This paper is only available as a PDF. To read, Please Download here.
Abstract
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, doublemasked
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.
Key words
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical TherapeuticsAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Adverse reactions from timolol administration.Ophthalmology. 1980; 87: 447-450
- Adverse respiratory and cardiovascular events attributed to timolol ophthalmic solution, 1978–1985.Am J Ophthalmol. 1986; 102: 606-611
- Ocular beta-blockers and systemic effects.Am J Ophthalmol. 1994; 98: 623-624
- Medical treatment of glaucoma—a reappraisal of the risks.Br J Ophthalmol. 1996; 80: 85-89
- Systemic adverse effects of topical ophthalmic agents. Implications tor older patients.Drugs Aging. 1997; 11: 352-360
- Psychiatric side effects from topical ocular timolol, a beta-adrenergic blocker.J Clin Psychopharmacol. 1987; 7: 264-267
- Changes in depressive status associated with topical beta-blockers.Int Ophthalmol. 1992; 16: 331-335
- Short-term “escape” long-term “drift.” The dissipation effects of the beta-adrenergic blocking agents.Surv Ophthalmol. 1983; 28: 235-240
- Efficacy of combining timolol with other antiglaucoma medications.Surv Ophthalmol. 1983; 28: 274-279
- Drug evaluation: Brimonidine.Expert Opin Invest Drugs. 1997; 6: 1063-1083
- Data on file. Allergan, Inc., Irvine, Calif1999
- The cardiovascular pulmonary ocular hypotensive effects of 0.2% brimonidine.Arch Ophthalmol. 1995; 113: 77-83
- Development and use of brimonidine in treating acute and chronic elevations of intraocular pressure: A review of safety, efficacy, dose response, and dosing studies.Surv Ophthalmol. 1996; 41: S19-S26
- A comparison of the safety efficacy of twice daily brimonidine 0.2% versus betaxolol 0.2 5% in subjects with elevated intraocular pressure.Surv Ophthalmol. 1996; 41: S39-S47
- Clinical experience with brimonidine 0.2% timolol 0.5% in glaucoma and ocular hypertension.Surv Ophthalmol. 1996; 41: S27-S37
- A 1-year study of brimonidine twice daily in glaucoma ocular hypertension. A controlled, randomized, multicenter clinical trial.Arch Ophthalmol. 1997; 115: 847-852
- Twelve-month results of an ongoing randomized trial comparing brimonidine tartrate 0.2% and timolol 0.5% given twice daily in patients with glaucoma or ocular hypertension.Ophthalmology. 1998; 105: 1960-1967
- Brimonidine tartrate 0.2% twice daily vs timolol 0.5% twice daily: 1-year results in glaucoma patients.Am J Opthalmol. 1999; 127: 20-26
- The clinical success rate and quality of life assessment of brimonidine tartrate 0.2% compared with timolol 0.5%, administered twice-daily, in patients with previously untreated open-angle glaucoma or ocular hypertension.Invest Ophthalmol Vis Sci. 1997; 38 (Suppl) (Abstract 3363): S729
- Brimonidine 0.2% versus betaxolol 0.25% as measured by the clinical success rate and quality of life effects in patients with glaucoma or ocular hypertension.Invest Ophthalmol Vis Sci. 1998; 39 (Suppl) (Abstract 941): S200
- Pavan-Langton D 3rd ed. Manual of Ocular Diagnosis and Therapy. Little, Brown and Company, Boston1991: 16-17
- A long-term clinical trial of timolol therapy versus no treatment in the management of glaucoma suspects.Ophthalmology. 1989; 96: 1460-1467
- A retrospective examination of druginduced allergy to Alphagan and a proposal for a new reporting system.Invest Ophthalmol Vis Sci. 1999; 40 (Suppl) (Abstract 2718): S515
Article info
Publication history
Accepted:
December 15,
1999
Identification
Copyright
© 2000 Published by Elsevier Inc.
