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AstraZeneca has announced the positive results of DECLARE (Effect Dapagliflozin on cardiovascular events), a cardiovascular effects test (CVOT) of Poshi (name of the ingredient: Dapagliffrozen).
The findings are presented in a recent clinical study (last-minute summary # 19485) at the 2018 Scientific Conference of the American Heart Association (AHA) in Chicago, Illinois, USA. He also appeared in the Journal of Medicine (NEJM).
The DECLARE-TIMI study58 has been one of the largest CVOTs of SGLT-2 inhibitors to date, involving 17,000 patients from 33 countries. As part of this study, Foshi reduced the incidence of heart failure or cardiovascular death by 17% (4.9% vs. 5.8%, the risk ratio as one of the two main evaluation criteria). 0.83, 95% confidence interval (CI) 0.73-0.95, p = 0.005). The tendency to reduce deaths due to hospitalization or cardiovascular disease due to heart failure has been consistently observed in patients with cardiovascular risk factors (hypertension, dyslipidemia, smoking) and in those with a history of cardiovascular disease.
There was a tendency to reduce the incidence of major cardiovascular events (MACE), which was also the main endpoint, but it was not statistically significant (8.8% vs. 9%). , 4%, hazard ratio (HR) 0.93, 95% confidence interval): 0.84-1.03, p = 0.17).
The results of the DECLARE study confirmed the safety profile of already established pork. Compared to placebo, no increase in cardiovascular mortality, cardiac arrest (myocardial infarction) or stroke, which is a major cardiovascular event (MACE), and confirmed non-inferiority compared to placebo, the main index of Evaluation of safety.
In addition, additional safety results were identified, including the incidence of limb amputation (1.4% vs. 1.3%), fracture (5.3% vs. 5.1%) , of bladder cancer (0.3% vs. 0.5%). .5), and so on. Diabetic ketoacidosis (0.3% vs. 0.1%) and bad infection (0.9% vs. 0.1%) were also rare.
Elisabeth Björk, Vice President of Global Drug Development of the Department of Renal and Cardiovascular Metabolic Diseases of AstraZeneca, said: "This study is a clinically significant result for 425 million diabetics worldwide, diabetic patients have 2 at 5 times greater risk of suffering from heart failure and are at increased risk of heart attack and stroke. "Heart failure is a dangerous complication with a survival rate of only 50 % Five years after diagnosis, It is important to have research results that can improve understanding and emphasize the importance. "
<© 2018 메디파나뉴스, 무단 전재 및 배포금지>& # 39; The Korean Medical News Center & # 39; MEDIPANA NEWS
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