SCORED (secondary analysis)
Trial question
What is the effect of sotagliflozin in patients with T2DM, CKD, and additional CVD risk?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 10584
10584 patients (4754 female, 5830 male).
Inclusion criteria: adult patients with T2DM, CKD, and additional CVD risk factors.
Key exclusion criteria: unstable antihyperglycemic treatment within 12 weeks prior to screening; planned coronary procedure or surgery after randomization; lower extremity complications requiring treatment; planning to start a sodium-glucose linked transporter-2 inhibitor.
Interventions
N=5292 sotagliflozin (at a dose of 200 mg PO daily, with possible up-titration to 400 mg PO daily within first 6 months).
N=5292 placebo (matching placebo).
Primary outcome
Incidence of total major adverse CV events
4.8
6.3
6.3/100 py
4.7/100 py
3.1/100 py
1.6/100 py
0.0/100 py
Sotagliflozin
Placebo
Significant
decrease ▼
Significant decrease in the incidence of total major adverse CV events (4.8 events /100 py vs. 6.3 events /100 py; HR 0.77, 95% CI 0.65 to 0.91).
Secondary outcomes
Significant decrease in the incidence of MI (1.8 events /100 py vs. 2.7 events /100 py; HR 0.68, 95% CI 0.52 to 0.89).
Significant decrease in the incidence of stroke (1.2 events /100 py vs. 1.8 events /100 py; HR 0.66, 95% CI 0.48 to 0.91).
Conclusion
In adult patients with T2DM, CKD, and additional CVD risk factors, sotagliflozin was superior to placebo with respect to the incidence of total major adverse CV events.
Reference
Rahul Aggarwal, Deepak L Bhatt, Michael Szarek et al. Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial. Lancet Diabetes Endocrinol. 2025 Apr;13(4):321-332.
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