411–1420
58. Lindsay TJ, Rodgers BC, Savath V, Hettinger K. Treating diabetic peripheral neuropathic pain. Am Fam Physician 2010;82:151–158
59. Saarto T, Wiffen PJ. Antidepressants for neuropathic pain. Cochrane Database Syst Rev 2007;4:CD005454
60. Boulton AJM. Management of diabetic peripheral neuropathy. Clin Diabetes 2005;23:9–15
61. Food and Drug Administration. FDA approves drug for neuropathic pain associated with diabetes. September 7, 2004. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108349.htm. Accessed March 18, 2015
62. Cymbalta (duloxetine) prescribing information. Indianapolis, Indiana: Eli Lilly and Company; December 2014. Available at: http://pi.lilly.com/us/cymbalta-pi.pdf. Accessed March 18, 2015
63. Max MB, Kishore-Kumar R, Schafer SC, et al. Efficacy of desipramine in painful diabetic neuropathy: a placebo-controlled trial. Pain 1991;45:3–9
64. Goldstein DJ, Lu Y, Detke MJ, et al. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain 2005;116:109–118
65. Raskin J, Pritchett YL, Wang F, et al. A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Pain Med 2005;6:346–356
66. Tanenberg RJ, Irving GA, Risser RC, et al. Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open-label, randomized, noninferiority comparison. Mayo Clin Proc 2011;86:615–624
67. Quilici S, Chancellor J, Lothgren M, et al. Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain. BMC Neurology 2009;9:6. doi: 10.1186/1471-2377-9-6
68. Kaur H, Hota D, Bhansali A, et al. A comparative evaluation of amitriptyline and duloxetine in painful diabetic neuropathy: a randomized, double-blind, cross-over clinical trial. Diabetes Care 2011;34:818–822
69. Boyle J, Eriksson MEV, Gribble L, et al. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care 2012;35:2451–2458
70. Tesfaye S, Wilhelm S, Lledo A, et al. Duloxetine and pregabalin: high-dose monotherapy or their combination? The “COMBO-DN study”—a multi-national, randomized, double-blind, parallel-group study in patients with diabetic peripheral neuropathic pain. Pain 2013;154:2616–2625
71. American Academy of Neurology. AAN summary of evidence-based guidelines for clinicians: treatment of painful diabetic neuropathy. 2011. Available at: https://www.aan.com/Guidelines/home/GetGuidelineContent/480. Accessed March 13, 2015
72. Red Book Online. Ann Arbor, Michigan: Truven Health Analytics. Accessed May 5, 2015
73. Effexor XR (venlafaxine extended release) prescribing information. Philadelphia, Pennsylvania: Wyeth Pharmaceuticals, Inc.; February 2015. Available at: http://labeling.pfizer.com/showlabeling.aspx?ID=100. Accessed March 20, 2015
74. Huizinga MM, Peltier A. Painful diabetic neuropathy: a managementcentered review. Clin Diabetes 2007;25:6–15
75. Morton WA, Sonne SC, Verga MA. Venlafaxine: a structurally unique and novel antidepressant. Ann Pharmacother 1995;29:387–395
76. Davis JL, Smith RL. Painful peripheral diabetic neuropathy treated with venlafaxine HCl extended release capsules [letter]. Diabetes Care 1999;22:1909–1910
77. Rowbotham MC, Goli V, Kunz NR, Lei D. Venlafaxine extended release in the treatment of painful diabetic neuropathy: a double-blind, placebo-controlled study. Pain 2004;110:697–706
78. Sindrup SH, Bach FW, Madsen C, et al. Venlafaxine versus imipramine in painful polyneuropathy: a randomized, controlled trial. Neurology 2003;60:1284–1289
79. Max MB, Lynch SA, Muir J, et al. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med 1992;326:1250–1256
80. Ulugol A, Karadag HC, Tamer M. Involvement of adenosine in the antiallodynic effect of amitriptyline in streptozotocin-induced diabetic rats. Neurosci Lett 2002;328:129–132
81. Davis JL, Lewis SB, Gerich JE, et al. Peripheral diabetic neuropathy treated with amitriptyline and fluphenazine. JAMA 1977;238:2291–2292
82. Richelson E. Pharmacology of antidepressants: characteristics of the ideal drug. Mayo Clin Proc 1994;69:1069–1081
83. Max MB. Endogenous monoamine analgesic systems: amitriptyline in painful diabetic neuropathy. Anesth Prog 1987;34:113–127
84. Bansal D, Bhansali A, Hota D, et al. Amitriptyline vs. pregabalin in painful diabetic neuropathy: a randomized double blind clinical trial. Diabet Med 2009;26:1019–1026
85. 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
86. McQuay H, Tramèr M, Nye B, et al. A systematic review of antidepressants in neuropathic pain. Pain 1996;68:217–227
87. Pearson L. Nurse Practitioner’s Drug Handbook, 3rd ed. Ambler, Pennsylvania: Springhouse Corporation; 2000
88. Norpramin (desipramine hydrochloride) prescribing information. Bridgewater, New Jersey: Sanofi-Aventis; June 2014. Available at: http://products.sanofi.us/norpramin/norpramin.pdf. Accessed March 24, 2015
89. Joss JD. Tricyclic antidepressant use in diabetic neuropathy. Ann Pharmacother 1999;33:996–1000
90. Hearn L, Moore RA, Derry S, et al. Desipramine for neuropathic pain in adults. Cochrane Database Syst Rev 2014;9:CD011003. doi: 10.1002/14651858.CD011003.pub2
91. Simmons Z, Feldman EL. The pharmacological treatment of painful diabetic neuropathy. Clin Diabetes 2000;18:5–10
92. St. Onge EL, Miller SA. Pain associated with diabetic peripheral neuropathy. P&T 2008;33:166–176
93. Standaert DG, Young AB. Treatment of central nervous system degenerative disorders. In: Hardman JG, Limbird LE, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics, 10th ed. New York, New York: McGraw-Hill; 2001:533
94. Lyrica (pregabalin) prescribing information. New York, New York: Pfizer, Inc.; December 2013. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=561. Accessed March 6, 2015
95. Mihic SJ, Harris RA. GABA and the GABAA receptor. Alcohol Health Res World 1997;21:127–131
96. Taylor CP, Angelotti T, Fauman E. Pharmacology and mechanism of action of pregabalin: the calcium channel alpha2-delta (alpha2-delta) subunit as a target for antiepileptic drug discovery. Epilepsy Res 2007;73:137–150
97. FDA Center for Drug Evaluation and Research. Approval package for application number 21-446. December 30, 2004. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_Lyrica%20Capsules_approv.PDF. Accessed March 18, 2015
98. Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebocontrolled trial. Pain 2004;110:628–638
99. Lesser H, Sharma U, LaMoreaux L, et al. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology 2004;63:2104–2110
100. 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;31:1448–1454
101. Huffman C, Stacey BR, Tuchman M, et al. Efficacy and safety of pregabalin in the treatment of patients with painful diabetic peripheral neuropathy and pain on walking. Clin J Pain 2015 Jan 6: doi:10.1097/AJP.0000000000000198
102. National Institute for Health Care and Excellence (NICE). Neuropathic pain—pharmacological management. NICE Clinical Guideline 173; November 2013. Available at: http://www.nice.org.uk/guidance/cg173/evidence/ cg173-neuropathic-pain-pharmacological-management-full-guideline3. Accessed March 17, 2015
103. Rickels K, Pollack MH, Feltner DE, et al. Pregabalin for treatment of generalized anxiety disorder. Arch Gen Psychiatry 2005;62:1022–1030
104. Montgomery SA, Tobias K, Zornberg GL, et al. Efficacy and safety of pregabalin in the treatment of generalized anxiety disorder: a 6-week, multicenter, randomized, double-blind, placebo-controlled comparison of pregabalin and venlafaxine. J Clin Psychiatry 2006;67:771–782
105. Neurontin (gabapentin) prescribing information. New York, New York: Pfizer, Inc.; September 2014. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=630. Accessed March 9, 2015
106. Cui JG, Linderoth B, Meyerson BA. Effects of spinal cord stimulation on touch-evoked allodynia involve GABAergic mechanisms: an experimental study in the mononeuropathic rat. Pain 1996;66:287–295
107. Backonja M, Beydoun A, Edwards KR, et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA 1998;280:1831–1836
108. Moore RA, Wiffen PJ, Derry S, et al. Gabapentin for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev 2014 Apr 27;4:CD007938. doi: 10.1002/14651858.CD007938.pub3
109. Dallocchio C, Buffa C, Mazzarello P, Chiroli S. Gabapentin vs. amitriptyline in painful diabetic neuropathy: an open-label pilot study. J Pain Symptom Manage 2000;20:280–285
110. Simpson DA. Gabapentin and venlafaxine for the treatment of painful diabetic neuropathy. J Clin Neuromusc Dis 2001;3:53–62
111. Chong MS, Hester J. Diabetic painful neuropathy: current and future treatment options. Drugs 2007;67:569–585
112. Tannenberg RJ. Diabetic peripheral neuropathy: painful or painless. Hospital Physician Nov/Dec 2009:1–8
113. Stacey BR, Dworkin RH, Murphy K, et al. Pregabalin in the treatment of refractory neuropathic pain: results of a 15-month open-label trial. Pain Med 2008;9:1202–1208
114. Food and Drug Administration. Valproate information. June 26, 2013. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrug- SafetyInformationforPatientsandProviders/ucm192645.htm. Accessed March 11, 2015
115. Depacon (valproate sodium) prescribing information. North Chicago, Illinois: AbbVie Inc.; January 2015. Available at: http://www.rxabbvie.com/pdf/depacon.pdf. Accessed March 16, 2015
116. Kochar DK, Rawar N, Agrawal RP, et al. Sodium valproate for painful diabetic neuropathy: a randomized double-blind placebo-controlled study. Q J Med 2004;97:33–38
117. Kochar DK, Jain N, Agrawal RP, et al. Sodium valproate in the management of painful neuropathy in type 2 diabetes—a randomized placebo-controlled study. Acta Neurol Scand 2002;106:248–252
118. Tegretol (carbamazepine) prescribing information. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; September 2014. Available at: http://www.pharma.us.novartis.com/product/pi/pdf/tegretol.pdf. Accessed March 18, 2015
119. Rull JA, Quibrera R, Gonzalez-Millan H, Lozano Castaneda O. Symptomatic treatment of peripheral diabetic neuropathy with carbamazepine (Tegretol): double blind crossover trial. Diabetologia 1969;5:215–218
120. Wiffen PJ, Derry S, Moore RA, et al. Carbamazepine for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev 2014 Apr 10;4:CD005451. doi: 10.1002/14651858.CD005451.pub3
121. Paton C, Procter AW. Carbamazepine monitoring. Psychiatr Bull 1993;17:718–720
122. Wiffen PJ, McQuay HJ, Moore RA. Carbamazepine for acute and chronic pain. Cochrane Database Syst Rev 2005 Jul 20;(3):CD005451
123. Vimpat (lacosamide) prescribing information. Smyrna, Georgia: UCB, Inc.; February 2015. Available at: http://www.ucb.com/_up/ucb_com_products/documents/Vimpat_Current_COL_02_2015.pdf. Accessed March 17, 2015
124. FierceBiotech. UCB Group receives not-approvable letter from FDA for lacosamide for diabetic neuropathic pain. July 29, 2008. Available at: http://www.fiercebiotech.com/press-releases/ucb-group-receives-not-approvableletter-fda-lacosamide-diabetic-neuropathic-pain. Accessed April 2, 2015
125. Hearn L, Derry S, Moore RA. Lacosamide for neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev 2012 Feb 15;2:CD009318. doi: 10.1002/14651858.CD009318.pub2
126. Lamictal (lamotrignine) prescribing information. Research Triangle Park, North Carolina, GlaxoSmithKline; December 2014. Available at: https://www.gsksource.com/gskprm/htdocs/documents/LAMICTAL-PI-MG.PDF. Accessed March 17, 2015
127. Wiffen PJ, Derry S, Moore RA. Lamotrigine for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev 2013 Dec 3;12:CD006044. doi: 10.1002/14651858.CD006044.pub4
128. Trileptal (oxcarbazepine) prescribing information. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; July 2014. Available at: http://www. pharma.us.novartis.com/product/pi/pdf/trileptal.pdf. Accessed March 17, 2015
129. Zhou M, Chen N, He L, et al. Oxcarbazepine for neuropathic pain. Cochrane Database Syst Rev 2013 Mar 28;3:CD007963. doi: 10.1002/14651858.CD007963.pub2
130. Topamax (topiramate) prescribing information. Titusville, New Jersey: Janssen Pharmaceuticals; March 2014. Available at: http://www.topamax.com/sites/default/files/topamax.pdf#zoom=100. Accessed March 17, 2015
131. Wiffen PJ, Derry S, Lunn MPT, et al. Topiramate for neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev 2013 Aug 30;8:CD008314. doi: 10.1002/14651858.CD008314.pub3
132. Chang G, Chen L, Mao J. Opioid tolerance and hyperalgesia. Med Clin North Am 2007;91:199–211
133. Ballantyne JC, Shin NS. Efficacy of opioids for chronic pain: a review of the evidence. Clin J Pain 2008;24:469–478
134. Chou R, Fanciullo GJ, Fine PG, et al. American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10:113–130
135. Purdue Pharma. Common errors in the media about Oxycontin (oxycodone HCl controlled-release) tablets CII. 2015. Available at: http://www.purduepharma.com/news-media/2011/12/common-errors-in-the-media-aboutoxycontin-oxycodone-hcl-controlled-release-tablets. Accessed March 25, 2015
136. Oxycontin (oxycodone extended release) prescribing information. Stamford, Connecticut: Purdue Pharma; April 2014. Available at: http://app.purduepharma.com/xmlpublishing/pi.aspx?id=o. Accessed March 25, 2015
137. Gimbel JS, Richards P, Portenoy RK. Controlled-release oxycodone for pain in diabetic neuropathy: a randomized controlled trial. Neurology 2003;60:927–934
138. Watson CPN, Moulin D, Watt-Watson J, et al. Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy. Pain 2003;105:71–78
139. Gaskell H, Moore RA, Derry S, et al. Oxycodone for neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev 2014 Jun 23;6:CD010692. doi: 10.1002/14651858.CD010692.pub2
140. Hanna M, O’Brien C, Wilson MC. Prolonged-release oxycodone enhances the effects of existing gabapentin therapy in painful diabetic neuropathy patients. Eur J Pain 2008;12:804–813
141. Avinza (morphine sulfate extended release) prescribing information. New York, New York: Pfizer, Inc.; April 2014. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=876. Accessed March 26, 2015
142. Food and Drug Administration. List of extended-release and long-acting opioid products required to have an opioid REMS. April 22, 2013. Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251735.htm. Accessed March 26, 2015
143. Gilron I, Bailey JM, Tu D, et al. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med 2005;352:1324–1334
144. Montfort EG, Witte AP, Ward K. Neuropathic pain: a review of diabetic neuropathy. US Pharm 2010;35:HS8–HS15
145. Food and Drug Administration. Supplemental approval. July 9, 2012. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s002ltr.pdf. Accessed March 26, 2015
146. Nucynta ER (tapentadol extended release) prescribing information. Titusville, New Jersey: Janssen Pharmaceuticals; April 2014. Available at: http://www.nucynta.com/shared/product/nucynta/nucyntaer-pi.pdf#zoom=100. Accessed March 26, 2015
147. Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin 2011;27:151–162
148. Vinik AI, Shapiro DY, Rauschkolb C, et al. A randomized withdrawal, placebo-controlled study evaluating the efficacy and tolerability of tapentadol extended release in patients with chronic painful diabetic peripheral neuropathy. Diabetes Care 2014;37:2302–2309
149. Macedo KA, Nailor MD. Focus on tapentadol: role in the treatment of neuropathic pain. Formulary 2013;48:395–402
150. Ultram ER (tramadol, extended release) prescribing information. Titusville, New Jersey: Janssen Pharmaceuticals; July 2014. Available at: http://www.janssenpharmaceuticalsinc.com/assets/ultramer.pdf. Accessed March 26, 2015
151. Raffa RB, Friderichs E, Reimann W, et al. Opioid and nonopioid components independently contribute to the mechanism of action of tramadol, an “atypical” opioid analgesic. J Pharmacol Exp Ther 1998;260:275–285
152. Harati Y, Gooch C, Swenson M, et al. Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy. Neurology 1998;50:1842–1846
153. Harati Y, Gooch C, Swenson M, et al. Maintenance of the long-term effectiveness of tramadol in treatment of the pain of diabetic neuropathy. J Diabetes Complications 2000;14:65–70
154. Freeman R, Raskin P, Hewitt DJ, et al. Randomized study of tramadol/ acetaminophen versus placebo in painful diabetic neuropathy. Curr Med Res Opin 2007;23:147–161
155. Hollingshead J, Dühmke RM, Cornblath DR. Tramadol for neuropathic pain. Cochrane Database Syst Rev 2006 Jul 19;3:CD003726
156. University of Maryland, Center for Substance Abuse Research. Dextromethorphan (DXM). October 29, 2013. Available at: http://www.cesar.umd.edu/cesar/drugs/dxm.asp. Accessed March 27, 2015
157. Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth 2000;47:585–596
158. Drug Enforcement Administration, Office of Diversion Control. Dextromethorphan. March 2014. Available at: http://www.deadiversion.usdoj.gov/drug_chem_info/dextro_m.pdf. Accessed March 27, 2015
159. Shulgin AT. Drugs of abuse in the future. Clin Toxicol 1975;8:405–456
160. Nelson KA, Park KM, Rabinovitz E, et al. High-dose oral dextromethorphan versus placebo in painful diabetic neuropathy and postherpetic neuralgia. Neurology 1997;48:1212–1218
161. Sang CN, Booher S, Gilron I, et al. Dextromethorphan and memantine in painful diabetic neuropathy and postherpetic neuralgia. Anesthesiology 2002;96:1053–1061
162. Zin CS, Nissen LM, Smith MT, et al. An update on the pharmacological management of post-herpetic neuralgia and painful diabetic neuropathy. CNS Drugs 2008;22:417–442
163. Tandan R, Lewis GA, Badger GB, et al. Topical capsaicin in painful diabetic neuropathy. Effect on sensory function. Diabetes Care 1991;15:15–18
164. The Capsaicin Study Group. A multicenter, double-blind, vehicle-controlled study. Arch Intern Med 1991;151:2225–2229
165. Capsaicin Study Group. Effect of treatment with capsaicin on daily activities of patients with painful diabetic neuropathy. Diabetes Care 1992;15:159–165
166. Low PA, Opfer-Gehrking TL, Dyck PJ, et al. Double-blind, placebo-controlled study of the application of capsaicin cream in chronic distal painful polyneuropathy. Pain 1995;62:163–168
167. Biesbroek R, Bril V, Hollander P, et al. A double-blind comparison of topical capsaicin and oral amitriptyline in painful diabetic neuropathy. Adv Ther 1995;12:111–120
168. Food and Drug Administration. FDA approves new drug treatment for long-term pain relief after shingles attacks. November 17, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm. Accessed March 27, 2015
169. Lidoderm (lidocaine patch 5%) prescribing information. Malvern, Pennsylvania: Endo Pharmaceuticals; January 2015. Available at: http://www.endo.com/File%20Library/Products/Prescribing%20Information/LIDODERM_ prescribing_information.html. Accessed March 30, 2015
170. Derry S, Rice ASC, Cole P, et al. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev 2013 Feb 28;2:CD007393. doi: 10.1002/14651858.CD007393.pub3
171. Dejgard A, Petersen P, Kastrup J. Mexiletine for treatment of chronic painful diabetic neuropathy. Lancet 1988;1:9–11
172. Stracke H, Meyer UE, Schumacher HE, Federlin K. Mexiletine in the treatment of diabetic neuropathy. Diabetes Care 1992;15:1550–1555
173. Oskarsson P, Ljunggren J-G, Lins P-E, et al. Efficacy and safety of mexiletine in the treatment of painful diabetic neuropathy. Diabetes Care 1997;20:1594–1597
174. Boulton AJM, Malik RA, Arezzo JC, Sosenko JM. Diabetic somatic neuropathies: a technical review. Diabetes Care 2004;27:1458–1486
175. Krishnan STM, Rayman G. Symptomatic diabetic neuropathy: an update. Curr Diabetes Rep 2004;16:2–9
176. Barbano RL, Herrmann DN, Hart-Gouleau S, et al. Effectiveness, tolerability, and impact on quality of life of the 5% lidocaine patch in diabetic polyneuropathy. Arch Neurol 2004;61:914–918
177. Baron R, Mayoral V, Leijon G, et al. 5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label, non-inferiority two-stage RCT study. Curr Med Res Opin 2009;25:1663–1676
178. Wolff R, Bala M, Westwood M, et al. 5% lidocaine medicated plaster in painful diabetic peripheral neuropathy (DPN): a systematic review. Swiss Med Wkly 2010;140:297–306
179. Flores MP, de Castro APCR, Nascimento JDS. Topical analgesics. Rev Bras Anestesiol 2012;62:244–252
180. Ho K, Huh BK, White WD, et al. Topical amitriptyline versus lidocaine in the treatment of neuropathic pain. Clin J Pain 2008;24:51–55
181. Lynch ME, Clark AJ, Sawynok J, et al. Topical 2% amitriptyline and 1% ketamine in neuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial. Anesthesiology 2005;103:140–146
182. Kopsky DJ, Hesslink K. High doses of topical amitriptyline in neuropathic pain: two cases and literature review. Pain Pract 2012;12:148–153
183. Estebe JP, Myers RR. Amitriptyline neurotoxicity: dose-related pathology after topical application to rat sciatic nerve. Anesthesiology 2004;100:1519–1525
184. University of Illinois at Chicago College of Pharmacy. What are the new recommendations for treatment of painful diabetic neuropathy? 2007. Available at: http://dig.pharm.uic.edu/faq/2011/Jun/faq2.aspx. Accessed March 30, 2015.