Phytosterols/stanols lower cholesterol concentrations in familial hypercholesterolemic subjects: a systematic review with meta-analysis

BACKGROUND: To-date, reviews regarding the cholesterol lowering capacity of phytosterols/stanols have focused on normo- and hypercholesterolemic (HC) subjects. Familial hypercholestrolemia (FH) is characterized by very high low-density lipoprotein cholesterol (LDL-C) concentrations and is considered a world public health problem due to the high incidence of premature coronary heart disease (CHD) in these patients. OBJECTIVE: To conduct a systematic review that investigates the efficacy of phytosterols/stanols in lowering total cholesterol (TC) and LDL-C concentrations in FH subjects. DESIGN: Randomized controlled intervention trials with the primary objective to investigate the effects of phytosterols/stanols on lipid concentrations in FH subjects were identified through selected international journal databases and reference lists of relevant publications. Two researchers extracted data from each identified trial and only trials of sufficient quality (e.g. controlled, randomized, double-blind, good compliance, sufficient statistical power) were included in the review. The main outcome measures were differences between treatment and control groups for LDL-C, TC, high-density lipoprotein cholesterol (HDL-C) and triacylglycerol (TG). RESULTS: Six out of 13 studies were of sufficient quality. Two were excluded from the meta-analysis because the sterols were administered in the granulate form at very high dosages (12 g/day and 24 g/day) compared to the other studies that used fat spreads as vehicle with dosages ranging from 1.6-2.8 g/day. The subjects were heterozygous, aged 2-69 years with baseline TC and LDL-C concentrations of +/-7 mmol/L and +/-5.4 mmol/L, respectively. The duration of the studies ranged from 4 weeks to 3 months. Fat spreads enriched with 2.3 +/- 0.5 g phytosterols/stanols per day significantly reduced TC from 7 to 11% with a mean decrease of 0.65 mmol/L [95% CI -0.88, -0.42 mmol/L], p < 0.00001 and LDL-C from 10-15% with a mean decrease of 0.64 mmol/L [95% CI -0.86, -0.43 mmol/L], p < 0.00001 in 6.5 +/- 1.9 weeks compared to control treatment, without any adverse effects. TG and HDL-C concentrations were not affected. CONCLUSION: Phytosterols/stanols may offer an effective adjunct to the cholesterol lowering treatment strategy of FH patients.