JUPITER, 2008 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of rosuvastatin versus placebo in apparently healthy individuals with low LDL-cholesterol levels of less than 130 mg per deciliter but elevated C-reactive-protein (high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher)

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NCT00239681    N Engl J Med 2008 Nov 9;:  



Studied treatment rosuvastatin 20 mg daily
Control treatment placebo
Women (%) 38%
Total cholesterol (mmol/l) 185 mg/dl
LDL change, end of study (%) -50%



Patients apparently healthy individuals with low LDL-cholesterol levels of less than 130 mg per deciliter but elevated C-reactive-protein (high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher)
Group sizes8901 / 8901
Inclusion criteriamales aged 50 years and older and females aged 60 years and older with no history of MI, stroke, or arterial revascularisation; LDL cholesterol level of less than 130 mg per deciliter (3.4 mmol per liter); high-sensitivity C-reactive protein level of 2.0 mg per liter or more; triglyceride level of less than 500 mg per deciliter (5.6 mmol per liter)
Exclusion criteriaprevious or current use of lipid-lowering therapy, current use of postmenopausal hormone-replacement therapy, evidence of hepatic dysfunction (an alanine aminotransferase level that was more than twice the upper limit of the normal range), a creatine kinase level that was more than three times the upper limit of the normal range, a creatinine level that was higher than 2.0 mg per deciliter (176.8 ìmol per liter), diabetes, uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg), cancer within 5 years before enrollment (with the exception of basal-cell or squamous-cell carcinoma of the skin), uncontrolled hypothyroidism (a thyroid-stimulating hormone level that was more than 1.5 times the upper limit of the normal range), and a recent history of alcohol or drug abuse or another medical condition that might compromise safety or the successful completion of the study
prior MI or CHD (%)
LDL (mmol/l) 108 mg/dl
HDL (mmol/l) 49 mg/dl
Triglycerides (mg/dl) 118 mg/dl
Diabetes(%)
BMI (kg/m2) 28.3
Stroke history
LV hypertrophy
History of hypertension (%)



Blindness double blind Inclusion period feb 2003 - dec 2006
Follow-up duration median 1.9 year Centers 1200
Lost to FU geographical localisation 26 countries
Primary endpoint MI, stroke, arterial revascularization, hospitalization for unstable angina, cardiovascular death Design Parallel groups
PeriodeInclusionfeb 2003 - dec 2006
HypotheseSuperiority



EndpointX1N1X0N0TE95% CI coronary events 31 8901 68 8901 0,46[0,30; 0,70] all cause deaths 198 8901 247 8901 0,80[0,66; 0,97] cardiovascular death - 8901 - 8901 no data cardiovascular events 83 8901 157 8901 0,53[0,40; 0,69] venous thromboembolism 34 8901 60 8901 0,57[0,37; 0,86] fatal stroke 3 8901 6 8901 0,50[0,13; 2,00] Haemorrhagic strokes 6 8901 9 8901 0,67[0,24; 1,87] coronary deaths - 8901 - 8901 no data stroke (fatal et non fatal) 33 8901 64 8901 0,52[0,34; 0,79] CV events (including revascularization) 142 8901 251 8901 0,57[0,46; 0,70] MI non fatal 22 8901 62 8901 0,35[0,22; 0,58] Infarctus non mortel et décès coronariens - 8901 - 8901 no data cardiac death - 8901 - 8901 no data non cardiovascular death - 8901 - 8901 no data AST >3 x ULN - 8901 - 8901 no data ALT >3 x ULN - 8901 - 8901 no data CPK >10 x ULN - 8901 - 8901 no data Pancreatitis 17 8901 17 8901 1,00[0,51; 1,96] incident diabetes 270 8901 216 8901 1,26[1,05; 1,52] Rhabdomyolyses - 8901 - 8901 no data décès par cancer - 8901 - 8901 no data Cancers mortels et non mortels - 8901 - 8901 no data Myopathies - 8901 - 8901 no data adverse events - 8901 - 8901 no data0,22,01,0

Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Macfadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med 2008 Nov 9;:     [PMID: 18997196]   link to pdf   add to Mendeley  

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ClinicalTrial.gov record NCT00239681



Registering number NCT00239681 (see trial on clinicaltrials.gov)
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