Acute cardiovascular events in type 2 diabetics treated with SGLT2i. Results of a real life registry
Authors: Goena Vives C , Larranaga Unanue I , Manas Alonso L , Quintas Ovejero L , Andres Imaz N , Moreno Rodrigo A , Maiz Alcorta B , Rico Dadebat N , Arana Suarez T , Diez Irizar S , Larranaga Gomez I , Agirrezabalaga Villar R , Aspiazu Abasolo A , Armentia Del Pozo AC , Egido Arroyo JF 
Published: April 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Introduction and objectives
Sodium-glucose co-transporter type 2 inhibitors (SGLT2i) have proven to reduce risk of cardiovascular outcomes in patients with type 2 diabetes mellitus (T2DM). The aim of this study is to analyse the adverse CV events of acute presentation in a diabetic population with poor control in which treatment with SGLT2i tries to improve it independently of the presence of previous established CV disease.

Material and methods
Retrospective observational study included 544 patients with inadequately controlled TDM2 from 2 hospitals and 10 primary care centres of reference for the 78,000 population. They received a SGLT2i (Empagliflozin, Dapagliflozin or Canagliflozin) as add-on therapy to other glucose-lowering medications between February 2018 and February 2019. Evolution was monitored until February 2020. We analysed the population"s baseline characteristics and the incidence of acute cardiovascular events during follow-up (stroke, peripheral arterial ischemia, ACS, adverse events and death).

Results
544 patients were included, 342 men (63%), with a mean age of 65.94 ± 10.26 years (52.2% &gt; 65 yo). The mean follow-up was 22.62 ± 6.3 months from the start of SGLT2i. Initial HbA1c was 7.95 ± 1.29%, mean BMI 31.39 ± 5.49 kg/m2, preserved renal function with mean GFR of 83.62 ± 0.53 ml/min/1.73 m2 and the duration of diabetes was 12.48 ± 7.75 years. At baseline, 32.5% (N = 177) were on insulin. Prior to the prescription of SGLT2i 11.6% (N = 63) were diagnosed of heart failure and 4.2% (N = 23) had suffered decompensation (during/on/in) the previous year. 23.7% (N = 127) had had previous adverse cardiovascular event: 98 patients injured 1 organ (22 stroke, 57 ischemic heart disease and 19 peripheral arterial ischemia), 24 injured 2 organs and 5 injured 3. A greater proportion of patients (409/544) received Empagliflozin (75.2%) followed by 98 Dapagliflozin (18%) and 37 Canagliflozin (6.8%). Just 16% (N = 87) of the patients discontinued treatment, due to genital infections in 3.1% (N = 17) and 3 drops in GF to &lt; 30 as main causes. Serious complications were rare (2 acidosis, 3 sepsis). No amputations or severe hypoglycaemia were reported. During the follow-up there were 12 deaths (2.2%) because of oncological pathology except for 2 cases of terminal heart failure. The incidence of acute cardiovascular events was low (N = 19, 3.5%) and they were non-fatal, but unlike the basal affectation in which coronary disease predominated, during the follow-up the new events were 7 strokes (1.3%) and 7 episodes of peripheral arterial ischemia (1.3%), 4 cases of ACS and 1 case of stroke + ACS. 10 patients had had previous events and in 9 cases it was de novo.

Conclusions
In our diabetic population, the use of SGLT2i is associated with few acute cardiovascular events in the first 1-3 years of follow-up, with good tolerance and low percentages of discontinuation of treatment due to adverse events.