Dosing to efficacy with neurontin: the STEPS trial. Study of Titration to Effect Profile of Safety.
The STEPS (Study of Titration to Effect Profile of Safety) trial, a 16-week, open-label, postmarketing multicenter study, assessed the efficacy of gabapentin as adjunctive therapy in patients with inadequately controlled partial seizures. Inclusion criteria were less restrictive than for Phase III studies, to include a population more representative of the patient population treated in clinical practice. Gabapentin was titrated up to a maximal dosage of 3600 mg/day to achieve seizure control or to tolerability. The efficacy analysis included compliant patients who had completed approximately 16 weeks of therapy (n = 1055); 573 received < or = 1800 mg/day and 482 received > or = 1800 mg/day. The average decrease in seizure frequency was 61%, the percentage of seizure-free patients was 46.35%, and the percentage of patients with a > or = 50% decrease in seizure frequency was 76.05%. The cumulative percentage of responders and of patients who were seizure free increased with each dosage increase. The results confirm that titration to efficacy is appropriate for adjunctive therapy with gabapentin in patients with partial epilepsy treated in clinical practice.
Morrell
M J
MJ
Department of Neurology, Columbia University College of Physicians & Surgeons, New York, New York, USA.
D000085:Acetates / Q000008:administration & dosage* / Q000627:therapeutic use; D000328:Adult; D000588:Amines; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D003509:Cyclohexanecarboxylic Acids; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D000077206:Gabapentin; D006801:Humans; D008297:Male; D010818:Practice Patterns, Physicians'; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid
D000085:Acetates; D000588:Amines; D000927:Anticonvulsants; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin