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CCU053: Risks and benefits of treatment with SGLT2 inhibitors and the impact of intercurrent illness with COVID-19

Safe People

Organisation name

University of Dundee,University of Liverpool

Organisation sector

Academic Institute

Applicant name(s)

Ewan Pearson

Huan Wang

Reecha Sofat

Sub-licence arrangements (if any)?

No

Safe Projects

Project ID

CCU053

Lay summary

The medications called Sodium glucose co-transporter-2 inhibitors (SGLT2i) were developed as a diabetes drug but are now being used in people without diabetes who have heart failure or kidney disease. In people with diabetes, infection with COVID-19 increases the risk of a severe diabetic illness called Diabetic Ketoacidosis (DKA). When this happens, harmful substances called ketones build up in the body, which can be life-threatening if this is not found and treated quickly. SGLT2i also increase the risk of DKA in people with diabetes and advice was issued that these drugs should be stopped in COVID-19 infection. However, SGLT2i may also be beneficial and improve COVID outcomes and were added as a treatment arm in the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial last year. There is a need to understand what happened to SGLT2i prescribing during the COVID pandemic and whether it was associated with adverse outcomes like DKA or improved COVID outcomes. This project will evaluate the risk of DKA in patients treated with SGLT2i and the contribution of COVID-19 infection to this risk. We will also evaluate the real-world outcomes of COVID-19 infection in patients treated with SGLT2i. This will complement the RECOVERY trial which will not be powered to evaluate DKA risk.

Public benefit statement

This project will inform on policy in relation to SGLT2i use in people with and without diabetes who develop COVID-19 infection. Visit the BHF Data Science Centre website for more detailed information about project outputs. https://bhfdatasciencecentre.org/projects/ccu053/

Technical summary

This project accessed the following datasets within the Trusted Research Environment(s) for CVD-COVID-UK / COVID-IMPACT: - ENGLAND: - Civil Registration - Deaths - COVID-19 SARI-Watch (formerly CHESS) - Covid-19 Second Generation Surveillance System - Covid-19 UK Non-hospital Antibody Testing Results - Covid-19 UK Non-hospital Antigen Testing Results - COVID-19 Vaccination Adverse Reaction - COVID-19 Vaccination Status - GPES Data for Pandemic Planning and Research (COVID-19) - Hospital Episode Statistics Accident and Emergency - Hospital Episode Statistics Admitted Patient Care - Hospital Episode Statistics Critical Care - ICNARC: Intensive Care National Audit and Research Centre - Medicines dispensed in Primary Care (NHSBSA data) - NICOR – NHFA: National Heart Failure Audit - Secondary Care Prescribed Medicines (EPMA) - Secondary Uses Services Payment By Results

Latest approval date

29/11/2022

Safe Data

Dataset(s) name

Data sensitivity level

De-Personalised

Safe Setting

Access type

TRE