Офтальмохирургия. 2021; : 94-99
Эффективность и безопасность различных лекарственных форм бримонидина при глаукоме и офтальмогипертензии
Сидорова А. В., Журавлев А. С., Старостина А. В., Елисеева М. А.
https://doi.org/10.25276/0235-4160-2021-2-94-99Аннотация
Цель. Представить данные о механизме действия, эффективности и побочных эффектах различных лекарственных форм бримонидина при глаукоме и офтальмогипертензии.
Материал и методы. Для выполнения обзора был осуществлен поиск источников литературы по реферативным базам PubMed и Scopus за период до 2021 года включительно, используя ключевые слова «brimonidine», «efficacy», «safety», «glaucoma medication». Все- го было отобрано 36 статей, относящихся к теме обзора. Начало публикаций по этой теме относится к 1995 г.
Результаты. Агонист α2-адренорецепторов бримонидин эффективно снижает ВГД и может быть использован в качестве монотерапии, адъювантной и заместительной терапии. Эффективность бримонидина аналогична эффективности тимолола и преобладает над бетаксололом, но уступает аналогам простагландинов. Новая лекарственная формула препарата бримонидин-пурит 0,15% обладает более благоприятным профилем безопасности и переносимости, чем оригинальный бримонидин 0,2%, при сохранении аналогичной эффективности. Однако большинству пациентов для поддержания целевого ВГД требуется два и более гипотензивных препарата. В дан- ном контексте бримонидин является одним из наиболее подходящих препаратов благодаря доказанной эффективности при комбинации с другими классами гипотензивных препаратов.
Заключение. Бримонидин может использоваться в качестве монотерапии при глаукоме и офтальмогипертензии. А также по результатам экспериментальных и клинических исследований выявлен потенциальный нейропротективный эффект бримонидина, который связан с прямым действием на клетки сетчатки, независимо от влияния препарата на внутриглазное давление.
Список литературы
1. Tham Y-C, Li X, Wong TY, Quigley HA, Aung T, Cheng C-Y. Global Prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11): 2081–2090. doi: 10.1016/j.ophtha.2014.05.013
2. Coleman AL, Miglior S. Risk factors for glaucoma onset and progression. Surv Ophthalmol. 2008;53(6):S310. doi: 10.1016/j.survophthal.2008.08.006
3. 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): 1268–1279. doi: 10.1001/archopht.120.10.1268
4. Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP. 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): 701–713; 829–830. doi: 10.1001/archopht.120.6.701
5. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Am J Ophthalmol. 1998;126(4): 487–497. doi: 10.1016/S0002-9394(98)00223-2
6. Hedman K, Alm A. A Pooled-Data Analysis of three randomized, double-masked, six-month clinical studies comparing the intraocular pressure reducing effect of latanoprost and timolol. Eur J Ophthalmol. 2000;10(2): 95–104. doi: 10.1177/112067210001000201
7. Cantor LB. Brimonidine in the treatment of glaucoma and ocular hypertension. Ther Clin Risk Manag. 2006;2(4): 337–346. doi: 10.2147/tcrm.2006.2.4.337
8. Alm A, Grierson I, Shields MB. Side effects associated with prostaglandin analog therapy. Surv Ophthalmol. 2008;53(6): S93–105. doi:10.1016/j.survophthal.2008.08.004
9. Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA. Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001;108(11): 1943–1953. doi: 10.1016/S0161-6420(01)00873-9
10. Walters TR. Development and use of brimonidine in treating acute and chronic elevations of intraocular pressure: A review of safety, efficacy, dose response, and dosing studies. Surv Ophthalmol. 1996;41: S19–26. doi: 10.1016/S0039-6257(96)82028-5
11. Toris CB, Gleason ML, Camras CB, Yablonski ME. Effects of brimonidine on aqueous humor dynamics in human eyes. Arch Ophthalmol. 1995;113(12): 1514–1517. doi: 10.1001/archopht.1995.01100120044006
12. Toris CB, Camras CB, Yablonski ME. Acute versus chronic effects of brimonidine on aqueous humor dynamics in ocular hypertensive patients. Am J Ophthalmol. 1999;128(1): 8–14. doi: 10.1016/S0002-9394(99)00076-8
13. Kesler A, Shemesh G, Rothkoff L, Lazar M. Effect of brimonidine tartrate 0.2% ophthalmic solution on pupil size. J Cataract Refract Surg. 2004;30(8): 1707–1710. doi: 10.1016/j.jcrs.2004.02.043
14. Niyadurupola N, Broadway DC. Pigment dispersion syndrome and pigmentary glaucoma – a major review. Clin Exp Ophthalmol. 2008;36(9): 868–882. doi: 10.1111/j.1442-9071.2009.01920.x
15. Acheampong AA, Shackleton M, John B, Burke J, Wheeler L, Tang-Liu D. Distribution of brimonidine into anterior and posterior tissues of monkey, rabbit, and rat Eyes. Drug Metab Dispos. 2002;30(4): 421–429. doi: 10.1124/dmd.30.4.421
16. Cantor LB. The evolving pharmacotherapeutic profile of brimonidine, an 2-adrenergic agonist, after four years of continuous use. Expert Opin Pharmacother. 2000;1(4): 815–834. doi: 10.1517/14656566.1.4.815
17. Schuman JS, Horwitz B, Choplin NT, David R, Albracht D, Chen K. A 1-Year study of brimonidine twice daily in glaucoma and ocular hypertension: A controlled, randomized, multicenter clinical trial. Arch Ophthalmol. 1997;115(7): 847–852. doi: 10.1001/archopht.1997.01100160017002
18. David R. Brimonidine (Alphagan®): A clinical profile four years after launch. Eur J Ophthalmol. 2001;11(2_suppl): 72–77. doi: 10.1177/112067210101102S10
19. Javitt J, Goldberg I. Comparison of the clinical success rates and quality of life effects of brimonidine tartrate 0.2% and betaxolol 0.25% suspension in patients with open-angle glaucoma and ocular hypertension. Brimonidine outcomes study group II. J Glaucoma. 2000;9(5): 398–408. doi: 10.1097/00061198-200010000-00009
20. Stewart WC, Sharpe ED, Harbin TS, Pastor SA, Day DG, Holmes KT. Brimonidine 0.2% versus dorzolamide 2% each given three times daily to reduce intraocular pressure. Am J Ophthalmol. 2000;129(6): 723–727. doi: 10.1016/S0002-9394(00)00381-0
21. Simmons ST. Efficacy of brimonidine 0.2% and dorzolamide 2% as adjunctive therapy to beta-blockers in adult patients with glaucoma or ocular hypertension. Clin Therap. 2001;23(4):604–619. doi: 10.1016/S0149-2918(01)80064-3
22. Carrasco FC, Arias Puente A, García Sáenz MC, Villarejo Díaz-Maroto I. Efficiency of brimonidine 0.2% and dorzolamide 2% as adjunctive therapy to beta-blockers. Arch Soc Esp Oftalmol. 2004;79(4): 163–168.
23. Noecker RJ, Herrygers LA, Anwaruddin R. Corneal and conjunctival changes caused by commonly used glaucoma medications. Cornea. 2004;23(5): 490–496. doi: 10.1097/01.ico.0000116526.57227.82
24. Bonniard AA, Yeung JY, Chan CC, Birt CM. Ocular surface toxicity from glaucoma topical medications and associated preservatives such as benzalkonium chloride (BAK). Expert Opin Drug Metab Toxicol. 2016;12(11): 1279–1289. doi: 10.1080/17425255.2016.1209481
25. Katz LJ. Twelve-month evaluation of brimonidine-purite versus brimonidine in patients with glaucoma or ocular hypertension. J Glaucoma. 2002;11(2): 119–126.
26. Dong JQ, Babusis DM, Welty DF, Acheampong AA, Tang-Liu D, Whitcup SM. Effects of the preservative Purite® on the bioavailability of brimonidine in the aqueous humor of rabbits. J Ocul Pharmacol Ther. 2004;20(4): 285–292. doi: 10.1089/1080768041725326
27. Mundorf T, Williams R, Whitcup S, Felix C, Batoosingh A. A 3-month comparison of efficacy and safety of brimonidine-Purite 0.15% and brimonidine 0.2% in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2003;19(1): 37–44. doi: 10.1089/108076803762718097
28. Konstas AGP, Karabatsas CH, Lallos N, Georgiadis N, Kotsimpou A, Stewart JA. 24-hour intraocular pressures with brimonidine Purite versus dorzolamide added to latanoprost in primary open-angle glaucoma subjects. Ophthalmology. 2005;112(4): 603–608. doi: 10.1016/j.ophtha.2004.11.032
29. Adkins JC, Balfour JA. Brimonidine. Drugs Aging. 1998;12(3): 225–241. doi: 10.2165/00002512-199812030-00005
30. Sullivan-Mee M, Pensyl D, Alldredge B, Halverson K, Gerhardt G, Qualls C. Brimonidine hypersensitivity when switching between 0.2% and 0.15% formulations. J Ocul Pharmacol Therap. 2010;26(4): 355–360. doi: 10.1089/jop.2009.0153
31. Donello JE, Padillo EU, Webster ML, Wheeler LA, Gil DW. Alpha(2)-adrenoceptor agonists inhibit vitreal glutamate and aspartate accumulation and preserve retinal function after transient ischemia. J Pharmacol Exp Ther. 2001;296(1): 216–223.
32. WoldeMussie E, Ruiz G, Wijono M, Wheeler LA. Neuroprotection of retinal ganglion cells by brimonidine in rats with laser-induced chronic ocular hypertension. Invest Ophthalmol Vis Sci. 2001;42(12): 2849–2855.
33. Mayor-Torroglosa S, Villa PD la, Rodríguez ME, López-Herrera MPL, Avilés-Trigueros M, García- Avilés A. Ischemia results 3 months later in altered ERG, degeneration of inner layers, and deafferented tectum: neuroprotection with brimonidine. Invest Ophthalmol Vis Sci. 2005;46(10): 3825–3835. doi: 10.1167/iovs.05-0392
34. Tsai J-C, Chang H-W. Comparison of the effects of brimonidine 0.2% and timolol 0.5% on retinal nerve fiber layer thickness in ocular hypertensive patients: a prospective, unmasked study. J Ocular Pharmacol Ther. 2005;21(6): 475–482. doi: 10.1089/jop.2005.21.475
35. Krupin T, Liebmann JM, Greenfield DS, Ritch R, Gardiner S. A randomized trial of brimonidine versus timolol in preserving visual function: results from the low-pressure glaucoma treatment study. Am J Ophthalmol. 2011;151(4): 671–681. doi: 10.1016/j.ajo.2010.09.026
36. Lee DA, Higginbotham EJ. Glaucoma and its treatment: a review. Am J Health Syst Pharm. 2005;62(7): 691–699. doi: 10.1093/ajhp/62.7.691
Fyodorov Journal of Ophthalmic Surgery. 2021; : 94-99
Efficacy and safety of various brimonidine formulations in the treatment of glaucoma and ocular hypertension
Sidorova A. V., Zhuravlev A. S., Starostina A. V., Eliseeva M. A.
https://doi.org/10.25276/0235-4160-2021-2-94-99Abstract
Purpose. To present data on the mechanism of action, efficacy, and side effects of various brimonidine dosage forms in the treatment of glaucoma and ocular hypertension.
Material and methods. To perform the review, literature sources were searched through the PubMed and Scopus databases up to and including 2021, using the keywords «brimonidine», «efficacy», «safety», «glaucoma medication». A total of 36 articles related to the topic of the review were selected. The beginning of publications on this topic dates back to 1995.
Results. Brimonidine, an alpha2-adrenoceptor agonist, effectively reduces intraocular pressure and can be used as monotherapy, adjuvant and replacement therapy. The effectiveness of brimonidine is similar to that of timolol and prevails over betaxolol but inferior to prostaglandin analogues. The new drug formulation brimonidine-purite 0.15% has a more favorable safety and tolerability profile than the original brimonidine 0.2% while maintaining similar efficacy. However, most patients require two or more hypotensive medications to maintain target IOP. In this context, brimonidine is one of the most appropriate drugs because of its pr oven efficacy when combined with other classes of hypotensive drugs.
Conclusion. Brimonidine can be used as monotherapy for glaucoma and ophthalmic hypertension. Experimental and clinical studies have shown a potential neuroprotective effect of brimonidine, which is associated with a direct effect on retinal cells, regardless of the effect of the drug on intraocular pressure.
References
1. Tham Y-C, Li X, Wong TY, Quigley HA, Aung T, Cheng C-Y. Global Prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11): 2081–2090. doi: 10.1016/j.ophtha.2014.05.013
2. Coleman AL, Miglior S. Risk factors for glaucoma onset and progression. Surv Ophthalmol. 2008;53(6):S310. doi: 10.1016/j.survophthal.2008.08.006
3. 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): 1268–1279. doi: 10.1001/archopht.120.10.1268
4. Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP. 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): 701–713; 829–830. doi: 10.1001/archopht.120.6.701
5. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Am J Ophthalmol. 1998;126(4): 487–497. doi: 10.1016/S0002-9394(98)00223-2
6. Hedman K, Alm A. A Pooled-Data Analysis of three randomized, double-masked, six-month clinical studies comparing the intraocular pressure reducing effect of latanoprost and timolol. Eur J Ophthalmol. 2000;10(2): 95–104. doi: 10.1177/112067210001000201
7. Cantor LB. Brimonidine in the treatment of glaucoma and ocular hypertension. Ther Clin Risk Manag. 2006;2(4): 337–346. doi: 10.2147/tcrm.2006.2.4.337
8. Alm A, Grierson I, Shields MB. Side effects associated with prostaglandin analog therapy. Surv Ophthalmol. 2008;53(6): S93–105. doi:10.1016/j.survophthal.2008.08.004
9. Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA. Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001;108(11): 1943–1953. doi: 10.1016/S0161-6420(01)00873-9
10. Walters TR. Development and use of brimonidine in treating acute and chronic elevations of intraocular pressure: A review of safety, efficacy, dose response, and dosing studies. Surv Ophthalmol. 1996;41: S19–26. doi: 10.1016/S0039-6257(96)82028-5
11. Toris CB, Gleason ML, Camras CB, Yablonski ME. Effects of brimonidine on aqueous humor dynamics in human eyes. Arch Ophthalmol. 1995;113(12): 1514–1517. doi: 10.1001/archopht.1995.01100120044006
12. Toris CB, Camras CB, Yablonski ME. Acute versus chronic effects of brimonidine on aqueous humor dynamics in ocular hypertensive patients. Am J Ophthalmol. 1999;128(1): 8–14. doi: 10.1016/S0002-9394(99)00076-8
13. Kesler A, Shemesh G, Rothkoff L, Lazar M. Effect of brimonidine tartrate 0.2% ophthalmic solution on pupil size. J Cataract Refract Surg. 2004;30(8): 1707–1710. doi: 10.1016/j.jcrs.2004.02.043
14. Niyadurupola N, Broadway DC. Pigment dispersion syndrome and pigmentary glaucoma – a major review. Clin Exp Ophthalmol. 2008;36(9): 868–882. doi: 10.1111/j.1442-9071.2009.01920.x
15. Acheampong AA, Shackleton M, John B, Burke J, Wheeler L, Tang-Liu D. Distribution of brimonidine into anterior and posterior tissues of monkey, rabbit, and rat Eyes. Drug Metab Dispos. 2002;30(4): 421–429. doi: 10.1124/dmd.30.4.421
16. Cantor LB. The evolving pharmacotherapeutic profile of brimonidine, an 2-adrenergic agonist, after four years of continuous use. Expert Opin Pharmacother. 2000;1(4): 815–834. doi: 10.1517/14656566.1.4.815
17. Schuman JS, Horwitz B, Choplin NT, David R, Albracht D, Chen K. A 1-Year study of brimonidine twice daily in glaucoma and ocular hypertension: A controlled, randomized, multicenter clinical trial. Arch Ophthalmol. 1997;115(7): 847–852. doi: 10.1001/archopht.1997.01100160017002
18. David R. Brimonidine (Alphagan®): A clinical profile four years after launch. Eur J Ophthalmol. 2001;11(2_suppl): 72–77. doi: 10.1177/112067210101102S10
19. Javitt J, Goldberg I. Comparison of the clinical success rates and quality of life effects of brimonidine tartrate 0.2% and betaxolol 0.25% suspension in patients with open-angle glaucoma and ocular hypertension. Brimonidine outcomes study group II. J Glaucoma. 2000;9(5): 398–408. doi: 10.1097/00061198-200010000-00009
20. Stewart WC, Sharpe ED, Harbin TS, Pastor SA, Day DG, Holmes KT. Brimonidine 0.2% versus dorzolamide 2% each given three times daily to reduce intraocular pressure. Am J Ophthalmol. 2000;129(6): 723–727. doi: 10.1016/S0002-9394(00)00381-0
21. Simmons ST. Efficacy of brimonidine 0.2% and dorzolamide 2% as adjunctive therapy to beta-blockers in adult patients with glaucoma or ocular hypertension. Clin Therap. 2001;23(4):604–619. doi: 10.1016/S0149-2918(01)80064-3
22. Carrasco FC, Arias Puente A, García Sáenz MC, Villarejo Díaz-Maroto I. Efficiency of brimonidine 0.2% and dorzolamide 2% as adjunctive therapy to beta-blockers. Arch Soc Esp Oftalmol. 2004;79(4): 163–168.
23. Noecker RJ, Herrygers LA, Anwaruddin R. Corneal and conjunctival changes caused by commonly used glaucoma medications. Cornea. 2004;23(5): 490–496. doi: 10.1097/01.ico.0000116526.57227.82
24. Bonniard AA, Yeung JY, Chan CC, Birt CM. Ocular surface toxicity from glaucoma topical medications and associated preservatives such as benzalkonium chloride (BAK). Expert Opin Drug Metab Toxicol. 2016;12(11): 1279–1289. doi: 10.1080/17425255.2016.1209481
25. Katz LJ. Twelve-month evaluation of brimonidine-purite versus brimonidine in patients with glaucoma or ocular hypertension. J Glaucoma. 2002;11(2): 119–126.
26. Dong JQ, Babusis DM, Welty DF, Acheampong AA, Tang-Liu D, Whitcup SM. Effects of the preservative Purite® on the bioavailability of brimonidine in the aqueous humor of rabbits. J Ocul Pharmacol Ther. 2004;20(4): 285–292. doi: 10.1089/1080768041725326
27. Mundorf T, Williams R, Whitcup S, Felix C, Batoosingh A. A 3-month comparison of efficacy and safety of brimonidine-Purite 0.15% and brimonidine 0.2% in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2003;19(1): 37–44. doi: 10.1089/108076803762718097
28. Konstas AGP, Karabatsas CH, Lallos N, Georgiadis N, Kotsimpou A, Stewart JA. 24-hour intraocular pressures with brimonidine Purite versus dorzolamide added to latanoprost in primary open-angle glaucoma subjects. Ophthalmology. 2005;112(4): 603–608. doi: 10.1016/j.ophtha.2004.11.032
29. Adkins JC, Balfour JA. Brimonidine. Drugs Aging. 1998;12(3): 225–241. doi: 10.2165/00002512-199812030-00005
30. Sullivan-Mee M, Pensyl D, Alldredge B, Halverson K, Gerhardt G, Qualls C. Brimonidine hypersensitivity when switching between 0.2% and 0.15% formulations. J Ocul Pharmacol Therap. 2010;26(4): 355–360. doi: 10.1089/jop.2009.0153
31. Donello JE, Padillo EU, Webster ML, Wheeler LA, Gil DW. Alpha(2)-adrenoceptor agonists inhibit vitreal glutamate and aspartate accumulation and preserve retinal function after transient ischemia. J Pharmacol Exp Ther. 2001;296(1): 216–223.
32. WoldeMussie E, Ruiz G, Wijono M, Wheeler LA. Neuroprotection of retinal ganglion cells by brimonidine in rats with laser-induced chronic ocular hypertension. Invest Ophthalmol Vis Sci. 2001;42(12): 2849–2855.
33. Mayor-Torroglosa S, Villa PD la, Rodríguez ME, López-Herrera MPL, Avilés-Trigueros M, García- Avilés A. Ischemia results 3 months later in altered ERG, degeneration of inner layers, and deafferented tectum: neuroprotection with brimonidine. Invest Ophthalmol Vis Sci. 2005;46(10): 3825–3835. doi: 10.1167/iovs.05-0392
34. Tsai J-C, Chang H-W. Comparison of the effects of brimonidine 0.2% and timolol 0.5% on retinal nerve fiber layer thickness in ocular hypertensive patients: a prospective, unmasked study. J Ocular Pharmacol Ther. 2005;21(6): 475–482. doi: 10.1089/jop.2005.21.475
35. Krupin T, Liebmann JM, Greenfield DS, Ritch R, Gardiner S. A randomized trial of brimonidine versus timolol in preserving visual function: results from the low-pressure glaucoma treatment study. Am J Ophthalmol. 2011;151(4): 671–681. doi: 10.1016/j.ajo.2010.09.026
36. Lee DA, Higginbotham EJ. Glaucoma and its treatment: a review. Am J Health Syst Pharm. 2005;62(7): 691–699. doi: 10.1093/ajhp/62.7.691
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