COMPARISON OF EFFICACY AND SAFETY SILODOSIN 8 MG ONCE DAILY AND SILODOSIN 4 MG TWICE DAILY IN BPH PATIENTS WITH LUTS

##plugins.themes.bootstrap3.article.main##

##plugins.themes.bootstrap3.article.sidebar##

PDF
Published 2019-01-09
Ramzie Nendra Diansyah Johan Renaldo Wahjoe Djatisoesanto Lukman Hakim

Abstract

Objective: This study was aimed to compare the efficacy and side effect of silodosin 8mg once daily and silodosin 4mg twice daily in BPH-LUTS patients after 4 and 12 weeks. Material & Methods: Single blind randomized controlled trials in 60 male patients aged ≥45 years with BPH-LUTS from July 2017 to October 2017 was divided into groups who received 8mg of silodosin once daily and those who received 4mg of silodosin twice daily. Efficacy and adverse events were evaluated after 4 and 12 weeks of treatment. Results:  There was no significant difference of mean age of the two groups was 67.93 ± 6.49 years and 69.07 ± 6.28 years respectively (p 0.49). Both doses of this drug decreased the International Prostate Symptom Score (IPSS) and significantly increased the maximum urinary flow (Qmax) (p<0.05) but there was no significant differences between the two groups (p>0.05). Ejaculation disorder was the most common side effect in all groups (6.7% and 5%) and there was no significant difference between the two groups (p>0.05). Conclusion: The administration of 8mg of once daily silodosin has similar efficacy as 4mg twice daily silodosin. There were no adverse events differences in the two groups. Ejaculation disorder is the most common adverse event of silodosin administration.


##plugins.themes.bootstrap3.article.details##

Keywords

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, International Prostate Symptom Score, Qmax, Ejaculation Disorder

References

Wei J, Calhoun E, Jacobsen S. Urologic Diseases in America Project: Benign prostatic hyperplasia. J Urol. 2005; 173: 1256.

McVary K. BPH: Epidemiology and comorbidities. Am J Manag Care. 2006; suppl (12): S122.

Roehrborn CG, McConnell J. Etiology, pathophysiology, epidemiology and natural history of benign prostatic hyperplasia. In: Walsh P, Retik A, Vaughan E, Wein A, editors. Campbell’s Urology. 10th ed. Philadelphia: Saunders; 2012. p. 2570–610.

Chute CG, Panser LA, Girman CJ, et al. The prevalence of prostatism: A population-based survey of urinary symptoms. J Urol. 1993; 150: 85–9.

Kok ET, Schouten BW, Bohnen AM, et al. Risk factors for lower urinary tract symptoms suggestive of benign prostatic hyperplasia in a community based population of healthy aging men: The Krimpen Study. J Urol. 2009; 181: 710–6.

Michel MC. The Pharmacological Profile of the α1A-Adrenoceptor Antagonist Silodosin. Eur Urol Suppl. European Association of Urology. 2010 Jul; 9(4): 486–90.

Chapple CR. BHP Disease Management. Introduction and concluding remarks. Eur Urol. 1999; 36(Suppl 3): 1-6.

Brooks JD. 2002. Anatomy of the lower urinary tract and male genitalia: Campbell’s Urology, 10th ed. Editor Walsh PC. Philadhelphia: WB Saunders Co; 2012. p. 41-80.

Pande S, Hazra A, Kundu AK. Evaluation of silodosin in comparison to tamsulosin in benign prostatic hyperplasia: A randomized controlled trial. Indian J Pharmacol. 2014; 46(6): 601–7.

Marks LS, Gittelman MC, Hill L a., et al. Silodosin in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia: A 9-Month, Open-label Extension Study. Urology. Elsevier Inc. 2009; 74(6): 1318–22.

Choo MS, Song M, Kim JH, et al. Safety and Efficacy of 8-mg Once-daily vs 4-mg Twice-daily Silodosin in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (SILVER Study): A 12-Week, Double-blind, Randomized, Parallel, Multicenter Study. Elsevier Inc. Urology. 2014; 83(4): 875-81.

Sato F, Furihata Y. Use of silodosin in a once daily administration for treating benign prostatic hyperplasia. Kissei Pharmaceuticals Co.,Ltd. 2008; [007]: 1-28. http://www.google.com/patents/WO2008106536A1?cl=en

European Medicines Agency. Silodyx (silodosin): EU summary of product characteristics. 2014. http://www.ema.europa.eu/.Accessed 8 Dec 2014.

Watson Pharma Inc. Rapaflo (silodosin) capsules: US prescribing information. 2013. http://www.actavis.com/. Accessed 8 Dec 2014.

Tatemichi S, Kobayashi K, Maezawa A, et al. a1-Adrenoceptor subtype selectivity and organ specificity of silodosin (KMD-3213) [in Japanese]. Yakugaku Zasshi. 2006; 126: 209–16.

Morganroth J, Lepor H, Hill LA, et al. Effects of the selective alpha 1a-adrenoreseptor antagonist silodosin on ECGs of Healthy men in a randomized, double-blind, placebo-and moxifloxacin-controlled study: A randomized controlled trial. Clin Pharmacol Ther. 2010, 87(5): 609-13.

Chapple CR, Tubaro A, editors. Male LUTS/BPH Made Easy. London: Springer London; 2014.

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(4): 997–1008.

Chapple CR, Montorsi F, Tammela TLJ, 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(3): 342–5.

Capogrosso I, Serino A, Ventimiglia E, et al. Effects of silodosin on sexual function-realistic picture from the everyday clinical practice. Andrology. 2015; 3: 1076–81.

Nagai A, Hara R, Yokoyama T, et al. Ejaculatory dysfunction caused by the new α1-blocker silodosin: A preliminary study to analyze human ejaculation using color Doppler ultrasonography. Int J Urol. 2008 Oct; 15(10): 915–8.

Hisasue SI, Furuya R, Itoh N, et al. Ejaculatory disorder caused by alpha-1 adrenoceptor antagonists is not retrograde ejaculation but a loss of seminal emission. Int J Urol. 2006; 13(10): 1311–6.

Homma Y, Kawabe K, Takeda M, et al. Ejaculation disorder is associated with increased efficacy of silodosin for benign prostatic hyperplasia. Urology. Elsevier Inc. 2010; 76(6): 1446–50.

Roehrborn CG, Kaplan S a, Lepor H, et al. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. Nature Publishing Group. 2011; 14(2): 143–8.

Section
Articles
Copyright Information
Department of Urology, Faculty of Medicine/Airlangga University