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Published in: Advances in Therapy 1/2019

01-01-2019 | Review

Silodosin: An Update on Efficacy, Safety and Clinical Indications in Urology

Authors: Luca Villa, Paolo Capogrosso, Umberto Capitanio, Alberto Martini, Alberto Briganti, Andrea Salonia, Francesco Montorsi

Published in: Advances in Therapy | Issue 1/2019

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Abstract

Introduction

Silodosin determines smooth muscle relaxation in bladder and prostate tissues, increases bladder blood flow in conditions of chronic bladder ischemia and regulates the activity of transcriptional factors responsible for stromal growth and prostate hyperplasia. Phase III trials have already demonstrated the efficacy and safety of silodosin in the treatment of patients bothered by lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Objective

We aimed to describe the rationality for the use of silodosin and to summarize the current literature on the use of Silodosin for the treatment of LUTS.

Methods

PubMed and Web of Science were queried with the terms: ‘silodosin’ in combination (AND) with the terms ‘lower urinary tract symptoms’, ‘LUTS’, ‘pathophysiology’, ‘symptoms’ OR therapy’. Studies published in the last 10 years (2007–2017) in adults and core clinical journals in English were included.

Results

Silodosin 8 mg once-daily was superior to placebo in improving IPSS total score, voiding subscore, storage subscore and QoL score, and at least as effective as tamsulosin 0.4 mg once-daily in all the efficacy analyses. In addition, studies assessing the effect on urodynamic parameters showed that silodosin determined a higher improvement in the bladder outlet obstruction index compared to other alpha1 adrenergic receptor antagonists. Concerning the safety profile, long-term data (after 9 months of treatment) confirmed the limited effect of silodosin on the cardiovascular and gastrointestinal systems. Although ejaculatory disorders represented the main complaint of patients taking silodosin, the discontinuation rate due to this condition remained low even in a long-term follow-up study (7.5%). Encouraging findings showed that silodosin may be administered as a medical expulsive therapy for promoting spontaneous stone passage of distal ureteral stones < 10 mm, to relieve LUTS in patients who underwent prostate cancer brachytherapy and to increase the likelihood of successful trials without a catheter in patients experiencing acute urinary retention.

Conclusion

Silodosin is one of the drugs approved for the treatment of BPH, being highly effective in improving not only LUTS but also urodynamic parameter impairments secondary to BPH. Moreover, it has shown efficacy as medical expulsive therapy for distal ureteral stones in previous prospective randomized trials.

Funding

Sponsorship for this study and article processing charges were funded by Recordati.
Literature
1.
go back to reference Issa MM, Fenter TC, Black L, et al. An assessment of the diagnosed prevalence of diseases in men 50 years of age or older. Am J Manag Care. 2006;12:S83–9.PubMed Issa MM, Fenter TC, Black L, et al. An assessment of the diagnosed prevalence of diseases in men 50 years of age or older. Am J Manag Care. 2006;12:S83–9.PubMed
2.
go back to reference Oelke M, Burger M, Castro-Diaz D, et al. Diagnosis and medical treatment of lower urinary tract symptoms in adult men: applying specialist guidelines in clinical practice. BJU Int. 2011;110:710–8.CrossRef Oelke M, Burger M, Castro-Diaz D, et al. Diagnosis and medical treatment of lower urinary tract symptoms in adult men: applying specialist guidelines in clinical practice. BJU Int. 2011;110:710–8.CrossRef
3.
go back to reference McVary KT, Roehrborn CG, Avins AL, et al. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011;185:1793–803.CrossRef McVary KT, Roehrborn CG, Avins AL, et al. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011;185:1793–803.CrossRef
4.
go back to reference De Nunzio C, Ahyai S, Autorino R, et al. Benign prostatic hyperplasia and lower urinary tract symptoms: research priorities. Eur Urol. 2011;60:1205–6.CrossRef De Nunzio C, Ahyai S, Autorino R, et al. Benign prostatic hyperplasia and lower urinary tract symptoms: research priorities. Eur Urol. 2011;60:1205–6.CrossRef
5.
go back to reference Parsons JK. Commentary on BPH and public health–have we lost the forest through the trees? J Urol. 2008;179:S81.CrossRef Parsons JK. Commentary on BPH and public health–have we lost the forest through the trees? J Urol. 2008;179:S81.CrossRef
6.
go back to reference Isaacs JT. Importance of the natural history of benign prostatic hyperplasia in the evaluation of pharmacologic intervention. Prostate Suppl. 1990;3:1–7.CrossRef Isaacs JT. Importance of the natural history of benign prostatic hyperplasia in the evaluation of pharmacologic intervention. Prostate Suppl. 1990;3:1–7.CrossRef
7.
go back to reference Netto NR Jr, de Lima ML, Netto MR, D’Ancona CA. Evaluation of patients with bladder outlet obstruction and mild international prostate symptom score followed up by watchful waiting. Urology. 1999;53:314–6.CrossRef Netto NR Jr, de Lima ML, Netto MR, D’Ancona CA. Evaluation of patients with bladder outlet obstruction and mild international prostate symptom score followed up by watchful waiting. Urology. 1999;53:314–6.CrossRef
8.
go back to reference Kupelian V, Wei JT, O’Leary MP, et al. Nocturia and quality of life: results from the Boston area community health survey. Eur Urol. 2012;61:78–84.CrossRef Kupelian V, Wei JT, O’Leary MP, et al. Nocturia and quality of life: results from the Boston area community health survey. Eur Urol. 2012;61:78–84.CrossRef
9.
go back to reference Tikkinen KA, Johnson TM 2nd, Tammela TL, et al. Nocturia frequency, bother, and quality of life: how often is too often? A population-based study in Finland. Eur Urol. 2010;57:488–96.CrossRef Tikkinen KA, Johnson TM 2nd, Tammela TL, et al. Nocturia frequency, bother, and quality of life: how often is too often? A population-based study in Finland. Eur Urol. 2010;57:488–96.CrossRef
10.
go back to reference Gratzke C, Bachmann A, Descazeaud A, et al. EAU guidelines on the assessment of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2015;67:1099–109.CrossRef Gratzke C, Bachmann A, Descazeaud A, et al. EAU guidelines on the assessment of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2015;67:1099–109.CrossRef
11.
go back to reference Tatemichi S, Kobayashi K, Maezawa A, et al. Alpha1-adrenoceptor subtype selectivity and organ specificity of silodosin (KMD-3213) [article in Japanese]. Yakugaku Zasshi. 2006;126:209–16.PubMed Tatemichi S, Kobayashi K, Maezawa A, et al. Alpha1-adrenoceptor subtype selectivity and organ specificity of silodosin (KMD-3213) [article in Japanese]. Yakugaku Zasshi. 2006;126:209–16.PubMed
12.
go back to reference Akiyama K, Noto H, Nishizawa O, et al. Effect of KMD-3213, an alpha1A-adrenoceptor antagonist, on the prostatic urethral pressure and blood pressure in male decerebrate dogs. Int J Urol. 2001;8:177–83.CrossRef Akiyama K, Noto H, Nishizawa O, et al. Effect of KMD-3213, an alpha1A-adrenoceptor antagonist, on the prostatic urethral pressure and blood pressure in male decerebrate dogs. Int J Urol. 2001;8:177–83.CrossRef
13.
go back to reference Schilit S, Benzeroual KE. Silodosin: a selective alpha1A-adrenergic receptor antagonist for the treatment of benign prostatic hyperplasia. Clin Ther. 2009;31:2489–502.CrossRef Schilit S, Benzeroual KE. Silodosin: a selective alpha1A-adrenergic receptor antagonist for the treatment of benign prostatic hyperplasia. Clin Ther. 2009;31:2489–502.CrossRef
14.
go back to reference Chapple CR, Montorsi F, Tammela TL, et al. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol. 2011;59:342–52.CrossRef Chapple CR, Montorsi F, Tammela TL, et al. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol. 2011;59:342–52.CrossRef
15.
go back to reference Marks LS, Gittelman MC, Hill LA, et al. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009;181:2634–40.CrossRef Marks LS, Gittelman MC, Hill LA, et al. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009;181:2634–40.CrossRef
16.
go back to reference Kawabe K, Yoshida M, Homma Y. Silodosin, a new alpha1A-adrenoceptor-selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo-controlled, double-blind study in Japanese men. BJU Int. 2006;98:1019–24.CrossRef Kawabe K, Yoshida M, Homma Y. Silodosin, a new alpha1A-adrenoceptor-selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo-controlled, double-blind study in Japanese men. BJU Int. 2006;98:1019–24.CrossRef
17.
go back to reference Yu HJ, Lin AT, Yang SS, et al. Non-inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). BJU Int. 2011;108:1843–8.CrossRef Yu HJ, Lin AT, Yang SS, et al. Non-inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). BJU Int. 2011;108:1843–8.CrossRef
18.
go back to reference Capitanio U, Salonia A, Briganti A, Montorsi F. Silodosin in the management of lower urinary tract symptoms as a result of benign prostatic hyperplasia: who are the best candidates. Int J Clin Pract. 2013;67:544–51.CrossRef Capitanio U, Salonia A, Briganti A, Montorsi F. Silodosin in the management of lower urinary tract symptoms as a result of benign prostatic hyperplasia: who are the best candidates. Int J Clin Pract. 2013;67:544–51.CrossRef
19.
go back to reference Nasu K, Moriyama N, Kawabe K, et al. Quantification and distribution of alpha 1-adrenoceptor subtype mRNAs in human prostate: comparison of benign hypertrophied tissue and non-hypertrophied tissue. Br J Pharmacol. 1996;119:797–803.CrossRef Nasu K, Moriyama N, Kawabe K, et al. Quantification and distribution of alpha 1-adrenoceptor subtype mRNAs in human prostate: comparison of benign hypertrophied tissue and non-hypertrophied tissue. Br J Pharmacol. 1996;119:797–803.CrossRef
20.
go back to reference Shibata K, Foglar R, Horie K, et al. KMD-3213, a novel, potent, alpha 1a-adrenoceptor-selective antagonist: characterization using recombinant human alpha 1-adrenoceptors and native tissues. Mol Pharmacol. 1995;48:250–8.PubMed Shibata K, Foglar R, Horie K, et al. KMD-3213, a novel, potent, alpha 1a-adrenoceptor-selective antagonist: characterization using recombinant human alpha 1-adrenoceptors and native tissues. Mol Pharmacol. 1995;48:250–8.PubMed
21.
go back to reference Martin DJ, Angel I, Arbilla S. Functional uroselectivity. Eur Urol. 1998;33(Suppl 2):12–8.CrossRef Martin DJ, Angel I, Arbilla S. Functional uroselectivity. Eur Urol. 1998;33(Suppl 2):12–8.CrossRef
22.
go back to reference Moriyama N, Akiyama K, Murata S. KMD-3213, a novel alpha1A-adrenoceptor antagonist, potently inhibits the functional alpha1-adrenoceptor in human prostate. Eur J Pharmacol. 1997;331:39–42.CrossRef Moriyama N, Akiyama K, Murata S. KMD-3213, a novel alpha1A-adrenoceptor antagonist, potently inhibits the functional alpha1-adrenoceptor in human prostate. Eur J Pharmacol. 1997;331:39–42.CrossRef
23.
go back to reference Goi Y, Tomiyama Y, Nomiya M, Sagawa K, Aikawa K, Yamaguchi O. Effects of silodosin, a selective α1A-adrenoceptor antagonist, on bladder blood flow and bladder function in a rat model of atherosclerosis induced chronic bladder ischemia without bladder outlet obstruction. J Urol. 2013;190:1116–22.CrossRef Goi Y, Tomiyama Y, Nomiya M, Sagawa K, Aikawa K, Yamaguchi O. Effects of silodosin, a selective α1A-adrenoceptor antagonist, on bladder blood flow and bladder function in a rat model of atherosclerosis induced chronic bladder ischemia without bladder outlet obstruction. J Urol. 2013;190:1116–22.CrossRef
24.
go back to reference Inoue S, Saito M, Tsounapi P, et al. Effect of silodosin on detrusor overactivity in the male spontaneously hypertensive rat. BJU Int. 2012;110:E118–24.CrossRef Inoue S, Saito M, Tsounapi P, et al. Effect of silodosin on detrusor overactivity in the male spontaneously hypertensive rat. BJU Int. 2012;110:E118–24.CrossRef
25.
go back to reference Aizawa N, Watanabe D, Fukuhara H, et al. Inhibitory effects of silodosin on the bladder mechanosensitive afferent activities and their relation with bladder myogenic contractions in male rats with bladder outlet obstruction. Neurourol Urodyn. 2018. https://doi.org/10.1002/nau.23547 (Epub ahead of print).CrossRefPubMed Aizawa N, Watanabe D, Fukuhara H, et al. Inhibitory effects of silodosin on the bladder mechanosensitive afferent activities and their relation with bladder myogenic contractions in male rats with bladder outlet obstruction. Neurourol Urodyn. 2018. https://​doi.​org/​10.​1002/​nau.​23547 (Epub ahead of print).CrossRefPubMed
26.
go back to reference Hennenberg M, Strittmatter F, Beckmann C, et al. Silodosin inhibits noradrenaline-activated transcription factors Elk1 and SRF in human prostate smooth muscle. PLoS ONE. 2012;7:e50904.CrossRef Hennenberg M, Strittmatter F, Beckmann C, et al. Silodosin inhibits noradrenaline-activated transcription factors Elk1 and SRF in human prostate smooth muscle. PLoS ONE. 2012;7:e50904.CrossRef
27.
go back to reference Matsukawa Y, Gotoh M, Komatsu T, Funahashi Y, Sassa N. Hattori R Efficacy of silodosin for relieving benign prostatic obstruction: prospective pressure flow study. J Urol. 2013;189:S117–21.CrossRef Matsukawa Y, Gotoh M, Komatsu T, Funahashi Y, Sassa N. Hattori R Efficacy of silodosin for relieving benign prostatic obstruction: prospective pressure flow study. J Urol. 2013;189:S117–21.CrossRef
28.
go back to reference Yamanishi T, Mizuno T, Tatsumiya K, et al. Urodynamic effects of silodosin, a new alpha 1A-adrenoceptor selective antagonist, for the treatment of benign prostatic hyperplasia. Neurourol Urodyn. 2010;29:558–62.PubMed Yamanishi T, Mizuno T, Tatsumiya K, et al. Urodynamic effects of silodosin, a new alpha 1A-adrenoceptor selective antagonist, for the treatment of benign prostatic hyperplasia. Neurourol Urodyn. 2010;29:558–62.PubMed
29.
go back to reference Fusco F, Creta M, Longo N, Persico F, Franco M, Mirone V. Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study. BMC Urol. 2018;18:12.CrossRef Fusco F, Creta M, Longo N, Persico F, Franco M, Mirone V. Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study. BMC Urol. 2018;18:12.CrossRef
30.
go back to reference Fusco F, Palmieri A, Ficarra V, et al. α1-Blockers improve benign prostatic obstruction in men with lower urinary tract symptoms: a systematic review and meta-analysis of urodynamic studies. Eur Urol. 2016;69:1091–101.CrossRef Fusco F, Palmieri A, Ficarra V, et al. α1-Blockers improve benign prostatic obstruction in men with lower urinary tract symptoms: a systematic review and meta-analysis of urodynamic studies. Eur Urol. 2016;69:1091–101.CrossRef
31.
go back to reference Fusco F, Creta M, Imperatore V, et al. Benign prostatic obstruction relief in patients with lower urinary tract symptoms suggestive of benign prostatic enlargement undergoing endoscopic surgical procedures or therapy with alpha-blockers: a review of urodynamic studies. Adv Ther. 2017;34:773–83.CrossRef Fusco F, Creta M, Imperatore V, et al. Benign prostatic obstruction relief in patients with lower urinary tract symptoms suggestive of benign prostatic enlargement undergoing endoscopic surgical procedures or therapy with alpha-blockers: a review of urodynamic studies. Adv Ther. 2017;34:773–83.CrossRef
32.
go back to reference Osman NI, Chapple CR, Tammela TL, Eisenhardt A, Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015;33:697–706.CrossRef Osman NI, Chapple CR, Tammela TL, Eisenhardt A, Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015;33:697–706.CrossRef
33.
go back to reference Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009;74:1318–22.CrossRef Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009;74:1318–22.CrossRef
34.
go back to reference Yamanishi T, Kaga K, Fuse M, Shibata C, Kamai T, Uchiyama T. Six-year follow up of silodosin monotherapy for the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: what are the factors for continuation or withdrawal? Int J Urol. 2015;22(12):1143–8.CrossRef Yamanishi T, Kaga K, Fuse M, Shibata C, Kamai T, Uchiyama T. Six-year follow up of silodosin monotherapy for the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: what are the factors for continuation or withdrawal? Int J Urol. 2015;22(12):1143–8.CrossRef
35.
go back to reference Ding H, Du W, Hou ZZ, Wang HZ, Wang ZP. Silodosin is effective for treatment of LUTS in men with BPH: a systematic review. Asian J Androl. 2013;15:121–8.CrossRef Ding H, Du W, Hou ZZ, Wang HZ, Wang ZP. Silodosin is effective for treatment of LUTS in men with BPH: a systematic review. Asian J Androl. 2013;15:121–8.CrossRef
36.
go back to reference Novara G, Tubaro A, Sanseverino R, et al. Systematic review and meta-analysis of randomized controlled trials evaluating silodosin in the treatment of non-neurogenic male lower urinary tract symptoms suggestive of benign prostatic enlargement. World J Urol. 2013;31:997–1008.CrossRef Novara G, Tubaro A, Sanseverino R, et al. Systematic review and meta-analysis of randomized controlled trials evaluating silodosin in the treatment of non-neurogenic male lower urinary tract symptoms suggestive of benign prostatic enlargement. World J Urol. 2013;31:997–1008.CrossRef
37.
go back to reference Novara G, Chapple CR, Montorsi F. A pooled analysis of individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). BJU Int. 2014;114:427–33.PubMed Novara G, Chapple CR, Montorsi F. A pooled analysis of individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). BJU Int. 2014;114:427–33.PubMed
38.
go back to reference Montorsi F, Gandaglia G, Chapple C, Cruz F, Desgrandchamps F, Llorente C. Effectiveness and safety of silodosin in the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia: a European phase IV clinical study (SiRE study). Int J Urol. 2016;23:572–9.CrossRef Montorsi F, Gandaglia G, Chapple C, Cruz F, Desgrandchamps F, Llorente C. Effectiveness and safety of silodosin in the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia: a European phase IV clinical study (SiRE study). Int J Urol. 2016;23:572–9.CrossRef
39.
go back to reference Matsukawa Y, Funahashi Y, Takai S, et al. Comparison of silodosin and naftopidil for efficacy in the treatment of benign prostatic enlargement complicated by overactive bladder: a randomized, prospective study (SNIPER study). J Urol. 2017;197:452–8.CrossRef Matsukawa Y, Funahashi Y, Takai S, et al. Comparison of silodosin and naftopidil for efficacy in the treatment of benign prostatic enlargement complicated by overactive bladder: a randomized, prospective study (SNIPER study). J Urol. 2017;197:452–8.CrossRef
40.
go back to reference Eisenhardt A, Schneider T, Cruz F. Oelke M Consistent and significant improvement of nighttime voiding frequency (nocturia) with silodosin in men with LUTS suggestive of BPH: pooled analysis of three randomized, placebo-controlled, double-blind phase III studies. World J Urol. 2014;32:1119–25.CrossRef Eisenhardt A, Schneider T, Cruz F. Oelke M Consistent and significant improvement of nighttime voiding frequency (nocturia) with silodosin in men with LUTS suggestive of BPH: pooled analysis of three randomized, placebo-controlled, double-blind phase III studies. World J Urol. 2014;32:1119–25.CrossRef
41.
42.
go back to reference McConnell JD, Roehrborn CG, Bautista OM, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003;349:2387–98.CrossRef McConnell JD, Roehrborn CG, Bautista OM, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003;349:2387–98.CrossRef
43.
go back to reference Roehrborn CG, Siami P, Barkin J, et al. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008;179:616–21.CrossRef Roehrborn CG, Siami P, Barkin J, et al. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008;179:616–21.CrossRef
44.
go back to reference Roehrborn CG, Siami P, Barkin J, et al. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010;57:123–31.CrossRef Roehrborn CG, Siami P, Barkin J, et al. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010;57:123–31.CrossRef
45.
go back to reference Matsukawa Y, Takai S, Funahashi Y, et al. Effects of withdrawing α1-blocker from combination therapy with α1-blocker and 5α-reductase inhibitor in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective and comparative trial using urodynamics. J Urol. 2017;198:905–12.CrossRef Matsukawa Y, Takai S, Funahashi Y, et al. Effects of withdrawing α1-blocker from combination therapy with α1-blocker and 5α-reductase inhibitor in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective and comparative trial using urodynamics. J Urol. 2017;198:905–12.CrossRef
46.
go back to reference Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011;65:487–507.CrossRef Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011;65:487–507.CrossRef
47.
go back to reference Matsukawa Y, Takai S, Funahashi Y, Kato M, Yamamoto T, Gotoh M. Long-term efficacy of a combination therapy with an anticholinergic agent and an α1-blocker for patients with benign prostatic enlargement complaining both voiding and overactive bladder symptoms: a randomized, prospective, comparative trial using a urodynamic study. Neurourol Urodyn. 2017;36:748–54.CrossRef Matsukawa Y, Takai S, Funahashi Y, Kato M, Yamamoto T, Gotoh M. Long-term efficacy of a combination therapy with an anticholinergic agent and an α1-blocker for patients with benign prostatic enlargement complaining both voiding and overactive bladder symptoms: a randomized, prospective, comparative trial using a urodynamic study. Neurourol Urodyn. 2017;36:748–54.CrossRef
48.
go back to reference MacDiarmid SA, Hill LA, Volinn W, Hoel G. Lack of pharmacodynamic interaction of silodosin, a highly selective alpha1a-adrenoceptor antagonist, with the phosphodiesterase-5 inhibitors sildenafil and tadalafil in healthy men. Urology. 2010;75:520–5.CrossRef MacDiarmid SA, Hill LA, Volinn W, Hoel G. Lack of pharmacodynamic interaction of silodosin, a highly selective alpha1a-adrenoceptor antagonist, with the phosphodiesterase-5 inhibitors sildenafil and tadalafil in healthy men. Urology. 2010;75:520–5.CrossRef
49.
go back to reference Buono R, Briganti A, Freschi M, et al. Silodosin and tadalafil have synergistic inhibitory effects on nerve-mediated contractions of human and rat isolated prostates. Eur J Pharmacol. 2014;744:42–51.CrossRef Buono R, Briganti A, Freschi M, et al. Silodosin and tadalafil have synergistic inhibitory effects on nerve-mediated contractions of human and rat isolated prostates. Eur J Pharmacol. 2014;744:42–51.CrossRef
50.
go back to reference Yoshida T, Kinoshita H, Shimada S, Taguchi M, Matsuda T. Comparison of silodosin monotherapy vs silodosin with tadalafil add-on therapy in patients with benign prostatic hyperplasia. Urology. 2017;106:159. Yoshida T, Kinoshita H, Shimada S, Taguchi M, Matsuda T. Comparison of silodosin monotherapy vs silodosin with tadalafil add-on therapy in patients with benign prostatic hyperplasia. Urology. 2017;106:159.
51.
go back to reference Canda AE, Turna B, Cinar GM, Nazli O. Physiology and pharmacology of the human ureter: basis for current and future treatments. Urol Int. 2007;78:289–98.CrossRef Canda AE, Turna B, Cinar GM, Nazli O. Physiology and pharmacology of the human ureter: basis for current and future treatments. Urol Int. 2007;78:289–98.CrossRef
52.
go back to reference Park HK, Choi EY, Jeong BC, Kim HH, Kim BK. Localizations and expressions of alpha-1A, alpha-1B and alpha-1D adrenoceptors in human ureter. Urol Res. 2007;35:325–9.CrossRef Park HK, Choi EY, Jeong BC, Kim HH, Kim BK. Localizations and expressions of alpha-1A, alpha-1B and alpha-1D adrenoceptors in human ureter. Urol Res. 2007;35:325–9.CrossRef
53.
go back to reference Kobayashi S, Tomiyama Y, Maruyama K, Hoyano Y, Yamazaki Y, Kusama H. Effects of four different alpha(1)-adrenoceptor antagonists on alpha-adrenoceptor agonist-induced contractions in isolated mouse and hamster ureters. J Smooth Muscle Res. 2009;45:187–95.CrossRef Kobayashi S, Tomiyama Y, Maruyama K, Hoyano Y, Yamazaki Y, Kusama H. Effects of four different alpha(1)-adrenoceptor antagonists on alpha-adrenoceptor agonist-induced contractions in isolated mouse and hamster ureters. J Smooth Muscle Res. 2009;45:187–95.CrossRef
54.
go back to reference Rajpathy J, Aswathaman K, Sinha M, Subramani S, Gopalakrishnan G, Kekre NS. An in vitro study on human ureteric smooth muscle with the alpha1-adrenoceptor subtype blocker, tamsulosin. BJU Int. 2008;102:1743–5.CrossRef Rajpathy J, Aswathaman K, Sinha M, Subramani S, Gopalakrishnan G, Kekre NS. An in vitro study on human ureteric smooth muscle with the alpha1-adrenoceptor subtype blocker, tamsulosin. BJU Int. 2008;102:1743–5.CrossRef
55.
go back to reference Davenport K, Timoney AG, Keeley FX Jr. Effect of smooth muscle relaxant drugs on proximal human ureteric activity in vivo: a pilot study. Urol Res. 2007;35:207–13.CrossRef Davenport K, Timoney AG, Keeley FX Jr. Effect of smooth muscle relaxant drugs on proximal human ureteric activity in vivo: a pilot study. Urol Res. 2007;35:207–13.CrossRef
56.
go back to reference Sasaki S, Tomiyama Y, Kobayashi S, Kojima Y, Kubota Y, Kohri K. Characterization of α1-adrenoceptor subtypes mediating contraction in human isolated ureters. Urology. 2011;77(762):e13–7. Sasaki S, Tomiyama Y, Kobayashi S, Kojima Y, Kubota Y, Kohri K. Characterization of α1-adrenoceptor subtypes mediating contraction in human isolated ureters. Urology. 2011;77(762):e13–7.
57.
go back to reference Kobayashi S, Tomiyama Y, Hoyano Y, et al. Effects of silodosin and naftopidil on the distal ureter and cardiovascular system in anesthetized dogs: comparison of potential medications for distal ureteral stone passage. J Urol. 2010;183:357–61.CrossRef Kobayashi S, Tomiyama Y, Hoyano Y, et al. Effects of silodosin and naftopidil on the distal ureter and cardiovascular system in anesthetized dogs: comparison of potential medications for distal ureteral stone passage. J Urol. 2010;183:357–61.CrossRef
58.
go back to reference Villa L, Buono R, Fossati N, Rigatti P, Montorsi F, Benigni F, Hedlund P. Effects by silodosin on the partially obstructed rat ureter in vivo and on human and rat isolated ureters. Br J Pharmacol. 2013;169:230–8.CrossRef Villa L, Buono R, Fossati N, Rigatti P, Montorsi F, Benigni F, Hedlund P. Effects by silodosin on the partially obstructed rat ureter in vivo and on human and rat isolated ureters. Br J Pharmacol. 2013;169:230–8.CrossRef
59.
go back to reference Tsuzaka Y, Matsushima H, Kaneko T, et al. Naftopidil vs silodosin in medical expulsive therapy for ureteral stones: a randomized controlled study in Japanese male patients. Int J Urol. 2011;18:792–5.CrossRef Tsuzaka Y, Matsushima H, Kaneko T, et al. Naftopidil vs silodosin in medical expulsive therapy for ureteral stones: a randomized controlled study in Japanese male patients. Int J Urol. 2011;18:792–5.CrossRef
60.
go back to reference Itoh Y, Okada A, Yasui T, et al. Efficacy of selective alpha1A adrenoceptor antagonist silodosin in the medical expulsive therapy for ureteral stones. Int J Urol. 2011;18:672–4.PubMed Itoh Y, Okada A, Yasui T, et al. Efficacy of selective alpha1A adrenoceptor antagonist silodosin in the medical expulsive therapy for ureteral stones. Int J Urol. 2011;18:672–4.PubMed
61.
go back to reference Itoh Y, Okada A, Yasui T, et al. Administration of the selective alpha 1A-adrenoceptor antagonist silodosin facilitates expulsion of size 5–10 mm distal ureteral stones, as compared to control. Int Urol Nephrol. 2013;45:675–8.CrossRef Itoh Y, Okada A, Yasui T, et al. Administration of the selective alpha 1A-adrenoceptor antagonist silodosin facilitates expulsion of size 5–10 mm distal ureteral stones, as compared to control. Int Urol Nephrol. 2013;45:675–8.CrossRef
62.
go back to reference Sur RL, Shore N, L’Esperance J, et al. Silodosin to facilitate passage of ureteral stones: a multi-institutional, randomized, double-blinded, placebo-controlled trial. Eur Urol. 2015;67(9):59–64. Sur RL, Shore N, L’Esperance J, et al. Silodosin to facilitate passage of ureteral stones: a multi-institutional, randomized, double-blinded, placebo-controlled trial. Eur Urol. 2015;67(9):59–64.
63.
go back to reference Kumar S, Jayant K, Agrawal MM, Singh SK, Agrawal S, Parmar KM. Role of tamsulosin, tadalafil, and silodosin as the medical expulsive therapy in lower ureteric stone: a randomized trial (a pilot study). Urology. 2015;85:59–63.CrossRef Kumar S, Jayant K, Agrawal MM, Singh SK, Agrawal S, Parmar KM. Role of tamsulosin, tadalafil, and silodosin as the medical expulsive therapy in lower ureteric stone: a randomized trial (a pilot study). Urology. 2015;85:59–63.CrossRef
64.
go back to reference Nickel JC, O’Leary MP, Lepor H, et al. Silodosin for men with chronic prostatitis/chronic pelvic pain syndrome: results of a phase II multicenter, double-blind, placebo controlled study. J Urol. 2011;186:125–31.CrossRef Nickel JC, O’Leary MP, Lepor H, et al. Silodosin for men with chronic prostatitis/chronic pelvic pain syndrome: results of a phase II multicenter, double-blind, placebo controlled study. J Urol. 2011;186:125–31.CrossRef
65.
go back to reference Shirakawa T, Haraguchi T, Shigemura K, et al. Silodosin versus naftopidil in Japanese patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized multicenter study. Int J Urol. 2013;20:903–10.CrossRef Shirakawa T, Haraguchi T, Shigemura K, et al. Silodosin versus naftopidil in Japanese patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized multicenter study. Int J Urol. 2013;20:903–10.CrossRef
66.
go back to reference Miyakita H, Yokoyama E, Onodera Y, et al. Short-term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia. Int J Urol. 2010;17(10):869–75.CrossRef Miyakita H, Yokoyama E, Onodera Y, et al. Short-term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia. Int J Urol. 2010;17(10):869–75.CrossRef
67.
go back to reference Shimizu N, Minami T, Sugimoto K, et al. Efficacy of silodosin in patients undergoing brachytherapy: a randomized trial involving a pressure flow study. World J Urol. 2014;32:1423–32.CrossRef Shimizu N, Minami T, Sugimoto K, et al. Efficacy of silodosin in patients undergoing brachytherapy: a randomized trial involving a pressure flow study. World J Urol. 2014;32:1423–32.CrossRef
68.
go back to reference Tsumura H, Satoh T, Ishiyama H, et al. Comparison of prophylactic naftopidil, tamsulosin, and silodosin for 125I brachytherapy-induced lower urinary tract symptoms in patients with prostate cancer: randomized controlled trial. Int J Radiat Oncol Biol Phys. 2011;81:e385–92.CrossRef Tsumura H, Satoh T, Ishiyama H, et al. Comparison of prophylactic naftopidil, tamsulosin, and silodosin for 125I brachytherapy-induced lower urinary tract symptoms in patients with prostate cancer: randomized controlled trial. Int J Radiat Oncol Biol Phys. 2011;81:e385–92.CrossRef
69.
go back to reference Kumar S, Tiwari DP, Ganesamoni R, Singh SK. Prospective randomized placebo-controlled study to assess the safety and efficacy of silodosin in the management of acute urinary retention. Urology. 2013;82:171–5.CrossRef Kumar S, Tiwari DP, Ganesamoni R, Singh SK. Prospective randomized placebo-controlled study to assess the safety and efficacy of silodosin in the management of acute urinary retention. Urology. 2013;82:171–5.CrossRef
70.
go back to reference Hagiwara K, Koie T, Iwamura H, et al. Efficacy and safety of silodosin and dutasteride combination therapy in acute urinary retention due to benign prostatic hyperplasia: a single-arm prospective study. Biomed Res Int. 2016;2016:4975851.CrossRef Hagiwara K, Koie T, Iwamura H, et al. Efficacy and safety of silodosin and dutasteride combination therapy in acute urinary retention due to benign prostatic hyperplasia: a single-arm prospective study. Biomed Res Int. 2016;2016:4975851.CrossRef
72.
go back to reference Michel MC. Alpha1-adrenoceptors and ejaculatory function. Br J Pharmacol. 2007;152:289–90.CrossRef Michel MC. Alpha1-adrenoceptors and ejaculatory function. Br J Pharmacol. 2007;152:289–90.CrossRef
73.
go back to reference Hellstrom WJ, Sikka SC. Effects of acute treatment with tamsulosin versus alfuzosin on ejaculatory function in normal volunteers. J Urol. 2006;176:1529–33.CrossRef Hellstrom WJ, Sikka SC. Effects of acute treatment with tamsulosin versus alfuzosin on ejaculatory function in normal volunteers. J Urol. 2006;176:1529–33.CrossRef
74.
go back to reference Tatemichi S, Kobayashi K, Yokoi R, et al. Comparison of the effects of four α1-adrenoceptor antagonists on ejaculatory function in rats. Urology. 2012;80(486):e9–16. Tatemichi S, Kobayashi K, Yokoi R, et al. Comparison of the effects of four α1-adrenoceptor antagonists on ejaculatory function in rats. Urology. 2012;80(486):e9–16.
75.
go back to reference Kobayashi K, Masumori N, Hisasue S, et al. Inhibition of seminal emission is the main cause of anejaculation induced by a new highly selective alpha1A-blocker in normal volunteers. J Sex Med. 2008;5(9):2185–90.CrossRef Kobayashi K, Masumori N, Hisasue S, et al. Inhibition of seminal emission is the main cause of anejaculation induced by a new highly selective alpha1A-blocker in normal volunteers. J Sex Med. 2008;5(9):2185–90.CrossRef
76.
go back to reference Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011;14:143–8.CrossRef Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011;14:143–8.CrossRef
77.
go back to reference Homma Y, Kawabe K, Takeda M, Yoshida M. Ejaculation disorder is associated with increased efficacy of silodosin for benign prostatic hyperplasia. Urology. 2010;76:1446–50.CrossRef Homma Y, Kawabe K, Takeda M, Yoshida M. Ejaculation disorder is associated with increased efficacy of silodosin for benign prostatic hyperplasia. Urology. 2010;76:1446–50.CrossRef
78.
go back to reference Gacci M, Ficarra V, Sebastianelli A. Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis. J Sex Med. 2014;11:1554–66.CrossRef Gacci M, Ficarra V, Sebastianelli A. Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis. J Sex Med. 2014;11:1554–66.CrossRef
79.
go back to reference Capogrosso P, Serino A, Ventimiglia E, et al. Effects of silodosin on sexual function—realistic picture from the everyday clinical practice. Andrology. 2015;3:1076–81.CrossRef Capogrosso P, Serino A, Ventimiglia E, et al. Effects of silodosin on sexual function—realistic picture from the everyday clinical practice. Andrology. 2015;3:1076–81.CrossRef
Metadata
Title
Silodosin: An Update on Efficacy, Safety and Clinical Indications in Urology
Authors
Luca Villa
Paolo Capogrosso
Umberto Capitanio
Alberto Martini
Alberto Briganti
Andrea Salonia
Francesco Montorsi
Publication date
01-01-2019
Publisher
Springer Healthcare
Published in
Advances in Therapy / Issue 1/2019
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-018-0854-2

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