Study Objective. To compare the efficacy and safety of plant sterols and stanols as well as policosanol in the treatment of coronary heart disease, as measured by a reduction in low-density lipoprotein cholesterol (LDL) levels.
Design. Systematic review and meta-analysis of randomized controlled trials.
Patients. A total of 4596 patients from 52 eligible studies.
Measurements and Main Results. We searched MEDLINE, EMBASE, the Web of Science, and the Cochrane Library from January 1967–June 2003 to identify pertinent studies. Reduction of LDL levels was the primary end point; effects on other lipid parameters and withdrawal of study patients due to adverse effects were the secondary end points. Weighted estimates of percent change in LDL were −11.0% for plant sterol and stanol esters 3.4 g/day (range 2–9 g/day [893 patients]) versus −2.3% for placebo (769 patients) in 23 eligible studies, compared with −23.7% for policosanol 12 mg/day (range 5–40 mg/day [1528 patients]) versus −0.11% for placebo (1406 patients) in 29 eligible studies. Cumulative p values were significantly different from placebo for both (p<0.0001). The net LDL reduction in the treatment groups minus that in the placebo groups was greater with policosanol than plant sterols and stanols (−24% versus −10%, p<0.0001). Policosanol also affected total cholesterol, high-density lipoprotein cholesterol (HDL), and triglyceride levels more favorably than plant sterols and stanols. Policosanol caused a clinically significant decrease in the LDL:HDL ratio. Pooled withdrawal rate due to adverse effects and combined relative risk for patients who withdrew were 0% and 0.84, respectively (95% confidence interval [CI] 0.36–1.95, p=0.69), for plant sterols and stanols across 20 studies versus 0.86% and 0.31, respectively (95% CI 0.20–0.48, p<0.0001), for policosanol across 28 studies.
Conclusion. Plant sterols and stanols and policosanol are well tolerated and safe; however, policosanol is more effective than plant sterols and stanols for LDL level reduction and more favorably alters the lipid profile, approaching antilipemic drug efficacy.