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J. Garcia-Sanchez, Xalacom Study Group; Efficacy and Safety of the Fixed Combination Latanoprost/Timolol versus the Unfixed Combination Brimonidine/Timolol in Patients with Elevated Intraocular Pressure: A 6-month, Masked-evaluator Study . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2198.
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Purpose: To compare the intraocular pressure (IOP)-lowering effect and safety of the fixed combination of latanoprost and timolol with that of the unfixed combination of brimonidine and timolol in patients with elevated IOP. Methods: This 6-month randomized, parallel-group study was conducted at 34 European sites. Patients with primary open-angle, pigmentary, or exfoliative glaucoma, or ocular hypertension with IOPs >20 mmHg on monotherapy, or >16 mmHg on dual therapy were included. Patients received either the fixed combination of latanoprost 0.005% and timolol 0.5% once daily at 8 AM, or the unfixed combination of brimonidine 0.2% and timolol 0.5% twice daily at 8 AM and 8 PM. At baseline and after 6 months of therapy, masked evaluators measured IOP in triplicate at 8 AM, 12 noon, and 4 PM. The primary efficacy outcome measure was the difference between groups in mean diurnal IOP reduction from baseline through 6 months of treatment. Diurnal IOP was calculated as the average of the 8 AM, 12 noon, and 4 PM IOP time-point values. Results: 325/334 randomized patients were included in intent-to-treat analyses (latanoprost/timolol, 163; brimonidine/timolol, 162). Mean (SD) baseline diurnal IOP levels were similar: 26.4 (2.70) and 26.5 (2.75) mmHg in each group, respectively; P=.851. At Month 6, mean diurnal IOP was reduced to 16.9 (2.75) mmHg in latanoprost/timolol patients and to 18.2 (3.06) mmHg in the brimonidine/timolol group. The estimated difference between treatment groups of the reduction by ANCOVA analysis was 1.3 mmHg (95% CI: 0.7, 1.9). No adverse events were reported by 76.4% and 75.5% of patients in the latanoprost/timolol and brimonidine/timolol groups, respectively. However, compared with the latanoprost/timolol group, a larger proportion of brimonidine/timolol-treated patients reported adverse events related to study medication (7.3% versus 18.6%) and more discontinued due to adverse advents (1.8% versus 10.8%). Conclusions: The fixed combination of latanoprost/timolol is more effective and better tolerated than the unfixed combination of brimonidine and timolol.
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