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Miscellaneous (6)

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Abstract #20975 Published in IGR 10-2

Bimatoprost/timolol fixed combination: A 3-month double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension

Brandt JD; Cantor LB; Katz LJ; Batoosingh AL; Chou C; Bossowska I; Ganfort Investigators Group II
Journal of Glaucoma 2008; 17: 211-216

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PURPOSE: To evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months. PATIENTS AND METHODS: Two double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension. RESULTS: Mean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mmHg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P < 0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mmHg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P = 0.003 for FC vs. BIM, and P < 0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P < 0.0001 vs. BIM) and TIM (6.8%, 18/263; P < 0.001 vs. FC). CONCLUSIONS: FC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.

Dr. J.D. Brandt, University of California, Davis, Sacramento, CA, USA

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Classification:

11.13.4 Betablocker and prostaglandin (Part of: 11 Medical treatment > 11.13 Combination therapy)

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