In order to bring you the best possible user experience, this site uses Javascript. If you are seeing this message, it is likely that the Javascript option in your browser is disabled. For optimal viewing of this site, please ensure that Javascript is enabled for your browser.
Did you know that your browser is out of date? To get the best experience using our website we recommend that you upgrade to a newer version. Learn more.

Dapagliflozin reduces death and hospitalisation in patients with heart failure

DAPA-HF trial presented in a Hot Line Session today at ESC Congress 2019 together with WCC

Diabetes and the Heart
Heart Failure


Paris, France – 1 Sept 2019: Dapagliflozin reduces death and hospitalisation in patients with heart failure and reduced ejection fraction with and without diabetes. The late breaking results of the DAPA-HF trial are presented in a Hot Line Session today at ESC Congress 2019 together with the World Congress of Cardiology(1).

Principal investigator Professor John McMurray of the University of Glasgow, UK said: “The most important finding of all is the benefit in patients without diabetes. This is truly a treatment for heart failure and not just a drug for diabetes.”

Sodium-glucose cotransporter 2 (SGLT2) inhibitors including dapagliflozin reduce the risk of developing heart failure in patients with type 2 diabetes. The DAPA-HF trial(2,3) investigated whether dapagliflozin was also useful in treating established heart failure, even in patients without diabetes.

The trial enrolled 4,744 patients with heart failure and reduced ejection fraction in 20 countries and randomly allocated them to either dapagliflozin 10 mg once daily or matching placebo. The primary endpoint was the composite of a first episode of worsening heart failure (hospitalisation for heart failure or an urgent heart failure visit requiring intravenous therapy) or death from cardiovascular causes.

The allocated treatments were given on top of standard care: 94% received an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker or angiotensin receptor–neprilysin inhibitor; 96% took a beta-blocker; and 71% took a mineralocorticoid receptor antagonist(4).

Over a median follow-up of 18.2 months, the primary outcome occurred in 386 of 2,373 patients (16.3%) in the dapagliflozin group and in 502 of 2,371 patients (21.2%) in the placebo group (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.65–0.85; p<0.00001).

The components of the primary outcome were also analysed separately. A total of 237 patients (10.0%) receiving dapagliflozin and 326 patients (13.7%) receiving placebo experienced a first episode of worsening heart failure (HR 0.70; 95% CI 0.59–0.83; p<0.00004) and 227 (9.6%) and 273 (11.5%), respectively, died from cardiovascular causes (HR 0.82; 95% CI 0.69–0.98; p=0.029).

Regarding side effects, 178 patients (7.5%) in the dapagliflozin group had an adverse event related to volume depletion compared to 162 (6.8%) in the placebo group, with no significant difference between groups. Adverse events related to renal dysfunction occurred in 153 patients (6.5%) in the dapagliflozin group versus 170 patients (7.2%) in the placebo group, with no significant difference between groups. Major hypoglycaemia and lower limb amputation and fracture were infrequent and occurred at similar rates in the two treatment groups.

Prof McMurray said: “Adverse events rarely required the discontinuation of treatment. There was no notable excess of any serious adverse event in the dapagliflozin group.”

He concluded: “The trial shows that dapagliflozin reduces death and hospitalisation, and improves health-related quality of life, in patients with heart failure and reduced ejection fraction, with and without diabetes. The clinical implications are potentially huge – few drugs achieve these results in heart failure and dapagliflozin does even when added to excellent standard therapy.”

ENDS 

Notes to editor

Notes to editors

Authors: ESC Press Office 
Mobile: +33 (0) 7 8531 2036
Email: press@escardio.org

Follow us on Twitter @ESCardioNews 

The hashtag for ESC Congress 2019 together with the World Congress of Cardiology is #ESCCongress

Funding: The DAPA-HF trial was funded by AstraZeneca.

Disclosures: Professor McMurray’s employer, Glasgow University, was paid by AstraZeneca for his role as Principal Investigator in the DAPA-HF trial with dapagliflozin.

References and notes

(1) DAPA-HF will be discussed during:

(2) DAPA-HF: Dapagliflozin And Prevention of Adverse-outcomes In Heart Failure trial.

(3) McMurray JJV, DeMets DL, Inzucchi SE, et al. A trial to evaluate the effect of the sodium-glucose co-transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA-HF). Eur J Heart Fail. 2019;21:665–675. doi: 10.1002/ejhf.1432.

(4) McMurray JJV, DeMets DL, Inzucchi SE, et al. The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics. Eur J Heart Fail. 2019. doi:10.1002/ejhf.1548.

 

About ESC Congress

ESC Congress is the world’s largest gathering of cardiovascular professionals contributing to global awareness of the latest clinical trials and breakthrough discoveries. ESC Congress 2019 together with the World Congress of Cardiology takes place from 31 August to 4 September at the Expo Porte de Versailles in Paris, France. Explore the scientific programme.

About the European Society of Cardiology 

The European Society of Cardiology brings together health care professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.

This press release accompanies both a presentation and an ESC press conference at ESC Congress 2019 together with the World Congress of Cardiology. It does not necessarily reflect the opinion of the European Society of Cardiology.