Duloxetine in the long-term management of diabetic peripheral neuropathic pain: An open-label, 52-week extension of a randomized controlled clinical trial

Current Therapeutic Research - Clinical and Experimental

Volumn 67, Issue 5, 2006, Pages 283-304

  Wernicke, Joachim F ^a   Raskin, Joel ^a   Rosen, Amy ^a   Pritchett, Yili L ^a   D'Souza, Deborah N ^a   Iyengar, Smriti ^a   Knopp, Kelly ^a   Le, Trong K ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

antidepressant; diabetic peripheral neuropathic pain; duloxetine; norepinephrine; pain; serotonin

Indexed keywords

AMITRIPTYLINE; ANALGESIC AGENT; ANTIBIOTIC AGENT; ANTICOAGULANT AGENT; ANTIDIABETIC AGENT; ANTIDIARRHEAL AGENT; ANTIHYPERTENSIVE AGENT; ANTITHROMBOCYTIC AGENT; BRONCHODILATING AGENT; DECONGESTIVE AGENT; DIURETIC AGENT; DULOXETINE; ELECTROLYTE; EXPECTORANT AGENT; GABAPENTIN; GLYCOSYLATED HEMOGLOBIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; LIPID; MUSCLE RELAXANT AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; PARACETAMOL; PLACEBO; SEROTONIN UPTAKE INHIBITOR; STEROID; THIOCTIC ACID; TRICYCLIC ANTIDEPRESSANT AGENT; VENLAFAXINE;

ADULT; ARTHRALGIA; ARTICLE; BACKACHE; BIOCHEMISTRY; BLOOD PRESSURE MONITORING; BODY WEIGHT; CATARACT EXTRACTION; CELLULITIS; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC NEUROPATHY; DIABETIC RETINOPATHY; DIARRHEA; DISEASE CLASSIFICATION; DISEASE COURSE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EXPOSURE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; ERECTILE DYSFUNCTION; FALLING; FATIGUE; FEMALE; FOLLOW UP; FOOT PAIN; HEART INFARCTION; HEART RATE; HEMATOLOGY; HUMAN; HYPERGLYCEMIA; HYPERHIDROSIS; HYPERTENSION; HYPOGLYCEMIA; INFLUENZA; LABORATORY TEST; LIMB PAIN; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; MULTICENTER STUDY; NAIL INFECTION; NAUSEA; NEUROPATHIC PAIN; OPEN STUDY; OUTCOME ASSESSMENT; OUTPATIENT; PARALLEL DESIGN; PERIPHERAL EDEMA; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; SIDE EFFECT; SINUS CONGESTION; SOMNOLENCE; STATISTICAL ANALYSIS; SWEATING; TELEPHONE; TREATMENT DURATION; TREATMENT WITHDRAWAL; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINALYSIS; VITAL SIGN; VOMITING; XEROSTOMIA;

EID: 33947122606     PISSN: 0011393X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.curtheres.2006.10.001     Document Type: Article

References (32)

1. Available at:. National Diabetes Information Clearinghouse. National Diabetes Statistics: Total prevalence of diabetes in the United States, all ages. Accessed March 28, 2005 (2005). http://diabetes.niddk.nih.gov/dm/pubs/statistics/index.htm#7
2. [published correction appears in Neurology. 1993;43:2345]. Dyck P.J., Kratz K.M., Karnes J.L., 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 43 (1993) 817-824
3. Ziegler D., Gries F.A., Spuler M., Lessmann F., and Diabetic Cardiovascular Autonomic Neuropathy Multicenter Study Group. The epidemiology of diabetic neuropathy. J Diabetes Complications 6 (1992) 49-57
4. Pfeifer M.A., Ross D.R., Schrage J.P., et al. A highly successful and novel model for treatment of chronic painful diabetic peripheral neuropathy. Diabetes Care 16 (1993) 1103-1115
5. Duby J.J., Campbell R.K., Setter S.M., et al. Diabetic neuropathy: An intensive review. Am J Health Syst Pharm 61 (2004) 160-176
6. Sumner C.J., Sheth S., Griffin J.W., et al. The spectrum of neuropathy in diabetes and impaired glucose tolerance. Neurology 60 (2003) 108-111
7. Max M.B., Culnane M., Schafer S.C., et al. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology 37 (1987) 589-596
8. Sindrup S.H., Ejlertsen B., Froland A., et al. Imipramine treatment in diabetic neuropathy: Relief of subjective symptoms without changes in peripheral and autonomic nerve function. Eur J Clin Pharmacol 37 (1989) 151-153
9. discussion 1-2. Max M.B., Kishore-Kumar R., Schafer S.C., et al. Efficacy of desipramine in painful diabetic neuropathy: A placebo-controlled trial. Pain 45 (1991) 3-9
10. Backonja M., Beydoun A., Edwards K.R., et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: A randomized controlled trial. JAMA 280 (1998) 1831-1836
11. 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 14 (2000) 65-70
12. Gimbel J.S., Richards P., and Portenoy R.K. Controlled-release oxycodone for pain in diabetic neuropathy: A randomized controlled trial. Neurology 60 (2003) 927-934
13. [published correction appears in Pain. 2005;113:248]. Rowbotham M.C., Goli V., Kunz N.R., and Lei D. Venlafaxine extended release in the treatment of painful diabetic neuropathy: A double-blind, placebo-controlled study. Pain 110 (2004) 697-706
14. Rosenstock J., Tuchman M., LaMoreaux L., and Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: A double-blind, placebo-controlled trial. Pain 110 (2004) 628-638
15. Goldstein D.J., Lu Y., Detke M.J., et al. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain 116 (2005) 109-118
16. Bolay H., and Moskowitz M.A. Mechanisms of pain modulation in chronic syndromes. Neurology 59 (2002) S2-S7
17. Basbaum A.I., and Fields H.L. Endogenous pain control systems: Brainstem spinal pathways and endorphin circuitry. Annu Rev Neurosci 7 (1984) 309-338
18. Clark F.M., and Proudfit H.K. 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 616 (1993) 200-210
19. Fields H.L., Heinricher M.M., and Mason P. Neurotransmitters in nociceptive modulatory circuits. Annu Rev Neurosci 14 (1991) 219-245
20. Fields H.L., and Basbaum A.I. Central nervous system mechanisms of pain modulation. In: Wall P.D., and Melzack R. (Eds). Textbook of Pain (1999), Churchill Livingstone, New York, NY 309-329
21. FDA approves drug for neuropathic pain associated with diabetes (2006). http://www.fda.gov/bbs/topics/news/2004/NEW01113.html
22. Bymaster F.P., Dreshfield-Ahmad L.J., Threlkeld P.G., et al. Comparative affinity of duloxetine and venlafaxine for serotonin and norepinephrine transporters in vitro and in vivo, human serotonin receptor subtypes, and other neuronal receptors. Neuropsychopharmacol 25 (2001) 871-880
23. Feldman E.L., Stevens M.J., Thomas P.K., et al. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care 17 (1994) 1281-1289
24. Farrar J.T., Young Jr. J.P., LaMoreaux L., et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 94 (2001) 149-158
25. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition (1994), American Psychiatric Association, Washington, DC
26. Available at:. World Medical Association Declaration of Helsinki. Recommendations guiding medical doctors in biomedical research involving human subjects (WMA). Accessed September 28, 2006 (1989), WMA, Ferney-Voltaire, France. http://wwwwma.net
27. Ware J.E., Snow K.K., Kosinski M., and Gandek B. SF-36® Health Survey Manual and Interpretation Guide (1993), The Health Institute, New England Medical Center, Boston, Mass
28. 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 (1996), Lippincott-Raven Publishers, Philadelphia, Pa 191-201
29. Ware Jr. J.E. SF-36 health survey update. Spine 25 (2000) 3130-3139
30. Ware J.E., Kosinski M., and Keller S.K. SF-36® Physical and Mental Health Summary Scales: A User's Manual (1994), The Health Institute, Boston, Mass
31. Mantel N., and Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 22 (1959) 719-748
32. Milliken G.A., and Johnson D.E. Analysis of Messy Data, Volume I: Designed Experiments (1993), Chapman and Hall, Boca Raton, Fla