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Efficacy and safety of dutasteride with tadalafil add-on therapy in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia

Gotoh D, Torimoto K, Morizawa Y, Hori S, Nakai Y, Miyake M, Fujimoto K

Research Square, 2022

Abstract

Abstract Objective: To evaluate the efficacy and safety of add-on therapy with the phosphodiesterase type 5 inhibitor tadalafil in Japanese men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) treated with dutasteride.Results: The participants had a mean age of 68.9 ± 7.4 years and prostate volume of 37.1 ± 14.2 mL as measured using transabdominal sonography. The efficacy indicators, such as International Prostate Symptom Score, quality of life score, night-time urinary frequency, and night-time maximum voided volume, improved significantly at 4 weeks, and the effects lasted until 24 weeks. Overactive bladder symptom score and sexual health inventory for men significantly improved at 12 weeks, and the effects lasted until 24 weeks. However, maximum urine flow and residual urine volume showed no improvement at any point. Adverse events occurred in two cases. Taken together, add-on therapy with tadalafil was effective for patients with LUTS/BPH resistant to dutasteride monotherapy. In addition, this therapy was not associated with severe adverse events.

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