Effectiveness and safety of brimonidine as adjunctive therapy for patients with elevated intraocular pressure in a large, open-label community trial.

PURPOSE: To determine the effectiveness and safety of brimonidine when used in combination with one or more glaucoma medications in patients with glaucoma or ocular hypertension. METHODS: Post hoc analysis of a multicenter, 2-month, open-label, prospective, clinical trial in which 2,335 patients received brimonidine as monotherapy, replacement therapy, or combination therapy. Patients who received brimonidine as combination therapy (n = 554) were examined in the current analysis. Efficacy was determined by the reduction in intraocular pressure (IOP) from baseline before the addition of brimonidine. Safety and tolerability parameters included adverse events and quality-of-life measures (e.g., ocular comfort, energy level, breathing ability, night vision). RESULTS: Addition of brimonidine to preexisting regimens resulted in an overall mean additional reduction in IOP of 17.9% (4.26 mm Hg) at month 2 (P < 0.001). Significant additional IOP lowering was provided by brimonidine in combination with each preexisting regimen evaluated (P < or = 0.061). When brimonidine was added to monotherapy with a nonselective beta-blocker, the mean additional IOP reduction was 15.5% (3.61 mm Hg, P < 0.001). Addition of brimonidine to latanoprost monotherapy provided a 32.2% (5.89 mm Hg) mean additional IOP reduction (P < 0.001). Addition of brimonidine to combination regimens that included latanoprost provided additional mean decreases in LOP ranging from 15.5% (3.63 mm Hg, P < 0.002) to 20.1% (6.62 mm Hg, P < 0.001). All quality-of-life parameters remained high or improved during the study. Mild to moderate adverse events were reported in 5.23% of patients (29 of 552); 98.1% of physicians rated brimonidine adjunctive therapy as good or excellent. CONCLUSIONS: Brimonidine, when added to existing glaucoma regimens, safely and effectively lowered IOP in this community-based trial.