COMPARATIVE EVALUATION OF ANTIHYPERTENSIVE DRUG’S EFFICACY IN PATIENTS WITH PRIMARY GLAUCOMA AT EARLY AND ADVANCED STAGES

Purpose. To comparatively evaluate the antihypertensive efficacy and tolerability of preservative-free Tafluprost 0,0015% and Latanoprost 0,005% with preservative (0.02% BACH) in patients with initial and advanced stages of POAG. patients and methods. 63 patients (83 eyes) with primary open-angle glaucoma, aged from 56 to 75 years. 21 Men, 42 women. Patients were randomized intwo groups. The first group consisted of 32 patients (38 eyes), they received Latanoprost 0,005% (Prolatan®, “Sentiss Pharma”,) 1 drop once daily in the evening. The second group consisted of 31 (45 eyes) of patients treated with Tafluprost 0,0015% (Taflotan® JSC, “Santen”, Finland) 1 drop once daily in the evening. The follow-up period was 3 months. results. All patients had received reliable decrease in the true IOP: on monotherapy with Prolatan® on average by 27.8% (from 22.5±0,14 to 17.6±0,14 mm Hg.St.) in the first month, 26.4% (22,5±0,14 to 17.8±0,14 mm Hg.St) in third. In patients treated with Taflotan, reduction of IOP was approximately on the same level: 29.7 % in a month, 26.8 % in three months. The study of perimetry showed significant improvement of the MD index by 17.4% in the first group and 20% in the second, index, PSD, respectively, 10.7% and 11.9%. Improved parameters as a result of reduction IOP of optic nerve head were in both groups. But a significant decrease in the volume and area of excavation, respectively, 8.4% and 24.4% as well asincreasing the area of the disc rim band by 20.8% were observed only in the first group (instillation Prolatan®). Side effects were registered in 6 patients from the first group and 7 patients from the second group. One patient had several side effects. A mild hyperemia was identified in 3 patients of the first group and 2 from the second group at 4 week, in 5 out of first and 4 from second 8 week. Flushing medium degree was observed in 2 patients of the first group and 3 of the second group at 4 week. Conclusion. Thus, a comparative study has shown that the antihypertensive efficacy of the drug Prolatan comparable with the value of the drug Taflotan. According to optical coherence tomography as a result of treatment significantly decreased the volume, the area of excavation and the increased area of the disc rim of the shoulder in patients of the first group and was not observed in patients of the second group, which may indirectly indicate possible neuroprotective properties of the drug Prolatan. Side effects were registered in both groups, mostly of local character in the form of hyperemia of mild and moderate, increased pigmentation and growth of eyelashes. Patients in both groups noted the complete absence of burning, discomfort, foreign body in the administration of the drugs for a long period of time, with no cases of general disorder.

1. Egorov E.A. [Glaucoma. National guidelines]. M.:Geotar Media 2013. 429 437. (In Russ.).

2. European Glaucoma Society. Terminology and guidelines for glaucoma. 4th edition, 2014. 195 p.

3. Pinheiro R., Panfil C., Schrage N., Dutescu R.M. The Impact of Glaucoma Medicationson Corneal Wound Healing. JGlaucoma. 2015 Jul 10. PMID:26164144.

4. Egorov E.A., Astakhov Ju.S., Erichev V.P., Boiko Ae.V. [Evaluation of efficacy and safety of preservative free tafluprost 0.0015% eye drops in patients with POAG and ophthalmohypertension]. Ocenka jeffektivnosti i bezopasnosti glaznyh kapel’ tafluprost 0,0015% bez konservanta u pacientov s oſtal’mogipertenziej i otkrytougol’noj glaukomoj [RMJ. Clin.Ophtalmol]. Rossijskij medicinskij zhurnal. Klinicheskaja oſtal’mologija. 2015;1:1 6 (in Russ.).

5. Petrov S.Iu. [Tafluprost a novel prostaglandin F2 alpha analog].Tafluprost – novyj analog prostaglandina F2α. [Annals of Ophthalmol.] Vestnik oſtal’mologii. 2014 Sep Oct;130(5):85.(in Russ.).

6. Egorov E.A., Nesterov A.P., Romanova O.V. [Prospects analog of prostaglandina of F2 alphaapplication of latanoprost in hypotension therapy of glaucoma].Perspektivy primenenija analoga prostaglandina F2 al’fa latanoprosta v gipotenzivnoj terapii glaukomy. [Annals of Ophthalmol.] Vestnik oſtal’mologii. 1998;114(4):19 20.(in Russ.).

7. Diestelhorst M., Nordmann J.P., Toris C.B. Combined therapy or latanoprost with timolol versus latanoprost monotherapy. Surv. Ophthalmol V.47(Suppl.1.):155 161. doi:10.1016/S0039 6257(02)00329 6.

8. Iester M., Mikelberg F.S., Courtright P., Drance S.M. Correlation between the visual field indices and Heidelberg Retina Tomograph parameters. J. Glaucoma. 1997;6:78 82. doi:10.1097/00061198 199704000 00002

9. Kurysheva N.I., Aseychev A.V. [Study of antiradical activity of modern hypotensiv drugs in the light of their neuroprotective effect].Izuchenie antiradikal’noj aktivnosti sovremennyh antiglaukomatoznyh preparatov v svete ih nejroprotektornogo dejstvija. [Glaucoma]. Glaukoma. 2004;4:6–10.(in Russ.).

10. Kurysheva N.I. [The role of imaging of the optic nerve and retinal nerve fiber layer in the early diagnosis of glaucoma].Rol’ metodov vizualizacii diska zritel’nogo nerva i sloja nervnyh volokon setchatki v rannej diagnostike glaukomy. [Glaucoma]. Glaukoma. 2007;1:6–22. (in Russ.).

11. Kudo H., Nakazawa T. Neuroprotective effect of ltanoprost on rat retinal ganglion cells. Graefe’s Arch. Clin. Exp.Ophthalmol. 2007;3:15 19. doi:10.1007/s00417 005 0215 0.

12. Parrish R.K., Palmberg P., Sheu W.P.; XLT Study Group. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12week, randomized, maskedevaluator multicenter study. Am. J. Ophthalmol. 2003;135(5):688–703.

13. Toris C.B., Camras C.B. Bimatoprost and travoprost: a review of recent studies of two new glaucoma drugs. Surv. Ophthalmol. 2002;47. Suppl. 1:105–115.

14. Pisella P. J., Pouliquen P., Baudouin C. Prevalence of ocular symptoms and signs with preserved and preservative free glaucoma medication. Br J Ophthalmol. 2002;86(4):418–423.

15. Erichev V. P., Ambarcumyan K. G., Fedorov A. A. [Clinical and morphological evidence of preservatives influence on eye surface in primary open angle glaucoma]. Kliniko morfologicheskie dokazatel’stva vlijanija konservantov na poverhnost’ glaza pri pervichnoj otkrytougol’noj glaukome [National journal of glaucoma]. Nacional’nyj zhurnal glaukoma. 2014;4:13–22 (in Russ.).

16. Baratz K. H., Nau C. B., Winter E. J. et al. Effects of glaucoma medications on corneal endothelium, keratocytes, and subbasal nerves among participants in the ocular hypertension treatment study. Cornea. 2006;25(9):1046–1052.

17. Uusitalo H., Chen E., Pfeiffer N. et al. Switching from a preserved to a preservative free prostaglandin preparation in topical glaucoma medication. Acta Ophthalmol. 2010;88(3):329–336.

18. Baudouin C. Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. Acta Ophthalmol. 2008;86 (7):716–726.

19. Baudouin C., Labbe A., Liang H. et al. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010; 29 (4):312–334.

20. Erb C. Das trockene Auge bei Glaukompatienten Bedeutung von Benzalkoniumchlorid in der Glaukomtherapie. Zeitschriſt fur praktische Augenheilkunde. 2007. Bd. 18. S. 1–12.

21. 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(4):725–735.

22. Rossi G. C., Pasinetti G. M., Scudeller L. et al. Risk factors to develop ocular surface disease in treated glaucoma or ocular hypertension patients. Eur J Ophthalmol. 2013;23(3):296–302.

23. Brignole Baudouin F., Desbenoit N., Hamm G. et al. A new safety concern for glaucoma treatment demonstrated by mass spectrometry imaging of benzalkonium chloride distribution in the eye, an experimental study in rabbits. PLoS ONE. 2012;7(11):e50180.

24. Vaede D., Baudouin C., Warnet J. M., Brignole Baudouin F. Preservatives in eye drops: toward awareness of their toxicity. J Fr Ophtalmol. 2010;33(7):505–524.