title: Tadalafil Administered Once Daily for Treatment of Lower Urinary Tract Symptoms in Korean men with Benign Prostatic Hyperplasia: Results from a Placebo-Controlled Pilot Study Using Tamsulosin as an Active Control.
abstract: OBJECTIVE
  Assess the efficacy and safety of once-daily tadalafil or tamsulosin versus placebo during 12 weeks on lower urinary tract symptoms (LUTS) in Korean men with benign prostatic hyperplasia (BPH).
  
  
  METHODS
  Following a 4-week placebo run-in period, 151 Korean men were randomly assigned to receive once-daily tadalafil 5 mg, tamsulosin 0.2 mg, or placebo for 12 weeks.
  
  
  RESULTS
  The International Prostate Symptom Score (IPSS) least squares mean changes from baseline to endpoint were numerically but not significantly improved in the tadalafil (-5.8) and tamsulosin (-5.4) groups compared with placebo (-4.2, P > 0.05). Decreases in IPSS obstructive and irritative subscores, IPSS Quality of Life score, and BPH Impact Index from baseline to endpoint were largest in the tadalafil group followed by tamsulosin, though none separated significantly from placebo. Increases in maximum urinary flow rate were small and not significantly different than placebo; the increase was largest in the tadalafil group (2.5 mL/sec), followed by the placebo (2.3 mL/sec) and tamsulosin (2.1 mL/sec) groups. The percentage of subjects reporting at least one treatment-emergent adverse event was 26.5, 13.7 and 3.9% in the tamsulosin, tadalafil and placebo groups, respectively.
  
  
  CONCLUSIONS
  In this pilot study in Korean men, those with BPH and treated with tadalafil 5 mg or tamsulosin 0.2 mg once daily experienced a reduction in LUTS, which was numerically (but not statistically) significant compared with the placebo. Tadalafil was well tolerated and few subjects discontinued the study due to treatment-emergent adverse events. Larger studies in Asian men with BPH and LUTS treated with phosphodiesterase type 5 inhibitors are needed.
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Sae Chul
authors.initials: SC
authors.lastname: Kim
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Jong Kwan
authors.initials: JK
authors.lastname: Park
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Sae Woong
authors.initials: SW
authors.lastname: Kim
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Lee
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Tai Young
authors.initials: TY
authors.lastname: Ahn
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Je Jong
authors.initials: JJ
authors.lastname: Kim
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Jae Seung
authors.initials: JS
authors.lastname: Paick
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Nam Cheol
authors.initials: NC
authors.lastname: Park
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Kwangsung
authors.initials: K
authors.lastname: Park
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Kweon Sik
authors.initials: KS
authors.lastname: Min
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Kraus
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Roberta J
authors.initials: RJ
authors.lastname: Secrest
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Albert
authors.initials: A
authors.lastname: Elion-Mboussa
authors.affiliation: Department of Urology, Chung-Ang University Hospital, Seoul, South KoreaDepartment of Urology, Chonbuk National University Hospital, Jeonju, South KoreaDepartment of Urology, Seoul St. Mary's Hospital, Seoul, South KoreaDepartment of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South KoreaDepartment of Urology, Asan Medical Center, Seoul, South KoreaDepartment of Urology, Korea University Hospital, Seoul, South KoreaDepartment of Urology, Seoul National University Hospital, Seoul, South KoreaDepartment of Urology, Pusan National University Hospital, Busan, South KoreaDepartment of Urology, Sexual Medicine Research Center, Chonnam National University, Gwangju, South KoreaDepartment of Urology, Busan Paik Hospital, Seoul, South KoreaDepartment of Urology, University of Texas Health Science Center, San Antonio, Texas, USAEli Lilly and Co., Lilly Research Laboratories, Indianapolis, Indiana, USA.
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
keywords: International Prostate Symptom Score; benign prostatic hyperplasia; lower urinary tract symptoms; tadalafil; tamsulosin