title: Tadalafil in the management of lower urinary tract symptoms: a review of the literature and current practices in Russia.
abstract: BACKGROUND
  Strong epidemiologic evidence supports correlation between lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) and erectile dysfunction (ED). The link has biologic plausibility given phosphodiesterase type 5 (PDE5) expression in pelvic structures. PDE5 inhibitors target pathophysiologic processes implicated in LUTS/BPH.
  
  
  METHODS
  This review highlights the efficacy and safety of the daily use of a PDE5 inhibitor tadalafil in LUTS/BPH, with a focus on LUTS/BPH medical management in Russia.
  
  
  RESULTS
  Alpha-blockers and phytotherapy are major components of the current LUTS/BPH therapy in Russia. Russian regulatory authorities granted approval for once-daily tadalafil for treatment of LUTS/BPH in January 2012. In a pivotal study, tadalafil 5 mg once-daily significantly improved International Prostate Symptom Score (IPSS) over 12 weeks vs. placebo (P = .004) regardless of baseline ED severity. IPSS improvement was maintained at 12 weeks. Integrated analysis of randomized studies showed that tadalafil 5 mg once-daily resulted in significant symptom improvements across a range of men with LUTS/BPH. Relief of LUTS due to tadalafil was independent of improvement in ED; improvements in IPSS and erectile function were only weakly correlated (r = -0.229). Another pooled analysis found similar improvement in LUTS/BPH between men with or without ED, with non-significant P values for treatment-by-ED-status interactions for total IPSS ( P = .73). Non-registration studies of tadalafil and alpha-blocker co-therapy in LUTS/BPH suggest an additive effect, but co-therapy is not recommended in current tadalafil prescribing instructions.
  
  
  CONCLUSIONS
  Tadalafil results in symptom improvements across a range of men with LUTS/BPH and represents a new treatment option for patients in Russia with LUTS/BPH.
authors.affiliation: Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Department of Urology, Moscow, Russia.
authors.forename: Alexander
authors.initials: A
authors.lastname: Govorov
authors.affiliation: Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Department of Urology, Moscow, Russia.
authors.forename: George
authors.initials: G
authors.lastname: Kasyan
authors.affiliation: Eli Lilly Vostok S.A.
authors.forename: Diana
authors.initials: D
authors.lastname: Priymak
authors.affiliation: Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Department of Urology, Moscow, Russia.
authors.forename: Dmitry
authors.initials: D
authors.lastname: Pushkar
authors.affiliation: Eli Lilly and Company, Lilly Corporate Centre, USA.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sorsaburu
keywords: Cialis; PDE5 inhibitor; alpha–blocker; erectile dysfunction; lower urinary tract symptoms/benign prostatic hyperplasia; sexual function; tadalafil