Tamsulosin: 3-year long-term efficacy and safety in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction: Analysis of a European, multinational, multicenter, open-label study

Objective: Th is open-la bel extension study evaluated the efficacy and saf ety of tamsulosin (0.4 mg as a modified release formulation) once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign pros tatic obstruction (BPO) treated for up to 3 years. Methods: Patients were e nrolled from two European, 12-week, placebo-controlled trials. This analysi s reports on 355 patients randomized originally to tamsulosin (n = 244) or placebo (n = 111) in the two placebo-controlled trials with follow-up data for up to 3 years. Results: The significant improvements in the primary eff icacy parameters, maximum urinary flow rate (Q(max)) and total Boyarsky sym ptom score that were observed during the placebo-controlled trials were sus tained throughout the long-term extension study for up to 3 years in patien ts who remained on therapy. Mean Q(max) increased from baseline (range 0.7- 1.8 ml/s; p < 0.05 vs. baseline) and remained between 11.5 and 12 ml/s duri ng the entire follow-up period. Total Boyarsky symptom score also improved from baseline (range -3.7 to -4.1 (or -39 to -44%); p < 0.001 vs. baseline) . Similarly, the percentage of treatment responders, defined as an increase in Q(max) of greater than or equal to 30% or a decrease in total symptom s core of greater than or equal to 25%, remained constant throughout the 3-ye ar period. The number of patients who had a clinically significant total Bo yarsky symptom score response ranged between 69 and 80%. During the 3-year study period, 95 patients (27%) experienced an adverse event considered to be possibly or probably related to study medication, the most common of whi ch (occurring in less than or equal to 6% of patients) were dizziness and a bnormal ejaculation. There were no clinically significant changes in blood pressure or pulse rate during the study. Conclusion: Long-term tamsulosin t herapy is safe, well-tolerated and improvements in urinary flow and symptom s a re maintained in patients with LUTS suggestive of BPO who remain on tre atment for up to 3 years. Copyright (C) 1999 S. Karger AG, Basel.