Comparison of Efficacy and Safety of Latanoprost versus Fixed Combination of Tafluprost and Timolol in Patients with Primary Open-Angle Glaucoma

ORIGINAL ARTICLE
Gentian Hoxha, Fëllanza Ismajli Hoxha, Flaka Shoshi

 
For citation: Hoxha G, Hoxha FI, Shoshi F. Comparison of Efficacy and Safety of Latanoprost versus Fixed Combination of Tafluprost and Timolol in Patients with Primary Open-Angle Glaucoma. International Journal of Biomedicine. 2024;14(4):621-625. doi:10.21103/Article14(4)_OA14
 
Originally published December 5, 2024
 

Abstract: 

Background: Glaucoma is a progressive disease that requires lifelong treatment to maintain visual function.  Elevated intraocular pressure (IOP) is considered the most important treatable risk factor for disease development and progression. The present prospective study was initiated to compare the IOP lowering efficacy and safety of the preservative-free (PF) fixed combination of 0.0015% tafluprost and 0.5% timolol maleate (FCTT) administered once daily versus 0.005% latanoprost (LT) once daily.
Materials and Methods: One hundred newly diagnosed patients with primary open-angle glaucoma (POAG) who fulfilled the inclusion/exclusion criteria were enrolled and randomized into two groups. The first LP group was prescribed 0.005% latanoprost eye drops once daily, whereas the second FCTT group was prescribed a PF fixed combination of 0.0015% tafluprost and 0.5% timolol once daily. In both groups, IOP was recorded at baseline, at the end of the fourth, eighth, and twelfth weeks, and six months after, and any adverse effects were assessed. The primary efficacy endpoint, absolute mean IOP reduction six months after LP or FCTT treatment from baseline IOP, was statistically significant for both treatment groups (P<0.0001). However, the IOP-lowering efficacy of latanoprost was superior to FCTT. In the LP group, IOP decreased from 26.32±2.0 mmHg at baseline to 18.40 ± 1.57 mmHg six months after treatment with a mean reduction of 8.60±1.57 mmHg (31.8%). In the FCTT group, IOP decreased from 26.23±1.97 mmHg at baseline to 17.49±1.28 mmHg six months after treatment, with a mean reduction of 6.51±1.28 mmHg (27.1%). Latanoprost caused a greater reduction in mean IOP than FCTT in the second follow-up visit (P<0.05), the third follow-up visit (P<0.05), and the difference was much greater in the fourth follow-up visit (P<0.0001)
 Conclusion: The absolute mean IOP reduction from baseline at six months is statistically significant in LP or FCTT treatment. Compared to FCTT, 0.005% latanoprost administered once daily has a more significant IOP-lowering effect and safety for up to six months.

Keywords: 
primary open-angle glaucoma • latanoprost • tafluprost/timolol fixed combination • intraocular pressure
References: 
  1. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26. PMID: 24974815.
  2. European Glaucoma Society Terminology and Guidelines for Glaucoma, 5th Edition. Br J Ophthalmol. 2021 Jun;105(Suppl 1):1-169. doi: 10.1136/bjophthalmol-2021-egsguidelines. PMID: 34675001.
  3. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):498-505. doi: 10.1016/s0002-9394(98)00272-4. PMID: 9780094.
  4. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol. 2000 Oct;130(4):429-40. doi: 10.1016/s0002-9394(00)00538-9. PMID: 11024415.
  5. Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268. PMID: 12365904.
  6. Rulli E, Quaranta L, Riva I, Poli D, Hollander L, Galli F, Katsanos A, Oddone F, Torri V, Weinreb RN; Italian Study Group on QoL in Glaucoma. Visual field loss and vision-related quality of life in the Italian Primary Open Angle Glaucoma Study. Sci Rep. 2018 Jan 12;8(1):619. doi: 10.1038/s41598-017-19113-z. Erratum in: Sci Rep. 2020 Feb 21;10(1):3189. doi: 10.1038/s41598-020-59555-6. PMID: 29330448; PMCID: PMC5766542.
  7. Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE, Mills RP; CIGTS Study Group. The Collaborative Initial Glaucoma Treatment Study: interim quality of life findings after initial medical or surgical treatment of glaucoma. Ophthalmology. 2001 Nov;108(11):1954-65. doi: 10.1016/s0161-6420(01)00874-0. PMID: 11713062.
  8. Toris CB, Gabelt BT, Kaufman PL. Update on the mechanism of action of topical prostaglandins for intraocular pressure reduction. Surv Ophthalmol. 2008 Nov;53 Suppl1(SUPPL1):S107-20. doi: 10.1016/j.survophthal.2008.08.010. PMID: 19038618; PMCID: PMC2727743.
  9. Tripathy K, Patel P, Geetha R. Latanoprost. 2024 Feb 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan–. PMID: 31082022.
  10. Holló G, Katsanos A, Boboridis KG, Irkec M, Konstas AGP. Preservative-Free Prostaglandin Analogs and Prostaglandin/Timolol Fixed Combinations in the Treatment of Glaucoma: Efficacy, Safety and Potential Advantages. Drugs. 2018 Jan;78(1):39-64. doi: 10.1007/s40265-017-0843-9. PMID: 29196953.
  11. Tabet R, Stewart WC, Feldman R, Konstas AG. A review of additivity to prostaglandin analogs: fixed and unfixed combinations. Surv Ophthalmol. 2008 Nov;53 Suppl1:S85-92. doi: 10.1016/j.survophthal.2008.08.011. PMID: 19038627.
  12. Holló G, Topouzis F, Fechtner RD. Fixed-combination intraocular pressure-lowering therapy for glaucoma and ocular hypertension: advantages in clinical practice. Expert Opin Pharmacother. 2014 Aug;15(12):1737-47. doi: 10.1517/14656566.2014.936850. Epub 2014 Jul 5. PMID: 24998246.
  13. Konstas AG, Katsanos A, Athanasopoulos GP, Voudouragkaki IC, Panagiotou ES, Pagkalidou E, Haidich AB, Giannoulis DA, Spathi E, Giannopoulos T, Katz LJ. Preservative-free tafluprost/timolol fixed combination: comparative 24-h efficacy administered morning or evening in open-angle glaucoma patients. Expert Opin Pharmacother. 2018 Dec;19(18):1981-1988. doi: 10.1080/14656566.2018.1534958. Epub 2018 Oct 17. PMID: 30328725.
  14. Figus M, Agnifili L, Lanzini M, Brescia L, Sartini F, Mastropasqua L, Posarelli C. Topical preservative-free ophthalmic treatments: an unmet clinical need. Expert Opin Drug Deliv. 2021 Jun;18(6):655-672. doi: 10.1080/17425247.2021.1860014. Epub 2020 Dec 16. PMID: 33280452.
  15. Konstas AG, Haidich AB, Rossetti L, Webers C. Prostaglandin-timolol fixed combinations efficacy: myth or reality? Eur J Ophthalmol. 2012 Jan-Feb;22(1):1-4. doi: 10.5301/ejo.5000077. PMID: 22167537.
  16. Aptel F, Cucherat M, Denis P. Efficacy and tolerability of prostaglandin-timolol fixed combinations: a meta-analysis of randomized clinical trials. Eur J Ophthalmol. 2012 Jan-Feb;22(1):5-18. doi: 10.5301/ejo.5000009. PMID: 22167538.
  17. Quaranta L, Biagioli E, Riva I, Rulli E, Poli D, Katsanos A, Floriani I. Prostaglandin analogs and timolol-fixed versus unfixed combinations or monotherapy for open-angle glaucoma: a systematic review and meta-analysis. J Ocul Pharmacol Ther. 2013 May;29(4):382-9. doi: 10.1089/jop.2012.0186. Epub 2012 Dec 11. PMID: 23231442.
  18. Kuwayama Y, DE-111 Collaborative Trial Group. Phase III doublemasked study of fixed combination tafluprost 0.0015%/timolol 0.5% (DE-111) versus tafluprost 0.0015% alone or given concomitantly with timolol 0.5% in primary open angle glaucoma and ocular hypertension. Atarashii Ganka. 2013;30(8):1185–1194.
  19. Kuwayama Y, DE-III Collaborative Trial Group. A long-term, openlabel study of fixed combination tafluprost 0.0015%/timolol 0.5% (DE-III) in patients with open-angle glaucoma or ocular hypertension. Atarashii Ganka. 2015;32(1):133–143.
  20. Holló G, Hommer A, Antón López A, Ropo A. Efficacy, safety, and tolerability of preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% versus concomitant use of the ingredients. J Ocul Pharmacol Ther. 2014 Aug;30(6):468-75. doi: 10.1089/jop.2013.0229. Epub 2014 Apr 16. PMID: 24738883.
  21. Robin AL, Novack GD, Covert DW, Crockett RS, Marcic TS. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. Am J Ophthalmol. 2007 Oct;144(4):533-40. doi: 10.1016/j.ajo.2007.06.012. Epub 2007 Aug 8. PMID: 17686450.
  22. Liang H, Baudouin C, Pauly A, Brignole-Baudouin F. Conjunctival and corneal reactions in rabbits following short- and repeated exposure to preservative-free tafluprost, commercially available latanoprost and 0.02% benzalkonium chloride. Br J Ophthalmol. 2008 Sep;92(9):1275-82. doi: 10.1136/bjo.2008.138768. PMID: 18723745; PMCID: PMC2569147.
  23. Whitson JT, Petroll WM. Corneal epithelial cell viability following exposure to ophthalmic solutions containing preservatives and/or antihypertensive agents. Adv Ther. 2012 Oct;29(10):874-88. doi: 10.1007/s12325-012-0057-1. Epub 2012 Oct 10. PMID: 23065664.
  24. Jaenen N, Baudouin C, Pouliquen P, Manni G, Figueiredo A, Zeyen T. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eur J Ophthalmol. 2007 May-Jun;17(3):341-9. doi: 10.1177/112067210701700311. PMID: 17534814.
  25. Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2. PMID: 25447269; PMCID: PMC4271134.
  26. Shoji T, Sato H, Mizukawa A, Hirota N, Enoki T, Kojima T, Kanda T, Takeuchi M. Hypotensive effect of latanoprost/timolol versus travoprost/timolol fixed combinations in NTG patients: a randomized, multicenter, crossover clinical trial. Invest Ophthalmol Vis Sci. 2013 Sep 17;54(9):6242-7. doi: 10.1167/iovs.13-11942. PMID: 23950156.
  27. Xing Y, Zhu L, Zhang K, Huang S. The efficacy of the fixed combination of latanoprost and timolol versus other fixed combinations for primary open-angle glaucoma and ocular hypertension: A systematic review and meta-analysis. PLoS One. 2020 Feb 27;15(2):e0229682. doi: 10.1371/journal.pone.0229682. PMID: 32106236; PMCID: PMC7046276.
  28. Li T, Lindsley K, Rouse B, Hong H, Shi Q, Friedman DS, Wormald R, Dickersin K. Comparative Effectiveness of First-Line Medications for Primary Open-Angle Glaucoma: A Systematic Review and Network Meta-analysis. Ophthalmology. 2016 Jan;123(1):129-40. doi: 10.1016/j.ophtha.2015.09.005. Epub 2015 Oct 31. PMID: 26526633; PMCID: PMC4695285.

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Received August 4, 2024.
Accepted September 30, 2024.
©2024 International Medical Research and Development Corporation.