Pitavastatin for Cardiovascular Disease Prevention in Individuals with HIV Infection

The following is a summary of “Pitavastatin to Prevent Cardiovascular Disease in HIV Infection,” published in the August 2023 issue of Infectious Disease by Grinspoon et al.

Researchers performed a cohort study to identify and evaluate primary prevention strategies for cardiovascular disease in people with human immunodeficiency virus (HIV) infection.

They conducted a phase 3 trial, enrolling 7,769 HIV-infected individuals at low-to-moderate cardiovascular risk under antiretroviral therapy. Participants were randomized to pitavastatin calcium (4 mg) or placebo. The main focus was major adverse cardiovascular events, a composite of cardiovascular death, myocardial infarction, unstable angina hospitalization, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or unclear cause of death.

The results showed a median age of 50 years (interquartile range, 45 to 55), a median CD4 count of 621 cells per cubic millimeter (interquartile range, 448 to 827), with HIV RNA below quantification in 87.5% of 5,997 participants (5,250). The trial ended early due to efficacy, with a median follow-up (5.1 years) (interquartile range, 4.3 to 5.9). Major adverse cardiovascular events occurred at an incidence of 4.81 per 1000 person-years in the pitavastatin group and 7.32 per 1000 person-years in the placebo group (hazard ratio, 0.65; 95% CI, 0.48 to 0.90; P=0.002). Muscle-related symptoms affected 2.3% (91) in the pitavastatin group and 1.4% (53) in the placebo group; diabetes mellitus was observed in 5.3% (206) and 4.0% (155).

They concluded pitavastatin reduces the risk of major adverse cardiovascular events in people with HIV infection over a median follow-up of 5.1 years.

Source: nejm.org/doi/full/10.1056/NEJMoa2304146?query=featured_home