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 α-blockers or PDE5 inhibitors, total testosterone level (<300/≥300 ng/dL), or prostate-specific
antigen predicted prostate volume (≤40/>40 mL). 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 α-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.
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Article info
Publication history
Published online: July 22, 2013
Accepted:
May 5,
2013
Received:
March 28,
2013
Footnotes
Financial Disclosure: The authors declare that they have no relevant financial interests.
Funding Support: The studies and analyses presented herein were sponsored by Eli Lilly and Company; editorial/medical writing support was provided by Thomas Melby of inVentiv Health Clinical and funded by Eli Lilly and Company.
Identification
Copyright
© 2013 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- ErratumUrologyVol. 83Issue 3
- PreviewThe authors of “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” by Porst H., Oelke M., Goldfischer E.R., Cox D., Watts S., Dey D., et al (Urology 2013;82:667-673) have identified errors mainly related to incorrect cutoff values for predicted prostate volume as outlined below. These errors do not change the interpretation of the data.
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