BACKGROUND: The present study assessed the long-term efficacy (>12 months) of tamsulosin in 123 patients with lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). METHODS: The patients received a starting dose of tamsulosin of 0.2 mg/day, with a further titration up to 0.4 mg/day until symptom relief. Subjective and objective clinical variables were assessed using the international prostate symptom score (IPSS), IPSS quality of life (QoL) score, BPH impact index score, peak urinary flow rate (Q(max)) and postvoid residual urine volume. RESULTS: Except for Q(max), all clinical variables showed significant sustained improvements from baseline throughout the study period (median follow up, 43 months). Thirty patients (24.4%) withdrew because of surgical interventions. The Cox proportional hazards model showed that a baseline IPSS total score >or=15 (HR [hazard ratio] 2.13; 95% CI 1.04-4.34) was predictive of failure for tamsulosin therapy. Furthermore, during the first 12 months, a lowest IPSS total score >or=13 (HR 2.34; 95% CI 1.12-4.89), a lowest IPSS QoL score >or=3 (HR 4.16; 95% CI 1.26-13.68), and a lowest BPH impact index score >or=4 (HR 3.54; 95% CI 1.62-7.75) were also predictive of failure for tamsulosin therapy. CONCLUSIONS: Tamsulosin treatment of BPH patients for more than 12 months showed a sustained, stable efficacy. Patients without short-term effects were prone to withdraw from tamsulosin therapy, but so did patients with a high baseline IPSS total score, even if therapy was effective for at least 12 months.
BACKGROUND: The present study assessed the long-term efficacy (>12 months) of tamsulosin in 123 patients with lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). METHODS: The patients received a starting dose of tamsulosin of 0.2 mg/day, with a further titration up to 0.4 mg/day until symptom relief. Subjective and objective clinical variables were assessed using the international prostate symptom score (IPSS), IPSS quality of life (QoL) score, BPH impact index score, peak urinary flow rate (Q(max)) and postvoid residual urine volume. RESULTS: Except for Q(max), all clinical variables showed significant sustained improvements from baseline throughout the study period (median follow up, 43 months). Thirty patients (24.4%) withdrew because of surgical interventions. The Cox proportional hazards model showed that a baseline IPSS total score >or=15 (HR [hazard ratio] 2.13; 95% CI 1.04-4.34) was predictive of failure for tamsulosin therapy. Furthermore, during the first 12 months, a lowest IPSS total score >or=13 (HR 2.34; 95% CI 1.12-4.89), a lowest IPSS QoL score >or=3 (HR 4.16; 95% CI 1.26-13.68), and a lowest BPH impact index score >or=4 (HR 3.54; 95% CI 1.62-7.75) were also predictive of failure for tamsulosin therapy. CONCLUSIONS:Tamsulosin treatment of BPH patients for more than 12 months showed a sustained, stable efficacy. Patients without short-term effects were prone to withdraw from tamsulosin therapy, but so did patients with a high baseline IPSS total score, even if therapy was effective for at least 12 months.