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. Glaucoma Trial Study Group.
The purpose of this study was to determine the effectiveness and safety of brimonidine 0.2% (Alphagan, Allergan Inc., Irvine, CA) as mono-, combination, or replacement therapy for reducing intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. The study method was an open-label, comparative clinical evaluation involving 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 were 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 evaluate adverse events and the change in IOP from visit 1 to visit 3. Patient data were grouped according to specific drug regimen, and drug regimens were categorized into supergroups of mono-, combination, and replacement therapy. 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 -2.33 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 "excellent". In conclusion, brimonidine is safe and effectively lowers IOP when used as mono-, combination, or replacement therapy as observed in a large community population.
Lee
D A
DA
Department of Ophthalmology, University of California, Los Angeles, School of Medicine, Jules Stein Eye Institute, 90095-7004, USA. leeda@jsei.ucla.edu
Gornbein
J
J
Abrams
C
C
D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000068438:Brimonidine Tartrate; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D011810:Quinoxalines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000316:Adrenergic alpha-Agonists; D011810:Quinoxalines; D000068438:Brimonidine Tartrate