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A double-blind trial of gabapentin monotherapy for newly diagnosed partial seizures. International Gabapentin Monotherapy Study Group 945-77.

AbstractBACKGROUND:
Gabapentin is widely approved as add-on therapy for epilepsy treatment for partial seizures with and without secondary generalization. To investigate the efficacy of gabapentin administered as monotherapy in patients with newly diagnosed partial epilepsy, a randomized double-blind trial was performed.
METHODS:
Eligible patients were randomized to receive one of three masked doses of gabapentin (300, 900, or 1,800 mg/day) or open-label carbamazepine (600 mg/day) and kept daily seizure diaries throughout the study. After titration, patients entered a 24-week evaluation phase. Patients were required to exit the study if they experienced an exit event, defined as a total of three simple or complex partial seizures, one generalized tonic-clonic (GTC) seizure, or status epilepticus. Patients could be withdrawn for lack of efficacy, adverse events, or noncompliance. Kaplan-Meier statistics were used to estimate the probability that patients would continue in the study without having an exit event.
RESULTS:
Time to exit event was longer for patients on 900 mg/day (n = 72) or 1,800 mg/day (n = 74) of gabapentin than for patients receiving 300 mg/day (n = 72; p = 0.0395 and 0.0175, respectively). The most clinically relevant measure of retention on treatment (exit event plus adverse event withdrawal rate) was similar for carbamazepine (n = 74) and 1,800 mg/day gabapentin (54% versus 57%) but was lower (better) for 900 mg/day gabapentin (44%). No unexpected new adverse events emerged with gabapentin monotherapy.
CONCLUSIONS:
Gabapentin at 900 or 1,800 mg/day is effective and safe as monotherapy for patients with newly diagnosed partial epilepsy.
AuthorsD W Chadwick, H Anhut, M J Greiner, J Alexander, G H Murray, E A Garofalo, M W Pierce
JournalNeurology (Neurology) Vol. 51 Issue 5 Pg. 1282-8 (Nov 1998) ISSN: 0028-3878 [Print] United States
PMID9818846 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Acetates
  • Amines
  • Anticonvulsants
  • Cyclohexanecarboxylic Acids
  • Carbamazepine
  • gamma-Aminobutyric Acid
  • Gabapentin
Topics
  • Acetates (adverse effects, therapeutic use)
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amines
  • Anticonvulsants (adverse effects, therapeutic use)
  • Carbamazepine (adverse effects, therapeutic use)
  • Child
  • Cyclohexanecarboxylic Acids
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Epilepsies, Partial (drug therapy)
  • Female
  • Gabapentin
  • Humans
  • Male
  • Medical Records
  • Middle Aged
  • Seizures (drug therapy)
  • gamma-Aminobutyric Acid

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