Background: “Triple whammy” (TW) refers to the simultaneous use of diuretics, renin-angiotensin-aldosterone system inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs). To date, the risk of developing acute kidney injury (AKI) associated to this combination has not been deeply investigated. The objectives are to analyze the incidence of AKI associated to the exposure to “triple whammy” including all NSAIDs versus non-exposure to this combination. Secondarily, the risk of hospitalization, severe adverse events, requirement of renal replacement therapy and mortality will be assessed. Also, the incidence of AKI associated to the exposure to “triple whammy” versus non-exposure will be analyzed, including only metamizole as NSAID. Methods: A systematic literature search of intervention studies and analytical observational studies will be conducted in the Cochrane Library, Medline and EMBASE, among others. AKI 12 months after the last prescription of the triple combination will be the main outcome. Relative frequencies, risk of bias and certainty of evidence will be analyzed. Additionally, sensitivity and subgroup analyses will be performed. Results: Once this systematic review has been completed, the results are expected to provide an estimate of the risk associated with this triple combination and the renal variables, in addition to new guidance on the renal treatment of patients potentially receiving triple therapy. Conclusions: This is intended to be the first systematic review of observational studies to analyse TW combination and AKI's risk based on well-validated epidemiological databases exploring drug safety issues.
Introducción: La pandemia causada por el SARS-Cov-2 ha puesto a la comunidad científica mundial en ritmo acelerado de investigación y busca por un tratamiento efectivo para COVID-19. Objetivo: Identificar y evaluar medicamentos en protocolos latinoamericanos de tratamiento farmacológico para el COVID-19. Método: Se analiza la evidencia y resultados de mega ensayo disponibles hasta la fecha sobre los medicamentos más frecuentes. Resultados: Los medicamentos más frecuentes en protocolos nacionales son hidroxicloroquina, lopinavir/ritonavir y remdesivir. Ninguno de los medicamentos que recopilan mayor cantidad de datos provenientes de estudios clínicos, a excepción de la dexametasona en un subgrupo reducido de pacientes, mostró, hasta el momento, diferencias significativas en la mortalidad. Conclusiones: La situación emergente de la COVID-19 ha determinado la toma de decisiones apresuradas y controversiales con base en estudios cuestionables y/o de baja calidad. Esto pone de relieve el carácter provisorio de la información y la posibilidad de generar cambios a medida que se dispongan de más resultados. La autorización anticipada de medicamentos expone un problema conocido. A pesar de que la agilidad regulatoria es necesaria en este momento, la velocidad no debe sobreponerse a los patrones básicos éticos y de confianza en la evidencia.
Background: “Triple whammy” (TW) refers to the simultaneous use of diuretics, renin-angiotensin-aldosterone system inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs). To date, the risk of developing acute kidney injury (AKI) associated to this combination has not been deeply investigated. The objectives are to analyze the incidence of AKI associated to the exposure to “triple whammy” including all NSAIDs versus non-exposure to this combination. Secondarily, the risk of hospitalization, severe adverse events, requirement of renal replacement therapy and mortality will be assessed. Also, the incidence of AKI associated to the exposure to “triple whammy” versus non-exposure will be analyzed, including only metamizole as NSAID. Methods: A systematic literature search of intervention studies and analytical observational studies will be conducted in the Cochrane Library, Medline and EMBASE, among others. AKI 12 months after the last prescription of the triple combination will be the main outcome. Relative frequencies, risk of bias and certainty of evidence will be analyzed. Additionally, sensitivity and subgroup analyses will be performed. Results: Once this systematic review has been completed, the results are expected to provide an estimate of the risk associated with this triple combination and the renal variables, in addition to new guidance on the renal treatment of patients potentially receiving triple therapy. Conclusions: This is intended to be the first systematic review of observational studies to analyse TW combination and AKI's risk based on well-validated epidemiological databases exploring drug safety issues.
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