Efficacy of Rosuvastatin Among Men and Women With Moderate Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein: A Secondary Analysis From the JUPITER (Justification for the Use of Statins in Prevention–an Intervention Trial Evaluating Rosuvastatin) Trial

doi:10.1016/j.jacc.2010.01.020

Journal of the American College of Cardiology

Volume 55, Issue 12, 23 March 2010, Pages 1266-1273

https://doi.org/10.1016/j.jacc.2010.01.020 Get rights and content

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Objectives

We evaluated the efficacy of statin therapy in primary prevention among individuals with moderate chronic kidney disease (CKD).

Background

Whether patents with moderate CKD (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73 m²) benefit from statin therapy is uncertain, particularly among those without hyperlipidemia or known cardiovascular disease.

Methods

Within the JUPITER (Justification for the Use of statins in Prevention–an Intervention Trial Evaluating Rosuvastatin) primary prevention trial of rosuvastatin 20 mg compared with placebo among men and women free of cardiovascular disease who had low-density lipoprotein cholesterol (LDL-C) <130 mg/dl and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/l, we performed a secondary analysis comparing cardiovascular and mortality outcomes among those with moderate CKD at study entry (n = 3,267) with those with baseline eGFR ≥60 ml/min/1.73 m² (n = 14,528). Median follow-up was 1.9 years (maximum 5 years).

Results

Compared with those with eGFR ≥60 ml/min/1.73 m², JUPITER participants with moderate CKD had higher vascular event rates (hazard ratio [HR]: 1.54, 95% confidence interval [CI]: 1.23 to 1.92, p = 0.0002). Among those with moderate CKD, rosuvastatin was associated with a 45% reduction in risk of myocardial infarction, stroke, hospital stay for unstable angina, arterial revascularization, or confirmed cardiovascular death (HR: 0.55, 95% CI: 0.38 to 0.82, p = 0.002) and a 44% reduction in all-cause mortality (HR: 0.56, 95% CI: 0.37 to 0.85, p = 0.005). Median LDL-C and hsCRP reductions as well as side effect profiles associated with rosuvastatin were similar among those with and without CKD. Median eGFR at 12 months was marginally improved among those allocated to rosuvastatin as compared with placebo.

Conclusions

Rosuvastatin reduces first cardiovascular events and all-cause mortality among men and women with LDL-C <130 mg/dl, elevated hsCRP, and concomitant evidence of moderate CKD. (JUPITER—Crestor 20 mg Versus Placebo in Prevention of Cardiovascular [CV] Events; NCT00239681)

Key Words

chronic kidney disease

CRP

statins

trial

Abbreviations and Acronyms

CKD

chronic kidney disease

eGFR

estimated glomerular filtration rate

hsCRP

high-sensitivity C-reactive protein

LDL-C

low-density lipoprotein cholesterol

NNT

number needed to treat

Cited by (0)

: The JUPITER trial was supported by Astra-Zeneca. The JUPITER trial was investigator-initiated; the study sponsor collected trial data and monitored sites but had no access to unblinded data until after drafting of the trial primary report, published in November 2008. During the period of this project, Dr. Ridker reports having received investigator-initiated research grant support from the National Heart Lung and Blood Institute, the National Cancer Institute, the Donald W. Reynolds Foundation, the Leducq Foundation, AstraZeneca, Novartis, Merck, Abbott, Roche, and Sanofi-Aventis; and consulting fees and/or lecture fees from Astra-Zeneca, Novartis, Merck, Merck-Schering Plough, Sanofi-Aventis, ISIS, Dade-Behring, and Vascular Biogenics; and he is listed as a co-inventor on patents held by the Brigham and Women's Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease. These patents have been licensed to several entities, including AstraZeneca. Dr. Cressman is an employee of AstraZeneca. Dr. Glynn reports receiving research grant support from the National Heart, Lung, and Blood Institute, AstraZeneca, and Bristol-Myers Squibb.