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      Fixed combination of travoprost and timolol maleate reduces intraocular pressure in Japanese patients with primary open-angle glaucoma or ocular hypertension: analysis by prostaglandin analogue

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          Abstract

          Background

          We have shown a decrease in mean intraocular pressure (IOP) by switching to travoprost/timolol fixed combination (TTFC) in subjects receiving prostaglandin analogue (PGA) monotherapy and requiring additional medication in a previous report. For analyzing factors affecting IOP reduction, baseline IOP and preceding PGA were selected as statistically and clinically significant factors. In this report, we examine IOP-lowering effect and adverse drug reactions by preceding PGA.

          Methods

          Patients with primary open angle glaucoma or ocular hypertension who received monotherapy with one of four PGAs (travoprost, latanoprost, tafluprost, or bimatoprost) for at least 3 months at 26 institutions and were determined to require additional medication by their primary physician were included. IOP reduction and adverse events were examined at 4, 8, and 12 weeks for each of four PGAs after switching to TTFC.

          Results

          In total, 157 patients who could be followed up for at least 4 weeks after switching to TTFC were included in the efficacy analysis. Multiple regression analysis was performed, and baseline IOP and PGA were found to be significant factors to IOP reduction. IOP reduction at week 12, adjusted with the regression model, was −3.5, −1.8, and −1.4 mmHg in the tafluprost, latanoprost, and travoprost groups, whereas it was −0.5 mmHg in the bimatoprost group. Along with differences in baseline IOP between groups, an IOP-lowering effect of >1 mmHg was noted in the tafluprost, latanoprost, and travoprost groups after the switch. IOP was maintained at 13.8–14.8 mmHg throughout the follow-up period. No serious adverse events or noteworthy issues were observed in any group after the switch.

          Conclusion

          Clinically significant IOP-reducing effects of TTFC were observed in the latanoprost, travoprost, and tafluprost groups when switching from each PGA monotherapy, while there were some differences in effects between groups, with minimal safety concerns.

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          Most cited references22

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          The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group.

          In a companion paper, we determined that intraocular pressure is part of the pathogenesis of normal-tension glaucoma by analyzing the effect of a 30% intraocular pressure reduction on the subsequent course of the disease. We report an intent-to-treat analysis of the study data to determine the effectiveness of pressure reduction. One eligible eye of 145 subjects with normal-tension glaucoma was randomized either to no treatment (control) or to a 30% intraocular pressure reduction from baseline. To be eligible for randomization, the normal-tension glaucoma eyes had to show documented progression of field defects or a new disk hemorrhage or had to have field defects that threatened fixation when first presented for the study. Survival analysis compared time to progression of all randomly assigned patients during the course of follow-up from the initial baseline at randomization. In a separate analysis, data of patients developing cataracts were censored at the time that cataract produced 2 lines of Snellen visual acuity loss. Visual field progression occurred at indistinguishable rates in the pressure-lowered (22/66) and the untreated control (31/79) arms of the study (P = .21). In an analysis with data censored when cataract affected visual acuity, visual field progression was significantly more common in the untreated group (21/79) compared with the treated group (8/66). An overall survival analysis showed a survival of 80% in the treated arm and of 60% in the control arm at 3 years, and 80% in the treated arm and 40% in the controls at 5 years. The Kaplan-Meier curves were significantly different (P = .0018). The analyses gave different results because of a higher incidence of cataract in the group that underwent filtration surgery. The favorable effect of intraocular pressure reduction on progression of visual change in normal-tension glaucoma was only found when the impact of cataracts on visual field progression, produced largely by surgery, was removed. Lowering intraocular pressure without producing cataracts is beneficial. Because not all untreated patients progressed, the natural history of normal-tension glaucoma must be considered before embarking on intraocular pressure reduction with therapy apt to exacerbate cataract formation unless normal-tension glaucoma threatens serious visual loss.
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            Prevalence and causes of low vision and blindness in a Japanese adult population: the Tajimi Study.

            To determine the prevalence and causes of low vision and blindness in a Japanese adult population. Population-based cross-sectional study. Randomly selected residents (n = 3870) of Tajimi City, Japan, who were 40 years of age or older. Of the 3021 study participants (78.1% of 3870 eligible persons), 2977 (76.9%) underwent a complete ophthalmologic examination including measurement of the best-corrected visual acuity (BCVA) with full subjective refraction using a Landolt ring chart at 5 m. Age- and gender-specific prevalence rates of low vision and blindness were estimated and causes were identified. Low vision and blindness were defined as BCVA in the better eye worse than 20/60 to a lower limit of 20/400 and worse than 20/400, respectively (World Health Organization [WHO] criteria) and worse than 20/40 but better than 20/200 and 20/200 or worse, respectively (United States criteria). The overall prevalence of blindness according to the WHO or U.S. criteria was 0.14% (n = 4; 95% confidence interval [CI], 0.06-0.32). The primary causes were optic atrophy, myopic macular degeneration, retinitis pigmentosa, and uveitis. The overall prevalence of low vision according to the WHO criteria was 0.39% (95% CI, 0.18%-0.60%) and according to the U.S. criteria was 0.98% (95% CI, 0.66%-1.30%), which was significantly greater in women and in the older half of the participants than in the younger half (P = 0.0079 and <0.0001, respectively). The leading causes of low vision in descending order were cataract followed by glaucoma, and those of monocular blindness were myopic macular degeneration, glaucoma, and trauma. The prevalence of low vision and blindness in Japanese adults was one of the lowest among those reported. The major causes of low vision were cataract and glaucoma, and the leading cause of monocular blindness was myopic macular degeneration.
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              Comparative Effectiveness of First-Line Medications for Primary Open-Angle Glaucoma: A Systematic Review and Network Meta-analysis.

              Primary open-angle glaucoma (POAG) is a highly prevalent condition worldwide and the most common cause of irreversible sight loss. The objective is to assess the comparative effectiveness of first-line medical treatments in patients with POAG or ocular hypertension through a systematic review and network meta-analysis, and to provide relative rankings of these treatments.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                Clinical Ophthalmology
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove Medical Press
                1177-5467
                1177-5483
                2017
                20 December 2016
                : 11
                : 55-61
                Affiliations
                [1 ]Department of Ophthalmology, The Jikei University School of Medicine, Nishi-Shimbashi, Minato-ku, Tokyo
                [2 ]Department of Ophthalmology, Ehime University Graduate School of Medicine, Shitsukawa, Toon-city, Ehime
                [3 ]Department of Integrative Genomics, Tohoku Medical Megabank Organization, Seiryo-machi, Sendai, Miyagi
                [4 ]Tajimi Iwase Eye Clinic, Hon-machi, Tajimi, Gifu
                [5 ]Department of Ophthalmology, Tokyo Teishin Hospital, Fujimi, Chiyoda-ku
                [6 ]Yoshikawa Eye Clinic, Naka-machi, Machida, Tokyo, Japan
                Author notes
                Correspondence: Tadashi Nakano, Department of Ophthalmology, The Jikei University School of Medicine, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan, Tel +81 3 3433 1111, Fax +81 3 3433 1936, Email tnakano@ 123456jikei.ac.jp
                Article
                opth-11-055
                10.2147/OPTH.S120639
                5189969
                4558c49b-6f79-4bdf-8e4c-5ee91f2e2cd6
                © 2017 Nakano et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Ophthalmology & Optometry
                adverse event intraocular pressure,prostaglandin analogue,switching therapy,travoprost/timolol fixed combination

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