RESUMEN
PURPOSE: The aim of this study was to evaluate the one-year efficacy, ability to lower intraocular pressure, and tolerability of ripasudil, a rho-kinase inhibitor, in patients with glaucoma inadequately controlled with maximum medical therapy. METHODS: This prospective, non-comparative, interventional case-series study included 39 patients with primary open-angle glaucoma inadequately controlled with maximum medical therapy before treatment with ripasudil. Ripasudil was administered twice per day as adjunctive therapy to ongoing glaucoma treatment. The primary endpoint was the degree of intraocular pressure reduction after 12 months of treatment; the secondary endpoints were the incidence of adverse events. RESULTS: We examined 39 eyes. The intraocular pressure reduction (given as the relative percentage of intraocular pressure reduction) from baseline was -2.6 mmHg (-15.5%; 95% confidence interval, -1.1 to -3.9 mmHg; P < 0.001) after 12 months of treatment. The adverse events were conjunctival hyperemia (all patients), blepharitis (three), allergic conjunctivitis (two), punctate keratitis (two), and ophthalmalgia (one). CONCLUSIONS: Treatment with ripasudil decreased intraocular pressure in patients with glaucoma that was poorly controlled with maximal medical therapy, and it was well-tolerated.
Asunto(s)
Antihipertensivos/administración & dosificación , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Presión Intraocular/efectos de los fármacos , Isoquinolinas/administración & dosificación , Sulfonamidas/administración & dosificación , Quinasas Asociadas a rho/antagonistas & inhibidores , Adulto , Anciano , Relación Dosis-Respuesta a Droga , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Glaucoma de Ángulo Abierto/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Soluciones Oftálmicas/administración & dosificación , Estudios Prospectivos , Factores de Tiempo , Tonometría Ocular , Resultado del Tratamiento , Adulto JovenRESUMEN
PURPOSE OF THE STUDY: The purpose of the study was to evaluate the intraocular pressure (IOP)-lowering effect and tolerability of ripasudil, a rho-kinase inhibitor, in patients with glaucoma inadequately controlled with maximum medical therapy. PATIENTS AND METHODS: This prospective, noncomparative, interventional case series study included 35 patients with primary open angle glaucoma, in whom the glaucoma was poorly controlled with maximum medical therapy before starting the treatment with ripasudil. Ripasudil was instilled twice a day as adjunctive therapy to the ongoing glaucoma treatment. The primary end point was the degree of IOP reduction after 3 months of treatment, whereas the secondary end points were the percentage of patients reaching the predefined target IOP and the incidence of adverse events. RESULTS: We examined 35 eyes of 35 patients with primary open angle glaucoma. The IOP reduction (relative percentage IOP reduction) from baseline was -2.8 mm Hg (-15.5%; 95% confidence interval, -1.6 to -3.9 mm Hg; P<0.001) after 3 months of treatment. The predefined target IOP was achieved in 48.5% (17/35) of the patients. The adverse events were conjunctival hyperemia (all patients), allergic conjunctivitis (2 patients), and ophthalmalgia (1 patient). CONCLUSIONS: The addition of ripasudil was effective in lowering the IOP in patients with glaucoma poorly controlled with maximal medical therapy; moreover, the drug was well tolerated. In 48.5% of the patients in whom the predefined target IOP was achieved, this adjunctive therapy helped avoid glaucoma surgery at least in the short term.