EFFICACY AND TOLERABILITY OF GABAPENTIN IN CLINICAL-PRACTICE

The efficacy and tolerability of gabapentin therapy for seizures in patients in clinical practice were retrospectively evaluated. Demographics, seizure type and history, prior anticonvulsant therapy, concomitant anticonvulsant medications, gabapentin dosing, side effects, seizure response, and tolerability data were obtained from 100 consecutive clinical practice patients (47 men and 53 women) treated with gabapentin. All patients had been previously treated with a mean of 2.9 anticonvulsant drugs and were currently taking a mean of 1.75 anticonvulsant drugs. Seventy-two patients experienced a greater than 50% reduction in seizures, and 23 of these patients experienced a greater than 75% reduction; 57 patients continued gabapentin treatment, 5 of whom remain seizure free and side effect free with gabapentin monotherapy. Of the 42 patients discontinuing treatment, 17 had no seizure reduction, 17 had side effects, and 8 had both. One additional patient died. The mean daily dosage for all 100 patients was 2107 mg, and the mean daily dosage for patients who continued gabapentin treatment was 2270 mg. No linear relationship was found between dosage and patient weight. Fifty-two patients had the dosage of at least 1 concomitant anticonvulsant medication reduced, 31 had at least 1 concomitant anticonvulsant medication removed from the regimen, and 9 required a dosage increase of at least 1 anticonvulsant medication. Twenty patients experienced fatigue, which was usually transient after treatment initiation; in 13 patients fatigue was associated with carbamazepine therapy. In addition, 7 patients experienced ataxia (6 of whom were taking concomitant carbamazepine), and 2 experienced weight gain. Patients experiencing side effects resulting in discontinuation were taking a mean daily dose of gabapentin of 1182 mg. The maximum effective and tolerable daily dosage under clinical practice conditions appears to exceed dosages established in clinical trials. The results of our study suggest broader treatment parameters for gabapentin than initially determined in the more restrictive clinical trials conducted during the drug's development.