Dapagliflozin and empagliflozin cut mortality in patients with heart failure with reduced ejection fraction whether or not patients have diabetes, a large real-world study has concluded.
The analysis of sodium glucose cotransporter 2 (SGLT-2) inhibitor drugs in patients on a national Danish registry found they were associated with a 25% lower risk of all-cause mortality, ‘supporting their effectiveness in routine clinical practice’.
Reporting in the BMJ, researchers examined outcomes in patients with heart failure aged over 45 years with left ventricular ejection fraction less than 40% between 2020 and 2023.
In their dataset, they reviewed 6,776 patients who started SGLT-2 inhibitors (79% on dapagliflozin, 21% prescribed empagliflozin) and 14,686 patients taking other standard-of-care heart failure drugs, taking into account time since diagnosis and other baseline characteristics.
Around 70% of patients taking SGLT-2 inhibitor were men, with an average age of 71 years and 20% of the cohort had type 2 diabetes.
The results showed 374 deaths among SGLT-2 inhibitors users at a rate of 5.8 per 100 person-years compared with 1,602 among non-users equating to 8.5 per 100 person-years.
The 25% reduction in the risk of all-cause death compared with non-use, was consistent across all patient groups, including those with and without type 2 diabetes, they found.
Analysis also showed that SGLT-2 inhibitors were associated with a 23% lower risk of cardiovascular death.
But there was no reduction in a combined measure of cardiovascular death or hospitalisation for heart failure or heart failure hospitalisation alone.
The ‘real-world’ data matches that seen in the clinical trials which had led to the recommendation of SGLT-2 inhibitors in several guidelines including NICE, the team concluded.
NICE recommended empagliflozin for chronic heart failure with preserved or mildly reduced ejection fraction in October 2023 following the approval of dapagliflozin in June.
‘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,’ the researchers from the University of Copenhagen said.
A linked editorial said the findings were observational but ‘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’.
But it also stressed that SGLT-2 inhibitors are still underused, and efforts are needed to ‘tackle barriers to prescribing’ in line with best-practice guidelines.
