TUESDAY, Nov. 8, 2022 (HealthDay News) -- For patients with type 2 diabetes, hypertriglyceridemia, and low high-density lipoprotein cholesterol levels, the incidence of cardiovascular events is not lower with pemafibrate versus placebo, according to a study published online Nov. 5 in the New England Journal of Medicine to coincide with the American Heart Association Scientific Sessions 2022, held from Nov. 5 to 7 in Chicago.
Aruna Das Pradhan, M.D., M.P.H., from Brigham and Women’s Hospital in Boston, and colleagues conducted a multinational, double-blind, randomized, controlled trial in which 10,497 patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia, and high-density lipoprotein cholesterol levels of 40 mg/dL or lower were randomly assigned to receive pemafibrate or matching placebo. Patients were followed for a median of 3.4 years.
The researchers found that at four months, the effects of pemafibrate versus placebo on lipid levels were −26.2 percent for triglycerides, −25.8 percent for very-low-density lipoprotein cholesterol, −25.6 percent for remnant cholesterol, −27.6 percent for apolipoprotein C-III, and 4.8 percent for apolipoprotein B. A primary end point (composite of nonfatal myocardial infarction, ischemic stroke, coronary revascularization, or death from cardiovascular causes) event occurred in 572 and 560 patients in the pemafibrate and placebo groups, respectively (hazard ratio, 1.03; 95 percent confidence interval, 0.91 to 1.15), with no effect modification observed in prespecified subgroups. There was no between-group difference seen in the overall incidence of serious adverse events, but pemafibrate was associated with increased incidence of adverse renal events and venous thromboembolism, and lower incidence of nonalcoholic fatty liver disease.
"These findings highlight the importance of rigorously confirming post hoc findings before implementing them in clinical practice," write the authors of an accompanying editorial.
Several authors disclosed financial ties to pharmaceutical companies, including Kowa Pharma, which manufactures pemafibrate and funded the study.