The effectiveness and safety of brimonidine as mono-, combination, or replacement therapy for patients with primary open-angle glaucoma or ocular hypertension: A post hoc analysis of an open-label community trial
Da. Lee et al., The effectiveness and safety of brimonidine as mono-, combination, or replacement therapy for patients with primary open-angle glaucoma or ocular hypertension: A post hoc analysis of an open-label community trial, J OCUL PH T, 16(1), 2000, pp. 3-18
The purpose of this study was to determine the effectiveness and safety of
brimonidine 0.2% (Alphagan((R)), Allergan Inc., Irvine, CA) as mono-, combi
nation, or replacement therapy for reducing intraocular pressure (IOP) in p
atients with primary open-angle glaucoma or ocular hypertension.
The study method was an open-label, comparative clinical evaluation involvi
ng 2335 patients. During the 2-month trial, data were collected at baseline
(visit 1), month 1 (visit 2), and month 2 (visit 3). Various parameters we
re evaluated, including glaucoma medications (visit 1), IOP (visit 1- visit
3), and adverse events. A subset cohort of 1254 patients was selected that
met specific study criteria. Data from these 1254 patients were used to ev
aluate adverse events and the change in IOP from visit 1 to visit 3, Patien
t data were grouped according to specific drug regimen, and drug regimens w
ere categorized into supergroups of mono-, combination, and replacement the
rapy.
The results of the study revealed that the overall mean change in IOP for 1
) monotherapy (n = 240) was -5.07 mm Hg (-20.2%), 2) combination therapy (n
= 554) was -4.01 mm Hg (-16.9%), 3) replacement therapy (n = 460) was -2.3
3 mm Hg (-9.8%), and 4) overall (n = 1254) was -3.59 mm Hg (-14.9%) (p < 0.
001 for all changes). Overall, 6.0% of the subjects reported adverse events
, with no hypersensitivity or unexpected systemic or ocular adverse events.
Eighty-five percent (85 %) of clinicians rated brimonidine as "good" to "e
xcellent".
In conclusion, brimonidine is safe and effectively lowers IOP when used as
mono-, combination, or replacement therapy as observed in a large community
population.