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A comparison of bimatoprost 0.03% versus the fixed-combination of latanoprost 0.005% and timolol 0.5% in adult patients with elevated intraocular pressure: an eight-week, randomized, open-label trial.

Author(s): Facio AC, Reis AS, Vidal KS, de Moraes CG, Suzuki R, Hatanaka M, Susanna R

Affiliation(s): Glaucoma Service, Department of Ophthalmology, University of Sao Paulo School of Medicine, Sao Paulo, Brazil.

Publication date & source: 2009-10, J Ocul Pharmacol Ther., 25(5):447-51.

Publication type: Comparative Study; Randomized Controlled Trial

INTRODUCTION AND PURPOSE: Bimatoprost and the fixed combination of latanoprost with timolol maleate are 2 medications widely used to treat glaucoma and ocular hypertension (OHT). The aim of the study is to compare the efficacy of these 2 drugs in reducing intraocular pressure (IOP) after 8 weeks of treatment in patients with primary open angle glaucoma (POAG) or OHT. METHODS: In this randomized, open-label trial, 44 patients with POAG or OHT were allocated to receive either bimatoprost (1 drop QD) or latanoprost/timolol (1 drop QD). Primary outcome was the mean diurnal IOP measurement at the 8th week, calculated as the mean IOP measurements taken at 8:00 am, 10:00 am, and 12:00 pm Secondary outcomes included the baseline change in IOP measured 3 times a day, after the water-drinking test (performed after the last IOP measurement), and the assessment of side effects of each therapy. RESULTS: The mean IOP levels of latanoprost/timolol (13.83, SD = 2.54) was significantly lower than of bimatoprost (16.16, SD = 3.28; P < 0.0001) at week 8. Also, the change in mean IOP values was significantly higher in the latanoprost/timolol group at 10:00 am (P = 0.013) and 12:00 pm (P = 0.01), but not at 8:00 am (P = ns). During the water-drinking test, there was no significant difference in IOP increase (absolute and percentage) between groups; however, there was a significant decrease in mean heart rate in the latanoprost/timolol group. Finally, no significant changes in blood pressure and lung spirometry were observed in either groups. CONCLUSIONS: The fixed combination of latanoprost/timolol was significantly superior to bimatoprost alone in reducing IOP in patients with POAG or OHT. Further studies with large sample sizes should be taken to support the superior efficacy of latanoprost/timolol, as well as to better assess its profile of side effects.

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