Rising dose study of safety and tolerance of flunarizine.
Rising dose study of safety and tolerance of flunarizine.
复制标题
氟桂利嗪安全性和耐受性的增加剂量研究。
DOI:
10.1007/bf00192365
复制
发表时间:
1995
影响因子:
2.9
通讯作者:
Treiman,DM
中科院分区:
文献类型:
--
作者:
Handforth,A;Mai,T;Treiman,DM
In a recent NIH-sponsored parallel-group placebo-controlled blinded study of flunarizine for the treatment of partial-onset seizures, the flunarizine serum concentration was controlled to a constant level among patients in order to reduce response variability. Flunarizine was found to exhibit modest anti-epileptic efficacy. A potential criticism of this study is that the chosen controlled concentration was too low to determine optimal efficacy.As a participating center in this study we investigated the effect of higher doses of open-label flunarizine on seizure frequency in 16 patients with refractory partial seizures. Following the completion of the blinded placebo/flunarizine phase, all patients were initiated at the flunarizine dose calculated to result in a serum concentration of 60 ng·ml−1. The dose was subsequently increased each 8–12 weeks to a maximum of 2.7 times the initial dose.On the initial maintenance flunarizine dose, seizure control was improved, with an average seizure reduction of 47% compared to pre-blinded-phase baseline. When higher doses were administered, adverse reactions were more common yet improved seizure control did not occur in most patients.These findings complement those of the concentration-controlled NIH study and suggest that appropriate flunarizine doses were utilized in that study.