Acta clinica Croatica, Vol. 49 No. 4, 2010.
Original scientific paper
Safety and Efficacy of Monotherapy Change to Fixed Combination (travoprost 0,004%/timolol0,5%) in 6 Months Follow up Period
Zdravko Mandić
Katia Novak-Lauš
Lovro Bojić
Smiljka Popović-Suić
Miroslav Ekert
Vukosava Maričić Došen
Goran Pelčić
Damira Clementi
Davor Dobutović
Dubravka Biuk
Renata Iveković
Željko Kovačić
Josip Pavan
Nikola Sušić
Mia Zorić Geser
Iva Krolo
Freja Barišić
Alenka Jurić-Miletić
Katarina Kapeli Dogan
Martina Tomić
Suzana Kovačević
Abstract
Purpose: To assess the safety and efficacy of changing antiglaucoma therapy to the travoprost 0,004%/timolol 0,5% (TTF C) fixed combination from previous monotherapies.
Methods: Prospective, open-label, observational, multicenter cohort. A change was done from prior monotherapy at day 0 to TTF C dosed once a day, regardless in the evening or in the morning, without washout period. Active evaluation of systemic and local tolerability (adverse events), and efficacy ie. intraocular pressure (IOP) lowering was done at control 1 (day 30), control 2 (day 90) and control 3 (day 120).
Results: 40/155/170 patients (79/309/339 eyes) completed the study (120 days/ 90 days/baseline, respectfully). At control 1 excluded were patients with low tolerability (severe hyperemia (6 patients), discomfort (4), chest pain (1)) and non responders (IOP lowering less than 15% from baseline IOP or target IOP >18 mmHg (4 patients)). Mean IOP at control 1 was 15,92±1,85 mm Hg (21,66% reduction) for 155 patients (non responders excluded), at control 2 was for 155 patients 15,67±2,17 mm Hg (21,14% reduction), and at control 3 for 40 patients 16,28±1,59 mm Hg (19,86% reduction). At control 2 analysis of IOP reduction by 4 groups of previous monotherapy (timolol 0,5% (N=33/66), latanoprost 0,005% (N=49/98), betaxolol 0,5% (N=30/60), and travoprost 0,004% (N=43/85) was performed. 40 patients/79 eyes endured to control 3 (after day 90 free samples were not available for all patients). Analysis of IOP reduction by 4 groups of previous monotherapy medications was performed (timolol 0,5%(N=7/14), latanoprost 0,005% (N=14/28), betaxolol 0,5% (N=7/14), travoprost 0,004% (N=12/23)).
Conclusions: Changing patients from prior monotherapy to TTF C can provide on average a further reduction in IOP, while demonstrating a favorable safety profile.
Keywords
Glaucoma – drug therapy; Ocular hypertension – drug therapy; Intraocular pressure – drug effects; Antihypertensive agents – administration and dosage; Drug combinations
Hrčak ID:
84790
URI
Publication date:
20.12.2010.
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