Multicenter, prospective, comparative cohort study evaluating the efficacy and safety of alfuzosin 10 mg with regard to blood pressure in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia with or without antihypertensive medications

Title
Multicenter, prospective, comparative cohort study evaluating the efficacy and safety of alfuzosin 10 mg with regard to blood pressure in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia with or without antihypertensive medications
Author(s)
문기학Li Tao Zhang[Li Tao Zhang]이성원[이성원]박광성[박광성]정우식[정우식]김세웅[김세웅]현재석[현재석]문두건[문두건]양상국[양상국]류지간[류지간]양대열[양대열]민권식[민권식]박종관[박종관]
Keywords
REAL-LIFE PRACTICE; PELVIC PAIN SYNDROME; DOUBLE-BLIND; FOLLOW-UP; PLACEBO; HYPERTENSION; EXPERIENCE; THERAPY; BPH; RETENTION
Issue Date
201501
Publisher
DOVE MEDICAL PRESS LTD
Citation
CLINICAL INTERVENTIONS IN AGING, v.10, pp.277 - 286
Abstract
Background: The objective of this study was to assess the efficacy and safety of alfuzosin 10 mg monotherapy or combined antihypertensive medication on blood pressure (BP) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS) with or without antihypertensive medication. Methods: This was a 3-month, multicenter, randomized, open-label study in 335 patients aged >45 years with a clinical diagnosis of BPH/LUTS by medical history and clinical examination, a total International Prostatic Symptom Score (IPSS) >= 8 points, a maximum flow rate >5 mL/sec and <= 15 mL/sec, and a voided volume >= 120 mL. Eligible subjects were randomized to receive alfuzosin 10 mg as monotherapy (group 1) or alfuzosin 10 mg + antihypertensive combination therapy (group 2). Based on baseline BP and hypertensive history with or without antihypertensive medications at first medical examination, group 1 was divided into two subgroups of normotensive and untreated hypertensive patients, and group 2 into two subgroups of controlled hypertensive and uncontrolled hypertensive patients. The primary study outcomes were change in IPSS, BP, and heart rate from baseline. Secondary outcomes were change in IPSS-quality of life score, maximum flow rate, average flow rate, voided volume, and post-voided volume. Results: The overall BP change was not significantly different between groups 1 and 2 (systolic BP, P=0.825; diastolic BP, P>0.999). In patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or combined with antihypertensive therapy significantly decreased systolic and diastolic BP. The mean difference in total IPSS and IPSS-quality of life scores from baseline between groups 1 and 2 was 0.45 (95% CI: -1.26, 2.16) and 0.12 (95% CI: -0.21, 0.45), respectively (both P>0.05). Maximum flow rate, average flow rate, voided volume, and post-voided volume at endpoint were numerically, but not significantly, changed from baseline (all P>0.05). Conclusion: This study shows that alfuzosin 10 mg is effective and well tolerated in patients with BPH/LUTS with or without antihypertensive medications. However, in patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or in combination with antihypertensive medication appears to decrease systolic and diastolic BP, and these patients should be warned about a decrease in BP on initiation of therapy.
URI
http://hdl.handle.net/YU.REPOSITORY/33700http://dx.doi.org/10.2147/CIA.S74102
ISSN
1178-1998
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의과대학 > 비뇨기과학교실 > Articles
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