Efficacy and Tolerability of Preservative-free Tafluprost 0.0015 % in the Treatment of Glaucoma and Ocular Hypertension
Authors:
M. Karhanová; P. Mlčák; Z. Fryšák; K. Marešová
Authors‘ workplace:
Oční klinika LF UP a FN, Olomouc, přednosta Doc. MUDr. Jiří Řehák, CSc., FEBO
Published in:
Čes. a slov. Oftal., 68, 2012, No. 4, p. 150-155
Category:
Original Article
Overview
Aim:
The aim of the study was to evaluate the efficacy, safety and local tolerability of preservative-free tafluprost 0.0015% (Taflotan®) in patients with glaucoma and ocular hypertension.
Materials and methods:
Multicentric, prospective observation study was performed in the Czech Republic from October 2010 to April 2011. A total of 78 centers participated and 754 patients were included. After the doctor’s decision to start the treatment with Taflotan®, the patient’s demographic data, previous treatment, intraocular pressure and the reason for switching the medication were recorded. At the follow-up visit after 6–12 weeks, the intraocular pressure, local tolerability (a 5-level scale), the patient’s and doctor’s satisfaction (a 4-level scale), and the patient’s preference were recorded.
Results:
Altogether, data of 496 patients were evaluated. The majority of them were women (64.9 %). The patients’ mean age was 58.5 years. The most common diagnosis was primary open angle glaucoma (79.2 %), followed by ocular hypertension (7.3 %), normal tension glaucoma (4.2 %), and pseudoexfoliation glaucoma (3.6 %). In 140 patients, tafluprost 0.0015% was the first antiglaucomatous medication started, 261 patients switched from another monotherapy, and 95 patients were treated with fixed- or nonfixed combinations before starting tafluprost 0.0015%. The most common reason for switching to Taflotan® was local intolerability to the current antiglaucomatous therapy (most often irritation of the eye and hyperemia). The intraocular pressure decreased significantly from 19.9 ± 4.5 mm Hg to 16.3 ± 3.0 mm Hg (p < 0.001). The subjective tolerability of the antiglaucomatous therapy improved rapidly, with 57.4 % of patients rating the tolerability of Taflotan® as “very good” and 34.5 % as “good”. In addition, 94.4 % of patients and 96.0 % of ophthalmologists were “very satisfied” or “satisfied” with the treatment. At the final visit, 79.8 % of patients preferred Taflotan® to the previous treatment.
Conclusion:
Taflotan® significantly decreased the intraocular pressure. It was well tolerated even in patients with previous intolerability to another antiglaucomatous therapy, including prostaglandins. The patients’ and ophthalmologists’ satisfaction with Taflotan® was high.
Key words:
tafluprost, intraocular pressure, prostaglandin analogs, local tolerability, hyperemia, preservatives
Sources
1. Baudouin, C.: Side effects of antiglaucomatous drugs on the ocular surface. Curr Opin Ophthalmol, 1996; 7: 80–86.
2. Baudouin, C., Labbé, A., Liang, H. et al.: Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res, 2010; 29: 312–334.
3. Bean, G.W., Camras, C.B.: Commercially available prostaglandin analogs for the reduction of intraocular pressure: similarities and differences. Surv Ophthalmol, 2008; 53(1): 69–84.
4. Brasnu, E., Brignole-Baudouin, F., Riancho, L. et al.: In vitro effects of preservative-free tafluprost and preserved latanoprost, travoprost, and bimatoprost in a conjunctival epithelial cell line. Curr Eye Res, 2008; 33: 303–312.
5. Detry, Morel, M.: Side effects of glaucoma medications. Bull Soc Belge Ophthalmol, 2006; 299: 27–40.
6. Erb, C., Gast, U., Schremmer, D.: German register for glaucoma patients with dry eye. Basic outcome with respect to dry eye. Graefes Arch Clin Exp Ophthalmol, 2008; 246: 1593–601.
7. Erb, C., Lanzl, I., Seidova, S.F. et al.: Preservatives-free tafluprost 0,0015% in the treatement of patiens with glaucoma and ocular hypertension. Adv Ther, 2011; 28(7): 575–585.
8. Fechtner, R.D., Godfrey, D.G., Budenz, D. et al.: Prevalence of ocular surface complaints in patients with glaucoma using topical intraocular pressure-lowering medications. Cornea, 2010; 29: 618–621.
9. Hamacher, T., Airaksinen, J., Saarela, V. et al.: Efficacy and safety levels of preserved and preservative-free tafluprost are equivalent in patients with glaucoma or ocular hypertension: results from a pharmacodynamics analysis. Acta Ophthalmol Suppl (Oxf), 2008; 242: 14–19.
10. Hommer, A., Mohammed Ramez, O., Burchert, M. at al.: IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma. Curr Med Res Opin, 2010; 26: 1905–1913.
11. Hommer, A., Kimmich, F.: Switching patiens from preserved prostaglandin-analog monoterapy to preservative-free tafluprost. Clin Ophthal, 2011; 5: 623–631.
12. Kahook, M.Y., Noecker, R.: Quantitative analysis of conjunctival goblet cells after chronic application of topical drugs. Adv Ther, 2008; 25: 743–751.
13. Kuppens, E.V., van Best, J.A., Sterk, C.C. et al.: Decreased basal tear turnover in patiens with untreated primary open-angle aglaucoma. Am J Ophthalmol, 1995; 120: 41–46.
14. Leske, M.C., Heijl, A., Hussein, M. et al.: Factors for glaucoma progression and the effect of treatment: the Early Manifest Glaucoma Treatment Trial. Arch Ophthalmol, 2003; 121: 48–56.
15. Leung, E.W., Kedeiros, F.A., Weinreb, R.N.: Prevalence of ocular surface disease in glaucoma patients. J Glaucoma, 2008; 17: 350–355.
16. Martone, G., Frezzotti, P., Tosi, G.M. et al.: An in vivo confocal microscopy analysis of effects of topical antiglaucoma therapy with preservative on corneal innervation and morphology. Am J Ophthalmol, 2009; 147: 725–735.
17. Pantcheva, M.B., Seibold, K.S., Awadallah, N.S. et al.: Tafluprost: a novel prostaglandin analog for treatment of glaucoma. Adv Ther, 2011; 28(9): 707–715.
18. Quigley, H.A., Broman, A.T.: The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol, 2006; 90: 262–267.
19. Sharif, N.A., Kelly, C.R., Crider, J.Y. et al.: Ocular hypotensive FP prostaglandin (PG) analogs, PG receptor, subtype binding affinities and selectivities, and agonist potencies at FP and other PG receptors in cultured cells. J Ocul Pharmacol Ther, 2003; 19, 501–515.
20. Takagi, Y., Nakajima, T., Shimazaki, A. et al.: Pharmacological characteristics of AFP-168 (tafluprost), a new prostanoid FP receptor agonist, as an ocular hypotensive drug. Exp. Eye Res, 2004; 78: 767–776.
21. Traverso, C.E., Ropo, A., Papadia, M. et al.: A phase II study on the duration and stability of the intraocular pressure-lowering effect and tolerability of tafluprost compared with latanoprost. J Ocul Pharmacol Ther, 2010; 26: 97–104.
22. Uusitalo, H., Pillunat, L.E., Ropo, A. et al.: Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study. Acta Ophthalmol, 2010; 88: 12–19.
23. Výborný, P., Sičáková, S.: Denní dávka benzalkonium chloridu – významné kritérium v léčbě glaukomu. Čes a Slov Oftal, 2011; 67(2): 63–66.
24. Weinreb, R.N., Toris, C.B., Gabelt, A.T. et al.: Effects of prostaglandins on the aqueous humor outflow pathways. Surv Ophthalmol, 2002; 47(1): 53–64.
Labels
OphthalmologyArticle was published in
Czech and Slovak Ophthalmology
2012 Issue 4
Most read in this issue
- Sub-internal Limiting Membrane Haemorrhage Treated by Pars Plana Vitrectomy
- Perforated Punctum Plugs in Treatment Lacrimal Punctal Stenosis
- Efficacy and Tolerability of Preservative-free Tafluprost 0.0015 % in the Treatment of Glaucoma and Ocular Hypertension
- Extrascleral Overgrowth of Malignant Choroidal Melanoma after Endoresection