Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial
Primary result · Total MACEResult — go to the resultHazard ratio 0.77 95% CI 0.65–0.91Authors' conclusion
Sotagliflozin reduced MACE, with independent reductions in myocardial infarction and stroke, among patients with type 2 diabetes, chronic kidney disease, and additional cardiovascular risk. The ischaemic benefit on both myocardial infarction and stroke has not been previously observed with other SGLT inhibitors and warrants investigation of combined SGLT1 and SGLT2 inhibition as a possible underlying mechanism.
Study context
- Population
- Adults (≥18 years) with T2D, CKD (eGFR 25–60 mL/min per 1.73 m²) and additional cardiovascular risk factors; 750 sites in 44 countries; median age 69 years, 44.9% femalerandomised 1:1
- Participants
- 10,584 adults
- Comparison
- Sotagliflozin vs placebo
- Sotagliflozinn = 5,292
- Placebon = 5,292reference
- Primary endpoint
- Total MACE (cardiovascular death, non-fatal MI, non-fatal stroke), first and subsequent events (prespecified secondary outcome of SCORED)
Methodological detailsprespecified, double-blind, placebo-controlled, multicentre, ended early, Trial ended early
- Prespecified
- Double-blind
- Placebo-controlled
- Multicentre
- Ended early
- Trial ended early
Primary result
Total MACE
Hazard ratio
0.77
95% CI 0.65–0.91
P = 0.0020
By group
Sotagliflozin
4.8 events per 100 person-years
Placebo
6.3 events per 100 person-years
As reported in the abstract
Secondary outcomes
Events per 100 person-years
| Outcome | Sotagliflozin | Placebo | HR (CI) | P value | |
|---|---|---|---|---|---|
| Total MI (fatal and non-fatal)Post-hoc endpoint | 1.8 | 2.7 | 0.68 (0.52–0.89) | P = 0.0041 | |
| Total stroke (fatal and non-fatal)Post-hoc endpoint | 1.2 | 1.8 | 0.66 (0.48–0.91) | P = 0.012 | |
| 0.512Hazard ratio (log scale) |
Total major adverse cardiovascular events (MACE) in prespecified subgroups
- Consistent effect among stratified subgroups without evidence of heterogeneity
Original publication
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