Efficacy and safety of a fixed combination of 1% brinzolamide and 0.1% brimonidine as treatment for glaucoma: a retrospective study focusing on the number of ingredients

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Abstract

Objective

To evaluate the intraocular pressure (IOP)-lowering effect based on the number of ingredients and survival rate due to adverse reactions of brinzolamide (1%)/brimonidine (0.1%) fixed combination (BBFC).

Methods and analysis

Among 424 patients newly administered BBFC from June 2020 to May 2021, 406 were retrospectively evaluated for adverse reactions and 299 were evaluated for the IOP-lowering effect of BBFC. Among those evaluated for IOP, group A (n=86) included patients whose treatment was changed to BBFC from other two ingredients, Group B (n=90) included patients who added one ingredient by switching to BBFC, and group C (n=123) included patients who added BBFC in addition to other drugs.

Results

The mean IOP (mm Hg) at BBFC initiation and at 3, 6 and 12 months after BBFC initiation was 14.1, 14.0, 14.3 and 13.8 in group A, 15.9, 14.4, 13.8 and 14.5 in group B and 17.2, 14.0, 14.1 and 14.9 in group C, respectively. Group A showed no significant difference in mean IOP from baseline to any time point after BBFC initiation, whereas groups B and C showed significant IOP reductions at all time points. Seventy-three (18%) patients discontinued treatment due to adverse reactions. The survival rate was 72% at 12 months after the start of BBFC when discontinuation due to adverse reactions was defined as failure.

Conclusion

Using BBFC, sustained IOP or decreasing IOP were observed depending on the number of ingredients. Drop-outs due to the adverse reactions should also be given attention.

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Most cited references 23

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Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial.

Anders Heijl, M. Leske, Bo Bengtsson … (2002)

To provide the results of the Early Manifest Glaucoma Trial, which compared the effect of immediately lowering the intraocular pressure (IOP), vs no treatment or later treatment, on the progression of newly detected open-angle glaucoma. Randomized clinical trial. Two hundred fifty-five patients aged 50 to 80 years (median, 68 years) with early glaucoma, visual field defects (median mean deviation, -4 dB), and a median IOP of 20 mm Hg, mainly identified through a population screening. Patients with an IOP greater than 30 mm Hg or advanced visual field loss were ineligible. Patients were randomized to either laser trabeculoplasty plus topical betaxolol hydrochloride (n = 129) or no initial treatment (n = 126). Study visits included Humphrey Full Threshold 30-2 visual field tests and tonometry every 3 months, and optic disc photography every 6 months. Decisions regarding treatment were made jointly with the patient when progression occurred and thereafter. Glaucoma progression was defined by specific visual field and optic disc outcomes. Criteria for perimetric progression were computer based and defined as the same 3 or more test point locations showing significant deterioration from baseline in glaucoma change probability maps from 3 consecutive tests. Optic disc progression was determined by masked graders using flicker chronoscopy plus side-by-side photogradings. After a median follow-up period of 6 years (range, 51-102 months), retention was excellent, with only 6 patients lost to follow-up for reasons other than death. On average, treatment reduced the IOP by 5.1 mm Hg or 25%, a reduction maintained throughout follow-up. Progression was less frequent in the treatment group (58/129; 45%) than in controls (78/126; 62%) (P =.007) and occurred significantly later in treated patients. Treatment effects were also evident when stratifying patients by median IOP, mean deviation, and age as well as exfoliation status. Although patients reported few systemic or ocular conditions, increases in clinical nuclear lens opacity gradings were associated with treatment (P =.002). The Early Manifest Glaucoma Trial is the first adequately powered randomized trial with an untreated control arm to evaluate the effects of IOP reduction in patients with open-angle glaucoma who have elevated and normal IOP. Its intent-to-treat analysis showed considerable beneficial effects of treatment that significantly delayed progression. Whereas progression varied across patient categories, treatment effects were present in both older and younger patients, high- and normal-tension glaucoma, and eyes with less and greater visual field loss.

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The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma.

Richard Miller, D Heuer, Janet Parrish … (2002)

Primary open-angle glaucoma (POAG) is one of the leading causes of blindness in the United States and worldwide. Three to 6 million people in the United States are at increased risk for developing POAG because of elevated intraocular pressure (IOP), or ocular hypertension. There is no consensus on the efficacy of medical treatment in delaying or preventing the onset of POAG in individuals with elevated IOP. Therefore, we designed a randomized clinical trial, the Ocular Hypertension Treatment Study. To determine the safety and efficacy of topical ocular hypotensive medication in delaying or preventing the onset of POAG. A total of 1636 participants with no evidence of glaucomatous damage, aged 40 to 80 years, and with an IOP between 24 mm Hg and 32 mm Hg in one eye and between 21 mm Hg and 32 mm Hg in the other eye were randomized to either observation or treatment with commercially available topical ocular hypotensive medication. The goal in the medication group was to reduce the IOP by 20% or more and to reach an IOP of 24 mm Hg or less. The primary outcome was the development of reproducible visual field abnormality or reproducible optic disc deterioration attributed to POAG. Abnormalities were determined by masked certified readers at the reading centers, and attribution to POAG was decided by the masked Endpoint Committee. During the course of the study, the mean +/- SD reduction in IOP in the medication group was 22.5% +/- 9.9%. The IOP declined by 4.0% +/- 11.6% in the observation group. At 60 months, the cumulative probability of developing POAG was 4.4% in the medication group and 9.5% in the observation group (hazard ratio, 0.40; 95% confidence interval, 0.27-0.59; P<.0001). There was little evidence of increased systemic or ocular risk associated with ocular hypotensive medication. Topical ocular hypotensive medication was effective in delaying or preventing the onset of POAG in individuals with elevated IOP. Although this does not imply that all patients with borderline or elevated IOP should receive medication, clinicians should consider initiating treatment for individuals with ocular hypertension who are at moderate or high risk for developing POAG.

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Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Collaborative Normal-Tension Glaucoma Study Group.

(1998)

To determine if intraocular pressure plays a part in the pathogenic process of normal-tension glaucoma. One eye of each eligible subject was randomized either to be untreated as a control or to have intraocular pressure lowered by 30% from baseline. Eyes were randomized if they met criteria for diagnosis of normal-tension glaucoma and showed documented progression or high-risk field defects that threatened fixation or the appearance of a new disk hemorrhage. The clinical course (visual field and optic disk) of the group with lowered intraocular pressure was compared with the clinical course when intraocular pressure remained at its spontaneous untreated level. One hundred-forty eyes of 140 patients were used in this study. Sixty-one were in the treatment group, and 79 were untreated controls. Twenty-eight (35%) of the control eyes and 7 (12%) of the treated eyes reached end points (specifically defined criteria of glaucomatous optic disk progression or visual field loss). An overall survival analysis showed a statistically significant difference between the two groups (P < .0001). The mean survival time +/-SD of the treated group was 2,688 +/- 123 days and for the control group, 1,695 +/- 143 days. Of 34 cataracts developed during the study, 11 (14%) occurred in the control group and 23 (38%) in the treated group (P = .0075), with the highest incidence in those whose treatment included filtration surgery. Intraocular pressure is part of the pathogenic process in normal-tension glaucoma. Therapy that is effective in lowering intraocular pressure and free of adverse effects would be expected to be beneficial in patients who are at risk of disease progression.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open Ophthalmol

Journal ID (iso-abbrev): BMJ Open Ophthalmol

Journal ID (hwp): bmjophth

Journal ID (publisher-id): bmjophth

Title: BMJ Open Ophthalmology

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2397-3269

Publication date Collection: 2022

Publication date (Electronic): 30 December 2022

Volume: 7

Issue: 1

Electronic Location Identifier: e001200

Affiliations

[1]departmentDepartment of Ophthalmology , Saneikai Tsukazaki Hospital , Himeji, Japan

Author notes

[Correspondence to ] Dr Ryota Aoki; r.aoki@ 123456tsukazaki-eye.net

Author information

Ryota Aoki http://orcid.org/0000-0003-0934-8866

Shunsuke Nakakura http://orcid.org/0000-0002-1094-1862

Article

Publisher ID: bmjophth-2022-001200

DOI: 10.1136/bmjophth-2022-001200

PMC ID: 9809237

SO-VID: de912bf0-9bd2-40af-801a-1b72669431e1

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 01 November 2022

Date accepted : 21 December 2022

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Keywords: glaucoma,intraocular pressure

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Keywords: glaucoma, intraocular pressure

Efficacy and safety of a fixed combination of 1% brinzolamide and 0.1% brimonidine as treatment for glaucoma: a retrospective study focusing on the number of ingredients

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Karger: Ophthalmology

Most cited references 23

Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial.

The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma.

Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Collaborative Normal-Tension Glaucoma Study Group.

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