高血圧患者に対する塩酸イミダブリルの有用性,特に空咳発現について,マレイン酸エナラプリルを対照とした比較検討 多施設共同空咳発現頻度調査

摘要

The incidence of cough and antihypertensive effect of imidapril were compared to those of enalapril by a cross over method in mild to severe hypertensive patients as a multicenter trial.Doctors in 196 institutes participated in this study and 539 patients were enrolled. The data in 489 of 539 patients in whom the study was correctly conducted on the protocol were analyzed.In 246 of 489 patients, imidapril (5-10mg/day) was given as an initial drug for 12 weeks and then it was switched to enalapril. Enalapril was also administered for 12 weeks. On the other hand, in 243 of 489 patients, enalapril (5-10mg/day) was given as an initial drug for 12 weeks and then it was switched to imidapril.To evaluate the incidence and the degree of cough induced by ACE inhibitors, the questionnaires were performed before the administration of drugs and every 4 weeks, and blood examinations were performed before the administration of drug, at the end of initial treatment and at the end of the study.1.The frequency of cough was significantly higher in the enalapril group (85/220, 38.6%) than in the imidapril group (32/210, 15.2%).The difference of the frequency was about 2.5 times.2.20.9% of the patients in whom cough was not observed by imidapril developed cough affer switching to enalapril.On the other hand,0.9% of the patients in whom cough was not observed by enalapril developed cough on imidapril.3.52.8% (37/70) of the patients in whom cough was observed by enalapril, didn't have cough after switching to imidapril. On the other hand, all of the patients in whom cough was observed by imidapril had cough after switching to enalapril.4.No significant difference was observed in antihypertensive effect between imidapril (115/180,63.9%) and enalapril (121/223,54.3%).5.No significant difference was observed in overall safety assessed as "no clinical problems" between imidapril(168/213,78.9%)and enalapril (121/223, 54.3%).From these results, it was considered that antihypertensive effect of imidapril is similar to those of enalapril, but the incidence of cough induced by imidapril is about a half of enalapril.