DOI: https://doi.org/10.1016/j.atherosclerosis.2014.12.043
Giuseppe Derosa a, b, *, Davide Romano a, Angela D’Angelo a, Pamela Maffioli a, c
a Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS, Policlinico S. Matteo, Pavia, Italy b Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy c PhD School in Experimental Medicine, University of Pavia, Pavia, Italy
Abstract
Aim: To evaluate the effects of Berberis aristata combined with Silybum marianum in dyslipidemic patients intolerant to statins at high doses.
Methods: 137 euglycemic, dyslipidemic subjects, with previous adverse events to statins at high doses, were enrolled. Statins were stopped for 1 month (run-in), then they were re-introduced at the half of the previously taken dose. At randomization, patients tolerating the half dose of statin, were assigned to add placebo or B. aristata/S. marianum 588/105 mg, 1 tablet during the lunch and 1 tablet during the dinner, for six months. We evaluated lipid profile and safety parameters variation at randomization, and after 3, and 6 months.
Results: B. aristata/S. marianum reduced fasting plasma glucose (−9 mg/dl), insulin (−0.7 μU/ml), and HOMA-index (−0.35) levels compared to baseline and also to placebo. Lipid profile did not significantly change after 6 months since the reduction of statin dosage and the introduction of B. aristata/S. marianum, while it worsened in the placebo group both compared to placebo and with active treatment (+23.4 mg/dl for total cholesterol, +19.6 mg/dl for LDL-cholesterol, +23.1 mg/dl for triglycerides with placebo compared to B. aristata/S. marianum). We did not record any variations of safety parameters in nether of groups.
Conclusions: B. aristata/S. marianum can be considered as addition to statins in patients not tolerating high dose of these drugs.