MetAAA Trial Patients Receiving Metformin Therapy Show Limited Improvement in Quality of Life Compared to AAA Patients with Placebo Intake-A Double-Blind, Randomized, and Placebo-Controlled Trial.

Background: Abdominal aortic aneurysm (AAA) is a multifactorial vascular disease with limited therapeutic options, as no pharmacological treatments currently exist to mitigate the progression of small AAAs. Quality of life (QoL) has emerged as a valuable supplementary metric for assessing the efficacy of pharmacological interventions. This study evaluated QoL scores of MetAAA trial patients on metformin therapy compared to those with placebo intake. Methods: Overall, 54 patients with AAA were included in the MetAAA trial (ClinicalTrials.gov-Identifier:NCT03507413) and randomized to either metformin or placebo treatment. All participants were asked to complete three established and validated (in total 659 longitudinally collected) QoL questionnaires: (1) the 36-Item Short Form Health Survey (SF-36), (2) the Aneurysm Symptom Rating Questionnaire (ASRQ), and (3) the Aneurysm-Dependent Quality of Life questionnaire (ADQoL). Results: A superior health-related QoL was found in metformin-treated AAA patients compared to enrolled AAA patients receiving a placebo. In detail, AAA patients undergoing metformin treatment showed a superior overall current QoL score (p = 0.038), general health perception (p = 0.013), improved physical functioning (p = 0.004), and increased energy/lower fatigue scores (p = 0.008). Furthermore, fewer limitations due to cognitive distress (p = 0.001) and lower limb function (p = 0.021) were detected. Other QoL subscales did not show statistical significance. Inflammatory blood parameters suggest that while systemic inflammation may have some impact on perceived QoL, the relationship is largely limited. Conclusions: In patients with small AAA, metformin led to a limited improvement in health-related QoL compared to a placebo.