Abstract | BACKGROUND: 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 [ 18F]-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 [ 18F]-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 [ 18F]-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:
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Authors | Rasmus S Ripa, Emilie H Zobel, Bernt J von Scholten, Jacob K Jensen, Tina Binderup, Lars J Diaz, Viktor R Curovic, Tine W Hansen, Peter Rossing, Andreas Kjaer |
Journal | Circulation. Cardiovascular imaging
(Circ Cardiovasc Imaging)
Vol. 14
Issue 7
Pg. e012174
(07 2021)
ISSN: 1942-0080 [Electronic] United States |
PMID | 34187185
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biomarkers
- Blood Glucose
- GLP1R protein, human
- Glucagon-Like Peptide-1 Receptor
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Incretins
- Radiopharmaceuticals
- hemoglobin A1c protein, human
- Fluorodeoxyglucose F18
- Liraglutide
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Topics |
- Aged
- Biomarkers
(blood)
- Blood Glucose
(drug effects, metabolism)
- Carotid Artery Diseases
(diagnostic imaging, drug therapy)
- Carotid Intima-Media Thickness
- Coronary Angiography
- Coronary Artery Disease
(diagnostic imaging, drug therapy)
- Denmark
- Diabetes Mellitus, Type 2
(blood, diagnosis, drug therapy)
- Double-Blind Method
- Female
- Fluorodeoxyglucose F18
- Glucagon-Like Peptide-1 Receptor
(agonists)
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Incretins
(adverse effects, therapeutic use)
- Liraglutide
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Positron Emission Tomography Computed Tomography
- Predictive Value of Tests
- Radiopharmaceuticals
- Time Factors
- Treatment Outcome
- Vasculitis
(diagnostic imaging, drug therapy)
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