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A comparison of the fixed combination of latanoprost and timolol with the unfixed combination of brimonidine and timolol in patients with elevated intraocular pressure. A six month, evaluator masked, multicentre study in Europe

¹ Hospital Clínico San Carlos, Madrid, Spain
² Hôpital Huriez, Lille, France
³ Klinikum der Universitat Regensburg, Regensburg, Germany
⁴ Klinik Pallas, Olten, Switzerland
⁵ Solihull Hospital, Solihull, UK
⁶ Clinica Oculistica, DiNOG Università di Genova, Genova, Italy
⁷ Pharmacia Corporation, Markham, Ontario, Canada

Correspondence to:
Correspondence to:
Professor J García-Sánchez
Hospital Clínico San Carlos, Servicio de Oftalmología, Pabellón, 8, 5a Planta, Ciudad Universitaria s/n, 28040 Madrid, Spain; iiorcdir{at}med.ucm.es

ABSTRACT
Purpose: To compare the intraocular pressure (IOP) reducing effect and safety of fixed combination (FC) latanoprost/timolol with unfixed combination (UFC) brimonidine/timolol in patients with increased IOP.

Methods: In this 6 month, randomised, evaluator masked, parallel group European study, patients with glaucoma or ocular hypertension and IOP 21 mm Hg on monotherapy or >16 mm Hg on dual therapy received either FC latanoprost/timolol at 8:00AM or UFC brimonidine/timolol at 8:00AM and 8:00PM. The primary outcome was the difference from baseline to month 6 in mean diurnal IOP reduction.

Results: 325 of 334 randomised patients were included in intent to treat analyses (FC latanoprost/timolol, 163; UFC brimonidine/timolol, 162). Baseline diurnal IOP levels were similar: FC latanoprost/timolol, 26.4 (SD 2.7) mm Hg; UFC brimonidine/timolol, 26.5 (SD 2.8) mm Hg (p = 0.851). At month 6, levels were 16.9 (SD 2.8) mm Hg in FC latanoprost/timolol patients and 18.2 (SD 3.1) mm Hg in UFC brimonidine/timolol patients (p<0.001). No adverse events were reported by 76.4% and 75.5% of patients receiving FC latanoprost/timolol versus UFC brimonidine/timolol, respectively. Larger proportions of brimonidine/timolol treated patients reported study medication related adverse events (18.6% v 7.3%) and discontinued study participation because of this (10.8% v 1.8%).

Conclusion: Fixed combination latanoprost/timolol administered once daily is both more effective and better tolerated than twice daily dosing with UFC brimonidine/timolol.

Abbreviations: FC, fixed combination; IOP, intraocular pressure; UFC, unfixed combination

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				A T Fung, S E Reid, M P Jones, P R Healey, P J McCluskey, and J C Craig Meta-analysis of randomised controlled trials comparing latanoprost with brimonidine in the treatment of open-angle glaucoma, ocular hypertension or normal-tension glaucoma Br. J. Ophthalmol., January 1, 2007; 91(1): 62 - 68. [Abstract] [Full Text] [PDF]