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BMI variability and cardiovascular outcomes within clinical trial and real-world environments in type 2 diabetes: an IMI2 SOPHIA study.
- Source :
-
Cardiovascular diabetology [Cardiovasc Diabetol] 2024 Jul 16; Vol. 23 (1), pp. 256. Date of Electronic Publication: 2024 Jul 16. - Publication Year :
- 2024
-
Abstract
- Background: BMI variability has been associated with increased cardiovascular disease risk in individuals with type 2 diabetes, however comparison between clinical studies and real-world observational evidence has been lacking. Furthermore, it is not known whether BMI variability has an effect independent of HbA1c variability.<br />Methods: We investigated the association between BMI variability and 3P-MACE risk in the Harmony Outcomes trial (n = 9198), and further analysed placebo arms of REWIND (n = 4440) and EMPA-REG OUTCOME (n = 2333) trials, followed by real-world data from the Tayside Bioresource (n = 6980) using Cox regression modelling. BMI variability was determined using average successive variability (ASV), with first major adverse cardiovascular event of non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death (3P-MACE) as the primary outcome.<br />Results: After adjusting for cardiovascular risk factors, a + 1 SD increase in BMI variability was associated with increased 3P-MACE risk in Harmony Outcomes (HR 1.12, 95% CI 1.08-1.17, P < 0.001). The most variable quartile of participants experienced an 87% higher risk of 3P-MACE (P < 0.001) relative to the least variable. Similar associations were found in REWIND and Tayside Bioresource. Further analyses in the EMPA-REG OUTCOME trial did not replicate this association. BMI variability's impact on 3P-MACE risk was independent of HbA1c variability.<br />Conclusions: 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.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Male
Female
Middle Aged
Aged
Treatment Outcome
Risk Assessment
Time Factors
Blood Glucose metabolism
Blood Glucose drug effects
Sodium-Glucose Transporter 2 Inhibitors therapeutic use
Sodium-Glucose Transporter 2 Inhibitors adverse effects
Randomized Controlled Trials as Topic
Risk Factors
Diabetes Mellitus, Type 2 diagnosis
Diabetes Mellitus, Type 2 mortality
Diabetes Mellitus, Type 2 complications
Diabetes Mellitus, Type 2 blood
Body Mass Index
Cardiovascular Diseases mortality
Cardiovascular Diseases diagnosis
Cardiovascular Diseases epidemiology
Glycated Hemoglobin metabolism
Biomarkers blood
Heart Disease Risk Factors
Subjects
Details
- Language :
- English
- ISSN :
- 1475-2840
- Volume :
- 23
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Cardiovascular diabetology
- Publication Type :
- Academic Journal
- Accession number :
- 39014446
- Full Text :
- https://doi.org/10.1186/s12933-024-02299-8