Hellenic Postprandial Lipemia Study (HPLS): Rationale and design of a prospective, open-label trial to determinate the prevalence of abnormal postprandial lipemia as well as its interaction with statins in patients at high- and very high-risk for cardiovascular disease.

ABSTRACT

Fasting and postprandial hypertriglyceridemia have been related to cardiovascular (CV) disease. We describe the design and methods of the Hellenic Postprandial Lipemia Study (HPLS, NCT02163044), a prospective, open-label, randomized, multicentre trial. The study will recruit 900 participants from 8 centers, and aims to determinate the prevalence of abnormal postprandial lipemia in patients at high- and very high-risk for CV disease, the efficacy of statin treatment and other medications on postprandial lipemia, and the interaction between postprandial lipemia and CV risk during a treatment period of 3 years. Participants will be screened in an outpatient lipid clinic setting. METHODS: High- and very high-risk individuals with fasting triglycerides (TGs) <220 mg/dL (2.5 mmol/L) will be included. At baseline visit demographic and clinical characteristics will be recorded. At the first follow-up visit (within 2-4 weeks from baseline), plasma TG concentrations will be measured, following an overnight 12 h fasting period, before and 4 h after ingestion of a commercially available oral fat tolerance test (OFTT) meal. Then a statin will be prescribed. At the second follow-up visit (within 3-5 month from baseline), plasma TG concentrations will be measured again following an overnight 12 h fasting period, before and 4 h after ingestion of OFTT and then patients will be followed annually for 3 years. CONCLUSION: HPLS is the largest trial assessing the effects of statin therapy on postprandial lipemia. Its results will provide useful insight on the prevalence of postprandial lipemia, the efficacy of statins regarding postprandial lipemia and the clinical significance of this effect. Clinical trial registration information The HPLS trial is registered with clinicaltrials.gov (NCT Identifier NCT02163044).