A statin a day reduces the risk of heart disease in younger people living with HIV, according to a new study published Sunday in the New England Journal of Medicine.
“What the study is saying is if you add a statin treatment to antiretroviral therapy … that will now prevent to a large degree, the excess cardiovascular risk associated with HIV,” said Steven Grinspoon, lead author of the study, and a professor of medicine at Harvard Medical School.
Recent studies have shown that people living with HIV have 1.5 to 2 times higher risk of developing cardiovascular disease compared to the rest of the population. However, the tools currently used make this determination underestimate the risk in people living with HIV. As a result, while the current treatment guidelines recognize that HIV increases the risk of cardiovascular disease, there was no evidence that providing treatment was effective until now.
The results from the new study could potentially lead to updated treatment guidelines for reducing cardiovascular risk in people living with HIV, experts told STAT. It is not clear when bodies like the American Heart Association or the American College of Cardiology might issue new guidelines but the findings are expected to start discussions between physicians and their patients and may result in more statins being prescribed to HIV patients.
This is an important study especially for patients with HIV infection who “might not be considered for statins anyway,” said Priscilla Hsue, professor of medicine at San Francisco School of Medicine, University of California who was not involved in the study. There are about 1.2 million people in the U.S. living with HIV, and more than 30,000 new infections are diagnosed every year, according to the most recent data from the CDC.
The study, called REPRIEVE, is the first to globally assess a way to prevent major adverse cardiovascular events, like heart attack and stroke, in people living with HIV. There were 7,769 participants who were between the ages 40 to 75 years old. About a third of the participants in the phase 3 trial were women and about 65% were non-white.
Researchers hypothesized that using a statin would both lower LDL cholesterol and reduce inflammation, which seems like a no-brainer. They were surprised, however, that participants who took pitavastatin lowered their risk of major adverse cardiovascular events by 35% compared to those taking a placebo — researchers only expected a 30% reduction.
The randomized double-blind trial was conducted in 12 countries in Asia, Europe, North America, South America and Africa. This is important because this study reflects the 37 million people who live with HIV globally, by including important sub groups that are typically not reflected in large studies.
“Oftentimes, studies don’t have enough women to make a determination or are not extended to Sub Saharan Africa or other countries,” said Grinspoon, the study author and the chief of the metabolism unit at Massachusetts General Hospital. “So this study being global is really, really important because we can say this is a global result, not just a result in North America.”
The results indicate that statins were equally effective in preventing heart attack and stroke — consistent with results from a previous study, called JUPITER, which focused on slightly older patients, with an average age of 66, not infected with HIV.
In the past, clinicians would address lifestyle changes or do watchful waiting, before prescribing a statin for patients who have low to moderate risk. But now, Grinspoon said, that he would consider prescribing a statin based on these new findings.
Given prior evidence of the effectiveness of statins in reducing cardiovascular risk, the results from the trial were not a surprise, said Matthew Feinstein, a physician-scientist at Northwestern Medicine and an assistant professor of cardiology at the Northwestern University Feinberg School of Medicine, who was not involved in the study. What he did find surprising were: one, “how big the benefit was and two, that the benefit extended in a somewhat lower risk population, at least by traditional cardiovascular risk assessments.”
Feinstein added that doctors would also extrapolate data from previous trials, like JUPITER, to help guide treatment, but these new clinical endpoints provide additional guidance for the medical community. Still, Feinstein said that there are unanswered questions, including if a high intensity statin would result in an even larger relative risk reduction and if there will be targeted therapies developed to tackle immune response and inflammation and potentially lower heart disease risk.
Beyond HIV, Grinspoon hopes that future analysis of the data collected will help address other inflammatory diseases that are associated with increased cardiovascular risk like psoriasis and lupus. This is a first step, but Grinspoon is excited that a way to prevent cardiovascular disease among those living with HIV was “hiding in plain sight.”