TY - JOUR
T1 - Lactic acidosis associated with metformin in patients with moderate to severe chronic kidney disease: Study protocol for a multicenter population-based case-control study using health databases
AU - Pedrós, Consuelo
AU - Ávila, Mónica
AU - Gómez-Lumbreras, Ainhoa
AU - Manríquez, Marcela
AU - Morros, Rosa
PY - 2019/5/30
Y1 - 2019/5/30
N2 - © 2019 The Author(s). Background: The use of metformin in patients with type 2 diabetes mellitus has been associated with lactic acidosis. However, the information available in patients with moderate-severe chronic kidney disease is scarce. Methods: The ALIMAR-C2 study is a case-control study to assess the association between metformin and lactic acidosis in patients with type 2 diabetes mellitus and moderate-severe chronic kidney disease. The study will be performed with computerized registered electronic health records from eight Spanish hospitals linked to their corresponding primary care health areas from 2010 to 2016, comprising approximately 22.1 million person-years of follow-up. Logistic regression will be used to assess the crude and adjusted risk of lactic acidosis associated with metformin use overall and stratifying by use and dose categories, and chronic kidney disease stage. The overall case fatality rate of lactic acidosis, as well as the case fatality rate stratified by chronic kidney disease stage, will be calculated. Discussion: The ALIMAR-C2 study will provide useful information about the risk of lactic acidosis in type 2 diabetes mellitus patients with renal impairment using metformin.
AB - © 2019 The Author(s). Background: The use of metformin in patients with type 2 diabetes mellitus has been associated with lactic acidosis. However, the information available in patients with moderate-severe chronic kidney disease is scarce. Methods: The ALIMAR-C2 study is a case-control study to assess the association between metformin and lactic acidosis in patients with type 2 diabetes mellitus and moderate-severe chronic kidney disease. The study will be performed with computerized registered electronic health records from eight Spanish hospitals linked to their corresponding primary care health areas from 2010 to 2016, comprising approximately 22.1 million person-years of follow-up. Logistic regression will be used to assess the crude and adjusted risk of lactic acidosis associated with metformin use overall and stratifying by use and dose categories, and chronic kidney disease stage. The overall case fatality rate of lactic acidosis, as well as the case fatality rate stratified by chronic kidney disease stage, will be calculated. Discussion: The ALIMAR-C2 study will provide useful information about the risk of lactic acidosis in type 2 diabetes mellitus patients with renal impairment using metformin.
KW - Case-control studies
KW - Chronic kidney failure
KW - Electronic health records
KW - Lactic acidosis
KW - Metformin
KW - Type 2 diabetes mellitus
U2 - https://doi.org/10.1186/s12882-019-1389-8
DO - https://doi.org/10.1186/s12882-019-1389-8
M3 - Article
C2 - 31146690
VL - 20
JO - BMC Nephrology
JF - BMC Nephrology
SN - 1471-2369
M1 - 193
ER -