Efectos de ozurdex en la presión intraocular. Estudio en la práctica clínica / Effects of ozurdex on intraocular pressure. A real life clinical practice study

OBJETIVO: El implante biodegradable de dexametasona ozurdex está aprobado por la Agencia Europea del Medicamento para el tratamiento de uveítis intermedia y posterior y el edema macular tras oclusión venosa retiniana y edema macular diabético. El propósito de este estudio es evaluar los efectos en la presión intraocular en una cohorte de pacientes de la práctica clínica en la vida real. MÉTODOS: Estudio retrospectivo de pacientes tratados con ozurdex en el Hospital Universitario Cruces en un periodo de seguimiento de 6 meses. Se registraron las siguientes variables: edad, sexo, diagnóstico e historia de glaucoma, presión intraocular, tratamiento antihipertensivo y grosor macular medidos antes de la inyección y después de ella tras 1, 2, 4 y 6 meses. Los test estadísticos utilizados fueron: prueba U de Mann-Whitney, test de Chi cuadrado (con corrección de Fisher en caso necesario) y test de Wilcoxon. El nivel de significación estadística se estableció en p < 0,05. RESULTADOS: Se evaluaron los efectos de 75 inyecciones en 67 pacientes (35 mujeres: 52%; edad media: 62 años). La presión intraocular media previa a la inyección fue 15,9 mmHg y 1, 2, 4 y 6 meses tras la inyección: 18,80 (p = 0,627); 18,84 (p = 0,494); 17,02 (p = 0, 796) y 15,5 (p = 0,829). No se observaron diferencias estadísticamente significativas en las medidas de presión intraocular entre pacientes con historia previa de glaucoma y aquellos sin diagnóstico previo. CONCLUSIONES: Ozurdex muestra un perfil de seguridad excelente en términos de presión intraocular en la práctica clínica. Incluso los pacientes con antecedente de glaucoma muestran tal perfil. Ozurdex es una buena opción terapéutica para enfermedades retinianas en estos pacientes

OBJECTIVE: The dexamethasone biodegradable implant, ozurdex, is approved by the US Food and Drug Administration and by the European Medical Agency for the treatment of intermediate and posterior uveitis, and for the treatment of macular edema following retinal vein occlusion and diabetic macular edema. The aim of this study was to assess the effects of intraocular pressure in a cohort of patients from a real-life clinical practice. METHODS: Retrospective review was performed on the clinical records of patients treated with Ozurdex in Hospital Universitario Cruces in a 6 month period. The following variables were recorded: age, gender, diagnosis and history of glaucoma; intraocular pressure, antihypertensive treatment and macular thickness were recorded before the injection, and in the 1st, 2nd, 4th, and 6th months after the injection. Statistical tests: Mann-Whitney U test, Chi square test (with Fisher correction when needed) and Wilcoxon test. The level of statistical significance was set at P<.05. RESULTS: The effects of 75 injections given to 67 patients (35 women: 52%; mean age: 62) were evaluated. Mean intraocular pressure before the injection was 15.9 mmHg and at 1st, 2nd, 4th and 6th months after de injection it was 18.80 (P=.627), 18.84 (P=.494), 17.02 (P=.796) and 15.5 (P=.829), respectively. No statistically significant differences were observed in intraocular pressure measurements at the mentioned follow-up visits between patients with and without a history of glaucoma. CONCLUSIONS: In real-life clinical practice, ozurdex shows an excellent safety profile in terms of intraocular hypertension. Patients with a history of glaucoma may also show this profile, with ozurdex being a good option to treat retinal diseases in these patients

[Effects of ozurdex on intraocular pressure. A real life clinical practice study]. / Efectos de ozurdex en la presión intraocular. Estudio en la práctica clínica.

OBJECTIVE: The dexamethasone biodegradable implant, ozurdex, is approved by the US Food and Drug Administration and by the European Medical Agency for the treatment of intermediate and posterior uveitis, and for the treatment of macular edema following retinal vein occlusion and diabetic macular edema. The aim of this study was to assess the effects of intraocular pressure in a cohort of patients from a real-life clinical practice. METHODS: Retrospective review was performed on the clinical records of patients treated with Ozurdex in Hospital Universitario Cruces in a 6 month period. The following variables were recorded: age, gender, diagnosis and history of glaucoma; intraocular pressure, antihypertensive treatment and macular thickness were recorded before the injection, and in the 1st, 2nd, 4th, and 6th months after the injection. STATISTICAL TESTS: Mann-Whitney U test, Chi square test (with Fisher correction when needed) and Wilcoxon test. The level of statistical significance was set at P<.05. RESULTS: The effects of 75 injections given to 67 patients (35 women: 52%; mean age: 62) were evaluated. Mean intraocular pressure before the injection was 15.9 mmHg and at 1st, 2nd, 4th and 6th months after de injection it was 18.80 (P=.627), 18.84 (P=.494), 17.02 (P=.796) and 15.5 (P=.829), respectively. No statistically significant differences were observed in intraocular pressure measurements at the mentioned follow-up visits between patients with and without a history of glaucoma. CONCLUSIONS: In real-life clinical practice, ozurdex shows an excellent safety profile in terms of intraocular hypertension. Patients with a history of glaucoma may also show this profile, with ozurdex being a good option to treat retinal diseases in these patients.