ABSTRACT
BACKGROUND: Brimonidine tartrate 0.2%, a selective alpha2-adrenergic receptor agonist, and betaxolol 0.25% suspension, a cardioselective beta1-adrenergic receptor antagonist, are used in the treatment of elevated intraocular pressure (IOP). OBJECTIVE: This study compared the clinical success and quality-of-life impact of 4 weeks of treatment with brimonidine 0.2% BID compared with those of 4 weeks of treatment with betaxolol 0.25% suspension BID in patients with elevated IOP. METHODS: This was a multisite, double-masked, comparative clinical trial in patients with glaucoma or ocular hypertension. Patients were randomly assigned to receive either brimonidine or betaxolol BID. Morning IOP was measured at baseline and at weeks 1 and 4 using Goldmann applanation. Efficacy was determined by reduction in IOP from baseline. Patients experiencing a > or =20% reduction in IOP were considered to have a successful IOP-lowering response. The Glaucoma Disability Index questionnaire was administered at week 4 to assess quality-of-life factors and the incidence of adverse events. Ophthalmic examinations were conducted at each visit. RESULTS: One hundred fifty-nine patients were randomized to treatment and completed the study, 81 receiving brimonidine and 78 receiving betaxolol. The majority were white (77.4%) and female (61.6%), and had a diagnosis of open-angle glaucoma (56.0%). After 4 weeks of treatment, both brimonidine and betaxolol effectively lowered IOP from baseline (mean IOP reductions: brimonidine, 5.96 mm Hg; betaxolol, 5.07 mm Hg; P = NS). However, a significantly higher percentage of brimonidine patients (52/81 [64.2%]) than betaxolol patients (37/78 [47.4%]) had a > or =20% reduction in IOP (P = 0.033). No serious adverse events were reported with either study medication. On the quality-of-life assessments, more betaxolol patients reported hyperemia (P = 0.011), and the reported hyperemia was significantly more severe in betaxolol patients (P = 0.009). CONCLUSIONS: After 4 weeks of treatment, brimonidine 0.2% BID was clinically successful in significantly more patients and was better tolerated than 4 weeks of treatment with betaxolol 0.25% BID in this population.
