- Question
- Does reducing inflammation, without changing lipid levels, lower the risk of recurrent cardiovascular events in patients with prior myocardial infarction and residual inflammation?
- Design
- Randomized, double-blind, placebo-controlled trial of 10061 patients with a median follow-up of 3.7 years.
- Population
- Patients with a previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg/L or more.
- Intervention
- Canakinumab, a monoclonal antibody targeting interleukin-1β, at 50 mg, 150 mg or 300 mg given subcutaneously every 3 months.
- Control
- Placebo given subcutaneously every 3 months.
- Primary outcome
- Composite of nonfatal myocardial infarction, nonfatal stroke or cardiovascular death.
- Results
- The primary end point rate was 4.50 events per 100 person-years with placebo and 3.86 with 150 mg (HR 0.85; 95% CI 0.74 to 0.98; P=0.021). The 50-mg dose showed no significant difference (HR 0.93; 95% CI 0.80 to 1.07; P=0.30) and the 300-mg dose had an HR of 0.86 (95% CI 0.75 to 0.99; P=0.031), without meeting the multiplicity-adjusted threshold. Only the 150-mg dose met that threshold, for both the primary end point and the secondary end point that added hospitalization for unstable angina leading to urgent revascularization (HR 0.83; 95% CI 0.73 to 0.95; P=0.005).
- Safety
- Canakinumab was associated with a higher incidence of fatal infection than placebo. There was no significant difference in all-cause mortality (HR 0.94; 95% CI 0.83 to 1.06; P=0.31). The drug did not reduce lipid levels.
- Conclusion
- Antiinflammatory therapy targeting the interleukin-1β pathway with canakinumab 150 mg every 3 months lowered recurrent cardiovascular events independently of lipid lowering.
- Why it matters
- It was the first clinical proof of the inflammatory hypothesis of atherothrombosis, showing that targeting inflammation without altering lipids can reduce cardiovascular events. It opened the way for other antiinflammatory strategies in cardiovascular prevention.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026