“We know that patients with HIV have an increased risk of cardiovascular disease,” stated Dr Michael Lu (Massachusetts General Hospital, MA, USA) [1]. “Also, the moderate-intensity statin pitavastatin has minimal interaction with the antiretroviral therapy that is used by patients with HIV.” The phase 3 REPRIEVE trial (NCT02344290) randomised 7,769 participants with HIV on antiretroviral therapy with a low-to-moderate 10-year atherosclerotic cardiovascular disease (ASCVD) risk to pitavastatin calcium or placebo [2]. The primary analysis at 5.1 years showed a reduction of 35% in MACE in participants on pitavastatin compared with those who were treated with a placebo. The current analysis, presented by Dr Lu, evaluated the effect of pitavastatin on non-calcified coronary plaque formation and inflammatory and immune biomarkers in 804 participants.
At 24 months, the authors observed a reduction of 7% in non-calcified coronary plaque volume in participants on pitavastatin compared with those on placebo (95% CI -8.6 to -0.1; P=0.044). In participants with plaques at baseline, the corresponding difference was 12%. Furthermore, the risk of non-calcified plaque progression was 33% lower in the pitavastatin group than in the placebo group (95% CI 0.52–0.88; P=0.003).
“We also noted significant reductions in Lp-PLA2 and oxidised LDL levels in pitavastatin-treated individuals compared with placebo-treated individuals,” added Dr Lu. Changes in other biomarkers, such as MCP-1, sCD14, and IL-6, did not significantly differ between the 2 study groups at 24 months. “The results of REPRIEVE are in a similar ballpark with respect to plaque changes as other trials investigating LDL-reducing agents in higher-risk populations,” according to Dr Lu.
In conclusion, in a primary prevention population of patients with HIV and a low-to-moderate ASCVD risk, 2 years of pitavastatin treatment was associated with reduced non-calcified plaque volumes, a lower risk of plaque progression, and a reduction in relevant biomarkers of lipid oxidation and arterial inflammation, potentially explaining the reduction in MACE that was reported in the primary analysis of this trial.
- Lu MT, et al. Effects of pitavastatin on coronary artery disease and inflammatory biomarkers: mechanistic substudy of the REPRIEVE primary prevention trial in HIV. LB06, AHA Scientific Sessions 2023, 11–13 November, Philadelphia, USA.
- Grinspoon SK, et al. N Engl J Med 2023;389:687–699.
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