PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: To examine the effect of liraglutide on peripheral perfusion measured as peripheral transcutaneous oxygen pressure (TcPo2) in individuals with type 2 diabetes and PAD.
UNASSIGNED: 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.
UNASSIGNED: Patients were randomized to receive 1.8 mg of subcutaneous liraglutide or conventional treatment of cardiovascular risk factors (control group) for 6 months.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04881110.
UNASSIGNED: To examine the effect of liraglutide on peripheral perfusion measured as peripheral transcutaneous oxygen pressure (TcPo2) in individuals with type 2 diabetes and PAD.
UNASSIGNED: 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.
UNASSIGNED: Patients were randomized to receive 1.8 mg of subcutaneous liraglutide or conventional treatment of cardiovascular risk factors (control group) for 6 months.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04881110.
摘要：
■糖尿病患者的外周动脉疾病（PAD）可能导致糖尿病足溃疡和下肢截肢。胰高血糖素样肽1受体激动剂在心血管风险高的2型糖尿病患者的试验中已证明对心血管有益。
■目的研究利拉鲁肽对2型糖尿病和PAD患者外周经皮氧分压（TcPo2）测量的外周灌注的影响。
■这项开放标签的随机临床试验于2021年2月1日至2022年6月30日之间进行，并于2022年12月30日在坎帕尼亚大学进行了最后一次随访。\"那不勒斯,意大利。55名2型糖尿病患者,PAD,包括30至49mmHg的TcPo2。
■患者随机接受1.8mg皮下利拉鲁肽或心血管危险因素的常规治疗（对照组），为期6个月。
■主要结果是组间外周灌注相对于基线的变化，以及各组中TcPo2相对于基线增加10%的个体比例的比较。
■55名参与者(平均[SD]年龄，67.5[8.5]岁;43[78%]男性)随机分组(利拉鲁肽组27人,对照组28人)进行分析。参与者的中位（IQR）血红蛋白A1c水平为6.9％（6.5％-7.8％），平均（SD）TcPo2为40.3（5.7）mmHg。两组经皮Po2随时间增加，在6个月后，利拉鲁肽组具有显著差异(估计治疗差异，11.2mmHg；95%CI，8.0-14.5mmHg；P<.001）。利拉鲁肽组的24名参与者（89％）和对照组的13名（46％）的TcPo2增加10％（相对风险，1.91；95%CI，1.26-2.90；P<.001）。与对照组相比,利拉鲁肽组患者的C反应蛋白显著降低（-0.4mg/dL;95%CI-0.7至-0.07mg/dL;P=.02），尿白蛋白与肌酐比值（-119.4mg/g；95%CI，-195.0至-43.8mg/g；P=.003），改善6分钟步行距离（25.1m；95%CI，21.8-28.3m；P<.001）。
■在这项针对2型糖尿病和PAD患者的随机临床试验中，利拉鲁肽在治疗6个月期间通过TcPo2测量检测到的外周灌注增加。这些结果支持在患有2型糖尿病的个体中使用利拉鲁肽来预防PAD的临床进展。
■ClinicalTrials.gov标识符：NCT04881110。
■目的研究利拉鲁肽对2型糖尿病和PAD患者外周经皮氧分压（TcPo2）测量的外周灌注的影响。
■这项开放标签的随机临床试验于2021年2月1日至2022年6月30日之间进行，并于2022年12月30日在坎帕尼亚大学进行了最后一次随访。\"那不勒斯,意大利。55名2型糖尿病患者,PAD,包括30至49mmHg的TcPo2。
■患者随机接受1.8mg皮下利拉鲁肽或心血管危险因素的常规治疗（对照组），为期6个月。
■主要结果是组间外周灌注相对于基线的变化，以及各组中TcPo2相对于基线增加10%的个体比例的比较。
■55名参与者(平均[SD]年龄，67.5[8.5]岁;43[78%]男性)随机分组(利拉鲁肽组27人,对照组28人)进行分析。参与者的中位（IQR）血红蛋白A1c水平为6.9％（6.5％-7.8％），平均（SD）TcPo2为40.3（5.7）mmHg。两组经皮Po2随时间增加，在6个月后，利拉鲁肽组具有显著差异(估计治疗差异，11.2mmHg；95%CI，8.0-14.5mmHg；P<.001）。利拉鲁肽组的24名参与者（89％）和对照组的13名（46％）的TcPo2增加10％（相对风险，1.91；95%CI，1.26-2.90；P<.001）。与对照组相比,利拉鲁肽组患者的C反应蛋白显著降低（-0.4mg/dL;95%CI-0.7至-0.07mg/dL;P=.02），尿白蛋白与肌酐比值（-119.4mg/g；95%CI，-195.0至-43.8mg/g；P=.003），改善6分钟步行距离（25.1m；95%CI，21.8-28.3m；P<.001）。
■在这项针对2型糖尿病和PAD患者的随机临床试验中，利拉鲁肽在治疗6个月期间通过TcPo2测量检测到的外周灌注增加。这些结果支持在患有2型糖尿病的个体中使用利拉鲁肽来预防PAD的临床进展。
■ClinicalTrials.gov标识符：NCT04881110。
