Cohen · The New England journal of medicine 2006 · prospective cohort study · n=12887

Sequence variations in PCSK9, low LDL, and protection against coronary heart disease.

Cited 3240 times in the scientific literature.

Level 3 - non-randomized controlled study

Prospective cohort study evaluating outcomes over a 15-year follow-up interval.

PubMed 16554528 · doi:10.1056/NEJMoa054013 · record verified 2026-08-30

What was done

Researchers analyzed the relationship between DNA-sequence variations in the PCSK9 gene that lower plasma LDL cholesterol and the 15-year incidence of coronary heart disease (myocardial infarction, fatal CHD, or coronary revascularization) in 3,363 Black subjects and 9,524 White subjects from the Atherosclerosis Risk in Communities study.

What was found

Among Black subjects, 2.6% had PCSK9 nonsense mutations associated with a 28% reduction in mean LDL cholesterol and an 88% reduction in CHD risk (hazard ratio, 0.11; 95% confidence interval, 0.02 to 0.81; P=0.03; P=0.008 for cholesterol reduction). Among White subjects, 3.2% had a PCSK9 sequence variation associated with a 15% reduction in LDL cholesterol and a 47% reduction in CHD risk (hazard ratio, 0.50; 95% confidence interval, 0.32 to 0.79; P=0.003).

Why it matters

This study shows that lifelong, genetically mediated reductions in LDL cholesterol yield substantial reductions in coronary event rates, validating PCSK9 as a critical regulator of cardiovascular risk.

Limits

The examined mutations were rare (2.6% and 3.2%), resulting in wide confidence intervals, particularly in the Black cohort. The observational design reflects lifelong exposure rather than adult-initiated pharmacological intervention, and potential confounding variables or non-lipid risk factor adjustments are not detailed in the abstract.

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