[Clinical efficacy and safety of long-term administration of YM617 for urinary obstruction of the lower urinary tract]

Abstract

The efficacy and safety of YM617, a new alpha 1-blocker, were evaluated in 121 patients with urinary obstruction of the lower urinary tract in the long-term administration study for 1 year. A total of 121 patients, i.e., 111 with benign prostatic hypertrophy (BPH), 6 with bladder neck sclerosis (BNS), 3 with BPH with BNS and 1 with female urinary obstruction, were orally administered 0.1 to 0.4 mg of YM617 once daily. Patients showing improvement of patient's impression and of subjective symptoms judged by the physician were increased until the 16th to 20th week, and it had been maintained there after. Objective findings were improved to a constant level after the 4th week. Patient's impression and subjective symptoms were improved in a certain dose-response relationship Side effects were observed in 3 patients but none were serious. YM617 proved to be useful in the treatment of patients with urinary obstruction of the lower urinary tract like BPH because it maintained the efficacy and safety in the long-term administration.