Impact of statins in microalbuminuric subjects with the metabolic syndrome: a substudy of the PREVEND Intervention Trial

AIMS: Microalbuminuria frequently clusters with the metabolic syndrome and may identify subjects at increased coronary risk. Statin treatment may reduce the incidence of major adverse cardiac events in subjects with the metabolic syndrome, but evidence is limited. We evaluated the impact of pravastatin treatment on the incidence of major adverse cardiac events in microalbuminuric subjects with the metabolic syndrome. METHODS AND RESULTS: This substudy of the PREVEND Intervention Trial (a randomized, placebo-controlled trial with a 2x2 factorial design) included 864 microalbuminuric subjects, who were randomized to fosinopril 20 mg or matching placebo and pravastatin 40 mg or matching placebo (mean follow-up 46 months). The metabolic syndrome was defined according to the NCEP ATPIII-report. Subjects with or without the metabolic syndrome were characterized by a higher age, male sex, and increased albuminuria. The incidence of major adverse cardiac events in subjects with the metabolic syndrome [9.1%; 95% confidence interval (CI) 6.0-13.0%] was increased vs. those without [3.6%; 95% CI 2.3-5.5%; P=0.007). Pravastatin treatment lowered the incidence of major adverse cardiac events in subjects with the metabolic syndrome after adjustment for age and sex (hazard ratio=0.39; 95% CI 0.17-0.89; P=0.025). CONCLUSION: This study supports the use of statins in microalbuminuric subjects with the metabolic syndrome to reduce the incidence of major adverse cardiac events.