Kuwayama Yasuaki, Hashimoto Masako, Kakegawa Reiko, Nomura Akio, Shimada Fumiki
Fukushima Eye Clinic, Osaka, Japan.
Santen Pharmaceutical Co., Ltd., Osaka, Japan.
Adv Ther. 2017 Jun;34(6):1411-1425. doi: 10.1007/s12325-017-0549-0. Epub 2017 May 13.
The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance.
This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected.
Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years.
Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with minimum safety concerns in the actual clinical practice. The observed treatment persistence suggests that tafluprost can be used long term owing to its benefit-risk profile.
Santen Pharmaceutical Co., Ltd., Osaka, Japan.
本研究旨在调查前列腺素类似物他氟前列素在实际临床实践中的长期降眼压效果及安全性，并确定他氟前列素的持续性作为其效益风险平衡的一个指标。
这是一项大规模、上市后、多中心、非干预性、开放标签的长期研究。在日本的真实环境中，对开始使用他氟前列素治疗的青光眼或高眼压症患者进行登记，并前瞻性观察2年。收集长期眼压和安全性数据。
在从553家医疗机构登记的4502例患者中，分析了4265例患者。大多数患者患有正常眼压性青光眼（44.4%）和原发性开角型青光眼（37.8%），高眼压症患者占7.0%。研究期间他氟前列素的治疗模式如下：初治单药治疗（48.1%）、转换单药治疗（18.4%）和联合治疗（33.5%）。在所有分析的患者中，开始使用他氟前列素后，在整个2年观察期内，平均眼压从18.6±5.9mmHg（第0个月）显著降低至15mmHg或更低。在各种治疗模式和疾病类型中均显示出显著的降眼压效果。795例患者（18.64%）观察到不良反应。主要不良反应包括眼睑色素沉着、眼部充血、睫毛改变、眼睑多毛症和虹膜色素沉着。Kaplan-Meier曲线显示，当因疗效不佳或不良事件停药被定义为治疗失败事件时，分别有84.6%和76.1%的患者持续使用他氟前列素1年和2年。此外，在初治患者（n = 2304）中，他氟前列素单药治疗的持续率1年为77.0%，2年为67.0%。
无论治疗模式或诊断如何，他氟前列素均显示出显著的长期降眼压效果，在实际临床实践中安全性担忧最小。观察到的治疗持续性表明，由于其效益风险特征，他氟前列素可长期使用。
日本大阪参天制药株式会社。
