Pregabalin

Hospital Pharmacy

Volumn 41, Issue 2, 2006, Pages 157-169

  Cada, Dennis J ^a   Levien, Terri ^a   Baker, Danial E ^a,b  

^a WASHINGTON STATE UNIVERSITY   (United States)

^b Drug Information Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALCOHOL; ALPRAZOLAM; ANTICONVULSIVE AGENT; ANTIDIABETIC AGENT; CARBAMAZEPINE; CARBAMAZEPINE 10,11 OXIDE; CENTRAL NERVOUS SYSTEM AGENTS; CHORIONIC GONADOTROPIN; CREATINE KINASE; CYTOCHROME P450; CYTOCHROME P450 1A2; CYTOCHROME P450 2A6; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 3A4; DIAZOXIDE; GABAPENTIN; LAMOTRIGINE; LORAZEPAM; OXYCODONE; PERGOLIDE; PHENOBARBITAL; PHENYTOIN; PLACEBO; PREGABALIN; TIAGABINE; TOPIRAMATE; UNINDEXED DRUG; VALPROIC ACID;

ABNORMAL THINKING; ADD ON THERAPY; ASTHENIA; BLEEDING; BLURRED VISION; CLINICAL TRIAL; CONSTIPATION; CREATINE KINASE BLOOD LEVEL; DIABETIC NEUROPATHY; DIARRHEA; DISEASE EXACERBATION; DIZZINESS; DRUG DOSAGE FORM; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FORMULARY; DRUG FORMULATION; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG INFORMATION; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENTIATION; ECG ABNORMALITY; FOOD AND DRUG ADMINISTRATION; FOOD DRUG INTERACTION; GENERALIZED ANXIETY DISORDER; HEADACHE; HUMAN; INJURY; INSOMNIA; NAUSEA; NEUROPATHIC PAIN; NONHUMAN; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; POSTHERPETIC NEURALGIA; PR INTERVAL; PSYCHOPATHY; QUALITY OF LIFE; REVIEW; SEIZURE; SIDE EFFECT; SOMNOLENCE; SUDDEN DEATH; TERATOGENICITY; THROMBOCYTOPENIA; WEIGHT GAIN; WITHDRAWAL SYNDROME; XEROSTOMIA;

EID: 33644543770     PISSN: 00185787     EISSN: None     Source Type: Journal    
DOI: 10.1310/hpj4102-157     Document Type: Review

References (60)

1. Lyrica [package insert]. New York, NY: Pfizer Inc.; 2005.
2. Neurontin [package insert]. New York, NY: Pfizer, Inc.; 2004.
3. Willmore LJ. Clinical pharmacology of new antiepileptic drugs. Neurology. 2000;55(suppl 3):S17-S24.
4. Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001;43:11-58.
5. Fink K, Dooley DJ, Meder WP, et al. Inhibition of neuronal Ca(2+) influx by gabapentin and pregabalin in the human neocortex. Neuropharmacology. 2002;42:229-236.
6. Jun JH, Yaksh TL. The effect of intrathecal gabapentin and 3-isobutyl gamma-aminobutyric acid on the hyperalgesia observed after thermal injury in the rat. Anesth Analg. 1998;86:348-354.
7. Field MJ, Oles RJ, Singh L. Pregabalin may represent a novel class of anxiolytic agents with broad spectrum of activity. Br J Pharmacol. 2001;132:1-4.
8. Field MJ, 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. 1999;80:391-398.
9. Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45(suppl 6):13-18.
10. Dooley DJ, Mieske CA, Borosky SA. Inhibition of K(+) evoked glutamate release from rat neocortical and hippocampal slices by gabapentin. Neurosci Lett. 2000;280:107-110.
11. Dooley DJ, Donovan CM, Pugsley TA. Stimulus-dependent modulation of [(3)H] norepinephrine release from rat neocortical slices by gabapentin and pregabalin. J Pharmacol Exp Ther. 2000;295:1086-1093.
12. Nozaki-Taguchi N, Chaplan SR, Higuera ES, Ajakwe RC, Yaksh TL. Vin-cristine-induced allodynia in the rat. Pain. 2001;93:69-76.
13. Maneuf YP, Hughes J, McKnight AT. Gabapentin inhibits the substance P-facilitated K(+) evoked release of [(3)H] glutamate from rat caudal trigeminal nucleus slices. Pain. 2001;93:191-196.
14. Whitworth TL, Quick MW. Upregulation of gamma-aminobutyric transporter expression: role of alkylated gamma-aminobutyric acid derivatives. Biochem Soc Trans. 2001;29(part 6):736-741.
15. Chen SR, Xu Z, Pan HL. Stereospecific effect of pregabalin on ectopic afferent discharges and neuropathic pain induced by sciatic nerve ligation in rats. Anesthesiology. 2001;95:1473-1479.
16. Houghton AK, Lu Y, Westlund KN. S-(+)-3-isobutylgaba and its stereoisomer reduces the amount of inflammation and hyperalgesia in an acute arthritis model in the rat. J Pharmacol Exp Ther. 1998;285:533-538.
17. Jones DL, Sorkin LS. Systemic gabapentin and S(+)-3-isobutyl-gamma- aminobutyric acid block secondary hyperalgesia. Brain Res. 1998;810:93-99.
18. Corrigan BW, Pool WF, Posvar EL, et al. Metabolic disposition of pregabalin in healthy volunteers [abstract PI-68]. Clin Pharmacol Ther. 2001;69(suppl 2):18.
19. Field MJ, Bramwell S, Hughes J, Singh L. Detection of static and dynamic components of mechanical allodynia in rat models of neuropathic pain: are they signaled by distinct primary sensory neurones? Pain. 1999;83:303-311.
20. Eutamene H, Coelho AM, Theodorou V, et al. Antinociceptive effect of pregabalin in septic shock-induced rectal hypersensitivity in rats. J Pharmacol Exp Ther. 2000;295:162-167.
21. Field MJ, Holloman EF, McCleary S, Hughes J, Singh L. Evaluation of gabapentin and S-(+)-3-isobutylgaba in a rat model of postoperative pain. J Pharmacol Exp Ther. 1997;282:1242-1246.
22. Hurley RW, Chatterjea D, Rose Feng M, Taylor CP, Hammond DL. Gabapentin and pregabalin can interact synergistically with naproxen to produce antihyperalgesia. Anesthesiology. 2002;97:1263-1273.
23. Kubota T, Fang J, Meltzer LT, Krueger JM. Pregabalin enhances non-rapid eye movement sleep. J Pharmacol Exp Ther. 2001;299:1095-1105.
24. Bockbrader HN, Hunt T, Strand J, Posvar E, Sedman A. Pregabalin pharmacokinetics and safety in healthy volunteers: results from two phase 1 studies [abstract P06.051]. Neurology. 2000;54(suppl 3):A421.
25. Randinitis EJ, Posvar EL, Alvey CW, Sedman AJ, Cook JA, Bockbrader HN. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol. 2003;43:277-283.
26. Alvey CW, Bockbrader HN, Busch JA, et al. Clinical pharmacokinetics of pregabalin in healthy volunteers [abstract1965-PO]. Presented at: 64th Scientific Sessions of the American Diabetes Association; June 4-8, 2004; Orlando, FL.
27. Bockbrader HN, Corrigan BW. Pharmacokinetics of pregabalin in patients with chronic pain [abstract1973-PO]. Presented at: 64th Scientific Sessions of the American Diabetes Association; June 4-8, 2004; Orlando, FL.
28. Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110:628-638.
29. Dworkin RH, Corbin AE, Young JP Jr, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology. 2003;60:1274-1283.
30. Sabatowski R, Galvez R, Cherry DA, et al; 1008-045 Study Group. Pregabalin reduces pain and improves sleep and mood disturbances in patients with postherpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain. 2004;109:26-35.
31. Freynhagen R, Strojek K, Griesing T, Whalen E, Balkenohl M. 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. 2005;115:254-263.
32. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004;63:2104-2110.
33. Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bockbrader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005;6:253-260.
34. Iacobellis D, Allen R, Lamoreaux L, Poole RM. A double-blind, placebo-controlled trial of pregabalin for the treatment of painful diabetic peripheral neuropathy [abstract P03.049]. Neurology. 2000;54(suppl 3):A177.
35. Sharma U, Allen R, Glessner C, Hes M, Lamoreaux L, Poole RM. Pregabalin effectively relieves pain in patients with diabetic peripheral neuropathy: study 1008-014 [abstract]. Diabetes. 2000;49(suppl 1):A167.
36. Glessner C, Sharma U, Iacobellis D, Moore J, Lamoreaux LL, Poole RM. Pregabalin relieves pain and reduces pain interference with sleep in patients with diabetic neuropathy [abstract753-P]. Presented at: 61st Scientific Sessions of the American Diabetes Association; June 22-26, 2001; Philadelphia, PA.
37. Sharma U, Glessner C, Moore J, Lamoreaux LK, Garofalo EA, Poole RM. Pregabalin is efficacious for relief of painful diabetic neuropathy [abstract P06.126]. Presented at: 54th Annual Meeting of the American Academy of Neurology; April 13-20, 2002; Denver, CO.
38. van Seventer R, Bladin C, Hoggart B, Martin S, Hsu T. Pregabalin dosed BID efficaciously improves self-reported sleep outcomes in patients with postherpetic neuralgia: report of a large, randomized, placebo-controlled trial [abstract]. Sleep. 2004;27:A49.
39. Crofford LJ, Rowbotham MC, Mease PJ, et al. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005;52:1264-1273.
40. Hill CM, Balkenohl M, Thomas DW, Walker R, Mathe H, Murray G. Pregabalin in patients with postoperative dental pain. Eur J Pain. 2001;5:119-124.
41. Jaffe M, Iacobellis D, Young JP, et al. Post-hoc results show beneficial effects of pregabalin in patients with osteoarthritis of the hip [abstract]. Arthritis Rheum. 2000;43(suppl):S337-S1621.
42. Kugler AR, Robbins JL. Pregabalin exposure and pregabalin dose are equivalent predictors of seizure reduction [abstract P04.093]. Presented at: 54th Annual Meeting of the American Academy of Neurology; April 13-20, 2002; Denver, CO.
43. French JA, Kugler AR, Knapp LE, et al. Pregabalin reduces the frequency of secondarily generalized tonic-clonic (SGTC) partial seizures [abstract S57.002]. Presented at: 54th Annual Meeting of the American Academy of Neurology; April 13-20, 2002; Denver, CO.
44. Miller R, Frame B, Corrigan BW, et al. Mixed effects modeling of pregabalin response in patients with refractory partial seizures [abstract]. Clin Pharmacol Ther. 2001;69(suppl 2): Abstract PIII-55.
45. French JA, Malicsi MJR, Kugler AR, Knapp LE, Bockbrader HN, Garofalo EA. Pregabalin adjunctive therapy in patients with partial seizures. Epilepsia. 1999;40:106.
46. Beydoun AA, Uthman BM, Ramsay RE, et al. Pregabalin add-on trial: double-blind, multicenter study in patients with partial epilepsy [abstract]. Epilepsia. 2000;41(suppl 7):253-254.
47. Fakhoury TA, Jackson TL, Abou-Khalil BW. Long term safety and efficacy of pregabalin [abstract]. Epilepsia. 1999;40(suppl 7):147.
48. Abou-Khalil BW, Vazquez BR, Beydoun AA, et al. Pregabalin in-patient monotherapy trial - study results and impact of seizure frequency of efficacy evaluations [abstract]. Epilepsia. 1999;40(suppl 7):109.
49. Elger C, Roder B, Bockbrader H, et al. Pregabalin in-patient monotherapy trial [abstract]. Epilepsia. 1999;40(suppl 2):247.
50. Abou-Khalil BW, Vazquez BR, Beydoun A, et al. Pregabalin in-patient monotherapy trial: a double-blind, low-dose active-controlled, multicenter study in patients with refractory partial epilepsy (Protocol 1008-007) [abstract]. Neurology. 1999;52(suppl 2):A390.
51. Beydoun A, Uthman BM, Kugler AR, Greiner MJ, Knapp LE, Garofalo EA; Pregabalin 1008-009 Study Group. Safety and efficacy of two pregabalin regimens for add-on treatment of partial epilepsy. Neurology. 2005;64:475-480.
52. French JA, Kugler AR, Robbins JL, Knapp LE, Garofalo EA. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology. 2003;60:1631-1637.
53. Arroyo S, Anhut H, Kugler AR, et al. Pregabalin add-on treatment: a randomized, double-blind, placebo-controlled, dose-response study in adults with partial seizures. Epilepsia. 2004;45:20-27.
54. Pande AC, Crockatt JG, Feltner DE, et al. Pregabalin in generalized anxiety disorder: a placebo-controlled trial. Am J Psychiatry. 2003;160:533-540.
55. Feltner DE, Crockatt JG, Dubovsky SJ, et al. A randomized, double-blind, placebo-controlled, fixed-dose, multicenter study of pregabalin in patients with generalized anxiety disorder. J Clin Psychopharmacol. 2003;23:240-249.
56. Pohl RB, Feltner DE, Fieve RR, Pande AC. Efficacy of pregabalin in the treatment of generalized anxiety disorder: double-blind, placebo-controlled comparison of BID versus TID dosing. J Clin Psychopharmacol. 2005;25:151-158.
57. New studies suggest Pfizer's pregabalin to be an effective treatment for generalized anxiety disorder: data suggest novel drug offers fast, sustained, clinical improvement [press release]. Philadelphia, PA: Pfizer, Inc.; May 21, 2002.
58. Pande AC, Feltner DE, Jefferson JW, et al. Efficacy of the novel anxiolytic pregabalin in social anxiety disorder: a placebo-controlled, multicenter study. J Clin Pyschopharmacol. 2004;24:141-149.
59. Brigell MG, Carter CM, Smith F, Garofalo EA. Prospective evaluation of the ophthalmologic safety of pregabalin shows no evidence of toxicity [abstract P06.026]. Presented at: 54th Annual Meeting of the American Academy of Neurology; April 13-20, 2002; Denver, CO.
60. Bockbrader HN, Wesche D. Pregabalin does not show pharmacokinetic drug-drug interactions with commonly used antiepileptic drugs when used as add-on therapy for partial epilepsy [abstract22]. Presented at: 14th Meeting of the European Neurological Society; June 26-30, 2004; Barcelona, Spain.