Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial

Abstract

OBJECTIVES To compare the efficacy and safety of two α1a/α1d adrenoceptor (AR) antagonists with different affinity for the α1AR subtypes, tamsulosin and naftopidil, in the treatment of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS Patients with BPH were randomized to receive either tamsulosin or naftopidil. The primary efficacy variables were the changes in the total International Prostate Symptom Score (IPSS), maximum flow rate on free uroflowmetry, and residual urine volume. The secondary efficacy variables were average flow rate, changes in the IPSS storage score, IPSS voiding score, and quality‐of‐life (QoL) Index score, from baseline to endpoint (12 weeks). Data on all randomized patients were included in the safety analyses for adverse effects and changes in blood pressure. RESULTS Of the 185 patients enrolled data for 144 who were eligible for inclusion in the efficacy analysis were analysed (75 from the tamsulosin and 69 from the naftopidil group). There was no significant difference in any variable at baseline between the groups. There were satistically significant improvements for all primary and secondary variables in both groups, except for residual urine in the tamsulosin group. However, there was no significant intergroup difference in the improvement of any efficacy variable between the groups. The adverse effects were comparable, with no significant differences in systolic and diastolic blood pressure after treatment in both groups. CONCLUSIONS This study suggests that naftopidil is as effective and safe as tamsulosin. Both drugs were effective in improving storage and voiding symptoms. However, there was no difference in clinical efficacy or adverse effects between the α1 AR antagonists with different affinity to α1 subtypes, α1a and α1d.

Correlation between the total volume, transitional zone volume of the prostate, transitional prostate zone index and lower urinary tract symptoms (LUTS)

“…Among these, it is important to emphasize the occurrence of progressive changes in the urinary bladder with aging, which take place at the same time as histopathological alterations of the prostate that may contribute to the LUTS [1,2]. These aspects reinforce the previous experiences that show the absence of a direct relationship between the prostate gland volume and the degree of urinary obstruction called ''prostatism sans prostate '' or ''small prostate, big residual'' [10,[23][24][25][26][27]. Explanations for this absence of correlation implied the occurrence of an intrinsic prostate tension, based on the contraction of stromal smooth muscles or extrinsic tension of the capsule on the transitional hypersplastic tissue [23][24][25].…”

Ejaculatory Disorders Caused by Alpha-1 Blockers for Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Comparison of Naftopidil and Tamsulosin in a Randomized Multicenter Study

“…In the present study, the improvements in the IPSS and QOL index were significantly higher with 0.2 mg tamsulosin than with 50 mg naftopidil. Gotoh et al [15] have reported the results of a prospective randomized study comparing the difference in clinical efficacy between 50 mg naftopidil and 0.2 mg tamsulosin for 12 weeks. They found no significant difference in the change of the IPSS between the 2 drugs (p = 0.060).…”

LUTS treatment: Future treatment options

“…However, this difference (which was suggested to depend on differences in affinity for a 1 -AR subtypes between the drugs) could not be reproduced in a randomized head-to-head comparison between the drugs. 41 Based on available evidence, the importance of the a 1D -ARs on the detrusor myocytes for LUTS generation cannot be established. Nor can it be excluded that a 1D -ARs located elsewhere in the bladder, for example, the vasculature, 42 or in other structures, are of importance.…”