Combination therapy with Tamsulosin plus Dutasteride Versus Tamsulosin in Benign Prostatic Hyperplasia: a Systematic review & Meta-analysis
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Abstract
Background: This study aims to compare combination therapy efficacy and safety with tamsulosin plus dutasteride versus tamsulosin in benign prostatic hyperplasia. Methods: An online search was conducted in PubMed, Cochrane Library, Embase, Scopus, and Web of Science to identify the relevant published studies up to July 2021. The reference list of the critical review articles was searched as well. The Cochrane risk of bias was used to assess the quality of studies. Meta-analysis was performed using the RevMan software v.5.3. Results: Six studies, including 6647 patients, were included. A significant improvement was observed in the combination therapy group compared to the tamsulosin group in terms of international prostate symptom score (mean difference [MD]=-2.59, %95 confidence interval [CI]: -4.20 to -0.99; P=0.002), prostate volume (MD=-10.13, %95 CI: -12.38 to -7.88; P<0.05), maximum urine flow rate (MD=1.05, %95 CI: 0.82 to 1.29; P<0.05), transitional zone volume (MD=-3.18, %95 CI: -3.57 to -2.79; P<0.05), and prostate-specific antigen (MD=-0.54, %95 CI: -0.80 to -0.29, P<0.05). The result of the subgroup showed that tamsulosin 0.2 mg in combination therapy was not effective in terms of international prostate symptom score (MD=-2.97; 95% CI: -7.49 to 1.56; P=0.20). Adverse events were more in combination therapy regarding erectile dysfunction, retrograde ejaculation, decreased libido, ejaculation failure, any adverse events, and any drug-related adverse event (P<0.05). However, there was no significant difference between the two groups regarding dizziness and any serious adverse event (P>0.05). Conclusion: This meta-analysis showed that combination therapy has greater efficacy in treating patients with benign prostatic hyperplasia; however, it is associated with higher adverse eventsLim KB. Epidemiology of clinical benign prostatic hyperplasia. Asian J Urol. 2017; 4(3):148-51. [DOI:10.1016/j.ajur.2017.06.004]
Kim EH, Brockman JA, Andriole GL. The use of 5-alpha reductase inhibitors in the treatment of benign prostatic hyperplasia. Asian J Urol. 2018; 5(1):28-32. [DOI:10.1016/j.ajur.2017.11.005]
McVary KT. BPH: Epidemiology and comorbidities. Am J Manag Care. 2006; 12(5 Suppl):S122-8.
Karami H, Hassanzadeh-Hadad A, Fallah-Karkan M. Comparing monotherapy with tadalafil or tamsulosin and their combination therapy in men with benign prostatic hyperplasia: A randomized clinical trial. Urol J. 2016; 13(6):2920-6.
Parsons JK. Benign prostatic hyperplasia and male lower urinary tract symptoms: Epidemiology and risk factors. Curr Bladder Dysfunct Rep. 2010; 5(4):212-8. [DOI:10.1007/s11884-010-0067-2]
Ebadzadeh M, Sharifian Amiri R, Jalili A, Sarrafinejad A, Zanganeh H, Ketabchi A. The effect of diclofenac sodium on nocturia caused by benign prostatic hyperplasia. J Kerman Univ Med Sci. 2019; 26(4):289-96. [DOI:10.22062/JKMU.2019.89522]
Patel ND, Parsons JK. Epidemiology and etiology of benign prostatic hyperplasia and bladder outlet obstruction. Indian J Urol. 2014; 30(2):170-6. [DOI:10.4103/0970-1591.126900]
Cakir SS, Polat EC, Ozcan L, Besiroglu H, Ötunctemur A, Ozbek E. The effect of prostatic inflammation on clinical outcomes in patients with benign prostate hyperplasia. Prostate Int. 2018; 6(2):71-4. [DOI:10.1016/j.prnil.2017.12.003]
Thiruchelvam N. Benign prostatic hyperplasia. Surgery. 2014; 32(6):314-22. [DOI:10.1016/j.mpsur.2014.04.006]
Stamatiou K. Management of benign prostatic hypertrophy- related urinary retention: Current trends and perspectives. Urol J. 2009; 6(4):237-44.
Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, et al. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013; 64(1):118-40. [DOI:10.1016/j.eururo.2013.03.004]
Kilic S, Kolukcu E, Erdemir F, Benli I, Arici A. The effects of oral 5-alpha reductase inhibitors on penile intracavernosal pressures and penile morphology in rat model. Urol J. 2019; 16(2):205-11. [DOI:10.22037/uj.v0i0.4164]
Vickman RE, Franco OE, Moline DC, Vander Griend DJ, Thumbikat P, Hayward SW. The role of the androgen receptor in prostate development and benign prostatic hyperplasia: A review. Asian J Urol. 2020; 7(3):191-202. [DOI:10.1016/j.ajur.2019.10.003]
Jiwrajka M, Yaxley W, Ranasinghe S, Perera M, Roberts MJ, Yaxley J. Drugs for benign prostatic hypertrophy. Aust Prescr. 2018; 41(5):150-3. [DOI:10.18773/austprescr.2018.045]
Shum CF, Lau W, Teo CPC. Medical therapy for clinical benign prostatic hyperplasia: α1 Antagonists, 5α reductase inhibitors and their combination. Asian J Urol. 2017; 4(3):185-90. [DOI:10.1016/j. ajur.2017.06.002]
Kruep EJ,PhillipsE, Hogue S,Eaddy M.Earlysymptom improvement and discontinuation of 5-α-reductase inhibitor (5ARI) therapy in patients with benign prostatic hyperplasia (BPH). Ann Pharmacother. 2014; 48(3):343-8. [DOI:10.1177/1060028013514213]
Pinheiro LC, Pisco JM. Treatment of benign prostatic hyperplasia. Tech Vasc Interv Radiol. 2012; 15(4):256-60. [DOI:10.1053/j. tvir.2012.09.004]
Kim BS, Kim T-H, Kim KH, Kim BH, Ha JY, Cho DH, et al. Patient- reported goal achievement after treating male benign prostatic hyperplasia with alpha-adrenergic antagonist: A 12-week prospective multicenter study. Urol J. 2019; 16(4):386-91. [DOI:10.22037/uj.v0i0.3784]
Roehrborn CG. Current medical therapies for men with lower urinary tract symptoms and benign prostatic hyperplasia: Achievements and limitations. Rev Urol. 2008; 10(1):14-25.
Zhu Y-P, Dai B, Zhang H-L, Shi G-h, Ye D-W. Impact of preoperative 5α-reductase inhibitors on perioperative blood loss in patients with benign prostatic hyperplasia: A meta-analysis of randomized controlled trials. BMC Urol. 2015; 15(1):47. [DOI:10.1186/s12894- 015-0043-4]
Marks LS, Partin AW, Dorey FJ, Gormley GJ, Epstein JI, Garris JB, et al. Long-term effects of finasteride on prostate tissue composition. Urology. 1999; 53(3):574-80. [DOI:10.1016/S0090-4295(98)00567- 6]
Roehrborn CG, Lukkarinen O, Mark S, Siami P, Ramsdell J, Zinner N. Long-term sustained improvement in symptoms of benign prostatic hyperplasia with the dual 5α-reductase inhibitor dutasteride: Results of 4-year studies. BJU Int. 2005; 96(4):572-7. [DOI:10.1111/j.1464-410X.2005.05686.x]
DerSarkissian M, Xiao Y, Duh MS, Lefebvre P, Swensen AR, Bell CF. Comparing clinical and economic outcomes associated with early initiation of combination therapy of an alpha blocker and dutasteride or finasteride in men with benign prostatic hyperplasia in the United States. J Manag Care Spec Pharm. 2016; 22(10):1204- 14. [DOI:10.18553/jmcp.2016.22.10.1204]
Roehrborn CG, Manyak MJ, Palacios-Moreno JM, Wilson TH, Roos EP, Santos JC, et al. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. 2018; 121(4):647-58. [DOI:10.1111/ bju.14057]
Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Morrill B, et al. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008; 179(2):616-21. [DOI:10.1016/j.juro.2007.09.084]
Greco K, McVary K. The role of combination medical therapy in benign prostatic hyperplasia. Int J Impot Res. 2008; 20(3):S33-43. [DOI:10.1038/ijir.2008.51]
MoherD,Liberati A,Tetzlaff J,Altman DG. Preferredreporting items for systematic reviews and meta-analyses: The PRISMA statement. Ann Intern Med. 2009; 151(4):264-9. [DOI:10.7326/0003-4819- 151-4-200908180-00135]
Choi JD, Kim JH, Ahn SH. Transitional zone index as a predictor of the efficacy of α-blocker and 5α-reductase inhibitor combination therapy in Korean patients with benign prostatic hyperplasia. Urol Int. 2016; 96(4):406-12. [DOI:10.1159/000442995]
Haque N, Masumori N, Sakamoto S, Ye Z, Yoon SJ, Kuo HC, et al. Superiority of dutasteride 0.5 mg and tamsulosin 0.2 mg for the treatment of moderate-to-severe benign prostatic hyperplasia in Asian men. Int J Urol. 2018; 25(11):944-51. [DOI:10.1111/iju.13785]
Hong SK, Min GE, Ha SB, Doo SH, Kang MY, Park HJ, et al. Effect of the dual 5α-reductase inhibitor, dutasteride, on serum testosterone and body mass index in men with benign prostatic hyperplasia. BJU Int. 2010; 105(7):970-4. [DOI:10.1111/j.1464-410X.2009.08915.x]
Joo K, Sung W, Park S, Yang W, Kim T. Comparison of α-blocker monotherapy and α-blocker plus 5α-reductase inhibitor combina- tion therapy based on prostate volume for treatment of benign pro- static hyperplasia. J Int Med Res. 2012; 40(3):899-908. [DOI:10.117 7/147323001204000308]
Roehrborn CG, Barkin J, Tubaro A, Emberton M, Wilson TH, Brotherton BJ, et al. Influence of baseline variables on changes in international prostate symptom score after combined therapy with dutasteride plus tamsulosin or either monotherapy in patients with benign prostatic hyperplasia and lower urinary tract symptoms: 4-year results of the CombAT study. BJU Int. 2014; 113(4):623-35. [DOI:10.1111/bju.12500]
Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, Brotherton B, Wang F, et al. Efficacy and safety of a fixed-dose combination of dutasteride and tamsulosin treatment (D uodart®) compared with watchful waiting with initiation of tamsulosin therapy if symptoms do not improve, both provided with lifestyle advice, in the management of treatment-naïve men with moderately symptomatic benign prostatic hyperplasia: 2-year CONDUCT study results. BJU Int. 2015; 116(3):450-9. [DOI:10.1111/ bju.13033]
Zhou Z, Cui Y, Wu J, Ding R, Cai T, Gao Z. Meta-analysis of the efficacy and safety of combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia. BMC Urol. 2019; 19(1):17. [DOI:10.1186/ s12894-019-0446-8]
Kim CI, Chang HS, Kim BK, Park CH. Long-term results of medical treatment in benign prostatic hyperplasia. Urology. 2006; 68(5):1015-9. [DOI:10.1016/j.urology.2006.06.003]
Logan YT, Belgeri MT. Monotherapy versus combination drug therapy for the treatment of benign prostatic hyperplasia. Am J Geriatr Pharmacother. 2005; 3(2):103-14. [DOI:10.1016/S1543- 5946(05)00031-0]
McVary KT. A review of combination therapy in patients with benign prostatic hyperplasia. Clin Ther. 2007; 29(3):387-98. [DOI:10.1016/S0149-2918(07)80077-4]
Sandhu JS, Vaughan ED. Combination therapy for the pharmacological management of benign prostatic hyperplasia. Drugs Aging. 2005; 22(11):901-12. [DOI:10.2165/00002512- 200522110-00002]
Shin TJ, Kim CI, Park CH, Kim BH, Kwon YK. α-Blocker monotherapy and α-blocker plus 5-alpha-reductase inhibitor combination treatment in benign prostatic hyperplasia; 10 years’ long-term results. Korean J Urol. 2012; 53(4):248-52. [DOI:10.4111/ kju.2012.53.4.248]
Chang HS, Park CH, Kim CI. Comparison of the long-term effect of alpha-blocker only and 5-alpha reductase inhibitor combination treatment on acute urinary retention and prostatic surgery for patients with benign prostatic hyperplasia. Korean J Urol. 2006; 47(1):7-12. [DOI:10.4111/kju.2006.47.1.7]
Miller J, Tarter T. Combination therapy with dutasteride and tamsulosin for the treatment of symptomatic enlarged prostate. Clin Interv Aging. 2009; 4:251-8. [DOI:10.2147/CIA.S4102]
Kim W, Jung JH, Kang TW, Song JM, Chung HC. Clinical effects of discontinuing 5-alpha reductase inhibitor in patients with benign prostatic hyperplasia. Korean J Urol. 2014; 55(1):52-6. [DOI:10.4111/kju.2014.55.1.52]
Kim SJ, Shin I-S, Eun S-J, Whangbo T-K, Kim JW, Cho YS, et al. Evi- dence is enough?: A systematic review and network meta-analysis of the efficacy of tamsulosin 0.2 mg and tamsulosin 0.4 mg as an ini- tial therapeutic dose in Asian benign prostatic hyperplasia patients. Int Neurourol J. 2017; 21(1):29-37. [DOI:10.5213/inj.1734826.413]
Füllhase C, Chapple C, Cornu J-N, De Nunzio C, Gratzke C, Kaplan SA, et al. Systematic review of combination drug therapy for non- neurogenic male lower urinary tract symptoms. Eur Urol. 2013; 64(2):228-43. [DOI:10.1016/j.eururo.2013.01.018]
Barkin J, Guimaraes M, Jacobi G, Pushkar D, Taylor S, van Vierssen Trip O. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5α-reductase inhibitor dutasteride. Eur Urol. 2003; 44(4):461-6. [DOI:10.1016/S0302-2838(03)00367-1]
Araki K, Naya Y, Inahara M, Suzuki F, Ota S, Tsuji H, et al. Early effect of dutasteride added to alpha-1 blocker therapy for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. Int J Urol. 2014; 21(8):815-9. [DOI:10.1111/iju.12459]
Kang DI, Chung JI. Current status of 5α-reductase inhibitors in prostate disease management. Korean J Urol. 2013; 54(4):213-9. [DOI:10.4111/kju.2013.54.4.213]
Emberton M, Zinner N, Michel MC, Gittelman M, Chung MK, Madersbacher S. Managing the progression of lower urinary tract symptoms/benign prostatic hyperplasia: Therapeutic options for the man at risk. BJU Int. 2007; 100(2):249-53. [DOI:10.1111/j.1464- 410X.2007.07056.x]
Carson III C, Rittmaster R. The role of dihydrotestosterone in benign prostatic hyperplasia. Urology. 2003; 61(4):2-7. [DOI:10.1016/S0090-4295(03)00045-1]
Miller J, Tarter TH. Update on the use of dutasteride in the management of benign prostatic hypertrophy. Clin Interv Aging. 2007; 2(1):99-104. [DOI:10.2147/ciia.2007.2.1.99]
Wang X, Wang X, Li S, Meng Z, Liu T, Zhang X. 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(9):e107593. [DOI:10.1371/journal.pone.0107593]
Sokhal AK, Sankhwar S, Goel A, Singh K, Kumar M, Purkait B, et al. A prospective study to evaluate sexual dysfunction and enlargement of seminal vesicles in sexually active men treated for benign prostatic hyperplasia by alpha-blockers. Urology. 2018; 118:92-7. [DOI:10.1016/j.urology.2017.08.025]
La Torre A, Giupponi G, Duffy D, Conca A, Cai T, Scardigli A. Sexual dysfunction related to drugs: A critical review. part V: α-blocker and 5-ARI drugs. Pharmacopsychiatry. 2016; 49(01):3-13. [DOI:10.1055/s-0035-1565100]
Favilla V, Russo GI, Privitera S, Castelli T, Giardina R, Calogero AE, et al. Impact of combination therapy 5-alpha reductase inhibitors (5-ARI) plus alpha-blockers (AB) on erectile dysfunction and de- crease of libido in patients with LUTS/BPH: A systematic review with meta-analysis. Aging Male. 2016; 19(3):175-81. [DOI:10.1080/1368 5538.2016.1195361]
Corona G, Tirabassi G, Santi D, Maseroli E, Gacci M, Dicuio M, et al. Sexual dysfunction in subjects treated with inhibitors of 5α-reductase for benign prostatic hyperplasia: A comprehensive review and meta-analysis. Andrology. 2017; 5(4):671-8. [DOI:10.1111/ andr.12353]
Kim SW, Lee WC, Kim MT, Ko K, Lee WK, Lee C-H, et al. Effects of low-dose tamsulosin on sexual function in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Korean J Urol. 2013; 54(10):697-702. [DOI:10.4111/ kju.2013.54.10.697]
Hagberg KW, Divan HA, Persson R, Nickel JC, Jick SS. Risk of erectile dysfunction associated with use of 5-α reductase inhibitors for benign prostatic hyperplasia or alopecia: Population based studies using the clinical practice research datalink. BMJ. 2016; 354:i4823. [DOI:10.1136/bmj.i4823]
Dimitropoulos K, Gravas S. Fixed-dose combination therapy with dutasteride and tamsulosin in the management of benign prostatic hyperplasia. Ther Adv Urol. 2016; 8(1):19-28. [DOI:10.1177/1756287215607419]
| Files | ||
| Issue | Vol 8 No 4 (2022) | |
| Section | Review Article(s) | |
| Keywords | ||
| Benign prostatic hyperplasia, Tamsulosin, Dutasteride, combination therapy | ||
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