Effect of dose reduction of dutasteride in combination with alpha-blockers in patients with lower urinary tract symptoms/benign prostatic enlargement

Context: Dutasteride is used in the treatment of benign prostate enlargement with reported many side effects.

Aims: The purpose of this study is to examine how different doses of dutasteride (0.5 mg) in combination with tamsulosin affect the outcome of treatment of benign prostatic enlargement (BPE).

Settings and design: Prospective study (phase III trial).

Subjects and methods: Between April 2017 and March 2020, this randomized study was conducted on 300 patients with moderate-to-severe lower urinary tract symptoms attributable to BPE and a prostate volume of more than 40 cc. The patients were divided into three therapy groups at random (one-to-one randomization), each with 100 patients: (Group I) daily tamsulosin 0.4 mg plus dutasteride (0.5 mg). (Group II) every other day tamsulosin 0.4 mg plus dutasteride 0.5 mg. (Group III) once a week tamsulosin 0.4 mg plus dutasteride 0.5 mg.

Statistical analysis: Statistical analysis was carried out with the help of the SPSS program 22. (IBM, Armonk, NY, USA). The mean and standard deviation (SD) are used to express quantitative data (SD). When comparing two means, an independent-samples t-test of significance was used. To compare more than two means, a one-way analysis of variance was utilized. For multiple comparisons between distinct variables, a post hoc test was performed.

Results: Patients were followed up every 3 months, with a 1-year follow-up to examine the medications' efficacy, prostate size reduction, and erectile function. After 1 year of treatment, all groups showed significant improvement in their symptom scores. However, Groups I and II experienced a considerable reduction in prostate size after therapy, but Group III experienced no meaningful reduction. In terms of sexual dysfunction, there was a considerable shift in Group I after 12 months.

Conclusions: Dutasteride treatment on the other day schedule has the same efficacy as the daily dose on prostate size at the same time; the other day scheduled dose has better preservation of sexual function.