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Br J Ophthalmol 2004;88:877-883 doi:10.1136/bjo.2003.029330
  • Clinical science
    • Scientific reports

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. J García-Sánchez1,
  2. J-F Rouland2,
  3. D Spiegel3,
  4. B Pajic4,
  5. I Cunliffe5,
  6. C Traverso6,
  7. J Landry7
  1. 1Hospital Clínico San Carlos, Madrid, Spain
  2. 2Hôpital Huriez, Lille, France
  3. 3Klinikum der Universitat Regensburg, Regensburg, Germany
  4. 4Klinik Pallas, Olten, Switzerland
  5. 5Solihull Hospital, Solihull, UK
  6. 6Clinica Oculistica, DiNOG Università di Genova, Genova, Italy
  7. 7Pharmacia Corporation, Markham, Ontario, Canada
  1. Correspondence to: Professor J García-Sánchez Hospital Clínico San Carlos, Servicio de Oftalmología, Pabellón, 8, 5a Planta, Ciudad Universitaria s/n, 28040 Madrid, Spain; iiorcdirmed.ucm.es
  • Accepted 3 November 2003

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.

Footnotes

  • MEMBERS OF THE EUROPEAN XALACOM STUDY GROUP

  • 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.

  • 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.

  • Italy: Massimo G. Bucci, Cattedra di Oftalmología, Rome; E Gandolfo, U.O. di Oculistica, Brescia; Alfredo Reibaldi, Sezione di Oftalmología, Catania.

  • 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.

  • Switzerland: Jean-Jacques Tritten, Hôpital Communal Ophthalmologie, La Chaux-de-Fonds NE; E Ravinet, Hôpital Ophtalmique, Lausanne.

  • 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.

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