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Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia.
J Urol. 2014 Mar; 191(3):727-33.JU

Abstract

PURPOSE

Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker. We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms.

MATERIALS AND METHODS

In an international, randomized, double-blind, parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS (International Prostate Symptom Score) of 13 or greater and prostate volume 30 ml or greater, 350 were treated with placebo/finasteride and 345 received tadalafil/finasteride for 26 weeks. Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS, erectile dysfunction improvements were assessed with the IIEF-EF (International Index of Erectile Function-Erectile Function) in sexually active men and safety was assessed by evaluating adverse events.

RESULTS

Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0, -5.2 and -5.5, respectively. Corresponding values for placebo/finasteride coadministration were -2.3, -3.8 and -4.5 (p ≤ 0.022 at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration. Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were -1.1, 0.6 and -0.0 (p <0.001 at all visits favoring tadalafil/finasteride coadministration). Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate.

CONCLUSIONS

The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction.

Authors+Show Affiliations

Instituto Médico Especializado, Buenos Aires, Argentina.University of Texas Southwestern Medical Center, Dallas, Texas.Department of Urology, Ospedale Papa Giovanni XXIII-Bergamo, Bergamo, Italy.Saltillo University Hospital, Saltillo, Mexico.Regional Urology LLC, Shreveport, Louisiana.Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg, Germany.Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana. Electronic address: viktrup_lars@lilly.com.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24096118

Citation

Casabé, Adolfo, et al. "Efficacy and Safety of the Coadministration of Tadalafil once Daily With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia." The Journal of Urology, vol. 191, no. 3, 2014, pp. 727-33.
Casabé A, Roehrborn CG, Da Pozzo LF, et al. Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. J Urol. 2014;191(3):727-33.
Casabé, A., Roehrborn, C. G., Da Pozzo, L. F., Zepeda, S., Henderson, R. J., Sorsaburu, S., Henneges, C., Wong, D. G., & Viktrup, L. (2014). Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. The Journal of Urology, 191(3), 727-33. https://doi.org/10.1016/j.juro.2013.09.059
Casabé A, et al. Efficacy and Safety of the Coadministration of Tadalafil once Daily With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia. J Urol. 2014;191(3):727-33. PubMed PMID: 24096118.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. AU - Casabé,Adolfo, AU - Roehrborn,Claus G, AU - Da Pozzo,Luigi F, AU - Zepeda,Sebastian, AU - Henderson,R Jonathan, AU - Sorsaburu,Sebastian, AU - Henneges,Carsten, AU - Wong,David G, AU - Viktrup,Lars, Y1 - 2013/10/02/ PY - 2013/09/04/accepted PY - 2013/10/8/entrez PY - 2013/10/8/pubmed PY - 2014/4/25/medline KW - erectile dysfunction KW - finasteride KW - lower urinary tract symptoms KW - prostatic hyperplasia KW - tadalafil SP - 727 EP - 33 JF - The Journal of urology JO - J. Urol. VL - 191 IS - 3 N2 - PURPOSE: Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker. We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms. MATERIALS AND METHODS: In an international, randomized, double-blind, parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS (International Prostate Symptom Score) of 13 or greater and prostate volume 30 ml or greater, 350 were treated with placebo/finasteride and 345 received tadalafil/finasteride for 26 weeks. Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS, erectile dysfunction improvements were assessed with the IIEF-EF (International Index of Erectile Function-Erectile Function) in sexually active men and safety was assessed by evaluating adverse events. RESULTS: Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0, -5.2 and -5.5, respectively. Corresponding values for placebo/finasteride coadministration were -2.3, -3.8 and -4.5 (p ≤ 0.022 at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration. Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were -1.1, 0.6 and -0.0 (p <0.001 at all visits favoring tadalafil/finasteride coadministration). Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate. CONCLUSIONS: The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction. SN - 1527-3792 UR - https://www.unboundmedicine.com/medline/citation/24096118/Efficacy_and_safety_of_the_coadministration_of_tadalafil_once_daily_with_finasteride_for_6_months_in_men_with_lower_urinary_tract_symptoms_and_prostatic_enlargement_secondary_to_benign_prostatic_hyperplasia_ L2 - https://www.jurology.com/doi/full/10.1016/j.juro.2013.09.059?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -