Researchers of a phase 3 trial aimed to determine whether statins, specifically pitavastatin, could reduce the incidence of major adverse cardiovascular events among HIV patients, as the risk of cardiovascular disease is increased in those with HIV infection.
Patients with HIV who received pitavastatin had a lower risk of cardiovascular disease compared to patients who received a placebo during a phase 3 trial called REPRIEVE.
Researchers of REPRIEVE aimed to determine whether statins, specifically pitavastatin, could reduce the incidence of major adverse cardiovascular events among this population, as the risk of cardiovascular disease is increased in those with HIV infection.
Published in The New England Journal of Medicine in August, the trial was made of 7,769 enrolled participants who were screened in 12 different countries from March 2015 to July 2019.
Participants were assigned in a 1:1 ratio to receive oral pitavastatin calcium (at a dose of 4 mg per day) or an identical placebo, which were both provided by Kowa Pharmaceuticals America.
The methods behind the study were chosen based on the understanding that statin therapy effectively reduces low-density lipoprotein (LDL) cholesterol — a key contributor to cardiovascular disease — and has beneficial effects on inflammatory and immunity issues.
Cardiovascular outcomes experienced in the trial primarily included cardiac ischemia, stroke or transient ischemic attack, TIA, with peripheral arterial ischemia being rare.
However, the trial was concluded earlier than planned as results revealed a massive 35% reduction in major adverse cardiovascular events in a 5-year follow-up among those in the pitavastatin group compared to the placebo group.
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, according to the study.
The reduction surpassed predictions based solely on the lowering of LDL cholesterol levels, suggesting that statins may have additional cardiovascular benefits beyond cholesterol management.
The observations in REPRIEVE are similar to findings from a study involving older individuals without HIV but with increased C-reactive protein levels. Results reveal the benefits of pitavastatin were present across various LDL cholesterol levels.
It's also important to note that the participants in the trial were all on antiretroviral therapy, which combined with the benefits of statin therapy, can complement the positive effects of antiretroviral treatment.
Antiretroviral therapy has been shown to reduce the risk of death and cardiovascular disease, but statin therapy could offer further advantages by addressing ongoing cardiovascular risks amongst diverse populations, the study suggests.
Trial researchers claim the results establish the need to expand recommendations for statin therapy in this population to provide valuable insights for healthcare practitioners. Though, it’s also recommended to further examine other statins and alternative strategies for cardiovascular risk management.