前立腺肥大症に伴う男性下部尿路症状に対するナフトピジルとシロドシンの無作為クロスオーバー試験

Abstract

We compared the efficacy, safety, and patient preferences for two α1-adrenoceptor (AR) antagonists with different affinity for AR subtypes, naftopidil (Naf) and silodosin (Silo), for the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia (male LUTS/BPH). New patients diagnosed with male LUTS/BPH were randomly divided into either the Naf-Silo group or the Silo-Naf group (Naf : 50-75 mg once daily for 2 weeks followed by 75 mg once daily for 4 weeks ; Silo : 2-4 mg twice daily for 2 weeks followed by 4 mg twice daily for 4 weeks). A survey was conducted to evaluate patient drug preferences after completion of the study and the reasons for the preferences. Naf and Silo improved the total International Prostate Symptom Score (IPSS) compared with baseline. There was no significant difference between Naf and Silo in improvement in the IPSS total score. Adverse effects were more frequent with Silo than with Naf (P=0. 002). No significant difference in patient preference for the drugs was observed. These findings indicate that Naf and Silo provide similar clinical efficacy, with no difference in patient preference for the drugs, although adverse effects were significantly more frequent with Silo than with Naf.