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The New England Journal of MedicinePitavastatin to Prevent Cardiovascular Disease in HIV Infection

The results provide essential insights into primary prevention strategies for this specific population, yielding significant implications for clinical practice.

The risk of cardiovascular disease (CVD) is a pressing concern among persons with HIV infection. The phase 3 trial conducted by Grinspoon et al. sought to assess the efficacy of daily pitavastatin calcium in preventing major adverse cardiovascular events among HIV-positive participants.

Study Design:

  • Participants: 7,769 HIV-infected participants with a low-to-moderate risk of cardiovascular disease, receiving antiretroviral therapy.
  • Intervention: Daily pitavastatin calcium (4 mg) or placebo.
  • Primary Outcome: Major adverse cardiovascular events, including cardiovascular death, myocardial infarction, hospitalization for unstable angina, etc.
  • Age and Health Metrics: Median age of 50 years, median CD4 count of 621 cells/mm³, HIV RNA below quantification in 87.5% of participants.
  • Duration: Median follow-up of 5.1 years.

Key Findings:

  • Efficacy: Incidence of major adverse cardiovascular events was 4.81 per 1000 person-years in the pitavastatin group and 7.32 in the placebo group (HR, 0.65; 95% CI, 0.48 to 0.90; P=0.002).
  • Adverse Events: Muscle-related symptoms in 2.3% of the pitavastatin group and 1.4% in the placebo group; diabetes mellitus in 5.3% and 4.0%, respectively.


  • Pitavastatin administration led to a lower risk of major adverse cardiovascular events over 5.1 years compared to placebo.

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Did You Know?
Individuals with HIV infection are estimated to have a 1.5 to 2 times higher risk of developing cardiovascular disease compared to those without HIV.

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