FLUNARIZINE FOR TREATMENT OF PARTIAL SEIZURES - RESULTS OF A CONCENTRATION-CONTROLLED TRIAL

被引:30
|
作者
PLEDGER, GW
SACKELLARES, JC
TREIMAN, DM
PELLOCK, JM
WRIGHT, FS
MIKATI, M
SAHLROOT, JT
TSAY, JY
DRAKE, ME
OLSON, L
HANDFORTH, CA
GARNETT, WR
SCHACHTER, S
KUPFERBERG, HJ
ASHWORTH, MR
MCCORMICK, C
LEIDERMAN, D
KAPETANOVIC, IM
DRISCOLL, S
OHARA, K
TORCHIN, CD
GENTILE, J
KAY, A
CEREGHINO, JJ
机构
[1] NINCDS,EPILEPSY BRANCH,BETHESDA,MD 20892
[2] UNIV MICHIGAN,ANN ARBOR,MI 48109
[3] UNIV CALIF LOS ANGELES,LOS ANGELES,CA
[4] VIRGINIA COMMONWEALTH UNIV,MED COLL VIRGINIA,RICHMOND,VA 23298
[5] CHILDRENS HOSP RES FDN,COLUMBUS,OH
[6] CHILDRENS HOSP,MED CTR,BOSTON,MA
[7] OHIO STATE UNIV,COLUMBUS,OH 43210
[8] BETH ISRAEL HOSP,BOSTON,MA 02215
关键词
D O I
10.1212/WNL.44.10.1830
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
The National Institutes of Health sponsored a randomized, double-blind, multicenter, placebo-controlled trial of flunarizine (FNR) in epileptic patients receiving concomitant phenytoin (PHT) or carbamazepine (CBZ). Because of FNR's long half-life (up to 7 weeks), a parallel rather than crossover design was used. Each patient received an individualized loading dose and maintenance dosage targeted at a 60-ng/ml plasma FNR concentration. Of 93 patients randomized, 92 provided seizure data for the full 25-week treatment period; one placebo-treated patient dropped out for personal reasons. Fifty-four patients received CBZ only, nine received PHT only, and 30 received both CBZ and PHT. Eighty-seven patients had a history of complex partial seizures, and 60 had secondarily generalized seizures. Eight patients discontinued FNR prematurely, all because of adverse neurologic or psychiatric signs or symptoms; depression was the specific cause in three cases. Calculated maintenance dosages, based on single-dose pharmacokinetic profiles, ranged from 7 to 138 mg/day (mean, 40 mg/day). Plasma FNR concentrations generally exceeded the target, with the highest concentrations observed immediately after loading; excluding the first three treatment weeks and all concentrations after a FNR dosage change, the median plasma FNR concentration was 71.7 ng/ml. The percent reduction from baseline seizure rate was statistically greater (p = 0.002) in the FNR-treated group (mean, 24.4%) than in the placebo-treated group (mean, 5.7%).
引用
收藏
页码:1830 / 1836
页数:7
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