Nomura Akio, Osaki Hirotaka, Shimada Fumiki, Kuwayama Yasuaki
Pharmacovigilance, Quality Compliance Division, Santen Pharmaceutical Co., Ltd., Osaka, Japan.
Fukushima Eye Clinic, Osaka, Japan.
Clin Ophthalmol. 2018 Mar 20;12:539-548. doi: 10.2147/OPTH.S158017. eCollection 2018.
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.
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.
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.
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.
本研究在日常临床实践环境下，评估他氟前列素对日本正常眼压性青光眼（NTG）患者视野进展的影响。
这是一项上市后、多中心、非干预性观察性研究。对开始使用他氟前列素治疗的NTG患者进行登记，并前瞻性观察2至3年，以研究其在日本对视野进展、眼压（IOP）的有效性及安全性。使用在2至3年期间5个或更多时间点获取的可靠汉弗莱视野的患者组成的视野分析集中的平均偏差（MD）斜率来评估视野进展。
在160家医疗机构登记的1454例患者中，1353例纳入安全性分析，416例纳入视野分析。由于有效性不足或安全原因，194例患者停用他氟前列素，388例患者因失访或其他原因停用他氟前列素。整个视野分析集中MD斜率为-0.09±0.85 dB/年，初治单药治疗患者为-0.02±0.80 dB/年，换药单药治疗患者为-0.07±0.68 dB/年，联合治疗患者为-0.32±1.04 dB/年。在初治单药治疗中，眼压降低10%或更高的患者（0.11±0.73 dB/年）与眼压降低<10%的患者（-0.22±0.87 dB/年）之间MD斜率存在显著差异。在根据基线时的MD和IOP以及是否存在玻璃体视网膜合并症进行分组的亚组分析中也观察到显著差异。9.53%的患者出现不良反应，无严重不良反应。
在56.7%的初治NTG眼中，他氟前列素单药治疗使眼压至少降低10%足以显著降低MD进展率。
