塩酸ピルジカイニド（ＳＵＮ１１６５）の上室性期外収縮に対する臨床評価 用量検討のための多施設二重盲検比較試験

Abstract

A multicenter double-blind controlled study was conducted in 109 patients with supraventricular premature contractions (SVPC) to find an optimal dose regimen for pilsicainide hydrochloride, a new antiarrhythmic agent.Patients were administered any one of daily oral doses of 75mg (low), 150mg (intermediate) and 225mg (high) of pilsicainide hydrochloride divided into three times a day for two weeks after one to two weeks of control period.Improvement of arrhythmia was assessed by the reduction in frequency and the grade of premature contractions, and global improvement was assessed from the results of improvement of arrhythmia and subjective symptoms. In the improvement of arrhythmia as well as global improvement, the high and intermediate dose groups showed significantly higher response rate than that in the low dose group, whereas no significant difference was observed between the intermediate and high dose groups.There were no significant differences in the overall safety rating among the three dose levels. Incidence of the cases in which some problems concerning safety was pointed out in the low, intermediate and high dose groups, were 6%, 11% and 21% respectively, and no serious case was observed.The clinical usefulness of the drug was assessed, based on the results of global improvement and the overall safety. The drug was assessed to be useful or better in 29% of the patients of low dose group, 61% of intermediate dose group, 70% of high dose group. The intermediate dose group showed significantly higher usefulness rating than that in the low dose group, but no significant difference was observed between the high and intermediate dose group.In conclusion, pilsicainide hydrochloride was shown to be useful in the supraventricular premature contractions, and an optimal dose of 150mg/day was suggested.