PMID- 19409693
OWN - NLM
STAT- MEDLINE
DCOM- 20100303
LR  - 20220408
IS  - 1873-7560 (Electronic)
IS  - 0302-2838 (Linking)
VI  - 56
IP  - 4
DP  - 2009 Oct
TI  - Effects of once-daily tadalafil on erectile function in men with erectile 
      dysfunction and signs and symptoms of benign prostatic hyperplasia.
PG  - 727-35
LID - 10.1016/j.eururo.2009.04.033 [doi]
AB  - BACKGROUND: Lower urinary tract symptoms (LUTS) secondary to benign prostatic 
      hyperplasia (BPH; BPH-LUTS) may be associated with erectile dysfunction (ED). 
      OBJECTIVE: To evaluate the effects of once-daily tadalafil on erectile function 
      in men with ED and BPH-LUTS. DESIGN, SETTING, AND PARTICIPANTS: Post hoc analysis 
      of a phase 2-3, multinational, randomized, double-blind, placebo-controlled, 
      parallel-group study of men with ED and moderate-to-severe LUTS secondary to BPH 
      who reported being sexually active. In contrast to typical ED trials, no sexual 
      activity threshold was required to participate. INTERVENTIONS: Screening and 4-wk 
      washout period for patients taking BPH and/or ED treatments; 4-wk placebo run-in 
      period; then once-daily placebo or tadalafil 2.5, 5, 10, or 20 mg for 12 wk. 
      MEASUREMENTS: International Index of Erectile Function-Erectile Function 
      (IIEF-EF) domain score, International Prostate Symptom Score (IPSS), peak urinary 
      flow rate (Q(max)), and postvoid residual volume (PVR). Analyses were performed 
      in men who reported being sexually active with a female partner and who expected 
      to remain so throughout the study. IIEF-EF data are presented for the BPH/ED 
      population overall and for subgroups stratified by baseline age group, body mass 
      index, BPH-LUTS severity, prostate-specific antigen, prior alpha-blocker use, and 
      prior ED therapy. RESULTS AND LIMITATIONS: Overall, 581 men were included 
      (placebo, n=115; tadalafil 2.5 mg, n=113; tadalafil 5 mg, n=117; tadalafil 10 mg, 
      n=120; tadalafil 20 mg, n=116). IIEF-EF domain score improvements from baseline 
      to end point with tadalafil were 5.4 (2.5 mg), 6.8 (5 mg), 7.9 (10 mg), and 8.2 
      (20 mg) versus 2.0 with placebo (least-squares means; all p values <0.001). 
      IIEF-EF domain score improvements were observed with tadalafil for all subgroup 
      analyses, with no significant differences between subgroup or 
      subgroup-by-treatment interaction terms. IPSS improvements from baseline to end 
      point were significantly greater for all tadalafil doses versus placebo (all p 
      values <0.05). Changes in Q(max) and PVR were small and not clinically 
      meaningful. CONCLUSIONS: These data support the use of once-daily tadalafil in 
      men with ED and BPH-LUTS. TRIAL REGISTRATION: http://www.clinicaltrials.gov: 
      NCT00384930.
FAU - Porst, Hartmut
AU  - Porst H
AD  - porst20354@aol.com
FAU - McVary, Kevin T
AU  - McVary KT
FAU - Montorsi, Francesco
AU  - Montorsi F
FAU - Sutherland, Peter
AU  - Sutherland P
FAU - Elion-Mboussa, Albert
AU  - Elion-Mboussa A
FAU - Wolka, Anne M
AU  - Wolka AM
FAU - Viktrup, Lars
AU  - Viktrup L
LA  - eng
SI  - ClinicalTrials.gov/NCT00384930
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090422
PL  - Switzerland
TA  - Eur Urol
JT  - European urology
JID - 7512719
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
EIN - Eur Urol. 2011 Jun;59(6):1082
MH  - Aged
MH  - Carbolines/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Erectile Dysfunction/*drug therapy/etiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phosphodiesterase Inhibitors/*administration & dosage
MH  - Prostatic Hyperplasia/*complications/diagnosis
MH  - Tadalafil
EDAT- 2009/05/05 09:00
MHDA- 2010/03/04 06:00
CRDT- 2009/05/05 09:00
PHST- 2008/12/16 00:00 [received]
PHST- 2009/04/14 00:00 [accepted]
PHST- 2009/05/05 09:00 [entrez]
PHST- 2009/05/05 09:00 [pubmed]
PHST- 2010/03/04 06:00 [medline]
AID - S0302-2838(09)00428-X [pii]
AID - 10.1016/j.eururo.2009.04.033 [doi]
PST - ppublish
SO  - Eur Urol. 2009 Oct;56(4):727-35. doi: 10.1016/j.eururo.2009.04.033. Epub 2009 Apr 
      22.