Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy.
OBJECTIVE
This randomised, double-blind study compared the newer antiepileptic drugs (AEDs) gabapentin (GBP) and lamotrigine (LTG) as monotherapy in newly diagnosed epilepsy.


METHODS
Patients with partial seizures with and/or without secondary generalization or primary generalized tonic-clonic seizures were randomized to either GBP or LTG. During 2- and 6-week titration periods, respectively, GBP dosage reached 1,800 mg/day, and LTG, 150 mg/day. In the subsequent 24-week maintenance phase, the dose could be adjusted based on seizure control or adverse events between 1,200 and 3,600 mg/day for GBP and 100 and 300 mg/day for LTG. The primary end point was time to exit, a composite of efficacy and tolerability. Evaluable patients were used for the primary efficacy analysis, whereas tolerability was examined on an intent-to-treat basis.


RESULTS
A total of 309 patients was randomized, and 291 (148 GBP, 143 LTG) were included in the evaluable population. Nineteen patients in each group had an exit event. The median time to exit was 69 days for GBP and 48 days for LTG. The hazard ratio was estimated as 1.043 (90% confidence intervals, 0.602-1.809). Overall, 106 (71.6% of the evaluable population) GBP-treated and 96 (67.1%) LTG-treated patients completed the study. Of those, 80 (75.5%) patients taking GBP and 73 (76.0%) taking LTG remained seizure free during the final 12 weeks of treatment. Only 14 (8.9%) GBP-treated patients and 15 (9.9%) LTG-treated patients withdrew because of study drug-related adverse events.


CONCLUSIONS
GBP and LTG monotherapy were similarly effective and well tolerated in patients with newly diagnosed epilepsy.
Epilepsy Unit, University Department of Medicine and Therapeutics, Western Infirmary, Glasgow, Scotland. Martin.J.Brodie@clinmed.gla.ac.uk
Martin J
MJ
Brodie
David W
DW
Chadwick
Henning
H
Anhut
Andreas
A
Otte
Silke-Lo
SL
Messmer
Stephen
S
Maton
Wilhelm
W
Sauermann
Guta
G
Murray
Elizabeth A
EA
Garofalo
D000085:Acetates / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000588:Amines; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D001247:Asthenia / Q000139:chemically induced; D002985:Clinical Protocols; D003509:Cyclohexanecarboxylic Acids; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D004828:Epilepsies, Partial / Q000188:drug therapy; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D000077206:Gabapentin; D006261:Headache / Q000139:chemically induced; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D016016:Proportional Hazards Models; D016019:Survival Analysis; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use*; D005680:gamma-Aminobutyric Acid
D000085:Acetates; D000588:Amines; D000927:Anticonvulsants; D003509:Cyclohexanecarboxylic Acids; D014227:Triazines; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D000077213:Lamotrigine