Administración de Serendictus® en pacientes con infarto cerebral agudo de etiología isquémica. Estudio COURAGE. -2
Fecha
2021
Autores
Cabrera García, Yusnabys
Título de la revista
ISSN de la revista
Título del volumen
Editor
Universidad Central ¨Marta Abreu¨ de Las Villas. Facultad de Química y Farmacia. Departamento de Farmacia
Resumen
La isquemia cerebral es considerada la tercera causa de muerte y la primera de discapacidad en adultos. Serendictus® es una terapia combinada entre el factor de crecimiento epidérmico (EGF) y el péptido liberador de la hormona de crecimiento (GHRP-6), con propiedades citoprotectoras en diferentes contextos experimentales relacionados con el sistema nervioso. Los efectos citoprotectores del EGF y el GHRP - 6 estimulan mecanismos pleiotrópicos de supervivencia, los cuales se han evidenciado en la mayor resistencia al daño en varias líneas celulares ante un amplio espectro de situaciones patogénicas. Ambos principios activos muestran un adecuado perfil de seguridad en seres humanos, en diferentes nichos terapéuticos, al igual que su combinación en pacientes afectados por la problemática de Salud objeto de esta investigación. El presente trabajo incluye los resultados obtenidos la evaluación de la seguridad evaluada en un ensayo clínico fase III, multicéntrico, abierto, controlado y aleatorizado, realizado con Serendictus® en pacientes con infarto cerebral agudo de etiología isquémica en el período de julio 2019 a la actualidad. El análisis de la frecuencia de eventos adversos y sus características nos hacen plantear, en términos de seguridad, que la coadministración EGF+GHRP-6 es segura y tolerable, se presentó la muerte de dos pacientes por eventos adversos representando este 5,3% del total de pacientes. Los resultados en términos de probabilidades de efecto beneficioso y de efectos neurológicos favorables fueron consistentes a través de todos los análisis ya escalas utilizadas, que incluye la evaluación por estratos y de manera global. La intervención farmacológica se asoció a una mayor y significativa supervivencia.
Cerebral ischemia is considered the third cause of death and the first cause of disability in adults. Serendictus® is a combination therapy between epidermal growth factor (EGF) and growth hormone releasing peptide (GHRP-6), with cytoprotective properties in different experimental contexts related to the nervous system. The cytoprotective effects of EGF and GHRP-6 stimulate pleiotropic survival mechanisms, which have been evidenced in the greater resistance to damage in several cell lines in a wide spectrum of pathogenic situations. Both active principles show an adequate safety profile in humans, in different therapeutic niches, as well as their combination in patients affected by the health problem that is the object of this research. The present work includes the results obtained from the safety evaluation evaluated in a phase III, multicenter, open, controlled and randomized clinical trial, carried out with Serendictus® in patients with acute cerebral infarction of ischemic etiology in the period from July 2019 to the present. The analysis of the frequency of adverse events and their characteristics make us consider, in terms of safety, that the co-administration of EGF + GHRP-6 is safe and tolerable; two patients died due to adverse events, representing this 5.3% of the patients total patients. The results in terms of probabilities of beneficial effect and favorable neurological effects were consistent across all the analyzes and at the scales used, including the evaluation by strata and globally. Pharmacological intervention was associated with a longer and significant survival.
Cerebral ischemia is considered the third cause of death and the first cause of disability in adults. Serendictus® is a combination therapy between epidermal growth factor (EGF) and growth hormone releasing peptide (GHRP-6), with cytoprotective properties in different experimental contexts related to the nervous system. The cytoprotective effects of EGF and GHRP-6 stimulate pleiotropic survival mechanisms, which have been evidenced in the greater resistance to damage in several cell lines in a wide spectrum of pathogenic situations. Both active principles show an adequate safety profile in humans, in different therapeutic niches, as well as their combination in patients affected by the health problem that is the object of this research. The present work includes the results obtained from the safety evaluation evaluated in a phase III, multicenter, open, controlled and randomized clinical trial, carried out with Serendictus® in patients with acute cerebral infarction of ischemic etiology in the period from July 2019 to the present. The analysis of the frequency of adverse events and their characteristics make us consider, in terms of safety, that the co-administration of EGF + GHRP-6 is safe and tolerable; two patients died due to adverse events, representing this 5.3% of the patients total patients. The results in terms of probabilities of beneficial effect and favorable neurological effects were consistent across all the analyzes and at the scales used, including the evaluation by strata and globally. Pharmacological intervention was associated with a longer and significant survival.
Descripción
Palabras clave
Enfermedad Cerebrovascular (ECV), Ictus, Terapéutica, Ensayo Clínico, Quimioterapia Combinada