Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes: The STARDUST randomized clinical trial #PAD #CLTI

In an intriguing study published in JAMA Network Open, researchers have unveiled promising results regarding the treatment of peripheral artery disease (PAD) in individuals with type 2 diabetes. The study, titled “Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial,” led by Paola Caruso, PhD, and her team, explores the efficacy of liraglutide, a glucagon-like peptide 1 receptor agonist, in improving peripheral perfusion.

Peripheral artery disease, a common complication of diabetes, significantly increases the risk of foot ulcers and lower extremity amputations. The STARDUST trial, conducted at the University of Campania “Luigi Vanvitelli” in Naples, Italy, aimed to assess whether liraglutide could enhance peripheral blood flow, as measured by peripheral transcutaneous oxygen pressure (TCPO2), in patients with type 2 diabetes and PAD. Fifty-five individuals with type 2 diabetes, PAD, and TcPo2 between 30 and 49 mm Hg were included.

The open-label randomized clinical trial included 55 participants with type 2 diabetes and PAD, who were divided into two groups. One group received 1.8 mg of subcutaneous liraglutide daily for six months, while the control group received conventional treatment for cardiovascular risk factors. The study’s primary outcomes focused on the change in peripheral perfusion between the two groups and the proportion of individuals achieving at least a 10% increase in TCPO2 from baseline.

The results were compelling. After six months, the liraglutide group showed a significant improvement in TCPO2 levels compared to the control group, with an estimated treatment difference of 11.2 mm Hg. Additionally, 89% of participants in the liraglutide group achieved a 10% increase in TCPO2, compared to only 46% in the control group. The study also observed significant reductions in C-reactive protein levels and urinary albumin to creatinine ratio, alongside an improvement in the 6-minute walking distance among the liraglutide group.

These findings suggest that liraglutide not only improves peripheral perfusion but may also offer a protective effect against the progression of PAD in individuals with type 2 diabetes. The study’s authors believe that liraglutide’s benefits extend beyond glycemic control, potentially improving endothelial function and reducing cardiovascular risk factors.

While the STARDUST trial provides valuable insights into the treatment of PAD in diabetic patients, the authors acknowledge certain limitations, including the study’s open-label design and relatively small sample size. They call for further research to confirm these findings and explore the long-term effects of liraglutide on peripheral perfusion and PAD progression.

This study marks a potentially iterative step forward in the management of PAD among diabetic patients, offering hope for improved outcomes and quality of life for those affected by this debilitating condition. For more details on this work, you can access the full article here.

Citations:
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2815948

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