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PMLiVE 10/22/2019 04:26
The FDA approval comes on the back of the DECLARE-TIMI 58 clinical trial, which showed that Farxiga (dapagliflozin) was able to reduce hospitalisations for heart failure and cardiovascular death in a broad diabetes patient population, most of whom had no cardiovascular disease at enrolment, compared with placebo ...
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AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors ...
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Healio News 10/21/2019 10:03
In DAPA-HF, dapagliflozin added to standard therapy for heart failure was associated with reduced risk for worsening heart failure and CV death for patients with heart failure with and without diabetes.
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ENDPOINTS 10/21/2019 08:55
The results showed that the Farxiga treatment did trigger a lower rate of hospitalization for heart failure — but the therapy was not better or worse than placebo in its impact on the rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke.
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The data has driven rapid adoption across multiple NHS trusts and international markets, as well as the expanded FDA clearance.
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Drugs.com 10/01/2019 00:10
Given the significant unmet need for heart failure treatments that are proven safe and effective in pediatric patients, this approval and the availability of a new treatment option is great news for these children and their families,” said Andrea Baer, Executive Director at ...
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PR Newswire 09/30/2019 08:30
Specified secondary outcomes included a composite of heart attack, stroke, or CV death and a composite of CV death or hospitalization for heart failure.
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CorMatrix Cardiovascular, a developer of regenerative cardiovascular medical devices, today announced it has completed enrollment of the adult arm of its FDA early feasibility IDE study for the Cor TRICUSPID ECM cardiac valve* for adults with endocarditis and for pediatric patients with ...
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