HIV and Cardiovascular Disease Study

Human immunodeficiency virus (HIV) infection is a greater threat and a gateway to a wide range of diseases. The risk of cardiovascular disease is increased among persons with HIV infection, hence studies are required to throw light on the same.

Pitavastatin and Its Role

Pitavastatin is a popular class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Phase 3 Trial Findings

A phase 3 trial reveals that patients with HIV infection when treated with pitavastatin had a lower risk of a major adverse cardiovascular event than those who received placebo over a follow-up of 5 years. The study is published in The New England Journal of Medicine.

In the current phase 3 trial, researchers randomly assigned 7,769 participants with HIV infection with a low-to-moderate risk of cardiovascular disease who were receiving antiretroviral therapy to receive daily pitavastatin calcium (at a dose of 4 mg) or placebo. The primary outcome was the occurrence of a major adverse cardiovascular event, which was defined as a composite of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause.

Key Findings

• The median age of the participants was 50 years (interquartile range, 45 to 55); the median CD4 count was 621 cells per cubic millimeter (interquartile range, 448 to 827), and the HIV RNA value was below quantification in 5,250 of 5,997 participants (87.5%) with available data.
• The trial was stopped early for efficacy after a median follow-up of 5.1 years (interquartile range, 4.3 to 5.9).
• The incidence of a major adverse cardiovascular event was 4.81 per 1,000 person-years in the pitavastatin group and 7.32 per 1,000 person-years in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.90; P=0.002).
• Muscle-related symptoms occurred in 91 participants (2.3%) in the pitavastatin group and in 53 (1.4%) in the placebo group; diabetes mellitus occurred in 206 participants (5.3%) and in 155 (4.0%), respectively.

Researchers concluded that “Participants with HIV infection who received pitavastatin had a lower risk of a major adverse cardiovascular event than those who received placebo over a median follow-up of 5.1 years.”

Reference

Grinspoon, Steven K. Fitch, Kathleen V, Zanni, Markella V. et al; Pitavastatin to Prevent Cardiovascular Disease in HIV Infection; New England Journal of Medicine, DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2304146.