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.
Conclusion:
- 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.