Abstract 8523: Randomized Trial of Nutraceuticals in Statin-Intolerant Patients Treated with Percutaneous Coronary Intervention
Introduction. Statins have a class I indication after percutaneous coronary intervention (PCI), but can not be used in statin-intolerant patients. Nutraceuticals, i.e. forms of compounds with biological activity derived from foods, that are capable of lowering LDL cholesterol might represent a useful therapeutic alternative. However, there are no data regarding the use of nutraceuticals after PCI.
Hypothesis. We performed a randomized, prospective, parallel group, single-blind trial to investigate the efficacy, safety, and tolerability of a nutraceutical-based protocol in statin-intolerant patients treated with PCI.
Methods. At time of PCI, we selected 80 patients with stable (70%) or unstable angina (30%) who had previously experienced statin withdrawn because of myalgias (75%), gastrointestinal intolerance (20%) or elevated alanine aminotrasferase (5%). Patients were randomized to receive for 1 year either nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg) or daily placebo. Primary outcomes included reasons for treatment discontinuation and a daily pain severity score, and secondary outcomes included plasma lipids.
Results. At entry, 40 patients were randomized to nutraceuticals and 40 to placebo. Clinical features and lipid profiles were similar between groups. During the 1-year trial, 2 patients of the nutraceutical-group stopped the pill due to myalgia (N=1) or gastrointestinal intolerance (N=1). After 1-year treatment, the mean pain severity did not differ significantly between nutraceutical and placebo groups. Similarly, levels of triglyceride, liver enzyme or creatine kinase were similar between groups. Conversely, total cholesterol level (205+31 vs 241+41 mg/dl) and low-density lipoprotein cholesterol (105+31 vs 131+41 mg/dl) were significantly (P=0.001) lower in the nutraceutical-group than in the placebo-group.
Conclusions. A combination of nutraceuticals with lipid-lowering biological activity can significantly decrease cholesterol levels without causing clinical or metabolic side effects, thus being a reliable treatment option in statin-intolerant patients treated with PCI.
- © 2011 by American Heart Association, Inc.