News | Heart Failure | March 28, 2020

Dapagliflozin Reduces Heart Failure Worsening and Death in DAPA-HF Sub-analysis

New data at ACC 2020 shows consistent effect of Farxiga in patients with heart failure with reduced ejection fraction, regardless of background therapy
 

Dapagliflozin Reduces Heart Failure Worsening and Death in DAPA-HF Sub-analysis. #ACC20 #ACC2020

March 28, 2020 — New data from a sub-analysis of the landmark Phase III DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) trial showed that AstraZeneca’s dapagliflozin (Farxiga) reduced the incidence of the primary composite endpoint of heart failure (HF) worsening or cardiovascular (CV) death compared to placebo, in patients with heart failure with reduced ejection fraction (HFrEF), irrespective of their background therapy (i.e. other medications for heart failure).[1] 

Farxiga was evaluated in patients who were receiving a broad range of pharmacological treatments, device therapies and cardiac resynchronization therapy for HFrEF. A consistent reduction in the primary outcome was observed across all these treatment subgroups.[1]

The results were made available at the American College of Cardiology (ACC) 2020 Scientific Session together with World Congress of Cardiology (ACC.20/WCC) and were published in the European Heart Journal.[2]

Dapagliflozin is indicated as a monotherapy and as part of combination therapies to improve glycemic control in adults with type-2 diabetes (T2D). In the U.S. it is also approved to reduce the risk of hospitalization for HF in patients with T2D and established CV disease or multiple CV risk factors.

In January 2020, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga to reduce the risk of CV death or the worsening of HF in adults with HFrEF with and without T2D. The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.

Overview of the DAPA-HF Trial

DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is an international, multi-centre, parallel-group, randomized, double-blinded trial in patients with heart failure and reduced ejection fraction (LVEF ≤ 40 percent), with and without T2D, designed to evaluate the effect of dapagliflozin 10 mg, compared with placebo, given once daily in addition to standard of care. The primary composite endpoint was time to the first occurrence of a worsening heart failure event (hospitalization or equivalent event; i.e. an urgent heart failure visit), or cardiovascular death.

What is Dapagliflozin? 

Dapagliflozin (Farxiga) is a first-in-class, oral once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycemic control, with the additional benefits of weight loss and blood-pressure reduction. In the DECLARE CV outcomes trial in adults with T2D, dapagliflozin  reduced the risk of the composite endpoint of hospitalization for HF or CV death versus placebo, when both were added to standard of care.

In the DAPA-HF trial, dapagliflozin on top of standard of care reduced both the incidence of cardiovascular death and the worsening of heart failure in patients with HFrEF, with and without T2D. Farxiga is also being investigated for patients with HF in the DELIVER (HFpEF) and DETERMINE (HFrEF and HFpEF) trials, as well as patients with chronic kidney disease (CKD)  in the DAPA-CKD trial. Farxiga has a robust program 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.

What is Heart Failure?

HF is a life-threatening disease in which the heart cannot pump enough blood around the body.[3] It affects approximately 64 million people worldwide, at least half of whom have a reduced ejection fraction, and is a chronic and degenerative disease where half of patients will die within five years of diagnosis.[4,5] HF remains as fatal as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancers).[6] It is the leading cause of hospitalization for those over the age of 65 and represents a significant clinical and economic burden.[7]

 

Related DAPA-HF Trial Content:

FDA Clears Dapagliflozin to Reduce Heart Failure Hospitalizations

Key Heart Failure Takeaways at AHA 2019

Farxiga Significantly Reduces Cardiovascular Death and Worsening of Heart Failure

Dapagliflozin Granted FDA Priority Review for Heart Failure With Reduced Ejection Fraction

New Heart Failure Devices and Drugs to Treat Heart Failure

 

Find more news from ACC 2020.

 

References:

1. Docherty KF et al. 2020 Consistent Benefit of Dapagliflozin According to Background Therapy in Patients with HFrEF: An Analysis of the DAPA-HF Trial. Presented at the American College of Cardiology’s 69th Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC); 28 March – 30 March, Chicago.

2. Kieran F Docherty, Pardeep S Jhund, Silvio E Inzucchi, et al. Effects of dapagliflozin in DAPA-HF according to background heart failure therapy. European Heart Journal, ehaa183, https://doi.org/10.1093/eurheartj/ehaa183. Published onlin 28 March 2020.

3. Mayo Clinic. Heart failure; 2017 [cited 2020 Mar 24]. Available from URL: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.

4. Travessa AMR, Menezes Falcão LF de. Treatment of Heart Failure With Reduced Ejection Fraction-Recent Developments. Am J Ther 2016; 23(2):e531-49.

5. Mozaffarian D et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation 2016; 133(4):e38-360.

6. Mamas, M. A., Sperrin, M., Watson, M. C., Coutts, A., et al. (2017). Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. European Journal of Heart Failure, 19(9), 1095-1104. https://doi.org/10.1002/ejhf.822.

7. Azad N, Lemay G. Management of chronic heart failure in the older population. J Geriatr Cardiol 2014; 11(4):329–37.

Related Content

Some of the top technology news from ACC 2021. Top left, the LAAOS III trial showed benefit when surgeons seal off the LAA during other open heart procedures. Bottom left, the ReCor Paradise renal denervation system helped lower blood pressure in patients who did not respond to medication. Top right, for patients with both heart failure and AFib it makes no differences is therapy is focused on controlling the heart rhythm or heart rate. Bottom right, the FLOWER-MI trial found no benefit to FFR-guided PCI.

Some of the top technology news from ACC 2021. Top left, the LAAOS III trial showed benefit when surgeons seal off the LAA during other open heart procedures. Bottom left, the ReCor Paradise renal denervation system helped lower blood pressure in patients who did not respond to medication. Top right, for patients with both heart failure and AFib it makes no difference if therapy is focused on controlling the heart rhythm or heart rate. Bottom right, the FLOWER-MI trial found no benefit to FFR-guided PCI in STEMI with multi-vessel disease.

Feature | ACC | June 08, 2021 | By Dave Fornell, Editor
Here are the top 10 takeaways from the late-breaking studies on cardiovascular technologies presented at the 2021 ...
AMERICAN COLLEGE OF CARDIOLOGY (ACC) Late-breaking clinical trial study presentations at ACC.21. @ACC21 @ACC2021
Feature | ACC | May 18, 2021 | Dave Fornell, Editor
The latest cardiology practice-changing scientific breakthrough, late-breaking study presentations have been announce
To help monitor the health of ACC 2021 in-person attendees for signs of COVID infection, the meeting will use BioIntelliSense's wearable BioButton continuous wireless temperature and vital signs monitoring. The wearable monitor is the size of a coin and is disposable.

To help monitor the health of ACC 2021 in-person attendees for signs of COVID infection, the meeting will use BioIntelliSense's wearable BioButton continuous wireless temperature and vital signs monitoring. The wearable monitor is the size of a coin and is disposable.

News | ACC | February 09, 2021 | By Dave Fornell, Editor
UPDATE Feb 22, 2021 — ...
The American College of Cardiology (ACC) released a list of the latest practice-changing presentations at the ACC.20 annual meeting March 28-30, 2020, in Chicago. This includes five late-breaking clinical trial (LBCT) sessions and three featured clinical research sessions. There also are two LBCT deep-dive sessions where the experts will break down the hottest trials and attendees can find out what the impact might be on the practice of cardiology and patients.
Feature | ACC | April 09, 2020 | Dave Fornell, Editor
Here is the list of American College of Cardiology (ACC) practice-
ACC Cancels 2020 Conference Amid Coronavirus Concerns. #COVID19 #coronavirus #2019nCoV
Feature | ACC | March 09, 2020 | Dave Fornell, Editor
March 9, 2020 — Less than week after the American College of Cardiolog...
American College of Cardiology Names Douglas Drachman Next Annual Scientific Session Vice Chair

Image courtesy of Massachusetts General Hospital

News | ACC | October 08, 2019
Douglas Drachman, M.D., FACC, has been selected as the next vice chair of the American College of Cardiology’s (ACC)...
SyncVision iFR Co-registration from Philips Healthcare maps pressure readings onto angiogram. Results from an international study presented at ACC 2019 indicates pressure readings obtained using iFR (instantaneous wave-free ratio, also referred to as instant wave-free ratio or instant flow reserve) in coronary arteries may localize stenoses that remain after interventions. FFR in the cath lab.

SyncVision iFR Co-registration from Philips Healthcare maps pressure readings onto angiogram. Results from an international study presented at ACC 2019 indicates pressure readings obtained using iFR (instantaneous wave-free ratio, also referred to as instant wave-free ratio or instant flow reserve) in coronary arteries may localize stenoses that remain after interventions.

Feature | ACC | March 27, 2019 | Greg Freiherr, Contributing Editor
The fingerprints of value-added medicine were all over products and works-in-progress on the exhibit floor of the a

The opening late-breaking trial at ACC 2019 is the Apple Heart Study, a large-scale, app-based study to identify atrial fibrillation using a smartwatch. Earlier, smaller trials showed this approach might be used in a population health application to proactively identify AFib patients earlier.

Feature | ACC | March 19, 2019
The American College of Cardiology (ACC) released a list of the late
A patient who received HeartMate III LVAD system at ACC.18. The HeartMate 3 was the topic of of the the key late-breaking trials at #ACC18

A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC.18. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at this year's conference.

Feature | ACC | March 27, 2018 | Dave Fornell
There were several notable presentations of new data on cardiovascular technologies at the recent 2018 American Colle