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Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies.
J Sex Med. 2013 Aug; 10(8):2044-52.JS

Abstract

INTRODUCTION

Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions.

AIM

The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes.

METHODS

Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4-week placebo run-in; changes from baseline were assessed vs. placebo using analysis of covariance.

MAIN OUTCOME MEASURES

International Prostate Symptom Score (IPSS), IPSS subscores, Quality-of-Life Index (IPSS-QoL), BPH Impact Index (BII), and International Index of Erectile Function-Erectile Function (IIEF-EF) Domain score were used in this study.

RESULTS

Tadalafil (N = 505) significantly improved total IPSS vs. placebo (N = 521); mean changes from baseline were -6.0 and -3.6, respectively (P < 0.001). Improvements in IIEF-EF Domain score (tadalafil, 6.4; placebo, 1.4) were also significant vs. placebo, as were the IPSS storage and voiding subscores, IPSS-QoL, and BII (all P < 0.001). No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated (r = -0.229). Treatment-emergent adverse events were consistent with previous reports.

CONCLUSIONS

Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated.

Authors+Show Affiliations

Private Practice of Urology and Andrology, Hamburg, Germany. Porst20354@aol.comNo 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

23782459

Citation

Porst, Hartmut, et al. "Effects of Tadalafil On Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia and On Erectile Dysfunction in Sexually Active Men With Both Conditions: Analyses of Pooled Data From Four Randomized, Placebo-controlled Tadalafil Clinical Studies." The Journal of Sexual Medicine, vol. 10, no. 8, 2013, pp. 2044-52.
Porst H, Roehrborn CG, Secrest RJ, et al. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. J Sex Med. 2013;10(8):2044-52.
Porst, H., Roehrborn, C. G., Secrest, R. J., Esler, A., & Viktrup, L. (2013). Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. The Journal of Sexual Medicine, 10(8), 2044-52. https://doi.org/10.1111/jsm.12212
Porst H, et al. Effects of Tadalafil On Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia and On Erectile Dysfunction in Sexually Active Men With Both Conditions: Analyses of Pooled Data From Four Randomized, Placebo-controlled Tadalafil Clinical Studies. J Sex Med. 2013;10(8):2044-52. PubMed PMID: 23782459.
* 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 and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. AU - Porst,Hartmut, AU - Roehrborn,Claus G, AU - Secrest,Roberta J, AU - Esler,Anne, AU - Viktrup,Lars, Y1 - 2013/06/19/ PY - 2013/6/21/entrez PY - 2013/6/21/pubmed PY - 2014/12/15/medline KW - Benign Prostatic Hyperplasia KW - Erectile Dysfunction KW - LUTS/BPH KW - Lower Urinary Tract Symptoms KW - PDE5 Inhibitor KW - Tadalafil SP - 2044 EP - 52 JF - The journal of sexual medicine JO - J Sex Med VL - 10 IS - 8 N2 - INTRODUCTION: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions. AIM: The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes. METHODS: Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4-week placebo run-in; changes from baseline were assessed vs. placebo using analysis of covariance. MAIN OUTCOME MEASURES: International Prostate Symptom Score (IPSS), IPSS subscores, Quality-of-Life Index (IPSS-QoL), BPH Impact Index (BII), and International Index of Erectile Function-Erectile Function (IIEF-EF) Domain score were used in this study. RESULTS: Tadalafil (N = 505) significantly improved total IPSS vs. placebo (N = 521); mean changes from baseline were -6.0 and -3.6, respectively (P < 0.001). Improvements in IIEF-EF Domain score (tadalafil, 6.4; placebo, 1.4) were also significant vs. placebo, as were the IPSS storage and voiding subscores, IPSS-QoL, and BII (all P < 0.001). No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated (r = -0.229). Treatment-emergent adverse events were consistent with previous reports. CONCLUSIONS: Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/23782459/Effects_of_tadalafil_on_lower_urinary_tract_symptoms_secondary_to_benign_prostatic_hyperplasia_and_on_erectile_dysfunction_in_sexually_active_men_with_both_conditions:_analyses_of_pooled_data_from_four_randomized_placebo_controlled_tadalafil_clinical_studies_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)30454-9 DB - PRIME DP - Unbound Medicine ER -