Efficacy and Safety of Naftopidil in Patients With Neurogenic Lower Urinary Tract Dysfunction: An 8-Week, Active-Controlled, Stratified-Randomized, Double-Blind, Double-Dummy, Parallel Group, Noninferiority, Multicenter Design

摘要

Purpose: The aim of this study was to evaluate the efficacy and safety of naftopidil compared with tamsulosin in patients withneurogenic lower urinary tract dysfunction (LUTD).Methods: This study was conducted as an 8-week, active-controlled, stratified-randomized, double-blind, double-dummy,parallel group, noninferiority, and multicenter clinical trial. After 2 weeks of screening, eligible subjects were randomly assigned to receive naftopidil (25 mg for 1 week followed by 75 mg for 7 weeks) or tamsulosin (0.2 mg for 8 weeks). Primaryendpoint was a change of International Prostatic Symptom Score (IPSS) total score after 8 weeks of treatment.Results: One hundred ninety-four subjects with neurogenic LUTD were included into this trial. There were no differences between the 2 groups in baseline characteristics, including urodynamic study results, subtype of LUTD, pretreatment and concomitant medication, and causes of neurogenic bladder. The medication compliance rate was 94.0% (naftopidil, 93.6%; tamsulosin, 94.4%). There was a statistically significant decrease of IPSS total score at 8 weeks versus baseline in both the naftopidil(-5.64±0.66) and tamsulosin (-6.53±0.65) groups (P0.0001 each). The mean difference between both groups was 0.89 (upper limit of 95% confidential interval, 2.72), which was lower than the noninferiority limit of 3 points. A subgroup analysis ofneurologic lesions and sex found no mean difference of IPSS total score in each group. There was also no difference in safetyprofiles, including treatment emergent adverse events.Conclusions: Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had asimilar safety profile.