Findings show lower mortality with SGLT-2 inhibitors in a real-life setting
Sodium glucose cotransporter 2 (SGLT-2) inhibitor drugs, initially developed to treat type 2 diabetes are associated with a reduced risk of all-cause and cardiovascular death among patients with heart failure in the real-life setting, finds a study published by The BMJ today.
Participants all had a type of heart failure known as heart failure with reduced ejection fraction (HFrEF) when the heart cannot sufficiently supply the body with blood due to its weakened pumping ability.
Clinical trials have shown that SGLT-2 inhibitors reduce the risk of worsening heart failure and death among patients with HFrEF, regardless of diabetes status. But the effectiveness of SGLT-2 inhibitors in heart failure patients outside the controlled settings of clinical trials remains largely unknown.
To address this, researchers drew on data from Danish national registers between July 2020 and June 2023 to identify patients aged 45 years or older with HFrEF, with an ejection fraction of 40% or less.
They then compared 6,776 of these patients who started SGLT-2 inhibitors (79% dapagliflozin, 21% empagliflozin) with 14,686 who remained on other standard heart failure drugs and did not use SGLT-2 inhibitors, matched on time since heart failure diagnosis and weighted to account for differences in baseline characteristics between the groups.
Most SGLT-2 inhibitor users were men (70%), with an average age of 71 years and 20% had type 2 diabetes. During a monitoring period of up to three years, there were 374 deaths among SGLT-2 inhibitors users (5.8 per 100 person-years) and 1,602 among non-users (8.5 per 100 person-years).
Use of SGLT-2 inhibitors was associated with a 25% reduction in the risk of all-cause death compared with non-use. This result was consistent across all patient groups, including those with and without type 2 diabetes.
Treatment with SGLT-2 inhibitors was also associated with a 23% lower risk of cardiovascular death, but there was no reduction in a combined measure of cardiovascular death or heart failure hospitalisation, nor heart failure hospitalisation alone.
This is an observational study, so no firm conclusions can be drawn about causality, and the researchers acknowledge that there may have been some misclassification of drug use. Nor can they rule out the possibility that other unmeasured factors may have affected the accuracy of their results.
However, their findings were based on high-quality data sources and rigorous analytical methods, suggesting that they are robust.
As such, the researchers conclude: “These results support the benefits of SGLT-2 inhibitors observed in clinical trials and provide novel and important data regarding their effectiveness in real-world clinical settings and across key clinical subgroups, including patients with and without diabetes.”
One must be careful in drawing conclusions from observational data, note researchers in a linked editorial. Nevertheless, they say these results “provide assurance that no unexpected harm results from SGLT-2 inhibitors when they are used for treatment of heart failure outside the clinical trial setting.”
However, SGLT-2 inhibitors are still underused, and robust implementation efforts “should tackle barriers to prescribing in an effort to increase evidence based prescribing,” they conclude.
[Ends]
07/11/2024
Notes for editors
Research: SGLT2 inhibitors and mortality among patients with heart failure with reduced ejection fraction: linked database study doi: 10.1136/bmj-2024-080925
Editorial: Safety of sodium-glucose cotransporter-2 inhibitors for heart failure doi: 10.1136/bmj.q2424
Journal: The BMJ
Funding: Novo Nordisk Foundation and Karolinska Institutet
Link to Academy of Medical Sciences press release labelling system:
http://press.psprings.co.uk/
Externally peer reviewed? Yes (research); No (linked editorial)
Evidence type: Observational; Opinion
Subjects: People
