Study DECLARE confirmed positive effect of dapagliflozin

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00159816%3A_____%2F19%3A00072593" target="_blank" >RIV/00159816:_____/19:00072593 - isvavai.cz</a>

Result on the web

<a href="https://www.prolekare.cz/casopisy/kardiologicka-revue/2019-1-12/studie-declare-potvrdila-priznivy-efekt-dapagliflozinu-109101" target="_blank" >https://www.prolekare.cz/casopisy/kardiologicka-revue/2019-1-12/studie-declare-potvrdila-priznivy-efekt-dapagliflozinu-109101</a>

DOI - Digital Object Identifier

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Result language

čeština

Original language name

Studie DECLARE potvrdila příznivý efekt dapagliflozinu

Original language description

SGLT2 - gliflozins are a new possibility of diabetes mellitus type 2 treatment. The mechanism of action is excretion of glucose by kidneys. The first mortality clinical trial with SGLT2 empagliflozin - EMPA-REG OUTCOME - was finished in 2015, and in the year 2017 the CANVAS programme with canagliflozin was published; other studies are ongoing. There is a large clinical programme for dapagliflozin, with smaller studies having shown a decrease in cardiovascular endpoints in a meta-analysis. DECLARE is an international clinical trial with dapagliflozin and the final results were presented at the congress of the American Heart Association in November 2018. The study included 17,160 patients with type 2 diabetes mellitus, who were randomised on placebo or dapagliflozin 10 mg/daily. The mean age was 63.8 + 6.8 years, mean duration of diabetes 11.8 + 7.8 years, mean glycated haemoglobin 8.3 +1.2 %. A total of 6,971 (40.6 %) were patients with confirmed cardiovascular disease, 10,189 (59.4 %) were patients with multiple risk factors. In the primary safety outcome analysis, dapagliflozin met the primary criterion for non-inferiority 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 %). A renal event occurred in 4.3 % in the dapagliflozin group and in 5.6 % in the placebo group and death from any cause occurred in 6.2 and 6.6 % respectively. All the results prove the benefits of dapagliflozin.

Czech name

Studie DECLARE potvrdila příznivý efekt dapagliflozinu

Czech description

SGLT2 - gliflozins are a new possibility of diabetes mellitus type 2 treatment. The mechanism of action is excretion of glucose by kidneys. The first mortality clinical trial with SGLT2 empagliflozin - EMPA-REG OUTCOME - was finished in 2015, and in the year 2017 the CANVAS programme with canagliflozin was published; other studies are ongoing. There is a large clinical programme for dapagliflozin, with smaller studies having shown a decrease in cardiovascular endpoints in a meta-analysis. DECLARE is an international clinical trial with dapagliflozin and the final results were presented at the congress of the American Heart Association in November 2018. The study included 17,160 patients with type 2 diabetes mellitus, who were randomised on placebo or dapagliflozin 10 mg/daily. The mean age was 63.8 + 6.8 years, mean duration of diabetes 11.8 + 7.8 years, mean glycated haemoglobin 8.3 +1.2 %. A total of 6,971 (40.6 %) were patients with confirmed cardiovascular disease, 10,189 (59.4 %) were patients with multiple risk factors. In the primary safety outcome analysis, dapagliflozin met the primary criterion for non-inferiority 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 %). A renal event occurred in 4.3 % in the dapagliflozin group and in 5.6 % in the placebo group and death from any cause occurred in 6.2 and 6.6 % respectively. All the results prove the benefits of dapagliflozin.

Type

J_SC - Article in a specialist periodical, which is included in the SCOPUS database

CEP classification

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OECD FORD branch

30218 - General and internal medicine

Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2019

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Kardiologická revue

ISSN

1212-4540

e-ISSN

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Volume of the periodical

21

Issue of the periodical within the volume

1

Country of publishing house

CZ - CZECH REPUBLIC

Number of pages

6

Pages from-to

7-12

UT code for WoS article

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EID of the result in the Scopus database

2-s2.0-85079040246