Estudios Clínicos e Información Científica sobre AINES

Desarrollo de las Controversias sobre la Seguridad Cardiovascular y Renal de los Coxibs

Las controversias acerca de la seguridad cardiovascular y renal de los coxibs llegaron a su punto más alto hacia mediados de 2001 con un artículo publicado por Mukherjee, Nissen y Topol en la revista de la asociación médica americana (JAMA)[lviii]. La publicación causó revuelo tanto en los EE.UU. como en el resto del mundo, ya que, los investigadores realizaron hallazgos que sugieren que los coxibs, celecoxib y rofecoxib, incrementan la tasa de eventos adversos cardiovasculares en los pacientes que reciben dichos medicamentos; por consiguiente, ellos sugieren tener precaución al prescribir estos medicamentos a pacientes en riesgo de morbilidad cardiovascular, mientras que se dispone de suficientes datos que puedan dar una definitiva a este asunto.

Sin embargo, los sucesos habían comenzado antes de la publicación de este estudio; a comienzos de 2001, la FDA obligó a los fabricantes de celecoxib y rofecoxib a colocar en las etiquetas de su producto la advertencia de que estos podían causar eventos adversos gastrointestinales. Los fabricantes argumentaron que sus productos pertenecen a una clase aparte de AINES que disminuyen la tasa de esos eventos adversos y que, por lo tanto, no debían obligarlos a colocar la advertencia; la FDA no soportó estos argumentos y los productos continuaron con la advertencia en su etiqueta[lix].

Mas adelante, a mediados del mismo año, la comunidad médica volvió a estremecerse cuando el asesor experto de la FDA, Dr. Wolfe, descubrió que le habían ocultado los datos completos de un estudio sobre la seguridad gastrointestinal de celecoxib. Luego de esto comenzó una controversia pública entre los investigadores y la compañía fabricante del producto, lo cual condujo a una investigación de la FDA[lx],[lxi].

Retomando el artículo del JAMA, este causó gran revuelo en los medios de comunicación y el público en general[lxii],[lxiii],[lxiv],[lxv],[lxvi],[lxvii],[lxviii],[lxix]. La comunidad médica, en los meses posteriores a su publicación, también se ha estado pronunciando, en cartas a las mas prestigiosas revistas médico – científicas[lxx],[lxxi] unos a favor y otros en contra. Lo cierto es que hacen falta muchos estudios clínicos que nos puedan dar más luz sobre estos asuntos.

El uso de los coxib, es un importante avance por lo que hay que esperar para sedimentar esta información, adquirir mayor experiencia y terminar de conocer las complicaciones derivadas con su uso como se ha descrito recientemente a nivel cardiovascular. Su utilidad en otras patologías como la enfermedad de Alzheimer, el síndrome de Barter y en la quimio-prevención del cáncer de colon, le abre una compuerta no menos interesante

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