دورية أكاديمية
أعرض في EDS

BMI variability and cardiovascular outcomes within clinical trial and real-world environments in type 2 diabetes: an IMI2 SOPHIA study.

التفاصيل البيبلوغرافية
العنوان: BMI variability and cardiovascular outcomes within clinical trial and real-world environments in type 2 diabetes: an IMI2 SOPHIA study.
المؤلفون: Massey RJ; Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK., Chen Y; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA., Panova-Noeva M; Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.; Center for Thrombosis and Haemostasis, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany., Mattheus M; Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany., Siddiqui MK; Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK.; Centre for Primary Care, Wolfson Institute of Population Health, Queen Mary University of London, London, UK., Schloot NC; Lilly Deutschland GmbH, Bad Homburg, Germany., Ceriello A; IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni, MI, Italy., Pearson ER; Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK., Dawed AY; Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, DD1 9SY, UK. aydawed@dundee.ac.uk.
المصدر: Cardiovascular diabetology [Cardiovasc Diabetol] 2024 Jul 16; Vol. 23 (1), pp. 256. Date of Electronic Publication: 2024 Jul 16.
نوع المنشور: Journal Article; Comparative Study; Observational Study
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101147637 Publication Model: Electronic Cited Medium: Internet ISSN: 1475-2840 (Electronic) Linking ISSN: 14752840 NLM ISO Abbreviation: Cardiovasc Diabetol Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2002-
مواضيع طبية MeSH: 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*, 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
مستخلص: 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.
(© 2024. The Author(s).)
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معلومات مُعتمدة: 875534 Innovative Medicines Initiative 2 Joint Undertaking
فهرسة مساهمة: Keywords: 3P-MACE risk; BMI variability; Cardiovascular disease; Diabetes management; HbA1c variability; Health outcomes; Type 2 diabetes
المشرفين على المادة: 0 (hemoglobin A1c protein, human)
0 (Glycated Hemoglobin)
0 (Biomarkers)
0 (Blood Glucose)
0 (Sodium-Glucose Transporter 2 Inhibitors)
تواريخ الأحداث: Date Created: 20240716 Date Completed: 20240717 Latest Revision: 20240719
رمز التحديث: 20240719
مُعرف محوري في PubMed: PMC11253469
DOI: 10.1186/s12933-024-02299-8
PMID: 39014446
قاعدة البيانات: MEDLINE
الوصف
تدمد:1475-2840
DOI:10.1186/s12933-024-02299-8