Bimatoprost/timolol fixed combination versus latanoprost in treatment-naïve glaucoma patients at high risk of progression: a pilot study.

Objective To compare a fixed combination of 0.03% bimatoprost and 0.5% timolol (BTFC) with latanoprost monotherapy (LM) in treatment-naïve patients with open-angle glaucoma (OAG) and risk factors for glaucomatous progression. Methods Patients were enrolled at 15 sites in Spain and Portugal, and were...

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Detalles Bibliográficos
Autores: Gutierrez Díaz, Esperanza, Silva Cotta, Jose, Muñoz Negrete, Francisco J., Gutierrez Ortiz, Consuelo, Morgan Warren, Robert J., Maltman, John, Millá, Elena, GIFT study group
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2014
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/112644
Acceso en línea:https://hdl.handle.net/2445/112644
Access Level:acceso abierto
Palabra clave:Glaucoma
Terapèutica oftalmològica
Oftalmologia
Ophthalmological therapeutics
Ophthalmology
Descripción
Sumario:Objective To compare a fixed combination of 0.03% bimatoprost and 0.5% timolol (BTFC) with latanoprost monotherapy (LM) in treatment-naïve patients with open-angle glaucoma (OAG) and risk factors for glaucomatous progression. Methods Patients were enrolled at 15 sites in Spain and Portugal, and were randomized 1:1 to BTFC or LM. Patients instilled one drop of medication once per day at 8 pm for 12 weeks. The primary outcome was change in intraocular pressure (IOP) at 12 weeks. Results Of 81 patients enrolled, 43 were randomized to BTFC and 38 to LM. Mean (SD) change in IOP from baseline to 12 weeks was significantly greater for BTFC than for LM: −13.5 mmHg (4.48) versus −11.4 mmHg (3.19), respectively (P=0.003). Similarly, at 12 weeks, significantly more BTFC patients than LM patients had IOP reductions of ≥40% (74.4% versus 47.4%, P=0.015) or ≥50% (46.5% versus 15.8%, P=0.003). Adverse events were more frequent with BTFC than with LM (33 versus 13 events), but most were mild in severity. The only serious adverse event (colon cancer) was adjudged unrelated to the study medication. Conclusion BTFC was effective and well tolerated in treatment-naïve patients with OAG at high risk of progression