Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension

Katrin Lorenz1, Klaus Rosbach2, Andreas Matt3, Norbert Pfeiffer11University Medical Center, Johannes Gutenberg-Universit&auml;t Mainz, Mainz, Germany; 2Private practice, Mainz, Germany; 3Private practice, K&ouml;ln-Hohenhaus, GermanyBackground: This study was conducted to evaluate th...

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Autores principales:	Lorenz K, Rosbach K, Matt A, Pfeiffer N
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/91a95307330c404ea13b83ea026fba90
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spelling	oai:doaj.org-article:91a95307330c404ea13b83ea026fba902021-12-02T05:06:11ZAddition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension1177-54671177-5483https://doaj.org/article/91a95307330c404ea13b83ea026fba902011-12-01T00:00:00Zhttp://www.dovepress.com/addition-of-a-fixed-combination-of-brinzolamide-1timolol-05-to-prostag-a8834https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Katrin Lorenz1, Klaus Rosbach2, Andreas Matt3, Norbert Pfeiffer11University Medical Center, Johannes Gutenberg-Universit&auml;t Mainz, Mainz, Germany; 2Private practice, Mainz, Germany; 3Private practice, K&ouml;ln-Hohenhaus, GermanyBackground: 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 &lt; 0.001). This significant decrease in mean IOP at week 12 was maintained across all PGA groups (P &lt; 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 &ge;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 pressureLorenz KRosbach KMatt APfeiffer NDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2011, Iss default, Pp 1745-1750 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Lorenz K Rosbach K Matt A Pfeiffer N Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension
description	Katrin Lorenz1, Klaus Rosbach2, Andreas Matt3, Norbert Pfeiffer11University Medical Center, Johannes Gutenberg-Universit&auml;t Mainz, Mainz, Germany; 2Private practice, Mainz, Germany; 3Private practice, K&ouml;ln-Hohenhaus, GermanyBackground: 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 &lt; 0.001). This significant decrease in mean IOP at week 12 was maintained across all PGA groups (P &lt; 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 &ge;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
format	article
author	Lorenz K Rosbach K Matt A Pfeiffer N
author_facet	Lorenz K Rosbach K Matt A Pfeiffer N
author_sort	Lorenz K
title	Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension
title_short	Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension
title_full	Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension
title_fullStr	Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension
title_full_unstemmed	Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension
title_sort	addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/91a95307330c404ea13b83ea026fba90
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Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension

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