Pregabalin: A novel γ-aminobutyric acid analogue in the treatment of neuropathic pain, partial-onset seizures, and anxiety disorders

Clinical Therapeutics

Volumn 29, Issue 1, 2007, Pages 26-48

  Tassone, Daniel M ^a   Boyce, Eric ^a   Guyer, Jennifer ^a   Nuzum, Donald ^a  

^a WINGATE UNIVERSITY   (United States)

Author keywords

diabetic peripheral neuropathy; epilepsy; generalized anxiety disorder; Lyrica; neuropathic pain; partial onset seizures; postherpetic neuralgia; pregabalin; social anxiety disorder

Indexed keywords

ALPRAZOLAM; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; CARBAMAZEPINE; CLOBAZAM; ETIRACETAM; FELBAMATE; GABAPENTIN; LAMOTRIGINE; LIDOCAINE; LORAZEPAM; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; OXCARBAZEPINE; PARACETAMOL; PHENOBARBITAL; PHENYTOIN; PREGABALIN; SEROTONIN UPTAKE INHIBITOR; TIAGABINE; TOPIRAMATE; TRAMADOL; TRICYCLIC ANTIDEPRESSANT AGENT; VALPROIC ACID; ZONISAMIDE;

ABNORMAL THINKING; ACCIDENTAL INJURY; AMBLYOPIA; AMNESIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; ATAXIA; BLURRED VISION; CLINICAL TRIAL; COLITIS; CONFUSION; CONSTIPATION; COORDINATION DISORDER; DIABETIC NEUROPATHY; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG RESPONSE; DRUG STRUCTURE; DRUG WITHDRAWAL; EUPHORIA; FLATULENCE; GAIT DISORDER; GENERALIZED ANXIETY DISORDER; HAMILTON ANXIETY SCALE; HEADACHE; HEART ARREST; HEART VENTRICLE EXTRASYSTOLE; HEMIPARESIS; HUMAN; INFECTION; LANGUAGE; MEDLINE; NAUSEA; NEUROPATHIC PAIN; PAIN ASSESSMENT; PARTIAL ONSET SEIZURE; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; RASH; SEIZURE; SIDE EFFECT; SOCIAL PHOBIA; SOMNOLENCE; SPEECH DISORDER; SYSTEMATIC REVIEW; TREMOR; VERTIGO; WEIGHT GAIN; WITHDRAWAL SYNDROME; XEROSTOMIA;

ANALGESICS; ANTICONVULSANTS; ANXIETY DISORDERS; CLINICAL TRIALS; DRUG INTERACTIONS; EPILEPSIES, PARTIAL; GAMMA-AMINOBUTYRIC ACID; HUMANS; NEURALGIA;

EID: 33947254401     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2007.01.013     Document Type: Article

References (54)

1. FDA approval letter of pregabalin for the management of neuropathic pain associated with diabetic peripheral neuropathy. Department of Health and Human Services (January 3, 2006). http://www.fda.gov/cder/foi/appletter/2004/21446ltr.pdf
2. FDA approval letter of pregabalin for the management of postherpetic neuralgia (January 3, 2006), Department of Health and Human Services
3. FDA approval letter of pregabalin as adjunctive therapy for adult patients with partial onset seizures (January 3, 2006), Department of Health and Human Services. http://www.fda.gov/cder/foi/appletter/2005/021724ltr.pdf Accessed
4. Pfizer's Lyrica approved for the treatment of generalized anxiety disorder in Europe (January 3, 2006). http://www.mediaroom.pfizer.com/index.php?s=press_releases&item=36
5. Fehrenbacher J.C., Taylor C.P., and Vasko M.R. Pregabalin and gabapentin reduce release of substance P and CGRP from rat spinal tissues only after inflammation or activation of protein kinase C. Pain 105 (2003) 133-141
6. Abstract. Corrigan B.W., Pool W.F., Posvar E.L., et al. Metabolic disposition of pregabalin in healthy volunteers. Clin Pharmacol Ther 69 (2001) P18
7. Stahl S.M. Mechanism of action of alpha2delta ligands: Voltage sensitive calcium channel (VSCC) modulators. J Clin Psychiatry 65 (2004) 1033-1034
8. Shneker B.F., and McAuley J.W. Pregabalin: A new neuromodulator with broad therapeutic indications. Ann Pharmacother 39 (2005) 2029-2037
9. Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia 45 Suppl 6 (2004) 13-18
10. Abstract. Bockbrader H., Hunt T., Strand J., et al. Pregabalin pharmacokineticsand safety in healthy volunteers: Results from two phase 1 studies. Neurology 54 Suppl 3 (2000) A421
11. Abstract. Busch J.A., Strand J.C., Posvar E.L., et al. Pregabalin (CI-1008) single-dose pharmacokinetics and safety/tolerance in healthy subjects after oral administration of pregabalin solution or capsule doses. Epilepsia 39 Suppl 6 (1998) 58
12. Abstract. Corrigan B., Burger P., and Bockbrader H. Population pharmacokinetics of pregabalin in healthy volunteers, renally impaired patients and patients with chronic pain. J Pain 3 Suppl 1 (2002) 47
13. Randinitis E.J., Posvar E.L., Alvey C.W., et al. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol 43 (2003) 277-283
14. New York, NY. Abstract N R378. Bockbrader H.N., and Wesche D. Pharmacokinetic profile of pregabalin: Results of a series of studies. Presented at: Annual Meeting of the American Psychiatric Association (May 1-6, 2004)
15. Bialer M., Johannessen S.I., Kupferberg H.J., et al. Progress report on new antiepileptic drugs: A summary of the Seventh Eilat Conference (EILAT VII). Epilepsy Res 61 (2004) 1-48
16. Abstract PI-68. Corrigan B.W., Pool W.F., Posvar E.L., et al. Metabolic disposition of pregabalin in healthy volunteers. Clin Pharmacol Ther 69 (2001) P18
17. Abstract. Corrigan B., Bockbrader H., Burger P., et al. Pregabalin population pharmacokinetics in patients with refractory partial seizures. Epilepsia 43 Suppl 8 (2002) 144-145
18. Dworkin R.H., Corbin A.E., Young Jr. J.P., et al. Pregabalin for the treatment of postherpetic neuralgia: A randomized, placebo-controlled trial. Neurology 60 (2003) 1274-1283
19. Lyrica oral capsules [prescribing information] (March 2006), Pfizer, Inc, New York, NY
20. Abstract. Bockbrader H.N., Burger P.J., Kugler A.R., et al. Population pharmacokinetic (PK) analyses of commonly prescribed antiepileptic drugs (AEDs) coadministered with pregabalin (PGB) in adult patients with refractory partial seizures. Epilepsia 42 Suppl 7 (2001) 84
21. Brodie M.J., Wilson E.A., Wesche D.L., et al. Pregabalin drug interaction studies: Lack of effect on the pharmacokinetics of carbamazepine, phenytoin, lamotrigine, and valpro ate in patients with partial epilepsy. Epilepsia 46 (2005) 1407-1413
22. Abstract. Bockbrader H.N., Psovar E.L., Hunt T., and Randinitis E.J. Pregabalin does not alter the effectiveness of an oral contraceptive. Neurology 62 Suppl 5 (2004) A97
23. Vinik A.I., Holland M.T., Le Beau J.M., et al. Diabetic neuropathies. Diabetes Care 15 (1992) 1926-1975
24. Dubinsky R.M., Kabbani H., El-Chami Z., et al., Quality Standards Subcommittee of the American Academy of Neurology. 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
25. Sabatowski R., Galvez R., Cherry D.A., et al., 1008045 Study Group. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post herpetic neuralgia: Results of a randomised, placebo-controlled clinical trial. Pain 109 (2004) 26-35
26. Freynhagen R., Strojek K., Griesing T., et al. 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 115 (2005) 254-263
27. Rosenstock J., Tuchman M., LaMoreaux L., and Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: A double-blind, placebocontrolled trial. Pain 110 (2004) 628-638
28. Lesser H., Sharma U., LaMoreaux L., and Poole R.M. Pregabalin relieves symptoms of painful diabetic neuropa thy: A randomized controlled trial. Neurology 63 (2004) 2104-2110
29. Richter R.W., Portenoy R., Sharma U., et al. Relief of painful diabetic peripheral neuropathywith Pregabalin: A randomized, placebo-controlled trial. J Pain 6 (2005) 253-260
30. French J.A., Kanner A.M., Bautista J., et al., Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology, the Quality Standards Subcommittee of the American Academy of Neurology, and the American Epilepsy Society. Efficacy and tolerability of the new antiepileptic drugs II: Treatment of refractory epilepsy: Report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 62 (2004) 1261-1273
31. Murphy J.V., and Patil A.A. Improving the lives of patients with medically refractory epilepsy by electrical stimulation of the nervous system. Expert Rev Med Devices 2 (2005) 175-189
32. Binnie C.D. Vagus nerve stimulation for epilepsy: A review. Seizure 9 (2000) 161-169
33. Sperling M.R. The consequences of uncontrolled epilepsy. CNS Spectr 9 (2004) 98-101
34. Sperling M.R. The consequences of uncontrolled epilepsy. CNS Spectr 9 (2004) 106-109
35. French J.A., Kugler A.R., Robbins J.L., et al. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology 60 (2003) 1631-1637
36. Arroyo S., Anhut H., Kugler A.R., et al., Pregabalin 1008-011 International Study Group. Prega-balin add-on treatment: A randomized, double-blind, placebo-controlled, dose-response study in adults with partial seizures. Epilepsia 45 (2004) 20-27
37. Beydoun A.A., Uthman B.M., Kugler A.R., et al., Pregabalin 1008009 Study Group. Safety and effica cy of two pregabalin regimens for add-on treatment of partial epilepsy. Neurology 64 (2005) 475-480
38. Miller R., Frame B., Corrigan B., et al. Exposure-response analysis of Pregabalin add-on treatment of patients with refractory partial seizures. Clin Pharmacol Ther 73 (2003) 491-505
39. Elger C., Brodie M.J., Anhut H., et al. Pregabalin add-on treatment in patients with partial seizures: A novel evaluation of flexible-dose and fixed-dose treatment in a doubleblind, placebo-controlled study. Epilepsia 46 (2005) 1926-1936
40. San Francisco, Calif. Abstract P04.099. Greiner M.J., Lee C.M., Knapp L.E., and Garafalo E.A. Pregabalin shows efficacy in reducing simple partial, complex partial, and secondarily generalized seizures. Program and abstract of the 56th Annual Meeting of the American Academy of Neurology (April 24-May 1, 2004)
41. Cramer J.A., Fischer R., BenMenachem E., et al. Epilepsia. New antiepileptic drugs: Comparison of key clinical trials 40 (1999) 590-600
42. Rickels K., Pollack M.H., Feltner D.E., et al. Pregabalin for treatment of generalized anxiety disorder: A 4-week, multicenter, double-blind, placebocontrolled trial of pregabalin and alprazolam. Arch Gen Psychiatry 62 (2005) 1022-1030
43. Pande A.C., Crockatt J.G., Feltner D.E., et al. Pregabalin in generalized anxiety disorder: A placebo-controlled trial. Am J Psychiatry 160 (2003) 533-540
44. Wittchen H.U., and Fehm L. Epidemiology, patterns of comorbidity, and associated disabilities of social phobia. Psychiatr Clin North Am 24 (2001) 617-641
45. CD003592. Kapczinski F., Lima M.S., Souza J.S., and Schmitt R. Antidepressants for generalized anxiety disorder. Cochrane Database Syst Rev 2 (2003)
46. Allgulander C., Bandelow B., Hollander E., et al., World Council of Anxiety. WCA recommen dations for the long-term treatment of generalized anxiety disorder. CNS Spectr 8 Suppl 1 (2003) 53-61
47. Heuzenroeder L., Donnelly M., Haby M.M., et al. Cost-effectiveness of psychological and pharmacological in terventions for generalized anxiety disorder and panic disorder. Aust N Z J Psychiatry 38 (2004) 602-612
48. Mitte K. Meta-analysis of cognitivebehavior treatments for generalized anxiety disorder: A comparison with pharm acotherapy. Psychol Bull 131 (2005) 785-795
49. Davidson J.R. Pharmacotherapy of social phobia. Acta Psychiatr Scand 108 Suppl 417 (2003) 65-71
50. Feltner D.E., Crockatt J.G., Dubovsky S.J., et al. A randomized, double-blind, placebo-controlled, fixed dose, multi center study of pregabalin in patients with generalized anxiety disorder. J Clin Psychopharmacol 23 (2003) 240-249
51. Pohl R.B., Feltner D.E., Fieve R.R., and Pande A.C. Efficacy of pregabalin in the treatment of generalized anxiety disorder: Double-blind, placebocontrolled comparison of BID versus TID dosing. J Clin Psychopharmacol 25 (2005) 151-158
52. Pande A.C., Feltner D.E., Jefferson J.W., et al. Efficacy of the novel anxiolytic pregabalin in social anxiety disor der: A placebo-controlled, multicenter study. J Clin Psychopharmacol 24 (2004) 141-149
53. [published correction appears in Arch Gen Psychiatry. 1991;48:51]. Rickels K., Schweizer Ex.2, Case W.G., and Greenblatt D.J. Long term therapeutic use of benzodiazepines. I. Effect of abrupt discontinuation. Arch Gen Psychiatry 47 (1990) 899-907
54. San Francisco, Calif. Abstract P04.096. Morrell M., Barrett J.A., Brigell M., and Chartier K. A double-blind placebocontrolled study to assess the effects of pregabalin on reproductive function in healthy males. Program and abstract presented at: Annual Meeting of the American Academy of Neurology (April 24-May 1, 2004)