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Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction.
Urology. 2010 Jun; 75(6):1452-8.U

Abstract

OBJECTIVES

To compare the safety and efficacy of the daily erectogenic therapy, tadalafil, on lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) in men with or without comorbid erectile dysfunction (ED).

METHODS

Following a 4-week placebo run-in period, men with moderate-to-severe BPH-LUTS were randomized to placebo or tadalafil 2.5, 5, 10, or 20 mg once daily for 12 weeks. International Prostate Symptom Scores (IPSS), IPSS quality of life, and BPH Impact Index were measured every 4 weeks. Safety was mainly assessed via spontaneous reports of adverse events. Data from men with (n=716) or without (n=340) ED at baseline were compared in posthoc analyses.

RESULTS

Men with ED were older and had more frequent hypertension, hyperlipidemia, coronary artery disease, and diabetes at baseline compared with men without ED. After 12 weeks, changes in IPSS in men with ED (least squares mean change from baseline, placebo: -2.4; tadalafil 2.5, 5, 10, 20 mg: -4.3, -4.8, -5.3, -5.6) and without ED (-2.4, -3.2, -5.3, -5.1, -4.5) were not significantly different (subgroup/interaction P values: .352/.644). Similar effects were observed for IPSS quality of life (with ED: -0.6, -0.9, -0.9, -1.0, -1.1; without ED: -0.6, -0.7, -0.9, -0.8, -0.8; 0.090/0.773) and BPH Impact Index (with ED: -0.7, -0.9, -1.3, -1.3, -1.4; without ED: -1.0, -0.7, -1.3, -1.3, -1.2; 0.753/0.852). Tadalafil was generally well tolerated, and men with or without ED had similar tolerability profiles.

CONCLUSIONS

Changes in BPH-LUTS after 12 weeks of treatment with placebo or various doses of once daily tadalafil were similar in men with or without comorbid ED.

Authors+Show Affiliations

Mayo Clinic, Jacksonville, Florida 32224, USA. Broderick.Gregory@mayo.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

20163842

Citation

Broderick, Gregory A., et al. "Effects of Tadalafil On Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men With or Without Erectile Dysfunction." Urology, vol. 75, no. 6, 2010, pp. 1452-8.
Broderick GA, Brock GB, Roehrborn CG, et al. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. Urology. 2010;75(6):1452-8.
Broderick, G. A., Brock, G. B., Roehrborn, C. G., Watts, S. D., Elion-Mboussa, A., & Viktrup, L. (2010). Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. Urology, 75(6), 1452-8. https://doi.org/10.1016/j.urology.2009.09.093
Broderick GA, et al. Effects of Tadalafil On Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men With or Without Erectile Dysfunction. Urology. 2010;75(6):1452-8. PubMed PMID: 20163842.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. AU - Broderick,Gregory A, AU - Brock,Gerald B, AU - Roehrborn,Claus G, AU - Watts,Steven D, AU - Elion-Mboussa,Albert, AU - Viktrup,Lars, Y1 - 2010/02/16/ PY - 2009/06/25/received PY - 2009/09/26/revised PY - 2009/09/29/accepted PY - 2010/2/19/entrez PY - 2010/2/19/pubmed PY - 2010/6/26/medline SP - 1452 EP - 8 JF - Urology JO - Urology VL - 75 IS - 6 N2 - OBJECTIVES: To compare the safety and efficacy of the daily erectogenic therapy, tadalafil, on lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) in men with or without comorbid erectile dysfunction (ED). METHODS: Following a 4-week placebo run-in period, men with moderate-to-severe BPH-LUTS were randomized to placebo or tadalafil 2.5, 5, 10, or 20 mg once daily for 12 weeks. International Prostate Symptom Scores (IPSS), IPSS quality of life, and BPH Impact Index were measured every 4 weeks. Safety was mainly assessed via spontaneous reports of adverse events. Data from men with (n=716) or without (n=340) ED at baseline were compared in posthoc analyses. RESULTS: Men with ED were older and had more frequent hypertension, hyperlipidemia, coronary artery disease, and diabetes at baseline compared with men without ED. After 12 weeks, changes in IPSS in men with ED (least squares mean change from baseline, placebo: -2.4; tadalafil 2.5, 5, 10, 20 mg: -4.3, -4.8, -5.3, -5.6) and without ED (-2.4, -3.2, -5.3, -5.1, -4.5) were not significantly different (subgroup/interaction P values: .352/.644). Similar effects were observed for IPSS quality of life (with ED: -0.6, -0.9, -0.9, -1.0, -1.1; without ED: -0.6, -0.7, -0.9, -0.8, -0.8; 0.090/0.773) and BPH Impact Index (with ED: -0.7, -0.9, -1.3, -1.3, -1.4; without ED: -1.0, -0.7, -1.3, -1.3, -1.2; 0.753/0.852). Tadalafil was generally well tolerated, and men with or without ED had similar tolerability profiles. CONCLUSIONS: Changes in BPH-LUTS after 12 weeks of treatment with placebo or various doses of once daily tadalafil were similar in men with or without comorbid ED. SN - 1527-9995 UR - https://www.unboundmedicine.com/medline/citation/20163842/Effects_of_tadalafil_on_lower_urinary_tract_symptoms_secondary_to_benign_prostatic_hyperplasia_in_men_with_or_without_erectile_dysfunction_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090-4295(09)03006-4 DB - PRIME DP - Unbound Medicine ER -