The U.S. National Institutes of Health trial found the cholesterol-lowering drugs so effective, in fact, that the study was stopped early.
Taking the daily statin pitavastatin calcium lowered the risk of major heart events by 35% in this patient group, according to an interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study.
“The REPRIEVE study reflects the evolution of HIV science, and progress from focusing mostly on approaches to treat and control the virus to finding ways to improve the overall health of people living with HIV,” said Dr. Hugh Auchincloss, acting director of the National Institute of Allergy and Infectious Diseases (NIAID).
“These new data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV,” he said in a news release from the NIH and the NIAID.
As people with HIV live longer thanks to decades of medical research and advances, premature heart disease and other chronic conditions have emerged as leading causes of illness and death.
Statins are known to prevent heart disease in those at risk in the general population. But researchers weren’t certain before the trial if statins would have the same impact on people living with HIV.
REPRIEVE began in 2015 with about 7,800 volunteers aged 40 to 75 years. More than 30% were women.
The REPRIEVE volunteers were all taking antiretroviral therapy, and had low-to-moderate traditional cardiovascular disease risk that would not typically be considered for statin treatment. The investigators conducted the trial in 12 countries in Asia, Europe, North America, South America and Africa.
The participants were randomly assigned to receive a daily dose of 4 mg of pitavastatin or a placebo. The researchers monitored them for major heart events and adverse reactions to the medication. It is considered safe for use with all prescribed antiretroviral therapy regimens.
Side effects for patients were similar to those in the general population taking statin therapy, the findings showed.
At its most recent meeting, the study’s Data Safety and Monitoring Board determined that the benefits outweighed any risks.
Study participants will continue to be monitored for several months. Results from a final review are expected to be published in the coming weeks.
“These latest findings represent the culmination of an unprecedented eight-year effort to generate evidence that can help clinicians better support the unique cardiovascular health needs of people living with HIV,” said Dr. Gary Gibbons, director of the U.S. National Heart, Lung, and Blood Institute. “REPRIEVE is important because there are limited existing interventions to help prevent adverse cardiovascular outcomes in this population.”
The U.S. Centers for Disease Control and Prevention has more on living with HIV.
SOURCE: U.S. National Institutes of Health/National Institute of Allergy and Infectious Diseases, news release, April 11, 2023
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