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Efficacy and Safety of Brimonidine and Dorzolamide for Intraocular Pressure Lowering in Glaucoma and Ocular Hypertension

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Efficacy and Safety of Brimonidine and Dorzolamide for Intraocular Pressure Lowering in Glaucoma and Ocular Hypertension Current Medical Research and Opinion ISSN: 0300-7995 (Print) 1473-4877 (Online) Journal homepage: http://www.tandfonline.com/loi/icmo20 Efficacy and safety of brimonidine and dorzolamide for intraocular pressure lowering in glaucoma and ocular hypertension L. Jay Katz, Steven T. Simmons & E. Randy Craven To cite this article: L. Jay Katz, Steven T. Simmons & E. Randy Craven (2007) Efficacy and safety of brimonidine and dorzolamide for intraocular pressure lowering in glaucoma and ocular hypertension, Current Medical Research and Opinion, 23:12, 2971-2983, DOI: 10.1185/030079907X242476 To link to this article: https://doi.org/10.1185/030079907X242476 Published online: 18 Oct 2007. Submit your article to this journal Article views: 97 View related articles Citing articles: 10 View citing articles Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=icmo20 CURRENT MEDICAL RESEARCH AND OPINION® 0300-7995 VOL. 23, NO. 12, 2007, 2971–2983 doi:10.1185/030079907X242476 © 2007 LIBRAPHARM LIMITED All rights reserved: reproduction in whole or part not permitted REVIEW Efficacy and safety of brimonidine and dorzolamide for intraocular pressure lowering in glaucoma and ocular hypertension L. Jay Katz a, Steven T. Simmons b and E. Randy Craven c a Glaucoma, Wills Eye Hospital, Philadelphia, PA, USA b Glaucoma Consultants of the Capital Region, Slingerlands, NY, USA c Glaucoma Consultants of Colorado, Littleton, CO, USA Address for correspondence: L. Jay Katz, MD, Glaucoma Wills Eye Hospital, 840 Walnut St, Ste 1110, Philadelphia, PA 19107, USA. Tel.: +1 215 928 3197; Fax: +1 215 928 0166; [email protected] Key words: Adjunctive – Brimonidine – Dorzolamide – Glaucoma – Intraocular pressure ABSTRACT Background: Brimonidine and dorzolamide are by brimonidine and dorzolamide were more intraocular pressure (IOP)-lowering medications pronounced when the medica tions were used most commonly used in second-line treatment of adjunctively with other classes of drugs. Six other glaucoma and ocular hypertension. trials showed similar efficacy, and one additional Scope: An evidence-based review of monotherapy study showed lower IOP with comparative clinical trials of brimonidine and dorzolamide treatment. Ocular burning was noted dorzolamide was under taken to determine the with dorzolamide more than any other adverse relative efficacy and safety of these drugs in event with either drug. Trials ranged widely in reducing IOP. Using the keywords ‘brimonidine’ duration of therapy and the time of day IOP and ‘dorzolamide’, all articles describing such measurements were taken, and many were too trials from September 1966 to July 2007 were small for sufficient statistical power. found in MEDLINE and EMBASE. Conclusion: Brimonidine and dorzolamide are Findings: In all identified studies, brimonidine both efficacious and reasonably well tolerated. and dorzolamide were both found to provide Possible overall distinctions in efficacy were significant IOP reduction from treated or untreated obscured by differences in study designs and baseline levels. Results of eight trials reported to treatment regimens, but adjunctive therapy with date indicate that brimonidine produced either a brimonidine may reduce IOP as effectively or more lower treated IOP or greater pressure reduction effectively than adjunctive or fixed combination from baseline than dorzolamide at one or more dorzolamide therapy. In certain patients with measured timepoints, and provided comparable glaucoma and ocular hypertension brimonidine IOP lowering over all other measurements. may be a better choice than dorzolamide for Differences between the IOP reductions provided second-line treatment. Introduction are representative members of two of these drug classes. Many classes of drugs are available to reduce intraocular Dorzolamide is a topical carbonic anhydrase pressure (IOP) in the treatment of glaucoma and ocular inhibitor that reduces IOP by suppressing aqueous hypertension (OHT). Dorzolamide and brimonidine humor pro duction1,2. Dorzolamide hydrochloride Paper 4023 2971 2.0% ophthalmic solution (Trusopt*), available in a IOP19,20, but they are sometimes used as monotherapy buffered isotonic solution of pH 5.6 preserved with and are frequently used as adjunctive therapy with benzalkonium chloride (BAK) 0.0075%, is indicated a prosta glandin analogue or a beta-blocker such as in the treatment of elevated IOP in patients with timolol21,22. Both brimonidine and dorzolamide are OHT or open-angle glaucoma. It can be used safely in commonly considered drugs for second-line therapy23. pediatric patients between the ages of 2 and 6 years3–5. In choosing between these medications, it is important In its pivotal trials for drug approval, dorzolamide TID to consider their relative efficacy and safety profiles. reduced IOP by 3–5 mmHg3 but was less effective than A literature search of the MEDLINE database timolol in lowering IOP at both peak and afternoon from 1966 through July 2007 and EMBASE from trough effect6,7. Dorzolamide is labeled for TID dosing 1988 through July 2007 using the search terms but is often used BID in clinical practice. There is a ‘brimonidine’ and ‘dorzolamide’ revealed multiple warning on the label that dorzolamide is a sulfonamide studies that directly compared these drugs in the that is systemically absorbed after topical application, treatment of glaucoma and OHT. All reports of studies so adverse reactions attributable to sulfonamides, that compared the IOP-lowering efficacy and/or safety including fatal reactions, are theoretically possible but of these two medications were included in this review. have not been reported. Dorzolamide is contraindicated The most relevant reports of studies that used just in patients with hypersensitivity to any component of one of the medications were included as background the medication. Common side effects associated with information. References cited in articles elicited by the dorzolamide treatment include ocular burning and search were reviewed and included when appropriate. stinging, bitter taste, and allergy. Relevant articles in languages other than English were Brimonidine is a selective alpha2-adrenergic receptor translated. This review summarizes and discusses agonist that has a dual mechanism of IOP lowering: it the results of those comparison studies, which are both reduces aqueous production and stimulates uveo- divided into three treatment situa tions: brimonidine scleral outflow8. In its pivotal trials for drug approval, and dorzolamide monotherapy, brimonidine and topical brimonidine tartrate 0.2% (Alphagan†), reduced dorzolamide as adjunctive therapy, or brimonidine– IOP at least as well as timolol at peak effect (2 h after timolol and dorzolamide–timolol fixed combinations. dosing) but less effectively than timolol at morning trough9–11. Brimonidine is indicated for reducing IOP in patients with open-angle glaucoma or OHT. It is Brimonidine and dorzolamide contraindicated in patients with hypersensitivity to any as monotherapy component of the medication and in patients receiving monoamine oxidase inhibitor therapy, and it should Three separate prospective, randomized studies with not be used in children under the age of 3 years12,13. The crossover designs have evaluated the efficacy and safety label recommends TID dosing, but brimonidine is most of brimonidine compared with dorzolamide as mono- commonly used BID in clinical practice. Common side therapy in glaucoma and OHT24–26. The results of these effects associated with brimon idine treatment include studies, described below, suggest that there is no overall conjunctival hyperemia, allergic conjunctivitis, eye difference between the drugs in the frequency of side pruritus, lethargy, and dry mouth14. effects, but ocular stinging and burning are more often New formulations of brimonidine contain brimonidine associated with dorzolamide treatment. When used tartrate 0.1 or 0.15% in a buffered solution of pH as mono therapy, brimonidine and dorzolamide show 6.6–7.4 preserved with Purite‡ 0.005%15. Although similar efficacy. the new formulations contain a reduced concentration A prospective, double-masked, randomized, crossover of brimonidine, they were shown in clinical trials study24 compared brimonidine 0.2% and dorzolamide to have the same IOP-lowering efficacy and better 2.0%, each dosed TID for 6 weeks, in 40 patients with tolerability compared with the brimonidine 0.2% glaucoma or OHT. The study design included a 2-week formulation because the change in pH provides better washout between treatment periods. IOP was measured bioavailability15,16. In contrast to the more commonly used at 8 a.m. and 10 a.m. at the study baseline and after preservative BAK, Purite has not been associated with 6 weeks of treatment. Mean baseline IOP for all patients ocular surface side effects after repeated exposure17,18. was 24.1 mmHg. After treatment, mean IOP was similar Both brimonidine and dorzolamide are less between groups at 8 a.m. (20.8 mmHg with brimonidine efficacious than the once-daily prostaglandin analogue and 20.7 mmHg with dorzolamide, p = 0.99). At drugs (latano prost, bimatoprost, travoprost) in reducing 10 a.m. (peak effect), mean IOP was 17.8 mmHg with * Trusopt is a registered trade name of Merck & Co, Inc; Whitehouse Station, NJ, USA † Alphagan is a registered trade name of Allergan Inc; Irvine, CA, USA ‡ Purite is a registered trade name of Allergan Inc; Irvine, CA, USA 2972 Efficacy and safety
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