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From the Walton Centre for Neurology and Neurosurgery (Dr. Chadwick), Liverpool, UK; and Parke-Davis Pharmaceutical Research, Freiburg (Drs. Anhut and Murray), Germany, and Ann Arbor (Drs. Greiner, Alexander, Garofalo, and Pierce), MI.
Address correspondence and reprint requests to Jeannine Alexander, Parke-Davis Pharmaceutical Research, 2800 Plymouth Road, Ann Arbor, MI 48105.
Background: 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 Patients could be withdrawn for lack of efficacy, adverse events, or noncompliance.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.
*See the Appendix on page 1287 for a listing of members of the International Gabapentin Monotherapy Study Group 945-77.
This study was supported by Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company.
Received March 25, 1998. Accepted in final form July 27, 1998.
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