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Los nuevos antidiabéticos en el punto de mira… ¿razones de seguridad o caza de brujas?
Publicado en Endocrinol Nutr. 2012;59:1-8. - vol.59 núm 01
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Introducción
Desde la polémica suscitada por la rosiglitazona, que acabó en septiembre de 2010 con su retirada del mercado por parte de la Agencia Europea del Medicamento (EMEA), los fármacos hipoglucemiantes de reciente introducción en el mercado o aquellos pendientes de su aprobación están en el punto de mira, son estrechamente evaluados y se pone en duda el balance del riesgo/beneficio ante el menor indicio de algún efecto adverso1, 2, 3. Se puede decir que así comienza una especie de caza de brujas por una parte beneficiosa, que obliga a las empresas farmacéuticas a diseñar ensayos clínicos cada vez más exigentes y con unos objetivos que se basan no solo en la mejoría de los parámetros analíticos, sino también en resultados clínicos. Por otro lado, no deberíamos olvidar que, a día de hoy, la diabetes mellitus tipo 2 (DM2) afecta en torno a 350 millones de personas en todo el mundo con la morbimortalidad asociada que ello supone, y que es necesario el desarrollo de nuevos fármacos hipoglucemiantes más potentes y seguros, a fin de poder controlar la pandemia y reducir su comorbilidad4. De hecho, ya en diciembre de 2008, el Comité Asesor de Fármacos Endocrinológicos y Metabólicos de la Food and Drug Administration (FDA) de Estados Unidos consensuó que, para asegurar el beneficio de un nuevo antidiabético, la empresa farmacéutica responsable debería demostrar que el tratamiento en cuestión no compromete la seguridad cardiovascular. Para ello, recomienda que el diseño de ensayos clínicos en fase II y III ...Bibliografía
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Nicolau Ramis, Joanaa; Masmiquel Comas, Lluísa
aServicio de Endocrinología y Nutrición, Hospital Son Llàtzer, Palma de Mallorca, España
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