Estudio de eventos adversos asociados al consumo de diferentes antidiabéticos en Colombia entre 2013 – 2018
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Objetivo: Realizar un estudio de eventos adversos (EA) en relación con el consumo de diferentes antidiabéticos en el periodo 2013-2018.
Métodos: estudio de corte trasversal retrospectivo utilizando las bases nacionales de ventas de medicamentos (SISMED) y los reportes de Eventos Adversos (INVIMA) de los actores de la red Nacional de Farmacovigilancia. Se calculó la Dosis Diaria Definida (DDD) por 1000 hab./día, número de reportes de EA, SOC afectado, seriedad y evaluación de causalidad. Se identificaron señales con el método de razón de notificación proporcional (PRR). Se comparó el consumo expresado en DDD por 1000 hab./día con el número de EA notificados.
Resultados: Se revisaron 1.066 registros de ventas y 1739 reportes de EA. De acuerdo a los datos registrados los iDPP-4 son los más consumidos (DDD= 3,24; EA=252), seguidos por los iSGLT-2 (DDD=0,94; EA=490) y los ARGLP-1 (DDD=0,385; EA=815). El medicamento más consumido fue sitagliptina. Exenatida fue el medicamento con el mayor número de notificaciones. El análisis de desproporcionalidad permitió identificar 8 señales: pancreatitis/vildagliptina (PRR=7,47 IC95%=1,66-33,57), amputaciones/liraglutida (PRR=11,03 IC95%=1,15-105,67), neoplasia-dapagliflozina y empagliflozina (PRR= 18,20 IC95%=3,84-86,28 y PRR=5,07 IC95%=1,04-24,08), urosepsis-empagliflozina (PRR=4,75 IC95%=1,78-12,71) extrasístoles supraventriculares-vildagliptina (PRR=94,85 IC95%=10,75-836,45), hiperglucemia-dapagliflozina (PRR=36,40 IC95%=6,33-209,44), infartos agudos al miocardio-exenatida y lixesenatida (PRR=6,70 IC95%=2,30-19,47 y PRR=11,05 IC95%= 76,22) y dolor abdominal-sitagliptina (PRR= 11,86 IC95%=3,03-46,33).
Conclusiones: No parece existir una relación entre las variables consumo -población expuesta- y número de notificaciones, que confirma la infra notificación de los sistemas de farmacovigilancia, sin embargo los iSGLT2 parecen presentar un crecimiento proporcional al incremento de notificaciones en función al consumo.
Aims: To appraise the notified adverse events (AE) survey related with the drug consume of antidiabetic drugs between 2013-2018. Methods: A transverse cross-sectional study was planned using the national database of sales of medicines (SISMED) and AE (INVIMA). Reports related to the research molecules were included. The variables to be evaluated included: DDD per 1000 hab-days, number of AE reports, affected SOC, seriousness and causality evaluation. The proportional reporting ratio method (PRR) was used to evaluate the existence of signals. Consumption expressed as DDD per 1000 population days was compared to the number of reported AE. Results: 1,066 sales registers and 1,739 AE reports were reviewed. According to the data, DPP-4 inhibitors are most consumed drug (DDD= 3,24; AE=252), followed by SGLT-2 inhibitors (DDD=0,94; AE=490) and finally GLP-1 RA (DDD=0,385; AE=815). The most consumed drug was sitagliptin. Exenatide was the drug with the highest number of notifications. The proportional reporting ratio allowed to identify 8 signals: pancreatitis-vildagliptin (PRR=7,47 CI95%=1,66-33,57), amputations-liraglutide (PRR=11,03 CI95%=1,15-105,67), neoplasia-dapagliflozin and empagliflozin (PRR= 18,20 CI95%=3,84-86,28 and PRR=5,07 CI95%=1,04-24,08), urosepsis-empagliflozin (PRR=4,75 CI95%=1,78-12,71) supraventricular extrasystole-Vildagliptin (PRR=94,85 CI95%=10,75-836,45), Hyperglycemia-dapagliflozin (PRR=36,40 CI95%=6,33-209,44), Acute myocardial infarctions-exenatide and lixisenatide (PRR=6,70 CI95%=2,30-19,47 and PRR=11,05 CI95%= 76,22) and abdominal pain -sitagliptina (PRR= 11,86 CI95%=3,03-46,33). Conclusions: It was found that there were not a clear behavior that related both variables as it was expected (More exposed population, they will consume more, more notifications are going to be submitted), nevertheless SGLT2 inhibitors seem to have a proportional growth of notifications of AE in function to drug consume.
Aims: To appraise the notified adverse events (AE) survey related with the drug consume of antidiabetic drugs between 2013-2018. Methods: A transverse cross-sectional study was planned using the national database of sales of medicines (SISMED) and AE (INVIMA). Reports related to the research molecules were included. The variables to be evaluated included: DDD per 1000 hab-days, number of AE reports, affected SOC, seriousness and causality evaluation. The proportional reporting ratio method (PRR) was used to evaluate the existence of signals. Consumption expressed as DDD per 1000 population days was compared to the number of reported AE. Results: 1,066 sales registers and 1,739 AE reports were reviewed. According to the data, DPP-4 inhibitors are most consumed drug (DDD= 3,24; AE=252), followed by SGLT-2 inhibitors (DDD=0,94; AE=490) and finally GLP-1 RA (DDD=0,385; AE=815). The most consumed drug was sitagliptin. Exenatide was the drug with the highest number of notifications. The proportional reporting ratio allowed to identify 8 signals: pancreatitis-vildagliptin (PRR=7,47 CI95%=1,66-33,57), amputations-liraglutide (PRR=11,03 CI95%=1,15-105,67), neoplasia-dapagliflozin and empagliflozin (PRR= 18,20 CI95%=3,84-86,28 and PRR=5,07 CI95%=1,04-24,08), urosepsis-empagliflozin (PRR=4,75 CI95%=1,78-12,71) supraventricular extrasystole-Vildagliptin (PRR=94,85 CI95%=10,75-836,45), Hyperglycemia-dapagliflozin (PRR=36,40 CI95%=6,33-209,44), Acute myocardial infarctions-exenatide and lixisenatide (PRR=6,70 CI95%=2,30-19,47 and PRR=11,05 CI95%= 76,22) and abdominal pain -sitagliptina (PRR= 11,86 CI95%=3,03-46,33). Conclusions: It was found that there were not a clear behavior that related both variables as it was expected (More exposed population, they will consume more, more notifications are going to be submitted), nevertheless SGLT2 inhibitors seem to have a proportional growth of notifications of AE in function to drug consume.
Abstract
Palabras clave propuestas
Adverse events; Eventos adversos; Drug consumption data; Datos de consumo de medicamentos; GLP-1 receptor analogues; Inhibidores de dipeptidil peptidasa; DPP-4 inhibitors; Análogos del receptor GLP-1; Inhibidores del cotransportador SGLT2; SGLT2 cotransporter inhibitors; Desproporcionalidad; Disproportionality; Farmacovigilancia; Pharmacovigilance