Prevention & lipidsRandomised controlled trial
An “Inclisiran First” Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease
- Randomised controlled trial
- pragmatic
- open-label
- multicentre
- 1:1 randomisation
Authors' conclusion
An "inclisiran first" implementation strategy led to greater LDL-C lowering compared with usual care without discouraging statin use or raising new safety concerns.
Study context
- Population
- US patients with atherosclerotic CVD and low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL despite maximally tolerated statins30.9% women
- Participants
- 450 patients
- Comparison
- "Inclisiran first" strategy plus usual care vs usual care alone
- Primary endpoint
- Percentage change in LDL-C from baseline; statin discontinuation rates
- Follow-up
- Day 330
Primary result
As reported in the abstract
LDL-C reduction from baseline to day 330
P < 0.001
Statin discontinuation
Further findings
LDL-C goal achievement
P < 0.001
<70 mg/dL
<55 mg/dL
Safety
TEAEs and serious TEAEs
TEAE
Serious TEAE
Injection-site TEAEs and TEAEs causing treatment withdrawal
Injection-site TEAE
TEAE causing withdrawal
Treatment-emergent adverse event (TEAEs) and serious TEAEs
- Rates compared similarly between strategies
Injection-site TEAEs and TEAEs causing treatment withdrawal
- More common with inclisiran first
Original publication
An “Inclisiran First” Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease. J Am Coll Cardiol. Published 7 April 2024. doi:10.1016/j.jacc.2024.03.382
Summarised from the published abstract; every number is checked against it