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ABSTRACT
Objective: This study evaluated the efficacy and safety of the α1A/α1D 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 ≥ 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.