Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus. A randomized controlled trial

Journal of the American Medical Association

Volumn 280, Issue 21, 1998, Pages 1831-1836

  Backonja, Miroslav ^a   Beydoun, Ahmad ^b   Edwards, Keith R ^d   Schwartz, Sherwyn L ^e   Fonseca, Vivian ^f   Hes, Marykay ^c,g   LaMoreaux, Linda ^c   Garofalo, Elizabeth ^c  

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

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c PFIZER INC   (United States)

^d PC   (United States)

^e Diabetes and Glandular Disease Clinic   (United States)

^f UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^g NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GABAPENTIN; PLACEBO;

ABDOMINAL PAIN; ADULT; ARTICLE; CLINICAL TRIAL; CONFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DIABETIC NEUROPATHY; DIARRHEA; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MOOD; MULTICENTER STUDY; NAUSEA; NEURALGIA; OUTCOMES RESEARCH; PAIN ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SLEEP; SOMNOLENCE; VERTIGO;

EID: 0032477294     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.280.21.1831     Document Type: Article

References (42)

1. Johnson PC, Doll SC, Cromey DW. Pathogenesis of diabetic neuropathy. Ann Neurol. 1986;19:450-457.
2. Pirart J. Diabetes mellitus and its degenerative complications: a prospective study of 4400 patients observed between 1947 and 1973. Diabetes Care. 1978;1:168-188, 252-263.
3. Diabetes Control and Complications Trial (DCCT) Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;14:977-986.
4. Diabetes Control and Complications Trial (DCCT) Research Group. Effect of intensive diabetes treatment on nerve conduction in the Diabetes Control and Complications Trial. Ann Neurol. 1995; 38:869-880.
5. Dyck PJ, Melton LJ, O'Brien PC, Service FJ. Approaches to improve epidemiological studies of diabetic neuropathy: insights from the Rochester Diabetic Neuropathy Study. Diabetes. 1997;46(suppl 2): S5-S8.
6. 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.
7. Dyck PJ, Litchy WJ, Lehman KA, Hokanson JL, Low PA, O'Brien PC. Variables influencing neuropathic endpoints: the Rochester Diabetic Neuropathy Study of healthy subjects. Neurology. 1995;45: 1115-1121.
8. Dyck PJ, Karnes JL, O'Brien PC, Litchy WJ, Low PA, Melton LJ. The Rochester Diabetic Neuropathy Study: reassessment of tests and criteria for diagnosis and staged severity. Neurology. 1992;42: 1164-1170.
9. Dyck PJ, Kratz KM, Lehman KA, et al. The Rochester Diabetic Neuropathy Study: design, criteria for types of neuropathy, selection bias, and reproducibility of neuropathic tests. Neurology. 1991;41: 799-807.
10. Proceedings of a consensus development conference on standardized measures in diabetic neuropathy. Neurology. 1992;42:1823-1839.
11. Albers JW, Brown MB, Sima AAF, Greene DA, for the Tolrestat Study Group for the Early Diabetes Intervention Trial. Nerve conduction measures in mild diabetic neuropathy in the Early Diabetes Intervention Trial: the effects of age, sex, type of diabetes, disease duration, and anthropometric factors. Neurology. 1996;46:85-91.
12. Report and recommendations of the San Antonio Conference on Diabetic Neuropathy. Diabetes. 1988;37:1000-1004.
13. Peripheral Nerve Society. Diabetic polyneuropathy in controlled clinical trials: consensus report of the Peripheral Nerve Society. Ann Neurol. 1995;38:478-482.
14. Fields HL. Painful dysfunction of the nervous system. In: Fields HL, ed. Pain. New York, NY: McGraw-Hill Information Services Co; 1987:133-169.
15. Dejgaard A. Pathophysiology and treatment of diabetic neuropathy. Diabet Med. 1998;15:97-112.
16. Pfeifer MA, Schumer MP, Gelber DA. Aldose reductase inhibitors: the end of an era or the need for different trial designs? Diabetes. 1997;46(suppl 2): S82-S89.
17. Calissi PT, Jaber LA. Peripheral diabetic neuropathy: current concepts in treatment. Ann Pharmacother. 1995;29:769-777.
18. Fedele D, Guigliano D. Peripheral diabetic neuropathy, current recommendations and future prospects for its prevention and management. Drugs. 1997;54:414-421.
19. Max MB. Thirteen consecutive well-designed randomized trials show that antidepressants reduce pain in diabetic neuropathy and postherpetic neuralgia. Pain Forum. 1995;4:248-253.
20. Kingery WS. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes. Pain. 1997;73:123-139.
21. Feldman EL, Stevens MJ, Greene DA. Treatment of diabetic neuropathy. In: Mazzaferri EL, Bar RS, Kreisberg RA, eds. Advances in Endocrinology and Metabolism. St Louis, Mo: Mosby-Year Book Inc; 1994:393-428.
22. Rosner H, Rubin L, Kestenbaum A. Gabapentin adjunctive therapy in neuropathic pain states. Clin J Pain. 1996;12:56-58.
23. Stacey BR, Tipton KD, Owen GT, Sinclair JD, Click RM. Gabapentin and neuropathic pain states: a case series report. Reg Anesth. 1996;2(suppl):65.
24. Neurontin prescribing information. In: Physicians' Desk Reference. Montvale, NJ: Medical Economics Co Inc; 1995:1856-1858.
25. Vollmer KO, Von Hodenberg A, Kolle EU. Pharmacokinetics and metabolism of gabapentin in rat, dog, and man. Arzneimittelforschung. 1986;36: 830-839.
26. Ojemann LM, Friel PN, Ojemann GA. Gabapentin concentrations in human brain [abstract]. Epilepsia. 1988;29:694.
27. Taylor CP, Gee NS, Su TZ, et al. A summary of mechanistic hypotheses of gabapentin pharmacology. Epilepsy Res. 1998;29:233-249.
28. Bennett GJ, Xie YK. A peripheral mononeuropathy in rat that produces disorders of pain sensation like those seen in man. Pain. 1988;33:87-107.
29. Xiao WH, Bennett GJ. Gabapentin relieves abnormal pain in a rat model of painful peripheral neuropathy. Soc Neurosci Abstracts. 1995;21:897.
30. Shimoyama N, Shimoyama M, Davis AM, Inturrisis CE, Elliott KJ. Spinal gabapentin in antinociceptive in the rat formalin test. Neurosci Lett. 1997;222:65-67.
31. Melzack R. The Short-Form McGill Pain Questionnaire. Pain. 1987;30:191-197.
32. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
33. Ware JE Jr, Snow KK, Konsinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston, Mass: The Health Institute, New England Medical Center; 1993.
34. McNair DM, Lorr M, Droppleman LF. Profile of Mood States: Manual. San Diego, Calif: Educational and Industrial Testing Service; 1981.
35. McQuay H, Carroll D, Jadad AR, Wiffen P, Moore A. Anticonvulsant drugs for management of pain: a systematic review. BMJ. 1995;311:1047-1052.
36. 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.
37. Max MB, Lynch SA, Muire J, Shoaf SE, Smoller B, Dubner R. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med. 1992;326:1250-1256.
38. Max MB, Culnane M, Schager SC, et al. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology. 1987;37:589-596.
39. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika. 1988; 75:800-802.
40. Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care. 1994;17:1281-1289.
41. Stracke H, Meyer UE, Schumacher HE, Federlin K. Mexiletine in the treatment of diabetic neuropathy. Diabetes Care. 1992;15:1550-1555.
42. Oskarsson P, Ljunggren JG, Lins PE. Efficacy and safety of mexiletine in the treatment of painful diabetic neuropathy. Diabetes Care. 1997;20:1594-1597.