Background: hyperlipidemia is one of the most important cardiovascular risk factors. Statins at high doses are
commonly prescribed to lower LDL-cholesterol, but are often poorly tolerated. In particular, muscle pain and
increase of creatine phosphokinase are frequent side effects. The purpose of this study was to assess whether the
addition of a nutraceutical to simvastatin may result in the achievement of the therapeutic target (LDL-cholesterol
less than 70 mg/dL) without side effects in patients with ischemic heart disease.
Methods: Sixty-four patients with ischemic heart disease treated with simvastatin 20mg who had not achieved the
therapeutic targetwere enrolled. Patients were randomised 1:1. Patients of group A (n=32) were given simvastatin
40 mg per day and patients of group B (n =32) were given simvastatin 20 mg plus 2 tablets of a nutraceutical
composed of bergamot, phytosterols, artichoke, vitamin C.
Results: After 3 months, patients in both groups showed a significant reduction from baseline in total cholesterol,
LDL-c and tryglicerides. However, in group A, 4 patients reported myalgia (9,7%) with an increase in creatine
phosphokinase; whereas no adverse events occurred in group B.
Conclusions: The association of a nutraceutical and simvastatin 20 mg may be a valid therapeutic option for the
treatment of hyperlipidemia in patientswith ischemic heart disease intolerant to statin at high doses, in the absence
of side effects. Further studies are needed to clarify the mechanisms of action of nutraceuticals.
© 2016 Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-ND license