The safety and tolerability profile of gabapentin in optimal doses;Perfil de seguridad y tolerabilidad de la gabapentina en dosis óptimas

Revista de Neurologia

Volumn 39, Issue 4, 2004, Pages 371-380

  Cañadillas Hidalgo, Francisco M ^a  

^a HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

Author keywords

Epilepsy; Gabapentin; High doses; Safety; Side effects; Tolerability

Indexed keywords

GABAPENTIN;

ABDOMINAL PAIN; ANOREXIA; ANORGASMIA; ASTHENIA; ATAXIA; BLOOD BRAIN BARRIER; BRONCHITIS; CHOREOATHETOSIS; CONVULSION; DIARRHEA; DIPLOPIA; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DYSARTHRIA; DYSPEPSIA; DYSTONIA; ECZEMA; FLAPPING TREMOR; FOCAL EPILEPSY; HEADACHE; HUMAN; HYPERACTIVITY; HYPERKINESIA; HYPERSALIVATION; MENTAL INSTABILITY; MYALGIA; NAUSEA; NYSTAGMUS; PARESTHESIA; RASH; REVIEW; RHINITIS; SIDE EFFECT; SOMNOLENCE; TREMOR; URINE INCONTINENCE; VISUAL IMPAIRMENT; VOMITING;

EID: 4744349344     PISSN: 02100010     EISSN: None     Source Type: Journal    
DOI: 10.33588/rn.3904.2003502     Document Type: Review

References (69)

1. Marson AG, Kadir ZA, Hutton JL, Chadwick DW. The new antiepileptic drugs: a systematic review of their efficacy and tolerability. Epilepsia 1997; 38: 859-80.
2. Chadwick DW, Anhut H, Greiner MJ, Alexander J, Murray GH, Garofalo EA, et al. A double-blind trial of gabapentin monotherapy for newly diagnosed partial seizures. International Gabapentin Monotherapy Study Group 945-77. Neurology 1998; 51: 1282-8.
3. Lesser RP, Pippenger CE, Lüders HO, Dinner DS. High-dose monotherapy in treatment of intractable seizures. Neurology 1984; 34: 707-11.
4. Cobos JE. High-dose phenytoin in the treatment of refractory epilepsy. Epilepsia 1987; 28: 111-4.
5. Ohtsuka Y, Amano R, Mizukawa M, Oka E, Ohtahara S. Treatment of intractable childhood epilepsy with high-dose valproate. Epilepsia 1992; 33: 158-64.
6. Walker MC, Parsalos PN. The tolerability and safety profile of gabapentin. Rev Contemp Pharmacother 1996; 7: 249-25.
7. McLean MJ. Gabapentin: Pharmacokinetics, efficacy, safety and tolerability. Drugs Today 1998; 34 (Suppl): 13-30.
8. Comstock TJ, Sica DA, Bockbrader HN, Underwood BA, Sedman AJ. Gabapentin pharmacokinetics in subjects with various degrees of renal function. J Clin Pharmacol 1990; 30: 862.
9. McLean MJ. Gabapentin in the management of convulsive disorders. Epilepsia 1999; 40 (Suppl 6): S39-50.
10. Taylor CP. Gabapentin: Mechanisms of action. In Levy RH, Mattson RH, Meldrum BS, eds. Antiepileptic Drugs. 4 ed. Raven Press: New York; 1995. p. 829-41.
11. Stewart BH, Kugler AR, Thompson PR, Bockbrader HN. A saturable transport mechanism in the intestinal absorption of gabapentin is the underlying cause of lack of proportionality between increasing dose and drug levels in plasma. Pharm Res 1993; 10: 276-81.
12. Wilson EA, Forrest G, Brodie MJ. High-dose gabapentin is absorbed and can be effective. Epilepsia 1996; 37 (Suppl 4): S127.
13. Wilson EA, Sills GJ, Forrest G, Brodie MJ. High dose gabapentin in refractory partial epilepsy: clinical observations in 50 patients. Epilepsy Res 1998; 29: 161-6.
14. Beydoun A, Fakhoury T, Nasreddine W, Abou-Khalil B. Conversion to high dose gabapentin monotherapy in patients with medically refractory partial epilepsy. Epilepsia 1998; 39: 188-93.
15. Gidal BE, Maly MM, Budde J, Lensmeyer GL, Pitterle ME, Jones JC. Effect of high-protein meal on gabapentin pharmacokinetics. Epilepsy Res 1996; 23: 71-6.
16. Gidal BE, Maly MM, Kowalski JW, Rutecki PA, Budde J, Pitterle ME, et al. Gabapentin absorption: effect of mixing with foods of varying macronutrient composition. Ann Pharmacother 1998; 32: 405-8.
17. Bourgeois B. New dosage and formulations of AEDs for use in pediatric epilepsy. Neurology 2002; 58 (Suppl 7): S2-5.
18. Ben-Menachen E, Persson II, Hedner T. Selected CSF biochemistry and gabapentin concentrations in the CSF and plasma in patients with partial seizures after a single oral dose of gabapentin. Epilepsiy Res 1990; 11: 45-9.
19. Ojemann LM, Friel PN, Ojemann GA. Gabapentin concentrations in human brain. Epilepsia 1990; 29: 694.
20. Radulovic LL, Türk D, von Hodenberg A, Vollmer KO, McNally WP, Dehart PD, et al. Disposition of gabapentin (Neurontin) in mice, rats, dogs and monkeys. Drug Metab Dispos 1995; 23: 441-8.
21. Herranz JL. Datos actuales sobre la Gabapentina. Rev Neurol 2000; 30 (Supl 1): S125-31.
22. Graves NM, Leppik IE, Wagner ML, Spencer MM, Erdmann GR. Effect of gabapentin on carbamazepine levels. Epilepsia 1990; 31: 644-5.
23. Hooper WD, Kavanagh MC, Herkes GK, Eadie MJ. Lack of a phamacokinetic interaction between phenobarbitone and gabapentin. Br J Clin Pharmacol 1990; 31: 171-4.
24. Graves NM, Holmes GB, Leppik IE, Rask C, Slavin M, Anhut H. Phamacokinetics of gabapentin in patients treated with phenytoin. Pharmacotherapy 1989; 9: 196.
25. Uthman BM, Hammond EJ, Wilder BJ. Absence of gabapentin and valproate interaction: An evoked potential and phamacokinetic study. Epilepsia 1990; 31: 645.
26. Goa KL, Sorkin EM. Gabapentin: A review of its pharmacological properties and clinical potential in epilepsy. Drugs 1993; 46: 409-27.
27. Tyndel F. Interaction of gabapentin with other antiepileptics. Lancet 1994; 343: 1363-4.
28. Sánchez A, Durán JA, García R, Margarito C, Poveda JL. Posible interacción gabapentina-fenitoína. Rev Neurol 2002; 34: 952-3.
29. Hussein G, Troupin AS, Montouris G. Gabapentin interaction with felbamato. Neurology 1996; 47: 1106.
30. Ramsay RE. Clinical efficacy and safety of gabapentin. Neurology 1994; 44 (Suppl 5): S23-30.
31. Fischer JH, Barr AN, Rogers SL, Fischer PA, Trudeau VL. Lack of serious toxicity following gabapentin overdose. Neurology 1994; 44: 982-3.
32. The US Gabapentin study group n.° 5. Gabapentin as add-on therapy in refractory partial epilepsy: a double-blinb, placebo-controlled, parallel-group study. Neurology 1993; 43: 2292-8.
33. UK Gabapentin study group. Gabapentin in partial epilepsy. Lancet 1990; 335: 1114-7.
34. Marson AG, Kadir ZA, Hutton JL, Chadwick DW. Gabapentin add-on for drug-resistant partial epilepsy (Cochrane Review). Cochrane Library. 2 ed. Oxford: Update Software; 2001.
35. Anhut H, Ashman P, Feuerstein TJ, Sauermann W, Saunders M, Schmidt B. Gabapentin (Neurontin) as add-on therapy in patients with partial seizures: a double-blind, placebo-controlled study. The International Gabapentin Study Group. Epilepsia 1994; 35: 795-801.
36. Appleton R, Fichtner K, LaMoreaux L, Alexander J, Halsall G, Murray G, et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 12 week, multicentre, double blind placebo controlled study. Epilepsia 1999; 40: 1147-54.
37. Sivenius J, Kaviainen R, Ylinen A, Riekkinen P. Double blind study of gabapentin in the treatment of partial seizues. Epilepsia 1991; 32: 539-42.
38. McLean MJ, Morrell MJ, Willmore LJ, Privitera MD, Faught RE, Holmes GL, et al. Safety and tolerability of gabapentin as adjuntive therapy in a large, multicenter study. Epilepsia 1999; 40: 965-72.
39. Beran R, Berkovic S, Black A, Danta G, Dunne J, Frasca J, et al. Australian Study of Titration to Effefct Profile of Safety (AUS-STEPS): High-dose gabapentin (Neurontin) in partial seizures. Epilepsia 2001; 42: 1135-9.
40. Bruni J on behalf of the NEON (Neurontin Evaluation of Outcomes in Neurological Practice) Study Investigators Group. Outcome evaluation of gabapentin as add-on therapy for partial seizures. Can J Neurol Sci 1998; 25: 134-40.
41. Baulac M, Cavalcanti D, Semah F, Arzimanoglou A, Poltal JJ. Gabapentin add-on therapy with adaptable doses in 610 patients with partial epilepsy: an open observational study. The French Gabapentin Collaborative Group. Seizure 1998; 7: 55-62.
42. Herranz JL, Sol JM, Hernández G, Grupo Español Colaborativo de Gabapentina. Gabapentina asociada en 559 pacientes con epilepsias parciales. Estudio obsevacional multicéntrico. Rev Neurol 2000; 30: 1141-5.
43. Heilbroner L, Devinski O. Monotherapy with gabapentin for partial epilepsy: a review of 30 cases. J Epilepsy 1997; 10: 220-4.
44. Beydoun A, Fisher J, Labar DR, Harden C, Cantrell D, Uthman BM, et al. Gabapentin monotherapy: II. A 26 week, double-blind, dosis controlled, multicenter study of conversion from polytherapy in outpatients with refractory complex partial or secondarily generalized seizures. Neurology 1997; 49: 746-52.
45. García-Fleta F, Medrano-Martínez V, Castaño- Pérez MD, Hernández-Lorido R, Mañes R. Gabapentina en 50 pacientes con epilepsia. Rev Neurol 2001; 32: 45-9.
46. Asconape J, Collins T. Weight gain associates with the use of gabapentin. Epilepsia 1995; 36 (Suppl 4): 72 [abstract].
47. De Toledo JC, Toledo C, De Cerce J, Ramsay RE. Changes in body weight with chronic, high dose gabapentin therapy. Ther Drug Monit 1997; 19: 394-6.
48. Bergey GK, Morris HH, Rosenfeld W, Blume WT, Penovich PE, Morrell MJ, et al. Gabapentin monotherapy: I. An eight day, double-blind, dose-controlled, multicenter study in hospitalized patients with refractory complex partial or secondarily generalized seizures. Neurology 1997; 49: 739-45.
49. Fisher RS, Sachdeo RC, Pellock J, Penovich PE, Magnus L, Bernstein P. Rapid initiation of gabapentin. A randomized, controlled trial. Neurology 2001; 56: 743-8.
50. Brodie MJ, Chadwick DW, Anhut H, Otte A, Messmer S, Maton S, et al. Gabapentin versus lamotrigine monotherapy: A double-blind comparison in newly diagnosed epilepsy. Epilepsia 2002; 43: 993-1000.
51. Ouellet D, Bockbrader HN, Wesche DL, Shapiro DY, Garofalo E. Population pharmacokinetics of gabapentin in infants and children. Epilepsy Res 2001; 47: 229-41.
52. Appleton R, Fichtner K, LaMoreaux L, Alexander J, Maton S, Murray G, et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 24 week, multicentre, open-label study. Dev Med Child Neurol 2001; 43: 269-730.
53. Korn-Merker E, Borusiak P, Boenigk HE. Gabapentin in childhood epilepsy: a prospective evaluation of efficacy and safety. Epilepsy Res 2000; 38: 27-32.
54. Cramer JA, Fisher R, Ben Menachen E, French J, Mattson RH. New antiepileptic drugs: Comparison of key clinical trials. Epilepsia 1999; 40: 590-600.
55. Marson AG, Kadir ZA, Hutton JL, Chadwick DW. The new antiepileptic drugs: A systematic review of their efficacy and tolerability. Epilepsia 1997; 38: 859-80.
56. Ragucci MV, Cohen JM. Gabapentin induced hypersensitivy syndrome. Clin Neuropharmacol 2001; 24: 103-5.
57. González-Sicilia L, Cano A, Serrano M, Hernández J. Stevens Johnson syndrome associated with gabapentin. Am J Med 1998; 105: 455.
58. Gallay BJ, de Mattos AM, Norman AJ. Reversible acute renal allograft dysfunction due to gabapentin. Tansplantation 2000; 70: 208-9.
59. Chudnow RS, Dewey RB Jr, Lawson CR. Choreoathetosis as a side-effect of gabapentin therapy in severely neurologically impaired patients. Arch Neurol 1997; 54: 910-2.
60. Steinhoff BJ, Herendorf G, Bittermann HJ, Kurth C. Isolated ataxia as a idiosyncrasic side-effect under gabapentin. Seizure 1997; 6: 503-4.
61. Reeves AL, So EL, Sharbrough FW, Krahn LE. Movement disorders associated with the use of gabapentin. Epilepsia 1996; 37: 988-90.
62. Clark D, Elliot J. Gabapentin induced anorgasmia. Neurology 1999; 53: 2209.
63. Poovathoor C, Ranganthan PC, El-Shafie O. Asterixis induced by gabapentin. Clin Neuropharmacol 2000; 23: 53.
64. Gil-Nagel A, Gapany S, Blesi K, Villanueva N, Bergen D. Incontinence during treatment with gabapentin. Neurology 1997; 48: 1467-8.
65. Farhat G, Yamount B, Mikati MA, Dermirjian S, Sawaya R, El Hajj F. Effect of antiepileptic drugs on bone density in ambulatory patients. Neurology 2002; 58: 1348-53.
66. Wilton LV, Shakir S. A postmarketing surveillance study of gabapentin as add-on therapy for 3100 patients in England. Epilepsia 2002; 43: 983-92.
67. Singler RE, Gough AW, de la Iglesia FA. Pancreatic acinar cell neoplasia in male Wistar rats following 2 years of gabapentin exposure. Toxicology 1995; 98: 73-92.
68. French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, Harden CL, et al. Efficacy and tolerability of the new antiepileptic drugs I: Treatment of new onset epilepsy. Report of the Therapeutics and Technology Assessment Subcommittee and Quality Standars Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 2004; 62: 1252-60.
69. French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, Harden CL, et al. Efficacy and tolerability of the new antiepileptic drugs II: Treatment of refractory epilepsy. Report of the Therapeutics and Technology Assessment Subcommittee and Quality Standars Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 2004; 62: 1261-73.