Abstract | INTRODUCTION: METHODS: A European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/ timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF- latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6. RESULTS: The subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 (p < 0.001). Mean (SD) IOP change at Month 6 was 6.6 (4.16), 6.3 (4.39), 5.6 (3.67), 4.9 (2.97), 4.6 (4.39), and 4.7 (3.64) mmHg for prior beta-blocker, preserved latanoprost, PF- latanoprost, tafluprost, bimatoprost, and travoprost subgroups, respectively. The largest IOP change was observed in the preserved latanoprost subgroup for each of the ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% IOP reduction categories at Month 6, demonstrating respective reductions of 8.06, 9.20, 10.64, and 11.55 mmHg. CFS was significantly reduced at Month 6 in the prior bimatoprost subgroup (p = 0.0013). Conjunctival hyperemia severity was significantly reduced at each study visit for prior preserved latanoprost users (p < 0.001). CONCLUSION: PF tafluprost/ timolol FC therapy provided statistically and clinically significant IOP reductions from Week 4 over the total 6-month period, in patients with OAG/OHT, regardless of the type of prior PGA or beta-blocker monotherapy used. Conjunctival hyperemia severity and CFS decreased significantly in prior bimatoprost and preserved latanoprost users, respectively. CLINICAL STUDY NUMBER: European Union electronic Register of Post-Authorization Studies (EU PAS) register number: EUPAS22204.
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Authors | Francesco Oddone, James Kirwan, Fernando Lopez-Lopez, Marina Zimina, Claudia Fassari, Gábor Holló, VISIONARY Study Group |
Journal | Advances in therapy
(Adv Ther)
Vol. 39
Issue 8
Pg. 3501-3521
(08 2022)
ISSN: 1865-8652 [Electronic] United States |
PMID | 35524840
(Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
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Copyright | © 2022. The Author(s). |
Chemical References |
- Antihypertensive Agents
- Drug Combinations
- Prostaglandins A
- Prostaglandins F
- tafluprost
- Latanoprost
- Timolol
- Bimatoprost
- Travoprost
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Topics |
- Adult
- Antihypertensive Agents
(adverse effects)
- Bimatoprost
(therapeutic use)
- Drug Combinations
- Glaucoma
(drug therapy)
- Glaucoma, Open-Angle
(drug therapy)
- Humans
- Hyperemia
(chemically induced, drug therapy)
- Intraocular Pressure
- Latanoprost
(therapeutic use)
- Ocular Hypertension
(chemically induced, drug therapy)
- Prospective Studies
- Prostaglandins A
(therapeutic use)
- Prostaglandins F
- Timolol
(adverse effects)
- Travoprost
(therapeutic use)
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