Single dose methodology to assess the influence of an α1‐adrenoceptor antagonist on uroflowmetric parameters in patients with benign prostatic hyperplasia

• Published in: British journal of clinical pharmacology 2000-03, Vol.49 (3), p.269-273
• Main Authors: Curtis, S. P., Eardley, I., Boyce, M., Larson, P., Haesen, R., Gottesdiener, K., Gertz, B. J.
• Format: Article
• Language: English
• Subjects: benign prostatic hyperplasia; Biological and medical sciences; Medical sciences; Pharmacology. Drug treatments; Short Reports; Urinary system; uroflowmetry; α1‐adrenoceptor antagonist
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1046/j.1365-2125.2000.00137.x

Aims  To establish methodology which rapidly and reliably assesses the effect of an α1‐adrenoceptor antagonist on peak urine flow rates in men with benign prostatic hyperplasia (BPH). This methodology could then be applied to screening new drugs to treat BPH. Methods  Twenty‐five patients with BPH enrolled in a double‐blind, placebo‐controlled, two‐period crossover study. Patients were either withdrawn from their current α1‐adrenoceptor antagonist therapy (n = 22) or were untreated prestudy (n = 3) and all met prespecified uroflowmetric criteria including: (1) a peak urine flow rate (Qmax)  0.200 for between group difference). Conclusions  Both single and multiple doses of tamsulosin 0.4 mg increased Qmax in men with BPH. A single dose produced a comparable response to multiple dose administration. The magnitude of the effect was greater than the effect generally seen in longer term clinical trials, but this difference may be explained by the patient population in this study which was preselected for ‘responsiveness’ to an α1‐adrenoceptor antagonist. These results support the utility of single dose uroflowmetric measurements in rapidly providing preliminary data on new investigational agents, specifically agents which act to increase urine flow in men with BPH. However, clinical efficacy would still need to be confirmed with longer term clinical trials.