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“Yesterday, we presented once-in-a-lifetime findings that sodium-glucose co-transporter-2 (SGLT2) inhibitors are truly a treatment for heart failure (HF) and not just diabetes,” says Professor John McMurray (University of Glasgow, Glasgow, UK), speaking about his Hot Line presentation on the DAPA-HF trial.
“HF is a very common complication of type 2 diabetes, occurring more frequently than stroke and as frequently as myocardial infarction,” explains Prof. McMurray. “Trials have shown that, in addition to effectively treating diabetes, SGLT2 inhibitors also reduce the risk of patients developing HF. And the benefits are seen fairly rapidly, within weeks of starting treatment. It follows naturally that the next question would be, ‘Can these drugs be used to treat patients with established HF, including those without diabetes?’ And this is what we wanted to look at in DAPA-HF.”
The trial randomised 4,744 patients with HF with reduced ejection fraction (HFrEF) (left ventricular ejection fraction ≤40%) from 20 countries to dapagliflozin (10 mg once daily) or matching placebo, in addition to standard care, comprising an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker or angiotensin receptor–neprilysin inhibitor (94%), beta-blocker (96%) and mineralocorticoid receptor antagonists (71%). The primary endpoint was a composite of the incidence of worsening HF or death from cardiovascular (CV) causes, analysed as a time-to-first event. The median follow-up was 18.2 months. Patients in DAPA-HF were similar to those included in HFrEF registries and other trials. Around half of the patients enrolled did not have a diagnosis of diabetes.
“We found that treatment with dapagliflozin led to a statistically significant reduction in the risk of the composite of worsening HF or CV death by 26% (p<0.00001),” says Prof. McMurray.
When analysed separately, a first episode of worsening HF was reduced by 30% (p=0.00003) and the risk of CV death was reduced by 18% (p=0.029).
“Dapagliflozin also reduced the risk of death from any cause by 17% (p=0.022) and it is quite unusual to see such a benefit in clinical trials,” comments Prof. McMurray.
The safety profile of dapagliflozin was good. There were no notable imbalances in frequencies between the treatment arms, including for serious adverse events or adverse events of interest. Adverse events related to volume depletion occurred in 7.5% of patients receiving dapagliflozin and 6.8% receiving placebo. Corresponding rates of adverse events related to renal dysfunction were 6.5% and 7.2%, respectively. Major hypoglycaemia and lower limb amputation and fracture were infrequent and occurred at similar rates in the two arms. The tolerability of treatment was supported by very low rates of discontinuation of study drug.
Quality of life (QoL) is a major issue for patients with HF and Prof. McMurray highlights the benefit of dapagliflozin on patients’ well-being. “Patients with HF report worse QoL than individuals with any other chronic condition. In DAPA-HF, compared with placebo, treatment with dapagliflozin led to more patients having a clinically important improvement in health-related QoL (15% more likely to improve; p<0.001) and fewer patients having an important deterioration in their health-related QoL (16% less likely to deteriorate; p<0.001).”
Summing up the trial results, Prof. McMurray says, “The results from DAPA-HF are remarkable. And probably the most important finding of all is that dapagliflozin was associated with benefit in patients without diabetes. With dapagliflozin, we did the three things you want to do for the patient in the ideal world: make them feel better, keep them out of hospital and keep them alive. That is why we are so delighted with the results.”
Meet the Trialist – DAPA-HF
Today, 08:00 – 08:30; Global Exchange 1
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