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

Ridker, Paul M.; Fonseca, Francisco A.H.; Genest, Jacques; Gotto, Antonio M.; Kastelein, John J.P.; Khurmi, Nardev S.; Köenig, Wolfgang; Libby, Peter; Lorenzatti, Alberto; Nordestgaard, Børge G.; Shepherd, James; Willerson, James T.; Glynn, Robert J.

doi:10.1016/j.amjcard.2007.09.072

Cited by 114 publications

(75 citation statements)

References 32 publications

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“…The JUPITER trial randomized 17 802 individuals from 26 countries and had followed them for a median of 1.9 years when it was stopped early because of convincing evidence of benefit for the primary endpoint. Further details about the study design and results are presented elsewhere (10,16 ). This visit included a blood sample that required participants to have fasted for at least 8 h and to be sitting for at least 5 min.…”

Section: Populationmentioning

confidence: 99%

Tracking of High-Sensitivity C-Reactive Protein after an Initially Elevated Concentration: The JUPITER Study

2009

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Background: The JUPITER (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin) trial suggests that increased high-sensitivity C-reactive protein (hsCRP) concentrations may be useful in decisions about the initiation of statin therapy for primary prevention of vascular disease. Although studies of specific populations have suggested that hsCRP is a reliable longitudinal marker, it is unclear how strongly hsCRP tracks in individuals after a single increased concentration. Methods: We evaluated tracking of hsCRP in 8901 individuals randomized to placebo in the JUPITER trial. These individuals had screening LDL cholesterol concentrations <130 mg/dL (<3.37 mmol/L) and hsCRP concentrations ≥2 mg/L, with subsequent hsCRP measurements made before randomization; at 13 weeks; 1, 2, 3, and 4 years later; and at trial termination. Longitudinal trends and associations were evaluated nonparametrically with box plots and Spearman correlations. After data transformation to achieve normality, repeated-measures regression models estimated the intraclass correlation of hsCRP, with and without controlling for known demographic, lifestyle, and medical determinants of hsCRP concentration. For comparison, we evaluated tracking of systolic and diastolic blood pressure; total, LDL, and HDL cholesterol; and fasting triglycerides. Results: The median hsCRP concentration in these untreated individuals showed modest regression to the mean over time, declining from 3.8 mg/L at randomization to 3.4 mg/L at 4 years. Tracking correlations for hsCRP over time were comparable to those for blood pressure and LDL cholesterol, but lower than those for HDL, fasting triglycerides, and total cholesterol. The intraclass correlation for repeated hsCRP measurements was 0.54 (95% CI, 0.53–0.55) without covariate adjustment and 0.50 (95% CI, 0.49–0.51) after adjustment for demographic, lifestyle, and comorbidity determinants. Conclusions: Concentrations of hsCRP show strong tracking, even after selection of individuals with initially high values. Without statin therapy, increased concentrations of hsCRP generally remain high over time.

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Section: Populationmentioning

confidence: 99%

Tracking of High-Sensitivity C-Reactive Protein after an Initially Elevated Concentration: The JUPITER Study

2009

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“…An impressive relationship between myocardial infarction, stroke and thromboembolic events was observed with hsCRP, even in the absence of other traditional risk factors (7)(8)(9). Interestingly, in the JUPITER trial, over one third of the entire population consisted of patients with MetS (10). Previous studies have reported a different impact of metabolic syndrome according to gender (11-13) on the relative risk for cardiovascular disease, possibly related to differences in the components of the MetS and other concomitant risk factors.…”

mentioning

confidence: 99%

Highly sensitive C-reactive protein and male gender are independently related to the severity of coronary disease in patients with metabolic syndrome and an acute coronary event

Monteiro

Pinheiro

Izar

et al. 2010

Braz J Med Biol Res

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“…Unexpectedly, the independent data-monitoring board terminated the trial early in March 2008 (after approximately 2 years of follow-up) because rosuvastatin was more beneficial than expected in reducing incident CVD events compared with placebo and it was felt to be unethical to withhold rosuvastatin from the group assigned to placebo. Table 2 summarizes the differences between the patient population enrolled in the JUPITER trial and patient populations enrolled in previous statin trials conducted for primary prevention of CVD (25 ). In particular, the median concentration of LDL-C in JUPITER was 108 mg/dL (2.79 mmol/L), with a 25th-75th percentile of 94 -119 mg/dL (2.43-3.08 mmol/L), which was lower than in previous trials.…”

Section: Jupiter Trial Summarymentioning

confidence: 99%

“…1 in the online Data Supplement schematically depicts the basic JUPITER trial design. A total of 17 802 asymptomatic individuals (men Ն50 years and women Ն60 years) who had no history of coronary artery disease, stroke, or diabetes and who had initial-screening LDL-C and hsCRP concentrations of Ͻ130 mg/dL (Ͻ3.36 mmol/L) and Ն2.0 mg/L, respectively, were randomized in a double-blind fashion to receive either 20 mg/day rosuvastatin or placebo (25 ). The trial, a well-designed investigator-initiated trial funded by AstraZeneca, was expected to last approximately 4 years.…”

Section: Jupiter Trial Summarymentioning

confidence: 99%

The Clinical Utility of High-Sensitivity C-Reactive Protein in Cardiovascular Disease and the Potential Implication of JUPITER on Current Practice Guidelines

2009

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Background: High-sensitivity C-reactive protein (hsCRP) testing is relatively inexpensive and has been shown to predict the risk of cardiovascular disease (CVD) and diabetes in multiple patient groups, including those treated with statin therapy. JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) is a recently completed large multicenter randomized clinical trial that tested whether statin therapy should be given to apparently healthy individuals with lower LDL cholesterol (LDL-C) concentrations but increased hsCRP concentrations. Content: This review discusses the literature on hsCRP in asymptomatic populations, analyzes it according to CVD and diabetes, and provides summary recommendations for the use of hsCRP in clinical practice. In this context, we highlight recent data from the landmark JUPITER trial, which demonstrated that hsCRP can be used to target high-risk patients who have typical LDL-C concentrations and no known vascular disease or diabetes and who would benefit from statin use. We also summarize evidence that among patients treated with statin therapy, achieving low hsCRP concentrations may be a clinically relevant therapeutic goal along with achieving very low LDL-C concentrations. Summary: JUPITER has demonstrated that combining hsCRP testing with traditional testing of lipids can reduce incident CVD in high-risk asymptomatic individuals by 44% and all-cause mortality by approximately 20%, extending the therapeutic use of statins for the primary prevention of CVD. Guidelines for practitioners could include testing asymptomatic individuals for increased concentrations of hsCRP in men ≥50 years and women ≥60 years when LDL-C concentrations are not increased and for whom the decision to treat with statin therapy is not otherwise clear.

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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

Cited by 114 publications

References 32 publications

Tracking of High-Sensitivity C-Reactive Protein after an Initially Elevated Concentration: The JUPITER Study

Tracking of High-Sensitivity C-Reactive Protein after an Initially Elevated Concentration: The JUPITER Study

Highly sensitive C-reactive protein and male gender are independently related to the severity of coronary disease in patients with metabolic syndrome and an acute coronary event

The Clinical Utility of High-Sensitivity C-Reactive Protein in Cardiovascular Disease and the Potential Implication of JUPITER on Current Practice Guidelines

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