An open-label 52-week clinical extension comparing duloxetine with routine care in patients with diabetic peripheral neuropathic pain

Pain Medicine

Volumn 8, Issue 6, 2007, Pages 503-513

  Wernicke, Joachim F ^a   Wang, Fujun ^a   Pritchett, Yili L ^a   Smith, Timothy R ^b   Raskin, Joel ^a   D'souza, Deborah N ^a   Iyengar, Smriti ^a   Chappell, Amy S ^a  

^a ELI LILLY AND COMPANY   (United States)

^b WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Antidepressant; Diabetic Peripheral Neuropathic Pain; Duloxetine; Norepinephrine; Pain; Serotonin

Indexed keywords

DULOXETINE; NARCOTIC ANALGESIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PLACEBO;

ABNORMAL LABORATORY RESULT; ADULT; AGED; ARTICLE; ASTHENIA; BODY WEIGHT; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC COMA; DIABETIC NEUROPATHY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG WITHDRAWAL; ECG ABNORMALITY; EYE DISEASE; FATALITY; FATIGUE; FEMALE; HEART FAILURE; HUMAN; HYPERHIDROSIS; HYPERTENSION; INSULIN DEPENDENT DIABETES MELLITUS; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NERVE FUNCTION; NEUROPATHIC PAIN; NEUROPATHY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTPATIENT CARE; PATIENT CARE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE;

EID: 34548219407     PISSN: 15262375     EISSN: 15264637     Source Type: Journal    
DOI: 10.1111/j.1526-4637.2006.00258.x     Document Type: Article

References (41)

1. Galer BS, Gianas A, Jensen MP. Painful diabetic polyneuropathy: Epidemiology, pain description, and quality of life. Diabetes Res Clin Pract 2000;47:123-8.
2. Callisi PT, Jaber LA. Peripheral diabetic neuropathy: Current concepts in treatment. Ann Pharmacother 1995;29:769-77.
3. Courteix C, Eschalier A, Laverenne J. Streptozocin-induced diabetic rats: Behavioral evidence for a model of chronic pain. Pain 1993;53:81-8.
4. Kim SH, Chung JM. An experimental model for peripheral neuropathy produced by segmental spinal nerve ligation in the rat. Pain 1992;50:355-63.
5. National Diabetes Information Clearinghouse (NDIC). National Diabetes Statistics: Total Prevalence of Diabetes in the United States, All Ages, 2002. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/ index.htm#7 (accessed August 14, 2005).
6. Eastman RC. Neuropathy in diabetes. In: National Diabetes Data Group, ed. Diabetes in America, 2nd edition. NIH Publication No. 95-1468. Washington, DC: Department of Health and Human Services, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 1995: 339-48.
7. Quattrini C, Tesfaye S. Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev 2003;19(suppl 1):S2-8.
8. 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.
9. Lynch ME. Antidepressants as analgesics: A review of randomized controlled trials. J Psychiatry Neurosci 2001;26:30-6.
10. Barkin RL, Fawcett J. The management challenges of chronic pain: The role of antidepressants. Am J Ther 2000;7:31-47.
11. Dejgard A, Petersen P, Kastrup J. Mexilitene for the treatment of chronic painful diabetic neuropathy. Lancet 1988;1:9-11.
12. Sindrup SH, Gram LF, Brosen K, Eshoj O, Mogensen BI. The SSRI paroxetine is effective in the treatment of diabetic neuropathy symptoms. Pain 1990;42:135-44.
13. Sindrup SH, Bjerre U, Dejgaard A, et al. The selective serotonin reuptake inhibitor citalopram relieves the symptoms of diabetic neuropathy. Clin Pharmacol Ther 1992;53:547-52.
14. Harati Y, Gooch C, Swenson M, et al. Maintenance of the long-term effectiveness of tramadol in treatment of pain in diabetic neuropathy. J Diabetes Complications 2000;14:65-70.
15. Watson CPN, Moulin D, Watt-Watson J, Gordon A, Eisenhoffer J. Controlled-release oxycodone relieves neuropathic pain: A randomized controlled trial in painful diabetic neuropathy. Pain 2003;105:71-8.
16. Eisenberg E, Luri Y, Braker C, Daoud D, Ishay A. Lamotrigine reduces painful diabetic neuropathy: A randomized, controlled study. Neurology 2001;57:505-9.
17. Backonja M, Glanzman RL. Gabapentin dosing for neuropathic pain: Evidence from randomized placebo controlled clinical trials. Clin Ther 2003;25:81-104.
18. Kunz N, Goli V, Entsuah A, Rudolph R. Diabetic neuropathic pain management with venlafaxine extended release. Eur Neuropsychopharmacol 2000;10(3):S389.
19. Wong DT, Bymaster FP. Dual serotonin and noradrenaline uptake inhibitor class of antidepressants - Potential for greater efficacy or just hype? Prog Drug Res 2002;58:169-222.
20. Basbaum AI, Fields HL. Endogenous pain control systems: Brainstem spinal pathways and endorphin circuitry. Annu Rev Neurosci 1984;7:309-38.
21. Clark FM, Proudfit HK. The projections of noradrenergic neurons in the A5 catecholamine cell group to the spinal cord in the rat: Anatomical evidence that A5 neurons modulate nociception. Brain Res 1993;616:200-10.
22. Coderre TJ, Katz J. Peripheral and central hyperexcitability: Differential signs and symptoms in persistent pain. Behav Brain Sci 1997;20:404-19.
23. Iyengar S, Webster AA, Hemrick-Luecke SK, Xu JY, Simmons RMA. Efficacy of duloxetine, a potent and balanced serotonin-norepinephrine reuptake inhibitor in persistent pain models in rats. J Pharmacol Exp Ther 2004;311:576-84.
24. Goldstein DJ, Lu Y, Detke MJ, Lee TC, Iyengar S. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain 2005;116:109-18.
25. Wernicke JF, Pritchett YL, D'Sonza DN, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology 2006;67:1411-20.
26. 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;6:346-56.
27. Raskin J, Wang F, Pritchett YL, Goldstein DJ. Duloxetine for patients with diabetic peripheral neuropathic pain: A 6-month open-label safety study. Pain Med 2006;7:373-85.
28. Detke MJ, Lu Y, Goldstein DJ, Hayes JR, Demitrack MA. Duloxetine, 60 mg once daily, for major depressive disorder: A randomized double-blind placebo-controlled trial. J Clin Psychiatry 2002;63:308-15.
29. Detke MJ, Lu Y, Goldstein DJ, McNamara RK, Demitrack MA. Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression. J Psychiatr Res 2002;36:383-90.
30. Goldstein DJ, Mallinckrodt C, Lu Y, Demitrack MA. Duloxetine in the treatment of major depressive disorder: A double-blind clinical trial. J Clin Psychiatry 2002;63:225-31.
31. Goldstein DJ, Lu Y, Detke MJ, et al. Duloxetine in the treatment of depression: A double-blind placebo-controlled comparison with paroxetine. J Clin Psychopharmacol 2004;24:389-99.
32. Raskin J, Goldstein DJ, Mallinckrodt CH, Ferguson MB. Duloxetine in the long-term treatment of major depressive disorder. J Clin Psychiatry 2003;64:1237-44.
33. Hudson JI, Wohlreich MM, Kajdasz DK, et al. Safety and tolerability of duloxetine in the treatment of major depressive disorder: Analysis of pooled data from eight placebo-controlled clinical trials. Hum Psychopharmacol Clin Exp 2005;20:327-41.
34. Goldstein DJ, Lu Y, Detke MJ, et al. Effects of duloxetine on painful physical symptoms associated with depression. Psychosomatics 2004;45:17-28.
35. Wernicke JF, Roskin J, Rosen A, et al. Duloxetine in the long-term management of diabetic peripheral neuropathic pain: An open-label, 52-week extension of a randomized controlled clinical trial. Curr Ther Res 2006;67:283-304.
36. Raskin J, Smith TR, Wong K, et al. Duloxetine versus routine care in the long-term management of diabetic peripheral neuropathic pain. J Palliat Med 2006;9:29-40.
37. Feldman EL, Stevens MJ, Thomas PK, et al. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care 1994;17:1281-9.
38. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey Manual and Interpretation Guide. Boston, MA: The Health Institute, New England Medical Center; 1993.
39. Kind P. The EuroQoL instrument: An index of health-related quality of life. In: Spilker B, ed. Quality of Life and Pharmacoeconomics in Clinical Trials, 2nd edition. Philadelphia, PA: Lippincott-Raven Publishers; 1996:191-201.
40. National Diabetes Information Clearinghouse (NDIC). National Diabetes Statistics: Deaths among People with Diabetes, United States, 2000. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/ index.htm#7 (accessed August 14, 2005).
41. National Diabetes Information Clearinghouse (NDIC). National Diabetes Statistics: Complications of Diabetes in the United States. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/#13 (accessed August 14, 2005).