PMID- 21707928
OWN - NLM
STAT- MEDLINE
DCOM- 20120113
LR  - 20151119
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 8
IP  - 9
DP  - 2011 Sep
TI  - A randomized, double-blind, placebo-controlled, parallel study to assess the 
      efficacy and safety of once-a-day tadalafil in men with erectile dysfunction who 
      are naive to PDE5 inhibitors.
PG  - 2617-24
LID - 10.1111/j.1743-6109.2011.02353.x [doi]
AB  - INTRODUCTION: The majority of subjects included in previous tadalafil once-a-day 
      clinical trials were non-naive to previous phosphodiesterase 5 (PDE5) inhibitors 
      on demand. A study on PDE5 inhibitor naive subjects was therefore warranted. AIM: 
      To evaluate the efficacy and safety of once-a-day tadalafil in PDE5 
      inhibitor-naive men with erectile dysfunction (ED). MAIN OUTCOMES MEASURES: 
      Primary efficacy end points were changes from baseline to end point in the 
      International Index of Erectile Function (IIEF) Erectile Function (EF) domain 
      score and the per-subject proportion of "yes" responses to sexual encounter 
      profile (SEP) question 2 (SEP2) and question 3 (SEP3). METHODS: PDE5 
      inhibitor-naive men with ED (N=217) were randomized in a 1:2 ratio to receive 
      placebo or tadalafil 5 mg once a day for 12 weeks. Enrollment began in January 
      2009 and the last subject completed in January 2010. RESULTS: At end point, least 
      square mean change from baseline IIEF-EF domain score (7.3 vs. 3.4), SEP2 (23.8% 
      vs. 12.2%) and SEP3 (39.5% vs. 21.5%), was significantly larger for tadalafil vs. 
      placebo (all P<0.001). The most common adverse events (AEs) in tadalafil-treated 
      subjects were back pain, nasopharyngitis, dyspepsia, headache, and myalgia. Four 
      subjects (2.7%) in the tadalafil group and one subject (1.4%) in the placebo 
      group discontinued because of AEs. CONCLUSIONS: In PDE5 inhibitor-naive men, 
      tadalafil once a day significantly improved EF compared with placebo. Safety 
      results were consistent with previous tadalafil once-a-day clinical trials.
CI  - (c) 2011 International Society for Sexual Medicine.
FAU - Montorsi, Francesco
AU  - Montorsi F
AD  - Department of Urology, Scientific Institute Hospital San Raffaele, Milan, Italy.
FAU - Aversa, Antonio
AU  - Aversa A
FAU - Moncada, Ignacio
AU  - Moncada I
FAU - Perimenis, Petros
AU  - Perimenis P
FAU - Porst, Hartmut
AU  - Porst H
FAU - Barker, Clare
AU  - Barker C
FAU - Shane, Michael A
AU  - Shane MA
FAU - Sorsaburu, Sebastian
AU  - Sorsaburu S
LA  - eng
SI  - ClinicalTrials.gov/NCT00836693
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110627
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
MH  - Age Factors
MH  - Carbolines/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Erectile Dysfunction/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Penile Erection/drug effects
MH  - Phosphodiesterase 5 Inhibitors/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Tadalafil
MH  - Treatment Outcome
EDAT- 2011/06/29 06:00
MHDA- 2012/01/14 06:00
CRDT- 2011/06/29 06:00
PHST- 2011/06/29 06:00 [entrez]
PHST- 2011/06/29 06:00 [pubmed]
PHST- 2012/01/14 06:00 [medline]
AID - S1743-6095(15)33661-4 [pii]
AID - 10.1111/j.1743-6109.2011.02353.x [doi]
PST - ppublish
SO  - J Sex Med. 2011 Sep;8(9):2617-24. doi: 10.1111/j.1743-6109.2011.02353.x. Epub 
      2011 Jun 27.