Jul 24, 2023
NIH-funded clinical trial finds cholesterol-lowering treatment reduced cardiovascular events by 35%.
A National Institute of Health-supported study found that statins, a class of cholesterol-lowering medications, may offset the high risk of cardiovascular disease in people living with HIV by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population. People living with HIV can have a 50-100% increased risk for cardiovascular disease. The findings are published in the New England Journal of Medicine(link is external).
“This research suggests that statins may provide an accessible, cost-effective measure to improve the cardiovascular health and quality of life for people living with HIV,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), a study funder. “Additional research can further expand on this effect, while providing a roadmap to rapidly translate research findings into clinical practice.”
For the double-blinded phase 3 trial, known as Randomized Trial to Prevent Vascular Events in HIV(link is external) (REPRIEVE) study, researchers randomized participants into either a treatment group, where they received a daily statin – in this case pitavastatin calcium – or a control group, where they received a placebo pill that contained no medication. The researchers followed participants for about five years, but ended the trial early when they discovered the treatment benefits outweighed potential risks.
To understand the benefits, the researchers compared how often participants in each group experienced major cardiovascular events, including heart attacks, strokes, or surgery to open a blocked artery. They found participants who took daily pitavastatin had 35% fewer major cardiovascular events than those who took a placebo. The researchers also measured the number of deaths in combination with major cardiovascular events during the study period and found participants in the treatment group were 21% less likely than those in the placebo group to experience these events. Additionally, those who took pitavastatin had a 30% reduction in their low-density lipoprotein (LDL) cholesterol levels.
“Lowering LDL cholesterol levels reduces risks for cardiovascular events, like having a heart attack and stroke, but these findings suggest there may be additional effects of statin therapy that explain these reduced risks among people living with HIV,” said Steven K. Grinspoon, M.D., the study chair who is also a professor of medicine at Harvard University and chief of the metabolism unit at Massachusetts General Hospital. “Ongoing research about how statin therapy may affect inflammation and increased immune activation among people with HIV may help us better understand the additional benefits we’re seeing with this treatment approach.”
To support optimal health outcomes among the study participants, researchers required those who enrolled to have normal liver and kidney function. They were also required to take antiretroviral therapy, which itself is critical to reducing the risk of HIV complications and related comorbidities, including cardiovascular disease.
REPRIEVE began in 2015 and enrolled 7,769 adults, ages 40-75, from 145 sites in 12 countries. Adults in the study were an average age of 50 and had low-to-moderate risks for cardiovascular disease, which meant they normally would not have been prescribed statins. Women accounted for 31% of participants. Approximately 41% of study participants identified as Black, 35% as white, 15% as Asian, and 9% as another race.
The researchers noted more work needs to be done to determine how these results will impact guidelines for the care of people living with HIV.“Our goal with REPRIEVE was to validate an intervention to improve the lives of people with HIV,” said Hugh Auchincloss, M.D., acting director of the National Institute of Allergy and Infectious Diseases (NIAID), the study sponsor. “This study, supported by thousands of participants and researchers, represented a global recognition that as HIV management has grown more successful, we also need to address the comorbidities such as cardiovascular diseases that afflict people with HIV.”
According to the World Health Organization, more than 38 million people worldwide live with HIV, a virus that suppresses the body’s immune system if untreated. About 1.5 million(link is external) new HIV cases were diagnosed in 2021.
About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advances scientific knowledge, improves public health, and saves lives. For more information, visit https://www.nhlbi.nih.gov.
About the National Institute of Allergy and Infectious Diseases (NIAID): NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available at https://www.niaid.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.