Prevention & lipids

Inflammation and Cholesterol as Predictors of Cardiovascular Events Among 13 970 Contemporary High-Risk Patients With Statin Intolerance

CirculationPublished Secondary analysis of the CLEAR-Outcomes randomised trial

Authors' conclusion

Among contemporary statin-intolerant patients, inflammation assessed by hsCRP predicted risk for future cardiovascular events and death more strongly than hyperlipidemia assessed by LDLC.

Study context

Population
Statin-intolerant patients randomised to bempedoic acid 180 mg daily or placebo
Participants
13,970 patients
Comparison
Highest vs lowest quartile of baseline high-sensitivity C-reactive protein (hsCRP) and of baseline LDL-C as predictors of CV events
Primary endpoint
Primary composite end point of:
  • Major CV events (MI, stroke, coronary revascularization or CV death) by baseline hsCRP
  • Low-density lipoprotein cholesterol (LDLC) quartile
Methodological detailsmultinational
  • Multinational

Primary result

As reported in the abstract

Primary composite end point (major CV events)
Hazard ratio (95% CI)
Highest hsCRP quartilevs Lowest hsCRP quartile
1.43(1.24–1.65)
Highest LDL-C quartilevs Lowest LDL-C quartile
1.19(1.04–1.37)

Further findings

OutcomeHR (95% CI)
CV mortalityHighest hsCRP quartilevs Lowest hsCRP quartile2.00 (1.53–2.61)
CV mortalityHighest LDL-C quartilevs Lowest LDL-C quartile0.90 (0.70–1.17)
All-cause mortalityHighest hsCRP quartilevs Lowest hsCRP quartile2.21 (1.79–2.73)
All-cause mortalityHighest LDL-C quartilevs Lowest LDL-C quartile0.95 (0.78–1.16)

hsCRP and LDL-C change with bempedoic acid vs placebo · 6 months

Median hsCRP reduced
21.6%
Mean LDL-C reduced
21.1%

Bempedoic acid efficacy across hsCRP and LDL-C levels

Similar efficacy in reducing CV events across all levels of hsCRP and LDL-C
Risks high with elevated hsCRP irrespective of LDL-C level

Original publication

Inflammation and Cholesterol as Predictors of Cardiovascular Events Among 13 970 Contemporary High-Risk Patients With Statin Intolerance. Circulation. Published 6 November 2023. doi:10.1161/circulationaha.123.066213

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