JUPITER trial

JUPITER study, 2008	TRC6751
[NCT00239681]	download pdf: rosuvastatin \| cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	rosuvastatin 20 mg daily
Control treatment	placebo

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)

Inclusion criteria

males 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 criteria

previous 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 �mol 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

Baseline characteristics

Women (%)	38%
Total cholesterol (mmol/l)	185 mg/dl
LDL (mmol/l)	108 mg/dl
HDL (mmol/l)	49 mg/dl
Triglycerides (mg/dl)	118 mg/dl
BMI (kg/m2)	28.3

Method and design

Randomized effectives	8901 / 8901 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	median 1.9 year
Premature discontinuation	Premature discontinuation for efficacy
Number of centre	1200
Geographic area	26 countries
Hypothesis	Superiority
Primary endpoint	MI, stroke, arterial revascularization, hospitalization for unstable angina, cardiovascular death

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
Primary end point	142 / 8901 (1,6%)	251 / 8901 (2,8%)	0,57	[0,46;0,69]
Nonfatal myocardial infarction	22 / 8901 (0,2%)	62 / 8901 (0,7%)	0,35	[0,22;0,58]
Any myocardial infarction	31 / 8901 (0,3%)	68 / 8901 (0,8%)	0,46	[0,30;0,70]
Nonfatal stroke	30 / 8901 (0,3%)	58 / 8901 (0,7%)	0,52	[0,33;0,80]
Any stroke	33 / 8901 (0,4%)	64 / 8901 (0,7%)	0,52	[0,34;0,78]
Arterial revascularization	71 / 8901 (0,8%)	131 / 8901 (1,5%)	0,54	[0,41;0,72]
Hospitalization for unstable angina	16 / 8901 (0,2%)	27 / 8901 (0,3%)	0,59	[0,32;1,10]
Arterial revascularization or hospitalization for unstable angina	76 / 8901 (0,9%)	143 / 8901 (1,6%)	0,53	[0,40;0,70]
Myocardial infarction, stroke, or confirmed death from cardiovascular causes	83 / 8901 (0,9%)	157 / 8901 (1,8%)	0,53	[0,41;0,69]
Death on known date	190 / 8901 (2,1%)	235 / 8901 (2,6%)	0,81	[0,67;0,98]
Any death	198 / 8901 (2,2%)	247 / 8901 (2,8%)	0,80	[0,67;0,96]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Coronary event

31 / 8901
68 / 8901
0,46 [0,30;0,70]

All cause death

198 / 8901
247 / 8901
0,80 [0,67;0,96]

cardiovascular events

83 / 8901
157 / 8901
0,53 [0,41;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]

Haemmorhagic stroke

6 / 8901
9 / 8901
0,67 [0,24;1,87]

new-onset diabetes

270 / 8901
216 / 8901
1,25 [1,05;1,49]

stroke (fatal and non fatal)

33 / 8901
64 / 8901
0,52 [0,34;0,78]

Non fatal MI

22 / 8901
62 / 8901
0,35 [0,22;0,58] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
Coronary event	31 / 8901 (0,3%)	68 / 8901 (0,8%)	0,46	[0,30;0,70]	Any myocardial infarction
All cause death	198 / 8901 (2,2%)	247 / 8901 (2,8%)	0,80	[0,67;0,96]	Any death
cardiovascular events	83 / 8901 (0,9%)	157 / 8901 (1,8%)	0,53	[0,41;0,69]	Myocardial infarction, stroke, or confirmed death from cardiovascular causes
Venous thromboembolism	34 / 8901 (0,4%)	60 / 8901 (0,7%)	0,57	[0,37;0,86]		12562
Fatal stroke	3 / 8901 (0,0%)	6 / 8901 (0,1%)	0,50	[0,13;2,00]
Haemmorhagic stroke	6 / 8901 (0,1%)	9 / 8901 (0,1%)	0,67	[0,24;1,87]
new-onset diabetes	270 / 8901 (3,0%)	216 / 8901 (2,4%)	1,25	[1,05;1,49]		12095
stroke (fatal and non fatal)	33 / 8901 (0,4%)	64 / 8901 (0,7%)	0,52	[0,34;0,78]	Any stroke
Non fatal MI	22 / 8901 (0,2%)	62 / 8901 (0,7%)	0,35	[0,22;0,58]	Nonfatal myocardial infarction
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0: 12095: Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, TognonStatins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials.Lancet 2010 Feb 27;375:735-742 12562: Squizzato A, Galli M, Romualdi E, Dentali F, Kamphuisen PW, Guasti L, Venco A, Ageno WStatins, fibrates, and venous thromboembolism: a meta-analysis.Eur Heart J 2010 May;31:1248-56

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of median 1.9 year)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Coronary event	3,48‰	7,64‰	-0,42%
All cause death	2,22%	2,77%	-0,55%
cardiovascular events	9,32‰	1,76%	-0,83%
Venous thromboembolism	3,82‰	6,74‰	-0,29%
Fatal stroke	0,34‰	0,67‰	-0,03%
Haemmorhagic stroke	0,67‰	1,01‰	-0,03%
new-onset diabetes	3,03%	2,43%	0,61%
stroke (fatal and non fatal)	3,71‰	7,19‰	-0,35%
Non fatal MI	2,47‰	6,97‰	-0,45%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for primary prevention

cholesterol lowering intervention in cardiovascular prevention for high risk patients with or without LDL cholesterol elevation

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

Reference(s)

TrialResults-center ID	TRC6751
Trials register #	NCT00239681
Study web site link	,