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Expert Opin Drug Saf ; 14(5): 619-23, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25759110

RESUMEN

BACKGROUND: To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost. METHODS: Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pressure (IOP) measurement and ocular surface status (tear film break-up time [TF-BUT], corneal staining and ocular surface disease index [OSDI]) were evaluated at baseline and 6 months later. RESULTS: A total of 44 patients were enrolled. Median (interquartile range [IQR]) baseline IOP was 18 (15.5 - 21) and 16 (14 - 17) mmHg (p < 0.0001) after 6 months. At baseline, 18 (40.9%) patients presented an IOP of < 18 mmHg, 11 (25%) < 16 mmHg, 2 (4.3%) < 14 mmHg and 1 (2.3%) < 12 mmHg; 6 months later the proportions were 36 (81.8%) (p < 0.0001), 21 (47.7%) (p = 0.00075), 8 (18.2%) (p = 0.0143) and 6 (13.6%) (p = 0.0253). Concerning safety, TF-BUT improved from 8 [IQR 6 - 10] to 10 [IQR 8 - 12] s (p < 0.0001). No eye developed corneal staining; punctate keratitis was absent in 13 (29.5%) patients at baseline and in 31 (70.4%) after 6 months (p < 0.001). OSDI changed from 16 (10 - 30) to 9 (2 - 20). CONCLUSIONS: No patient treated with PQ-Travoprost developed ocular surface disease after 6 months of monotherapy, whereas many patients reached a good IOP control with lower IOP values. Ocular surface status statistically improved when examined by TF-BUT and corneal staining.


Asunto(s)
Antihipertensivos/efectos adversos , Polímeros/efectos adversos , Conservadores Farmacéuticos/efectos adversos , Travoprost/efectos adversos , Anciano , Antihipertensivos/administración & dosificación , Compuestos de Benzalconio/efectos adversos , Compuestos de Benzalconio/química , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Humanos , Presión Intraocular/efectos de los fármacos , Latanoprost , Masculino , Persona de Mediana Edad , Hipertensión Ocular/tratamiento farmacológico , Polímeros/química , Conservadores Farmacéuticos/química , Prostaglandinas F Sintéticas/administración & dosificación , Prostaglandinas F Sintéticas/efectos adversos , Travoprost/administración & dosificación
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