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Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction.
BJU Int. 2013 Nov; 112(7):990-7.BI

Abstract

OBJECTIVES

To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia (BPH-LUTS) in men without erectile dysfunction (ED). To compare these with effects in men with ED.

PATIENTS AND METHODS

After a 4-week washout period and 4-week placebo run-in period, 1089 men without ED (n = 338) and with ED (n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs. In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH-LUTS using the International Prostate Symptom Score (IPSS) and the BPH Impact Index (BII) and IPSS quality-of-life (IPSS-QoL) subscores. Safety was assessed using treatment-emergent adverse events. The treatment-by-ED-status interaction was used to assess efficacy differences between the with/without ED subgroups.

RESULTS

Men without ED were similar in BPH-LUTS severity/previous therapy to men with ED. Tadalafil significantly reduced BPH-LUTS from baseline when compared with placebo in men without ED (IPSS -5.4 vs -3.3, P < 0.01; IPSS voiding subscore -3.5 vs -2.0, P < 0.01; IPSS storage subscore -1.9 vs -1.3, P < 0.05). Tadalafil also significantly improved quality of life from baseline when compared with placebo in men without ED (IPSS-QoL -1.0 vs -0.7, BII -1.4 vs -1.0; both P < 0.05). Between-ED-subgroup interactions were not significant (all P > 0.68). Tadalafil was safe and well tolerated.

CONCLUSION

Tadalafil 5 mg once daily improved BPH-LUTS in men without ED by a magnitude similar to that observed in men with ED. The adverse event profile in men without ED was consistent with that observed in men with ED.

Authors+Show Affiliations

St Joseph's Health Care London, University of Western Ontario, London, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23937669

Citation

Brock, Gerald, et al. "Tadalafil once Daily in the Treatment of Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia (BPH) in Men Without Erectile Dysfunction." BJU International, vol. 112, no. 7, 2013, pp. 990-7.
Brock G, Broderick G, Roehrborn CG, et al. Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction. BJU Int. 2013;112(7):990-7.
Brock, G., Broderick, G., Roehrborn, C. G., Xu, L., Wong, D., & Viktrup, L. (2013). Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction. BJU International, 112(7), 990-7. https://doi.org/10.1111/bju.12251
Brock G, et al. Tadalafil once Daily in the Treatment of Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia (BPH) in Men Without Erectile Dysfunction. BJU Int. 2013;112(7):990-7. PubMed PMID: 23937669.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction. AU - Brock,Gerald, AU - Broderick,Gregory, AU - Roehrborn,Claus G, AU - Xu,Lei, AU - Wong,David, AU - Viktrup,Lars, Y1 - 2013/08/13/ PY - 2013/8/14/entrez PY - 2013/8/14/pubmed PY - 2013/12/16/medline KW - BPH KW - LUTS KW - erectile dysfunction KW - lower urinary tract symptoms KW - phosphodiesterase type 5 inhibitors KW - prostatic hyperplasia KW - tadalafil SP - 990 EP - 7 JF - BJU international JO - BJU Int. VL - 112 IS - 7 N2 - OBJECTIVES: To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia (BPH-LUTS) in men without erectile dysfunction (ED). To compare these with effects in men with ED. PATIENTS AND METHODS: After a 4-week washout period and 4-week placebo run-in period, 1089 men without ED (n = 338) and with ED (n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs. In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH-LUTS using the International Prostate Symptom Score (IPSS) and the BPH Impact Index (BII) and IPSS quality-of-life (IPSS-QoL) subscores. Safety was assessed using treatment-emergent adverse events. The treatment-by-ED-status interaction was used to assess efficacy differences between the with/without ED subgroups. RESULTS: Men without ED were similar in BPH-LUTS severity/previous therapy to men with ED. Tadalafil significantly reduced BPH-LUTS from baseline when compared with placebo in men without ED (IPSS -5.4 vs -3.3, P < 0.01; IPSS voiding subscore -3.5 vs -2.0, P < 0.01; IPSS storage subscore -1.9 vs -1.3, P < 0.05). Tadalafil also significantly improved quality of life from baseline when compared with placebo in men without ED (IPSS-QoL -1.0 vs -0.7, BII -1.4 vs -1.0; both P < 0.05). Between-ED-subgroup interactions were not significant (all P > 0.68). Tadalafil was safe and well tolerated. CONCLUSION: Tadalafil 5 mg once daily improved BPH-LUTS in men without ED by a magnitude similar to that observed in men with ED. The adverse event profile in men without ED was consistent with that observed in men with ED. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/23937669/Tadalafil_once_daily_in_the_treatment_of_lower_urinary_tract_symptoms__LUTS__suggestive_of_benign_prostatic_hyperplasia__BPH__in_men_without_erectile_dysfunction_ L2 - https://doi.org/10.1111/bju.12251 DB - PRIME DP - Unbound Medicine ER -