Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost

Robert D Fechtner1, Paul Harasymowycz2, Donald R Nixon3, Steven D Vold4, Fiaz Zaman5, Julia M Williams6, David A Hollander61Glaucoma Division, University of Medicine and Dentistry New Jersey, Newark, NJ, USA; 2University of Montreal, Montreal, QC, Canada; 3Royal Victoria Hospital, Barrie, ON, Canada...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Fechtner RD, Harasymowycz P, Nixon DR, Vold SD, Zaman F, Williams JM, Hollander DA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/73e32f73ba1d4802b037b6ccc3f0c3df
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:73e32f73ba1d4802b037b6ccc3f0c3df
record_format	dspace
spelling	oai:doaj.org-article:73e32f73ba1d4802b037b6ccc3f0c3df2021-12-02T04:45:17ZTwelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost1177-54671177-5483https://doaj.org/article/73e32f73ba1d4802b037b6ccc3f0c3df2011-07-01T00:00:00Zhttp://www.dovepress.com/twelve-week-randomized-multicenter-study-comparing-a-fixed-combination-a7830https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Robert D Fechtner1, Paul Harasymowycz2, Donald R Nixon3, Steven D Vold4, Fiaz Zaman5, Julia M Williams6, David A Hollander61Glaucoma Division, University of Medicine and Dentistry New Jersey, Newark, NJ, USA; 2University of Montreal, Montreal, QC, Canada; 3Royal Victoria Hospital, Barrie, ON, Canada; 4Boozman-Hof Regional Eye Clinic, Rogers, AR, USA; 5Houston Eye Associates, Houston, TX, USA; 6Allergan Inc, Irvine, CA, USAObjective: To evaluate the additive intraocular pressure (IOP)-lowering efficacy and safety of fixed-combination brimonidine 0.2%/timolol 0.5% compared with timolol 0.5% at peak and trough effect when used as therapy adjunctive to latanoprost 0.005% in patients with glaucoma or ocular hypertension who require additional IOP lowering.Methods: In this prospective, randomized, multicenter, investigator-masked, parallel-group study, patients were treated with latanoprost monotherapy for at least four weeks prior to baseline. At baseline on latanoprost, patients with IOP &ge;21 mmHg in at least one eye were randomized to twice-daily fixed brimonidine-timolol (n = 102) or timolol (n = 102), each adjunctive to latanoprost for 12 weeks. IOP was measured at 8 am and 10 am at baseline, week 6, and week 12 and evaluated in the per protocol population. The primary efficacy endpoint was peak IOP lowering at 10 am, week 12. Safety measures included adverse events.Results: Baseline mean IOP was similar at 10 am in the treatment groups (brimonidine-timolol 23.4 mmHg; timolol 23.0 mmHg). The mean additional reduction from latanoprost-treated baseline IOP was 8.3 mmHg (35.5%) with fixed brimonidine-timolol and 6.2 mmHg (27.0%) with timolol at 10 am, week 12 (P &lt; 0.001). Patients treated with fixed brimonidine-timolol adjunctive to latanoprost were significantly more likely than patients treated with adjunctive timolol to achieve an IOP &lt;18 mmHg (P = 0.028) and a &ge;20% reduction in IOP from baseline (P = 0.047) at both 8 am and 10 am in week 12. Adverse events occurred in 14.7% of fixed brimonidine-timolol patients and 12.7% of timolol patients. Biomicroscopy findings were similar between the treatment groups after 12 weeks of treatment.Conclusion: Fixed-combination brimonidine-timolol reduced IOP significantly more effectively than timolol when used as adjunctive therapy to latanoprost in patients with glaucoma and ocular hypertension. Both fixed brimonidine-timolol and timolol were well tolerated as agents adjunctive to latanoprost.Keywords: brimonidine, drug combinations, glaucoma, intraocular pressure, ocular hypertension, timololFechtner RDHarasymowycz PNixon DRVold SDZaman FWilliams JMHollander DADove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2011, Iss default, Pp 945-953 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Fechtner RD Harasymowycz P Nixon DR Vold SD Zaman F Williams JM Hollander DA Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
description	Robert D Fechtner1, Paul Harasymowycz2, Donald R Nixon3, Steven D Vold4, Fiaz Zaman5, Julia M Williams6, David A Hollander61Glaucoma Division, University of Medicine and Dentistry New Jersey, Newark, NJ, USA; 2University of Montreal, Montreal, QC, Canada; 3Royal Victoria Hospital, Barrie, ON, Canada; 4Boozman-Hof Regional Eye Clinic, Rogers, AR, USA; 5Houston Eye Associates, Houston, TX, USA; 6Allergan Inc, Irvine, CA, USAObjective: To evaluate the additive intraocular pressure (IOP)-lowering efficacy and safety of fixed-combination brimonidine 0.2%/timolol 0.5% compared with timolol 0.5% at peak and trough effect when used as therapy adjunctive to latanoprost 0.005% in patients with glaucoma or ocular hypertension who require additional IOP lowering.Methods: In this prospective, randomized, multicenter, investigator-masked, parallel-group study, patients were treated with latanoprost monotherapy for at least four weeks prior to baseline. At baseline on latanoprost, patients with IOP &ge;21 mmHg in at least one eye were randomized to twice-daily fixed brimonidine-timolol (n = 102) or timolol (n = 102), each adjunctive to latanoprost for 12 weeks. IOP was measured at 8 am and 10 am at baseline, week 6, and week 12 and evaluated in the per protocol population. The primary efficacy endpoint was peak IOP lowering at 10 am, week 12. Safety measures included adverse events.Results: Baseline mean IOP was similar at 10 am in the treatment groups (brimonidine-timolol 23.4 mmHg; timolol 23.0 mmHg). The mean additional reduction from latanoprost-treated baseline IOP was 8.3 mmHg (35.5%) with fixed brimonidine-timolol and 6.2 mmHg (27.0%) with timolol at 10 am, week 12 (P &lt; 0.001). Patients treated with fixed brimonidine-timolol adjunctive to latanoprost were significantly more likely than patients treated with adjunctive timolol to achieve an IOP &lt;18 mmHg (P = 0.028) and a &ge;20% reduction in IOP from baseline (P = 0.047) at both 8 am and 10 am in week 12. Adverse events occurred in 14.7% of fixed brimonidine-timolol patients and 12.7% of timolol patients. Biomicroscopy findings were similar between the treatment groups after 12 weeks of treatment.Conclusion: Fixed-combination brimonidine-timolol reduced IOP significantly more effectively than timolol when used as adjunctive therapy to latanoprost in patients with glaucoma and ocular hypertension. Both fixed brimonidine-timolol and timolol were well tolerated as agents adjunctive to latanoprost.Keywords: brimonidine, drug combinations, glaucoma, intraocular pressure, ocular hypertension, timolol
format	article
author	Fechtner RD Harasymowycz P Nixon DR Vold SD Zaman F Williams JM Hollander DA
author_facet	Fechtner RD Harasymowycz P Nixon DR Vold SD Zaman F Williams JM Hollander DA
author_sort	Fechtner RD
title	Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
title_short	Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
title_full	Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
title_fullStr	Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
title_full_unstemmed	Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
title_sort	twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/73e32f73ba1d4802b037b6ccc3f0c3df
work_keys_str_mv	AT fechtnerrd twelveweekrandomizedmulticenterstudycomparingafixedcombinationofbrimonidinetimololwithtimololastherapyadjunctivetolatanoprost AT harasymowyczp twelveweekrandomizedmulticenterstudycomparingafixedcombinationofbrimonidinetimololwithtimololastherapyadjunctivetolatanoprost AT nixondr twelveweekrandomizedmulticenterstudycomparingafixedcombinationofbrimonidinetimololwithtimololastherapyadjunctivetolatanoprost AT voldsd twelveweekrandomizedmulticenterstudycomparingafixedcombinationofbrimonidinetimololwithtimololastherapyadjunctivetolatanoprost AT zamanf twelveweekrandomizedmulticenterstudycomparingafixedcombinationofbrimonidinetimololwithtimololastherapyadjunctivetolatanoprost AT williamsjm twelveweekrandomizedmulticenterstudycomparingafixedcombinationofbrimonidinetimololwithtimololastherapyadjunctivetolatanoprost AT hollanderda twelveweekrandomizedmulticenterstudycomparingafixedcombinationofbrimonidinetimololwithtimololastherapyadjunctivetolatanoprost
_version_	1718401087976767488

Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost

Ejemplares similares