Cardiovascular risk profiles: A cross-sectional study evaluating the generalizability of the glucagon-like peptide-1 receptor agonist cardiovascular outcome trials REWIND, LEADER and SUSTAIN-6 to the real-world type 2 diabetes population in the United Kingdom

Webb, Joanne; Mount, Julie; von Arx, Lill Brith; Rachman, Jonathan; Spanopoulos, Dionysis; Wood, Robert; Tritton, Theo; Massey, Olivia; Idris, Iskandar

Abstract

Aims: To determine the proportion of UK patients with type 2 diabetes (T2D) who meet the cardiovascular (CV) or combined CV/core eligibility criteria used for the CV outcome trials (CVOTs) of UK-marketed glucagon-like peptide-1 receptor agonists (GLP-1RAs) showing CV benefit (dulaglutide in REWIND, liraglutide in LEADER and injectable semaglutide in SUSTAIN-6). Materials and Methods: Adults with T2D on/before June 2018 were identified from the UK Clinical Practice Research Datalink GOLD primary care database and linked to Hospital Episode Statistics data (Protocol 19_262). Patient CV and clinical data were evaluated against the CVOT eligibility criteria. Data were analysed descriptively. Results: The study cohort (N=33 118 patients with T2D) had a mean (standard deviation) age of 66.0 (13.3) years and 56.6% were male. Almost two-thirds (64.5%) of the study cohort met the CV criteria for REWIND, versus 43.0% for both LEADER and SUSTAIN-6. The proportions of the study cohort who met the CVOT criteria of “established CV disease” and “CV risk factors only” for REWIND were 22.4% and 42.1%, respectively, versus 38.7% and 4.3%, respectively, for both LEADER and SUSTAIN-6. The proportions of patients satisfying both CV and core criteria were 44.4% for REWIND, 13.3% for LEADER and 13.5% for SUSTAIN-6. Study findings remained consistent when restricted to GLP-1RA users. Conclusions: REWIND captured a trial population more representative of the real-world T2D population in the United Kingdom than LEADER or SUSTAIN-6 with regard to both CV and combined CV/core eligibility criteria.

Citation

Webb, J., Mount, J., von Arx, L. B., Rachman, J., Spanopoulos, D., Wood, R., Tritton, T., Massey, O., & Idris, I. (2022). Cardiovascular risk profiles: A cross-sectional study evaluating the generalizability of the glucagon-like peptide-1 receptor agonist cardiovascular outcome trials REWIND, LEADER and SUSTAIN-6 to the real-world type 2 diabetes population in the United Kingdom. Diabetes, Obesity and Metabolism, 24(2), 289-295. https://doi.org/10.1111/dom.14580

• Journal Article Type: Article
• Acceptance Date: Oct 15, 2021
• Online Publication Date: Oct 20, 2021
• Publication Date: Feb 1, 2022
• Deposit Date: Oct 15, 2021
• Publicly Available Date: Oct 21, 2022
• Journal: Diabetes, Obesity and Metabolism
• Print ISSN: 1462-8902
• Electronic ISSN: 1463-1326
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 24
• Issue: 2
• Pages: 289-295
• DOI: https://doi.org/10.1111/dom.14580
• Keywords: type 2 diabetes; cardiovascular disease; GLP-1 RA; cardiovascular outcome trials; real-world evidence
• Public URL: https://nottingham-repository.worktribe.com/output/6461560
• Publisher URL: https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14580
• Additional Information: This is the peer reviewed version of the following article: Webb, J., Mount, J., Von Arx, L., Rachman, J., Spanopoulos, D., Wood, R., …Idris, I. (2021). Cardiovascular risk profiles: A cross-sectional study evaluating the generalisability of the glucagon-like peptide-1 receptor agonist cardiovascular outcome trials REWIND, LEADER and SUSTAIN-6 to the real-world type 2 diabetes population in the UK. Diabetes, Obesity and Metabolism, 2022; 24( 2): 289- 295 which has been published in final form at https://doi.org/10.1111/dom.14580. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited.