Post-marketing survey results on the use of the food supplement Colestat

Abstract

Cardiovascular diseases are the leading cause of mortality worldwide, generating a heavy economic impact. Elevated plasma levels of low-density lipoprotein cholesterol (LDL-C) are a major risk factor for atherosclerotic cardiovascular disease, and lowering LDL-C reduces the risk of cardiovascular adverse events. Current evidence suggests that some clinically tested lipid-lowering nutraceuticals could be safely used, alongside lifestyle changes, to improve plasma lipid levels in subjects affected by mild-to-moderate dyslipidaemia with low cardiovascular risk. This real-life survey observed the use of Colestat, an oral supplement containing Dif1Stat and whole Olea europaea extract, in subjects with borderline lipid levels for whom statin therapy was not recommended. A post-marketing survey enabled the assessment of treatment adherence, usability, and perceived quality of the product in routine clinical practice. A total of 272 adults, managed in primary care by general practitioners, received one capsule daily for a minimum of 3 months. Of these, 44 continued supplementation for 6 months, undergoing repeated laboratory testing. The combined formulation demonstrated excellent acceptability and high adherence across the entire study population, and was effective in reducing plasma LDL-C (−18.3%), total cholesterol, and triglycerides (TGs). Colestat was well tolerated and displayed a favourable safety profile, as indicated by the absence of clinically relevant changes in biochemical markers of hepatic function (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase) and muscle integrity (creatine phosphokinase), which remained essentially unchanged from baseline. During the observation period, both the LDL/high-density lipoprotein cholesterol (HDL) and TC/HDL ratios declined, approaching levels associated with lower cardiovascular risk.