Araki E, et al. - Among patients with type 2 diabetes comorbid with hypertriglyceridemia, researchers strived to gauge the efficacy and safety of pemafibrate (K-877) on their lipid and glucose metabolism. Findings revealed that pemafibrate substantially ameliorated the lipid abnormalities. It was found to be well tolerated in such individuals.

Methods

• Herein, enrollees were randomly allocated into 3 groups.
• They received placebo (n = 57), 0.2 mg/day pemafibrate (n = 54), or 0.4 mg/day pemafibrate (n = 55) for 24 weeks (treatment period 1).
• Follow-up treatment was provided for another 28 weeks (treatment period 2), in which the placebo was switched to 0.2 mg/day pemafibrate.
• The primary objectives included the results of treatment period 1.

Results

• Substantially reduced fasting serum triglyceride levels by ∼45% were noted in the pemafibrate groups when compared to the placebo group (P < 0.001).
• The pemafibrate groups also illustrated marked decreases in non-HDL and remnant lipoprotein cholesterol, apolipoprotein (Apo) B100, ApoB48, and ApoCIII levels as well as prominent increases in HDL cholesterol and ApoA-I levels.
• No significant alteration was found in the LDL cholesterol levels among the pemafibrate groups.
• When compared to the placebo group, the 0.2 mg/day pemafibrate group demonstrated a notably reduced HOMA-insulin resistance score.
• Nonetheless, there were no prominent changes in fasting plasma glucose, fasting insulin, glycoalbumin, or HbA1c levels compared with placebo.
• In addition, substantially increased fibroblast growth factor 21 levels were exhibited by the pemafibrate groups compared with the placebo group.
• Comparable rates of adverse events and drug reactions were disclosed among all groups.