TY - JOUR
T1 - Adjunctive use of tafluprost with timolol provides additive effects for reduction of intraocular pressure in patients with glaucoma
AU - Egorov, Evgeny
AU - Ropo, Auli
AU - Erichev, Valery
AU - Astakhov, Yury
AU - Alekseev, Vladimir
AU - Takhchidi, Khristo
AU - Zhaboedov, Gennadiy
AU - Pasechnikova, Natalija
AU - Kaljurand, Kuldar
AU - Palumaa, Kadi
AU - Lagnovska, Guna
AU - Eugeny, Egorov Eugeny Alexeevich
AU - Staritskaya, Tatiana Vasilierna
AU - Egorov, Tatiana Evgen evna
AU - Romana, Tatyana Borisovna
AU - Sheremetyeva, Svetlana Sergeevna
AU - Oganezova, Janna Grigorievna
AU - Erichev, Valeriy Petrovich
AU - Vagizona, Yakouhova Liya
AU - Astakhov, Yuri Sergueevich
AU - Alekseevna, Dal Galina
AU - Lisochkina, Alla Borisovna
AU - Atlasova, Liya Kasimovna
AU - Panin, Andrey Victorovich
AU - Levko, Michael
AU - Martynova, Elena
AU - Kolotov, Alexander
AU - Mironova, Emilia Mikailovna
AU - Proshina, Olga I.
AU - Kozlova, Elena E.
AU - Sochinskaya, Valentina K.
AU - Grishina, Tamara S.
AU - Zhaboedov, Gennadiy D.
AU - Petrenko, Oksana V.
AU - Tymoshenkova, Oksana Vladymyrivna
AU - Vitovska, Oksana P.
AU - Kurilina, Olena I.
AU - Parkhomenko, Oleg G.
AU - Pasechnokova, Natalija V.
AU - Korol, Andriy Rostislavovich
AU - Klyuev, Georgiy O.
AU - Romodanova, Kateryna Sergeevna
AU - Nevska, Alla
AU - Padanevych, Emiliya
AU - Kaljurand, Kuldar
AU - Pastak, Marko
AU - Seljagina, Natalia
AU - Palumaa, Kadi
AU - Somma, Kaire
AU - Laganovska, Guna
AU - Baumane, Kristine
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
KW - Additive
KW - Adjunctive
KW - Glaucoma
KW - Intraocular pressure
KW - Tafluprost
KW - Timolol
UR - http://www.scopus.com/inward/record.url?scp=65249101762&partnerID=8YFLogxK
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U2 - 10.1177/112067210901900207
DO - 10.1177/112067210901900207
M3 - Article
C2 - 19253237
AN - SCOPUS:65249101762
SN - 1120-6721
VL - 19
SP - 214
EP - 222
JO - European Journal of Ophthalmology
JF - European Journal of Ophthalmology
IS - 2
ER -