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- Title
Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial.
- Authors
Caruso, Paola; Maiorino, Maria Ida; Longo, Miriam; Porcellini, Chiara; Matrone, Rita; Digitale Selvaggio, Lucia; Gicchino, Maurizio; Carbone, Carla; Scappaticcio, Lorenzo; Bellastella, Giuseppe; Giugliano, Dario; Esposito, Katherine
- Abstract
Key Points: Question: What is the effect of liraglutide on peripheral perfusion in people with type 2 diabetes and peripheral artery disease (PAD)? Findings: In this open-label randomized clinical trial of 55 individuals with type 2 diabetes and PAD, liraglutide was associated with a significant increase of transcutaneous oxygen pressure (TcPo2) compared with conventional treatment of cardiovascular risk factors. An increase of at least 10% of TcPo2 from baseline was achieved by 89% of participants treated with liraglutide and 46% of the control group. Meaning: The administration of liraglutide improved peripheral perfusion in people with type 2 diabetes and PAD, suggesting that it may prevent the clinical progression of PAD. This randomized clinical trial of individuals with type 2 diabetes and peripheral artery disease examines the effect of daily administered liraglutide on peripheral perfusion. Importance: Peripheral artery disease (PAD) in diabetes may lead to diabetic foot ulcer and lower-extremities amputation. Glucagon-like peptide 1 receptor agonists have proven cardiovascular benefits in trials of people with type 2 diabetes at high cardiovascular risk. Objective: To examine the effect of liraglutide on peripheral perfusion measured as peripheral transcutaneous oxygen pressure (TcPo2) in individuals with type 2 diabetes and PAD. Design, Setting, and Participants: This open-label randomized clinical trial was conducted between February 1, 2021, and June 30, 2022, with a final follow-up on December 30, 2022, at University of Campania "Luigi Vanvitelli," Naples, Italy. Fifty-five individuals with type 2 diabetes, PAD, and TcPo2 between 30 and 49 mm Hg were included. Interventions: Patients were randomized to receive 1.8 mg of subcutaneous liraglutide or conventional treatment of cardiovascular risk factors (control group) for 6 months. Main Outcomes and Measures: Coprimary outcomes were the change from baseline of peripheral perfusion between groups and the comparison of the proportion of individuals who reached 10% increase of TcPo2 from baseline in each group. Results: Fifty-five participants (mean [SD] age, 67.5 [8.5] years; 43 [78%] male) were randomized (27 to the liraglutide group and 28 to the control group) and analyzed. Participants had a median (IQR) hemoglobin A1c level of 6.9% (6.5%-7.8%) and a mean (SD) TcPo2 of 40.3 (5.7) mm Hg. Transcutaneous Po2 increased over time in both groups, with significant differences favoring the liraglutide group after 6 months (estimated treatment difference, 11.2 mm Hg; 95% CI, 8.0-14.5 mm Hg; P <.001). The 10% increase of TcPo2 occurred in 24 participants (89%) in the liraglutide group and 13 (46%) in the control group (relative risk, 1.91; 95% CI, 1.26-2.90; P <.001). Compared with the control group, individuals in the liraglutide group had a significant reduction of C-reactive protein (−0.4 mg/dL; 95% CI, −0.7 to −0.07 mg/dL; P =.02), urinary albumin to creatinine ratio (−119.4 mg/g; 95% CI, −195.0 to −43.8 mg/g; P =.003), and improvement of 6-minute walking distance (25.1 m; 95% CI, 21.8-28.3 m; P <.001). Conclusions and Relevance: In this randomized clinical trial of people with type 2 diabetes and PAD, liraglutide increased peripheral perfusion detected by TcPo2 measurement during 6 months of treatment. These results support the use of liraglutide to prevent the clinical progression of PAD in individuals with type 2 diabetes. Trial Registration: ClinicalTrials.gov Identifier: NCT04881110
- Subjects
ITALY; GLUCAGON-like peptide-1 agonists; SELF-evaluation; PATIENT compliance; LEG; CREATININE; ACADEMIC medical centers; GLYCOSYLATED hemoglobin; BODY mass index; T-test (Statistics); PERIPHERAL vascular diseases; STATISTICAL sampling; QUESTIONNAIRES; TRANSCUTANEOUS blood gas monitoring; RANDOMIZED controlled trials; DESCRIPTIVE statistics; CHI-squared test; RELATIVE medical risk; LONGITUDINAL method; CONTROL groups; PRE-tests &; post-tests; TYPE 2 diabetes; DRUG efficacy; PERFUSION; ALBUMINS; BLOOD pressure; DATA analysis software; DRUGS; CONFIDENCE intervals; SUBCUTANEOUS injections; C-reactive protein; PHARMACODYNAMICS; EVALUATION
- Publication
JAMA Network Open, 2024, Vol 7, Issue 3, pe241545
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.1545