Clinical success and quality of life with brimonidine 0.2% or timolol 0.5% used twice daily in glaucoma or ocular t hypertension: a randomized clinical trial. Brimonidine Outcomes Study Group I.
OBJECTIVE
To compare the clinical success rates and quality of life impact of brimonidine 0.2% with timolol 0.5% in newly diagnosed patients naive to glaucoma therapy.


METHODS
A prospective, multicenter, randomized, double-masked, clinical effectiveness trial in which the clinical outcomes of twice daily brimonidine tartrate 0.2% were compared with those of timolol maleate 0.5% in patients with glaucoma and' ocular hypertension was conducted. Two hundred nineteen patients were enrolled--111 in the brimonidine group and 108 in the timolol group. Patients instilled their study medications twice daily for 4 months. Factors for determining clinical success were reduction of intraocular pressure (IOP), safety, and adverse events. Quality of life effects were assessed with the SF-36 Health Survey and Glaucoma Disability Index questionnaires.


RESULTS
Clinical success was 71% (75/106) with brimonidine and 70% (73/105) with timolol as initial treatment. The overall mean decrease in IOP was 6.5 mm Hg with brimonidine and 6.2 mm Hg with timolol. Few patients reported a specific adverse event and, with the exception of a slightly higher rate of ocular burning and stinging in the brimonidine group, there were no significant between-group differences. No significant chronotropic effects on the heart were seen with brimonidine, while small but significant mean decreases in heart rate were seen at months 1 and 4 with timolol. Mean systolic and diastolic blood pressure remained relatively stable in both groups. Quality of life remained stable, with no significant between-group differences.


CONCLUSIONS
As a first-line agent for the treatment of glaucoma and ocular hypertension, brimonidine has clinical effectiveness equivalent to timolol, but with less chronotropic effect on the heart. Brimonidine is a viable alternative to timolol for first-line therapy in glaucoma and ocular hypertension.
Javitt
J C
JC
Department of Ophthalmology, Georgetown University Medical Center, Washington, DC, USA.
Schiffman
R M
RM
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; D001794:Blood Pressure / Q000187:drug effects; D000068438:Brimonidine Tartrate; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D005901:Glaucoma / Q000188:drug therapy*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D011788:Quality of Life; D011810:Quinoxalines / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D011795:Surveys and Questionnaires; D013999:Timolol / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D000319:Adrenergic beta-Antagonists; D009883:Ophthalmic Solutions; D011810:Quinoxalines; D000068438:Brimonidine Tartrate; D013999:Timolol