Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension
Katrin Lorenz, Klaus Rosbach, Andreas Matt, Norbert Pfeiffer, Katrin Lorenz, Klaus Rosbach, Andreas Matt, Norbert Pfeiffer
Abstract
Background: This study was conducted to evaluate the safety and efficacy of adding a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin analog (PGA) monotherapy in patients with primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension who require additional intraocular pressure (IOP) reduction.
Methods: This was a prospective, multicenter (n = 5), open-label, single-arm, Phase IV clinical trial in which patients currently being treated with a PGA but requiring additional IOP reduction were administered brinzolamide 1%/timolol 0.5% twice daily as adjunctive therapy to their current PGA monotherapy regimen. The primary objective was to examine the IOP-lowering efficacy of brinzolamide-timolol when used as adjunctive therapy.
Results: Forty-seven patients enrolled in and completed the study. After 12 weeks of adjunctive brinzolamide-timolol therapy, the mean IOP of the total patient population decreased from 22.1 mmHg at baseline to 16.7 mmHg. The mean IOP reduction of 5.4 mmHg (24.4%) was both clinically and statistically significant (P < 0.001). This significant decrease in mean IOP at week 12 was maintained across all PGA groups (P < 0.05). No significant differences were observed in symptom frequency between baseline and week 12 for any of the six solicited symptoms. A total of 17 adverse events from six patients was reported, of which ten were drug-related. Most (n = 7) of the drug-related adverse events were mild or moderate in intensity. None of the adverse events required any treatment or resulted in treatment interruption or discontinuation. Of the 90 eligible eyes, 85.6% had a decrease in IOP of at least 3 mmHg from baseline and 98% of patients had a decrease in IOP of ≥1 mmHg.
Conclusion: This study suggests that a fixed combination of brinzolamide 1%/timolol 0.5% can provide additional IOP reduction effectively and safely when used as adjunctive therapy for patients receiving insufficient IOP reduction from PGA monotherapy.
Keywords: adjunctive therapy; brinzolamide; carbonic anhydrase inhibitor; fixed combination; glaucoma; intraocular pressure.
Figures
References
- European Glaucoma Society. Terminology and Guidelines for Glaucoma. 3rd ed. Savona, Italy: Dogma; 2008.
- Travatan [package insert] Fort Worth, TX: Alcon Laboratories Inc; 2004.
- Xalatan [package insert] New York, NY: Pfizer Inc; 2009.
- Lumigan [package insert] Irvine, CA: Allergan Inc; 2010.
- Centofanti M, Oddone F, Vetrugno M, et al. Efficacy of the fixed combinations of bimatoprost or latanoprost plus timolol in patients uncontrolled with prostaglandin monotherapy: a multicenter, randomized, investigator-masked, clinical study. Eur J Ophthalmol. 2009;19:66–71.
- Feuerhake C, Buchholz P, Kimmich F. Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study. Curr Med Res Opin. 2009;25:1037–1043.
- Azarga. Summary of product characteristics. Chicago, IL: Alcon Pharma; 2008.
- Kaback M, Scoper SV, Arzeno G, et al. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5% Ophthalmology. 2008;115:1728–1734.
- Manni G, Denis P, Chew P, et al. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009;18:293–300.
- Vold SD, Evans RM, Stewart RH, Walters T, Mallick S. A one-week comfort study of BID-dosed brinzolamide 1%/timolol 0.5% ophthalmic suspension fixed combination compared to BID-dosed dorzolamide 2%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2008;24:601–605.
- Bournias TE, Lai J. Brimonidine tartrate 0.15%, dorzolamide hydrochloride 2%, and brinzolamide 1% compared as adjunctive therapy to prostaglandin analogs. Ophthalmology. 2009;116:1719–1724.
- Cheng JW, Li Y, Wei RL. Systematic review of intraocular pressure-lowering effects of adjunctive medications added to latanoprost. Ophthalmic Res. 2009;42:99–105.
- Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009;25:1645–1653.
- Azopt [package insert] Fort Worth, TX: Alcon Laboratories Inc; 2008.
- Timolol maleate ophthalmic solution USP [package insert] Fort Worth, TX: Alcon Laboratories, Inc; 2004.
- Andrade S. Compliance in the real world. Value Health. 1998;1:171–173.
Source: PubMed