Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial.
Summary
In patients with type 2 diabetes and chronic kidney disease, sotagliflozin reduced total MACE versus placebo (HR 0.77) and independently reduced myocardial infarction (HR 0.68) and stroke (HR 0.66). Benefits were consistent across subgroups, highlighting a potential ischemic risk reduction unique to dual SGLT1/2 inhibition.
Key Findings
- Sotagliflozin reduced total MACE vs placebo (4.8 vs 6.3 events per 100 person-years; HR 0.77, 95% CI 0.65-0.91).
- Myocardial infarction was reduced (1.8 vs 2.7 events per 100 person-years; HR 0.68, 95% CI 0.52-0.89).
- Stroke was reduced (1.2 vs 1.8 events per 100 person-years; HR 0.66, 95% CI 0.48-0.91).
- Effects were consistent across stratified subgroups without evidence of heterogeneity.
Clinical Implications
For T2D patients with CKD at high ischemic risk, sotagliflozin may be prioritized to reduce MI and stroke in addition to heart failure benefits; care teams should consider dual SGLT1/2 inhibition when selecting glucose-lowering therapy.
Why It Matters
This is the first robust evidence that a dual SGLT1/2 inhibitor reduces MI and stroke in T2D with CKD, extending beyond the heart failure benefits typical of SGLT2 inhibitors.
Limitations
- Secondary analysis may be hypothesis-generating despite prespecification.
- Trial stopped early; follow-up duration for ischemic endpoints not fully detailed in the abstract.
Future Directions
Head-to-head comparisons with SGLT2-only inhibitors and mechanistic studies of SGLT1 inhibition on ischemic pathways are warranted; evaluate generalizability beyond T2D with CKD.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- II - Prespecified secondary analysis within an RCT provides high-quality but not primary endpoint evidence.
- Study Design
- OTHER