title: Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride.
abstract: BACKGROUND
  Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described.
  
  
  OBJECTIVE
  Assess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED).
  
  
  METHODS
  A randomized, double-blind, PBO-controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks.
  
  
  METHODS
  International Index of Erectile Function (IIEF) domain and single-item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF-Erectile Function domain scores (IIEF-EF; MCID defined as ≥4-point improvement); and sexual dysfunction adverse events (AEs).
  
  
  RESULTS
  Compared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED (P ≤ 0.002 for all measures) and among patients without baseline ED (P ≤ 0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4, 12, and 26 weeks of therapy (P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints). The incidence of sexual AEs was low: five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs, including ED, decreased/lost libido, and ejaculation disorders.
  
  
  CONCLUSIONS
  TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated, regardless of the presence/absence of ED at treatment initiation.
authors.affiliation: Instituto H. Ellis, São Paulo, Brazil; Department of Urology, Ipiranga Hospital, São Paulo, Brazil.
authors.forename: Sidney
authors.initials: S
authors.lastname: Glina
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.forename: Adil
authors.initials: A
authors.lastname: Esen
authors.forename: Alexey
authors.initials: A
authors.lastname: Plekhanov
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sorsaburu
authors.forename: Carsten
authors.initials: C
authors.lastname: Henneges
authors.forename: Hartwig
authors.initials: H
authors.lastname: Büttner
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D002243:Carbolines / Q000627:therapeutic use*; D003075:Coitus; D015897:Comorbidity; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D018120:Finasteride / Q000627:therapeutic use*; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D000068581:Tadalafil; D016896:Treatment Outcome
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D018120:Finasteride; D000068581:Tadalafil
keywords: 5-Alpha Reductase Inhibitors; Benign Prostatic Hyperplasia; Ejaculatory Function; Erectile Dysfunction; Finasteride; Lower Urinary Tract Symptoms; Orgasmic Function; Phosphodiesterase Type 5 Inhibitors; Tadalafil