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Abstract

It has been established that increased cardiovascular risk is seen in individuals with elevated triglycerides; however, whether reduction of the same alleviates the risk is still unclear. A decrease in triglycerides and improvement in other lipid levels is observed with Pemafibrate, a selective peroxisome proliferator-activated receptor α modulator. Pradhan and researchers conducted a randomized, double-blind clinical trial on an international scale. Patients with type 2 diabetes mellitus were divided into two groups; high-density lipoprotein (HDL) cholesterol levels of 40 mg per deciliter and or lower and mild to moderate hypertriglyceridemia (200 to 499 mg per deciliter), where one group received a placebo and the other 200µg tablets BD Pemafibrate. A cohort of parameters, namely coronary revascularization, ischemic stroke, myocardial infarction, and death from cardiovascular disease, were factored in as the primary efficacy endpoints. An HDL cholesterol level of 33 mg per deciliter, a median baseline fasting triglyceride level of 271 mg per deciliter, and an LDL cholesterol level of 78 mg per deciliter were observed in a sum-total 10,497 patients, of whom 66.9% had a previous history of cardiovascular disease. After 16 months, a significant reduction of 26.2% for triglycerides, -25.8% for very-low-density lipoprotein (VLDL) cholesterol, 25.6% for remnant cholesterol (cholesterol transported in triglyceride-rich lipoproteins after lipolysis and lipoprotein remodeling), 27.6% for apolipoprotein C-III, and 4.8% for apolipoprotein B were observed in Pemafibrate group in comparison to the placebo group. In both groups, no significant difference was seen in the incidence of adverse events. However, a lower incidence of non-alcoholic fatty liver disease and a higher incidence of venous thromboembolism and adverse renal events were associated with Pemafibrate. N Engl J Med ( 2022) DOI: 10.1056/NEJMoa2210645.