Arcangelo Sebastianelli1, Pietro Spatafora1, Jacopo Frizzi1, Omar Saleh1, Cosimo De Nunzio2, Andrea Tubaro2, Linda Vignozzi3, Mario Maggi3, Sergio Serni1, Kevin T McVary4, Steven A Kaplan5, Stavros Gravas6, Christopher Chapple7, Mauro Gacci8. 1. Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Florence, Italy. 2. Department of Urology, Sant'Andrea Hospital, University "La Sapienza", Rome, Italy. 3. Department of Clinical Physiopathology, University of Florence, Florence, Italy. 4. Center for Male Health, Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL, USA. 5. Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA. 6. Department of Urology, University of Thessaly, Larissa, Greece. 7. Department of Urology, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK. 8. Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Florence, Italy. Electronic address: maurogacci@yahoo.it.
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 0.4mg/d plus tadalafil 5mg/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.
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 0.4mg/d plus tadalafil 5mg/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.
Authors: Angelo Porreca; Federico Mineo Bianchi; Antonio Salvaggio; Daniele D'Agostino; Alessandro Del Rosso; Daniele Romagnoli; Paolo Corsi; Michele Colicchia; Umberto Barbaresi; Lorenzo Bianchi; Marco Giampaoli; Riccardo Schiavina; Katie Palmer; Francesco Del Giudice; Martina Maggi; Matteo Ferro; Alessandro Sciarra; Ettore De Berardinis; Gian Maria Busetto Journal: World J Urol Date: 2020-07-03 Impact factor: 4.226
Authors: A Sebastianelli; P Spatafora; S Morselli; L Vignozzi; S Serni; K T McVary; S Kaplan; S Gravas; C Chapple; Mauro Gacci Journal: Curr Urol Rep Date: 2020-10-27 Impact factor: 3.092