PMID- 23876588
OWN - NLM
STAT- MEDLINE
DCOM- 20131217
LR  - 20151119
IS  - 1527-9995 (Electronic)
IS  - 0090-4295 (Linking)
VI  - 82
IP  - 3
DP  - 2013 Sep
TI  - Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms 
      suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 
      4 multinational, randomized, placebo-controlled clinical studies.
PG  - 667-73
LID - S0090-4295(13)00616-X [pii]
LID - 10.1016/j.urology.2013.05.005 [doi]
AB  - OBJECTIVE: To assess the efficacy and safety of tadalafil, a phosphodiesterase 5 
      (PDE5) inhibitor efficacious for erectile dysfunction and lower urinary tract 
      symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH), in population 
      subgroups, using pooled data from 4 international, randomized, placebo-controlled 
      studies in men with LUTS/BPH. METHODS: The safety database included 1500 men 
      randomized to tadalafil 5 mg once daily or placebo for 12 weeks. Changes in total 
      International Prostate Symptom Score (IPSS), IPSS-quality of life index, and BPH 
      impact index were examined overall, and changes in IPSS or adverse events (AEs) 
      were examined across subgroups of interest. Treatment-group differences were 
      assessed using analysis of covariance. RESULTS: Results of pooled data confirmed 
      that tadalafil (N = 752) resulted in significant improvements from baseline vs 
      placebo (N = 746) in IPSS (mean difference -2.3; P <.001), and also in BPH impact 
      index and IPSS-quality of life index (both P <.001). Subgroup analyses 
      demonstrated that IPSS improvements were significant regardless of baseline LUTS 
      severity (IPSS <20/>/=20), age (</=65/>65 years), recent previous use of alpha-blockers 
      or PDE5 inhibitors, total testosterone level (<300/>/=300 ng/dL), or 
      prostate-specific antigen predicted prostate volume (<40/>/=40 mL). [corrected] 
      Rates of treatment emergent AEs were comparable between subgroups of baseline age 
      (</=65/>65 years), previous PDE5 inhibitor use, and the presence or absence of 
      pre-existing diabetes, hypertension, or cardiovascular disease (including 
      hypertension), but somewhat higher for recent previous alpha-blocker use. CONCLUSION: 
      In these pooled data analyses, tadalafil 5 mg improved LUTS/BPH across subgroups 
      of age, LUTS severity, testosterone levels, and prostate volume. Rates of AEs 
      were similar across the subgroups assessed.
CI  - Copyright (c) 2013 Elsevier Inc. All rights reserved.
FAU - Porst, Hartmut
AU  - Porst H
AD  - Department of Urology, Hannover Medical School, Hannover, Germany. 
      Porst20354@aol.com
FAU - Oelke, Matthias
AU  - Oelke M
FAU - Goldfischer, Evan R
AU  - Goldfischer ER
FAU - Cox, David
AU  - Cox D
FAU - Watts, Steven
AU  - Watts S
FAU - Dey, Debashish
AU  - Dey D
FAU - Viktrup, Lars
AU  - Viktrup L
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130719
PL  - United States
TA  - Urology
JT  - Urology
JID - 0366151
RN  - 0 (Adrenergic alpha-Antagonists)
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 3XMK78S47O (Testosterone)
RN  - 742SXX0ICT (Tadalafil)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
EIN - Urology. 2014 Mar;83(3):684
MH  - Adrenergic alpha-Antagonists/therapeutic use
MH  - Age Factors
MH  - Aged
MH  - Back Pain/chemically induced
MH  - Carbolines/pharmacology/*therapeutic use
MH  - Dyspepsia/chemically induced
MH  - Headache/chemically induced
MH  - Humans
MH  - Lower Urinary Tract Symptoms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Nasopharyngitis/chemically induced
MH  - Organ Size/drug effects
MH  - Phosphodiesterase 5 Inhibitors/pharmacology/*therapeutic use
MH  - Prostate/*pathology
MH  - Prostate-Specific Antigen/blood
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Tadalafil
MH  - Testosterone/blood
EDAT- 2013/07/24 06:00
MHDA- 2013/12/18 06:00
CRDT- 2013/07/24 06:00
PHST- 2013/03/28 00:00 [received]
PHST- 2013/04/26 00:00 [revised]
PHST- 2013/05/05 00:00 [accepted]
PHST- 2013/07/24 06:00 [entrez]
PHST- 2013/07/24 06:00 [pubmed]
PHST- 2013/12/18 06:00 [medline]
AID - S0090-4295(13)00616-X [pii]
AID - 10.1016/j.urology.2013.05.005 [doi]
PST - ppublish
SO  - Urology. 2013 Sep;82(3):667-73. doi: 10.1016/j.urology.2013.05.005. Epub 2013 Jul 
      19.