title: Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study.
abstract: BACKGROUND
  Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH-LUTS.
  
  
  OBJECTIVE
  This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH-LUTS in men with both conditions during 12 weeks of double-blinded therapy.
  
  
  METHODS
  Men were ≥ 45 years old, sexually active, and experiencing ED for ≥ 3 months and BPH-LUTS for >6 months. Randomization (baseline) followed a 4-week placebo lead-in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co-primary and key secondary measures at end point (last post-baseline observation).
  
  
  METHODS
  The co-primary measures were the International Index of Erectile Function-erectile function (IIEF-EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment-emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed.
  
  
  RESULTS
  Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF-EF domain scores (both P < 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P < 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least-squares mean ± standard error change from baseline at end point, placebo -3.8 ± 0.5, tadalafil 2.5 mg -4.6 ± 0.4, and 5 mg -6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P < 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters.
  
  
  CONCLUSIONS
  Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.
authors: Urology Associates/Urologic Medical Research, Kitchener, Canada. blairegerdie@mac.com
authors: Russell Blair
authors: RB
authors: Egerdie
authors: Stephen
authors: S
authors: Auerbach
authors: Claus G
authors: CG
authors: Roehrborn
authors: Pierre
authors: P
authors: Costa
authors: Martin Sanchez
authors: MS
authors: Garza
authors: Anne L
authors: AL
authors: Esler
authors: David G
authors: DG
authors: Wong
authors: Roberta J
authors: RJ
authors: Secrest
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002243:Carbolines / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D000068581:Tadalafil; D016896:Treatment Outcome
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil