Prevention & lipidsRandomised controlled trial
Pitavastatin to Prevent Cardiovascular Disease in Human Immunodeficiency Virus (HIV) Infection
- Randomised controlled trial
- phase 3
- placebo-controlled
- stopped early for efficacy
Median age 50 years (IQR 45 to 55); median CD4 count 621 cells/mm³ (IQR 448 to 827); HIV RNA below quantification in 5250 of 5997 (87.5%) with available data
Authors' conclusion
Participants with HIV infection who received pitavastatin had a lower risk of a major adverse cardiovascular event than those who received placebo over a median follow-up of 5.1 years.
Study context
- Population
- Persons with HIV infection at low-to-moderate CVD risk receiving ART
- Participants
- 7,769 persons
- Comparison
- Pitavastatin vs placebo
- Primary endpoint
- MACE:
- CV death
- MI
- Hospitalization for unstable angina
- Stroke
- TIA
- Peripheral arterial ischemia
- Revascularization
- Death from undetermined cause
- Follow-up
- Median 5.1 years
Primary result
As reported in the abstract
Hazard ratio
0.65
95% CI 0.48–0.90
P = 0.002
By group
Pitavastatin vs Placebo
HR 0.65 (95% CI 0.48–0.90); P = 0.002
Safety
Muscle-related symptoms
Diabetes mellitus
Original publication
Pitavastatin to Prevent Cardiovascular Disease in HIV Infection. N Engl J Med. Published 23 July 2023. doi:10.1056/nejmoa2304146
Summarised from the published abstract; every number is checked against it