EFFICACY OF SILODOSIN VS TAMSULOSIN IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA: A DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL
DOI:
https://doi.org/10.22159/ijap.2019.v11s6.33558Keywords:
Benign prostate hyperplasia, Alpha blocker, IPSS, Maximal flow rateAbstract
Objective: Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate associated with aging. BPH can cause lower urinary tract syndrome (LUTS). Medical therapy for patients with moderate and severe LUTS symptoms comprises a-1 adrenergic receptor antagonists. This study aimed to determine whether there are differences in the international prostate symptom score (IPSS) and maximal flow rate (Qmax) of patients with BPH receiving either silodosin or tamsulosin over 12 w.
Methods: This study was a double-blind randomized clinical trial. Subjects were 50 men aged ³ 50 y diagnosed with BPH with an IPSS ³ 8 at the Gatot Soebroto Indonesian Army Hospital. The participants received either silodosin or tamsulosin. Their IPSS and Qmax were assessed at the initial assessment and after 4, 8, and 12 w of treatment.
Results: The initial median IPSS was 15 in the tamsulosin group and 17 in the silodosin group (P = 0.808). After 12 w of therapy, the median IPSS decreased to 9 in the tamsulosin group and 10 in the silodosin group (P = 0.186). The initial median Qmax was 10.1 ml/s in the tamsulosin group and 10.9 ml/s in the silodosin group (P = 0.290). After 12 w of therapy, the median Qmax increased to 12.1 ml/s in the tamsulosin group and 11.9 ml/s in the silodosin group (P = 0.969). Although the differences between groups were not significant, the initial and 12-week IPSS and Qmax values differed significantly within each group.
Conclusion: There were no significant between-group differences in the IPSS or Qmax after 12 w of therapy. However, both silodosin and tamsulosin produced significant differences between initial and 12-week assessments of IPSS and Qmax.
Downloads
References
2. Egan KB. The epidemiology of benign prostatic hyperplasia associated with lower urinary tract symptoms: prevalence and incident rates. Urol Clin North Am 2016;43:289–97.
3. Tobergte DR, Curtis S. EAU guidelines 2016. J Chem Inf Model 2013;53:1689–99.
4. Platz EA, Joshu CE, Mondul AM, Peskoe SB, Willett WC, Giovannucci E. Incidence and progression of lower urinary tract symptoms in a large prospective cohort of United States men. J Urol 2012;188:496–501.
5. Natarajan B, Kalra Y. Silodosin versus tamsulosin in symptomatic benign prostatic hyperplasia-our experience. IOSR J Pharm 2015;5:8–10.
6. Silva J, Silva CM, Cruz F. Current medical treatment of lower urinary tract symptoms/BPH: do we have a standard? Curr Opin Urol 2014;24:21–8.
7. Takao T, Tsujimura A, Kiuchi H, Matsuoka Y, Miyagawa Y, Nonomura N, et al. Early efficacy of silodosin in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Int J Urol 2008;15:992–6.
8. Tatemichi S, Kobayashi K, Yokoi R, Maruyama K, Hoyano Y, Kobayashi M, et al. Comparison of the effects of four alpha1-adrenoceptor antagonists on ejaculatory function in rats. Urology 2012;80:486, e9–16.
9. Miyakita H, Yokoyama E, Onodera Y, Utsunomiya T, Tokunaga M, Tojo T, 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;17:869–75.
10. 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.
11. Gravas S, Bach T, Drake M, Gacci M, Gratzke C, Herrmann TRW, et al. EAU guidelines on non-neurogenic male LUTS including benign prostatic obstruction (BPO). Eur Assoc Urol 2017;2:129–46.
12. Yoshida M, Kudoh J, Homma Y, Kawabe K. Safety and efficacy of silodosin for treatment of benign prostatic hyperplasia. Clin Intervent Aging 2011;6:161–72.
13. Chapple CR, Montorsi F, Tammela TLJ, Wirth M, Koldewijn E, Fernandez EF. 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.
14. Takeshita H, Moriyama S, Arai Y, Washino S, Saito K, Chiba K, et al. Randomized crossover comparison of the short-term efficacy and safety of single half-dose silodosin and tamsulosin hydrochloride in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. LUTS 2016;8:38–43.
15. 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;46:601–7.
16. Manohar CMS, Naggabhushana M, Karthikeyan VS, Sanjay RP, Kamath AJ, Keshavamurty R. Safety and efficacy of tamsulosin, alfuzosin or silodosin as monotherapy for LUTS in BPH-a double-blind randomized trial. Cent European J Urol 2017;70:148–53.
Published
How to Cite
Issue
Section
