medwireNews: Results of the STARDUST trial suggest that in addition to liraglutide’s role as a glucose-lowering medication for type 2 diabetes, it may also help to improve blood flow in the lower limbs of those affected by peripheral arterial disease (PAD).
Peripheral perfusion at 6 months, as measured by the peripheral transcutaneous oxygen pressure (TcPO2), was increased to a significantly greater extent from baseline in the 27 participants treated with liraglutide than in the 28 controls who were not, at a respective 14.2 mmHg and 2.9 mmHg, giving an 11.3 mmHg between-group difference.
And significantly more of the liraglutide-treated than control group participants achieved the co-primary endpoint of a 10% increase in TcPO2, at 89% versus 46%.
“These results support the use of liraglutide to prevent the clinical progression of PAD in individuals with type 2 diabetes,” the team of Italian researchers propose in JAMA Network Open.
Maria Ida Maiorino and colleagues, from the University of Campania “Luigi Vanvitelli” in Naples, conducted the open label randomized trial between February 2021 and June 2022 to examine the possible pleiotropic effects of the glucagon-like peptide (GLP)-1 receptor agonist on the vascular system in people with both type 2 diabetes and imaging-confirmed PAD.
They recruited individuals aged 35 years or older who were seen at their institution and randomly assigned them to receive daily liraglutide or not, with both groups receiving tailored therapeutic prescriptions to manage blood glucose and cardiovascular risk factors to within current medical standards. Liraglutide was initiated at a dose of 0.6 mg/day and up-titrated weekly to reach a maximum target dose of 1.8 mg/day.
TcPO2 was measured using peripheral transcutaneous oximetry at the medial malleolus and the dorsum of the foot, which gave a measure of the level of perfusion coming from the posterior and anterior tibial arteries. For the measurement to be taken, participants were required to lay in the supine position for 20 minutes while an electrochemical transducer was passed over the lower limb areas.
Most (78%) of the participants were men, the researchers acknowledge, “although this is consistent with PAD epidemiology.” All of the participants were White, the mean age was 67.5 years, and the mean starting TcPO2 was 40.3 mmHg.
The baseline characteristics of the liraglutide and control groups were largely similar in terms of the duration of diabetes (11 vs 10 years), mean glycated hemoglobin levels (7.1 vs 6.8% or 54 vs 51 mmol/L), mean starting weight (80.9 vs 81.9 kg), and mean BMI (29.9 vs 28.1 kg/m2).
There was more variation in some other baseline variables, however, such as systolic (130 vs 140 mmHg) and diastolic (70 vs 80 mmHg) blood pressure, total cholesterol (143.5 vs 155.2 mg/dL), and the urinary albumin-to-creatine ratio (UACR; 47.4 vs 60.0 mg/g).
“After 6 months, significant differences from baseline for several additional outcomes were observed mostly within the liraglutide group,” observe the researchers.
These included a 0.4 mg/dL greater decrease in C-reactive protein with than without liraglutide, alongside a 119.4 mg/g greater decrease in UACR, and a 25-minute greater increase in the 6-minute walking distance.
“These results suggest a potential beneficial effect of liraglutide in improving endothelial function in people with type 2 diabetes and PAD,” comment the researchers.
They observe that their “[r]esults were obtained during a 6-month follow-up; therefore, a long-term evaluation should be performed to investigate the durability of the effect.”
The team concludes that the results highlight the possible beneficial effect of liraglutide on peripheral perfusion in people with type 2 diabetes and PAD, adding that “[w]hether this effect is associated with other GLP-1 [receptor agonists] should be clarified in future studies.”
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