Skip to main content
Erschienen in: Advances in Therapy 6/2017

13.05.2017 | Original Research

Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence

verfasst von: Yasuaki Kuwayama, Masako Hashimoto, Reiko Kakegawa, Akio Nomura, Fumiki Shimada

Erschienen in: Advances in Therapy | Ausgabe 6/2017

Einloggen, um Zugang zu erhalten

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.
Literatur
1.
Zurück zum Zitat European Glaucoma Society. Terminology and guidelines for glaucoma. 3rd ed. Savona: DOGMA; 2008. European Glaucoma Society. Terminology and guidelines for glaucoma. 3rd ed. Savona: DOGMA; 2008.
2.
Zurück zum Zitat Kuwayama Y, Komemushi S. Phase III confirmatory study of 0.0015% DE-085 (tafluprost) ophthalmic solution as compared to 0.005% latanoprost ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. Atarashii Ganka (J Eye). 2008;25:1595–602. Kuwayama Y, Komemushi S. Phase III confirmatory study of 0.0015% DE-085 (tafluprost) ophthalmic solution as compared to 0.005% latanoprost ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. Atarashii Ganka (J Eye). 2008;25:1595–602.
3.
Zurück zum Zitat Kuwayama Y, Komemushi S, Tafluprost Multi-center Study Group. Intraocular pressure-lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal-tension glaucoma: randomized, double-blind, multicenter, phase III study. Nippon Ganka Gakkai Zasshi. 2010;114:436–43.PubMed Kuwayama Y, Komemushi S, Tafluprost Multi-center Study Group. Intraocular pressure-lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal-tension glaucoma: randomized, double-blind, multicenter, phase III study. Nippon Ganka Gakkai Zasshi. 2010;114:436–43.PubMed
4.
Zurück zum Zitat Kuwayama Y, Nomura A. Prospective observational post-marketing study of tafluprost for glaucoma and ocular hypertension: short-term efficacy and safety. Adv Ther. 2014;31:461–71.CrossRefPubMed Kuwayama Y, Nomura A. Prospective observational post-marketing study of tafluprost for glaucoma and ocular hypertension: short-term efficacy and safety. Adv Ther. 2014;31:461–71.CrossRefPubMed
5.
Zurück zum Zitat Iwase A, Suzuki Y, Araie M, et al. The prevalence of primary open-angle glaucoma in Japanese: the Tajimi Study. Ophthalmology. 2004;111:1641–8.PubMed Iwase A, Suzuki Y, Araie M, et al. The prevalence of primary open-angle glaucoma in Japanese: the Tajimi Study. Ophthalmology. 2004;111:1641–8.PubMed
6.
Zurück zum Zitat Inoue K, Setogawa A, Tomita G. Nonresponders to prostaglandin analogs among normal-tension glaucoma patients. J Ocul Pharmacol Ther. 2016;32:90–6.CrossRefPubMed Inoue K, Setogawa A, Tomita G. Nonresponders to prostaglandin analogs among normal-tension glaucoma patients. J Ocul Pharmacol Ther. 2016;32:90–6.CrossRefPubMed
7.
Zurück zum Zitat Yoshino T, Fukuchi T, Togano T, Seki M, Ikegaki H, Abe H. Eyelid and eyelash changes due to prostaglandin analog therapy in unilateral treatment cases. Jpn J Ophthalmol. 2013;57:172–8.CrossRefPubMed Yoshino T, Fukuchi T, Togano T, Seki M, Ikegaki H, Abe H. Eyelid and eyelash changes due to prostaglandin analog therapy in unilateral treatment cases. Jpn J Ophthalmol. 2013;57:172–8.CrossRefPubMed
8.
Zurück zum Zitat Zimmerman TJ, Hahn SR, Gelb L, Tan H, Kim EE. The impact of ocular adverse effects in patients treated with topical prostaglandin analogs: changes in prescription patterns and patient persistence. J Ocul Pharmacol Ther. 2009;25:145–52.CrossRefPubMed Zimmerman TJ, Hahn SR, Gelb L, Tan H, Kim EE. The impact of ocular adverse effects in patients treated with topical prostaglandin analogs: changes in prescription patterns and patient persistence. J Ocul Pharmacol Ther. 2009;25:145–52.CrossRefPubMed
9.
Zurück zum Zitat Zhou Z, Althin R, Sforzolini BS, Dhawan R. Persistency and treatment failure in newly diagnosed open angle glaucoma patients in the United Kingdom. Br J Ophthalmol. 2004;88:1391–4.CrossRefPubMedPubMedCentral Zhou Z, Althin R, Sforzolini BS, Dhawan R. Persistency and treatment failure in newly diagnosed open angle glaucoma patients in the United Kingdom. Br J Ophthalmol. 2004;88:1391–4.CrossRefPubMedPubMedCentral
10.
Zurück zum Zitat Nordstrom BL, Friedman DS, Mozaffari E, Quigley HA, Walker AM. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:598–606.CrossRefPubMed Nordstrom BL, Friedman DS, Mozaffari E, Quigley HA, Walker AM. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140:598–606.CrossRefPubMed
11.
Zurück zum Zitat Owen CG, Carey IM, de Wilde S, Whincup PH, Wormald R, Cook DG. Persistency with medical treatment for glaucoma and ocular hypertension in the United Kingdom: 1994–2005. Eye. 2009;23:1098–110.CrossRefPubMed Owen CG, Carey IM, de Wilde S, Whincup PH, Wormald R, Cook DG. Persistency with medical treatment for glaucoma and ocular hypertension in the United Kingdom: 1994–2005. Eye. 2009;23:1098–110.CrossRefPubMed
12.
Zurück zum Zitat Rahman MQ, Abeysinghe SS, Kelly S, et al. Persistence of glaucoma medical therapy in the Glasgow Glaucoma Database. Br J Ophthalmol. 2011;95:966–70.CrossRefPubMed Rahman MQ, Abeysinghe SS, Kelly S, et al. Persistence of glaucoma medical therapy in the Glasgow Glaucoma Database. Br J Ophthalmol. 2011;95:966–70.CrossRefPubMed
13.
Zurück zum Zitat Holló G, Thelen U, Teus MA, et al. Long-term outcomes of prostaglandin analog versus timolol maleate in ocular hypertensive or primary open-angle glaucoma patients in Europe. J Ocul Pharmacol Ther. 2011;27:493–8.CrossRefPubMed Holló G, Thelen U, Teus MA, et al. Long-term outcomes of prostaglandin analog versus timolol maleate in ocular hypertensive or primary open-angle glaucoma patients in Europe. J Ocul Pharmacol Ther. 2011;27:493–8.CrossRefPubMed
14.
Zurück zum Zitat Friström B, Uusitalo H. A randomized, 36-month, post-marketing efficacy and tolerability study in Sweden and Finland of latanoprost versus non-prostaglandin therapy in patients with glaucoma or ocular hypertension. Acta Ophthalmol. 2010;88:37–43.CrossRefPubMed Friström B, Uusitalo H. A randomized, 36-month, post-marketing efficacy and tolerability study in Sweden and Finland of latanoprost versus non-prostaglandin therapy in patients with glaucoma or ocular hypertension. Acta Ophthalmol. 2010;88:37–43.CrossRefPubMed
Metadaten
Titel
Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence
verfasst von
Yasuaki Kuwayama
Masako Hashimoto
Reiko Kakegawa
Akio Nomura
Fumiki Shimada
Publikationsdatum
13.05.2017
Verlag
Springer Healthcare
Erschienen in
Advances in Therapy / Ausgabe 6/2017
Print ISSN: 0741-238X
Elektronische ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-017-0549-0

Weitere Artikel der Ausgabe 6/2017

Advances in Therapy 6/2017 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.