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Fixed combination lowers IOP better than monotherapy
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A fixed combination of brinzolamide 1% and brimonidine 0.2% was more effective than brimonidine or brinzolamide alone in lowering intraocular pressure, according to a recent study published in Ophthalmology.
Aung and colleagues conducted a randomized, multicenter, double-masked clinical trial of 560 patients with primary open-angle glaucoma or ocular hypertension over 6 months.
As detailed in the study, the patients either had an uncontrolled IOP or were taking at least two medications that were lowering their IOP.
Throughout the study, the researchers measured IOP, blood pressure, pulse, best-corrected visual acuity and ocular signs and also noted reports from the participants regarding adverse events and serious adverse events.
Participants were dosed twice a day: 193 with brinzolamide 1% and brimonidine 0.2% fixed combination, 192 with brinzolamide 1% monotherapy and 175 with brimonidine 0.2% monotherapy.
Results showed that, at 3 months, the brinzolamide 1% and brimonidine 0.2% fixed combination lowered mean diurnal IOP more than brinzolamide or brimonidine monotherapy. The fixed combination therapy showed an IOP change of 7.9 mm Hg, while brinzolamide and brimonidine showed an IOP change of 6.5 mm Hg and 6.4 mm Hg, respectively. Throughout the study, participants in the brinzolamide 1% and brimonidine 0.2% fixed combination group saw a mean percentage IOP reduction from baseline of 26.7% to 36.0% while participants in the brinzolamide and brimonidine groups saw 22.4% to 27.9% and 20.6% to 31.3%, respectively.
Additionally, researchers found the incidences of severe adverse effects to be similar among all three groups.
The researchers noted that fixed combination medications may provide greater benefits than taking several medications simultaneously, including an easier dosing regimen, no washout and decreased exposure to preservatives.
“The safety and IOP-lowering efficacy provided by two-times-per-day dosing of brinzolamide 1% and brimonidine 0.2% fixed combination may be advantageous to patients with an inadequate response to monotherapy or in whom β-blockers are contraindicated, especially those who would benefit from a less complex medication schedule,” the researchers concluded.
Disclosures: Aung has received grant support from Alcon, Allergan, Santen, Ellex and Ocular Therapeutix; consulting fees from Alcon, Allergan, Santen, Pfizer, Merck Sharp & Dohme, Bausch + Lomb and Quark; and travel support from Alcon, Allergan, Santen, Pfizer and Ellex. Goldberg is a consultant and advisory board member for Alcon, Allergan, ForSight, Merck and Pfizer; on the speakers bureau for Alcon; and has received travel support from Alcon and Pfizer. The other authors have no relevant financial disclosures.
Perspective
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Blair Lonsberry, MS, OD, MEd, FAAO
This study evaluates the safety and IOP-lowering efficacy of brinzolamide 1% and brimonidine 0.2% fixed combination (BBFC) administered twice a day compared with each of its individual active components. In the U.S., the currently approved dosing for the fixed combination is three times a day, although a twice daily dosing regimen is approved in the European Union and most countries.
Despite the recommendation for three-times-a-day dosing, most glaucoma practitioners recommend twice daily dosing to their patients, so this study provides important data to validate what is done in real-world practice. An increased efficacy of the fixed combination was noted vs. monotherapy (IOP lowering for twice daily dosing was similar to the previously published data for three times daily dosing), and the safety profile was consistent with the known safety profile of each of its individual components.
There are definite advantages to using fixed-combination products (e.g., improved compliance, less potential exposure to preservatives, reduced chance of second drop washout) ,and this study demonstrates that a more convenient dosing regimen of twice daily still maintains IOP lowering efficacy and potentially makes the primary obstacle of three times daily dosing less of a concern.
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