TY - JOUR
T1 - Reduction of secondarily generalized tonic-clonic (SGTC) seizures with pregabalin
AU - Briggs, Deborah E.
AU - Lee, Caroline M.
AU - Spiegel, Katharyn
AU - French, Jacqueline A.
N1 - Funding Information:
Financial declarations: Dr Briggs declares that she has no potential conflicts of interest. Ms Lee and Dr Spiegel were employees of Pfizer during the time these individual trials were performed and during the development of this paper. They are no longer employees of Pfizer. Both own stock in Pfizer. Twenty percent of Dr French's salary derives from work on behalf of The Epilepsy Therapy Development Project, a non-profit organization. The Epilepsy Therapy Development Project has received funds from Pfizer. Dr French has received no funds from Pfizer in the last 12 months outside of her salary. She has provided consulting work for Pfizer and has attended consulting meetings.
PY - 2008/11
Y1 - 2008/11
N2 - Purpose: To determine whether pregabalin reduces SGTC seizures in clinically refractory epilepsy. Methods: Design: Post hoc analysis performed on pooled data from three double-blind, placebo-controlled trials of similar design. Participants: Patients with partial seizures who failed ≥2 antiepileptic drugs at maximally tolerated doses. This analysis excluded those who did not have an SGTC seizure during baseline or treatment periods. Outcome measure: Absolute and conditional reduction analyses examined change from baseline in SGTC seizure rates. The absolute reduction analysis used response ratio (RRatio) to compare reduction in seizure-frequency from baseline (B) during a 12-week treatment (T) period [RRatio = ((T - B)/(T + B)) × 100]. The conditional analysis examined proportional risk of having SGTC seizure if a partial seizure had occurred. Results: Of 1052 intent-to-treat patients, 409 were included. Sixteen were seizure-free during treatment and not included in the conditional analysis. A significant reduction in absolute SGTC seizures from baseline was observed in patients receiving pregabalin 600 mg/day (treatment RRatio, -33 versus placebo, -3.7; P = 0.0005). A lower dose of pregabalin (300 mg/day), administered in one study, demonstrated a trend (nonsignificant) toward reduced SGTC seizures (treatment, -24.7 versus placebo, -10.0; P = 0.2493). Conclusion: As adjunctive therapy, pregabalin 600 mg/day is effective in reducing the absolute frequency of SGTC seizures in patients with refractory partial epilepsy, but not secondary generalization.
AB - Purpose: To determine whether pregabalin reduces SGTC seizures in clinically refractory epilepsy. Methods: Design: Post hoc analysis performed on pooled data from three double-blind, placebo-controlled trials of similar design. Participants: Patients with partial seizures who failed ≥2 antiepileptic drugs at maximally tolerated doses. This analysis excluded those who did not have an SGTC seizure during baseline or treatment periods. Outcome measure: Absolute and conditional reduction analyses examined change from baseline in SGTC seizure rates. The absolute reduction analysis used response ratio (RRatio) to compare reduction in seizure-frequency from baseline (B) during a 12-week treatment (T) period [RRatio = ((T - B)/(T + B)) × 100]. The conditional analysis examined proportional risk of having SGTC seizure if a partial seizure had occurred. Results: Of 1052 intent-to-treat patients, 409 were included. Sixteen were seizure-free during treatment and not included in the conditional analysis. A significant reduction in absolute SGTC seizures from baseline was observed in patients receiving pregabalin 600 mg/day (treatment RRatio, -33 versus placebo, -3.7; P = 0.0005). A lower dose of pregabalin (300 mg/day), administered in one study, demonstrated a trend (nonsignificant) toward reduced SGTC seizures (treatment, -24.7 versus placebo, -10.0; P = 0.2493). Conclusion: As adjunctive therapy, pregabalin 600 mg/day is effective in reducing the absolute frequency of SGTC seizures in patients with refractory partial epilepsy, but not secondary generalization.
KW - Placebo-controlled study
KW - Pregabalin
KW - Refractory partial epilepsy
KW - Secondarily generalized tonic-clonic
KW - Seizure reduction
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U2 - 10.1016/j.eplepsyres.2008.07.004
DO - 10.1016/j.eplepsyres.2008.07.004
M3 - Article
C2 - 18752932
AN - SCOPUS:64149132484
SN - 0920-1211
VL - 82
SP - 86
EP - 92
JO - Epilepsy Research
JF - Epilepsy Research
IS - 1
ER -