Baseline characteristics of participants in the JUPITER trial, a randomized placebo-controlled primary prevention trial of statin therapy among individuals with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein.
Level 2 - randomized trial
Baseline characteristics and protocol description of an individual randomized controlled trial
PubMed 18036365 · doi:10.1016/j.amjcard.2007.09.072
What was done
This paper describes the baseline characteristics of the Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial. The study is a randomized, double-blind, placebo-controlled primary prevention trial evaluating rosuvastatin 20 mg/day versus placebo in individuals with low-to-average low-density lipoprotein (LDL) cholesterol (<130 mg/dL or 3.36 mmol/L) and elevated high-sensitivity C-reactive protein (hs-CRP ≥2 mg/L) recruited across 26 countries.
What was found
The trial randomized 17,802 participants. At baseline, the median LDL cholesterol level was 108 mg/dL (interquartile range 94 to 119 mg/dL). The enrolled cohort includes 6,801 women (38.2%) and 5,577 participants with metabolic syndrome (32.1%). Clinical efficacy and safety outcome results are not reported in this baseline paper.
Why it matters
JUPITER established a large, international cohort to test whether statin therapy reduces cardiovascular events in individuals who do not traditionally qualify for lipid-lowering therapy due to low baseline LDL levels but have elevated inflammatory risk marked by hs-CRP.
Limits
This publication is restricted to baseline descriptive data and trial rationale; it contains no outcome, efficacy, or safety findings. Findings describe a selected population meeting strict inclusion thresholds (LDL <130 mg/dL and hs-CRP ≥2 mg/L), limiting generalizability to other risk profiles.
Cited by
- contradicts In the JUPITER trial, individuals with high LDL cholesterol but low inflammatory markers had lower cardiovascular risk than those with both high LDL and high inflammation.