Acidosis con hiperlactacidemia por metformina: frecuencia de su diagnóstico en la práctica clínica habitual y relación con la insuficiencia renal / Metformin-associated hyperlactacidaemia acidosis: Diagnosis rate in standard clinical practice and its relationship with renal failure

Antecedentes y objetivos: Estudio observacional sobre la diferencia entre el número de casos diagnosticados en situación clínica habitual de acidosis con hiperlactacidemia sospechosa de ser causada por metformina y su incidencia según la ficha técnica. Adicionalmente se exploró la relación con la función renal de la acidosis hiperlactacidémica por metformina. Pacientes: Se identificaron los casos de acidosis entre los años 2013 y 2014 mediante el análisis del CMBD y las peticiones al laboratorio. Se seleccionó a los pacientes que presentaban lactato venoso > 2,7 mmol/L en el momento de ser atendidos y para los que constaba el uso ambulatorio de metformina. La relación causal con la metformina fue evaluada independientemente por varios investigadores. Los casos incidentes se calcularon con base en el número de pacientes a los que se les había dispensado un medicamento que contuviera metformina durante el mismo periodo en el área estudiada. Resultados: Se identificaron 476 casos de acidosis, de los que en 20 se consideró que la metformina era sospechosa de causar el cuadro de acidosis con hiperlactacidemia, lo que supone una incidencia de 6,57/10.000 pacientes. El 85% de los casos presentaban insuficiencia renal aguda. Conclusiones: La incidencia aparente de acidosis con hiperlactacidemia en pacientes tratados con metformina es mayor que la establecida en la ficha técnica (inferior a 1/10.000). El desarrollo de acidosis con hiperlactacidemia por metformina está relacionado con el deterioro agudo de la función renal

Background and objectives: Observational study on the difference between the number of cases of acidosis with hyperlactacidaemia suspected of being caused by metformin diagnosed in standard clinical practice and the incidence of this condition according to the datasheet. The study also explored the relationship between renal function and metformin-associated hyperlactacidaemia acidosis. Patients: We identified cases of acidosis between 2013 and 2014 by analysing the minimum basic data set and laboratory requests. We selected patients who presented venous lactate levels >2.7 mmol/L at the time they were treated and for whom the use of outpatient metformin was confirmed. The causal relationship with metformin was independently evaluated by several researchers. The incident cases were calculated based on the number of patients who had been dispensed a drug containing metformin during the same period in the study area. Results: We identified 476 cases of acidosis. Metformin was suspected of causing the condition of acidosis with hyperlactacidaemia in 20 of these cases, which represents an incidence rate of 6.57/10,000 patients. Eighty-five percent of the cases presented acute renal failure. Conclusions: The apparent incidence of acidosis with hyperlactacidaemia in patients treated with metformin is greater than that established in the datasheet (<1/10,000). The onset of metformin-associated hyperlactacidaemia acidosis is related to acute renal impairment

Metformin-associated hyperlactacidaemia acidosis: Diagnosis rate in standard clinical practice and its relationship with renal failure. / Acidosis con hiperlactacidemia por metformina: frecuencia de su diagnóstico en la práctica clínica habitual y relación con la insuficiencia renal.

BACKGROUND AND OBJECTIVES: Observational study on the difference between the number of cases of acidosis with hyperlactacidaemia suspected of being caused by metformin diagnosed in standard clinical practice and the incidence of this condition according to the datasheet. The study also explored the relationship between renal function and metformin-associated hyperlactacidaemia acidosis. PATIENTS: We identified cases of acidosis between 2013 and 2014 by analysing the minimum basic data set and laboratory requests. We selected patients who presented venous lactate levels >2.7 mmol/L at the time they were treated and for whom the use of outpatient metformin was confirmed. The causal relationship with metformin was independently evaluated by several researchers. The incident cases were calculated based on the number of patients who had been dispensed a drug containing metformin during the same period in the study area. RESULTS: We identified 476 cases of acidosis. Metformin was suspected of causing the condition of acidosis with hyperlactacidaemia in 20 of these cases, which represents an incidence rate of 6.57/10,000 patients. Eighty-five percent of the cases presented acute renal failure. CONCLUSIONS: The apparent incidence of acidosis with hyperlactacidaemia in patients treated with metformin is greater than that established in the datasheet (<1/10,000). The onset of metformin-associated hyperlactacidaemia acidosis is related to acute renal impairment.