Interv Akut Kardiol. 2019;18(4):232-234
DECLARE study confirms cardiovascular effect of dapagliflozín
- 1 1Ústav fyziologie, LF MU, Brno
- 2 2Interní kardioangiologická klinika FN u sv. Anny a LF MU, Brno
DECLARE is an international clinical trial with dapagliflozin and was published the last year. The study included 17 160 patients with diabetes mellitus type 2, who were randomised on placebo or dapagliflozin 10mg/daily. Mean age was 63.8 ± 6.8 years, mean duration of diabetes 11.8 ± 7.8 years, mean glycated haemoglobin 8.3 ± 1.2 %. 6 971 (40.6 %) were patients with confirmed cardiovascular disease (CVD). 10 189 (59.4 %) were patients with multiple risc factors (MRF), 1 316 (7.7 %) had low ejection fraction. In the primary safety outcome analysis dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (8.8 % dapagliflozin vs 9.4 % placebo, p = 0.17) In the primary efficacy outcome dapagliflozin did result in a lower rate of cardiovascular deaths or hospitalisation for heart failure (4.9 % vs. 5.8 %). All cause mortality was lowered 6.2 % vs. 6.6 % and renoprotective effect was seen 4.3 % vs. 5.6 %. A subanalysis in patients with reduced ejection fraction was published in the year 2019 and these patients have shown a greater effect of dapagliflozin than patinets with preserved ejection fraction. These results were confirmed by the DAPA HF trial presented at European cardiology congress in Paris in September 2019 and it is suposed, that SGLT2 can get the indication Ia,A for patients with diabetes mellitus and heart failure with reduced ejection fraction.
Keywords: dapagliflozin, DECLARE, low ejection fraction, mortality, hospitalisations, heart failure
Published: December 1, 2019 Show citation
