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Jupiter study

Study characteristics: - industry-sponsored study - 18,000 subjects - men >= 50 years - women >= 60 years - without known cardiovascular disease - LDL cholesterol < 130 mg/dL - serum CRP >= 2 mg/L Exclusion criteria (extensive) - diabetes - uncontrolled hypertension - cholesterol-lowering medications Treatment: - rosuvastatin 20 mg QD vs placebo Primary endpoint: - 1st major cardiovascular event - myocardial infarction, unstable angina, stroke, arterial revascularization, death from cardiovascular cause Results: - median follow-up = 1.9 years - study stopped early because of markedly positive results in favor of rosuvastatin - rosuvatation lowered LDL cholesterol by a mean of 50% - rosuvatation lowered serum CRP by a mean of 37% - primary endpoint less frequent in rosuvastatin group; hazzard ratio 0.56 - mortality lower in rosuvastatin group; hazzard ratio 0.8 - for every 1000 patients who received rosuvastatin for 1 year, 6 fewer major cardiovascular events & 3 fewer deaths - incidence of diabetes significantly higher in rosuvastatin group - median hemoglobin A1c higher in rosuvastatin group - subgroup of elderly > 70 years of age (< 25% > 77) a) lower rate of occurrence of major cardiovascular events in rosuvastatin group 1.22 vs 1.99 per 100 person years) b) lower all cause mortality in rosuvastatin group (1.64 vs 2.04 per 100 person years) not statistically significant c) serious adverse effects, muscular symptoms, new diabetes, GI, renal and hepatic complications more common in rosuvastatin group, but not significantly d) benefit of rosuvastatin absent in participants without hypertension Notes: - major discrepancy between significant reduction in nonfatal stroke & myocardial infarction, but no effect on mortality [5] - cardiovascular mortality was low (5-18%) compared with total mortality (expected ~ 40%) [5] - absolute size effect small (per editorialist) - incidence of diabetes worrisome (per editorialist) - industry-sponsored study stopped early is suspect - financial incentives appear to be substantial - results do not support the use of statins for primary prevention of cardiovascular disease [5]

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rosuvastatin (Crestor)

General

statin clinical trials

References

  1. Ridker PM et al Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008, 359:2195 PMID: 18997196
  2. Hlatky MA Expanding the orbit of primary prevention - Moving beyond Jupiter N Engl J Med 2008, 359:2280 PMID: 18997195
  3. Spatz ES et al From here to JUPITER: Identifying new patients for statin therapy using data from the 1999-2004 National Health and Nutrition Examination Survey. Circ Cardiovasc Qual Outcomes 2009 Jan; 2:41. PMID: 20031811 - Despres JP. Bringing JUPITER down to earth. Lancet. 2009 Apr 4;373(9670):1147-8. Epub 2009 Mar 28. Review. PMID: 19329179 - Kritek P, Campion EW. JUPITER clinical directions--polling results. N Engl J Med. 2009 Mar 5;360(10):e14. No abstract available. PMID: 19264683 - Nissen SE. The Jupiter trial: key findings, controversies, and implications. Curr Cardiol Rep. 2009 Mar;11(2):81-2. No abstract available. PMID: 19236822 - Fuster V, Bansilal JUPITER strikes earth. Nat Clin Pract Cardiovasc Med. 2009 Mar;6(3):159. PMID: 19234496
  4. Glynn RJ et al. Rosuvastatin for primary prevention in older persons with elevated C-reactive protein and low to average low-density lipoprotein cholesterol levels: Exploratory analysis of a randomized trial. Ann Intern Med 2010 Apr 20; 152:488. PMID: 20404379 - Zieman SJ and Ouyang P. Statins for primary prevention in older adults: Who is at high risk, who is old, and what denotes primary prevention? Ann Intern Med 2010 Apr 20; 152:528. PMID: 20404384
  5. de Logeril M et al Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy Arch Intern Med. 2010;170(12):1032-1036 PMID: 20585068 http://archinte.ama-assn.org/cgi/content/short/170/12/1032