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Erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) combined responders to tadalafil after 12 weeks of treatment.
BJU Int. 2016 Jul; 118(1):153-60.BI

Abstract

OBJECTIVE

To analyse the proportion of men taking tadalafil 5 mg once daily who experience a combined improvement in symptoms of both erectile dysfunction (ED) and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH).

MATERIALS AND METHODS

The data from men aged ≥45 years randomized to tadalafil 5 mg once daily or placebo enrolled in one of four randomized, placebo-controlled LUTS/BPH clinical trials were analysed (N = 927). A novel classification of 'combined responders' to ED and LUTS/BPH treatment was defined, based on published criteria for men who showed improvement in both International Index of Erectile Function - Erectile Function domain (IIEF-EF) score and total International Prostate Symptom Score (IPSS). Descriptive analyses assessed the covariate distribution by responder status. Unadjusted and adjusted logistic regressions provided odds ratios with 95% confidence intervals comparing combined responders with all others (partial and non-responders).

RESULTS

Among men randomized to tadalafil 5 mg, 40.5% were combined responders (n = 189). Among placebo randomized men, 18.3% were combined responders (n = 84). Combined responders, in the total population, had the highest baseline IPSS and lowest baseline IIEF-EF scores, corresponding to the highest level of dysfunction. The majority of men were aged ≤65 years, white, non-obese, non-smokers, and regular alcohol consumers. Only treatment, baseline IPSS, baseline IIEF-EF, obesity and psychoactive medication use were significantly associated with responder status (P ≤ 0.05). Tadalafil-treated men had 2.8 times significantly increased adjusted odds of being combined responders vs non-responders (P < 0.001). For each unit decrease in baseline IIEF-EF or alcoholic drink consumption per week there was a 4% significant increase in the adjusted odds of being a combined responder to tadalafil therapy.

CONCLUSIONS

This novel measure of combined response is useful in differentiating patients with clinically relevant symptom improvement for both ED and LUTS/BPH after treatment with tadalafil 5 mg once daily vs placebo. This combined responder measure may be useful in future assessment of treatment benefits across patient groups after various types of treatment intervention (e.g. surgical vs pharmacotherapy vs non-pharmacological intervention).

Authors+Show Affiliations

Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.New England Research Institutes, Inc., Watertown, MA, USA.Men's Health Center, The Miriam Hospital, Providence, RI, USA.Global Statistical Sciences and Advanced Analytics, USA.Eli Lilly and Company, Indianapolis, IN, USA.New England Research Institutes, Inc., Watertown, MA, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26765325

Citation

Roehrborn, Claus G., et al. "Erectile Dysfunction and Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia (LUTS/BPH) Combined Responders to Tadalafil After 12 Weeks of Treatment." BJU International, vol. 118, no. 1, 2016, pp. 153-60.
Roehrborn CG, Egan KB, Miner MM, et al. Erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) combined responders to tadalafil after 12 weeks of treatment. BJU Int. 2016;118(1):153-60.
Roehrborn, C. G., Egan, K. B., Miner, M. M., Ni, X., Wong, D. G., & Rosen, R. C. (2016). Erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) combined responders to tadalafil after 12 weeks of treatment. BJU International, 118(1), 153-60. https://doi.org/10.1111/bju.13406
Roehrborn CG, et al. Erectile Dysfunction and Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia (LUTS/BPH) Combined Responders to Tadalafil After 12 Weeks of Treatment. BJU Int. 2016;118(1):153-60. PubMed PMID: 26765325.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) combined responders to tadalafil after 12 weeks of treatment. AU - Roehrborn,Claus G, AU - Egan,Kathryn B, AU - Miner,Martin M, AU - Ni,Xiao, AU - Wong,David G, AU - Rosen,Raymond C, Y1 - 2016/02/11/ PY - 2016/1/15/entrez PY - 2016/1/15/pubmed PY - 2017/5/26/medline KW - BPH KW - LUTS KW - erectile dysfunction KW - tadalafil SP - 153 EP - 60 JF - BJU international JO - BJU Int VL - 118 IS - 1 N2 - OBJECTIVE: To analyse the proportion of men taking tadalafil 5 mg once daily who experience a combined improvement in symptoms of both erectile dysfunction (ED) and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). MATERIALS AND METHODS: The data from men aged ≥45 years randomized to tadalafil 5 mg once daily or placebo enrolled in one of four randomized, placebo-controlled LUTS/BPH clinical trials were analysed (N = 927). A novel classification of 'combined responders' to ED and LUTS/BPH treatment was defined, based on published criteria for men who showed improvement in both International Index of Erectile Function - Erectile Function domain (IIEF-EF) score and total International Prostate Symptom Score (IPSS). Descriptive analyses assessed the covariate distribution by responder status. Unadjusted and adjusted logistic regressions provided odds ratios with 95% confidence intervals comparing combined responders with all others (partial and non-responders). RESULTS: Among men randomized to tadalafil 5 mg, 40.5% were combined responders (n = 189). Among placebo randomized men, 18.3% were combined responders (n = 84). Combined responders, in the total population, had the highest baseline IPSS and lowest baseline IIEF-EF scores, corresponding to the highest level of dysfunction. The majority of men were aged ≤65 years, white, non-obese, non-smokers, and regular alcohol consumers. Only treatment, baseline IPSS, baseline IIEF-EF, obesity and psychoactive medication use were significantly associated with responder status (P ≤ 0.05). Tadalafil-treated men had 2.8 times significantly increased adjusted odds of being combined responders vs non-responders (P < 0.001). For each unit decrease in baseline IIEF-EF or alcoholic drink consumption per week there was a 4% significant increase in the adjusted odds of being a combined responder to tadalafil therapy. CONCLUSIONS: This novel measure of combined response is useful in differentiating patients with clinically relevant symptom improvement for both ED and LUTS/BPH after treatment with tadalafil 5 mg once daily vs placebo. This combined responder measure may be useful in future assessment of treatment benefits across patient groups after various types of treatment intervention (e.g. surgical vs pharmacotherapy vs non-pharmacological intervention). SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/26765325/Erectile_dysfunction_and_lower_urinary_tract_symptoms_associated_with_benign_prostatic_hyperplasia__LUTS/BPH__combined_responders_to_tadalafil_after_12_weeks_of_treatment_ L2 - https://doi.org/10.1111/bju.13406 DB - PRIME DP - Unbound Medicine ER -