Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지
DOI QR코드

DOI QR Code

Effectiveness and Safety Verification of Brinzolamide Combination Therapy on Primary Open-angle Glaucoma or Ocular Hypertension: A Systematic Review and Meta-analysis Study

브린졸라미드 복합제의 개방각 녹내장 또는 고안압증에 대한 효과 및 안전성 검증: 체계적 문헌 고찰 및 메타분석 연구

  • Kim, Jin A (College of Pharmacy, Chungbuk National University) ;
  • Lee, Heeyoung (Department of Clinical Medicinal Sciences, Konyang University)
  • 김진아 (충북대학교 약학대학) ;
  • 이희영 (건양대학교 임상의약학과)
  • Received : 2021.07.22
  • Accepted : 2021.09.13
  • Published : 2021.09.30
Download PDF
⟨ Previous Next ⟩

Abstract

Background: The treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT) for intraocular pressure (IOP) reduction is recommended to proceed with the use of the compound. Therefore, this study aimed to evaluate the efficacy and safety of brinzolamide combination therapy on POAG and OHT following the subgroup analysis among types of brinzolamide combined medications. Methods: By June 2019, PubMed, EMBASE and Cochrane Library were searched to find a study that met our inclusion criteria. Based on randomized control trials (RCTs), we collected studies that tested the brinzolamide combination therapy in POAG and OHT patients, and analyzed the literature identified by the results of the study on IOP reduction and adverse reactions. Results: A total of 13 literature was collected to conduct an analysis including 2,197 patients. The intervention included brinzolamide combination therapies, combined with timolol, brimonidine, PGA or combined with both brimonidine and PGA. The analysis showed significant decreasing tendency for values at morning and end treatment per day in the use of brinzolamide combination therapy in the absolute IOP change (mean difference (MD) -1.41; 95% CI -1.92, -0.90; p<0.001 vs. MD -1.46; 95% CI -2.03, -0.89; p<0.00001, respectively). We could see higher adverse reactions in the brinzolamide combination group using intervention (odds ratio 1.43; 95% CI 1.20, 1.71; p<0.0001). Conclusion: Regarding IOP reduction in POAG and OHT patients, brinzolamide combination therapy is more effective but less safe than control treatment, which diverse among types of combined medications. Thus, more individualized therapy should be applied in real-world practice.

Keywords

Acknowledgement

본 연구의 자료 수집에 도움을 주신 이수현 선생님께 감사드립니다.

References

  1. Resnikoff S, Pascolini D, Etya'ale D, et al. Global data on visual impairment in the year 2002. Bull World Health Organ 2004;82(11):844-51.
  2. Peters D, Bengtsson B, Heijl A. Factors associated with lifetime risk of open-angle glaucoma blindness. Acta Ophthalmol 2014;92(5):421-25. https://doi.org/10.1111/aos.12203
  3. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology 2014;121(11):2081-90. https://doi.org/10.1016/j.ophtha.2014.05.013
  4. Sharif NA. Glaucomatous optic neuropathy treatment options: the promise of novel therapeutics, techniques and tools to help preserve vision. Neural Regen Res 2018;13(7):1145-50. https://doi.org/10.4103/1673-5374.235017
  5. Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA 2014;311(18):1901-11. https://doi.org/10.1001/jama.2014.3192
  6. Terminology and guidelines for glaucoma (4th edition) 2014. European Glaucoma Society Guidelines. Available from http://www.icoph.org/dynamic/attachments/resources/egs_guidelines_4_english.pdf. Accessed August 16, 2021.
  7. Nguyen QH. Combination of brinzolamide and brimonidine for glaucoma and ocular hypertension: critical appraisal and patient focus. Patient Prefer Adherence 2014;8:853-64. https://doi.org/10.2147/PPA.S53162
  8. Higginbotham EJ. Considerations in glaucoma therapy: fixed combinations versus their component medications. Clin Ophthalmol 2010;4:1-9.
  9. Ong SS, Sanka K, Mettu PS, et al. Resident compliance with the american academy of ophthalmology preferred practice pattern guidelines for primary open-angle glaucoma. Ophthalmology 2013;120(12):2462-9. https://doi.org/10.1016/j.ophtha.2013.05.019
  10. Nguyen QH. The role of prostaglandin analogues in the treatment of glaucoma in the 21st century. Int Ophthalmol Clin 2004;44(2):15-27. https://doi.org/10.1097/00004397-200404420-00004
  11. Iester M. Brinzolamide ophthalmic suspension: a review of its pharmacology and use in the treatment of open angle glaucoma and ocular hypertension. Clin Ophthalmol 2008;2(3):517-23. https://doi.org/10.2147/OPTH.S3182
  12. DeSantis L. Preclinical overview of brinzolamide. Surv Ophthalmol 2000;44(Suppl 2):S119-29. https://doi.org/10.1016/S0039-6257(99)00108-3
  13. Greig SL, Deeks ED. Brinzolamide/brimonidine: a review of its use in patients with open-angle glaucoma or ocular hypertension. Drugs Aging 2015;32(3):251-60. https://doi.org/10.1007/s40266-015-0250-4
  14. Webers CA, Beckers HJ, Nuijts RM, Schouten JS. Pharmacological management of primary open-angle glaucoma: second-line options and beyond. Drugs Aging 2008;25(9):729-59. https://doi.org/10.2165/00002512-200825090-00002
  15. Cheng JW, Li Y, Wei RL. Systematic review of intraocular pressure-lowering effects of adjunctive medications added to latanoprost. Ophthalmic Res 2009;42(2):99-105. https://doi.org/10.1159/000225963
  16. Dzhumataeva ZA. [Prostaglandin analogues in glaucoma treatment]. Vestn Oftalmol 2016;132(4):62-7. https://doi.org/10.17116/oftalma2016132462-67
  17. Lusthaus JA, Goldberg I. Brimonidine and brinzolamide for treating glaucoma and ocular hypertension; a safety evaluation. Expert Opin Drug Saf 2017;16(9):1071-8. https://doi.org/10.1080/14740338.2017.1346083
  18. Prum BE, Jr., Rosenberg LF, Gedde SJ, et al. Primary open-angle glaucoma preferred practice pattern(®) Guidelines. Ophthalmology 2016;123(1):P41-111.
  19. Glaucoma: diagnosis and management. National Institute for Health and Care Excellence. Available from https://www.nice.org.uk/guidance/ng81/chapter/Recommendations#treatment. Accessed August 16, 2021.
  20. Liu Y, Zhao J, Zhong X, Wei Q, Huang Y. Efficacy and safety of brinzolamide as add-on to prostaglandin analogues or β-Blocker for glaucoma and ocular hypertension: A systematic review and meta-analysis. Front Pharmacol 2019;10:679. https://doi.org/10.3389/fphar.2019.00679
  21. Joshi SR, Akat PB, Ramanand JB, Ramanand SJ, Karande VB, Jain SS. Evaluation of brimonidine-timolol fixed combination in patients of primary open-angle glaucoma. Indian J Ophthalmol 2013;61(12):765-7. https://doi.org/10.4103/0301-4738.116456
  22. Craven ER, Walters TR, Williams R, Chou C, Cheetham JK, Schiffman R. Brimonidine and timolol fixed-combination therapy versus monotherapy: a 3-month randomized trial in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther 2005;21(4):337-48. https://doi.org/10.1089/jop.2005.21.337
  23. Sherwood MB, Craven ER, Chou C, et al. Twice-daily 0.2% brimonidine-0.5% timolol fixed-combination therapy vs monotherapy with timolol or brimonidine in patients with glaucoma or ocular hypertension: a 12-month randomized trial. Arch Ophthalmol 2006;124(9):1230-8. https://doi.org/10.1001/archopht.124.9.1230
  24. Knobloch K, Yoon U, Vogt PM. Preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement and publication bias. J Craniomaxillofac Surg 2011;39(2):91-2. https://doi.org/10.1016/j.jcms.2010.11.001
  25. Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011;343:d5928. https://doi.org/10.1136/bmj.d5928
  26. Aihara M, Adachi M, Matsuo H, Togano T, Fukuchi T, Sasaki N. Additive effects and safety of fixed combination therapy with 1% brinzolamide and 0.5% timolol versus 1% dorzolamide and 0.5% timolol in prostaglandin-treated glaucoma patients. Acta Ophthalmol 2017;95(8):e720-6. https://doi.org/10.1111/aos.13401
  27. Fechtner RD, Myers JS, Hubatsch DA, Budenz DL, DuBiner HB. Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial. Eye (Lond) 2016;30(10):1343-50. https://doi.org/10.1038/eye.2016.126
  28. Michaud JE, Friren B. Comparison of topical brinzolamide 1% and dorzolamide 2% eye drops given twice daily in addition to timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension. Am J Ophthalmol 2001;132(2):235-43. https://doi.org/10.1016/S0002-9394(01)00974-6
  29. Yoshikawa K, Kozaki J, Maeda H. Efficacy and safety of brinzolamide/timolol fixed combination compared with timolol in Japanese patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol 2014;8:389-99. https://doi.org/10.2147/OPTH.S58293
  30. Aung T, Laganovska G, Hernandez Paredes TJ, Branch JD, Tsorbatzoglou A, Goldberg I. Twice-daily brinzolamide/brimonidine fixed combination versus brinzolamide or brimonidine in openangle glaucoma or ocular hypertension. Ophthalmology 2014;121(12):2348-55. https://doi.org/10.1016/j.ophtha.2014.06.022
  31. Feldman RM, Tanna AP, Gross RL, et al. Comparison of the ocular hypotensive efficacy of adjunctive brimonidine 0.15% or brinzolamide 1% in combination with travoprost 0.004%. Ophthalmology 2007;114(7):1248-54. https://doi.org/10.1016/j.ophtha.2007.03.012
  32. Feldman RM, Katz G, McMenemy M, Hubatsch DA, Realini T. A randomized trial of fixed-dose combination brinzolamide 1%/brimonidine 0.2% as adjunctive therapy to travoprost 0.004. Am J Ophthalmol 2016;165:188-97. https://doi.org/10.1016/j.ajo.2016.02.026
  33. Hollo G, Chiselita D, Petkova N, et al. The efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to travoprost in patients with ocular hypertension or primary open-angle glaucoma. Eur J Ophthalmol 2006;16(6):816-23. https://doi.org/10.1177/112067210601600606
  34. Kaback M, Scoper SV, Arzeno G, et al. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5%. Ophthalmology 2008;115(10):1728-34. https://doi.org/10.1016/j.ophtha.2008.04.011
  35. Nguyen QH, McMenemy MG, Realini T, Whitson JT, Goode SM. Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%. J Ocul Pharmacol Ther 2013;29(3):290-7. https://doi.org/10.1089/jop.2012.0235
  36. Shin D. Adjunctive therapy with brinzolamide 1% ophthalmic suspension (Azopt) in patients with open-angle glaucoma or ocular hypertension maintained on timolol therapy. Surv Ophthalmol 2000;44(Suppl 2):S163-8. https://doi.org/10.1016/S0039-6257(99)00106-X
  37. Day DG, Hollander DA. Brimonidine purite 0.1% versus brinzolamide 1% as adjunctive therapy to latanoprost in patients with glaucoma or ocular hypertension. Curr Med Res Opin 2008;24(5):1435-42. https://doi.org/10.1185/030079908X301848
  38. Katz G, Dubiner H, Samples J, Vold S, Sall K. Three-month randomized trial of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%. JAMA Ophthalmol 2013;131(6):724-30. https://doi.org/10.1001/jamaophthalmol.2013.188
  39. Kwon YH, Fingert JH, Kuehn MH, Alward WL. Primary open-angle glaucoma. N Engl J Med 2009;360(11):1113-24. https://doi.org/10.1056/NEJMra0804630
  40. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol 2002;120(6):701-13. https://doi.org/10.1001/archopht.120.6.701
  41. Sommer A, Tielsch JM, Katz J, et al. Relationship between intraocular pressure and primary open angle glaucoma among white and black Americans. The Baltimore Eye Survey. Arch Ophthalmol 1991;109(8):1090-5.
  42. Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol 2002;120(10):1268-79. https://doi.org/10.1001/archopht.120.10.1268
  43. Costagliola C, Del Prete A, Verolino M, et al. Effect of 0.005% latanoprost once daily on intraocular pressure in glaucomatous patients not adequately controlled by beta-blockers twice daily: a 3-year follow-up. Experience and incidence of side effects in a prospective study on 76 patients. Graefes Arch Clin Exp Ophthalmol 2002;240(5):379-86. https://doi.org/10.1007/s00417-002-0469-8
  44. van der Valk R, Webers CA, Schouten JS, Zeegers MP, Hendrikse F, Prins MH. Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. Ophthalmology 2005;112(7):1177-85. https://doi.org/10.1016/j.ophtha.2005.01.042
  45. Shoji N, Ogata H, Suyama H, et al. Intraocular pressure lowering effect of brinzolamide 1.0% as adjunctive therapy to latanoprost 0.005% in patients with open angle glaucoma or ocular hypertension: an uncontrolled, open-label study. Curr Med Res Opin 2005;21(4):503-8. https://doi.org/10.1185/030079905X38222
  46. Miura K, Ito K, Okawa C, Sugimoto K, Matsunaga K, Uji Y. Comparison of ocular hypotensive effect and safety of brinzolamide and timolol added to latanoprost. J Glaucoma 2008;17(3):233-7. https://doi.org/10.1097/IJG.0b013e31815072fe
  47. Puscas I, Coltau M. Prostaglandins with vasodilating effects inhibit carbonic anhydrase while vasoconstrictive prostaglandins and leukotriens B4 and C4 increase CA activity. Int J Clin Pharmacol Ther 1995;33(3):176-81.
  48. U.S Food and Drug Administration. Drug@FDA: FDA-Approved Drugs-SIMBRINZA (NOVARTIS). Available from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204251. Accessed July 17, 2021.
  49. Ministry of Food and Drug Safety. SIMBRINZA ophthalmic suspension (NOVARTIS KOREA Co. Ltd). Available from https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=201503767. Accessed July 17, 2021.
  50. Taniguchi T, Kitazawa Y. The potential systemic effect of topically applied beta-blockers in glaucoma therapy. Curr Opin Ophthalmol 1997;8(2):55-8. https://doi.org/10.1097/00055735-199704000-00010
  51. Whitson JT, Realini T, Nguyen QH, McMenemy MG, Goode SM. Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension. Clin Ophthalmol 2013;7:1053-60. https://doi.org/10.2147/OPTH.S46881
  52. Silver LH. Clinical efficacy and safety of brinzolamide (Azopt), a new topical carbonic anhydrase inhibitor for primary open-angle glaucoma and ocular hypertension. Brinzolamide Primary Therapy Study Group. Am J Ophthalmol 1998;126(3):400-8.
  53. Topouzis F, Goldberg I, Bell K, et al. Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension. Eur J Ophthalmol 2021;31(1):103-11. https://doi.org/10.1177/1120672119878044
  54. Ministry of Food and Drug Safety. AZOPT ophthalmic suspension (brinzolamide) (NOVARTIS KOREA. Co. Ltd.) Available from https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=200109116. Accessed August 17, 2021.
  55. U.S Food and Drug Administration. Drug@FDA: FDA-Approved Drugs-AZOPT. NOVARTIS. Available from https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020816s023lbl.pdf. Accessed August 17, 2021.