Pitavastatin showed no difference in health-related quality of life compared with placebo in people with HIV.
This randomized controlled trial enrolled 733 people with HIV aged 40 to 75 years who were on antiretroviral therapy and had low-to-moderate risk for atherosclerotic cardiovascular disease. Participants were randomized to receive pitavastatin or placebo and were followed for 24 months. The primary outcome was health-related quality of life assessed using the Short Form-36-Item Health Survey Version 2 physical and mental component summary scores. Secondary outcomes included cardiometabolic characteristics and coronary atherosclerosis.
At baseline, median physical component summary scores were 54.5 for pitavastatin versus 54.1 for placebo, while median mental component summary scores were 52.9 for pitavastatin versus 52.8 for placebo. Between baseline and month 24, declines in both physical and mental component scores were minimal with no apparent difference by treatment group. Associations with lower physical component scores included older age, Black non-Hispanic race/ethnicity, ART regimen class, elevated BMI, and cigarette smoking.
Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported in the study. The study authors noted limited evidence concerning the relationship between cardiometabolic characteristics and health-related quality of life, as well as potential effects of statin therapy among people with HIV. Among this cohort of antiretroviral-treated people with HIV, baseline cardiometabolic risk factors were associated with worse self-reported physical health-related quality of life, with no apparent effect of statin therapy on these scores.