Efficacy and safety of tamsulosin for benign prostatic hyperplasia: clinical experience in the primary care setting

Authors: Flannery, Michael T.¹; Ramsdell, Joe²; Ranhosky, Alan³; Davidai, Giora⁴; Ruoff, Gary⁵

Source: Current Medical Research and Opinion, Volume 22, Number 4, April 2006 , pp. 721-730(10)

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Abstract:

Objective: This study evaluated the efficacy and safety of the α_1A/α_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 ≥ 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.

Keywords: BENIGN PROSTATIC HYPERPLASIA; ALPHA-BLOCKER; PRIMARY CARE SETTING; TAMSULOSIN

Document Type: Research article

DOI: http://dx.doi.org/10.1185/030079906X96443

Affiliations: 1: Department of Internal Medicine, University of South Florida, Tampa, FL, USA 2: UCSD School of Medicine, San Diego, CA, USA 3: Department of Clinical Research, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA 4: General Medicine/Cardiology, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA 5: Westside Family Medical Center, Kalamazoo, MI, USA

Publication date: 2006-04-01

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Efficacy and safety of tamsulosin for benign prostatic hyperplasia: clinical experience in the primary care setting

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