1043-3155 Pediatr Neurol Briefs pedneurbriefs Pediatr Neurol Briefs Pediatric Neurology Briefs Pediatr Neurol Briefs 2166-6482 1043-3155 2166-3155 Pediatric Neurology Briefs Publishers Chicago, IL, USA PNB-8-49 10.15844/pedneurbriefs-8-7-1 Antiepileptic Therapies Neurology Pediatrics Nervous System Diseases Child Development Brain Diseases Neurosurgery Child Infant Gabapentin [Neurontin®]: Efficacy and Safety http://orcid.org/0000-0002-0173-7931 Millichap J. Gordon MD 1 2 * Division of Neurology, Children's Memorial Hospital, Chicago, IL Departments of Pediatrics and Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL Correspondence: Dr. J. Gordon Millichap, E-mail: jgmillichap@northwestern.edu 07 1994 01 06 2016 8 7 49 49 Copyright: © 1994 The Author(s) 1994 This work is licensed under the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Clinical efficacy and safety of gabapentin

The results of three large, placebo-controlled, multicenter clinical trials of gabapentin as add-on therapy in patients with refractory partial seizures are summarized in a report from the Departments of Neurology and Psychiatry and the International Center for Epilepsy, University of Miami School of Medicine, and the Veterans Affairs Medical Center, Miami, FL.

 Gabapentin Tonic-Clonic Seizures Ataxia

The results of three large, placebo-controlled, multicenter clinical trials of gabapentin as add-on therapy in patients with refractory partial seizures are summarized in a report from the Departments of Neurology and Psychiatry and the International Center for Epilepsy, University of Miami School of Medicine, and the Veterans Affairs Medical Center, Miami, FL. In a total of 705 patients (646 evaluable), mean age 33 years, treated the responder rate (RR) ranged from 17.6 to 28% in those receiving 600 to 1800 mg gabapentin daily; the median seizure frequency decreased by 17.8 to 31.9% in gabapentin-treated compared with 0.3 to 12.5% in placebo-control patients. Based on the RR (the percentage of patients with >50% decrease in seizure frequency), a dose-response effect was present for simple partial, complex partial, and secondarily generalized tonic-clonic seizures. Adverse effects, primarily mild to moderate in severity and transient, mainly affected the CNS and included somnolence (24%), dizziness (20%), and ataxia (17%). Skin rash in only 0.54% gabapentin-treated patients compared to an average 5 to 10% incidence with traditional AEDs. No significant changes in liver function were noted. [1]

COMMENT. Gabapentin is approved for patients >12 years of age with partial and secondarily generalized seizures. The role of gabapentin in the management of epilepsy is the subject of five papers in the above Neurology supplement. In addition to efficacy and safety addressed by Ramsay RE, the profile of desirable properties of a new AED are outlined by Mattson RH, the mechanism of action of gabapentin is reviewed by Taylor CP, and its lack of drug interaction and advantageous pharmacokinetics are stressed by McLean MJ. The absence of interactions between gabapentin and other AEDs and the rarity of serious adverse effects should encourage the expansion of clinical trials to include children younger than 12 years of age.

 Ramsay RE Clinical efficacy and safety of gabapentin Neurology 1994 Jun 44 6 Suppl 5 S23 30 8022537