TY - JOUR
T1 - Ongoing clinical assessment of the safety profile and efficacy of brimonidine compared with timolol
T2 - Year-three results
AU - Melamed, Shlomo
AU - David, Robert
N1 - Funding Information:
This study was supported by Allergan, Inc., Irvine, California. Neither Shlomo Melamed, MD, nor any member of the Brimonidine Study Group II has a proprietary interest in brimonidine or in its manufacturer. The study group members were: Cecil C. Beehler, MD, Fort Myers, Florida; Stephen Blaydes, MD, Bluefield, West Virginia; David L. Cooke, MD, St. Joseph, Michigan; Monte S. Dirks, MD, Denver,
PY - 2000
Y1 - 2000
N2 - 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.
AB - 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.
KW - Brimonidine
KW - Glaucoma
KW - Ocular hypertension
KW - Timolol
KW - Visual fields
UR - http://www.scopus.com/inward/record.url?scp=0033965538&partnerID=8YFLogxK
U2 - 10.1016/S0149-2918(00)87981-3
DO - 10.1016/S0149-2918(00)87981-3
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AN - SCOPUS:0033965538
SN - 0149-2918
VL - 22
SP - 103
EP - 111
JO - Clinical Therapeutics
JF - Clinical Therapeutics
IS - 1
ER -