SGLT-2 inhibitor did not decrease risk of stroke in diabetic patients

Background

Diabetes mellitus (DM) patients have a 2-fold increased risk of stroke compared with individuals without DM [1]. With the exception of pioglitazone and semaglutide, intensive or specific glucose-lowering agents have not significantly reduced the risk of stroke in type 2 DM (T2DM) patients [2-5].

In this analysis of 7020 patients enrolled in the EMPA-REG OUTCOME trial, the impact of empagliflozin versus placebo on cerebrovascular events was evaluated.

Main results

• There was no significant difference between empagliflozin and placebo in the occurrence of stroke (HR 1.18, 95% CI 0.89–1.56, P=0.26).
• The proportion of patients with recurrent stroke during the trial was similar between the empagliflozin and placebo groups (0.3% vs 0.3%).
• Nonfatal disabling stroke was reported in 0.2% of patients on empagliflozin and 0.3% of patients on placebo (HR 0.82, 95% CI 0.30–2.26, P=0.70).
• Fatal stroke was reported in similar proportions of patients in the empagliflozin and placebo groups (0.3 and 0.5%, respectively, HR 0.72, 95% CI 0.33–1.55, P=0.40) as was the composite of non-fatal disabling stroke or fatal stroke (0.6% and 0.7%, respectively, HR 0.81, 95% CI, 0.43–1.50, P=0.50).
• There was no significant difference in the risk of TIA (HR 0.85, 95% CI 0.51–1.42, P=0.54) or the composite of stroke or TIA (HR 1.05, 95% CI 0.82–1.35, P=0.87) with empagliflozin versus placebo.
• Systolic blood pressure (SBP) decreased in patients treated with empagliflozin (mean change from baseline to last value on treatment −3.3 [SE 0.3] mmHg), but returned to its baseline level at follow-up (30 days after end of treatment).
• Patients with the largest SBP decreases from baseline (≥30 mmHg) did not have an increased risk of stroke compared with other patients.
• In the empagliflozin group, haematocrit increased during treatment (mean change from baseline to last value on treatment 3.61% [SE 0.06]), but decreased toward baseline at follow-up (30 days after end of treatment).
• Patients with the largest increases from baseline in haematocrit (increases ≥90th percentile, which corresponded to a change in haematocrit of 9 percentage points) did not have an increased risk of stroke compared with patients not meeting this threshold.
• The risk of stroke was comparable between patients with and without atrial fibrillation at baseline or during the study in the placebo and empagliflozin groups.

Conclusion

References

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