Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

Stefan Pfennigsdorf,1 Osman Ramez,2 Gerrit von Kistowski,3 Birgit M&auml;der,4 Peter Eschstruth,5 Michael Frob&ouml;se,6 Ulrich Thelen,7 Christoph Spraul,8 Dietmar Schnober,9 Hazel Cooper,10 Thomas Laube111Polch Ophthalmology Practice, Polch, 2Buxtehude Ophthalmology Practice, Buxteh...

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Autores principales:	Laube T, Cooper H, Schnober D, Spraul C, Thelen U, Frob&ouml;se M, Eschstruth P, M&auml;der B, von Kistowski G, Ramez O, Pfennigsdorf S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2012
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/d88bb6db52fb4fc8bf0b7c4b0b83b470
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spelling	oai:doaj.org-article:d88bb6db52fb4fc8bf0b7c4b0b83b4702021-12-02T04:55:36ZMulticenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension1177-54671177-5483https://doaj.org/article/d88bb6db52fb4fc8bf0b7c4b0b83b4702012-05-01T00:00:00Zhttp://www.dovepress.com/multicenter-prospective-open-label-observational-study-of-bimatoprost--a9886https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Stefan Pfennigsdorf,1 Osman Ramez,2 Gerrit von Kistowski,3 Birgit M&auml;der,4 Peter Eschstruth,5 Michael Frob&ouml;se,6 Ulrich Thelen,7 Christoph Spraul,8 Dietmar Schnober,9 Hazel Cooper,10 Thomas Laube111Polch Ophthalmology Practice, Polch, 2Buxtehude Ophthalmology Practice, Buxtehude, 3N&uuml;rnberg Ophthalmology Practice, N&uuml;rnberg, 4Wei&szlig;wasser Ophthalmology Practice, Wei&szlig;wasser, 5Ophthalmology Practice, Kiel, 6Ophthalmology Practice, Bielefeld, 7Group Practice, M&uuml;nster, 8Group Practice, Ulm, 9Ophthalmology Practice, Werdohl, Germany; 10Allergan, Marlow, UK, 11Group Practice, D&uuml;sseldorf, GermanyBackground: Bimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP). This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice.Methods: Data were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10&ndash;14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians&rsquo; discretion.Results: Bimatoprost 0.01% significantly lowered mean IOP from baseline by &ndash;4.1 mmHg (P &lt; 0.0001) in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by &ndash;6.5 mmHg (P &lt; 0.0001). Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of &beta;-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%), ocular hyperemia (1.4%), and conjunctival hyperemia (1.2%). Physicians and patients rated tolerability and adherence as high, and most patients said they would continue with bimatoprost 0.01% treatment.Conclusion: Bimatoprost 0.01% can produce additional IOP-lowering effects when used in routine clinical practice in patients who have received prior therapy, in addition to lowering IOP in previously untreated patients. A high rate of continuation of therapy with bimatoprost 0.01% was observed in patients who switched from a variety of different medications. The results suggest that bimatoprost 0.01% is a suitable first-choice therapy in patients with primary open-angle glaucoma or ocular hypertension.Keywords: bimatoprost 0.01%, glaucoma, observational, ocular hypertension, intraocular pressureLaube TCooper HSchnober DSpraul CThelen UFrob&ouml;se MEschstruth PM&auml;der Bvon Kistowski GRamez OPfennigsdorf SDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2012, Iss default, Pp 739-746 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Laube T Cooper H Schnober D Spraul C Thelen U Frob&ouml;se M Eschstruth P M&auml;der B von Kistowski G Ramez O Pfennigsdorf S Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension
description	Stefan Pfennigsdorf,1 Osman Ramez,2 Gerrit von Kistowski,3 Birgit M&auml;der,4 Peter Eschstruth,5 Michael Frob&ouml;se,6 Ulrich Thelen,7 Christoph Spraul,8 Dietmar Schnober,9 Hazel Cooper,10 Thomas Laube111Polch Ophthalmology Practice, Polch, 2Buxtehude Ophthalmology Practice, Buxtehude, 3N&uuml;rnberg Ophthalmology Practice, N&uuml;rnberg, 4Wei&szlig;wasser Ophthalmology Practice, Wei&szlig;wasser, 5Ophthalmology Practice, Kiel, 6Ophthalmology Practice, Bielefeld, 7Group Practice, M&uuml;nster, 8Group Practice, Ulm, 9Ophthalmology Practice, Werdohl, Germany; 10Allergan, Marlow, UK, 11Group Practice, D&uuml;sseldorf, GermanyBackground: Bimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP). This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice.Methods: Data were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10&ndash;14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians&rsquo; discretion.Results: Bimatoprost 0.01% significantly lowered mean IOP from baseline by &ndash;4.1 mmHg (P &lt; 0.0001) in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by &ndash;6.5 mmHg (P &lt; 0.0001). Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of &beta;-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%), ocular hyperemia (1.4%), and conjunctival hyperemia (1.2%). Physicians and patients rated tolerability and adherence as high, and most patients said they would continue with bimatoprost 0.01% treatment.Conclusion: Bimatoprost 0.01% can produce additional IOP-lowering effects when used in routine clinical practice in patients who have received prior therapy, in addition to lowering IOP in previously untreated patients. A high rate of continuation of therapy with bimatoprost 0.01% was observed in patients who switched from a variety of different medications. The results suggest that bimatoprost 0.01% is a suitable first-choice therapy in patients with primary open-angle glaucoma or ocular hypertension.Keywords: bimatoprost 0.01%, glaucoma, observational, ocular hypertension, intraocular pressure
format	article
author	Laube T Cooper H Schnober D Spraul C Thelen U Frob&ouml;se M Eschstruth P M&auml;der B von Kistowski G Ramez O Pfennigsdorf S
author_facet	Laube T Cooper H Schnober D Spraul C Thelen U Frob&ouml;se M Eschstruth P M&auml;der B von Kistowski G Ramez O Pfennigsdorf S
author_sort	Laube T
title	Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension
title_short	Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension
title_full	Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension
title_fullStr	Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension
title_full_unstemmed	Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension
title_sort	multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension
publisher	Dove Medical Press
publishDate	2012
url	https://doaj.org/article/d88bb6db52fb4fc8bf0b7c4b0b83b470
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Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

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