Pregabalin for the treatment of painful diabetic peripheral neuropathy: A double-blind, placebo-controlled trial

Pain

Volumn 110, Issue 3, 2004, Pages 628-638

  Rosenstock, Julio ^a   Tuchman, Michael ^b   Lamoreaux, Linda ^c   Sharma, Uma ^c  

^a Dallas Diabetes and Endocrine Center   (United States)

^b Palm Beach Neurological Center   (United States)

^c PFIZER INC   (United States)

Author keywords

Anticonvulsants; Painful diabetic neuropathy; Pregabalin

Indexed keywords

PLACEBO; PREGABALIN;

ADULT; AMBLYOPIA; ANALGESIA; ANALYTIC METHOD; ANAMNESIS; ANXIETY; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC NEUROPATHY; DIARRHEA; DISEASE ASSOCIATION; DISEASE DURATION; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DRUG WITHDRAWAL; EUPHORIA; FEMALE; FLATULENCE; FLU LIKE SYNDROME; HEADACHE; HEALTH SURVEY; HUMAN; HYPERGLYCEMIA; INCIDENCE; INFECTION; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; METHODOLOGY; MOOD; MULTICENTER STUDY; NAUSEA; NEUROLOGIC EXAMINATION; NEUROPATHIC PAIN; PAIN ASSESSMENT; PATIENT; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PHYSICAL EXAMINATION; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SAFETY; SCORING SYSTEM; SLEEP; SLEEP DISORDER; SOMNOLENCE; VISUAL ANALOG SCALE; VOMITING;

ADOLESCENT; ADULT; AGED; CONFIDENCE INTERVALS; DIABETIC NEUROPATHIES; DOUBLE-BLIND METHOD; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; LEAST-SQUARES ANALYSIS; MALE; MIDDLE AGED; PAIN MEASUREMENT;

EID: 3843088696     PISSN: 03043959     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.pain.2004.05.001     Document Type: Article

References (45)

1. American Diabetes Association. All about diabetes. Available at: http://www.diabetes.org/diabetes-research/research-home.jsp; Accessed April 5, 2004.
2. Archer A.G., Watkins P.J., Sharma A.K., Payan J. The natural history of acute painful neuropathy in diabetes mellitus. J Neurol Neurosurg Psychiat. 46:1983;491-499
3. Atkinson J.H., Ancoli-Israel S., Slater M.A., Garfin S.R., Gillin J.C. Subjective sleep disturbance in chronic back pain. Clin J Pain. 4:1988;225-232
4. 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. J Am Med Assoc. 280:1998;1831-1836
5. Benbow S.J., Chan A.W., Bowsher D., MacFarlane I.A., Williams C. A prospective study of painful symptoms, small-fibre function and peripheral vascular disease in chronic painful diabetic neuropathy. Diabetic Med. 11:1994;17-21
6. Berry D. Statistical methodology in the pharmaceutical sciences. 1990;403-408 Marcel Dekker, New York
7. Bialer M., Johannessen S.I., Kupferberg H.J., Levy R.H., Loiseau P., Perucca E. Progress report on new antiepileptic drugs: a summary of the fourth Eilat converence (EILAT-IV. Epilsepsy Res. 1999;34.1-3441
8. Collins S.L., Moore R.A., McQuay H.J., Wiffen P. Antidepressants and anticonvulsants for diabetic neuropathy and postherpetic neuralgia: a quantitative systematic review. J Pain Symptom Manage. 20:(6):2000;449-458
9. +-evoked glutamate release from rat neocortical and hippocampal slices by gabapentin. Neurosci Lett. 280:2000;107-110
10. 3H]norepinephrine release from rat neocortical slices by gabapentin and pregabalin. J Pharmacol Exp Ther. 295:2000;1086-1093
11. Dworkin R.H., Corbin A.E., Young J.P. Jr, et al. Pregabalin for the treatment of postherpetic neuralgia. Neurology. 60:2003;1274-1283
12. Farrar J.T., Young J.P., LaMoreaux L., Werth J.L., Poole M. Clinical importance of changes in chronic pain intensity on an 11-point numerical pain rating scale. Pain. 94:2001;149-158
13. Field M.J., Holloman E.F., McCleary S., Hughes J., Singh L. Evaluation of gabapentin and S-(+)-3-isobutylgaba in a rat model of postoperative pain. J Pharmacol Exp Ther. 282:1997;1242-1246
14. Field M.J., Oles R.J., Lewis A.S., McCleary S., Hughes J., Singh L. Gabapentin (Neurontin) and S-(+)-3-isobutyl GABA represent a novel class of selective antihyperalgesic agents. Br J Pharmacol. 121:1997;1513-1522
15. Field M.J., McCleary S., Hughes J., Singh L. Gabapentin and pregabalin, but not morphine and amitriptyline, block both static and dynamic components of mechanical allodynia induced by streptozocin in the rat. Pain. 80:1999;391-398
16. 2+ influx by gabapentin and pregabalin in the human neocortex. Neuropharmacology. 42:2002;229-236
17. 2δ subunit of a calcium channel. J Biol Chem. 271:1996;5768-5776
18. Haythornthwaite J.A., Hegel M.T., Kerns R.D. Development of a sleep diary for chronic pain patients. J Pain Symptom Manage. 65:1991;65-71
19. Kubota T., Fang J., Mesltzer L.T., Krueger J.M. Pregabalin enhances nonrapid eye movement sleep. J Pharmacol Exp Ther. 299:2001;1095-1105
20. 3H]glutamate from rat caudal trigeminal nucleus slices. Pain. 93:2001;191-196
21. McKinlay J., Marceau L. US public health and the 21st century: diabetes mellitus. Lancet. 356:2000;757-761
22. McNair D.M., Lorr M., Droppleman L.F. Profile of mood states: manual. 1981;Educational and Industrial Testing Service, San Diego
23. McQuay H., Carroll D., Jadad A.R., Wiffen P., Moore A. Anticonvulsant drugs for management of pain: a systematic review. Br Med J. 311:1995;1047-1052
24. McQuay H.J., Tramer M., Nye B.A., Carroll D., Wiffen P.J., Moore R.A. A systematic review of antidepressants in neuropathic pain. Pain. 68:1996;217-227
25. Melzak R. The short-form McGill pain questionnaire. Pain. 30:1987;191-197
26. Morin C.M., Gibson D., Wade J. Self-reported sleep and mood disturbance in chronic pain patients. Clin J Pain. 14:1998;311-314
27. Morley G.K., Mooradian A.D., Levine A.S., Morley J.E. Mechanism of pain in diabetic peripheral neuropathy. Am J Med. 77:1984;79-82
28. Pilowsky I., Crettenden I., Townley M. Sleep disturbance in pain clinic patients. Pain. 23:1985;27-33
29. Pirart J. Diabetes mellitus and its degenerative complications: a prospective study of 4400 patients observed between and 1947 and 1973. Diabetes Metab. 3:1977;97-107
30. Ross E.L. The evolving role of antiepileptic drugs in treating neuropathic pain. Neurology. 55:(suppl 1):2000;S41-S46
31. Rowbotham M., Harden N., Stacey B., Bernstein P., Magnus-Miller L. Gabapentin for the treatment of postherpetic neuralgia. A randomized controlled trial. J Am Med Assoc. 280:1998;1837-1842
32. ® User's guide, Version 6). vols 1 and 2:1989;SAS Institute, Inc., Cary, NC
33. Sharma U., Iacobellis D., Glessner C., Moore J., Young J.P., LaMoreaux L., Poole R.M., the Pregabalin 1008-14/29 Study Groups. Pregabalin effectively relieves pain in two studies of patients with painful diabetic peripheral neuropathy (Studies 1008-14/-29). Presented at the Meeting of the American Pain Society; November 2-5, 2000; Atlanta, GA. 2000
34. Sindrup S.H., Jensen T.S. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 83:(3):1999;389-400
35. Sindrup S.H., Andersen G., Madsen C., Smith T., Brosen K., Jensen T.S. Tramadol relieves pain and allodynia in polyneuropathy: a randomised, double-blind, controlled trial. Pain. 83:(1):1999;85-90
36. Smith M.T., Perlis M.L., Smith M.S., Giles D.E., Carmody T.P. Sleep quality and presleep arousal in chronic pain. J Behav Med. 23:2000;1-13
37. Smith R.G. The epidemiology and treatment of depression when it coexists with somatoform disorders, somatization or depression. Gen Hosp Psychiatry. 14:1992;265-272
38. Steel R., Torrie J. Principles and procedures of statistics. 1960;McGraw-Hill, New York, NY. P. 308-10
39. Ware J.E. Jr, Snow K.K., Kosinski M., Gandek B. SF-36-item short form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 30:1992;473-483
40. Watkins P.J. Natural history of the diabetic neuropathies. Q J Med. 77:1990;1209-1218
41. Watson C.P., Moulin D., Watt-Watson J., Gordon A., Eisenhoffer J. Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy. Pain. 105:(1-2):2003;71-78
42. Welty D., Wang Y., Busch J.A., Taylor C.P., Vartanian M.G., Radulovic L.L., pharmacodynamics P.D. Pharmacokinetics (PK) and pharmacokinetics (PD) of CI-1008 (pregabalin) and gabapentin in rats with maximal electroshock [abstract]. Epilepsia. 38:(suppl 8):1997;35. Abstract 1.110
43. Young R.J., Ewing D.J., Clarke B.F. Chronic and remitting painful diabetic neuropathy. Diabetes Care. 11:1988;34-40
44. Zhang W.Y., Po A.L.W. The effectiveness of topically applied capsaicin: a meta-analysis. Eur J Clin Pharmacol. 46:1994;517-522
45. Ziegler D., Gries F.A., Spuler M., Lessmann F. The epidemiology of diabetic neuropathy. J Diab Comp. 6:1992;49-57