The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients
Received 24 November 2017
Accepted for publication 20 February 2018
Published 20 March 2018 Volume 2018:12 Pages 539—548
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
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
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