Clinical evaluation of SUN 1165 in patients with ventricular premature contractions - A multicenter double-blind dose finding study.:A Multicenter Double-Blind Dose Finding Study

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A multicenter double-blind controlled study was conducted in 146 patients with ventricularpremature contractions (VPC) to find an optimal dose regimen for SUN 1165 (N- [2, 6-dimethylphenyl] -8-pyrrolizidinylacetamide hydrochloride hemihydrate), a new antiarrhythmicagent. Patients were administered any one of a daily oral dosage of 75 mg (low), 150 mg (intermediate), and 225 mg (high) of SUN 1165, divided into three doses a day for twoweeks after one to two weeks of control period. Improvement of arrhythmia was assessed by the reduction in frequency and the gradeof premature contractions, and global improvement was assessed from the results of improvementof arrhythmia and subjective symptoms. In the improvement of arrhythmia aswell as global improvement, the high-and intermediate-dose groups showed significantlyhigher response rate than the low-dose group, whereas no significant difference was observedbetween the intermediate-and high-dose groups. There were no significant differences in the overall safety rating among the three doselevels.Incidences of the cases in which some problems concerning safety were pointed outin the low-, intermediate-and high-dose groups, were 6%, 9%, and 15%, respectively andno serious case was observed. The clinical usefulness of the drug was assessed, based on the results of global improvementand the overall safety. The drug was assessed to be useful or better in 30% of thepatients of the low-dose group, 61% of the intermediate-dose group, 74% of the highdosegroup.The high-and intermediate-dose groups showed significantly higher usefulnessrating than the low-dose group, but no significant difference was observed between thehigh-and intermediate-dose groups. In conclusion, SUN 1165 was shown to be useful in the treatment of ventricular prematurecontractions, and an optimal dosage of 150mg/day was suggested.
一般社団法人日本臨床薬理学会の論文

Clinical evaluation of SUN 1165 in patients with ventricular premature contractions - A multicenter double-blind dose finding study.:A Multicenter Double-Blind Dose Finding Study

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