OBJECTIVE:

Statin intolerance, whether real or perceived, is a growing issue in clinical practice. Our aim was to evaluate the effects of reduced-dose statin therapy complemented with nutraceuticals.

METHODS:

First phase: Initially, 53 type 2 diabetic statin-treated patients received a supplementation with fish oil (1.7 g EPA + DHA/day), chocolate containing plant sterols (2.2 g/day), and green tea (two sachets/day) for 6 weeks.

Second phase:

“Good responders” to supple-mentation were identified after multivariate analysis (n¼10), and recruited for a pilot protocol of statin dose reduction. “Good responders” were then provided with supplementation for 12 weeks: standard statin therapy was kept during the first 6 weeks and reduced by 50% from weeks 6e12.

RESULTS:

First phase: After 6 weeks of supplementation, plasma LDL-C (-13.7% 3.7,P¼.002) and C-reactive protein ( 35.5% 5.9,P¼.03) were reduced. Analysis of lathosterol and campesterol in plasma suggested that intensity of LDL-C reduction was influenced bycholesterol absorption rate rather than its synthesis.

Second phase:

no difference was observed for plasma lipids, inflammation, cholesterol effluxcapacity, or HDL particles after statin dose reduction when compared to standard therapy.

CONCLUSIONS:

Although limited by the small sample size, our study demonstrates the potential for a new therapeutic approach combining lower statin dose and specific dietary compounds. Further studies should elucidate “good responders” profile as a tool for personalized medicine. This may be particularly helpful in the many patients with or at risk for CVD who cannot tolerate high dose statin therapy.

Trial registration:

ClinicalTrials.gov, NCT02732223.