Drug safety evaluation of pregabalin

Expert Opinion on Drug Safety

Volumn 11, Issue 3, 2012, Pages 487-502

  Toth, Cory ^a  

^a UNIVERSITY OF CALGARY   (Canada)

Author keywords

Adverse effects; Anticonvulsant drugs; Long term studies; Neuropathic pain; Pharmacotherapy; Pregabalin; Randomized clinical trials; Review; Safety

Indexed keywords

AMITRIPTYLINE; CELECOXIB; DULOXETINE; GABAPENTIN; LIDOCAINE; PLACEBO; PREGABALIN;

ABNORMAL THINKING; AMNESIA; ANESTHESIA; ANGIONEUROTIC EDEMA; ANGIOSARCOMA; ARTICLE; ASTHENIA; BLISTER; BLURRED VISION; BRAIN DISEASE; CHRONIC PAIN; CONSTIPATION; DEPERSONALIZATION; DIABETIC NEUROPATHY; DIZZINESS; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ERYTHEMA; EUPHORIA; EVIDENCE BASED MEDICINE; FLAPPING TREMOR; GAIT DISORDER; GYNECOMASTIA; HUMAN; HYPERKERATOSIS; HYPERSENSITIVITY REACTION; INCREASED APPETITE; INFECTION; LOW BACK PAIN; MYOCLONUS; NEUROPATHIC PAIN; NONHUMAN; PATIENT MONITORING; PERIPHERAL EDEMA; POSTHERPETIC NEURALGIA; POSTOPERATIVE PAIN; PREVALENCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RESPIRATION DEPRESSION; SEDATION; SIDE EFFECT; SOMNOLENCE; STEVENS JOHNSON SYNDROME; URTICARIA; WEIGHT GAIN; WHEEZING; XEROSTOMIA;

ANTICONVULSANTS; EVIDENCE-BASED MEDICINE; GAMMA-AMINOBUTYRIC ACID; HUMANS; PATIENT SAFETY; RISK ASSESSMENT; RISK FACTORS; SEIZURES; TREATMENT OUTCOME;

EID: 84860113660     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2012.677026     Document Type: Article

References (131)

1. Oteri A, Trifiro G, Gagliostro MS, et al. Prescribing pattern of anti-epileptic drugs in an Italian setting of elderly outpatients: a population-based study during 2004-07. Br J Clin Pharmacol 2010;70(4):514-22
2. Bauer CS, Nieto-Rostro M, Rahman W, et al. The increased trafficking of the calcium channel subunit alpha2delta-1 to presynaptic terminals in neuropathic pain is inhibited by the alpha2delta ligand pregabalin. J Neurosci 2009;29(13):4076-88
3. Eroglu C, Allen NJ, Susman MW, et al. Gabapentin receptor alpha2delta-1 is a neuronal thrombospondin receptor responsible for excitatory CNS synaptogenesis. Cell 2009;139(2):380-92
4. Moulin DE, Clark AJ, Gilron I, et al. Pharmacological management of chronic neuropathic pain-consensus statement and guidelines from the Canadian Pain Society. Pain Res Manag 2007;12(1):13-21 (Pubitemid 46744774)
5. Dworkin RH, O'Connor AB, Audette J, et al. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc 2010;85(3 Suppl):S3-14
6. O'Connor AB, Dworkin RH. Treatment of neuropathic pain: an overview of recent guidelines. Am J Med 2009;122(10 Suppl):S22-32
7. Treede RD, Jensen TS, Campbell JN, et al. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology 2008;70(18):1630-5 (Pubitemid 351620320)
8. Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain 2006;7(4):281-9
9. Bouhassira D, Lanteri-Minet M, Attal N, et al. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain 2008;136(3):380-7 (Pubitemid 351680253)
10. Toth C, Lander J, Wiebe S. The prevalence and impact of chronic pain with neuropathic pain symptoms in the general population. Pain Med 2009;10(5):918-29
11. Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain 2002;18(6):350-4 (Pubitemid 35291575)
12. Poliakov I, Toth C. The impact of pain in patients with polyneuropathy. Eur J Pain 2011;10:1015-22
13. Doth AH, Hansson PT, Jensen MP, Taylor RS. The burden of neuropathic pain: a systematic review and meta-analysis of health utilities. Pain 2010;149(2):338-44
14. Berger A, Dukes EM, Oster G. Clinical characteristics and economic costs of patients with painful neuropathic disorders. J Pain 2004;5(3):143-9 (Pubitemid 38879392)
15. Rodriguez MJ, Garcia AJ. A registry of the aetiology and costs of neuropathic pain in pain clinics: results of the registry of aetiologies and costs (REC) in neuropathic pain disorders study. Clin Drug Investig 2007;27(11):771-82 (Pubitemid 47529293)
16. Gore M, Brandenburg NA, Dukes E, et al. Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep. J Pain Symptom Manage 2005;30(4):374-85 (Pubitemid 41527124)
17. Argoff CE. The coexistence of neuropathic pain, sleep, and psychiatric disorders: a novel treatment approach. Clin J Pain 2007;23(1):15-22
18. Cornwall A, Donderi DC. The effect of experimentally induced anxiety on the experience of pressure pain. Pain 1988;35(1):105-13 (Pubitemid 19011070)
19. Nicholson B, Verma S. Comorbidities in chronic neuropathic pain. Pain Med 2004;5(Suppl 1):S9-27
20. Ohayon MM. Specific characteristics of the pain/depression association in the general population. J Clin Psychiatry 2004;65(Suppl 12):5-9
21. Wilson KG, Eriksson MY, D'Eon JL, et al. Major depression and insomnia in chronic pain. Clin J Pain 2002;18(2):77-83 (Pubitemid 34205397)
22. Satzinger G, Hartenstein J, Herrmann M, et al. Cyclic amino acids. Ger. Offen.: DE 2460891, 1976
23. Tansey B. Huge penalty in drug fraud; Pfizer settles felony case in neurontin off-label promotion. San Francisco Chronicle, May 14, 2004
24. Mellick GA, Mellick LB. Reflex sympathetic dystrophy treated with gabapentin. Arch Phys Med Rehabil 1997;78(1):98-105 (Pubitemid 27034255)
25. Mellick GA, Mellicy LB, Mellick LB. Gabapentin in the management of reflex sympathetic dystrophy. J Pain Symptom Manage 1995;10(4):265-6
26. Mellick LB, Mellick GA. Successful treatment of reflex sympathetic dystrophy with gabapentin. Am J Emerg Med 1995;13(1):96
27. Rice AS, Maton S. Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain 2001;94(2):215-24 (Pubitemid 33016615)
28. Backonja MM. Gabapentin monotherapy for the symptomatic treatment of painful neuropathy: a multicenter, double-blind, placebo-controlled trial in patients with diabetes mellitus. Epilepsia 1999;40(Suppl 6):S57-9; discussion S73-54
29. Martinez JA, Kasamatsu M, Rosales-Hernandez A, et al. Comparison of central versus peripheral delivery of pregabalin in neuropathic pain states. Mol Pain 2011. [Epub ahead of print]
30. Lyrica Prescribing Information. Available from: http://labeling.pfizer. com/ShowLabeling.aspx?id=561
31. Perret D, Luo ZD. Targeting voltage-gated calcium channels for neuropathic pain management. Neurotherapeutics 2009;6(4):679-92
32. Gajraj NM. Pregabalin: its pharmacology and use in pain management. Anesth Analg 2007;105(6):1805-15 (Pubitemid 350190582)
33. Field MJ, Oles RJ, Singh L. Pregabalin may represent a novel class of anxiolytic agents with a broad spectrum of activity. Br J Pharmacol 2001;132(1):1-4 (Pubitemid 32128426)
34. 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(2):229-36 (Pubitemid 34137026)
35. Micheva KD, Taylor CP, Smith SJ. Pregabalin reduces the release of synaptic vesicles from cultured hippocampal neurons. Mol Pharmacol 2006;70(2):467-76 (Pubitemid 44092307)
36. Hutson SM, Berkich D, Drown P, et al. Role of branched-chain aminotransferase isoenzymes and gabapentin in neurotransmitter metabolism. J Neurochem 1998;71(2):863-74 (Pubitemid 28480436)
37. Xu Y, Oz G, LaNoue KF, et al. Whole-brain glutamate metabolism evaluated by steady-state kinetics using a double-isotope procedure: effects of gabapentin. J Neurochem 2004;90(5):1104-16 (Pubitemid 39167344)
38. Gotz E, Feuerstein TJ, Lais A, Meyer DK. Effects of gabapentin on release of gamma-aminobutyric acid from slices of rat neostriatum. Arzneimittelforschung 1993;43(6):636-8 (Pubitemid 23176484)
39. Lucke A, Musshoff U, Kohling R, et al. Gabapentin potentiation of the antiepileptic efficacy of vigabatrin in an in vitro model of epilepsy. Br J Pharmacol 1998;124(2):370-6 (Pubitemid 28248028)
40. Parker DA, Ong J, Marino V, Kerr DI. Gabapentin activates presynaptic GABAB heteroreceptors in rat cortical slices. Eur J Pharmacol 2004;495(2-3):137-43 (Pubitemid 38891870)
41. Brawek B, Loffler M, Weyerbrock A, Feuerstein TJ. Effects of gabapentin and pregabalin on K+-evoked 3H-GABA and 3H-glutamate release from human neocortical synaptosomes. Naunyn Schmiedebergs Arch Pharmacol 2009;379(4):361-9
42. Vartanian MG, Radulovic LL, Kinsora JJ, et al. Activity profile of pregabalin in rodent models of epilepsy and ataxia. Epilepsy Res 2006;68(3): 189-205
43. Bockbrader HN, Wesche D, Miller R et al. A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clin Pharmacokinet 2010;49(10):661-9
44. Su TZ, Feng MR, Weber ML. Mediation of highly concentrative uptake of pregabalin by L-type amino acid transport in Chinese hamster ovary and caco-2 cells. J Pharmacol Exp Ther 2005;313(3):1406-15 (Pubitemid 40727048)
45. Piyapolrungroj N, Li C, Bockbrader H, et al. Mucosal uptake of gabapentin (neurontin) vs. pregabalin in the small intestine. Pharm Res 2001;18(8):1126-30 (Pubitemid 32900397)
46. Randinitis EJ, Posvar EL, Alvey CW, et al. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol 2003;43(3):277-83 (Pubitemid 36232656)
47. Toth C. Substitution of gabapentin therapy with pregabalin therapy in neuropathic pain due to peripheral neuropathy. Pain Med 2010;11:456-65
48. Chizh BA, Gohring M, Troster A, et al. Effects of oral pregabalin and aprepitant on pain and central sensitization in the electrical hyperalgesia model in human volunteers. Br J Anaesth 2007;98(2):246-54 (Pubitemid 47072006)
49. Bansal D, Bhansali A, Hota D, et al. Amitriptyline vs. pregabalin in painful diabetic neuropathy: a randomized double blind clinical trial. Diabet Med 2009;26(10):1019-26
50. Satoh J, Yagihashi S, Baba M, et al. Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial. Diabet Med 2011;28(1):109-16
51. Freeman R, Durso-Decruz E, Emir B. Efficacy, safety, and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses. Diabetes Care 2008;31(7):1448-54
52. 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 2005;115(3):254-63 (Pubitemid 40725282)
53. Hurley RW, Lesley MR, Adams MC, et al. Pregabalin as a treatment for painful diabetic peripheral neuropathy: a meta-analysis. Reg Anesth Pain Med 2008;33(5):389-94
54. Quilici S, Chancellor J, Lothgren M, et al. Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain. BMC Neurol 2009;9:6
55. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology 2004;63(11):2104-10 (Pubitemid 39636259)
56. 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(3):628-38 (Pubitemid 39036794)
57. Richter RW, Portenoy R, Sharma U, et al. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain 2005;6(4):253-60 (Pubitemid 40488803)
58. Sharma U, Griesing T, Emir B, Young JP Jr. Time to onset of neuropathic pain reduction: a retrospective analysis of data from nine controlled trials of pregabalin for painful diabetic peripheral neuropathy and postherpetic neuralgia. Am J Ther 2010;17(6):577-85
59. Sampathkumar P, Drage LA, Martin DP. Herpes zoster (shingles) and postherpetic neuralgia. Mayo Clin Proc 2009;84(3):274-80
60. Dworkin RH, Corbin AE, Young JP Jr, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology 2003;60(8):1274-83 (Pubitemid 36460982)
61. Sabatowski R, Galvez R, Cherry DA, et al. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain 2004;109(1-2):26-35 (Pubitemid 38479767)
62. van Seventer R, Feister HA, Young JP Jr, et al. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin 2006;22(2):375-84 (Pubitemid 44296762)
63. Stacey BR, Barrett JA, Whalen E, et al. Pregabalin for postherpetic neuralgia: placebo-controlled trial of fixed and flexible dosing regimens on allodynia and time to onset of pain relief. J Pain 2008;9(11):1006-17
64. Baron R, Mayoral V, Leijon G, et al. 5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label, non-inferiority two-stage RCT study. Curr Med Res Opin 2009;25(7):1663-76
65. Achar A, Chatterjee G, Ray TG, Naskar B. Comparative study of clinical efficacy with amitriptyline, pregabalin, and amitriptyline plus pregabalin combination in postherpetic neuralgia. Indian J Dermatol Venereol Leprol 2010;76(1):63-5
66. Barbarisi M, Pace MC, Passavanti MB, et al. Pregabalin and transcutaneous electrical nerve stimulation for postherpetic neuralgia treatment. Clin J Pain 2010;26(7):567-72
67. Rehm S, Binder A, Baron R. Post-herpetic neuralgia: 5% lidocaine medicated plaster, pregabalin, or a combination of both? A randomized, open, clinical effectiveness study. Curr Med Res Opin 2010;26(7):1607-19
68. Moore RA, Straube S, Wiffen PJ, et al. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev 2009(3):CD007076
69. Verhaak PF, Kerssens JJ, Dekker J, et al. Prevalence of chronic benign pain disorder among adults: a review of the literature. Pain 1998;77(3):231-9 (Pubitemid 28451511)
70. Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum 1998;41(5):778-99 (Pubitemid 28225778)
71. Elliott AM, Smith BH, Penny KI, et al. The epidemiology of chronic pain in the community. Lancet 1999;354(9186):1248-52 (Pubitemid 29469353)
72. Freynhagen R, Baron R. The evaluation of neuropathic components in low back pain. Curr Pain Headache Rep 2009;13(3):185-90
73. Romano CL, Romano D, Bonora C, Mineo G. Pregabalin, celecoxib, and their combination for treatment of chronic low-back pain. J Orthop Traumatol 2009;10(4):185-91
74. Baron R, Freynhagen R, Tolle TR, et al. The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy. Pain 2010;150(3):420-7
75. Finnerup NB. A review of central neuropathic pain states. Curr Opin Anaesthesiol 2008;21(5):586-9
76. Siddall PJ, Cousins MJ, Otte A, et al. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology 2006;67(10):1792-800 (Pubitemid 44900755)
77. Vranken JH, Dijkgraaf MG, Kruis MR, et al. Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen. Pain 2008;136(1-2):150-7 (Pubitemid 351491377)
78. Kim JS, Bashford G, Murphy TK, et al. Safety and efficacy of pregabalin in patients with central post-stroke pain. Pain 2011;152(5):1018-23
79. Navarro A, Saldana MT, Perez C, et al. Patient-reported outcomes in subjects with neuropathic pain receiving pregabalin: evidence from medical practice in primary care settings. Pain Med 2010;11(5):719-31
80. Navarro A, Saldana MT, Perez C, et al. A cost-consequences analysis of the effect of pregabalin in the treatment of peripheral neuropathic pain in routine medical practice in primary care settings. BMC Neurol 2011;11:7
81. Saldana MT, Navarro A, Perez C, et al. A cost-consequences analysis of the effect of pregabalin in the treatment of painful radiculopathy under medical practice conditions in primary care settings. Pain Pract 2010;10(1):31-41
82. Perez C, Saldana MT, Navarro A, et al. Trigeminal neuralgia treated with pregabalin in family medicine settings: its effect on pain alleviation and cost reduction. J Clin Pharmacol 2009;49(5):582-90
83. Saldana MT, Navarro A, Perez C, et al. Patient-reported-outcomes in subjects with painful lumbar or cervical radiculopathy treated with pregabalin: evidence from medical practice in primary care settings. Rheumatol Int 2010;30(8):1005-15
84. Ifuku M, Iseki M, Hidaka I, et al. Replacement of gabapentin with pregabalin in postherpetic neuralgia therapy. Pain Med 2011;12(7):1112-16
85. Tanenberg RJ, Irving GA, Risser RC, et al. Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open-label, randomized, noninferiority comparison. Mayo Clin Proc 2011;86(7):615-26
86. Mishra S, Bhatnagar S, Nirvani Goyal G, et al. A Comparative Efficacy of Amitriptyline, Gabapentin, and Pregabalin in Neuropathic Cancer Pain: A Prospective Randomized Double-Blind Placebo-Controlled Study. Am J Hosp Palliat Care 2011 [Epub ahead of print]
87. Perez C, Navarro A, Saldana MT, et al. Pregabalin and gabapentin in matched patients with peripheral neuropathic pain in routine medical practice in a primary care setting: findings from a cost-consequences analysis in a nested case-control study. Clin Ther 2010;32(7):1357-70
88. Gore M, Sadosky A, Tai KS, Stacey B. A retrospective evaluation of the use of gabapentin and pregabalin in patients with postherpetic neuralgia in usual-care settings. Clin Ther 2007;29(8):1655-70 (Pubitemid 47500130)
89. Delahoy P, Thompson S, Marschner IC. Pregabalin versus gabapentin in partial epilepsy: a meta-analysis of dose-response relationships. BMC Neurol 2010;10:104
90. Bramness JG, Sandvik P, Engeland A, Skurtveit S. Does Pregabalin (Lyrica ((R))) Help Patients Reduce their Use of Benzodiazepines? A Comparison with Gabapentin using the Norwegian Prescription Database. Basic Clin Pharmacol Toxicol 2010. [Epub ahead of print]
91. 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(3):240-9 (Pubitemid 36807791)
92. 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(2):151-8 (Pubitemid 40395093)
93. Hindmarch I, Trick L, Ridout F. A double-blind, placebo-and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers. Psychopharmacology (Berl) 2005;183(2):133-43 (Pubitemid 41609265)
94. Chiechio S, Zammataro M, Caraci F, et al. Pregabalin in the treatment of chronic pain: an overview. Clin Drug Investig 2009;29(3):203-13
95. Rowbotham M, Harden N, Stacey B, et al. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA 1998;280(21):1837-42 (Pubitemid 28544424)
96. Rice AS, Maton S. Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain 2001;94(2):215-24 (Pubitemid 33016615)
97. Norton JW. Gabapentin withdrawal syndrome. Clin Neuropharmacol 2001;24(4):245-6 (Pubitemid 32717862)
98. Chalabianloo F, Schjott J. Pregabalin and its potential for abuse. Tidsskr Nor Laegeforen 2009;129(3):186-7
99. European Medicines Agency (EMA). Lyrica (pregabalin) Scientific Discussion. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/ medicines/human/medicines/000546/human-med-000894.jsp&mid=WC0b01ac058001 d124&jsenabled=true. Accessed 8 February 2012
100. Schwan S, Sundstrom A, Stjernberg E, et al. A signal for an abuse liability for pregabalin-results from the Swedish spontaneous adverse drug reaction reporting system. Eur J Clin Pharmacol 2010;66(9):947-53
101. Schifano F, D'Offizi S, Piccione M, et al. Is there a recreational misuse potential for pregabalin? Analysis of anecdotal online reports in comparison with related gabapentin and clonazepam data. Psychother Psychosom 2011;80(2):118-22
102. Pregabalin Summary of Product Characteristics. Available from: http://www.medicines.org.uk/emc/medicine/14651. Accessed 8 February 2012
103. Arif H, Buchsbaum R, Weintraub D, et al. Comparison and predictors of rash associated with 15 antiepileptic drugs. Neurology 2007;68(20):1701-9 (Pubitemid 46763258)
104. Rowan AJ, Ramsay RE, Collins JF, et al. New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. Neurology 2005;64(11):1868-73 (Pubitemid 40800699)
105. Smith TL, Baldwin A, Cunningham LL Jr, Cook AM. Rash associated with pregabalin use. Ann Pharmacother 2008;42(12):1899-902
106. Huppertz HJ, Feuerstein TJ, Schulze-Bonhage A. Myoclonus in epilepsy patients with anticonvulsive add-on therapy with pregabalin. Epilepsia 2001;42(6):790-2 (Pubitemid 32605944)
107. Heckmann JG, Ulrich K, Dutsch M, Neundorfer B. Pregabalin associated asterixis. Am J Phys Med Rehabil 2005;84(9):724 (Pubitemid 41248467)
108. Malaga I, Sanmarti FX. Two cases of painful gynecomastia and lower extremity pain in association with pregabalin therapy. Epilepsia 2006;47(9):1576-9 (Pubitemid 44393873)
109. Oaklander AL, Buchbinder BR. Pregabalin-withdrawal encephalopathy and splenial edema: a link to high-altitude illness? Ann Neurol 2005;58(2):309-12 (Pubitemid 41098888)
110. Prilipko O, Delavelle J, Seeck M. Pregabalin-withdrawal encephalopathy and splenial edema. Ann Neurol 2006;59(1):214
111. Einarsdottir S, Bjornsson E. Pregabalin as a probable cause of acute liver injury. Eur J Gastroenterol Hepatol 2008;20(10):1049
112. Lindh J. Hepatic adverse effects of pregabalin (Lyrica). Lakartidningen 2010;107(4):194
113. Dogan S, Ozberk S, Yurci A. Pregabalin-induced hepatotoxicity. Eur J Gastroenterol Hepatol 2011;23(7):628
114. Sendra JM, Junyent TT, Pellicer MJ. Pregabalin-induced hepatotoxicity. Ann Pharmacother 2011;45(6):e32
115. Eipe N, Penning J. Postoperative respiratory depression with pregabalin: a case series and a preoperative decision algorithm. Pain Res Manag 2011;16(5):353-6
116. Jokela R, Ahonen J, Tallgren M, et al. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain 2008;134(1-2):106-12 (Pubitemid 350251009)
117. Pregabalin: new drug. Very similar to gabapentin. Prescrire Int 2005;14:203-6
118. Bockbrader HN, Burger P, Knapp L. Pregabalin effect on steady-state pharmacokinetics of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, valproate, and tiagabine. Epilepsia 2011;52(2):405-9
119. Cada DJ, Levien D, Baker DE. Pregabalin. Hospital Pharmacy 2006;41(2):157-72
120. Rosenstock J, Cappelleri JC, Bolinder B, Gerber RA. Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with type 1 or type 2 diabetes. Diabetes Care 2004;27(6):1318-23 (Pubitemid 38679977)
121. Richter RW, Portenoy R, Sharma U, et al. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain 2005;6(4):253-60 (Pubitemid 40488803)
122. Tolle T, Freynhagen R, Versavel M, et al. Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study. Eur J Pain 2008;12(2):203-13 (Pubitemid 350180540)
123. Arezzo JC, Rosenstock J, Lamoreaux L, Pauer L. Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: A double-blind placebo-controlled trial. BMC Neurol 2008;8:33
124. Baron R, Mayoral V, Leijon G, et al. Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy. Curr Med Res Opin 2009;25(7):1677-87
125. Zin CS, Nissen LM, O'Callaghan JP, et al. Preliminary study of the plasma and cerebrospinal fluid concentrations of IL-6 and IL-10 in patients with chronic pain receiving intrathecal opioid infusions by chronically implanted pump for pain management. Pain Med 2010;11(4):550-61
126. Pontari MA, Krieger JN, Litwin MS, et al. Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial. Arch Intern Med 2010;170(17):1586-93
127. van Seventer R, Bach FW, Toth CC, et al. Pregabalin in the treatment of post-traumatic peripheral neuropathic pain: a randomized double-blind trial. Eur J Neurol 2010;17(8):1082-9
128. Simpson DM, Schifitto G, Clifford DB, et al. Pregabalin for painful HIV neuropathy: a randomized, double-blind, placebo-controlled trial. Neurology 2010;74(5):413-20
129. Moon DE, Lee DI, Lee SC, et al. Efficacy and tolerability of pregabalin using a flexible, optimized dose schedule in Korean patients with peripheral neuropathic pain: a 10-week, randomized, double-blind, placebo-controlled, multicenter study. Clin Ther 2010;32(14):2370-85
130. Gray P, Kirby J, Smith MT, et al. Pregabalin in severe burn injury pain: A double-blind, randomised placebo-controlled trial. Pain 2011;152(6):1279-88
131. Semel D, Murphy TK, Zlateva G, et al. Evaluation of the safety and efficacy of pregabalin in older patients with neuropathic pain: results from a pooled analysis of 11 clinical studies. BMC Fam Pract 2010;11:85