Effect of Silodosin on Specific Urinary Symptoms Associated with Benign Prostatic Hyperplasia: Analysis of International Prostate Symptom Scores in 2 Phase III Clinical Studies

Overview

Journal Open Access J Urol

Publisher Dove Medical Press

Specialty Urology

Date 2013 Nov 8

PMID 24198629

Citations 2

Authors

Marc C Gittelman

Leonard S Marks

Lawrence A Hill

Weining Volinn

Gary Hoel

Affiliations

Soon will be listed here.

Abstract

Purpose: Pooled results from 2 randomized, placebo-controlled, US phase III studies (NCT00224107, NCT00224120) showed that silodosin, a uroselective α-blocker, significantly improved International Prostate Symptom Scores (IPSS) in men with symptomatic benign prostatic hyperplasia (BPH). This analysis evaluated the effect of silodosin on each symptom assessed by IPSS questionnaire.

Materials And Methods: Study participants (N = 923) were men aged ≥50 years with IPSS ≥13 and Qmax 4-15 mL/s. They received silodosin 8 mg or placebo once daily for 12 weeks. Patient responses to 7 IPSS questions were collected at weeks 0 (baseline), 0.5, 1, 2, 4, and 12 and scored on a 6-point scale. Efficacy of silodosin versus placebo was assessed by analysis of covariance.

Results: For each symptom, the 2 treatment groups had similar mean baseline scores. Decrease in score from baseline (mean ± standard deviation) to last observation was significantly greater with silodosin than with placebo for all symptoms (P < 0.005); symptom improvement with silodosin (versus placebo) was greatest for weak stream (silodosin, -1.1 ± 1.4 versus placebo, -0.5 ± 1.2; P < 0.0001) and smallest for nocturia (silodosin, -0.6 ± 1.1 versus placebo, -0.4 ± 1.2; P = 0.0037). Compared with placebo, silodosin significantly improved nocturia within 1 week (silodosin, -0.5 ± 1.07 versus placebo, -0.3 ± 1.05; P = 0.009) and all other symptoms within 3 to 4 days (P < 0.01).

Conclusions: Silodosin significantly improved all BPH-associated symptoms assessed by IPSS questionnaire within the first week of treatment. All improvements were maintained over the 12-week study period.

Citing Articles

After low and high dose-rate interstitial brachytherapy followed by IMRT radiotherapy for intermediate and high risk prostate cancer.

Nakamura S, Murakami N, Inaba K, Wakita A, Kobayashi K, Takahashi K BMC Cancer. 2016; 16:296.

PMID: 27142069 PMC: 4855811. DOI: 10.1186/s12885-016-2329-7.

Silodosin: a review of its use in the treatment of the signs and symptoms of benign prostatic hyperplasia.

Keating G Drugs. 2015; 75(2):207-17.

PMID: 25575983 DOI: 10.1007/s40265-014-0344-z.

References

Lepor H . Alpha blockers for the treatment of benign prostatic hyperplasia. Rev Urol. 2008; 9(4):181-90. PMC: 2213889. View

Hatano A, Takahashi H, Tamaki M, Komeyama T, Koizumi T, Takeda M . Pharmacological evidence of distinct alpha 1-adrenoceptor subtypes mediating the contraction of human prostatic urethra and peripheral artery. Br J Pharmacol. 1994; 113(3):723-8. PMC: 1510428. DOI: 10.1111/j.1476-5381.1994.tb17053.x. View

Marshall I, Burt R, Chapple C . Noradrenaline contractions of human prostate mediated by alpha 1A-(alpha 1c-) adrenoceptor subtype. Br J Pharmacol. 1995; 115(5):781-6. PMC: 1908509. DOI: 10.1111/j.1476-5381.1995.tb15001.x. View

Murata S, Taniguchi T, Takahashi M, Okada K, Akiyama K, Muramatsu I . Tissue selectivity of KMD-3213, an alpha(1)-adrenoreceptor antagonist, in human prostate and vasculature. J Urol. 2000; 164(2):578-83. View

Yamagishi R, Akiyama K, Nakamura S, Hora M, Masuda N, Matsuzawa A . Effect of KMD-3213, an alpha 1a-adrenoceptor-selective antagonist, on the contractions of rabbit prostate and rabbit and rat aorta. Eur J Pharmacol. 1996; 315(1):73-9. DOI: 10.1016/s0014-2999(96)00589-4. View

Rudner X, Berkowitz D, Booth J, Funk B, Cozart K, DAmico E . Subtype specific regulation of human vascular alpha(1)-adrenergic receptors by vessel bed and age. Circulation. 1999; 100(23):2336-43. DOI: 10.1161/01.cir.100.23.2336. View

Marks L, Gittelman M, Hill L, 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(6):1318-22. DOI: 10.1016/j.urology.2009.06.072. View

Madersbacher S, Marszalek M, Lackner J, Berger P, Schatzl G . The long-term outcome of medical therapy for BPH. Eur Urol. 2007; 51(6):1522-33. DOI: 10.1016/j.eururo.2007.03.034. View

Marks L, Gittelman M, Hill L, Volinn W, Hoel G . 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(6):2634-40. DOI: 10.1016/j.juro.2009.02.034. View

10.

Barry M, Fowler Jr F, OLeary M, Bruskewitz R, HOLTGREWE H, MEBUST W . The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992; 148(5):1549-57; discussion 1564. DOI: 10.1016/s0022-5347(17)36966-5. View

11.

Akiyama K, Hora M, Tatemichi S, Masuda N, Nakamura S, Yamagishi R . KMD-3213, a uroselective and long-acting alpha(1a)-adrenoceptor antagonist, tested in a novel rat model. J Pharmacol Exp Ther. 1999; 291(1):81-91. View

12.

Yamada S, Okura T, Kimura R . In vivo demonstration of alpha(1A)-adrenoceptor subtype selectivity of KMD-3213 in rat tissues. J Pharmacol Exp Ther. 2000; 296(1):160-7. View

13.

Shibata K, Foglar R, Horie K, Obika K, Sakamoto A, Ogawa S . KMD-3213, a novel, potent, alpha 1a-adrenoceptor-selective antagonist: characterization using recombinant human alpha 1-adrenoceptors and native tissues. Mol Pharmacol. 1995; 48(2):250-8. View

14.

Schwinn D, Roehrborn C . Alpha1-adrenoceptor subtypes and lower urinary tract symptoms. Int J Urol. 2008; 15(3):193-9. PMC: 2329815. DOI: 10.1111/j.1442-2042.2007.01956.x. View