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Abstract #22467 Published in IGR 10-4
An eight-week, multicentric, randomized, interventional, open-label, phase-4, parallel comparison of the efficacy and tolerability of the fixed combination of timolol maleate 0.5%/brimonidine tartrate 0.2% versus fixed combination of timolol maleate 0.5%
Hatanaka M; Grigera DE; Barbosa WL; Jordao M; Susanna R JrJournal of Glaucoma 2008; 17: 674-679
PURPOSE: To compare the efficacy and tolerability of the fixed combination of timolol maleate 0.5%/brimonidine tartrate 0.2% versus fixed combination of timolol maleate 0.5%/dorzolamide 2% in patients with elevated intraocular pressure (IOP) over 8 weeks. PATIENTS AND METHODS: This 8-week, multicentric, interventional, randomized, open-label, parallel group study was conducted at four centers in Brazil and one center in Argentina. Patients with open-angle glaucoma or ocular hypertension were randomized to receive bilaterally fixed combination of brimonidine/timolol maleate 0.5% or fixed combination of dorzolamide 2%/timolol 0.5% twice daily at 8:00 AM and 8:00 PM. A modified diurnal tension curve (8:00 a.m., 10:30 a.m., 02:00 p.m., and 4:00 p.m.) followed by the water drinking test (WDT), which estimates IOP peak of diurnal tension curve, were performed in the baseline and week-8 visits. Adverse events data were recorded at each visit. RESULTS: A total of 210 patients were randomized (brimonidine/timolol, n = 111; dorzolamide/timolol, n = 99). Mean baseline IOP was 23.43 ± 3.22 mmHg and 23.43 ± 4.06 mmHg in the patients treated with brimonidine/timolol and dorzolamide/timolol, respectively (P = 0.993). Mean diurnal IOP reduction after 8 weeks were 7.02 ± 3.06 mmHg and 6.91 ± 3.67 mmHg, respectively (P = 0.811). The adjusted difference between groups (analysis of covariance) at week 8 was not statistically significant (P = 0.847). Mean baseline WDT peak was 27.79 ± 4.29 mmHg in the brimonidine/timolol group and 27.68 ± 5.46 mmHg in the dorzolamide/timolol group. After 8 weeks of treatment, mean WDT peaks were 20.94 ± 3.76 mmHg (P < 0.001) and 20.98 ± 4.19 (P < 0.001), respectively. The adjusted difference between groups (analysis of covariance) was not statistically significant (P=0.469). No statistical difference in terms of adverse events was found between groups. CONCLUSIONS: Both fixed combinations were capable of significantly reducing the mean diurnal IOP, mean diurnal peak, and mean WDT peak after 8 weeks of treatment. Also, both fixed combinations are well tolerated with few side effects.
Dr. M. Hatanaka, University of São Paulo School of Medicine, Sao Paulo, Brazil
