Seguridad de fármacos antineoplásicos e inmunomoduladores aplicados a la neurología

Martino, Gabriel; Rojas, Galeno; Paz, María Pilar Sánchez de; Isa, Santiago; Bullrich, María Bres; Camino, María Victoria; Hierro, Xavier Merchán-del; Aldinio, Victoria; Parisi, Virginia; Persi, Gabriel; Silva, Nahuel Pereira de; Gatto, Emilia

doi:10.1016/j.neuarg.2019.03.001

Cited by 5 publications

(4 citation statements)

References 26 publications

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“…La mayoría de estos fármacos son probados en condiciones favorables, es decir, que se prueban en pocos ensayos clínicos de corta duración, los cuales frecuentemente incluyen una menor cantidad de pacientes en comparación con los ensayos de fármacos convencionales. Debido a esto, podría haber una limitación en el conocimiento de las RAM a la hora de introducir estos fármacos en el mercado, y la información acerca de potenciales problemas de seguridad a largo plazo podría ser desconocida (22,23) .…”

Section: Discussionunclassified

Seguridad y tolerabilidad de cabozantinib en cáncer renal y hepatocarcinoma

Furelos

Bueno²,

Legazpi³

et al. 2022

Ars Pharm

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Introducción: Cabozantinib es un fármaco indicado en el tratamiento de cáncer renal y hepatocarcinoma con eficacia demostrada en ensayos clínicos. Sin embargo, cuando analizamos su perfil de seguridad, los propios ensayos pivotales muestran un elevado porcentaje de efectos adversos, siendo necesario en muchos casos reducir la dosis o interrumpir el tratamiento debido a la toxicidad. Por ello, nuestro estudio pretende analizar la tolerabilidad y seguridad de cabozantinib en nuestra población. Método: Estudio observacional, retrospectivo y unicéntrico. Se evaluaron diferentes variables relacionadas con la seguridad y tolerabilidad del fármaco. Para valorar la toxicidad se utilizaron los criterios del National Cancer Institute (CTCAE versión 5.0). La tolerancia se evaluó basándose en la presencia de efectos adversos durante el tratamiento con cabozantinib. Se realizó un análisis estadístico descriptivo e inferencial de los datos. Resultados: Se incluyeron un total de 17 pacientes (edad media: 63,5 años). Todos ellos presentaron efectos adversos. Las principales toxicidades presentadas de cualquier grado fueron astenia, diarrea, toxicidad cutánea, hipomagnesemia, hipertransaminemia y síndrome palmo-plantar. Un 41,2% fueron de grado 3, siendo las principales reacciones adversas la hipertransaminemia y la hipomagnesemia. Un 23,5% necesitaron un ingreso hospitalario debido a la toxicidad del fármaco. Un 94,1% de pacientes precisaron reducción de dosis por toxicidad a 40 mg. Conclusiones: Cabozantinib presenta un perfil de seguridad poco favorable con un alto porcentaje de efectos adversos que obligan a la reducción de dosis o a la interrupción del tratamiento.

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Section: Discussionunclassified

Seguridad y tolerabilidad de cabozantinib en cáncer renal y hepatocarcinoma

Furelos

Bueno²,

Legazpi³

et al. 2022

Ars Pharm

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“…Considering the major assets of the current research and the few ones published in Argentina, this might be the first one which has a detailed analysis of neurological diseases (Martino et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

Pharmacovigilance in Neuroscience

Sánchez-de-Paz

Da-Prat-de-Magalhaes

Isa

et al. 2021

JACN

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Background: Adverse drug reactions (ADRs) have a high impact on morbidity and mortality of the population, becoming a public health issue. Studying and publishing about these is referred as pharmacovigilance.Objective: To describe and compare the adverse reactions produced by drugs of nervous system action (CNS-D) and neurological ADRs produced by drugs of systemic action (Sys-D). To further develop the need of reporting adverse reactions. Methods: An observational, cross-sectional, retrospective study performed on a database of neurological consultations which took place at the Neurology department. Patients meeting the inclusion criteria were selected and divided into two groups: Sys-D and CNS-D. Demographic and neurological variables were analyzed. Parametric and non-parametric statistics were used according to distribution. The Naranjo Algorithm (NA) was used to define causality.Results: 71 ADRs were described, from which 63.38% (n=45) were produced by CNS-D, especially antiepileptics by 47% (n=21) and psycholeptics by 44%. Of the total, 36.62% (n=26) were caused by Sys-D, such as antineoplastics (n=9) and antibiotics (n=9), being Cefepime the most frequent. The diagnosis of ADRs caused by a Sys-D was delayed prolonging hospitalization (p 0.05) due to a lower NA score (p 0.003) compared to the CNS-D group.Conclusion: Multiple frequently used drugs of systemic action, such as antineoplastics and antibiotics, generate neurological adverse effects. From our analysis, it was presumed that the suspicion of a neurological ADR caused by these drugs was scarce, thus causing a higher morbidity for the patient.

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“…In cancer patients, MEs play a highly important role, since the prevalence of cancer and the rapid development of new treatments have given rise to a larger diversity of cancer therapies in recent years [10][11][12] . Antineoplastic drugs are considered to be of high risk, which is why concern about treatment safety has paralleled the development and expansion of cancer treatments over the past decades 13,14 .…”

Section: Introductionmentioning

confidence: 99%

Retrospective study of medication errors and their impact on the safety of the oncological patient

Mejía-Salas,

Morales-Pérez,

Osorio-Espinoza

2024

GAMO

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Background: Medication errors (MEs) are an unintentional failure in the oncological treatment process. The analysis of ME is necessary, since in recent years, there has been a great diversity of cancer therapies. Objective: To identify the factors that predispose and trigger ME in the State Oncological Center ISSEMYM. Method: This was an retrospective cross-sectional study in which the proportion of ME extracted from the database of the clinical pharmacy service during the 2015-2020 period were quantified, classified according to the Ruiz-Garabo update. For the analysis, descriptive statistics were used with frequency values, percentages, and contingency tables with the Chi-square test (χ 2 ) and odds ratio. Results: A total of 10,542 MEs were obtained, of which 7725 were avoided, which shows the importance of the participation of the pharmaceutical staff involved in the pharmacological therapeutic stage. Conclusion: The pharmacist ensures the continuous improvement of the procedures and the guarantee of patient safety oncology.

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Seguridad de fármacos antineoplásicos e inmunomoduladores aplicados a la neurología

Cited by 5 publications

References 26 publications

Seguridad y tolerabilidad de cabozantinib en cáncer renal y hepatocarcinoma

Seguridad y tolerabilidad de cabozantinib en cáncer renal y hepatocarcinoma

Pharmacovigilance in Neuroscience

Retrospective study of medication errors and their impact on the safety of the oncological patient

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