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The approval is based on data from the randomized, double-blind, placebo-controlled phase III study DAPA-HF. In addition to standard therapy compared to placebo, dapagliflozin was able to significantly reduce the risk of the primary combined endpoint of cardiovascular death or worsening of heart failure (defined as hospitalization or emergency medical contact for heart failure) of a relative 26%. The risk of death from cardiovascular causes was reduced by a relative 18% with dapagliflozin compared with placebo. Furthermore, the assessment of so-called Patient Reported Outcomes (PRO), an established measurement tool for recording patient perception, resulted in a significant and clinically relevant improvement in perceived health status with dapagliflozin.
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