Risk of Venous Thromboembolism with Pemafibrate in Dyslipidemia: A Nationwide, Retrospective, Cohort Study Using a...

The study aimed to assess whether pemafibrate, a selective peroxisome proliferator-activated receptor α modulator, increases the risk of venous thromboembolism (VTE) in real-world clinical practice in Japan.

In this retrospective cohort study, we utilized a claims database with data from December 2017 to July 2023. The exposed group consisted of patients with dyslipidemia using pemafibrate, while the control group included patients not using fibrate drugs. Each exposed patient was randomly matched with five control patients at a 1:5 ratio using time-matching. The primary endpoint was the number of days until the first occurrence of VTE, which was defined using ICD-10 codes and anticoagulant prescription records. We used a Cox proportional hazards model with standardized mortality ratio weight (SMRW) to estimate the adjusted hazard ratio (HR) and 95% confidence interval (CI) for the exposed group relative to the control group.

The study included 23,195 patients in the exposed group and 115,975 in the control group. In the full analysis population, 46.6% of patients were women, with a median age of 70.0 years and a median BMI of 23.6. VTE occurred in 1.2% (286/23,195) of the exposed group and 2.0% (2297/115,975) of the control group, with an incidence rate of 0.95 and 1.33 per 100 person-years, respectively. There was no significant increase in the risk of VTE in the exposed group (HR, 0.925; 95%CI, 0.809-1.058).

We found no increase in VTE risk associated with pemafibrate in clinical practice in Japan.