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Pitavastatin to Prevent Cardiovascular Disease in HIV Infection
Steven K Grinspoon1, Kathleen V Fitch1, Markella V Zanni1
1From the Metabolism Unit (S.K.G., K.V.F., M.V.Z., M.R.D., E.S.F., S.E.L., S.M.), the Cardiovascular Imaging Research Center, Department of Radiology (K.P., B.F., M.T.L.), and the Yvonne L. Munn Center for Nursing Research (S.E.L.), Massachusetts General Hospital and Harvard Medical School, the Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health (T.U., J.L.-C., H.J.R.), and the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School (S.D.W.) - all in Boston; the Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati (C.J.F.), and the Division of Infectious Diseases, Ohio State University Medical Center, Columbus (C.D.M.); the Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York (J.A.A.); the Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham (E.T.O.); the Department of Medicine, Duke Global Health Institute and Duke Clinical Research Institute, Duke University (G.S.B.), and Duke University Research Institute, Duke University School of Medicine (P.S.D.) - both in Durham, NC; the Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (J.S.C.); the Infectious Diseases Service, Hospital Clinic and University of Barcelona, Barcelona, and CIBER de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid - both in Spain (E.M.); DLH, Silver Spring (J.C.R.), and the Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (P.D.-N.), and the Division of AIDS, National Institute of Allergy and Infectious Diseases (B.A.-S.), National Institutes of Health, Bethesda - all in Maryland; and Cleerly, Denver (U.H.).
Insights
Daily pitavastatin significantly reduced major adverse cardiovascular events in people with human immunodeficiency virus (HIV) infection. This study highlights pitavastatin as a key strategy for primary cardiovascular disease prevention in the HIV-positive population.
Area of Science:
- Cardiovascular Medicine
- Infectious Diseases
- Clinical Trials
Background:
- Individuals with human immunodeficiency virus (HIV) infection face an elevated risk of cardiovascular disease (CVD).
- There is a critical need for effective primary prevention strategies for CVD in this vulnerable population.
- Antiretroviral therapy (ART) is standard care for HIV, but CVD risk remains a concern.
Purpose of the Study:
- To evaluate the efficacy of pitavastatin calcium in preventing major adverse cardiovascular events (MACE) in participants with HIV.
- To assess the safety and tolerability of pitavastatin in this specific patient group.
- To provide data on primary CVD prevention strategies for individuals with HIV.
Main Methods:
- A phase 3 randomized, placebo-controlled trial involving 7769 participants with HIV on ART and low-to-moderate CVD risk.
- Participants received daily pitavastatin calcium (4 mg) or a placebo.
- The primary outcome was the composite incidence of MACE, including cardiovascular death, myocardial infarction, stroke, and other cardiovascular events.
Main Results:
- The trial was stopped early for efficacy after a median follow-up of 5.1 years.
- Pitavastatin significantly reduced the incidence of MACE by 35% compared to placebo (4.81 vs. 7.32 per 1000 person-years; hazard ratio, 0.65; P=0.002).
- Muscle-related symptoms and new-onset diabetes were slightly more frequent in the pitavastatin group but generally well-tolerated.
Conclusions:
- Daily pitavastatin significantly lowers the risk of major adverse cardiovascular events in individuals with HIV infection.
- Pitavastatin represents a valuable primary prevention strategy for cardiovascular disease in the HIV-positive population.
- The findings support the use of pitavastatin for reducing CVD burden in people living with HIV.
Background:
The risk of cardiovascular disease is increased among persons with human immunodeficiency virus (HIV) infection, so data regarding primary prevention strategies in this population are needed.
Methods:
In this phase 3 trial, we randomly assigned 7769 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.
Results:
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 5250 of 5997 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 1000 person-years in the pitavastatin group and 7.32 per 1000 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.
Conclusions:
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. (Funded by the National Institutes of Health and others; REPRIEVE ClinicalTrials.gov number, NCT02344290.).
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