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Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report.
J Sex Med. 2009 Feb; 6(2):544-52.JS

Abstract

INTRODUCTION

Alpha1-blockers (AB) are the first-line monotherapy for lower urinary tract symptoms (LUTS). Phosphodiesterase type 5 (PDE5) inhibitors are the first-line treatment for erectile dysfunction (ED). Numerous studies have supposed a significant association between ED and LUTS, but a causal relationship cannot be established.

AIM

The aim was to evaluate the efficacy of a combined therapy with an AB (alfuzosin) and PDE5 inhibitors (tadalafil) in patients with LUTS and ED.

METHODS

This was a randomized, open-label, three-arm study. A total of 66 men complaining of ED and LUTS were included in the study. Patients were assessed at baseline and after 12 weeks of study treatment, and then underwent randomized allocation to either alfuzosin 10 mg once a day (22 patients) or tadalafil 20 mg on alternative days (21 patients), or a combination of both (23 patients).

MAIN OUTCOME MEASURES

All participants completed the erectile function domain of the International Index of Erectile Function (IIEF-EF) and the International Prostatic Symptom Score (IPSS). Other efficacy variables included maximum urinary flow rate (Qmax) and medium urinary flow rate (Qave).

RESULTS

IIEF-EF tended to improve with alfuzosin alone (+15%), while it was clearly improved with tadalafil alone (+36.3%). The greatest improvement was experienced with the combination therapy (+37.6%). Improvement in Qmax was observed in all groups, but patients receiving combination therapy had greater improvement (29.6%) than patients receiving either only alfuzosin (21.7%) or only tadalafil (9.5%). IPSS was significantly improved in alfuzosin group (27.2%), was more marked with the combination therapy (41.6%), and a small increase, although not significant, was also observed with tadalafil (8.4%).

CONCLUSIONS

Combined therapy improved ED and LUTS as demonstrated by the significant improvement in uroflowmetry measures and in IPSS and IIEF-EF scores. A significant improvement was also observed in quality of life assessments. The beneficial effects of tadalafil on LUTS similar to the benefits of alfuzosin on ED, although present, were smaller.

Authors+Show Affiliations

Department of Urology, University of Trieste, Trieste, Italy. gioliguori@libero.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19138360

Citation

Liguori, Giovanni, et al. "Efficacy and Safety of Combined Oral Therapy With Tadalafil and Alfuzosin: an Integrated Approach to the Management of Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction. Preliminary Report." The Journal of Sexual Medicine, vol. 6, no. 2, 2009, pp. 544-52.
Liguori G, Trombetta C, De Giorgi G, et al. Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. J Sex Med. 2009;6(2):544-52.
Liguori, G., Trombetta, C., De Giorgi, G., Pomara, G., Maio, G., Vecchio, D., Ocello, G., Ollandini, G., Bucci, S., & Belgrano, E. (2009). Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. The Journal of Sexual Medicine, 6(2), 544-52. https://doi.org/10.1111/j.1743-6109.2008.01109.x
Liguori G, et al. Efficacy and Safety of Combined Oral Therapy With Tadalafil and Alfuzosin: an Integrated Approach to the Management of Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction. Preliminary Report. J Sex Med. 2009;6(2):544-52. PubMed PMID: 19138360.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. AU - Liguori,Giovanni, AU - Trombetta,Carlo, AU - De Giorgi,Gioacchino, AU - Pomara,Giorgio, AU - Maio,Giuseppe, AU - Vecchio,Daniele, AU - Ocello,Giuseppe, AU - Ollandini,Giangiacomo, AU - Bucci,Stefano, AU - Belgrano,Emanuele, Y1 - 2008/12/02/ PY - 2009/1/14/entrez PY - 2009/1/14/pubmed PY - 2009/8/18/medline SP - 544 EP - 52 JF - The journal of sexual medicine JO - J Sex Med VL - 6 IS - 2 N2 - INTRODUCTION: Alpha1-blockers (AB) are the first-line monotherapy for lower urinary tract symptoms (LUTS). Phosphodiesterase type 5 (PDE5) inhibitors are the first-line treatment for erectile dysfunction (ED). Numerous studies have supposed a significant association between ED and LUTS, but a causal relationship cannot be established. AIM: The aim was to evaluate the efficacy of a combined therapy with an AB (alfuzosin) and PDE5 inhibitors (tadalafil) in patients with LUTS and ED. METHODS: This was a randomized, open-label, three-arm study. A total of 66 men complaining of ED and LUTS were included in the study. Patients were assessed at baseline and after 12 weeks of study treatment, and then underwent randomized allocation to either alfuzosin 10 mg once a day (22 patients) or tadalafil 20 mg on alternative days (21 patients), or a combination of both (23 patients). MAIN OUTCOME MEASURES: All participants completed the erectile function domain of the International Index of Erectile Function (IIEF-EF) and the International Prostatic Symptom Score (IPSS). Other efficacy variables included maximum urinary flow rate (Qmax) and medium urinary flow rate (Qave). RESULTS: IIEF-EF tended to improve with alfuzosin alone (+15%), while it was clearly improved with tadalafil alone (+36.3%). The greatest improvement was experienced with the combination therapy (+37.6%). Improvement in Qmax was observed in all groups, but patients receiving combination therapy had greater improvement (29.6%) than patients receiving either only alfuzosin (21.7%) or only tadalafil (9.5%). IPSS was significantly improved in alfuzosin group (27.2%), was more marked with the combination therapy (41.6%), and a small increase, although not significant, was also observed with tadalafil (8.4%). CONCLUSIONS: Combined therapy improved ED and LUTS as demonstrated by the significant improvement in uroflowmetry measures and in IPSS and IIEF-EF scores. A significant improvement was also observed in quality of life assessments. The beneficial effects of tadalafil on LUTS similar to the benefits of alfuzosin on ED, although present, were smaller. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/19138360/Efficacy_and_safety_of_combined_oral_therapy_with_tadalafil_and_alfuzosin:_an_integrated_approach_to_the_management_of_patients_with_lower_urinary_tract_symptoms_and_erectile_dysfunction__Preliminary_report_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)32387-0 DB - PRIME DP - Unbound Medicine ER -