Safety and efficacy of tamsulosin 0.4 mg as an initial dose in 1,219 Korean patients with moderate to severe lower urinary tract symptoms: data from a phase IV study.

Background: An initial dose of tamsulosin 0.2 mg is frequently prescribed for Asian men. We investigated the safety and efficacy of tamsulosin 0.4 mg as the initial dose in Korean men with moderate to severe lower urinary tract symptoms (LUTSs) in everyday clinical practice. Materials and methods: A phase IV study was conducted in South Korea. Eligible patients were prescribed tamsulosin 0.4 mg for 6 months. We excluded patients with previous exposure to LUTS drugs and patients with an international prostate symptom score (IPSS) < 8. Results: The mean total IPSS, storage subscore, voiding symptoms subscore, and quality of life significantly decreased from 18.0, 10.8, 7.2, and 3.8 to 12.8, 7.5, 5.3, and 2.6, respectively, after 6 months of treatment. The number of nocturia episodes significantly decreased from 3.0 to 2.2 in patients who reported at least 2 nocturia events at baseline. A mean reduction in the IPSS was quantitatively equivalent in all age groups. The mean reduction in the IPSS was greater in the IPSS ≥ 20 group than in the IPSS < 20 group (mean reduction in the total IPSS: -2.6 in the IPSS < 20 group; -9.4 in the IPSS ≥ 20 group). All treatment-emergent adverse events were mild. The most frequently recorded treatment-emergent adverse event was dizziness, which was reported in 22 patients (1.8%). Conclusion: Treatment of LUTS with tamsulosin 0.4 mg as the initial dose for 6 months in Korean men was effective in improving LUTS and showed a favorable safety profile in a real-life setting.