Preview

Russian Ophthalmological Journal

Advanced search

Adjunctive antihypertensive therapy of primary glaucoma with a fixed combination drug of 1% brinzolamide and 0.5% timolol: efficacy and safety

https://doi.org/10.21516/2072-0076-2023-16-2-67-73

Abstract

Purpose: a comparative study of the efficacy and safety of the combination drug Brinzopt Plus and the original drug Azarga used as adjunctive therapy in patients with primary open-angle glaucoma (POAG) previously treated with latanoprost.

Material and methods. 30 patients (42 eyes) with advanced and far advanced POAG were randomly divided into 2 groups of equal size. The patients of the main group (21 eyes) received Brinzopt Plus, those of the control group had the original drug Azarga, one instillation 2 times a day. The target points were intraocular pressure (IOP), visual acuity, perimetric indices (MD, PSD), mean retinal nerve fiber layer thickness, minimal neuroretinal rim width, retinal nerve fiber layer thickness in the macula, ganglion cell layer thickness in the macula, inner plexiform layer thickness, as well as the number of adverse events. The observation period was 12 weeks. IOP was measured at 4 and 12 weeks.

Results. After 2 weeks, both groups showed a statistically significant decrease in IOP, which remained stable after 4 and 12 weeks. The average decrease in IOP in Brinzopt Plus recipients was 25% and revealed no statistically significant differences with the original drug at any control point. A positive dynamic of visual acuity, static perimetry and optical coherence tomography values, which showed no significant intergroup differences, was recorded. Among the adverse events, manifestations of mild local discomfort were recorded in 4 out of 15 patients of the main group and in 3 out of 15 patients of the control group. No serious or systemic adverse events were noted.

Conclusion. Brinzopt Plus has an efficacy comparable to the original drug and a favorable safety profile.

About the Authors

S. Yu. Petrov
Helmholtz National Medical Research Center of Eye Diseases
Russian Federation

Sergey Yu. Petrov, Dr. of Med. Sci., head of glaucoma department,

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062



O. M. Kalinina
Helmholtz National Medical Research Center of Eye Diseases
Russian Federation

Olga M. Kalinina, Cand. of Med. Sci., head of glaucoma unit,

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062



L. V. Yakubova
Helmholtz National Medical Research Center of Eye Diseases
Russian Federation

Lia V. Yakubova, Cand. of Med. Sci., senior researcher, glaucoma department,

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062



S. M. Kosakyan
Helmholtz National Medical Research Center of Eye Diseases
Russian Federation

Srbui M. Kosakyan, Cand. of Med. Sci., ophthalmologist, glaucoma department,

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062



L. V. Vasilenkova
Helmholtz National Medical Research Center of Eye Diseases
Russian Federation

Ljubov V. Vasilenkova, Cand. of Med. Sci., researcher, glaucoma department,

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062



O. M. Filippova
Helmholtz National Medical Research Center of Eye Diseases
Russian Federation

Olga M. Filippova, Cand. of Med. Sci., researcher, glaucoma department,

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062



A. N. Zhuravleva
Helmholtz National Medical Research Center of Eye Diseases
Russian Federation

Anastasia N. Zhuravleva, Cand. of Med. Sci., researcher, glaucoma department,

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062



O. I. Markelova
Helmholtz National Medical Research Center of Eye Diseases
Russian Federation

Oksana I. Markelova, PhD student, glaucoma department,

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062



References

1. Delgado MF, Abdelrahman AM, Terahi M, et al. Management of glaucoma in developing countries: challenges and opportunities for improvement. Clinicoecon Outcomes Res. 2019; 11: 591–604. doi:10.2147/CEOR.S218277

2. Tham YC, Li X, Wong TY, et al. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014; 121 (11): 2081–90. doi:10.1016/j.ophtha.2014.05.013

3. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006; 90 (3): 262–7. doi:10.1136/ bjo.2005.081224

4. Neroev V.V., Mikhailova L.A. Ophthalmic morbidity in Russia. In: Ophthalmology. National Guidelines. Avetisov S.E., Egorov E.A., Moshetova L.K., Takhchidi Kh.P., eds. Moscow: GEOTAR-Media; 2018: 15–9 (In Russ.).

5. Peters D, Bengtsson B, Heijl A Factors associated with lifetime risk of openangle glaucoma blindness. Acta Ophthalmol. 2014; 92 (5): 421–5. doi:10.1111/aos.12203

6. Primary open angle glaucoma. Clinical Guidelines. Moscow; 2020 (In Russ.).

7. Kalouda P, Keskini C, Anastasopoulos E, Topouzis F. Achievements and limits of current medical therapy of glaucoma. Dev Ophthalmol. 2017; 59: 1–14. doi:10.1159/000458482

8. Hommer A, Hubatsch DA, Cano-Parra J Safety and efficacy of adding fixedcombination Brinzolamide/Timolol Maleate to prostaglandin therapy for treatment of ocular hypertension or glaucoma. J Ophthalmol. 2015: 131970. doi:10.1155/2015/131970

9. Lanzl I, Raber T Efficacy and tolerability of the fixed combination of brinzolamide 1% and timolol 0.5 % in daily practice. Clin Ophthalmol. 2011; 5: 291–8. doi:10.2147/OPTH.S16355

10. Lorenz K, Rosbach K, Matt A, Pfeiffer N. Addition of a fixed combination of brinzolamide 1 % / timolol 0.5 % to prostaglandin monotherapy in patients with glaucoma or ocular hypertension. Clin Ophthalmol. 2011; 5: 1745–50. doi:10.2147/OPTH.S25987

11. Shimizu Y, Nakakura S, Nishiyama M, Tabuchi H, Kiuchi Y. Efficiency, safety, and patient preference of switching from dorzolamide 1 % / timolol 0.5 % to brinzolamide 1 % / timolol 0.5 % while maintaining the prostaglandin F2-alpha analog. Clin Ophthalmol. 2015; 9: 475–82. doi:10.2147/OPTH.S79680

12. 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. doi:10.2165/00002512-200825090-00002

13. Hollo G, Topouzis F, Fechtner RD. Fixed-combination intraocular pressurelowering therapy for glaucoma and ocular hypertension: advantages in clinical practice. Expert Opin Pharmacother. 2014; 15 (12): 1737–47. doi:10.1517/146 56566.2014.936850

14. Hommer A, Hubatsch DA, Cano-Parra J. Safety and efficacy of adding fixedcombination Brinzolamide/Timolol Maleate to prostaglandin therapy for treatment of ocular hypertension or glaucoma. J Ophthalmol. 2015: 131970. doi:10.1155/2015/131970

15. Konstas AG, Hollo G, Haidich AB, et al. Comparison of 24-hour intraocular pressure reduction obtained with brinzolamide/timolol or brimonidine/timolol fixed-combination adjunctive to travoprost therapy. J Ocul Pharmacol Ther. 2013; 29 (7): 652–7. doi:10.1089/jop.2012.0195

16. Instruction for Azarga medical using. (In Russ.). Available at: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=19efb292-37fc-4218-9446-bbe9f285a614 (accessed 20.01.2023).

17. Instruction for Brinzopt Plus medical using (In Russ.). Available at: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=cea045f4-a085-4630-9ee5-9d99cebd2c3e (accessed 20.01.2023).

18. On the Circulation of Medicines. Federal Law. 12.04.2010 № 61-FZ (with change 11/06/2021) (In Russ.). Available at: http://www.consultant.ru/document/cons_doc_LAW_99350/

19. Decision of the Council of the Eurasian Economic Commission “On the Rules for Registration and Expertise of Medicines for Medical Use” of 03.11.2016 № 78 (ed 23.04.2021); (changed and supplemented 06.10.2021) (In Russ.). Available at: http://www.consultant.ru/document/cons_doc_LAW_207379/


Review

For citations:


Petrov S.Yu., Kalinina O.M., Yakubova L.V., Kosakyan S.M., Vasilenkova L.V., Filippova O.M., Zhuravleva A.N., Markelova O.I. Adjunctive antihypertensive therapy of primary glaucoma with a fixed combination drug of 1% brinzolamide and 0.5% timolol: efficacy and safety. Russian Ophthalmological Journal. 2023;16(2):67-73. (In Russ.) https://doi.org/10.21516/2072-0076-2023-16-2-67-73

Views: 1035


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2072-0076 (Print)
ISSN 2587-5760 (Online)