A new randomized clinical trial shows that pitavastatin or other statins may help reduce major cardiovascular events in those living with HIV. These benefits are not just due to LDL cholesterol reduction.
HIV significantly increases atherosclerotic cardiovascular disease incidence in those living with HIV. Studies suggest that those living with HIV have twice the risk of stroke and myocardial infarction as the general population. Hence, it is necessary to take preventative measures; however, the cause of this higher risk is unclear. A phase III study published in the New England Journal of Medicine explored the role of pitavastatin in reducing cardiovascular disease risk in HIV patients.
Trial Was Stopped Early Due to Evidence of Treatment Efficacy
The study had a sample size of 7769 individuals living with well-controlled HIV. They were each given 4 mg of pitavastatin daily. The median age of participants was 50 years. Of the total participants, 5997 individuals, or 87.5%, had undetectable HIV RNA. The median CD4 count of the participants was 621 cells per cubic millimeter.
The study findings were highly encouraging, and the trial was stopped early as it reached its targets, resulting in a median follow-up period of 5.1 years. During this period, the incidence of major cardiovascular events was 4.81 per 1000 person-years in the pitavastatin group compared to 7.32 per 1000 person-years in the placebo group. The drug was well tolerated, with myalgia reported in 2.3% of the pitavastatin group, compared to 1.4% in the placebo group.
The pitavastatin group also had a slightly higher diabetes risk at 5.3%, compared to 4% in the placebo group. At the beginning of the study, LDL cholesterol levels were equal in both groups. However, post-treatment, LDL cholesterol declined from 107 to 74 mg per deciliter in the pitavastatin group, but it did not significantly decline in the placebo group.
Bottom Line
HIV significantly increases the risk of major cardiovascular events, causing premature deaths. However, the reason for the increased remains unclear. This study found that pitavastatin therapy may have a role in reducing the risk. The study was discontinued prematurely due to significant its benefits for the participants.
Researchers found that pitavastatin may reduce cardiovascular event hazards by as much as 35%. This risk reduction is at a median follow-up of 5.1 years. Hence, the benefits might be even greater if the therapy is continued for extended periods. The risk reduction was greater than predicted; thus, researchers believe these effects cannot be explained by lowering LDL cholesterol alone. Further, researchers say that other statins may also have similar benefits.
Source:
Grinspoon, S., Fitch, K. V., Zanni, M. V., Fichtenbaum, C. J., Umbleja, T., Aberg, J. A., Overton, E. T., Malvestutto, C., Bloomfield, G. S., Currier, J. S., Martínez, E., Roa, J. C., Diggs, M. R., Fulda, E. S., Paradis, K., Wiviott, S. D., Foldyna, B., Looby, S. E., Desvigne‐Nickens, P., . . . Douglas, P. S. (2023). Pitavastatin to prevent cardiovascular disease in HIV infection. The New England Journal of Medicine, 389(8), 687–699. https://doi.org/10.1056/nejmoa2304146
