Cardiometabolic & kidneySecondary analysis
Heart Failure Outcomes Captured by Adverse Event Reporting in Participants with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Observations from the VERTIS CV Trial
- Secondary analysis of the VERTIS CV randomised trial
- placebo-controlled
Authors' conclusion
The effect of ertugliflozin was consistent across the spectrum of total investigator-reported HF AEs and was similar in magnitude to adjudicated HHF events.
Study context
- Population
- Participants with T2DM and atherosclerotic CVDreceived ≥1 dose
- Participants
- 8,238 participants
- Comparison
- Ertugliflozin vs placebo
- Primary endpoint
- All reported HF events independent of adjudication confirmation
Primary result
As reported in the abstract
Investigator-reported HF AEs
Ertugliflozin vs PlaceboHazard ratio (95% CI)P value
first HF AE
0.69(0.57–0.84)
P < 0.001total HF AEs
0.66(0.57–0.78)
P < 0.001- First heart failure (HF) events captured
- 420
- Total HF events captured
- 627
Further findings
First and total HF serious AEs (SAEs)
- Similar results to HF adverse events (AEs)
Oedema; orthopnoea/dyspnoea
- Ertugliflozin reduced oedema risk, but not orthopnoea/dyspnoea
Original publication
Heart Failure Outcomes Captured by Adverse Event Reporting in Participants with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Observations from the VERTIS CV Trial. Eur J Heart Fail. Published 10 January 2025. doi:10.1002/ejhf.3511
Summarised from the published abstract; every number is checked against it