2023-11-09 03:17:58
DELIVER Phase 3 post-mortem analysis… the more comorbidities, the greater the benefit
[의약뉴스] Research results have been published showing that AstraZeneca’s SGLT-2 inhibitor Farxiga (ingredient name: dapagliflozin) provides benefits even to patients with heart failure accompanied by heart, kidney, and metabolic diseases.
The American College of Cardiology journal JACC: Heart Failure recently published the results of a post-hoc analysis evaluating the DELIVER phase 3 clinical trial according to whether cardio-metabolic disease occurred.
▲ Research results have been published showing that Farxiga is effective in preventing secondary events in heart failure patients regardless of whether they have heart-kidney-metabolic diseases.
SGLT-2 inhibitors such as Farxiga started out as diabetes treatments with blood sugar lowering and weight loss effects, and have shown positive results in both heart failure and renal failure, opening the era of integrated management of heart-kidney-metabolic diseases.
Among these, DELIVER is a large-scale phase 3 clinical trial that confirmed the effectiveness of Farxiga in preventing secondary events (worsening heart failure or cardiovascular death) in heart failure patients with preserved ejection fraction (HFpEF) with a left ventricular ejection fraction of 40% or more.
In this study, the efficacy of Farxiga in preventing secondary events compared to placebo was evaluated in 6,263 patients who participated in the DELIVER phase 3 clinical trial according to whether they had heart (arteriosclerotic cardiovascular disease), kidney (chronic kidney disease), or metabolic disease (type 2 diabetes). evaluated.
Of the 6,263 heart failure patients who participated in the study, 1,952 (31%) had one of three diseases, 2,245 (36%) had two, and 1,236 (20%) had three diseases.
In addition, the more comorbid diseases, the higher the risk of secondary events, and the risk of secondary events was twice as high when three diseases were present compared to those with only one disease. (HR=2.16. 95% CI 1.72~2.72 , P<0.001)
However, the secondary event prevention effect of Farxiga compared to placebo showed a consistent trend regardless of the type of comorbidity (Pinteraction = 0.773) or the number of comorbidities (Pinteraction = 0.734), and the benefit of Farxiga was also found in patients with the most comorbidities. It was the biggest.
Specifically, the number of patients who need to be treated for 2 years to prevent one secondary event (Numbers Needs Treat, NNT) is 52 for patients without cardiac-renal-metabolic diseases other than heart failure and 1 for patients with them. 39 people were counted, 2 types were counted 33 people, and 3 types were counted 24 people. Treatment-related abnormalities were similar regardless of comorbidities.
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