November 14, 2023
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Key takeaways:
- In patients with HIV at low to moderate CVD risk, pitavastatin lowered noncalcified plaque volume and reduced risk for plaque progression vs. placebo.
- The statin also lowered LDL and inflammatory biomarkers.
PHILADELPHIA — Pitavastatin lowered noncalcified plaque volume and reduced risk for plaque progression compared with placebo in patients with HIV at low to moderate risk for CVD, according to new data from the REPRIEVE trial.
As Healio previously reported, in the main results of REPRIEVE, pitavastatin reduced major adverse CV events by 35% compared with placebo in patients with HIV at low to moderate risk for CVD. Michael T. Lu, MD, MPH, co-principal investigator of the REPRIEVE Data Coordinating Center, co-director of the Massachusetts General Hospital (MGH) Cardiovascular Imaging Research Center, associate chair of imaging science in the MGH department of radiology and associate professor of radiology at Harvard Medical School, presented the results of a mechanistic substudy of REPRIEVE at the American Heart Association Scientific Sessions.
In patients with HIV at low to moderate CVD risk, pitavastatin lowered noncalcified plaque volume and reduced risk for plaque progression vs. placebo.
Image: Adobe Stock
For the mechanistic substudy, Lu and colleagues enrolled 804 participants (mean age, 51 years; 17% women; 53% white) with HIV on antiretroviral therapy from the main REPRIEVE trial. Substudy participants to conduct viahad coronary CTA for noninvasive quantification of change in coronary plaque volume and composition at study entry and after 2 years.
Michael T. Lu
“The idea behind the mechanistic substudy was, using coronary CT and blood biomarkers, to identify potential mechanisms for the anticipated reduction in MACE with pitavastatin,” Lu told Healio.
The primary outcome was change in noncalcified plaque and noncalcified plaque progression, defined as any increase in plaque or new plaque, at 2 years.
Steven K. Grinspoon
Pamela S. Douglas
At 2 years, compared with the placebo arm, the pitavastatin arm had a –4.3 mm3 greater decrease in noncalcified plaque volume (95% CI, –8.6 to –0.1; P = .044), equivalent to a 7% decrease, REPRIEVE co-principal investigators Lu, Heather J. Ribaudo, PhD, principal research scientist in biostatistics at Harvard T.H. Chan School of Public Health, Steven K. Grinspoon, MD, professor of medicine at Harvard University and chief of the metabolism unit at MGH, Pamela S. Douglas, MD, Ursula Geller Professor of Research in Cardiovascular Diseases in the department of medicine at Duke University, and colleagues found.
Risk for noncalcified plaque progression at 2 years was 33% lower in the pitavastatin group than in the placebo group (relative risk = 0.67; 95% CI, 0.52-0.88; P = .003), according to the results.
The pitavastatin group also had a –1.2 mm3 greater decrease in low attenuation plaque volume (95% CI, –2.2 to –0.1; P = .026) compared with placebo.
LDL was decreased by an average of –28.5 mg/dL in the pitavastatin group compared with –0.8 mg/dL in the placebo group, according to the researchers.
Lu said pitavastatin also had a positive effect on inflammatory biomarkers, as the pitavastatin group had greater reduction in lipoprotein-associated phospholipase A2 (P < .001) and oxidized LDL (P < .001), with a trend toward lowering of high-sensitivity C-reactive protein (P for difference in levels at 2 years = .021; P for difference in change from baseline = .09) compared with placebo.
Change in LDL and achieved LDL less than 70 mg/dL were associated with lower risk for noncalcified plaque progression in unadjusted analyses, but not when adjusted for baseline plaque, he said.
The results “may provide some explanation for the way pitavastatin is preventing cardiovascular events in this low to moderate risk population with HIV,” Lu told Healio. “Most of these patients would not be on a statin by current guidelines. But even in these low-risk patients, pitavastatin can prevent cardiac events, can prevent coronary plaque progression [and] can reduce inflammatory biomarkers. Other studies will be coming out looking at more experimental biomarkers to help identify new therapeutic targets.”
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Sources/Disclosures
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Source:
Lu MT, et al. LBS.06. Future of lipid lowering therapy – Novel mechanisms and approaches. Presented at: American Heart Association Scientific Sessions; Nov. 11-13, 2023; Philadelphia.
Disclosures:
REPRIEVE was primarily funded by the NIH/NHLBI, with additional support from Gilead, Kowa Pharmaceuticals and ViiV Healthcare. Lu reports receiving unrelated institutional research funding from American Heart Association, AstraZeneca, Ionis, Johnson & Johnson Innovation, National Academy of Medicine, the NHLBI and the Risk Management Foundation of the Harvard Medical Institutions Inc.
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