SCORED (original research)
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.
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 deaths from cardiovascular causes, hospitalizations for heart failure, or urgent visits for heart failure
5.6
7.5
7.5/100 py
5.6/100 py
3.8/100 py
1.9/100 py
0.0/100 py
Sotagliflozin
Placebo
Significant
decrease ▼
Significant decrease in the incidence of deaths from cardiovascular causes, hospitalizations for HF, or urgent visits for HF (5.6 events /100 py vs. 7.5 events /100 py; HR 0.74, 95% CI 0.63 to 0.88).
Secondary outcomes
Significant decrease in the incidence of hospitalizations for HF or urgent visits for HF (3.5 events /100 py vs. 5.1 events /100 py; HR 0.67, 95% CI 0.55 to 0.82).
No significant difference in the incidence of deaths from cardiovascular causes (2.2 events /100 py vs. 2.4 events /100 py; HR 0.9, 95% CI 0.73 to 1.12).
Significant decrease in the incidence of deaths from cardiovascular causes, hospitalizations for HF, nonfatal MI, or nonfatal stroke (7.6 events /100 py vs. 10.4 events /100 py; HR 0.72, 95% CI 0.63 to 0.83).
Safety outcomes
No significant difference in adverse events leading to withdrawal of trial regimen.
Significant differences in diarrhea (8.5% vs. 6.0%), diabetic ketoacidosis (0.6% vs. 0.3%), genital mycotic infections (2.4% vs. 0.9%), volume depletion (5.3% vs. 4.0%).
Conclusion
In adult patients with T2DM, CKD, and additional CVD risk, sotagliflozin was superior to placebo with respect to the incidence of deaths from cardiovascular causes, hospitalizations for HF, or urgent visits for HF.
Reference
Deepak L Bhatt, Michael Szarek, Bertram Pitt et al. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139.
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