BMI variability and cardiovascular outcomes within clinical trial and real-world environments in type 2 diabetes: an IMI2 SOPHIA study
Primary result · 3P-MACE per +1 SD increase in BMI variability (Harmony Outcomes)Result — go to the resultHazard ratio 1.12 95% CI 1.08–1.17Authors' conclusion
In individuals with type 2 diabetes, increased BMI variability was found to be an independent risk factor for 3P-MACE across cardiovascular outcome trials and real-world datasets. Future research should attempt to establish a causal relationship between BMI variability and cardiovascular outcomes.
Study context
- Population
- Individuals with T2D in Harmony Outcomes, placebo arms of REWIND and EMPA-REG OUTCOME, and the Tayside Bioresource
- Participants
- 9,198 / 4,440 / 2,333 / 6,980
- Comparison
- Higher vs lower BMI variability
- Harmony Outcomesn = 9,198
- REWINDn = 4,440
- EMPA-REG OUTCOMEn = 2,333
- Tayside Bioresourcen = 6,980
- Primary endpoint
- First 3P-MACE: non-fatal stroke, non-fatal MI or cardiovascular death
Methodological detailsCox regression, adjusted for cardiovascular risk factors
- Cox regression
- Adjusted for cardiovascular risk factors
Primary result
As reported in the abstract
3P-MACE per +1 SD increase in BMI variability (Harmony Outcomes)
Hazard ratio
1.12
95% CI 1.08–1.17
P < 0.001
+1 SD BMI variability
HR 1.12 (95% CI 1.08–1.17); P < 0.001
Per +1 SD increase in BMI variability, as printed
Further findings
3P-MACE, most vs least variable BMI quartile (Harmony Outcomes)
- Most variable quartile had higher 3P-MACE risk vs least variable (P < 0.001)
- 87%
Replication in other cohorts
- Similar associations in REWIND and Tayside Bioresource
- Not replicated in EMPA-REG OUTCOME
- Effect independent of HbA1c variability
Original publication
BMI variability and cardiovascular outcomes within clinical trial and real-world environments in type 2 diabetes: an IMI2 SOPHIA study. Cardiovasc Diabetol. Published 16 July 2024. doi:10.
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