Additional Treatment with Fenofibrate for Patients Treated with Pitavastatin Under Ordinary Medical Practice for Hypertriglyceridemia in Japan (APPROACH-J Study)

Safety and efficacy of combination therapy of pitavastatin and fenofibrate were examined in consecutive case series with fasting serum triglycerides ≥ 150 mg/dL despite receiving pitavastatin 1 or 2 mg daily for over 2 months and additionally administered micronized fenofibrate 67 mg daily for another 4 to 16 weeks. Such low doses were selected in consideration of safety, and normal liver and renal functions were incorporated in inclusion criteria. In result, a total of 56 cases were examined. The addition of fenofibrate 67 mg to pitavastatin 1 mg/2 mg yielded a 36.8%/35.6% reduction in triglycerides and 6.4%/12.4% elevation in high-density lipoprotein cholesterol, respectively. Almost 70% of the patients achieved triglycerides <150 mg/dL. Statistically significant elevation and decrease were observed in high-density lipoprotein cholesterol level and low-density lipoprotein cholesterol, respectively. Laboratory tests for liver, renal and muscle function statistically significantly elevated after starting fenofibrate co-administration, which were considered comparable to the effect of fenofibrate alone. No myopathy or serious adverse events were reported. In conclusion, while the safety and tolerability need to be further examined over the longer term, and careful monitoring is still needed, this regimen could be considered as one of the treatment option for hypercholesterolemia associated with hypertriglyceridemia.