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

被引：5

作者：

Pedros, Consuelo ^{[1
,2
,8
]}

Avila, Monica ^{[3
]}

Gomez-Lumbreras, Ainhoa ^{[4
,5
,10
]}

Mariquez, Marcela ^{[2
,3
]}

Morros, Rosa ^{[4
,6
,7
,9
]}

Videla, Sebastian ^{[8
]}

Prat-Vallverdu, Oriol ^{[10
]}

Fuentes, Inmaculada ^{[11
]}

Valderrama, Angelica ^{[12
]}

Aguilera, Cristina ^{[13
]}

Maria Barriocanal, Ana ^{[14
]}

Saez-Penataro, Joaquin ^{[15
,16
]}

Antonijoan, Rosa ^{[17
]}

Delgado, Claudia E. ^{[18
]}

Llanos, Lucia ^{[19
]}

Laredo, Leonor ^{[20
]}

Aguilar, Monica ^{[21
]}

Sanz, Teresa ^{[22
]}

Hernandez, Montserrat ^{[23
]}

Estevez, Jose C. ^{[24
]}

Ruiz, Sergio ^{[25
]}

Murgui, Lluis ^{[26
]}

Corbella, Xavier ^{[27
]}

Fulladosa, Xavier ^{[28
]}

Perez-Maraver, Manuel ^{[29
]}

Alonso, Virginia ^{[30
]}

Mata-Cases, Manel ^{[31
]}

机构：

[1] Bellvitge Univ Hosp, Clin Pharmacol Dept, Barcelona, Spain

[2] Bellvitge Biomed Res Inst IDIBELL, Barcelona, Spain

[3] Bellvitge Biomed Res Inst IDIBELL, Clin Res & Clin Trials Unit, Barcelona, Spain

[4] Fdn Univ Inst Primary Hlth Care Res Jordi Gol & G, Med Res Unit, Barcelona, Spain

[5] Girona Univ, Dept Med Sci, Girona, Spain

[6] Univ Autonoma Barcelona, Dept Farmacol Terapeut & Toxicol, Barcelona, Spain

[7] Catalan Hlth Inst, Barcelona, Spain

[8] Bellvitge Univ Hosp, Bellvitge Biomed Res Inst IDIBELL, Clin Pharmacol Dept, Barcelona, Spain

[9] Univ Autonoma Barcelona, Unitat Estudis Med, Inst Univ Invest Atencio Primaria IDIAP Jordi Goi, Dept Farmacol Terapeut & Toxicol, Barcelona, Spain

[10] Inst Univ Invest Atencio Primaria IDIAP Jordi Goi, Unitat Estudis Med, Barcelona, Spain

[11] Hosp Univ Vall dHebron, Vall dHebron Inst Recerca, Serv Farmacol Clin, Barcelona, Spain

[12] Vall dHebron Inst Recerca, Barcelona, Spain

[13] Hosp Univ Vail dHebron, Serv Farmacol Clin, Barcelona, Spain

[14] Fundacio Inst Invest Ciencies Salut Germans Trias, Clin Res & Clin Trials Unit UPIC, Barcelona, Spain

[15] Hosp Clin Barcelona, Area Med, Serv Farmacol Clin, Barcelona, Spain

[16] Univ Barcelona, Barcelona, Spain

[17] Hosp Santa Creu & Sant Pau, Serv Farmacol Clin, Barcelona, Spain

[18] St Pau Biomed Res Inst, Clin Res & Clin Trials Unit, Barcelona, Spain

[19] Fdn Jimenez Diaz, Hlth Res Inst, Clin Res & Clin Trials Unit, Barcelona, Spain

[20] Hosp Clin San Carlos, Inst Invest Sanitaria Hosp Clin San Carlos IdISSC, Serv Farmacol Clin, Barcelona, Spain

[21] Ramon Y Cajal Hosp, IRyCIS, Clin Pharmacol Unit, Barcelona, Spain

[22] Gerencia Asistencial Atenc Primaria Madrid, Unidad Apoyo Invest, Madrid, Spain

[23] Asistencial Atenc Primaria Madrid, Gerencia Adjunta Proc Asistenciales, Madrid, Spain

[24] Gerencia Asistencial Atenc Primaria Madrid, Unidad Apoyo Tecn, Madrid, Spain

[25] Gerencia Asistencial Atenc Primaria Madrid, Gerencia Adjunta Proc Asistenciales, Madrid, Spain

[26] Bellvitge Univ Hosp, Subdirectorate Informat Syst, Barcelona, Spain

[27] Bellvitge Univ Hosp, Internal Med Dept, Bellvitge Biomed Res Inst IDIBELL, Barcelona, Spain

[28] Bellvitge Univ Hosp, Nephrol Dept, Bellvitge Biomed Res Inst IDIBELL, Barcelona, Spain

[29] Bellvitge Univ Hosp, Endocrinol Dept, Bellvitge Biomed Res Inst IDIBELL, Barcelona, Spain

[30] Bellvitge Univ Hosp, Intens Med Dept, Bellvitge Biomed Res Inst IDIBELL, Barcelona, Spain

[31] USR Barcelona, Inst Catala Salut, CAP La Mina, Inst Univ Invest Atencio Primaria IDIAP Jordi Gol, Barcelona, Spain

来源：

BMC NEPHROLOGY | 2019年 / 20卷 / 1期

关键词：

Metformin; Type 2 diabetes mellitus; Chronic kidney failure; Lactic acidosis; Case-control studies; Electronic health records; RENAL IMPAIRMENT; RISK; FRAMEWORK;

D O I：

10.1186/s12882-019-1389-8

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：8

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