Empagliflozin across the stages of diabetic heart disease
Abstract
This editorial refers to ‘Effects of empagliflozin on risk for cardiovascular death and heart failure hospitalization across the spectrum of heart failure risk in the EMPA-REG OUTCOME® trial’†, by D. Fitchett et al., on page 363. Heart failure (HF) is one of the most pervasive complications occurring in patients with type 2 diabetes (T2D). The risk of HF with preserved (HFPEF) and reduced (HFREF) ejection fraction is four- to five-fold higher among patients with T2D as compared with those without the condition, and is associated with a poor prognosis, with a median survival of ∼4 years from the time of diagnosis.1 , 2 Although fasting plasma glucose levels and glycated haemoglobin (HbA1c) are significantly associated with an increased risk of HF,3 intensive glycaemic control with oral glucose-lowering agents or insulin has failed to reduce the risk of HF-related events as compared with standard treatment.4 , 5 In the recent EMPA-REG OUTCOME® trial, the sodium–glucose co-transporter-2 (SGLT-2) inhibitor empagliflozin was the first glucose-lowering drug able to reduce cardiovascular mortality and hospitalizations for HF (HHF) in T2D patients at high cardiovascular (CV) risk.6 In this trial, 7020 patients were randomized to receive 10 or 25 mg of empagliflozin or placebo once daily. After a median observation time of 3.1 years, empagliflozin (pooled 10 and 25 mg doses) significantly reduced the primary composite outcome of CV death, non-fatal myocardial infarction (MI), or…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 7,020 participants or records.
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