To determine the effect of statins on the progression of subclinical atherosclerosis in a population of HIV-infected adults on antiretroviral therapy.
Double-blind, randomized clinical trial METHODS:: SATURN-HIV was a 96-week double-blind, randomized clinical trial of 10 mg daily rosuvastatin (n = 72) versus placebo (n = 75) in a population of HIV-infected subjects on stable antiretroviral therapy with LDL-cholesterol ≤130 mg/dL (≤3.36mmol/L) and evidence of heightened T-cell activation (CD8+CD38+HLA-DR+ ≥19%) or increased inflammation (high sensitivity C-reactive protein ≥2 mg/L (≥19mmol/L)). Change in common carotid artery IMT (CCA-IMT) was the primary outcome. Secondary outcomes were changes in LDL and coronary artery calcium (CAC).
Median (Q1, Q3) age was 46 (40, 53) years; 78% were male and 68% African American; 49% were on a protease inhibitor. Mean (95% CI) change in LDL was -21 (-27 to -15) mg/dL [-0.54 (-0.70 to -0.39) mmol/L] in the rosuvastatin arm. In a multivariable linear mixed-effects model, assignment to statin was associated with 0.019 mm (95% CI: 0.002-0.037 mm) less progression of CCA-IMT over 96 weeks. We did not find substantial effect modification by level of inflammation or immune activation biomarkers, except for a borderline statistically significant interaction for soluble vascular cell adhesion molecule (p = 0.065). There was no difference in CAC change (p = 0.61).
Rosuvastatin effectively lowers LDL and appears to substantially slow progression of CCA-IMT in patients with treated HIV infection. Future study is needed to determine whether subjects with higher levels of inflammation or immune activation derive greater cardiovascular benefit from statin therapy.