Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens

Pain

Volumn 115, Issue 3, 2005, Pages 254-263

  Freynhagen, Rainer ^a   Strojek, Krzysztof ^b   Griesing, Teresa ^c   Whalen, Ed ^c   Balkenohl, Michael ^c  

^a UNIVERSITY HOSPITAL DÜSSELDORF   (Germany)

^b Department of Internal Diseases Diabetology and Nephrology ^*  (Poland)

^c PFIZER INC   (United States)

Author keywords

Diabetic neuropathy; Dosing; Neuropathic pain; Postherpetic neuralgia; Pregabalin; Sleep

Indexed keywords

PLACEBO; PREGABALIN;

ADULT; ARTICLE; BODY WEIGHT DISORDER; CHRONIC PAIN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC NEUROPATHY; DIZZINESS; DOSE CALCULATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEART ARREST; HUMAN; LEG EDEMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUROPATHIC PAIN; PAIN ASSESSMENT; PAIN THRESHOLD; POSTHERPETIC NEURALGIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SLEEP PATTERN; SOMNOLENCE; VERTIGO; WEIGHT GAIN;

ADULT; AGED; AGED, 80 AND OVER; ANTICONVULSANTS; DIABETIC NEUROPATHIES; DOUBLE-BLIND METHOD; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; MALE; MIDDLE AGED; NEURALGIA; PLACEBOS; SLEEP; TREATMENT OUTCOME;

EID: 19444362218     PISSN: 03043959     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.pain.2005.02.032     Document Type: Article

References (48)

1. AGS Panel on Persistent Pain in Older Persons The management of persistent pain in older persons J Am Geriatr Soc 50 6 Suppl. 2002 S205 S224
2. N. Attal Chronic neuropathic pain: mechanisms and treatment Clin J Pain 16 3 Suppl. 2000 S118 S130
3. M. Backonja, and R.L. Glanzman Gabapentin dosing for neuropathic pain: evidence from randomized, placebo-controlled clinical trials Clin Ther 25 1 2003 81 104
4. M. Backonja, A. Beydoun, K.R. Edwards, S.L. Schwartz, V. Fonseca, M. Hes, L. LaMoreaux, and E. Garofalo 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. Z.H. Bajwa, and C.C. Ho Herpetic neuralgia. Use of combination therapy for pain relief in acute and chronic herpes zoster Geriatrics 56 2001 18 24
6. V. Biton, K.R. Edwards, G.D. Montouris, J.C. Sackellares, C.L. Harden, and M. Kamin Topiramate titration and tolerability Ann Pharmacother 35 2001 173 179
7. C. Bonezzi, and L. Demartini Treatment options in postherpetic neuralgia Acta Neurol Scand 173 Suppl. 1999 25 35
8. D. Bowsher The management of postherpetic neuralgia Postgrad Med J 73 1997 623 629
9. N.A. Calcutt Potential mechanisms of neuropathic pain in diabetes Int Rev Neurobiol 50 2002 205 228
10. S.R. Chen, Z. Xu, and H.L. Pan Stereospecific effect of pregabalin on ectopic afferent discharges and neuropathic pain induced by sciatic nerve ligation in rats Anesthesiology 95 2001 1473 1479
11. P.W. Choo, K. Galil, J.G. Donahue, A.M. Walker, D. Spiegelman, and R. Platt Risk factors for postherpetic neuralgia Arch Intern Med 157 1997 1217 1224
12. L. Diop, F. Raymond, H. Fargeau, F. Petoux, M. Chovet, and A.M. Doherty Pregabalin (CI-1008) inhibits the trinitrobenzene sulfonic acid-induced chronic colonic allodynia in the rat J Pharmacol Exp Ther 302 2002 1013 1022
13. 3H]norepinephrine release from rat neocortical slices Synapse 45 2002 171 190
14. R.M. Dubinsky, H. Kabbani, Z. El-Chami, C. Boutwell, and H. Ali Practice parameter: treatment of postherpetic neuralgia. An evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology Neurology 63 2004 959 965
15. R.H. Dworkin, and R.K. Portenoy Pain and its persistence in herpes zoster Pain 67 1996 241 251
16. R.H. Dworkin, A.E. Corbin, J.P. Young Jr, U. Sharma, L. LaMoreaux, H. Bockbrader, E.A. Garofalo, and R.M. Poole Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial Neurology 60 2003 1274 1283
17. I.G. Egbunike, and B.J. Chaffee Antidepressants in the management of chronic pain syndromes Pharmacotherapy 10 1990 262 270
18. H. Eutamene, A.M. Coelho, V. Theodorou, M. Toulouse, M. Chovet, A. Doherty, J. Fioramonti, and L. Bueno Antinociceptive effect of pregabalin in septic shock-induced rectal hypersensitivity in rats J Pharmacol Exp Ther 295 2000 162 167
19. J.T. Farrar, J.P. Young Jr, L. LaMoreaux, J.L. Werth, and R.M. Poole Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale Pain 94 2001 149 158
20. J.A. Ferrendelli Concerns with antiepileptic drug initiation: safety, tolerability, and efficacy Epilepsia 42 Suppl. 4 2001 28 30
21. M.J. Field, S. McCleary, J. Hughes, and L. Singh 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
22. 2+ influx by gabapentin and pregabalin in the human neocortex Neuropharmacology 42 2002 229 236
23. T. Forouzanfar, W.E. Weber, M. Kemler, and M. van Kleef What is a meaningful pain reduction in patients with complex regional pain syndrome type 1? Clin J Pain 19 2003 281 285
24. R.D. Hays, and A.L. Stewart Sleep measures A.L. Stewart J.E. Ware Jr Measuring functioning and well-being 1992 Duke Univ. Press Durham, NC 235 259
25. H. Hurst, and J. Bolton Assessing the clinical significance of change scores recorded on subjective outcome measures J Manipulative Physiol Ther 27 1 2004 26 35
26. G.E. Kanazi, R.W. Johnson, and R.H. Dworkin Treatment of postherpetic neuralgia: an update Drugs 59 2000 1113 1126
27. R.G. Kost, and S.E. Straus Postherpetic neuralgia-pathogenesis, treatment, and prevention N Engl J Med 335 1996 32 42
28. H. Lesser, U. Sharma, L. LaMoreaux, and R.M. Poole Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial Neurology 63 2004 2104 2110
29. 2-δ calcium channel subunit and its correlation with allodynia in spinal nerve-injured rats J Neurosci 21 2001 1868 1875
30. 3H]glutamate from rat caudal trigeminal nucleus slices Pain 93 2001 191 196
31. H.J. McQuay, M. Tramer, B.A. Nye, D. Carroll, P.J. Wiffen, and R.A. Moore A systematic review of antidepressants in neuropathic pain Pain 68 1996 217 227
32. K. Meyer-Rosberg, A. Kvarnstrom, E. Kinnman, T. Gordh, L.O. Nordfors, and A. Kristofferson Peripheral neuropathic pain - a multidimensional burden for patients Eur J Pain 5 4 2001 379 389
33. T.P. Nash Treatment options in painful diabetic neuropathy Acta Neurol Scand 173 Suppl. 1999 36 42
34. C. Quattrini, and S. Tesfaye Understanding the impact of painful diabetic neuropathy Diabetes Metab Res Rev 19 Suppl. 1 2000 S2 S8
35. Richter RW, Portenoy R, Sharma U, LaMoreaux L, Knapp L. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain [in press].
36. J. Rosenstock, M. Tuchman, U. Sharma, C. Glessner, L. LaMoreaux, and E.A. Garofalo Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial Pain 110 2004 628 638
37. E.L. Ross The evolving role of antiepileptic drugs in treating neuropathic pain Neurology 55 Suppl. 1 2000 S41 S46
38. M.C. Rowbotham Postherpetic neuralgia Semin Neurol 14 1994 247 254
39. M. Rowbotham, N. Harden, B. Stacey, P. Bernstein, and L. Magnus-Miller Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial J Am Med Assoc 280 1998 1837 1842
40. M. Rowbotham, J. Young, U. Sharma, and L. Knapp Pregabalin shows reduction in pain by day three of treatment: analysis of daily pain scores J Pain 4 2 Suppl. 1 2003 63 [Abstract 846]
41. G.E. Ruoff Slowing the initial titration rate of tramadol improves tolerability Pharmacotherapy 19 1999 88 93
42. R. Sabatowski, R. Gálvez, D.A. Cherry, F. Jacquot, E. Vincent, P. Maisonobe, M. Versavel, and the 1008-045 Study Group Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomized, placebo-controlled clinical trial Pain 109 2004 26 35
43. K.E. Schmader Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy Clin J Pain 18 2002 350 354
44. M.N. Seetharam, and J.M. Pellock Risk-benefit assessment of carbamazepine in children Drug Saf 6 1991 148 158
45. T.N. Vu Current pharmacologic approaches to treating neuropathic pain Curr Pain Headache Rep 8 2004 15 18
46. J. Wallin, J.G. Cui, V. Yakhnitsa, G. Schechtmann, B.A. Meyerson, and B. Linderoth Gabapentin and pregabalin suppress tactile allodynia and potentiate spinal cord stimulation in a model of neuropathy Eur J Pain 6 2002 261 272
47. C.J. Woolf, and R.J. Mannion Neuropathic pain: aetiology, symptoms, mechanisms, and management Lancet 353 1999 1959 1964
48. J.M. Wright Review of the symptomatic treatment of diabetic neuropathy Pharmacotherapy 14 1994 689 697