A 21-week open-label clinical trial of pregabalin as adjunctive therapy in partial seizures at multiple centers in Mexico (PREPS Mexico).
OBJECTIVE
To investigate the efficacy of pregabalin in the treatment of refractory partial seizures.


METHODS
This was a 21-week, open-label study of pregabalin (150-600 mg/day) as an adjunctive therapy in adults with refractory partial seizures. The study included an 8-week baseline period, a 9-week dose-optimization period, and a 12-week treatment-observation period. The primary assessment was mean percentage change in 28-day seizure rate between baseline and the last 12 weeks of treatment.


RESULTS
In total, 136 Mexican patients were included in this study (55.9% women; mean age/epilepsy duration, 35.2/22.9 years). The median and mean (95% confidence interval [CI]) 28-day baseline seizure rates were 3.9 and 7.8 (5.4-10.2), respectively. The mean (95% CI) reduction in seizure frequency was 51.2% (43.0-59.3) over the last 12 weeks of treatment, while the median reduction was 57.9%. The percentage of patients with a ≥ 5 0% or ≥ 75% reduction in seizure frequency was 63.6% and 48.8%, respectively. The percentage of patients who were seizure-free during the last 4 and 12 weeks of treatment was 40.5% and 20.7%, respectively. The most common adverse events were somnolence (39.7%), dizziness (16.2%), and weight gain (14.0%).


CONCLUSIONS
Pregabalin was well tolerated and associated with significant reductions in seizure frequency.
CIMA Centro Internacional de Medicina, Consultorio 16, Haciendas del Valle No 7120, Col Plaza Haciendas Chihuahua, Chihuahua 31238, Mexico. drleopoldo.rivera@yahoo.com
Leopoldo
L
Rivera-Castaño
Raul
R
Leal-Cantu
Paula
P
Abreu
Marita
M
Guerrero
Gabriela
G
Davila
D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000453:epidemiology*; D005260:Female; D006801:Humans; D008297:Male; D008800:Mexico / Q000453:epidemiology; D008875:Middle Aged; D000069583:Pregabalin; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
D000927:Anticonvulsants; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid