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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. Electronic supplementary material The online version of this article (10.1186/s12882-019-1389-8) contains supplementary material, which is available to authorized users.

Objectius: Avaluar la morbiditat i la mortalitat dels pacients diabètics hipertensos tractats amb un inhibidor de l'enzim convertidor d'angiotensina (IECA) i / o un antagonista del receptor d'angiotensina II (ARAII) a Catalunya. Mètodes: Estudi de cohorts amb seguiment de fins a 5 anys en pacients amb diabetis mellitus tipus 2 (DM2) i hipertensió arterial (HTA) que van iniciar el tractament amb un IECA o un ARAII entre 2.006 i 2.007, excloent els pacients amb antecedents de malalties cardiovasculars i renals. Les dades provenien de la base de dades SIDIAP i els informes d’alta hospitalària i les variables recollides foren: dades demogràfiques, factors de risc cardiovascular, característiques de la DM2 i HTA, tractament farmacològic, esdeveniments cardiovasculars i renals durant el seguiment i mortalitat. Resultats: Es van incloure 8.371 pacients (5.081 amb IECA, 2.457 amb ARAII i 833 amb tots dos). La meitat eren homes, amb una mitjana (DE) de 66,6 (11) anys i 32% fumadors. La durada de la DM2 va ser de 4 (4,8) anys, 56% amb HbA1c 30 kg/m2. La durada de l’HTA va ser de 3,5 (4,7) anys i només el 25% presentaven TA controlada. En l'anàlisi, segons la inclusió, ajustat per edat, sexe i característiques basals de les malalties, destaca un augment del risc amb ARAII respecte als IECA (HR, IC del 95%) d'AIT (1,67, 1,17 a 2,38) i diàlisi (3, 1,09 a 8,36), però sense diferencies quan es mirava la suma de la morbimortalitat cardiovascular o renal. Els resultats van ser superiors en la suma d’esdeveniments cardiovasculars (1,38, 1,18 a 1,60), en els renals (1,71, 1,42 a 2,05) i en mortalitat global (1,31, 1,07 a 1,60). Conclusions: Les cohorts eren diferents en les característiques basals. El major risc de complicacions i mortalitat que s’observa amb els ARAII en el model cru, desapareix al ajustar-se per les diferencies basals entre les cohorts de IECA i ARAII. La cohort de pacients tractats amb teràpia dual presenta un major risc cardiovascular i renal basal que li confereix una major incidència d’esdeveniments i mortalitat, tot i el tractament., Objectives: to evaluate the morbidity and mortality in hypertensive and diabetic patients treated with an angiotensin converting enzyme inhibitor (ACEI) and/or with an angiotensin II receptor antagonist (ARB) in Catalonia. Methods: Cohort study with a five-year follow up in patients with type 2 diabetes mellitus (T2DM) and hypertension that started treatment between 2006 and 2007. Those with history of cardiovascular and renal diseases were excluded. Data were obtained from SIDIAP database and hospital discharge reports. Variables: demographic characteristics, cardiovascular risk factors, T2DM and hypertension features, drug therapy, cardiovascular and renal events during follow-up and mortality. Results: We included 8,371 patients (5,081 with ACEI, 2,457 with ARB and 833 with both). Half were men, mean (SD) age 66.6 (11) years and 32% smokers. The T2DM duration was 4 (4.8) years, 56% with HbA1c 30 kg/m2. The hypertension duration was 3.5 (4.7) years and only 25% had a controlled blood pressure. The analysis was performed by inclusion treatment, adjusted for age, sex and baseline disease characteristics. An increased risk for transient ischemic attack (HR 1.67, 95%CI 1.17 to 2.38) and dialysis (3, 1,09 to 8,36) is observed with ARBs, in comparison to ACEIs, but no differences were found when looking at the sum of cardiovascular or renal morbimortality. The results were superior in the sum of cardiovascular events (1.38, 1.18 to 1.60), renal events (1.71, 1.42 to 2.05) and global mortality (1.31, 1.07 to 1.60). Conclusions: Cohorts were different in baseline characteristics. The higher risk of complications and mortality for ARBs observed in the unadjusted model disappears when adjusting for baseline differences between the ACEIs and ARBs cohorts. The patient cohort treated with the dual therapy has a basal cardiovascular and renal higher risk, which confers a higher incidence of events and mortality, despite the treatment.