JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

Summary

The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

Timeline

Start

2003-02

Primary completion

2008-09

Completion

2008-09

Outcome

Met primary endpoint

Stopped: “See detailed description for reason.”

registry Rosuvastatin vs Placebo; p <0.0001; Hazard Ratio (HR) 0.56 (95% CI 0.46 to 0.69); Regression, Cox NCT00239681 ↗

Publications

• Hoshi RA, Alotaibi M, Liu Y, Watrous JD, Ridker PM, Glynn RJ, Serhan CN, Luttmann-Gibson H, Moorthy MV, Jain M, Demler OV, Mora S. One-Year Effects of High-Intensity Statin on Bioactive Lipids: Findings From the JUPITER Trial. Arterioscler Thromb Vasc Biol. 2024 Jul;44(7):e196-e206. doi: 10.1161/ATVBAHA.124.321058. Epub 2024 Jun 6.
• Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
• Ajala ON, Demler OV, Liu Y, Farukhi Z, Adelman SJ, Collins HL, Ridker PM, Rader DJ, Glynn RJ, Mora S. Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality: A Secondary Analysis of the JUPITER Randomized Clinical Trial. J Am Heart Assoc. 2020 Sep;9(17):e016507. doi: 10.1161/JAHA.119.016507. Epub 2020 Aug 15.
• Akinkuolie AO, Lawler PR, Chu AY, Caulfield M, Mu J, Ding B, Nyberg F, Glynn RJ, Ridker PM, Hurt-Camejo E, Chasman DI, Mora S. Group IIA Secretory Phospholipase A2, Vascular Inflammation, and Incident Cardiovascular Disease. Arterioscler Thromb Vasc Biol. 2019 Jun;39(6):1182-1190. doi: 10.1161/ATVBAHA.118.311894.
• Dagenais GR, Jung H, Lonn E, Bogaty PM, Dehghan M, Held C, Avezum A, Jansky P, Keltai M, Leiter LA, Lopez-Jaramillo P, Toff WD, Bosch J, Yusuf S. Effects of Lipid-Lowering and Antihypertensive Treatments in Addition to Healthy Lifestyles in Primary Prevention: An Analysis of the HOPE-3 Trial. J Am Heart Assoc. 2018 Jul 22;7(15):e008918. doi: 10.1161/JAHA.118.008918.
• Khera AV, Demler OV, Adelman SJ, Collins HL, Glynn RJ, Ridker PM, Rader DJ, Mora S. Cholesterol Efflux Capacity, High-Density Lipoprotein Particle Number, and Incident Cardiovascular Events: An Analysis From the JUPITER Trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin). Circulation. 2017 Jun 20;135(25):2494-2504. doi: 10.1161/CIRCULATIONAHA.116.025678. Epub 2017 Apr 27.
• Akinkuolie AO, Glynn RJ, Padmanabhan L, Ridker PM, Mora S. Circulating N-Linked Glycoprotein Side-Chain Biomarker, Rosuvastatin Therapy, and Incident Cardiovascular Disease: An Analysis From the JUPITER Trial. J Am Heart Assoc. 2016 Jul 13;5(7):e003822. doi: 10.1161/JAHA.116.003822.
• Dugani SB, Akinkuolie AO, Paynter N, Glynn RJ, Ridker PM, Mora S. Association of Lipoproteins, Insulin Resistance, and Rosuvastatin With Incident Type 2 Diabetes Mellitus : Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 May 1;1(2):136-45. doi: 10.1001/jamacardio.2016.0096.
• Lawler PR, Akinkuolie AO, Chandler PD, Moorthy MV, Vandenburgh MJ, Schaumberg DA, Lee IM, Glynn RJ, Ridker PM, Buring JE, Mora S. Circulating N-Linked Glycoprotein Acetyls and Longitudinal Mortality Risk. Circ Res. 2016 Apr 1;118(7):1106-15. doi: 10.1161/CIRCRESAHA.115.308078. Epub 2016 Mar 7.
• Mora S, Caulfield MP, Wohlgemuth J, Chen Z, Superko HR, Rowland CM, Glynn RJ, Ridker PM, Krauss RM. Atherogenic Lipoprotein Subfractions Determined by Ion Mobility and First Cardiovascular Events After Random Allocation to High-Intensity Statin or Placebo: The Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial. Circulation. 2015 Dec 8;132(23):2220-9. doi: 10.1161/CIRCULATIONAHA.115.016857. Epub 2015 Sep 25.
• Chu AY, Giulianini F, Barratt BJ, Ding B, Nyberg F, Mora S, Ridker PM, Chasman DI. Differential Genetic Effects on Statin-Induced Changes Across Low-Density Lipoprotein-Related Measures. Circ Cardiovasc Genet. 2015 Oct;8(5):688-95. doi: 10.1161/CIRCGENETICS.114.000962. Epub 2015 Aug 13.
• Everett BM, Zeller T, Glynn RJ, Ridker PM, Blankenberg S. High-sensitivity cardiac troponin I and B-type natriuretic Peptide as predictors of vascular events in primary prevention: impact of statin therapy. Circulation. 2015 May 26;131(21):1851-60. doi: 10.1161/CIRCULATIONAHA.114.014522. Epub 2015 Mar 30.
• Everett BM, Mora S, Glynn RJ, MacFadyen J, Ridker PM. Safety profile of subjects treated to very low low-density lipoprotein cholesterol levels (<30 mg/dl) with rosuvastatin 20 mg daily (from JUPITER). Am J Cardiol. 2014 Dec 1;114(11):1682-9. doi: 10.1016/j.amjcard.2014.08.041. Epub 2014 Sep 16.
• Pena JM, Aspberg S, MacFadyen J, Glynn RJ, Solomon DH, Ridker PM. Statin therapy and risk of fracture: results from the JUPITER randomized clinical trial. JAMA Intern Med. 2015 Feb;175(2):171-7. doi: 10.1001/jamainternmed.2014.6388.
• Khera AV, Everett BM, Caulfield MP, Hantash FM, Wohlgemuth J, Ridker PM, Mora S. Lipoprotein(a) concentrations, rosuvastatin therapy, and residual vascular risk: an analysis from the JUPITER Trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). Circulation. 2014 Feb 11;129(6):635-42. doi: 10.1161/CIRCULATIONAHA.113.004406. Epub 2013 Nov 17.
• Mora S, Glynn RJ, Ridker PM. High-density lipoprotein cholesterol, size, particle number, and residual vascular risk after potent statin therapy. Circulation. 2013 Sep 10;128(11):1189-97. doi: 10.1161/CIRCULATIONAHA.113.002671. Epub 2013 Sep 3.
• Ridker PM, Pradhan A, MacFadyen JG, Libby P, Glynn RJ. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet. 2012 Aug 11;380(9841):565-71. doi: 10.1016/S0140-6736(12)61190-8.
• Mora S, Glynn RJ, Boekholdt SM, Nordestgaard BG, Kastelein JJ, Ridker PM. On-treatment non-high-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and lipid ratios in relation to residual vascular risk after treatment with potent statin therapy: JUPITER (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin). J Am Coll Cardiol. 2012 Apr 24;59(17):1521-8. doi: 10.1016/j.jacc.2011.12.035.
• Stein EA, Vidt DG, Shepherd J, Cain VA, Anzalone D, Cressman MD. Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a retrospective analysis of renal adverse events among 40,600 participants in the rosuvastatin clinical development program. Atherosclerosis. 2012 Apr;221(2):471-7. doi: 10.1016/j.atherosclerosis.2011.12.011. Epub 2012 Jan 3.
• Dorresteijn JA, Visseren FL, Ridker PM, Wassink AM, Paynter NP, Steyerberg EW, van der Graaf Y, Cook NR. Estimating treatment effects for individual patients based on the results of randomised clinical trials. BMJ. 2011 Oct 3;343:d5888. doi: 10.1136/bmj.d5888.
• Albert MA, Glynn RJ, Fonseca FA, Lorenzatti AJ, Ferdinand KC, MacFadyen JG, Ridker PM. Race, ethnicity, and the efficacy of rosuvastatin in primary prevention: the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial. Am Heart J. 2011 Jul;162(1):106-14.e2. doi: 10.1016/j.ahj.2011.03.032. Epub 2011 Jun 12.
• Ridker PM, MacFadyen JG, Glynn RJ, Chasman DI. Kinesin-like protein 6 (KIF6) polymorphism and the efficacy of rosuvastatin in primary prevention. Circ Cardiovasc Genet. 2011 Jun;4(3):312-7. doi: 10.1161/CIRCGENETICS.110.959353. Epub 2011 Apr 14.
• Koenig W, Ridker PM. Rosuvastatin for primary prevention in patients with European systematic coronary risk evaluation risk >/= 5% or Framingham risk >20%: post hoc analyses of the JUPITER trial requested by European health authorities. Eur Heart J. 2011 Jan;32(1):75-83. doi: 10.1093/eurheartj/ehq370. Epub 2010 Oct 22.
• Ridker PM, Macfadyen JG, Nordestgaard BG, Koenig W, Kastelein JJ, Genest J, Glynn RJ. Rosuvastatin for primary prevention among individuals with elevated high-sensitivity c-reactive protein and 5% to 10% and 10% to 20% 10-year risk. Implications of the Justification for Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial for "intermediate risk". Circ Cardiovasc Qual Outcomes. 2010 Sep;3(5):447-52. doi: 10.1161/CIRCOUTCOMES.110.938118. Epub 2010 Aug 24.
• Ridker PM, Genest J, Boekholdt SM, Libby P, Gotto AM, Nordestgaard BG, Mora S, MacFadyen JG, Glynn RJ, Kastelein JJ; JUPITER Trial Study Group. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial. Lancet. 2010 Jul 31;376(9738):333-9. doi: 10.1016/S0140-6736(10)60713-1. Epub 2010 Jul 23.
• Ridker PM, MacFadyen J, Cressman M, Glynn RJ. 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. J Am Coll Cardiol. 2010 Mar 23;55(12):1266-1273. doi: 10.1016/j.jacc.2010.01.020. Epub 2010 Mar 4.
• Mora S, Glynn RJ, Hsia J, MacFadyen JG, Genest J, Ridker PM. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation. 2010 Mar 9;121(9):1069-77. doi: 10.1161/CIRCULATIONAHA.109.906479. Epub 2010 Feb 22.
• Ridker PM, MacFadyen JG, Fonseca FA, Genest J, Gotto AM, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Number needed to treat with rosuvastatin to prevent first cardiovascular events and death among men and women with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin (JUPITER). Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):616-23. doi: 10.1161/CIRCOUTCOMES.109.848473. Epub 2009 Sep 22.
• Everett BM, Glynn RJ, MacFadyen JG, Ridker PM. Rosuvastatin in the prevention of stroke among men and women with elevated levels of C-reactive protein: justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER). Circulation. 2010 Jan 5;121(1):143-50. doi: 10.1161/CIRCULATIONAHA.109.874834. Epub 2009 Dec 21.
• Glynn RJ, 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, Ridker PM. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N Engl J Med. 2009 Apr 30;360(18):1851-61. doi: 10.1056/NEJMoa0900241. Epub 2009 Mar 29.
• 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; JUPITER Trial Study Group. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet. 2009 Apr 4;373(9670):1175-82. doi: 10.1016/S0140-6736(09)60447-5. Epub 2009 Mar 28.
• 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; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207. doi: 10.1056/NEJMoa0807646. Epub 2008 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rosuvastatin	Small molecule	20 mg	Oral

Indications