Landmark Trial for Dapagliflozin: AstraZeneca diabetes drug Forxiga shows benefits in patients with heart failure

Dapagliflozin(Forxiga) is currently available and indicated for type 2 diabetes in India and not yet approved for treatment for heart failure in India.

New Delhi: AstraZeneca recently announced detailed results from the landmark Phase III DAPA-HF trial for Forxiga (dapagliflozin) that showed the medicine on top of standard of care reduced both the incidence of cardiovascular death and the worsening of heart failure.

DAPA-HF is the first outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in patients with reduced ejection fraction (HFrEF), with and without type-2 diabetes (T2D). Forxiga is currently approved to treat patients with T2D.

Forxiga is a first-in-class, oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with T2D.

Topline results announced in August 2019 showed DAPA-HF met the primary endpoint. The detailed results of the trial presented recently at the ESC Congress 2019 in Paris, France, showed Forxiga reduced the composite of cardiovascular (CV) death or worsening of heart failure by 26% (p<0.0001) and showed a reduction in each of the individual components of the composite endpoint.

Commenting on the same, Mene Pangalos, Executive Vice President, BioPharmaceuticals RnD, said, “Forxiga is well
established in the treatment of type-2 diabetes, and these exciting new findings offer clinically meaningful insights into the potential of the medicine to reduce the burden of heart failure in patients with and without type-2 diabetes. We are proud to be contributing to the scientific body of evidence during the ESC Congress 2019.”

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John McMurray, MD, University of Glasgow, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, said, “We are very pleased that Forxiga was so effective in our trial – it did all the things we would like any drug to do in heart failure, which is to improve symptoms, reduce hospital admissions and increase survival. Even better, Forxiga was as effective in heart failure patients without diabetes as in those with diabetes.”

In analysing each of the components of the primary composite endpoint, there was a 30% decrease (p<0.0001) in the risk of experiencing a first episode of worsening heart failure and an 18% decrease (p=0.0294) in the risk of dying from cardiovascular causes. The effect of Forxiga on the primary composite endpoint was generally consistent across the key subgroups examined.

Heart Failure affects approximately 64 million people worldwide, with at least 8–10 million patients with Heart Failure in India 1. Heart Failure is the first complication of type 2 diabetes-related Cardiovascular disease presenting high mortality risk. 40.4% of Asian patients with Heart failure has an underlying type 2 diabetes 2.

As per Global data, nearly 50% of patients diagnosed with Heart Failure succumb within 5 years of diagnosis 2,3,4 HF remains as ‘malignant’ as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancers). 5 Further heart failure strikes Indians young, a decade younger than their western counterparts 3.

Dr Balbir Singh, Chairman, Interventional Cardiology and Electrophysiology, Medanta Hospital commenting on the new findings said“ At least 68 per cent of people aged 65 or older with diabetes die from some form of heart disease. Adults with diabetes are two to four times more likely to die from heart disease than adults without diabetes. The success of this decade has been newer drugs which not only control diabetes but also reduce deaths from
heart disease particularly heart failure”.

The safety profile of Forxiga in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. The proportion of patients with volume depletion (7.5% versus 6.8%) and renal adverse events (6.5% vs 7.2%), which are common of concern when treating heart failure, were comparable to placebo. Major hypoglycaemic events (0.2% versus 0.2%) were rare in both treatment groups.

Dapagliflozin(Forxiga) is currently available and indicated for type 2 diabetes in India and not yet approved for treatment for heart failure in India.

Forxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience.