Cardiovascular outcome trial · N Engl J Med 2023
REPRIEVE trial
Pitavastatin to Prevent Cardiovascular Disease in HIV Infection.
The bottom line
In people with HIV at low-to-moderate cardiovascular risk, daily pitavastatin significantly reduced major adverse cardiovascular events compared with placebo, though with modestly more muscle symptoms and diabetes.
BenefitUS status: US-approved
At a glance
- Medicine
- Pitavastatin calcium 4 mg daily
- Compared with
- Placebo
- People
- 7,769
- Who took part
- Persons with HIV infection receiving antiretroviral therapy, with low-to-moderate cardiovascular risk; median age 50 years, median CD4 count 621 cells/mm3
- Design
- randomized, double-blind, placebo-controlled
- Follow-up
- median follow-up of 5.1 years (interquartile range, 4.3 to 5.9)
- Main question
- Major adverse cardiovascular event: composite of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause
Main result
The incidence of a major adverse cardiovascular event was 4.81 per 1000 person-years in the pitavastatin group and 7.32 per 1000 person-years in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.90; P = 0.002).
Safety
Muscle-related symptoms occurred in 91 participants (2.3%) in the pitavastatin group and in 53 (1.4%) in the placebo group; diabetes mellitus occurred in 206 participants (5.3%) and in 155 (4.0%), respectively.
In the trial's own words
“The incidence of a major adverse cardiovascular event was 4.81 per 1000 person-years in the pitavastatin group and 7.32 per 1000 person-years in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.90; P = 0.002).”
Quoted from the abstract of N Engl J Med 2023, checked word for word against PubMed. PubMed 37486775 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the REPRIEVE trial find?
In people with HIV at low-to-moderate cardiovascular risk, daily pitavastatin significantly reduced major adverse cardiovascular events compared with placebo, though with modestly more muscle symptoms and diabetes.
Who was in REPRIEVE?
7,769 people. Persons with HIV infection receiving antiretroviral therapy, with low-to-moderate cardiovascular risk; median age 50 years, median CD4 count 621 cells/mm3.
What was REPRIEVE's main result?
The incidence of a major adverse cardiovascular event was 4.81 per 1000 person-years in the pitavastatin group and 7.32 per 1000 person-years in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.90; P = 0.002).
Related trials
- LODESTAR (2023)In patients with coronary artery disease, rosuvastatin and atorvastatin provide similar long-term cardiovascular protection, but rosuvastatin carries a higher risk of new-onset diabetes requiring medication and cataract surgery.
- SPORT (2023)In people with elevated ASCVD risk but no prior ASCVD, low-dose rosuvastatin (5 mg) lowered LDL-C far more than placebo or any of six common dietary supplements, which showed no significant LDL-C benefit over placebo.
- SAMSON (2021)In patients who had previously stopped statins due to side effects, symptom scores were equally elevated on statin and placebo compared with no treatment, indicating most statin-associated symptoms are a nocebo effect rather than a pharmacological effect of the drug.
- StatinWISE (2021)In patients with prior statin-associated muscle symptoms, atorvastatin 20 mg did not cause more muscle symptoms than placebo when tested in a blinded n-of-1 design, and most participants intended to resume statin therapy.
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