Methods: 113 women who completed the RCT (SDD group: n=51; placebo group: n=62) consented at the final (two-year) study visit for their baseline, one-year and two-year serum samples to be analyzed for serum inflammatory biomarkers. Analyses by ELISA included CRP (high-sensitivity ELISA), IL-6, myeloperoxidase (MPO), IL-1b and TNF-a; serum lipids (total cholesterol, HDL, LDL, VLDL, triglycerides) were analyzed by a commercial laboratory. Statistical analyses were performed using Generalized Estimating Equations; primary analyses were intent-to-treat (ITT). Pre-specified subgroup analyses also were performed. All results are presented as ratios of median values (SDD versus placebo) unless otherwise indicated.
Results: By ITT, median CRP levels were reduced by 18% for SDD subjects compared to placebo, which was statistically significant (ratio of median values: 0.82, 95% CI: 0.70 to 0.97; p=0.02). There was no significant difference between groups with respect to IL-6, MPO, and serum lipids based on ITT. IL-1b was not detectable in any serum samples and TNF-a levels were below assay detection limits in 68% of all serum samples. In women more than 5 years postmenopausal, SDD was significantly associated with an increase in HDL cholesterol over time (difference in means [mg/dl] (SDD-placebo): 5.99; 95% CI: 1.17 to 10.81, p= 0.01). In the same subgroup, SDD treatment was marginally associated with a decrease in VLDL (0.87, 95% CI: 0.76 to 1.00; p=0.06) and triglycerides (0.87, 95% CI: 0.76 to 1.01; p=0.06).
Conclusions: In a two-year RCT in PM women, SDD treatment, relative to placebo, resulted in improvement in several serum inflammatory biomarkers associated with CVD risk. Supported by NIDCR grant R01DE012872.