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%/Dorzolamide 2% in Patients With Elevated Intraocular Pressure
| Autor: | D. E. Grigera, Marcelo Lopes da Silva Jordão, Marcelo Hatanaka, Remo Susanna, Wilma L. Barbosa |
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| Rok vydání: | 2008 |
| Předmět: |
Male
genetic structures Timolol Ocular hypertension Glaucoma law.invention Clinical Management Randomized controlled trial Brimonidine Tartrate law Medicine Aged 80 and over Sulfonamides Middle Aged Circadian Rhythm Drug Combinations Treatment Outcome Tolerability Brimonidine Latanoprost Female Glaucoma Open-Angle medicine.drug Adult medicine.medical_specialty Water Drinking Test Thiophenes Tonometry Ocular Young Adult Dorzolamide Quinoxalines Ophthalmology Humans Fluctuations Antihypertensive Agents Intraocular Pressure Aged business.industry Diurnal Tension Curve medicine.disease Dorzolamide-Timolol eye diseases Water-Drinking Test Fixed Combinations Ocular Hypertension Ophthalmic Solutions business Open-Angle Glaucoma |
| Zdroj: | Web of Science Repositório Institucional da UNITAU Universidade de Taubaté (UNITAU) instacron:UNITAU |
| Popis: | Made available in DSpace on 2019-09-12T16:53:50Z (GMT). No. of bitstreams: 0 Previous issue date: 2008 Allergan Inc 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 Lit 4 centers in Brazil and 1 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 AM 10:30 AM, 02:00 PM, and 4:00 PM) 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 mm Hg and 23.43 +/- 4.06 mm Hg 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 mm Hg and 6.91 +/- 3.67 mm Hg. respectively (P = 0.811). The adjusted difference between groups (analysis of covariance) Lit week 8 was not statistically significant (P = 0.847). Mean baseline WDT peak was 27.79 +/- 4.29 mm Hg in the brimonidine/timolol group and 27.68 +/- 5.46 mm Hg in the dorzolamide/timolol group. After 8 weeks of treatment, mean WDT peaks were 20.94 +/- 3.76 mm Hg (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. [Hatanaka, Marcelo; Susanna, Remo, Jr.] Univ Sao Paulo, Sch Med, Sao Paulo, Brazil [Barbosa, Wilma L.] Universidade de Taubaté (Unitau), Sao Paulo, Brazil [Jordao, Marcelo] Hosp Servidor Publ Estadual, Sao Paulo, Brazil [Grigera, Daniel E.] Univ Salvador, Buenos Aires, DF, Argentina |
| Databáze: | OpenAIRE |
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