Article Impact Level: HIGH Data Quality: STRONG Summary of The Lancet Diabetes & Endocrinology, S2213858724003620. https://doi.org/10.1016/S2213-8587(24)00362-0 Dr. Rahul Aggarwal et al.
Points
- A secondary analysis of the SCORED trial assessed the effects of sotagliflozin, a dual SGLT1/2 inhibitor, on ischemic cardiovascular events in patients with type 2 diabetes, chronic kidney disease, and cardiovascular risk factors.
- Sotagliflozin demonstrated a significant decrease in major adverse cardiovascular events (MACE) when compared to placebo, with rates of 4.8 versus 6.3 events per 100 person-years (HR 0.77, p=0.0020).
- The medication demonstrated a 32% reduction in myocardial infarction risk (HR 0.68, p=0.0041) and a 34% decrease in stroke risk (HR 0.66, p=0.012) when compared to placebo.
- Analyses of subgroups indicated no notable differences in treatment effects, implying wide relevance across various patient demographics.
- Sotagliflozin stands out among SGLT2 inhibitors by effectively reducing the risks of myocardial infarction and stroke, underscoring the promise of dual SGLT1/2 inhibition in mitigating ischemic events in high-risk populations.
Summary
A secondary analysis of the SCORED trial examined the impact of sotagliflozin, a dual SGLT1/2 inhibitor, on ischemic outcomes in individuals with type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. This study was a randomized, double-blind, placebo-controlled trial involving 10,584 patients with a median age of 69 years (IQR 63–74). Participants were assigned to receive either sotagliflozin (n=5292) or a placebo (n=5292). The research focused on evaluating total major adverse cardiovascular events (MACE), which include cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke. Other outcomes assessed were myocardial infarction and stroke separately.
The findings indicated that sotagliflozin led to a notable decrease in the overall MACE rate when compared to placebo (4.8 events versus 6.3 events per 100 person-years; hazard ratio [HR] 0.77, 95% CI 0.65–0.91; p=0.0020). Sotagliflozin demonstrated a notable reduction in the occurrence of myocardial infarction (1.8 compared to 2.7 events per 100 person-years; HR 0.68, 95% CI 0.52–0.89; p=0.0041) and stroke (1.2 versus 1.8 events per 100 person-years; HR 0.66, 95% CI 0.48–0.91; p=0.012). Subgroup analyses indicated that the treatment effect remained uniform across different patient groups, implying a lack of variability in the findings.
The results demonstrate that sotagliflozin, in contrast to a placebo, markedly lowered the risk of major adverse cardiovascular events, myocardial infarction, and stroke among these patients. The unique advantage observed here, absent in other SGLT inhibitors, underscores the promise of dual SGLT1/2 inhibition as an innovative approach to mitigate ischemic events in individuals with diabetes, chronic kidney disease, and cardiovascular risk. Additional exploration of the mechanisms contributing to the noted advantages is necessary.
Link to the article: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(24)00362-0/abstract
References Aggarwal, R., Bhatt, D. L., Szarek, M., Cannon, C. P., Leiter, L. A., Inzucchi, S. E., Lopes, R. D., McGuire, D. K., Lewis, J. B., Riddle, M. C., Davies, M. J., Banks, P., Carroll, A. K., Scirica, B. M., Ray, K. K., Kosiborod, M. N., Cherney, D. Z. I., Udell, J. A., Verma, S., … Steg, P. G. (2025). Effect of sotagliflozin on major adverse cardiovascular events: A prespecified secondary analysis of the SCORED randomised trial. The Lancet Diabetes & Endocrinology, S2213858724003620. https://doi.org/10.1016/S2213-8587(24)00362-0
