PMID- 27988986
OWN - NLM
STAT- MEDLINE
DCOM- 20170630
LR  - 20180427
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 119
IP  - 5
DP  - 2017 May
TI  - Efficacy and safety of tadalafil 5 mg once daily in the treatment of lower 
      urinary tract symptoms associated with benign prostatic hyperplasia in men aged 
      >/=75 years: integrated analyses of pooled data from multinational, randomized, 
      placebo-controlled clinical studies.
PG  - 793-803
LID - 10.1111/bju.13744 [doi]
AB  - OBJECTIVE: To assess efficacy and safety of tadalafil in men aged >/=75 years with 
      lower urinary tract symptoms associated with benign prostatic hyperplasia 
      (LUTS/BPH) and additional safety in men aged >/=75 years with erectile dysfunction 
      (ED). PATIENTS AND METHODS: We conducted an integrated analysis of 12 phase 
      II-III randomized, double-blind and/or open-label extension studies to evaluate 
      short-term (12-26 weeks) efficacy and short- and longer-term (42-52 weeks) safety 
      in men aged <75 years vs men aged >/=75 years. All men received once-daily 
      tadalafil 5 mg or placebo. The efficacy outcome was International Prostate 
      Symptom Score (IPSS). Safety measurements included treatment-emergent adverse 
      events (TEAEs), adverse events (AEs) leading to discontinuation, serious AEs 
      (SAEs), and cardiovascular AEs. All analyses were intention-to-treat. Changes 
      from baseline to efficacy endpoint and differences in changes between treatment 
      groups were estimated as least-squares means using analysis of covariance models. 
      RESULTS: Change in the mean IPSS was significantly different in men aged <75 
      years vs those aged >/=75 years across tadalafil and placebo groups 
      (treatment-by-age interaction P = 0.034). Tadalafil was not statistically 
      significantly better than placebo in men aged >/=75 years, but effect size varied 
      between studies. Maintenance of efficacy with tadalafil was observed across age 
      groups. Short-term tadalafil safety findings for men aged <75 vs >/=75 years 
      included: TEAEs (52 [33.8%] vs 503 [30.1%]), AEs leading to discontinuation (3 
      [1.9%] vs 50 [3.0%]), SAEs (4 [2.6%] vs 15 [0.9%]) and cardiovascular AEs (4 
      [2.6%] vs 30 [1.8%]). Long-term tadalafil safety data did not reveal clinically 
      relevant differences between age groups. Limitations include exclusion of men 
      with serious co-existing conditions and limited sample sizes of men aged >/=75 
      years. CONCLUSIONS: Efficacy with once-daily tadalafil 5 mg in the treatment of 
      LUTS/BPH differed between men aged <75 vs >/=75 years, with significant efficacy in 
      the <75-year age group. The older age group had more concomitant diseases and 
      used more drugs, which may have reduced efficacy. The small sample size precluded 
      uni-/multivariate analyses to assess plausible interference from confounding 
      factors. Tadalafil had a reassuring safety profile and no evidence of increased 
      cardiovascular AEs in aging men.
CI  - (c) 2016 The Authors BJU International (c) 2016 BJU International Published by John 
      Wiley & Sons Ltd.
FAU - Oelke, Matthias
AU  - Oelke M
AD  - Department of Urology, Hannover Medical School, Hannover, Germany.
FAU - Wagg, Adrian
AU  - Wagg A
AD  - Geriatric Medicine, University of Alberta, Edmonton, AB, Canada.
FAU - Takita, Yasushi
AU  - Takita Y
AD  - Medicines Development Unit Japan, Eli Lilly Japan, Kobe, Hyogo, Japan.
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 - Viktrup, Lars
AU  - Viktrup L
AD  - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20170122
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
CIN - Eur Urol. 2017 Jun;71(6):990. PMID: 28162817
CIN - J Urol. 2018 Oct;200(4):675. PMID: 30227541
MH  - Aged
MH  - Clinical Trials, Phase II as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Humans
MH  - Lower Urinary Tract Symptoms/*drug therapy/*etiology
MH  - Male
MH  - Phosphodiesterase 5 Inhibitors/*administration & dosage/adverse effects
MH  - Prostatic Hyperplasia/*complications
MH  - Randomized Controlled Trials as Topic
MH  - Tadalafil/*administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - #UroBPH
OT  - #erectiledysfunction
OT  - benign prostatic hyperplasia
OT  - elderly
OT  - lower urinary tract symptoms
OT  - tadalafil
EDAT- 2016/12/19 06:00
MHDA- 2017/07/01 06:00
CRDT- 2016/12/19 06:00
PHST- 2016/12/19 06:00 [pubmed]
PHST- 2017/07/01 06:00 [medline]
PHST- 2016/12/19 06:00 [entrez]
AID - 10.1111/bju.13744 [doi]
PST - ppublish
SO  - BJU Int. 2017 May;119(5):793-803. doi: 10.1111/bju.13744. Epub 2017 Jan 22.