Abstract | INTRODUCTION: This study investigated the intraocular pressure (IOP)-lowering effects and safety of tafluprost ophthalmic solution 0.0015% in actual clinical practice. METHODS: We started a mandatory prospective 2-year observational study, which collected IOP, conjunctival hyperemia score, corneal staining score, and adverse event data from glaucoma and ocular hypertension ( OH) patients not previously treated with tafluprost at 2, 12, and 24 months. This report analyzes the 2-month findings. RESULTS: Of the 4,180 patients from 553 medical institutions in Japan, most patients had primary open-angle glaucoma (POAG, 38.1%) or normal-tension glaucoma (NTG, 44.2%). After 2 months of tafluprost administration, IOP was significantly reduced by 4.3 ± 5.2 mmHg in POAG, 2.4 ± 2.5 mmHg in NTG, 3.6 ± 5.3 mmHg in primary angle-closure glaucoma, 5.6 ± 7.1 mmHg in other types of glaucoma, and 5.3 ± 4.8 mmHg in OH. IOP was significantly reduced by 4.3 ± 4.0 mmHg in the naïve monotherapy group, 1.9 ± 3.5 mmHg in switching from prior treatment, and 3.7 ± 4.1 mmHg in the add-on therapy group. Among patients switched, the prostaglandin analog ( PGA) latanoprost was the previous predominant drug (57.4%), followed by travoprost (13.8%). Significant IOP reductions were observed by 1.5 ± 3.4 mmHg in switching from latanoprost and 1.3 ± 3.7 mmHg in switching from travoprost. The conjunctival hyperemia score peaked at 1 month in the naïve monotherapy and add-on therapy groups, whereas it was significantly decreased in patients switched from another PGA. The corneal staining score showed no particular changes. Incidence of adverse drug reaction (ADR) was 7.70 % (322/4,180 patients), and all major ADRs involved the eyes or skin around the eyes. CONCLUSION:
Tafluprost showed significant IOP-lowering effects without any safety concerns in patients with various types of glaucoma and OH in daily clinical practice and tafluprost is highly effective in any therapeutic patterns.
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Authors | Yasuaki Kuwayama, Akio Nomura |
Journal | Advances in therapy
(Adv Ther)
Vol. 31
Issue 4
Pg. 461-71
(Apr 2014)
ISSN: 1865-8652 [Electronic] United States |
PMID | 24615289
(Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Ophthalmic Solutions
- Prostaglandins F
- tafluprost
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Topics |
- Aged
- Conjunctival Diseases
(chemically induced)
- Female
- Glaucoma
(diagnosis, drug therapy)
- Humans
- Intraocular Pressure
(drug effects)
- Japan
- Male
- Middle Aged
- Ocular Hypertension
(diagnosis, drug therapy)
- Ophthalmic Solutions
(administration & dosage, adverse effects)
- Product Surveillance, Postmarketing
(methods)
- Prospective Studies
- Prostaglandins F
(administration & dosage, adverse effects)
- Tonometry, Ocular
(methods)
- Treatment Outcome
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