Background: Safety and efficacy of tamsulosin and tadalafil for men with benign prostatic enlargement (BPE) and/or erectile dysfunction (ED) are defined. However, there are only a few pilot studies on combination therapy with these drugs for men with lower urinary tract symptom (LUTS)/BPE and ED. Moreover, preliminary reports are limited to 12 wk, without any information about subsequent therapies. Objective: To evaluate the impact of discontinuation of tamsulosin versus tadalafil 12 wk after combination therapy. Design, setting, and participants: Fifty consecutive patients with moderate-to-severe LUTS (International Prostate Symptom Score [IPSS] > 7) and mild-to-severe ED (International Index of Erectile Function-5 [IIEF-5] < 22) were treated with combination therapy (tamsulosin 0.4 mg/d plus tadalafil 5 mg/d) for 12 wk. After 12 wk, 25 patients discontinued tamsulosin (Group TAD), while 25 patients discontinued tadalafil (Group TAM). Outcome measurements and statistical analysis: Efficacy variables were IPSS (total, voiding, storage) and IIEF-5. Paired samples t test and analysis of variance were used. Results and limitations: Groups TAD and TAM presented similar features (age, BMI, metabolic profile) including symptoms scores at baseline. Similar and significant improvements in IPSS (total, voiding, and storage) and IIEF-5 were recorded in both groups after 12 wk of combination therapy (all p < 0.001). Total IPSS was similar between the two groups at the end of the trial. However, we found between-group significant differences from baseline to 24 wk and from 12 to 24 wk in storage-IPSS (Group TAD: –3.32 vs Group TAM: –1.24, p = 0.002; Group TAD: +0.24 vs Group TAM: +1.20, p = 0.040, respectively) and in IIEF-5 (Group TAD: +4.64 vs Group TAM: +0.16, p < 0.001; Group TAD: –1.64 vs Group TAM: –4.40, p = 0.003). No significant treatment-related adverse event was recorded in both groups. Conclusions: After 12 wk of combination therapy, monotherapy with tadalafil for further 12 wk allows to preserve the improvement of storage IPSS and IIEF-5, in addition to total IPSS. Patient summary: In this report we evaluated the discontinuation of tamsulosin or tadalafil after 12 wk of combination therapy. We found that tadalafil monotherapy, for a further 12 wk, aids in retaining the improvement of storage symptoms and erectile function.

Which Drug to Discontinue 3 Months After Combination Therapy of Tadalafil plus Tamsulosin for Men with Lower Urinary Tract Symptom and Erectile Dysfunction? Results of a Prospective Observational Trial / Sebastianelli, A.; Spatafora, P.; Frizzi, J.; Saleh, O.; De Nunzio, C.; Tubaro, A.; Vignozzi, L.; Maggi, M.; Serni, S.; Mcvary, K. T.; Kaplan, S. A.; Gravas, S.; Chapple, C.; Gacci, M.. - In: EUROPEAN UROLOGY FOCUS. - ISSN 2405-4569. - (2019). [10.1016/j.euf.2019.09.015]

Which Drug to Discontinue 3 Months After Combination Therapy of Tadalafil plus Tamsulosin for Men with Lower Urinary Tract Symptom and Erectile Dysfunction? Results of a Prospective Observational Trial

Saleh O.;De Nunzio C.;Tubaro A.;Vignozzi L.;
2019

Abstract

Background: Safety and efficacy of tamsulosin and tadalafil for men with benign prostatic enlargement (BPE) and/or erectile dysfunction (ED) are defined. However, there are only a few pilot studies on combination therapy with these drugs for men with lower urinary tract symptom (LUTS)/BPE and ED. Moreover, preliminary reports are limited to 12 wk, without any information about subsequent therapies. Objective: To evaluate the impact of discontinuation of tamsulosin versus tadalafil 12 wk after combination therapy. Design, setting, and participants: Fifty consecutive patients with moderate-to-severe LUTS (International Prostate Symptom Score [IPSS] > 7) and mild-to-severe ED (International Index of Erectile Function-5 [IIEF-5] < 22) were treated with combination therapy (tamsulosin 0.4 mg/d plus tadalafil 5 mg/d) for 12 wk. After 12 wk, 25 patients discontinued tamsulosin (Group TAD), while 25 patients discontinued tadalafil (Group TAM). Outcome measurements and statistical analysis: Efficacy variables were IPSS (total, voiding, storage) and IIEF-5. Paired samples t test and analysis of variance were used. Results and limitations: Groups TAD and TAM presented similar features (age, BMI, metabolic profile) including symptoms scores at baseline. Similar and significant improvements in IPSS (total, voiding, and storage) and IIEF-5 were recorded in both groups after 12 wk of combination therapy (all p < 0.001). Total IPSS was similar between the two groups at the end of the trial. However, we found between-group significant differences from baseline to 24 wk and from 12 to 24 wk in storage-IPSS (Group TAD: –3.32 vs Group TAM: –1.24, p = 0.002; Group TAD: +0.24 vs Group TAM: +1.20, p = 0.040, respectively) and in IIEF-5 (Group TAD: +4.64 vs Group TAM: +0.16, p < 0.001; Group TAD: –1.64 vs Group TAM: –4.40, p = 0.003). No significant treatment-related adverse event was recorded in both groups. Conclusions: After 12 wk of combination therapy, monotherapy with tadalafil for further 12 wk allows to preserve the improvement of storage IPSS and IIEF-5, in addition to total IPSS. Patient summary: In this report we evaluated the discontinuation of tamsulosin or tadalafil after 12 wk of combination therapy. We found that tadalafil monotherapy, for a further 12 wk, aids in retaining the improvement of storage symptoms and erectile function.
2019
Benign Prostatic Hyperplasia; Benign Prostatic Obstruction; combination therapy; Erectile Dysfunction; lower urinary tract symptoms; tadalafil; tamsulosin
01 Pubblicazione su rivista::01a Articolo in rivista
Which Drug to Discontinue 3 Months After Combination Therapy of Tadalafil plus Tamsulosin for Men with Lower Urinary Tract Symptom and Erectile Dysfunction? Results of a Prospective Observational Trial / Sebastianelli, A.; Spatafora, P.; Frizzi, J.; Saleh, O.; De Nunzio, C.; Tubaro, A.; Vignozzi, L.; Maggi, M.; Serni, S.; Mcvary, K. T.; Kaplan, S. A.; Gravas, S.; Chapple, C.; Gacci, M.. - In: EUROPEAN UROLOGY FOCUS. - ISSN 2405-4569. - (2019). [10.1016/j.euf.2019.09.015]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1457506
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