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Observational Study
. 2021 Jul 9;20(1):139.
doi: 10.1186/s12933-021-01323-5.

Cardiovascular and mortality benefits of sodium-glucose co-transporter-2 inhibitors in patients with type 2 diabetes mellitus: CVD-Real Catalonia

Jordi Real #  1   2 , Bogdan Vlacho #  1 , Emilio Ortega  3   4 , Joan Antoni Vallés  1   5 , Manel Mata-Cases  1   2   6 , Esmeralda Castelblanco  1   2 , Eric T Wittbrodt  7 , Peter Fenici  8 , Mikhail Kosiborod  9 , Dídac Mauricio  10   11   12   13 , Josep Franch-Nadal  14   15   16
Affiliations
Observational Study

Cardiovascular and mortality benefits of sodium-glucose co-transporter-2 inhibitors in patients with type 2 diabetes mellitus: CVD-Real Catalonia

Jordi Real et al. Cardiovasc Diabetol. .

Abstract

Background: Evidence from prospective cardiovascular (CV) outcome trials in type 2 diabetes (T2DM) patients supports the use of sodium-glucose co-transporter-2 inhibitors (SGLT2i) to reduce the risk of CV events. In this study, we compared the risk of several CV outcomes between new users of SGLT2i and other glucose-lowering drugs (oGLDs) in Catalonia, Spain.

Methods: CVD-REAL Catalonia was a retrospective cohort study using real-world data routinely collected between 2013 and 2016. The cohorts of new users of SGLT2i and oGLDs were matched by propensity score on a 1:1 ratio. We compared the incidence rates and hazard ratio (HR) for all-cause death, hospitalization for heart failure, chronic kidney disease, and modified major adverse CV event (MACE; all-cause mortality, myocardial infarction, or stroke).

Results: After propensity score matching, 12,917 new users were included in each group. About 27% of users had a previous history of CV disease. In the SGLT2i group, the exposure time was 60% for dapagliflozin, 26% for empagliflozin and 14% for canagliflozin. The use of SGLT2i was associated with a lower risk of heart failure (HR: 0.59; 95% confidence interval [CI] 0.47-0.74; p < 0.001), all-cause death (HR = 0.41; 95% CI 0.31-0.54; p < 0.001), all-cause death or heart failure (HR = 0.55; 95% CI 0.47-0.63; p < 0.001), modified MACE (HR = 0.62; 95% CI 0.52-0.74; p < 0.001), and chronic kidney disease (HR = 0.66; 95% CI 0.54-0.80; p < 0.001).

Conclusions: In this large, retrospective observational study of patients with T2DM from a Catalonia, initiation of SGLT-2i was associated with lower risk of mortality, as well as heart failure and CKD.

Keywords: All-cause mortality; Heart failure; SGLT2i; Type 2 diabetes mellitus.

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Conflict of interest statement

The CVD REAL study was conceived and funded by AstraZeneca, and led by its independent Executive Scientific Board. The CVD REAL Catalonia study design adaptation, data collection and analyses have been conducted independently from AstraZeneca. The manuscript writing, results interpretation and conclusions are those of the authors alone. M. M.-C. has received advisory honorarium from Astra-Zeneca, Bayer, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received speaker honorarium from Astra-Zeneca, Bayer, Boehringer Ingelheim, GSK, Lilly, Menarini, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi. J. F.-N. has received advisory and or speaking fees from Astra-Zeneca, Ascensia, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, Sanofi, and Boehringer. D. M. has received advisory and/or speaking fees from Astra-Zeneca. Ascensia, Boehringer Ingelheim, GSK, Lilly, MSD, Novartis, Novo Nordisk, and Sanofi; he has received research grants to the institution from Astra-Zeneca, GSK, Lilly, MSD, Novartis, Novo Nordisk, Sanofi, and Boehringer. M. K. reports research grants fees from Astra Zeneca, Boehringer Ingelheim; consultant/Advisory Board fees from Amgen, Applied Therapeutics, Astra Zeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Merck (Diabetes), Novo Nordisk, Sanofi and Vifor Pharma; other research support fees from Astra Zeneca, and Honorarium fees from Astra Zeneca, Boehringer Ingelheim, Novo Nordisk. P. F. and E. T. W. are full time employees of AstraZeneca. P. F., M. K. and E. T. W. are members of the CVD REAL Executive Scientific Committee, conceived and led the initial CVD REAL global studies and analyses. J. R. B. V. and E. C. have no conflict of interest to declare.

Figures

Fig. 1
Fig. 1
Incidence rates of the different events per 100 person-years by treatment. CKD chronic kidney disease, HF heart failure, MACE major adverse cardiovascular events, MI myocardial infarction, oGLDs other glucose-lowering drugs, PY patient-years of exposure, SGLT2i sodium–glucose co-transporter inhibitors
Fig. 2
Fig. 2
Forest plot of the adjusted incident hazard ratios (HR) and 95% CI for the different outcomes. CKD chronic kidney disease, CI confidence interval, HF heart failure, MACE major adverse cardiovascular events, HR hazard ratio, MI myocardial infarction, oGLDs other glucose-lowering drugs, PY patient-years of exposure, SGLT2i sodium–glucose co-transporter inhibitors
See this image and copyright information in PMC

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