Journal article
BMI variability and cardiovascular outcomes within clinical trial and real-world environments in type 2 diabetes: an IMI2 SOPHIA study
- Abstract:
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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.
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.
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.
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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 2.8MB, Terms of use)
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(Preview, Supplementary materials, pdf, 1.0MB, Terms of use)
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- Publisher copy:
- 10.1186/s12933-024-02299-8
Authors
+ European Commission
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- Funder identifier:
- https://ror.org/00k4n6c32
- Programme:
- Horizon 2020 research and innovation program
- Publisher:
- BioMed Central
- Journal:
- Cardiovascular Diabetology More from this journal
- Volume:
- 23
- Issue:
- 1
- Article number:
- 256
- Place of publication:
- England
- Publication date:
- 2024-07-16
- Acceptance date:
- 2024-06-10
- DOI:
- EISSN:
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1475-2840
- Pmid:
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39014446
- Language:
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English
- Keywords:
-
- Pubs id:
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2398952
- Local pid:
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pubs:2398952
- Source identifiers:
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W4400676307
- Deposit date:
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2026-04-02
- ARK identifier:
Terms of use
- Copyright holder:
- Massey et al.
- Copyright date:
- 2024
- Rights statement:
- © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
- Licence:
- CC Attribution (CC BY)
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