Abstract 9757: Randomized Trial of Ezetimibe versus Nutraceuticals in Statin-intolerant Patients Treated With Percutaneous Coronary Intervention
Treatment with statins has a class IA indication after percutaneous coronary intervention (PCI), but it's often discontinued by patients (pts) due to side effects. Pharmacologic alternatives, including ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions), have been shown to be useful after PCI. However, which of these 2 therapeutic approaches is more effective after PCI is still not known. To clarify this point, a prospective, randomized pilot trial has been performed to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant pts treated with PCI.
Methods. At time of PCI, 100 pts, with stable angina who had previously experienced statin withdrawn for intolerance, were selected. Pts were randomized to receive for 3 months either ezetimibe (10 mg/day) or a commercially available nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg). Primary outcome included achievement of therapeutic goals by pts, secondary outcomes were plasma lipids levels, tolerability and safety.
Results. At entry, 50 pts were randomized to ezetimibe (group A) and 50 to nutraceutical combined pill (group B). Baseline clinical features and lipid profiles were similar between groups. During the 3 months trial, 3 patients of group B stopped the pill due to myalgia whereas in the group A 2 patients had gastrointestinal intolerance. At third month evaluation, levels of triglyceride, liver enzymes or creatine kinase were similar between groups. Conversely, while in the group A none of the patients achieved the therapeutic target, 16 patients reached the target in the group B. Also cholesterol level showed a significantly higher reduction in group B compared to group A (in particular, LDL cholesterol decreased from 175 ± 10 to 165 ± 8 mg/dl (-5,8 %) in group A, and from 175 ± 13 to 133 ± 10 mg/dl (-24%) in group B (P=0.001).
Conclusions: our results strongly suggest that a combination of nutraceuticals with lipid-lowering biological activity can significantly decrease cholesterol levels without causing clinical or metabolic side effects and that it is more effective than ezetimibe 10 mg/day in statin-intolerant patients treated with PCI.
- © 2012 by American Heart Association, Inc.