Abstract
Introduction
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.
Methods
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.
Results
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.
Conclusion
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.
Funding
Santen Pharmaceutical Co., Ltd., Osaka, Japan.
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Acknowledgements
Sponsorship and article processing charges for this study were funded by Santen Pharmaceutical Co., Ltd., Osaka, Japan. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. We wish to express our gratitude to the physicians at the medical institutions that cooperated in the study. English language editing and manuscript preparation for submission for this study were provided by Springer Healthcare Communications. This support was funded by Santen Pharmaceutical Co., Ltd.
Disclosures
Yasuaki Kuwayama is a consultant for Alcon Japan, Kowa Company, Ltd., Otsuka Pharmaceutical, Pfizer Japan, Santen Pharmaceutical, and Senju Pharmaceutical and has received speaker honoraria from Alcon Japan, Kowa Company, Ltd., Otsuka Pharmaceutical, Pfizer Japan, Santen Pharmaceutical, and Senju Pharmaceutical. Masako Hashimoto is an employee of Santen Pharmaceutical Co., Ltd. Reiko Kakegawa is an employee of Santen Pharmaceutical Co., Ltd. Akio Nomura is an employee of Santen Pharmaceutical Co., Ltd. Fumiki Shimada is an employee of Santen Pharmaceutical Co., Ltd.
Compliance with Ethics Guidelines
This mandatory observational study was conducted in accordance with the requirements of the Good Post-Marketing Study Practice (MHLW Ordinance No. 171; December 20, 2004), the regulatory authority in Japan. Because the study protocol was reviewed and approved by the regulatory authority in Japan prior to initiation, approval by the ethics review committees at each participating medical institution was not required. The Japanese regulatory authority does not require informed consent for post-marketing observational studies; therefore, this study did not obtain informed consent from patients.
Data Availability
The datasets during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Kuwayama, Y., Hashimoto, M., Kakegawa, R. et al. Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence. Adv Ther 34, 1411–1425 (2017). https://doi.org/10.1007/s12325-017-0549-0
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DOI: https://doi.org/10.1007/s12325-017-0549-0