[The effects of dutasteride on voiding and storage symptoms in men with benign
prostatic hyperplasia]. [Article in Japanese]
Author(s): Tsukamoto T, Shirai T, Sakamoto S, Akiyama A, Takeuchi H, Yajima M, Terao T, Endo
Y.
Affiliation(s): The Department of Urology, Sapporo Medical University School of Medicine.
Publication date & source: 2010, Hinyokika Kiyo. , 56(12):677-82
We investigated the effects of dutasteride on voiding and storage symptoms by a
post-hoc analysis from two randomized, placebo-controlled, parallel-group studies
(Japanese phase II study and phase III study) which assessed the efficacy and
safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).
Men aged 50 years and older, with a prostate volume of 30 cc or greater, an
International Prostate Symptom Score (IPSS) of 8 or higher and maximal urinary
flow rate of 15 ml/sec or lower were randomized to placebo or dutasteride groups.
The number of subjects for the placebo and dutasteride groups was respectively 72
and 72 in the phase II study, and 185 and 193 in the phase III study. Questions
1, 3, 5 and 6 of IPSS were related to voiding symptoms, and Questions 2, 4 and 7
were related to storage symptoms. Changes between pre- and post-treatments were
evaluated. In the phase II study, dutasteride significantly improved voiding
symptoms and numerically improved storage symptoms compared with the placebo at
week 24. In the phase III study, dutasteride significantly improved voiding and
storage symptoms compared with the placebo after 52 weeks. These consistent
results suggest that dutasteride is effective for both voiding and storage
symptoms in Japanese men with BPH.
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