Comparison of the clinical success rates and quality of life effects of brimonidine tartrate 0.2% and betaxolol 0.25% suspension in patients with open-angle glaucoma and ocular hypertension. Brimonidine Outcomes Study Group II.
OBJECTIVE
To compare the clinical effectiveness and the impact on quality of life of twice-daily brimonidine 0.2% with those of twice-daily betaxolol 0.25% in patients with glaucoma or ocular hypertension.


METHODS
A prospective, double-masked, randomized, comparative, multicenter, 4-month "real-life" clinical trial involving 188 patients. Medications were instilled twice daily. Efficacy was determined through measurement of intraocular pressure; safety and tolerability were measured using reports of adverse events, a quality of life survey (Glaucoma Disability Index), heart rate, and blood pressure. Patients with an inadequate response in intraocular pressure after 1 month or those who experienced significant adverse events in the first month were switched to the alternative study arm and remained taking the alternative medication for a total of 4 months or left the study. The main outcome measure was clinical success, as determined by evaluation of the efficacy, safety, and tolerability of drug treatment, and was achieved when the investigator recommended that the patient continue the treatment after completion of the study.


RESULTS
As initial therapy, clinical success was achieved in 74% of patients treated with brimonidine, as compared with 57% of patients treated with betaxolol (P = 0.027). The overall mean decrease in intraocular pressure from baseline was 5.9 mm Hg with brimonidine and 3.8 mm Hg with betaxolol. Both treatments were well tolerated, and there were no significant between-group differences in the incidence of adverse events or in the quality of life summary scores.


CONCLUSIONS
Twice-daily brimonidine 0.2% and betaxolol 0.25% suspension were safe and effective as first-line therapy for glaucoma and ocular hypertension. In this study, brimonidine showed clinical effectiveness superior to that of betaxolol.
Javitt
J
J
Department of Ophthalmology, Georgetown University Medical Center, Washington, DC, USA.
Goldberg
I
I
D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015784:Betaxolol / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure; D000068438:Brimonidine Tartrate; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006339:Heart Rate; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D011788:Quality of Life; D011810:Quinoxalines / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D013535:Suspensions; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D000319:Adrenergic beta-Antagonists; D009883:Ophthalmic Solutions; D011810:Quinoxalines; D013535:Suspensions; D000068438:Brimonidine Tartrate; D015784:Betaxolol