Adjunctive use of tafluprost with timolol provides additive effects for reduction of intraocular pressure in patients with glaucoma

Evgeny Egorov, Auli Ropo, Valery Erichev, Yury Astakhov, Vladimir Alekseev, Khristo Takhchidi, Gennadiy Zhaboedov, Natalija Pasechnikova, Kuldar Kaljurand, Kadi Palumaa, Guna Lagnovska, Egorov Eugeny Alexeevich Eugeny, Tatiana Vasilierna Staritskaya, Egorov Tatiana Evgen'evna, Romana Tatyana Borisovna, Svetlana Sergeevna Sheremetyeva, Janna Grigorievna Oganezova, Erichev Valeriy Petrovich, Yakouhova Liya Vagizona, Astakhov Yuri SergueevichDal Galina Alekseevna, Lisochkina Alla Borisovna, Atlasova Liya Kasimovna, Panin Andrey Victorovich, Michael Levko, Elena Martynova, Alexander Kolotov, Emilia Mikailovna Mironova, Olga I. Proshina, Elena E. Kozlova, Valentina K. Sochinskaya, Tamara S. Grishina, Gennadiy D. Zhaboedov, Oksana V. Petrenko, Oksana Vladymyrivna Tymoshenkova, Oksana P. Vitovska, Olena I. Kurilina, Oleg G. Parkhomenko, Natalija V. Pasechnokova, Andriy Rostislavovich Korol, Georgiy O. Klyuev, Kateryna Sergeevna Romodanova, Alla Nevska, Emiliya Padanevych, Kuldar Kaljurand, Marko Pastak, Natalia Seljagina, Kadi Palumaa, Kaire Somma, Guna Laganovska, Kristine Baumane

Research output: Contribution to journalArticle

17 Scopus citations

Abstract

Purpose. This study investigated the efficacy and safety of tafluprost as an adjunctive therapy to timolol in patients with open-angle glaucoma or ocular hypertension, uncontrolled by timolol monotherapy. Methods. This was a randomized, double-masked, parallel-group, multinational and multicenter 12-week phase III study. Tafluprost 0.0015% (once daily: 20:10) or vehicle were administered as adjunctive therapy to timolol 0.5% (twice daily: 08:00 and 20:00) for 6 weeks, after which all patients received tafluprost for 6 weeks. Intraocular pressure (IOP) measurements were conducted at 08:00, 10:00, and 16:00 at baseline, and weeks 2, 4, 6, and 12. Results. A total of 185 patients were randomized to tafluprost (n = 96) or vehicle (n = 89). Reductions in IOP were seen in both groups, which were consistently more pronounced with tafluprost. At week 6, the change from baseline in diurnal IOP ranged from -5.49 to -5.82 mm Hg, and the overall treatment difference (tafluprost vehicle) was -1.49 mmHg (upper 95% confidence interval, -0.66; p<0.001, intention-to-treat population, repeated measurements of the analysis of covariance model). At week 12, the change from baseline ranged from -6.22 to -6.79 mmHg in the tafluprost group. Patients switched from vehicle to tafluprost achieved a similar decrease in IOP to those who received tafluprost throughout the study (group difference at 12 weeks, -0.09 mmHg, p=0.812). There were more ocular adverse events with tafluprost compared with vehicle (42% vs. 29%, respectively), but most were mild in severity. Conclusions. As adjunctive therapy to timolol, tafluprost achieved a consistently greater reduction in IOP compared with vehicle, and was well tolerated.

Original languageEnglish (US)
Pages (from-to)214-222
Number of pages9
JournalEuropean Journal of Ophthalmology
Volume19
Issue number2
DOIs
StatePublished - 2009

Keywords

  • Additive
  • Adjunctive
  • Glaucoma
  • Intraocular pressure
  • Tafluprost
  • Timolol

ASJC Scopus subject areas

  • Ophthalmology

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    Egorov, E., Ropo, A., Erichev, V., Astakhov, Y., Alekseev, V., Takhchidi, K., Zhaboedov, G., Pasechnikova, N., Kaljurand, K., Palumaa, K., Lagnovska, G., Eugeny, E. E. A., Staritskaya, T. V., Evgen'evna, E. T., Borisovna, R. T., Sheremetyeva, S. S., Oganezova, J. G., Petrovich, E. V., Vagizona, Y. L., ... Baumane, K. (2009). Adjunctive use of tafluprost with timolol provides additive effects for reduction of intraocular pressure in patients with glaucoma. European Journal of Ophthalmology, 19(2), 214-222. https://doi.org/10.1177/112067210901900207