期刊
CIRCULATION-CARDIOVASCULAR IMAGING
卷 14, 期 7, 页码 -出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1161/CIRCIMAGING.120.012174
关键词
atherosclerosis; cardiovascular diseases; carotid arteries; glucagon-like peptide 1; inflammation; Type 2 Diabetes
资金
- Novo Nordisk A/S
- Skibsreder Per Henriksen, R. og hustrus fund
- Steno Diabetes Center Copenhagen
- Department of Clinical Physiology
- Nuclear Medicine PET
- Rigshospitalet & Cluster for Molecular Imaging
- University of Copenhagen, Denmark [670261]
- Research Foundation of Rigshospitalet
- Research Council of the Capital Region of Denmark
- Lundbeck Foundation
- Novo Nordisk Foundation
- John and Birthe Meyer Foundation
In this study, liraglutide did not change vascular inflammation in patients with type 2 diabetes. While there may be a potential effect in individuals with a history of cardiovascular disease, the overall results did not show a significant impact.
Background: The mechanism behind the cardiovascular protection observed with human GLP-1 RA (glucagon-like peptide-1 receptor agonists) in type 2 diabetes is unknown. We hypothesized that treatment with the GLP-1 RA liraglutide had a positive effect on vascular inflammation. Methods: LIRAFLAME (Effect of liraglutide on vascular inflammation in type-2 diabetes: A randomized, placebocontrolled, double-blind, parallel clinical PET/CT trial) was a double-blind, randomized controlled trial performed at a single university hospital clinic in Denmark. Patients with type 2 diabetes were via computer-generated randomization list assigned (1:1) liraglutide up to 1.8 mg or placebo once daily for 26 weeks. The primary end point was change in vascular inflammation over 26 weeks assessed by [F-18]-fluorodeoxyglucose positron emission tomography/computed tomography. Analyses were based on intention-to-treat. Key secondary outcomes included change in other indices of atherosclerosis. Results: Between October 26, 2017, and August 16, 2019, 147 patients were screened and 102 were randomly assigned to liraglutide (n=51) or placebo (n=51) and 99 (97%) completed the trial. Change in the [F-18]-fluorodeoxyglucose positron emission tomography measure of vascular inflammation (active-segment target-to-background ratio) did not differ between treatment groups: change from baseline to 26 weeks was -0.04 (95% CI, -0.17 to 0.08) in the liraglutide group compared with -0.09 (-0.19 to 0.01) in the placebo group (mean difference, 0.05 [95% CI, -0.11 to 0.21], P=0.53). Secondary analyses restricted to [F-18]-fluorodeoxyglucose positron emission tomography of the carotid arteries as well as other indices of atherosclerosis confirmed the primary result. We performed an explorative analysis of interaction between treatment group and history of cardiovascular disease (P=0.052). Conclusions: In this low to moderate risk population with type 2 diabetes, liraglutide did not change vascular inflammation assessed as [F-18]-fluorodeoxyglucose uptake compared with placebo. An explorative analysis indicated a possible effect in persons with history of cardiovascular disease, in line with current guidelines where liraglutide is recommended to patients with history of cardiovascular disease. Registration: URL: ; Unique identifier: NCT03449654.
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