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: