Article Text
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.
- FC, fixed combination
- IOP, intraocular pressure
- UFC, unfixed combination
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Footnotes
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MEMBERS OF THE EUROPEAN XALACOM STUDY GROUP
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France: Farida Bouzegaou, Hôpital Saint-Antoine, Paris; Phillipe Denis, Hôpital Edouard Herriot, Lyon; Jean-François Huet, Centre Hospitalier André Mignot, Le Chesnay; Stéphane Jaulerry, Hôpital de Tarbes, Tarbes; Jean-Pierre Pisella, Hôpital Ambroise Paré Service Ophtalmologie, Boulogne; Wilford Williamson, Centre Hospitalier de Pau, Pau.
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Germany: Kurt-Georg Berger, Private Practice, Friedrichsdorf; Heinrich Deuker, Private Practice, Darmstadt; Norbert Freiburg, Private Practice, Plettenberg; Thomas Hamacher, Private Practice, Starnberg; Maria-Luise Scherzer, Private Practice, Regenstauf; Ernst Schmack, Private Practice, Iserlohn; Dietmar Schnober, Private Practice, Werdohl; Reinhard Terlinde, Private Practice, Coesfeld.
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Italy: Massimo G. Bucci, Cattedra di Oftalmología, Rome; E Gandolfo, U.O. di Oculistica, Brescia; Alfredo Reibaldi, Sezione di Oftalmología, Catania.
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Spain: Alfonso Arias, Fundación Hospital Alcorcón, Alcorcón; Josep Callizo, Hospital Joan XIII, Tarragona; Francisco Honrubia, Hospital Miguel Servet, Zaragoza; Soledad Jiménez, Hospital Puerta del Mar, Cádiz; Manuel Sánchez-Salorio, Instituto Gallego de Oftalmología, Santiago de Compostela; Pedro Tañá, Hospital General de Alicante, Alicante; Miguel Teus, Hospital Príncipe de Asturias, Alcalá de Henares.
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Switzerland: Jean-Jacques Tritten, Hôpital Communal Ophthalmologie, La Chaux-de-Fonds NE; E Ravinet, Hôpital Ophtalmique, Lausanne.
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United Kingdom: C J MacEwen, Ninewells Hospital, Dundee; Donald Montgomery, Glasgow Royal Infirmary, Glasgow; R Sanders, Queen Margaret Hospital, Dunfermline; Stephen Vernon, Queen’s Medical Centre, Nottingham.