The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients

Akio Nomura,1 Hirotaka Osaki,1 Fumiki Shimada,1 Yasuaki Kuwayama2 1Pharmacovigilance, Quality Compliance Division, Santen Pharmaceutical Co., Ltd., Osaka, Japan; 2Fukushima Eye Clinic, Osaka, Japan Purpose: This study evaluates the effect of tafluprost on visual field progression in normal-tension...

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Autores principales:	Nomura A, Osaki H, Shimada F, Kuwayama Y
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	MD slope NTG Observational post-marketing study Ophthalmology Visual field RE1-994
Acceso en línea:	https://doaj.org/article/127162fd2fdd4bc388c0968e532bfa93
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spelling	oai:doaj.org-article:127162fd2fdd4bc388c0968e532bfa932021-12-02T08:44:40ZThe clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients1177-5483https://doaj.org/article/127162fd2fdd4bc388c0968e532bfa932018-03-01T00:00:00Zhttps://www.dovepress.com/the-clinical-effectiveness-of-tafluprost-on-japanese-normal-tension-gl-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Akio Nomura,1 Hirotaka Osaki,1 Fumiki Shimada,1 Yasuaki Kuwayama2 1Pharmacovigilance, Quality Compliance Division, Santen Pharmaceutical Co., Ltd., Osaka, Japan; 2Fukushima Eye Clinic, Osaka, Japan Purpose: This study evaluates the effect of tafluprost on visual field progression in normal-tension glaucoma (NTG) in a Japanese population under daily clinical practice settings.Patients and methods: This is a post-marketing, multicenter, non-interventional, observational study. Patients with NTG who initiated tafluprost treatment were registered and prospectively observed for 2–3 years to investigate its effectiveness on visual field progression and intraocular pressure (IOP) and safety in Japan. Visual field progression was evaluated using mean deviation (MD) slopes in a visual field analysis set that comprised patients with reliable Humphrey visual fields taken at 5 or more time points throughout the 2–3 years.Results: Of the 1,454 patients registered from 160 medical institutions, 1,353 were set for safety analysis and 416 were set for visual field analysis. Due to insufficient effectiveness or safety reasons 194 patients discontinued tafluprost, and 388 patients discontinued tafluprost due to being lost to follow-up or another reason. The MD slopes were −0.09±0.85 dB/year in the entire visual field analysis set, -0.02±0.80 dB/year in naïve monotherapy patients, −0.07±0.68 dB/year in switching monotherapy patients, and −0.32±1.04 dB/year in concomitant therapy patients. In naïve monotherapy, a significant difference in MD slopes was observed between patients with an IOP reduction of 10% or higher (0.11±0.73 dB/year) vs patients with an IOP reduction of <10% (−0.22±0.87 dB/year). Significant differences were also observed in the subset analyses when the patients were divided by both MD and IOP at baseline, and presence of vitreoretinal concomitant disease. The adverse reactions were observed in 9.53% patients without any serious adverse reactions.Conclusion: An at least 10% IOP reduction with tafluprost monotherapy in 56.7% of the treatment-naïve NTG eyes was sufficient to significantly reduce the MD rate of progression. Keywords: MD slope, NTG, observational post-marketing study, ophthalmology, visual fieldNomura AOsaki HShimada FKuwayama YDove Medical PressarticleMD slopeNTGObservational post-marketing studyOphthalmologyVisual fieldOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 539-548 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	MD slope NTG Observational post-marketing study Ophthalmology Visual field Ophthalmology RE1-994
spellingShingle	MD slope NTG Observational post-marketing study Ophthalmology Visual field Ophthalmology RE1-994 Nomura A Osaki H Shimada F Kuwayama Y The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients
description	Akio Nomura,1 Hirotaka Osaki,1 Fumiki Shimada,1 Yasuaki Kuwayama2 1Pharmacovigilance, Quality Compliance Division, Santen Pharmaceutical Co., Ltd., Osaka, Japan; 2Fukushima Eye Clinic, Osaka, Japan Purpose: This study evaluates the effect of tafluprost on visual field progression in normal-tension glaucoma (NTG) in a Japanese population under daily clinical practice settings.Patients and methods: This is a post-marketing, multicenter, non-interventional, observational study. Patients with NTG who initiated tafluprost treatment were registered and prospectively observed for 2–3 years to investigate its effectiveness on visual field progression and intraocular pressure (IOP) and safety in Japan. Visual field progression was evaluated using mean deviation (MD) slopes in a visual field analysis set that comprised patients with reliable Humphrey visual fields taken at 5 or more time points throughout the 2–3 years.Results: Of the 1,454 patients registered from 160 medical institutions, 1,353 were set for safety analysis and 416 were set for visual field analysis. Due to insufficient effectiveness or safety reasons 194 patients discontinued tafluprost, and 388 patients discontinued tafluprost due to being lost to follow-up or another reason. The MD slopes were −0.09±0.85 dB/year in the entire visual field analysis set, -0.02±0.80 dB/year in naïve monotherapy patients, −0.07±0.68 dB/year in switching monotherapy patients, and −0.32±1.04 dB/year in concomitant therapy patients. In naïve monotherapy, a significant difference in MD slopes was observed between patients with an IOP reduction of 10% or higher (0.11±0.73 dB/year) vs patients with an IOP reduction of <10% (−0.22±0.87 dB/year). Significant differences were also observed in the subset analyses when the patients were divided by both MD and IOP at baseline, and presence of vitreoretinal concomitant disease. The adverse reactions were observed in 9.53% patients without any serious adverse reactions.Conclusion: An at least 10% IOP reduction with tafluprost monotherapy in 56.7% of the treatment-naïve NTG eyes was sufficient to significantly reduce the MD rate of progression. Keywords: MD slope, NTG, observational post-marketing study, ophthalmology, visual field
format	article
author	Nomura A Osaki H Shimada F Kuwayama Y
author_facet	Nomura A Osaki H Shimada F Kuwayama Y
author_sort	Nomura A
title	The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients
title_short	The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients
title_full	The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients
title_fullStr	The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients
title_full_unstemmed	The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients
title_sort	clinical effectiveness of tafluprost on japanese normal-tension glaucoma patients
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/127162fd2fdd4bc388c0968e532bfa93
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The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients

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