OBJECTIVE: This study evaluated the efficacy and safety of the alpha(1A)/alpha(1D) subtype-selective blocker tamsulosin for the increasingly common treatment of benign prostatic hyperplasia (BPH) in the primary care setting. METHODS: A total of 493 men (age > or = 45 years), 99.6% of whom had moderate or severe BPH at baseline, were given tamsulosin 0.4 mg/day in a multicenter, open-label study conducted over 45 days by 42 primary care physicians and two urologists. RESULTS: Mean American Urological Association (AUA) Symptom Score decreased by 7.5 from a baseline of 20.0 on day 4, representing a 37.5% improvement over baseline (p < 0.001). AUA Obstructive and Irritative Scores declined significantly by day 4 (-4.7 and -2.7, respectively), as did AUA Bother Score (-5.4, p < 0.001) and mean BPH Impact Score (-2.5, p < 0.001). The Investigator's Global Assessment showed slight or greater improvement in 77.2% of patients (13.7% markedly improved). Effects were maintained from day 4 through day 45. CONCLUSIONS: Overall, patients treated with tamsulosin in a primary care setting experienced rapid, significant improvement in their signs and symptoms of BPH, based upon the change in the AUA Symptom Score. Tamsulosin was well tolerated; no new safety concerns were observed. Tamsulosin was not associated with significant effects on blood pressure or first-dose hypotension.
OBJECTIVE: This study evaluated the efficacy and safety of the alpha(1A)/alpha(1D) subtype-selective blocker tamsulosin for the increasingly common treatment of benign prostatic hyperplasia (BPH) in the primary care setting. METHODS: A total of 493 men (age > or = 45 years), 99.6% of whom had moderate or severe BPH at baseline, were given tamsulosin 0.4 mg/day in a multicenter, open-label study conducted over 45 days by 42 primary care physicians and two urologists. RESULTS: Mean American Urological Association (AUA) Symptom Score decreased by 7.5 from a baseline of 20.0 on day 4, representing a 37.5% improvement over baseline (p < 0.001). AUA Obstructive and Irritative Scores declined significantly by day 4 (-4.7 and -2.7, respectively), as did AUA Bother Score (-5.4, p < 0.001) and mean BPH Impact Score (-2.5, p < 0.001). The Investigator's Global Assessment showed slight or greater improvement in 77.2% of patients (13.7% markedly improved). Effects were maintained from day 4 through day 45. CONCLUSIONS: Overall, patients treated with tamsulosin in a primary care setting experienced rapid, significant improvement in their signs and symptoms of BPH, based upon the change in the AUA Symptom Score. Tamsulosin was well tolerated; no new safety concerns were observed. Tamsulosin was not associated with significant effects on blood pressure or first-dose hypotension.