Pemafibrate is a safe and effective method for lowering triglyceride and cholesterol levels in patients with type 2 diabetes (T2D) and hypertriglyceridemia, according to study results published in Diabetes, Obesity and Metabolism.
To evaluate the long-term safety and efficacy of pemafibrate treatment, researchers randomly assigned 166 patients with T2D and hypertriglyceridemia (triglyceride level ≥150 and ≤1000 mg/dL) to receive placebo or pemafibrate 0.2 or 0.4 mg/day for 24 weeks. At 24 weeks, participants receiving placebo were switched to pemafibrate 0.2 mg/day for 28 additional weeks, whereas those receiving daily pemafibrate from initiation continued as usual until week 52.
At week 52, patients in the pemafibrate 0.4 mg/day group (n = 55) experienced, on average, a 46.4% reduction in fasting serum triglyceride level compared with a 42.3% average reduction in the pemafibrate 0.2 mg/day group (n = 54) and a 48.2% average reduction in the placebo/pemafibrate 0.2 mg/day group (n = 57).
The researchers discovered that pemafibrate treatment resulted in stable reductions in levels of triglyceride, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and total cholesterol. The same was true for remnant lipoprotein cholesterol and other apolipoprotein levels.
Overall, pemafibrate treatment was well tolerated throughout the study, with no significant differences in adverse events between groups (45 events in the placebo/pemafibrate 0.2 mg/day group, 42 events in the pemafibrate 0.2 mg/day group, and 43 events in the pemafibrate 0.4 mg/day group). There were 21 serious adverse events in 16 patients, all of which were deemed not be caused by study treatment.
Several limitations were noted for this study, including an inability to generalize results because of the population’s homogeneity.
In summarizing their findings, the researchers said, “the efficacy and safety of pemafibrate in patients with type 2 diabetes with hypertriglyceridemia noted during the previous 24-week placebo-controlled period were sustained over 52 weeks. Pemafibrate rarely had unfavorable effects on liver and renal function test results even in patients with type 2 diabetes.”
Araki E, Yamashita S, Arai H, et al. The efficacy and safety of pemafibrate in patients with type 2 diabetes and elevated triglyceride levels: 52-week data from the PROVIDE study [published online March 4, 2019]. Diabetes Obes Metab. doi:10.1111/dom.13686