Procedures
The framework of the study design was provided (Fig. Study design. Abbreviation: IPE = icosapent ethylFor patients who had not received any other lipid-altering treatment and had been on a stable dosage of statin therapy for more than four weeks (with or without ezetimibe), this screening and stabilization phase lasted six weeks. For patients who stopped receiving other TG-altering treatments, it persisted for eight weeks (as mentioned above).In order to ensure that the patients adhered to the lifestyle recommendations, visit 2 included a telephone interview. If patients' average overnight TG levels at visits 3 and 4 (separated by one week) were in the range of 5.6–22.6 mmol/L, they were eligible to participate in the following 12-week double-blind session. Patients were offered an optional TG measurement at visit 4.1 and an extra stabilization week if average fasting TG levels dropped outside of this range (one week later). According to the average fasting TG levels at visits 4 and 4.1, eligibility was reevaluated.Those who met the inclusion criteria were monitored for a week before being randomly assigned to receive either 4 g/day of IPE (take two capsules of IPE, each with a dosage of 1 g, twice a day), 2 g/day of IPE (take one capsule of IPE with a dosage of 1 g and one capsule of placebo twice a day), or a placebo capsule (two placebo capsules twice daily) starting at visit 5 (week 0).Mealtime, oral study medications were taken with or at the end of meals. All study medications (both IPE and placebo capsules) were provided by Amarin Pharmaceuticals Ireland Limited, which is based in Dublin, Ireland. Light liquid paraffin was used to fill each placebo capsule.