Sotagliflozin SCORED MACE benefit

New analyses of the SCORED trial revealed that SGLT1/2 inhibitor sotagliflozin provides up to 23% risk reduction of major cardiovascular adverse events (MACE) in patients with type 2 diabetes, chronic kidney disease, and at high risk for cardiovascular disease (CVD).

The phase 3 SCORED trial (NCT03315143) compared the treatment of sotagliflozin with placebo in 10,584 patients with type 2 diabetes and chronic kidney disease. The primary endpoint of risk of complex events such as cardiovascular death, heart failure hospitalisation, and emergency room visit for heart failure was met, and published last year, showing that sotagliflozin reduced the risk for cardiovascular outcomes [1].

At the ACC Scientific Session, Prof. Deepak Bhatt (Brigham and Women's Hospital, MA, USA) presented a pre-specified, secondary analysis of the SCORED results, looking specifically at the 16-month effect of sotagliflozin versus placebo for the combined incidence of total MACE, which included cardiovascular death, first and recurrent episodes of non-fatal myocardial infarction, and non-fatal stroke [2]. The new analysis compared the 5,144 randomised participants who entered the trial with a history of CVD with the 5,440 participants without CVD history. CVD history included myocardial infarction, stroke, coronary revascularisation, and peripheral vascular disease.

The incidence of MACE (including first and recurrent events), total myocardial infarction (non-fatal and fatal), and total stroke (non-fatal and fatal) was reduced in patients with CVD history treated with sotagliflozin by up to 23%. These cardiovascular benefits were consistent in a subgroup analysis in patients with preserved left ventricular ejection fraction (HFpEF) and those with reduced left ventricular ejection fraction (HFrEF).

In those without CVD history, sotagliflozin reduced the risk of total cardiovascular events by 26% compared with placebo, indicating that the effect was similar (HR 0.74; 95% CI 0.63–0.88; P<0.001). Likewise, the outcomes for total myocardial infarction and total stroke were similar. Sotagliflozin lowered the risk of myocardial infarction by 31% in CVD-history patients compared with placebo. In those without CVD history, treatment with sotagliflozin did not achieve statistical significance but lowered the risk by 34% compared with the placebo. The reduction in MACE was consistent across patients with coronary artery disease (HR 0.79), cerebrovascular disease (HR 0.72), and peripheral arterial disease (HR 0.77).

In a meta-analysis of MACE in 4 sotagliflozin studies with a placebo comparator, totalling 20,292 patients, Prof. Bhatt noted that sotagliflozin reduced the risk of MACE by 21% (HR 0.79; 95% CI 0.64–0.96; P=0.02). “These benefits showed a significant difference from the placebo group from the third month of treatment,” he said.

1. 
   
   1. Bhatt DL, et al. N Engl J Med 2021;384:129–139.
   2. Bhatt DL, et al. Sotagliflozin Significantly Reduces Cardiovascular Death, Myocardial Infarction, And Stroke In The SCORED Trial. Abstract 403–08, ACC 2022, 2–4 April, Washington DC, USA.

 

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Posted on 15 June, 202222 February, 2024