Background: People with HIV are at increased risk for coronary artery disease. This study aimed to determine the effect of rosuvastatin on atherosclerotic progression in people with HIV at moderate cardiovascular risk.
Methods: Participants with well controlled HIV (suppressed viral load, ART for >6 months) who were at moderate cardiovascular risk (10 year Framingham risk score 10-15%) with no indication for statin therapy were recruited from a single centre in Australia and four centres in Switzerland. They were randomised 1:1 (stratified by site) to 20mg of rosuvastatin or matched placebo. Participants on a protease inhibitor received dose reduced (10mg) rosuvastatin.
All participants had assessment of carotid intima media thickness (cIMT) and fasting bloods at baseline, week 48 and 96. cIMT was measured at three sites, carotid bulb, common carotid artery (CCA) and internal carotid artery (ICA) bilaterally (the average of the combined sides presented here).
The primary endpoint was the change from baseline to week 96 in CCA cIMT.
Results: 87 individuals were randomised (55: Australia - 32: Switzerland). Predominantly male (85 [97%]) with a median age 54 years (range 42-67), 29 (33%) were current smokers.
There was no difference in baseline IMT between groups; carotid bulb 0.790mm versus 0.81mm, p=0.43; CCA 0.690mm versus 0.722mm, p= 0.447; ICA 0.650mm versus 0.647mm, p=0.9252 (rosuvastatin, placebo arms respectively). Despite significantly decreases in LDL cholesterol with rosuvastatin (mean change -1.06mmol/L versus -0.06mmol/L, p< 0.0001) there was no difference in progression of IMT from baseline to 96 weeks at any site [carotid bulb (p=0.211), CCA (p=0.876) or ICA (p=0.950)] in those on rosuvastatin. At week 96 there was no difference in cIMT at any site between treatment arms (p=0.993, p=0.791, p=0.462 respectively).
One participant developed type 2 diabetes and one cerebrovascular disease (both on rosuvastatin). Three participants had acute myocardial infarctions while on study (two on rosuvastatin, one on placebo). Two participants (one from each arm) had significant increases in creatinine kinase.
Conclusions: In this study of people with well controlled HIV at moderate cardiovascular risk who did not otherwise warrant statin therapy addition of rosuvastatin did not alter the progression of cIMT over 96weeks.