Combining phytosterols with statin-based therapies leads to greater LDL cholesterol reduction, study shows
- Adding phytosterols to statin-based therapies significantly improve LDL cholesterol reduction.
- For LDL cholesterol reduction, taking phytosterols with a statin is equivalent to doubling statin dose.
- Effective amount is a supplement with free (unesterified) plant sterols (1,000 mg, twice daily).
This randomized, open-label study with blinded end points was designed to evaluate the effects of adding phytosterols to statin-based therapies for patients with hypercholesterolemia.
For this study, researchers enrolled 86 adults (21 men, 62 women), 55 to 68 years of age, from a university-affiliated outpatient cardiology clinic (Federal University of Sao Paulo). All subjects met the criteria for lipid-lowering therapy based on the National Cholesterol Education Program, Adult Treatment Panel III guidelines.
All subjects completed a 4-week, run-in period with atorvastatin (10 mg/day) (baseline). Subjects were then randomly assigned to one of three treatment groups for 4 weeks: a higher dosage of atorvastatin (40 mg/day), ezetimibe (10 mg/day), or combination of both (Phase 1). Finally, a supplement providing free (unesterified) phytosterols (1,000 mg, twice daily, with meals) was added to the Phase 1 treatments for an additional 4 weeks (Phase 2). Lipids, apolipoproteins, and plasma markers of cholesterol absorption or synthesis (i.e., campesterol, β-sitosterol, and desmosterol) were assayed at all time points and within- and between-group analyses were performed.
At the end of Phase 1, atorvastatin alone or combined with ezetimibe significantly reduced total and LDL cholesterol, while ezetimibe treatment alone had no effect. Atorvastatin (40 mg) reduced total and LDL cholesterol by 3% and 22%, respectively, and significantly altered markers of sterol absorption (P<.05 for all). Combined therapy significantly reduced total and LDL cholesterol by 22% and 38%, respectively, and significantly altered markers of sterol absorption (P<.05 for all). Ezetimibe (10 mg) had no effect on lipid levels, but significantly (P<.05) altered markers of sterol absorption.
At the end of Phase 2, adding phytosterols (2g/day) to atorvastatin alone or combined with ezetimibe resulted in further significant cholesterol reductions. In the atorvastatin group, total and LDL cholesterol were reduced by an additional 7.5% and 6.5%, respectively (P<.05). This is reported to be equal to doubling the statin dose. In the combined therapy group, total and LDL cholesterol were reduced by an additional 5% and 4%, respectively (P<.05). No further effects in cholesterol absorption or synthesis markers were reported.
These finding indicate that the extra reduction in LDL cholesterol obtained from phytosterols supplementation has clinical value for patients at high risk for coronary heart disease, especially patients who fail to achieve lipid targets with statin therapy alone.