Ongoing clinical assessment of the safety profile and efficacy of brimonidine compared with timolol: year-three results. Brimonidine Study Group II.
OBJECTIVE
We compared the safety profile and efficacy of brimonidine 0.2% BID with those of timolol 0.5% BID over 3 years in patients with ocular hypertension and glaucoma.


METHODS
Ninety-four eligible patients from an ongoing multicenter, interventional, double-masked clinical trial were followed through year 3, 48 receiving brimonidine 0.2% and 46 receiving timolol 0.5%. Study visits occurred at months 24, 27, 30, 33, and 36. The primary efficacy variable was mean reduction from baseline intraocular pressure (IOP) at trough. Visual acuity, visual fields, and safety variables (adverse events, ocular symptoms, heart rate, blood pressure, and laboratory test results) were monitored throughout the study.


RESULTS
The 2 treatment groups were well matched, with no significant differences in demographic or clinical characteristics. Both drug regimens caused significant mean reductions from baseline IOP at trough during year 3 (P < 0.001), with no significant differences between groups at any study visit. The overall mean reduction from baseline IOP at trough was 5.02 mm Hg with brimonidine and 5.57 mm Hg with timolol (P = 0.383). Brimonidine caused reductions in IOP at trough that were equivalent to those with timolol at months 30 and 36 (within the 95% CI). Visual fields were unchanged or improved in 95% of patients in both treatment groups. Both drug regimens appeared to be safe and were well tolerated. Ocular allergy occurred in 2 brimonidine-treated patients (4.2%). There were no statistically significant differences in adverse-event reports and no clinically significant effects on any ocular or systemic safety variable in either group.


CONCLUSIONS
Brimonidine 0.2% BID continues to appear to be safe, well tolerated, and effective in the long-term management of ocular hypertension and glaucoma. Over 3 years, it provided sustained IOP-lowering efficacy and visual-field preservation equal to those with timolol 0.5% BID.
Melamed
S
S
Sam Rothberg Glaucoma Center, Goldshleger Eye Institute, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
David
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R
D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000009:adverse effects* / 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; D005260:Female; D005901:Glaucoma / Q000188:drug therapy*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D011810:Quinoxalines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D013999:Timolol / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D014787:Vision Tests
D000316:Adrenergic alpha-Agonists; D000319:Adrenergic beta-Antagonists; D011810:Quinoxalines; D000068438:Brimonidine Tartrate; D013999:Timolol