TAMSULOSIN, A SELECTIVE ALPHA(1C)-ADRENOCEPTOR ANTAGONIST - A RANDOMIZED, CONTROLLED TRIAL IN PATIENTS WITH BENIGN PROSTATIC OBSTRUCTION (SYMPTOMATIC BPH)

Objective To evaluate the efficacy and safety of tamsulosin 0.4 mg onc e daily (as a modified-release formulation) compared with placebo in p atients with benign prostatic enlargement, lower urinary tract symptom s and prostatic 'obstruction' (symptomatic benign prostatic hyperplasi a [BPH]). Patients and methods Of 313 patients with symptomatic BPH en rolled in a 2-week placebo run-in period, 296 were subsequently random ized to receive either placebo (98 patients) or tamsulosin 0.4 mg once daily (198 patients) for 12 weeks, The primary variables assessed to determine efficacy were maximum urinary flow rate (Q(max)) from free-n ow measurements and the total Boyarsky symptom score. Results Tamsulos in produced greater improvements in Q(max) (1.4 mL/s, 13.1%) than did placebo (0.4 mL/s, 3:8%) (P=0.028) and a greater decrease in total sym ptom score (3.4 points, 35.8% reduction) than did placebo (2.2 points, 23.7% reduction) (P=0.002), Significantly more tamsulosin-treated pat ients (67%) than placebo-treated patients (44%) had a greater than or equal to 25% decrease in total symptom score after 12 weeks (P<0.001). Treatment with tamsulosin for 12 weeks also produced significant impr ovements in average urinary flow rate (P=0.040), irritative (P=0.013) and obstructive (P=0.014) symptom scores and symptoms of nocturia (P=0 .022) and hesitancy (P=0.004). Tamsulosin was tolerated well by the pa tients, The incidence of adverse events emerging during treatment was comparable in the tamsulosin- and placebo-treated groups (34% and 24% respectively, P=0.109), as was the incidence of cardiovascular-related adverse events (5% and 7% respectively; P=0.596). There were no signi ficant differences in changes in blood pressure or pulse rates between the tamsulosin- and placebo-treated groups. Conclusion Tamsulosin 0.4 mg once daily is safe, well tolerated and clinically effective in imp roving symptoms and urinary flow rate in patients with symptomatic BPH .