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A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
J Sex Med. 2012 Jun; 9(6):1624-33.JS

Abstract

INTRODUCTION

Safety and efficacy of tamsulosin and vardenafil are well established: however, there is no report regarding combined therapy with these drugs for lower urinary tract symptoms (LUTSs) secondary to benign prostatic hyperplasia (BPH).

AIM

To compare the safety and efficacy of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in patients with LUTS/BPH in a randomized trial with 12-week follow-up.

METHODS

We conducted a randomized, double-blind, placebo-controlled study on 60 men with persistent storage LUTS after 2-week run-in with tamsulosin.

MAIN OUTCOME MEASURES

International Prostate Symptom Score (IPSS), IPSS-bother, International Index of Erectile Function, Version 5 (IIEF-5) and Over Active Bladder questionnaire (OAB-q) scores, uroflowmetry data (Qmax, Qave), and postvoiding residual urine were recorded after run-in (baseline), and 2 and 12 weeks after treatment. Differences between vardenafil and placebo at different times were calculated with unpaired samples t-test. Between-group differences in change from baseline to 2 and 12 weeks were evaluated with analysis of variance.

RESULTS

We found a between-group significant difference from baseline to 12 weeks in the following: (i) Qmax (placebo: +0.07, vardenafil: +2.56, P = 0.034); (ii) Qave (placebo: -0.15, vardenafil: +1.02, P = 0.031); (iii) irritative-IPSS subscores (placebo: -1.67, vardenafil: -3.11, P = 0.039); and (iv) IIEF (placebo: +0.06, vardenafil: +2.61, P = 0.030). No patient reported any serious (grade ≥ 2) adverse event (AE). There were no differences in the incidence of common, treatment-related AEs between men undergoing combined therapy or tamsulosin alone.

CONCLUSIONS

The combination of tamsulosin and vardenafil for 12 weeks was well tolerated and more effective to improve both LUTS and erectile function, as compared with tamsulosin alone. Further studies are needed to assess the role of combined therapy of phosphodiesterase type 5 inhibitors and alpha blockers in treating LUTS/BPH.

Links

Aggregator Full Text
Publisher Full Text
linkinghub.elsevier.com
onlinelibrary.wiley.com

Authors+Show Affiliations

Gacci M
Department of Urology, University of Florence, Florence, Italy. maurogacci@yahoo.it
Vittori G
No affiliation info available
Tosi N
No affiliation info available
Siena G
No affiliation info available
Rossetti MA
No affiliation info available
Lapini A
No affiliation info available
Vignozzi L
No affiliation info available
Serni S
No affiliation info available
Maggi M
No affiliation info available
Carini M
No affiliation info available

MeSH

Adrenergic alpha-1 Receptor AntagonistsAgedDouble-Blind MethodDrug Therapy, CombinationErectile DysfunctionHumansImidazolesLower Urinary Tract SymptomsMalePhosphodiesterase 5 InhibitorsPiperazinesProstatic HyperplasiaSulfonamidesSulfonesTamsulosinTriazinesVardenafil Dihydrochloride

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22510238

Clinical Trial Links

Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms

Citation

Gacci, Mauro, et al. "A Randomized, Placebo-controlled Study to Assess Safety and Efficacy of Vardenafil 10 Mg and Tamsulosin 0.4 Mg Vs. Tamsulosin 0.4 Mg Alone in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia." The Journal of Sexual Medicine, vol. 9, no. 6, 2012, pp. 1624-33.
Gacci M, Vittori G, Tosi N, et al. A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Sex Med. 2012;9(6):1624-33.
Gacci, M., Vittori, G., Tosi, N., Siena, G., Rossetti, M. A., Lapini, A., Vignozzi, L., Serni, S., Maggi, M., & Carini, M. (2012). A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The Journal of Sexual Medicine, 9(6), 1624-33. https://doi.org/10.1111/j.1743-6109.2012.02718.x
Gacci M, et al. A Randomized, Placebo-controlled Study to Assess Safety and Efficacy of Vardenafil 10 Mg and Tamsulosin 0.4 Mg Vs. Tamsulosin 0.4 Mg Alone in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Sex Med. 2012;9(6):1624-33. PubMed PMID: 22510238.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. AU - Gacci,Mauro, AU - Vittori,Gianni, AU - Tosi,Nicola, AU - Siena,Giampaolo, AU - Rossetti,Mario Alberto, AU - Lapini,Alberto, AU - Vignozzi,Linda, AU - Serni,Sergio, AU - Maggi,Mario, AU - Carini,Marco, Y1 - 2012/04/17/ PY - 2012/4/19/entrez PY - 2012/4/19/pubmed PY - 2012/10/12/medline SP - 1624 EP - 33 JF - The journal of sexual medicine JO - J Sex Med VL - 9 IS - 6 N2 - INTRODUCTION: Safety and efficacy of tamsulosin and vardenafil are well established: however, there is no report regarding combined therapy with these drugs for lower urinary tract symptoms (LUTSs) secondary to benign prostatic hyperplasia (BPH). AIM: To compare the safety and efficacy of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in patients with LUTS/BPH in a randomized trial with 12-week follow-up. METHODS: We conducted a randomized, double-blind, placebo-controlled study on 60 men with persistent storage LUTS after 2-week run-in with tamsulosin. MAIN OUTCOME MEASURES: International Prostate Symptom Score (IPSS), IPSS-bother, International Index of Erectile Function, Version 5 (IIEF-5) and Over Active Bladder questionnaire (OAB-q) scores, uroflowmetry data (Qmax, Qave), and postvoiding residual urine were recorded after run-in (baseline), and 2 and 12 weeks after treatment. Differences between vardenafil and placebo at different times were calculated with unpaired samples t-test. Between-group differences in change from baseline to 2 and 12 weeks were evaluated with analysis of variance. RESULTS: We found a between-group significant difference from baseline to 12 weeks in the following: (i) Qmax (placebo: +0.07, vardenafil: +2.56, P = 0.034); (ii) Qave (placebo: -0.15, vardenafil: +1.02, P = 0.031); (iii) irritative-IPSS subscores (placebo: -1.67, vardenafil: -3.11, P = 0.039); and (iv) IIEF (placebo: +0.06, vardenafil: +2.61, P = 0.030). No patient reported any serious (grade ≥ 2) adverse event (AE). There were no differences in the incidence of common, treatment-related AEs between men undergoing combined therapy or tamsulosin alone. CONCLUSIONS: The combination of tamsulosin and vardenafil for 12 weeks was well tolerated and more effective to improve both LUTS and erectile function, as compared with tamsulosin alone. Further studies are needed to assess the role of combined therapy of phosphodiesterase type 5 inhibitors and alpha blockers in treating LUTS/BPH. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/22510238/A_randomized_placebo_controlled_study_to_assess_safety_and_efficacy_of_vardenafil_10_mg_and_tamsulosin_0_4_mg_vs__tamsulosin_0_4_mg_alone_in_the_treatment_of_lower_urinary_tract_symptoms_secondary_to_benign_prostatic_hyperplasia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)34013-3 DB - PRIME DP - Unbound Medicine ER -
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