PMID- 24119319
OWN - NLM
STAT- MEDLINE
DCOM- 20140930
LR  - 20220419
IS  - 1873-7560 (Electronic)
IS  - 0302-2838 (Linking)
VI  - 65
IP  - 2
DP  - 2014 Feb
TI  - Tadalafil once daily in men with erectile dysfunction: an integrated analysis of 
      data obtained from 1913 patients from six randomized, double-blind, 
      placebo-controlled, clinical studies.
PG  - 455-64
LID - S0302-2838(13)01024-5 [pii]
LID - 10.1016/j.eururo.2013.09.037 [doi]
AB  - BACKGROUND: This analysis explores tadalafil once-daily treatment for 12 wk in 
      clinical subpopulations of men with erectile dysfunction (ED). OBJECTIVE: Assess 
      the efficacy and safety of once-daily tadalafil 2.5mg and 5mg in patients with 
      different ED characteristics and comorbidities. DESIGN, SETTING, AND 
      PARTICIPANTS: This analysis integrated data from six randomized, double-blind, 
      placebo-controlled studies that assigned 1913 men with >/=3-mo history of ED either 
      to once-daily placebo (n=596), tadalafil 2.5mg (n=394), or tadalafil 5mg (n=923). 
      Clinical factors examined included: ethnicity, age, obesity, alcohol consumption, 
      smoking, comorbidities, concomitant medication, and ED characteristics (etiology, 
      duration, severity). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Descriptive 
      statistics were reported for efficacy and safety, including International Index 
      of Erectile Function Erectile Function Domain (IIEF-EF) scores and Sexual 
      Encounter Profile question 3 (SEP3) responses. Clinical factors were included in 
      analysis of covariance models using last observation carried forward for SEP3 and 
      IIEF-EF scores. RESULTS AND LIMITATIONS: Both tadalafil doses significantly 
      improved SEP3 responses (least-squares [LS] mean change: 17.8% and 23.6%, 
      respectively) and IIEF-EF scores (LS mean change: 4.2; 5.4) compared with placebo 
      (p<0.01). Treatment with 2.5mg and 5mg tadalafil resulted in IIEF-EF LS mean 
      improvements >/=4 (minimal clinically important difference [MCID]) in patients with 
      hypertension (4.3 [95% confidence interval (CI), 2.9-5.7]; 4.7 [95% CI, 
      3.5-5.8]), cardiac disorder (7.0 [95% CI, 4.7-9.3]; 6.3 [95% CI, 4.4-8.2]), or 
      hyperlipidemia (5.3 [95% CI, 3.4-7.1]; 5.8 [95% CI, 4.3-7.4]). Obese patients 
      (4.7 [95% CI, 3.4-6.0]), smokers (4.8 [95% CI, 3.0-6.7]), and psychogenic ED (7.3 
      [95% CI, 5.0-9.6]) reached MCID only after treatment with 5mg tadalafil. 
      Severity-specific MCID (IIEF-EF change >/=7) was achieved by 44.5% of patients with 
      severe baseline ED treated with tadalafil 5mg, compared with 11.6% of 
      placebo-treated patients. No unexpected safety findings were observed. These 
      analyses were performed on integrated data and can only provide descriptive 
      results to guide further investigations. CONCLUSIONS: Treatment with tadalafil 
      2.5mg or 5mg once daily was well tolerated and resulted in clinically important 
      improvements in patients with mild (54.3% and 74.8%, respectively), moderate 
      (51.3% and 63.1%, respectively), or severe (33.7% and 44.5%, respectively) ED.
CI  - Copyright (c) 2013. Published by Elsevier B.V.
FAU - Porst, Hartmut
AU  - Porst H
AD  - Private Practice of Urology/Andrology, Hamburg, Germany.
FAU - Gacci, Mauro
AU  - Gacci M
AD  - Department of Urology, University of Florence, Careggi Hospital, Florence, Italy.
FAU - Buttner, Hartwig
AU  - Buttner H
AD  - Eli Lilly Biomedicines BU - Men's Health Therapeutic Area Europe, c/o Lilly 
      Deutschland, GmbH, Bad Homburg, Germany.
FAU - Henneges, Carsten
AU  - Henneges C
AD  - Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg, Germany.
FAU - Boess, Frank
AU  - Boess F
AD  - Lilly Deutschland GmbH, Medical Department, Bad Homburg, Germany. Electronic 
      address: boess_frank@lilly.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT00381732
SI  - ClinicalTrials.gov/NCT00422734
SI  - ClinicalTrials.gov/NCT00547183
SI  - ClinicalTrials.gov/NCT00836693
SI  - ClinicalTrials.gov/NCT00855582
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20131002
PL  - Switzerland
TA  - Eur Urol
JT  - European urology
JID - 7512719
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
CIN - Eur Urol. 2014 Feb;65(2):465-6. PMID: 24563912
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Carbolines/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Erectile Dysfunction/diagnosis/*drug therapy/physiopathology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Penile Erection/*drug effects
MH  - Phosphodiesterase 5 Inhibitors/*administration & dosage/adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Recovery of Function
MH  - Retrospective Studies
MH  - Severity of Illness Index
MH  - Tadalafil
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Comorbidities
OT  - Diabetes
OT  - Erectile dysfunction
OT  - Metabolic syndrome
OT  - Once daily
OT  - Phosphodiesterase type 5 inhibitors
OT  - Tadalafil
EDAT- 2013/10/15 06:00
MHDA- 2014/10/01 06:00
CRDT- 2013/10/15 06:00
PHST- 2013/06/04 00:00 [received]
PHST- 2013/09/20 00:00 [accepted]
PHST- 2013/10/15 06:00 [entrez]
PHST- 2013/10/15 06:00 [pubmed]
PHST- 2014/10/01 06:00 [medline]
AID - S0302-2838(13)01024-5 [pii]
AID - 10.1016/j.eururo.2013.09.037 [doi]
PST - ppublish
SO  - Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 
      2.