Comparative Effectiveness and Safety of Monodrug Therapies for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Network Meta-analysis

Jin-Qiu Yuan, Chen Mao, Samuel Yeung-Shan Wong, Zu-Yao Yang, Xiao-Hong Fu, Xiao-Yu Dai, Jin-Ling Tang, Jin-Qiu Yuan, Chen Mao, Samuel Yeung-Shan Wong, Zu-Yao Yang, Xiao-Hong Fu, Xiao-Yu Dai, Jin-Ling Tang

Abstract

A wide array of drugs are available for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), but the evidence for the comparative effectiveness is controversial.The objective of this study is to evaluate the comparative effectiveness and safety of monodrug therapies for BPH.Data sources are MEDLINE, EMBASE, and the Cochrane Library.We included randomized controlled trials that compared α-blockers, 5-alpha reductase inhibitors (5ARIs), muscarinic receptor antagonists (MRAs), phosphodiesterase-5 inhibitor (PDE5-Is), or placebo for the treatment of BPH.Comparative effectiveness and safety were pooled by both traditional meta-analysis and network meta-analysis. Summary effect size was calculated as mean difference (MD) and relative risk (RR), together with the 95% confidence intervals (CIs).This study included 58,548 participants from 124 trials in total. When compared with placebo, α-blockers, 5ARIs, and PDE5-Is reduced International Prostate Symptom Score (IPSS) by -1.35 to -3.67 points and increased peak urinary flow rate (PUF) by -0.02 to 1.95 mL/s, with doxazosin (IPSS: MD, -3.67[-4.33 to -3.02]; PUF: MD, 1.95[1.61 to 2.30]) and terazosin (IPSS: MD, -3.37 [-4.24 to -2.50]; PUF: MD, 1.21[0.74 to 1.66]) showing the greatest improvement. The improvement in the IPSS was comparable among tamsulosin, alfuzosin, naftopidil, silodosin, dutasteride, sildenafil, vardenafil, and tadalafil. The incidence of total adverse events and withdraws due to adverse events were generally comparable among various agents.In conclusion, α-blockers, 5ARIs, and PDE5-Is are effective for BPH, with doxazosin and terazosin appearing to be the most effective agents. Drug therapies for BPH are generally safe and well-tolerated, with no major difference regarding the overall safety profile.

Conflict of interest statement

The authors have no funding and conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Flowchart of study selection.
FIGURE 2
FIGURE 2
The network of pairwise comparisons from the included trials. The lines indicate available direct comparisons from included randomized controlled trials. The width of the lines is proportional to the number of studies for the comparisons.

References

    1. Nickel JC, Mendez-Probst CE, Whelan TF, et al. 2010 Update: guidelines for the management of benign prostatic hyperplasia. Can Urol Assoc J 2010; 4:310–316.
    1. Stohrer M, Blok B, Castro-Diaz D, et al. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol 2009; 56:81–88.
    1. McVary KT. BPH: epidemiology and comorbidities. Am J Manag Care 2006; 12:S122–S128.
    1. Parsons JK, Bergstrom J, Silberstein J, et al. Prevalence and characteristics of lower urinary tract symptoms in men aged > or = 80 years. Urology 2008; 72:318–321.
    1. Wei JT, Calhoun E, Jacobsen SJ. Urologic diseases in america project: benign prostatic hyperplasia. J Urol 2008; 179:S75–S80.
    1. Lepor H. Medical treatment of benign prostatic hyperplasia. Rev Urol 2011; 13:20–33.
    1. Graham DY. Endoscopic ulcers are neither meaningful nor validated as a surrogate for clinically significant upper gastrointestinal harm. Chin J Gastroenterol Hepatol 2009; 7:1147–1150.
    1. McVary KT, Roehrborn CG, Avins AL, et al. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol 2011; 185:1793–1803.
    1. Speakman MJ, Kirby RS, Joyce A, et al. British Association of Urological S. Guideline for the primary care management of male lower urinary tract symptoms. BJU Int 2004; 93:985–990.
    1. Scaglione F, Lucini V, Pannacci M, et al. Comparison of the potency of different brands of Serenoa repens extract on 5alpha-reductase types I and II in prostatic co-cultured epithelial and fibroblast cells. Pharmacology 2008; 82:270–275.
    1. Tacklind J, Macdonald R, Rutks I, et al. Serenoa repens for benign prostatic hyperplasia. Cochrane Database Syst Rev 2012; 12:CD001423.
    1. Wilt T, Mac Donald R, Ishani A, et al. Cernilton for benign prostatic hyperplasia. Cochrane Database Syst Rev 2000; CD001042.
    1. Chung MS, Lee SH, Lee DH, et al. Comparative rapid onset of efficacy between doxazosin gastrointestinal therapeutic system and tamsulosin in patients with lower urinary tract symptoms from benign prostatic hyperplasia: A Multicentre, Prospective, Randomised Study. J Urol 2012; 187:1193–1199.
    1. Zhang K, Yu W, Jin J, et al. Effect of doxazosin gastrointestinal therapeutic system 4 mg vs tamsulosin 0.2 mg on nocturia in Chinese men with lower urinary tract symptoms: A Prospective, Multicenter, Randomized, Open, Parallel Study. Urology 2011; 78:636–640.
    1. Pompeo AC, Rosenblatt C, Bertero E, et al. A randomised, double-blind study comparing the efficacy and tolerability of controlled-release doxazosin and tamsulosin in the treatment of benign prostatic hyperplasia in Brazil. Int J Clin Pract 2006; 60:1172–1177.
    1. Kirby RS, Quinn S, Mallen S, et al. Doxazosin controlled release vs tamsulosin in the management of benign prostatic hyperplasia: an efficacy analysis. Int J Clin Pract 2004; 58:6–10.
    1. Tsujii T. Comparison of prazosin, terazosin and tamsulosin in the treatment of symptomatic benign prostatic hyperplasia: A short-term open, randomized multicenter study. Int J Urol 2000; 7:199–205.
    1. Yuan J, Liu Y, Yang Z, et al. The efficacy and safety of alpha-1 blockers for benign prostatic hyperplasia: an overview of 15 systematic reviews. Curr Med Res Opin 2013; 29:279–287.
    1. Kirby RS, Roehrborn C, Boyle P, et al. Efficacy and tolerability of doxazosin and finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: the Prospective European Doxazosin and Combination Therapy (PREDICT) trial. Urology 2003; 61:119–126.
    1. Debruyne FM, Jardin A, Colloi D, et al. Sustained-release alfuzosin, finasteride and the combination of both in the treatment of benign prostatic hyperplasia. European ALFIN Study Group. Eur Urol 1998; 34:169–175.
    1. Lee E. Comparison of tamsulosin and finasteride for lower urinary tract symptoms associated with benign prostatic hyperplasia in Korean patients. J Int Med Res 2002; 30:584–590.
    1. Rigatti P, Brausi M, Scarpa RM, et al. A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Prostate Cancer Prostatic Dis 2003; 6:315–323.
    1. Wang X, Wang X, Li S, et al. Comparative effectiveness of oral drug therapies for lower urinary tract symptoms due to benign prostatic hyperplasia: a systematic review and network meta-analysis. PLoS One 2014; 9:e107593.
    1. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration; 2011: Available at: . Accessed: June 1, 2015.
    1. Dias S, Welton NJ, Sutton AJ, Ades AE. NICE DSU Technical Support Document 2:A Generalised Linear Modelling Framework for Pairwise and Network Meta-Analysis of Randomized Controlled Trials (last updated April 2012). 2011. Available at: . Accessed: June 1, 2015.
    1. Caldwell DM, Welton NJ, Ades AE. Mixed treatment comparison analysis provides internally coherent treatment effect estimates based on overviews of reviews and can reveal inconsistency. J Clin Epidemiol 2010; 63:875–882.
    1. Dias S, Sutton AJ, Welton NJ, Ades AE. NICE DSU Technical Support Document 3: Heterogeneity: subgroups, meta-regression, bias and bias-adjustment (last updated April 2012). 2011. Available at:. Accessed: June 1, 2015.
    1. Dias S, Welton NJ, Sutton AJ, et al. NICE DSU Technical Support Document 4: Inconsistency in Networks of Evidence Based on Randomised Controlled Trials (last updated April 2012). 2011. Available at: . Accessed: June 1, 2015.
    1. Song F, Loke YK, Walsh T, et al. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ 2009; 338:b1147.
    1. Wald DS, Law M, Morris JK, et al. Combination therapy versus monotherapy in reducing blood pressure: meta-analysis on 11,000 participants from 42 trials. Am J Med 2009; 122:290–300.
    1. Dias S, Welton NJ, Sutton AJ, et al. Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials. Med Decis Making 2013; 33:641–656.
    1. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009; 339:b2700.
    1. Lepor H. Alpha blockers for the treatment of benign prostatic hyperplasia. Rev Urol 2007; 9:181–190.
    1. Perk J, De Backer G, Gohlke H, et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J 2012; 33:1635–1701.
    1. Wu XJ, Zhi Y, Zheng J, et al. Dutasteride on benign prostatic hyperplasia: a meta-analysis on randomized clinical trials in 6460 patients. Urology 2014; 83:539–543.
    1. Edwards JE, Moore RA. Finasteride in the treatment of clinical benign prostatic hyperplasia: a systematic review of randomised trials. BMC Urol 2002; 2:14.
    1. McConnell JD, Bruskewitz R, Walsh P, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group. N Engl J Med 1998; 338:557–563.
    1. Thompson IM, Jr, Goodman PJ, Tangen CM, et al. Long-term survival of participants in the prostate cancer prevention trial. N Engl J Med 2013; 369:603–610.
    1. Andriole GL, Bostwick DG, Brawley OW, et al. Effect of dutasteride on the risk of prostate cancer. N Engl J Med 2010; 362:1192–1202.
    1. Kaplan SA, Roehrborn CG, Rovner ES, et al. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA 2006; 296:2319–2328.
    1. Abrams P, Kaplan S, De Koning Gans HJ, et al. Safety and tolerability of tolterodine for the treatment of overactive bladder in men with bladder outlet obstruction. J Urol 2006; 175:999–1004.discussion 1004.
    1. Dong Y, Hao L, Shi Z, et al. Efficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a meta-analysis. Urol Int 2013; 91:10–18.
    1. Yuan J, Zhang R, Yang Z, et al. Comparative effectiveness and safety of oral phosphodiesterase type 5 inhibitors for erectile dysfunction: a systematic review and network meta-analysis. Eur Urol 2013; 63:902–912.

Source: PubMed

3
Abonnieren