PMID- 7925148 OWN - NLM STAT- MEDLINE DCOM- 19941121 LR - 20190813 IS - 0013-9580 (Print) IS - 0013-9580 (Linking) VI - 35 IP - 5 DP - 1994 Sep-Oct TI - Efficacy and tolerance of long-term, high-dose gabapentin: additional observations. PG - 1032-7 AB - Gabapentin (GBP) has shown antiepileptic efficacy and good tolerance in clinical trials. Much remains to be learned about its clinical use. As a participating center in the US Gabapentin Study Group, we report observations that have practical implications for patient management. Twenty-three patients with intractable partial-onset seizures initiated open-label treatment after a blinded placebo-controlled add-on dose efficacy study. In the titration phase, GBP and concurrent antiepileptic drugs (AEDs) were adjusted to achieve optimal efficacy on maximally tolerated GBP doses. Nine patients had no significant improvement in seizure control and discontinued GBP. The remaining 14 patients were observed while treated long-term with stable-dose GBP and concurrent AEDs. Improvement was maintained as long as patients were followed: < or = 4 years. The protocol-allowed upper dose limit, 2,400 mg/day, was well tolerated by 16 of 23 patients, indicating that higher doses may be tolerated. GBP discontinuation did not cause rebound increases in seizure frequency. The most common adverse events (AEs) (in 14 of 23) were similar to those induced by concurrent AEDs and responded to reduction of concurrent AEDs. Many patients reported positive psychostimulatory effects. These observations extend previous findings indicating that GBP is an effective and well-tolerated drug for treatment of partial-onset seizures. FAU - Handforth, A AU - Handforth A AD - Neurology Service, Department of Veterans Affairs Medical Center, West Los Angeles, California 90073. FAU - Treiman, D M AU - Treiman DM LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - Epilepsia JT - Epilepsia JID - 2983306R RN - 0 (Acetates) RN - 0 (Amines) RN - 0 (Anticonvulsants) RN - 0 (Cyclohexanecarboxylic Acids) RN - 0 (Placebos) RN - 56-12-2 (gamma-Aminobutyric Acid) RN - 6CW7F3G59X (Gabapentin) SB - IM MH - Acetates/administration & dosage/adverse effects/*therapeutic use MH - Adult MH - *Amines MH - Anticonvulsants/administration & dosage/adverse effects/*therapeutic use MH - *Cyclohexanecarboxylic Acids MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Therapy, Combination MH - Drug Tolerance MH - Epilepsies, Partial/*drug therapy MH - Female MH - Follow-Up Studies MH - Gabapentin MH - Humans MH - Male MH - Middle Aged MH - Patient Dropouts MH - Placebos MH - *gamma-Aminobutyric Acid EDAT- 1994/09/01 00:00 MHDA- 1994/09/01 00:01 CRDT- 1994/09/01 00:00 PHST- 1994/09/01 00:00 [pubmed] PHST- 1994/09/01 00:01 [medline] PHST- 1994/09/01 00:00 [entrez] AID - 10.1111/j.1528-1157.1994.tb02551.x [doi] PST - ppublish SO - Epilepsia. 1994 Sep-Oct;35(5):1032-7. doi: 10.1111/j.1528-1157.1994.tb02551.x.