Effects of dutasteride on storage and voiding symptoms in male patients with lower urinary tract symptoms as a result of benign prostatic obstruction: the 1-year outcomes from a prospective urodynamic study.

OBJECTIVES: To investigate the effects of dutasteride 0.5 mg once daily for 12 months on lower urinary tract symptoms in treatment-naïve patients with benign prostatic hyperplasia. METHODS: The present open-label, single-center, prospective study recruited 105 outpatients. International Prostate Symptom Score, Overactive Bladder Symptom Score, quality of life score testing and Benign Prostatic Hyperplasia Impact Index were used for assessing subjective symptoms. Urodynamic study including uroflowmetry, cystometry and pressure flow study were carried out to evaluate objective symptoms. As parameters of storage function, first desire to void, maximum cystometric capacity and occurrence of involuntary detrusor contraction were measured, whereas maximum flow rate, detrusor pressure at maximum flow rate, post-void residual urine and bladder outlet obstruction index were assessed as parameters of voiding function. Wilcoxon's rank-sum test, Student's t-test and the χ(2)-test were carried out to evaluate changes in subjective and objective symptoms. RESULTS: A total of 97 patients with a mean age of 68.8 years and mean prostate volume of 57.6 mL were included in the analysis. Subjective symptom parameters improved significantly after 2 months, and progressively improved until after 12 months. Significant improvements in storage function objective parameters and voiding function objective parameters were observed after 6 months, and further improvements were obtained after 12 months. CONCLUSIONS: Dutasteride is effective in relieving lower urinary tract symptoms by improving storage and voiding function, as well as subjective symptoms in patients with benign prostatic hyperplasia.

Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia.

OBJECTIVES: To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH). METHODS: This was a randomized, double-blind, placebo-controlled, parallel-group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated. RESULTS: Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug-related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting. CONCLUSIONS: Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one-year treatment period.

[Assessment of recommended dose of dutasteride on Japanese men with benign prostatic hyperplasia: a randomized, double-blind, placebo-controlled, parallel-group, dose response study].

The efficacy, safety and recommended dose of dutasteride on Japanese men with benign prostatic hyperplasia (BPH) have been assessed in a randomized, double-blind, placebo-controlled, parallel-group study. A total of 284 patients with BPH were randomized to dutasteride (0.05, 0.5 or 2.5 mg) or placebo once daily for 24 weeks. At week 24, the 0.5 mg dose of dutasteride decreased serum dihydrotestosterone (DHT) levels by approximately 90% and reduced prostate volume by approximately 25%, comparable with the highest dose ofdutasteride 2.5 mg. In addition, dutasteride 0.5 mg significantly improved International Prostate Symptom Score (IPSS) and Q(max) compared to placebo. These results show that 0.5 mg appears to be the lowest dose at which DHT was almost completely suppressed, together with a substantial reduction of prostate volume. Dutasteride was generally well tolerated throughout 24 weeks therapy. Given the above, 0.5 mg has been chosen as the recommended dose in Japanese men with BPH.