Taking into account all these issues, we conducted a randomised,
controlled, open-label study on patients suffering from ischemic heart
disease who had not achieved the therapeutic target with a previous
treatment with simvastatin 20 mg/day in order to evaluate the efficacy
of the combination therapy of a statin and a nutraceutical. Specifically,
the purpose of the study was to assess whether the combination of a
nutraceutical (bergamot, phytosterols, artichoke and vitamin C) to
simvastatin may result in the achievement of the target range in the absence
of side effects. The primary endpointwas to verify the therapeutic
efficacy of the combination of simvastatin and the nutraceutical, the
secondary endpoint was to evaluate their tolerability.