Duloxetine for the management of diabetic peripheral neuropathic pain: Evaluation of functional outcomes

Pain Medicine

Volumn 8, Issue 5, 2007, Pages 410-418

  Armstrong, David G ^a   Chappell, Amy S ^b   Le, Trong K ^b   Kajdasz, Daniel K ^b   Backonja, Miroslav ^c   D'Souza, Deborah N ^b   Russell, James M ^b  

^a ROSALIND FRANKLIN UNIVERSITY OF MEDICINE AND SCIENCE   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

Antidepressants; Diabetic neuropathy

Indexed keywords

ACETYLSALICYLIC ACID; DULOXETINE; PARACETAMOL; PLACEBO;

ADULT; AGED; ARTICLE; BRIEF PAIN INVENTORY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC NEUROPATHY; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; FUNCTIONAL ASSESSMENT; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROPATHIC PAIN; OUTCOME ASSESSMENT; PERIPHERAL NEUROPATHY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SELF REPORT; SHORT FORM 36; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT;

AGED; DIABETIC NEUROPATHIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PAIN MEASUREMENT; PATIENT SATISFACTION; PERIPHERAL NERVES; PLACEBOS; QUESTIONNAIRES; SEROTONIN UPTAKE INHIBITORS; THIOPHENES; TREATMENT OUTCOME;

EID: 34547432986     PISSN: 15262375     EISSN: 15264637     Source Type: Journal    
DOI: 10.1111/j.1526-4637.2007.00276.x     Document Type: Article

References (51)

1. National Diabetes Information Clearinghouse (NDIC). National Diabetes Statistics: Total prevalence of diabetes in the United States, all ages, 2005. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/ index.htm#7 (accessed January 9, 2007).
2. Amos AF, McCarty DJ, Zimmet P. The rising global burden of diabetes and its complications: Estimates and projections to the year 2010. Diabet Med 1997; 14 (suppl 5): S1-85.
3. Boulton AJ, Vinik AI, Arezzo JC, et al. Diabetic neuropathies: A statement by the American Diabetes Association. Diabetes Care 2005; 28: 956-62.
4. Calcutt NA. Potential mechanisms of neuropathic pain in diabetes. Int Rev Neurobiol 2002; 50: 205-28.
5. Nash TP. Treatment options in painful diabetic neuropathy. Acta Neurol Scand Suppl 1999; 173: 36-42.
6. Schmader K. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain 2002; 18: 350-4.
7. National Diabetes Information Clearinghouse. Diabetic Neuropathies: The Nerve Damage of Diabetes. NIH Publication No. 02-3185 2002. Available at: http://diabetes.niddk.nih.gov/dm/pubs/neuropathies (accessed January 8, 2007).
8. Galer BS, Gianas A, Jensen MP. Painful diabetic polyneuropathy: Epidemiology, pain description, and quality of life. Diabetes Res Clin Pract 2000; 47: 123-8.
9. Quattrini C, Tesfaye S. Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev 2003; 19 (suppl 1): S2-8.
10. Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM. Preventive foot care in people with diabetes. Diabetes Care 2003; 26 (suppl 1): S78-9.
11. Vileikyte L, Rubin RR, Leventhal H. Psychological aspects of diabetic neuropathic foot complications: An overview. Diabetes Metab Res Rev 2004; 20 (suppl 1): S13-8.
12. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005; 293: 217-28.
13. Peters EJ, Lavery LA, Armstrong DG. Diabetic lower extremity infection: Influence of physical, psychological, and social factors. J Diabetes Complications 2005; 19: 107-12.
14. Gore M, Brandenburg N, Dukes E, et al. Pain severity in diabetic peripheral neuropathy (DPN) impacts patient functioning, symptom levels of anxiety and depression, and sleep. 23rd APS Annual Scientific Meeting, Vancouver, BC, Canada, May 6-9, 2004.
15. Sullivan SD, Lew DP, Devine EB, et al. Health state preference assessment in DPN. Pharmacoeconomics 2002; 20: 1079-89.
16. Wunderlich RP, Peters EJ, Bosma J, Armstrong DG. Pathophysiology and treatment of painful diabetic neuropathy of the lower extremity. South Med J 1998; 91: 894-8.
17. Wong DT, Bymaster FP. Dual serotonin and noradrenaline uptake inhibitor class of anti-depressants-Potential for greater efficacy or just hype? Prog Drug Res 2002; 58: 169-222.
18. Wernicke JF, Pritchett YL, D'Souza DN, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology 2006; 67: 1411-20.
19. 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 (6): 346-56.
20. Goldstein DJ, Lu Y, Detke MJ, Lee TC, Iyengar S. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain 2005; 116: 109-18.
21. Detke MJ, Lu Y, Goldstein DJ, Hayes JR, Demitrack MA. Duloxetine, 60mg once daily, for major depressive disorder: A randomized double-blind placebo-controlled trial. J Clin Psychiatry 2002; 63: 308-15.
22. 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.
23. 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.
24. 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.
25. Nemeroff CB, Schatzberg AF, Goldstein DJ, et al. Duloxetine for the treatment of major depressive disorder. Psychopharmacol Bull 2002; 36: 106-32.
26. Mallinckrodt CH, Goldstein DJ, Detke MJ, et al. Duloxetine: A new treatment for the emotional and physical symptoms of depression. J Clin Psychiatry 2003; 5: 19-28.
27. 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 2005; 20: 327-41.
28. Goldstein DJ, Lu Y, Detke MJ, et al. Effects of duloxetine on painful physical symptoms associated with depression. Psychosomatics 2004; 45: 17-28.
29. American Psychiatric Association (APA). Diagnostic and Statistical Manual of Mental Disorders, 4th edition. Washington, DC: American Psychiatric Association; 1994.
30. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The mini-international neuropsychiatric interview (MINI): The development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998; 59 (suppl 20): 22-33.
31. 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.
32. 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.
33. Ware JE. SF-36 Health Survey Update. Spine 2000; 25: 3130-9.
34. Ware JE, Kosinski M, Keller SD. SF-36 ® Physical and Mental Health Summary Scales: A User's Manual. Boston, MA: The Health Institute; 1994.
35. Cleeland CS, Ryan KM. Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994; 23: 129-38.
36. Gilron I, Booher SL, Rowan JS, Smoller B, Max MB. A randomized controlled trial of high dose dextromethorphan in facial neuralgias. Neurology 2000; 55: 964-71.
37. Semenchuk M, Sherman S, Davis B. Doubleblind, randomized trial of bupropion SR for the treatment of neuropathic pain. NEUROLOGY 2001; 57: 1583-8.
38. Gimbel JS, Richards P, Portenoy RK. Controlled- release oxycodone for pain in diabetic neuropathy: A randomize controlled trial. Neurology 2003; 60: 927-34.
39. Dworkin RH, Backonja M, Rowbotham MC, et al. Advances in neuropathic pain: Diagnosis, mechanisms, and treatment recommendations. Arch Neurol 2003; 60: 1524-34.
40. 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.
41. EuroQoL Group. EuroQoL-A new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208.
42. Ware JE, Snow KK, Kosinski M. SF-36 Health Survey. Manual and Interpretation Guide. Lincoln, RI: QualityMetric Incorporated; 1993, 2000.
43. Stewart AL, Greenfield S, Hays RD, et al. Functional status and well-being of patients with chronic conditions: Results from the medical outcomes study. JAMA 1989; 262: 907-13.
44. Peyrot M, Rubin RR. Levels and risks of depression and anxiety symptomatology among diabetic adults. Diabetes Care 1997; 20: 585-90.
45. Glasgow RE, Ruggiero L, Eakin EG, Dryfoos J, Chobanian L. Quality of life and associated characteristics in a large national sample of adults with diabetes. Diabetes Care 1997; 20: 562-7.
46. Klein BEK, Klein R, Moss SE. Self-rated health and diabetes of long duration: The Wisconsin epidemiologic study of diabetic retinopathy. Diabetes Care 1998; 21: 236-40.
47. Reiber GE, Boyko EJ, Smith DG. Lower extremity foot ulcers and amputations in individuals with diabetes. In: Harris MI, Cowie CC, Stern MP, Boyko EJ, Reiber GE, Bennett PH, eds. Diabetes in America, 2nd edition. National Institutes of Health Publication No. 95-1468. Bethesda, MD: National Institutes of Health; 1995: 409-28.
48. Vileikyte L. Psychological aspects of diabetic peripheral neuropathy. Diabetes Rev 1999; 7: 387-94.
49. Vileikyte L. Psychological and behavioral issues in diabetic neuropathic foot ulceration. In: Boulton AJ, Connor H, Cavanagh PR, eds. The Foot in Diabetes, 3rd edition. Chichester, UK: John Wiley & Sons; 2000: 123-32.
50. Vileikyte L. Diabetic foot ulcers: A quality of life issue. Diabetes Metab Res Rev 2001; 17: 246-9.
51. Vileikyte L, Peyrot M, Bundy C, et al. The development and validation of a neuropathy- and foot ulcer-specific quality of life instrument. Diabetes Care 2003; 26: 2549-55.