The trial did not achieve statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days.
DARE-19 was the first Phase III trial to evaluate the safety and efficacy of a sodium-glucose co-transporter-2 (SGLT2) inhibitor in patients hospitalised with COVID-19 who also have risk factors for developing serious complications, including hypertension (HTN), type-2 diabetes (T2D), atherosclerotic cardiovascular disease (ASCVD), heart failure (HF) or chronic kidney disease (CKD) Stages 3-4.1,2 Cardiac, renal and metabolic comorbidities have been associated with poor outcomes and death in patients hospitalised with COVID-19.3,4
The safety and tolerability profile for Farxiga at 30 days in the trial was consistent with the well-established safety profile of the medicine.
The full DARE-19 trial results will be presented at the
DARE-19
DARE-19 was an international, randomised, double-blind, placebo-controlled, investigator-sponsored Phase III trial in 1,250 patients evaluating the efficacy and safety of Farxiga in addition to background local standard of care therapy in adults who are hospitalised with COVID-19 at the time of trial enrolment. Patients enrolled in DARE-19 also had a medical history of HTN, ASCVD, heart failure, T2D or CKD Stages 3-4 and received Farxiga or placebo for 30 days.1,2
Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. The research for Farxiga is advancing from cardiorenal effects to prevention and organ protection as science continues to identify the underlying links between the heart, kidneys and pancreas. Damage to one of these organs can cause the other organs to fail - contributing to leading causes of death worldwide, including T2D, HF and CKD.
For nearly a decade Farxiga has been an effective monotherapy and part of combination therapy as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. Following results from the landmark DECLARE-TIMI 58 Phase III cardiovascular (CV) outcomes trial,5 it is approved in adults with T2D to reduce the risk of hospitalisation for heart failure or CV death when added to standard of care. Farxiga is also the first SGLT2 inhibitor approved for the treatment of HFrEF in adults with and without T2D.
In
DapaCare is a robust programme of clinical trials to evaluate the potential CV, renal and organ protection benefits of Farxiga. It 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. It is currently being assessed in patients with HFpEF in the DELIVER Phase III trial. Farxiga is also being tested in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI Phase III trial - a first of its kind, indication-seeking registry-based randomised controlled trial.
Cardiovascular, Renal and Metabolism (CVRM) together forms one of
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References
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2. Kosiborod M et al. Effects of dapagliflozin on prevention of major clinical events and recovery in patients with respiratory failure because of COVID-19: Design and rationale for the DARE-19 study. Diabetes Obes Metab. 2021; 23(4):886-896.
3. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in
4. Madjid M, Safavi-Naeini P, Solomon SD, et al. Potential effects of coronaviruses on the cardiovascular system: a review. JAMA Cardiol. 2020;5:831-840.
5. Wiviott SD, Raz I, Bonaca MP, et al, for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes [article and supplementary appendix]. N Engl J Med. 2019:380:347-357.
6. Kumbhani DJ. Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease-DAPA-CKD. Abstract presented at: Annual Meeting of the
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