Effect of Statin Therapy on C-Reactive Protein Levels: The Pravastatin Inflammation/CRP Evaluation (PRINCE): A Randomized Trial and Cohort Study - PRINCE

Description:

Effect of Statin Therapy on C-Reactive Protein Levels: The Pravastatin Inflammation/CRP Evaluation (PRINCE): A Randomized Trial and Cohort Study.

Hypothesis:

Retrospective studies have shown a reduction of C-reactive protein (CRP) attributable to therapy with statins that is independent of lipid lowering and appears to be a class effect. This study sought to specifically determine the anti-inflammatory effects of pravastatin as measured by CRP reduction.

Study Design

Study Design:

Patients Enrolled: 2,884

Drug/Procedures Used:

A community-based prospective randomized double-blind trial in 1,702 men and women without CVD and an open-labeled study in 1,182 patients with known CVD off statins for at least 12 weeks was used. The study lasted 24 weeks. The primary prevention group received 40 mg/d of pravastatin or placebo and the secondary prevention cohort 40 mg/d of open-labeled pravastatin. The main outcome was change in high-sensitivity CRP (hsCRP) at 24 weeks.

Principal Findings:

Compared with placebo, in the primary prevention cohort, pravastatin reduced the hsCRP by 16.9%, reflecting a decrease of 0.02 mg while there was no change with placebo. This effect was seen as early as 12 weeks and present in all subgroups independent of other variables including gender, baseline, or on-treatment lipid levels, diabetes and use of ASA and hormone replacement therapy. A similar 14.3% reduction in hsCRP occurred in the open-labeled cohort with CVD.

Statins appear to have anti-inflammatory effects in addition to lipid-lowering effects.

Interpretation:

CRP is clearly a marker for coronary risk and has been shown to be reducred by statins as a class effect.

References:

1. Albert MA, Danielson E, Rifai N, Ridker PM. JAMA 2001;286:64-70.

Keywords: Inflammation, C-Reactive Protein, Secondary Prevention, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Pravastatin, Lipids, Coronary Disease, Hormone Replacement Therapy, Primary Prevention, Diabetes Mellitus


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