Effects of Pemafibrate on Cardio-Ankle Vascular Index (CAVI) in Patients with Type 2 Diabetes or Ischemic Heart Disease: A 24-Week Observational Study

Background: Pemafibrate is a novel selective peroxisome proliferator-activated receptor alpha modulator (SPPARMα) that improves lipid profile, but its effects on cardiovascular events remain unproven. This study examined changes in the cardio-ankle vascular index (CAVI), a marker of arterial stiffness, in high-risk patients with type 2 diabetes mellitus (T2DM) or ischemic heart disease (IHD) treated with pemafibrate. Methods : In this single-center, prospective, observational study, 95 patients with T2DM and/or IHD, who had hypertriglyceridemia (≥150 mg/dL) and started pemafibrate (0.2 mg/day) were analyzed. The primary outcome was change in CAVI after 24 weeks. Secondary outcomes included changes in lipid profile, apolipoproteins, and liver enzymes. Results: No significant change in CAVI was observed after 24 weeks of treatment (median [interquartile range (IQR)]; baseline vs 24 weeks: CAVI 9.4 [8.8-10.6] vs. 9.6 [8.9-10.8], p=0.715). However, pemafibrate significantly reduced triglycerides (233 mg/dL [171-329] to 143 mg/dL [111-187], p<0.001), apolipoprotein C-II (8.1 mg/dL [6.1-10.2] to 6.3 mg/dL [5.3-8.3], p<0.001), apolipoprotein C-III (15.3 mg/dL [12.2-18.3] to 11.6 mg/dL [9.3-14.2], p<0.001) and liver enzymes; and increased high-density lipoprotein cholesterol (45 mg/dL [39-52] to 50 mg/dL [40-60], p<0.001), apolipoprotein A-I and apolipoprotein A-II (both p<0.05). Calculated small dense low-density lipoprotein cholesterol also decreased significantly (40 mg/dL [31-49] to 36 mg/dL [28-45], p=0.002). Conclusion: Although pemafibrate improves lipid profile and liver enzymes, its direct impact on vascular stiffness, as measured by CAVI, may be limited in short-term treatment. Further studies with extended follow-up are necessary to clarify its potential cardiovascular benefits, particularly in high-risk patients with T2DM and/or IHD.