Coronary disease & ACSRandomised controlled trial
Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers in HIV
- Randomised controlled trial
- double-blind
- placebo-controlled
- 31 US clinical research sites
- Enrolled April 2015 to February 2018
Authors' conclusion
In PWH at low to moderate CVD risk, 24 months of pitavastatin reduced noncalcified plaque volume and progression as well as markers of lipid oxidation and arterial inflammation.
Study context
- Population
- People with HIV on ART without known cardiovascular disease (CVD), at low to moderate 10-year CVD risk611 analysed
- Participants
- 804 people
- Comparison
- Pitavastatin vs placebo
- Pitavastatinn = 302
- Placebon = 309reference
- Primary endpoint
- Change in noncalcified coronary plaque volume and progression of noncalcified plaque (coronary computed tomography angiography (CTA))
- Follow-up
- 24 months
Primary result
As reported in the abstract
Pitavastatin
−1.7
mean change · SD 25.2 · mm3
Placebo
2.6
mean change · SD 27.1 · mm3
Pitavastatin vs PlaceboBaseline adjusted difference, mm3 (95% CI)P value
noncalcified plaque volume; 7% greater reduction (95% CI 1-12)
−4.3(−8.6 to −0.1)
P = 0.04Pitavastatin vs PlaceboRelative risk (95% CI)P value
progression of noncalcified plaque
0.67(0.52–0.88)
P = 0.003Further findings
| Outcome | Pitavastatin | Placebo | P value |
|---|---|---|---|
| Change in LDL-C · 24 months | mean change −28.5 (95% CI −31.9–-25.1) mg/dL | mean change −0.8 (95% CI −3.8–2.2) | |
| Change in oxidized LDL · 24 months | −29% (95% CI −32–-26) | −13% (95% CI −17–-9) | P < 0.001 |
| Change in lipoprotein-associated phospholipase A2 · 24 months | −7% (95% CI −11–-4) | 14% (95% CI 10–18) | P < 0.001 |
Change in noncalcified plaque volume, subgroup with plaque at baseline · 24 months
- Larger effect size in the subgroup with plaque at baseline
- −8.8 mm3 [95% CI, −17.9 to 0.4]
Original publication
Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers in HIV. JAMA Cardiol. Published 1 April 2024. doi:10.1001/jamacardio.2023.5661
Summarised from the published abstract; every number is checked against it