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.
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).
  
  
  CONCLUSIONS
  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.
authors: Department of Urology, Chonbuk National University, Medical School and Biomedical Research Institute and Clinical Trial Center for Medical Devices of Chonbuk National University Hospital, Jeonju, Republic of Korea.
authors: Li Tao
authors: LT
authors: Zhang
authors: Department of Urology, College of Medicine, Sungkyunkwan University, Seoul, Republic of Korea.
authors: Sung Won
authors: SW
authors: Lee
authors: Department of Urology, College of Medicine, Chonnam National University, Gwangju, Republic of Korea.
authors: Kwangsung
authors: K
authors: Park
authors: Department of Urology, College of Medicine, Ewha Woman's University, Seoul, Republic of Korea.
authors: Woo Sik
authors: WS
authors: Chung
authors: Department of Urology, College of Medicine, Catholic University, Seoul, Republic of Korea.
authors: Sae Woong
authors: SW
authors: Kim
authors: Department of Urology, College of Medicine, Kyungsang National University, Jinju, Republic of Korea.
authors: Jae Seog
authors: JS
authors: Hyun
authors: Department of Urology, College of Medicine, Korea University, Seoul, Republic of Korea.
authors: Doo Geon
authors: DG
authors: Moon
authors: Department of Urology, Chungju Hospital, College of Medicine, Konkuk University, Chungju, Republic of Korea.
authors: Sang-Kuk
authors: SK
authors: Yang
authors: Department of Urology, College of Medicine, Inha University, Incheon, Republic of Korea.
authors: Ji Kan
authors: JK
authors: Ryu
authors: Department of Urology, College of Medicine, Hallym University, Seoul, Republic of Korea.
authors: Dae Yul
authors: DY
authors: Yang
authors: Department of Urology, College of Medicine, Youngnam University, Daegu, Republic of Korea.
authors: Ki Hak
authors: KH
authors: Moon
authors: Department of Urology, College of Medicine, Inje University, Busan, Republic of Korea.
authors: Kweon Sik
authors: KS
authors: Min
authors: Department of Urology, Chonbuk National University, Medical School and Biomedical Research Institute and Clinical Trial Center for Medical Devices of Chonbuk National University Hospital, Jeonju, Republic of Korea.
authors: Jong Kwan
authors: JK
authors: Park
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure; D004359:Drug Therapy, Combination; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000453:epidemiology; D011788:Quality of Life; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D064804:Urological Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000959:Antihypertensive Agents; D011799:Quinazolines; D064804:Urological Agents; C047638:alfuzosin
keywords: alfuzosin; antihypertensive medication; benign prostatic hyperplasia; blood pressure; lower urinary tract symptoms
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