PREGABALIN SHOWS EFFICACY IN REDUCING SIMPLE PARTIAL, COMPLEX PARTIAL, AND SECONDARILY GENERALIZED SEIZURES
Abstract number :
2.244
Submission category :
Year :
2003
Submission ID :
3912
Source :
www.aesnet.org
Presentation date :
12/6/2003 12:00:00 AM
Published date :
Dec 1, 2003, 06:00 AM
Authors :
Martha J. Greiner, Alan R. Kugler, Caroline M. Lee, Lloyd E. Knapp, Elizabeth A. Garofalo Pfizer Global Research and Development, Pfizer Inc, Ann Arbor, MI
Pregabalin is an alpha[sub]2[/sub]-delta ([alpha][sub]2[/sub]-[delta]) ligand that exhibits analgesic, anxiolytic, and anticonvulsant activity. This current study determines whether pregabalin is efficacious when examining the individual seizure subtypes of simple partial, complex partial, and secondarily generalized tonic-clonic seizures (SGTC).
Data in this analysis were from a pooled analysis of three large, randomized, placebo-controlled, parallel-group, add-on, epilepsy studies, which consisted of 8-week baseline and 12-week double-blind phases. Refractory patients were currently receiving at least one but no more than three AEDs. Pregabalin was administered in doses of 50, 150, 300, or 600 mg/day, in BID or TID regimens. In these trials, pregabalin dosed at 150, 300, or 600 mg/day (BID or TID) was highly effective in reducing seizure frequency versus placebo. Primary population was intent-to-treat (ITT), defined as all patients randomized to treatment that received at least one dose of study medication. Individual studies were not powered to detect differences by seizure type, therefore a post-hoc meta-analysis was performed pooling across the 3 similarly designed studies by dose regimen and total daily dose. Pregabalin RRatio values, percent change, and responder rates were compared to placebo using 95% CI and/or p-values.
As was seen for all partial seizures combined, pregabalin shows evidence of increasing efficacy with increasing dose within each seizure subtype. At doses starting at 150 mg/day, pregabalin showed significant (p[le]0.0142) reduction compared to placebo in complex partial seizures. At 600 mg/day, pregabalin was superior to placebo in reducing simple partial, complex partial, and SGTC seizures (p[le]0.0139). Percent change and responder rate meta-analyses reveal similar conclusions.
Pregabalin is well-tolerated. Pregabalin is efficacious in reducing simple partial, complex partial, and secondarily generalized tonic-clonic seizures.
[Supported by: Pfizer Global Research and Development.]