Non-inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)

BJU International

Volumn 108, Issue 11, 2011, Pages 1843-1848

  Yu, Hong Jeng ^a   Lin, Alex Tong Long ^b   Yang, Stephen Shei Dei ^c   Tsui, Ke Hung ^d   Wu, Hsi Chin ^e   Cheng, Chen Li ^f   Cheng, Hong Lin ^g   Wu, Tony T ^h   Chiang, Po Hui ^d  

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b NATIONAL YANG MING UNIVERSITY   (Taiwan)

^c BUDDHIST TZU CHI GENERAL HOSPITAL   (Taiwan)

^d CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^e China Medical University Hospital   (China)

^f TAICHUNG VETERANS GENERAL HOSPITAL   (Taiwan)

^g NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^h KAOHSIUNG VETERANS GENERAL HOSPITAL   (Taiwan)

Author keywords

benign prostatic hyperplasia (BPH); non inferiority test; silodosin; tamsulosin

Indexed keywords

SILODOSIN; TAMSULOSIN;

AGED; ARTICLE; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EJACULATION DISORDER; HUMAN; INTERNATIONAL PROSTATE SYMPTOM SCORE; LOWER URINARY TRACT SYMPTOM; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; PARALLEL DESIGN; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; PULSE RATE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; UNSPECIFIED SIDE EFFECT; URINE FLOW RATE;

ADRENERGIC ALPHA-1 RECEPTOR ANTAGONISTS; ADULT; AGED; BLOOD PRESSURE; DOUBLE-BLIND METHOD; HUMANS; INDOLES; LOWER URINARY TRACT SYMPTOMS; MALE; MIDDLE AGED; PROSTATIC HYPERPLASIA; SULFONAMIDES; TREATMENT OUTCOME; URODYNAMICS;

EID: 81255137901     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/j.1464-410X.2011.10233.x     Document Type: Article

References (26)

1. Lepor H,. Pathophysiology of lower urinary tract symptoms in the aging male population. Rev Urol 2005; 7 (Suppl. 7): S3-11
2. Baazeem A, Elhilali MM,. Surgical management of benign prostatic hyperplasia: current evidence. Nat Clin Pract Urol 2008; 5: 540-9
3. Chapple CR,. A Comparison of varying alpha-blockers and other pharmacotherapy options for lower urinary tract symptoms. Rev Urol 2005; 7 (Suppl. 4): S22-30
4. 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
5. Murata S, Taniguchi T, Takahashi M, Okada K, Akiyama K, Muramatsu I,. Tissue selectivity of KMD-3213, an α1-adrenoreceptor antagonist, in human prostate and vasculature. J Urol 2000; 164: 578-83 (Pubitemid 30481987)
6. Tatemichi S, Kobayashi K, Maezawa A, Kobayashi M, Yamazaki Y, Shibata N,. [Alpha1-adrenoceptor subtype selectivity and organ specificity of silodosin (KMD-3213)]. Yakugaku Zasshi 2006; 126: 209-16
7. Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G,. Rapid efficacy of the highly selective alpha-1A-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
8. Yamanishi T, Mizuno T, Tatsumiya K, Watanabe M, Kamai T, Yoshida K,. Urodynamic effects of silodosin, a new alpha 1A-adrenoceptor selective antagonist, for the treatment of benign prostatic hyperplasia. Neurourol Urodyn 2010; 29: 558-62
9. 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 2009; 182: 2831-5
10. Chen TI, Wu TT,. The efficacy and safety of tamsulosin in treating symptomatic benign prostatic hyperplasia. J Urol ROC 2000; 11: 155-60
11. Li NC, Chen S, Yang XH, Du LD, Wang JY, YQ N, The Beijing Tamsulosin Study Group. Efficacy of low-dose tamsulosin in Chinese patients with symptomatic benign prostatic hyperplasia. Clin Drug Investig 2003; 23: 781-7 (Pubitemid 38037266)
12. Park CH, Chang HS, Oh BR, et al,. Efficacy of low-dose tamsulosin on lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a nonblind multicentre Korean study. Clin Drug Investig 2004; 24: 41-7 (Pubitemid 38197751)
13. Jones B, Jarvis P, Lewis JA, Ebbutt AF,. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996; 313: 36-9 (Pubitemid 26229889)
14. Christensen E,. Methodology of superiority vs. equivalence trials and non-inferiority trials. J Hepatol 2007; 46: 947-54 (Pubitemid 46546604)
15. Kawabe K, Yoshida M, Homma Y,; Silodosin Clinical Study Group. Silodosin Clinical Study Group. 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 (Pubitemid 44536452)
16. Kawabe K, Ueno A, Takimoto Y, Aso Y, Kato H,. Use of an alpha 1-blocker, YM617, in the treatment of benign prostatic hypertrophy. YM617 Clinical Study Group. J Urol 1990; 144: 908-12
17. Lee E, Lee C,. Clinical comparison of selective and non-selective alpha-1A-adrenoceptor antagonists in benign prostatic hyperplasia: studies on tamsulosin in a fixed dose and terazosin in increasing doses. Br J Urol 1997; 80: 606-11
18. 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
19. Madersbacher S, Marszalek M, Lackner J, Berger P, Schatzl G,. The long-term outcome of medical therapy for BPH. Eur Urol 2007; 51: 1522-23
20. Kihara K, Sato K, Ando M, Sato T, Oshima H,. A mechanism of retrograde ejaculation after bilateral hypogastric nerve transections in the dog. J Urol 1992; 148: 1307-9
21. Noguchi Y, Ohtake A, Suzuki M, Sasamata M,. In vivo study on the effects of α1-adrenoceptor antagonists on intraurethral pressure in the prostatic urethra and intraluminal pressure in the vas deferens in male dogs. Eur J Pharmacol 2008; 580: 256-61
22. Schilit S, Benzeroual KE,. Silodosin: a selective α1A-adrenergic receptor antagonist for the treatment of benign prostatic hyperplasia. Clin Ther 2009; 31: 2489-502
23. 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
24. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol 2003; 170: 530-47
25. Kobayashi S, Tomiyama Y, Tatemichi S, Hoyano Y, Kobayashi M, Yamazaki Y,. Effects of silodosin and tamsulosin on the urethra and cardiovascular system in young and old dogs with benign prostatic hyperplasia. Eur J Pharmacol 2009; 613: 135-40
26. Chapple CR, Montorsi F, Tammela TL, Wirth M, Koldewijn E, Fernández Fernández E,; on behalf of the European Silodosin Study Group. 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