Seguridad de los iSGLT-2. Revisión de las reacciones adversas notificadas a nivel nacional

espanolObjetivo Conocer las reacciones adversas medicamentosas (RAM) producidas por los inhibidores del co-transportador sodio-glucosa tipo 2 (iSGLT-2) notificadas en Espana desde su comercializacion. Material y metodos Estudio de todas las notificaciones existentes en la base de datos del Sistema Espanol de Farmacovigilancia de medicamentos de uso humano derivadas del uso de iSGLT-2. Resultados Se recopilaron 311 notificaciones: 169 relacionadas con dapagliflozina (54,34%), 81 con empagliflozina (26,05%) y 61 con canagliflozina (19,61%). El 52,1% de los pacientes fueron mujeres y el 47,6%, hombres. La edad media fue de 62,07 ± 12,176 anos. Un total de 167 notificaciones (53,7%) fueron clasificadas como no-graves y 144 (46,3%), como graves. Se notificaron 534 RAM, siendo las mas frecuentes las infecciones del tracto urinario (37 casos; 6,9%), cetoacidosis diabetica (30; 5,6%), balanopostitis (24; 4,5%), cetoacidosis (16; 3%), candidiasis vulvovaginal (16; 3%), mareo (11; 2,1%) y disuria, balanitis candidiasica y prurito vulvovaginal (10; 1,9%). El desenlace de las 534 RAM fue: recuperado sin secuelas, 55,6%; todavia no recuperado, 14%; no recuperado, 4,9%; mortal, 1,1%, y desconocido, 24,3%. Conclusiones La mayoria de las RAM notificadas son infecciones del tracto urogenital, cetoacidosis y dano renal, y aunque las primeras en su mayoria no fueron graves, la cetoacidosis y el dano renal si lo fueron, generando ingresos y haciendo peligrar la vida de los pacientes, por lo que creemos que ello nos obliga a hacer una prescripcion cuidadosa, a consultar las advertencias publicadas por las autoridades sanitarias y notificar cualquier RAM que se sospeche de esta familia terapeutica para su mejor y mas completo conocimiento. EnglishObjective To analyse the adverse drug reactions (ADRs) caused by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) notified in Spain since they have been on the market. Material and methods An analysis was made of all the notifications registered in the Spanish Pharmacovigilance System of drugs for human use, arising from the use of SGLT2i. Results A total of 311 notifications were recorded, of which 169 (54.34%) were related to dapagliflozin, 81 (26.05%) to empagliflozin, and 61 (19.61%) to canagliflozin. There was a ratio of 52.1% women to 47.9% men. The mean age was 62.07 ± 12.17 years. There were 167 (53.7%) notifications were classified as non-serious and 144 (46.3%) as serious. A total of 534 ADRs were notified, with the most common being urinary tract infections in 37 (6.9%) cases, diabetic ketoacidosis in 30 (5.6%), balanoposthitis in 24 (4.5%), ketoacidosis in 16 (3%), vulvovaginal candidiasis in 16 (3%), dizzy spells in 11 (2.1%), and 10 (1.9%) with dysuria, Candida balanitis, and vulvovaginal pruritus. As regards the outcomes of the 534 ADRs, 55.6% recovered with no sequelae, with 14% still recovering, 4.9% not recovered, fatal in 1.1%, and unknown in 24.3%. Conclusions The majority of the ADRs notified are infections of the urogenital tract, ketoacidosis, and kidney damage. Although the majority of the former were not serious, the ketoacidosis and kidney damage were, leading to hospital admission and being life threatening in some patients. For these reasons, it is recommended that they are, prescribed with caution, the warnings published by the health authorities consulted, as well as notify any ADR that is suspected in this therapeutic group, in order to improve and provide us with further knowledge.