Meta‐analysis of risk of major adverse cardiovascular events in adults with type 2 diabetes treated with bexagliflozin
Authors' conclusion
Bexagliflozin did not increase the risk of MACE in participants with T2D when compared with placebo or active control. Both the preapproval and postapproval thresholds for CV safety were met and bexagliflozin has been approved by the US Food and Drug Administration.
Study context
- Population
- Participants with T2D enrolled in nine phase 2 and 3 double-blind RCTs
- Participants
- 4,090 participants9 RCTs
- Comparison
- Bexagliflozin vs placebo or active control
- Outcome
- HR for time to first non-fatal stroke, non-fatal MI, CV death or hospitalization for unstable angina (MACE+), tested for non-inferiority to a ratio of 1.8
Methodological detailsphase 2 and 3 double-blind RCTs, blinded adjudication of major adverse cardiovascular events (MACE), non-inferiority, All potential MACE adjudicated by a blinded committee
- Phase 2 and 3 double-blind RCTs
- Blinded adjudication of MACE
- Non-inferiority
- All potential MACE adjudicated by a blinded committee
Pooled result
As reported in the abstract
MACE+:
- Non-fatal stroke
- Non-fatal MI
- CV death
- Hospitalization for unstable angina
- HR for MACE+
- 0.80 (95% CI 0.58, 1.09)
- Non-inferiority objective fulfilled
- P<0.0001
Further pooled results
MACE (non-fatal stroke, non-fatal myocardial infarction (MI) or cardiovascular (CV) death), time to first occurrence; first key secondary endpoint
- HR for MACE
- 0.82 (95% CI 0.59, 1.13)
- Non-inferiority shown
- P = 0.0023
- Non-inferiority margin: HR 1.3; non-inferiority met
CV death or first hospitalization for HF
- Superiority not shown
Original publication
Meta‐analysis of risk of major adverse cardiovascular events in adults with type 2 diabetes treated with bexagliflozin. Diabetes Obes Metab. Published 27 December 2023. doi:10.
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