DECLARE-TIMI 58 trial in the context of EMPA-REG OUTCOME and CANVAS
https://doi.org/10.14341/DM10289
Abstract
The article discussed results of the DECLARE-TIMI 58 study in the aspects of the previously finished trials (EMPA-REG OUTCOME and CANVAS).
All three SGLT2i demonstrated the reduction of the risk of hospitalization for heart failure, as well as the risk of progression chronic kidney disease. At the same time, the patient populations are different. In EMPA-REG OUTCOME almost all the patients had previously diagnosed cardiovascular disease; in CANVAS 44.4% of patients did not have a confirmed cardiovascular disease, but had cardiovascular risk factors, and in DECLARE TIMI 58 there were 59% of such patients.
Assessment of the published data suggests that the risk of a combined cardiovascular endpoint, including death from cardiovascular causes, myocardial infarction, and stroke, seems to be most pronounced in patients who already have established cardiovascular disease, and this effect is achieved mainly by reducing cardiovascular mortality. In the population of patients with type 2 diabetes who do not have cardiovascular disease, but who have cardiovascular risk factors, this effect is not detected.
Contrary, risk-reduction of hospitalization for CHF and slowing the progression of CKD is manifested both in a population of patients with established cardiovascular disease and in the population of patients with multiple cardiovascular risk factors.
In this regard, DECLARE-TIMI 58, as well as previously published data, open up new option for an earlier start of SGLT-2i for primary prevention and/or slowing the progression of nephropathy, reducing the risk of heart failure, and its prevention, as well as reduction of cardiovascular morbidity and mortality in patients with type 2 diabetes, regardless of the presence or absence of cardiovascular pathology in the anamnesis.
Supporting agencies: The review was prepared with the financial support of AstraZeneca.
About the Author
Marina V. Shestakova
Endocrinology Research Centre
Russian Federation
Russian Federation
MD, PhD, Professor
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3. Fig. 1. The frequency of occurrence of the primary endpoint "cardiovascular death or hospitalization for heart failure" (adapted from [8]). RR - relative risk; CI - confidence interval | |
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4. Fig. 2. The frequency of occurrence of the primary endpoint "cardiovascular death or hospitalization for heart failure in various populations." | |
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5. Fig. 3. Frequency of occurrence of large cardiovascular events (MACE) in various populations. | |
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6. Fig. 4. The incidence of secondary endpoints in the DECLARE study. | |
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7. Fig. 5. The ratio of patients with established atherosclerotic cardiovascular diseases and patients with risk factors for developing atherosclerotic cardiovascular diseases in the EMPA-REG OUTCOME, CANVAS and DECLARE-TIMI 58 studies. | |
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8. Fig. 6. Meta-analysis of the main combined endpoint (MACE) in the studies of DECLARE-TIMI 58, EMPA-REG OUTCOME and CANVAS (adapted from [16]). | |
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For citations:
Shestakova M.V. DECLARE-TIMI 58 trial in the context of EMPA-REG OUTCOME and CANVAS. Diabetes mellitus. 2019;22(6):592-601. (In Russ.) https://doi.org/10.14341/DM10289
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