Impact of rosuvastatin on atherosclerosis in people with HIV at moderate cardiovascular risk; a randomised, controlled trial.

: People living with HIV-1 (PLHIV) are at increased risk for cardiovascular disease. Objective This study aimed to determine if PLHIV would benefit from starting statins at a lower threshold than currently recommended in the general population. Design A double-blind multicentre, randomised, placebo-controlled trial was performed. Methods Participants (n = 88) with well controlled HIV, at moderate cardiovascular risk (Framingham score of 10-15%), and not recommended for statins were recruited from Australia and Switzerland. They were randomised 1:1 to rosuvastatin (n = 44) 20 mg daily, 10 mg if co-administered with ritonavir/cobicistat-boosted antiretroviral therapy, or placebo (n = 40) for 96 weeks. Assessments including fasting blood collection and carotid intima media thickness (CIMT) were performed at baseline, and weeks 48 and 96. The primary outcome was the change from baseline to week 96 in CIMT. (clinicaltrials.gov:NCT01813357) RESULTS:: Participants were predominantly male (82 (97·6%)); mean age 54 years (SD 6·0). At 96 weeks there was no difference in the progression of CIMT between the rosuvastatin (mean 0·004 mm, SE 0·0036) and placebo (0·0062 mm, SE 0·0039) arms (p value = 0·684), leading to no difference in CIMT levels between groups at week 96 (rosuvastatin arm, 0·7232 mm (SE 0·030); placebo arm 0·7785 mm (SE 0·032), p = 0·075).Adverse events were common (n = 146) and predominantly in the rosuvastatin arm (108 [73·9%]). Participants on rosuvastatin were more likely to cease study medication due to an adverse event (7 [15.9%] vs 2 [5·0%], p = 0.011). Conclusions In PLHIV statins prescribed at a lower threshold than guidelines did not lead to improvements in CIMT but was associated with significant adverse events.