Tough questions about the value of statin therapy for primary prevention: Did jupiter miss the moon?

Journal of Managed Care Pharmacy

Volumn 16, Issue 6, 2010, Pages 417-423

  Curtiss, Frederic R ^a   Fairman, Kathleen A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN;

CANCER RISK; CARDIOVASCULAR DISEASE; CATARACT; CLINICAL PRACTICE; CLINICAL TRIAL; CONFIDENCE INTERVAL; DIABETES MELLITUS; DRUG COST; ECONOMIC ASPECT; EDITORIAL; HEART INFARCTION; HUMAN; KIDNEY FAILURE; LIVER DYSFUNCTION; META ANALYSIS; MORTALITY; MYALGIA; MYOPATHY; SIDE EFFECT; STROKE; SYSTEMATIC REVIEW; TREATMENT OUTCOME; METHODOLOGY; PRIMARY PREVENTION; RANDOMIZED CONTROLLED TRIAL; STANDARD;

CARDIOVASCULAR DISEASES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; PRIMARY PREVENTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 77957255539     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2010.16.6.417     Document Type: Editorial

References (36)

1. Park A. Who should take statins? The debate continues. Time. June 29, 2010. Available at: http://www.time.com/time/health/article/0,8599,2000324,00. html. Accessed July 6, 2010.
2. Hughes S. JUPITER gets a battering, but Ridker fights back. The heart. org. June 28, 2010. Available at: http://www.theheart.org/article/1092925/print. do. Accessed July 6, 2010.
3. Crownover BK, Curtiss FR. Forecasting cholesterol management - end of the statin gold rush? J Manag Care Pharm. 2006;12(6):479-85. Available at: http://www.amcp.org/data/jmcp/editorial-479-485.pdf.
4. Curtiss FR. Methods to attain optimal outcomes with lipid-lowering drug therapy. J Manag Care Pharm. 2004;10(3):267-70. Available at: http://www.amcp.org/data/jmcp/EditorialSubjects-266-2709.pdf.
5. Pletcher MJ, Lazar L, Bibbins-Domingo K, et al. Comparing impact and cost-effectiveness of primary prevention strategies for lipid-lowering. Ann Intern Med. 2009;150(4):243-54. Available at: http://www.annals.org/content/150/ 4/243.full.pdf+html. Accessed July 6, 2010.
6. Price for generic simvastatin, 20 mg strength. Available at: http://www.drugstore.com/pharmacy/drugindex/rxsearch.asp?search=simvastatin. Accessed July 6, 2010.
7. RegenceRx. Rx Price Guide. Available at: http://www.regencerx.com/learn/ rxPriceGuide/index.html. Accessed July 3, 2010.
8. Ray KK, Seshasai SRK, Erqou S, et al. Statins and all-cause mortality in high-risk primary prevention. Arch Intern Med. 2010;170(12):1024-31.
9. Brugts JJ, Yetgin T, Hoeks SE, et al. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials. BMJ. 2009;338:b2376. Online 2 July 2009: Available at: http://www.bmj.com/cgi/reprint/338/jun30-1/b2376. Accessed July 3, 2010.
10. Hippisley-Cox J, Coupland C. Unintended effects of statins in men and women in England and Wales: population based cohort study using QResearch database. BMJ. 2010;340:c2197. Online May 20, 2010. Available at: http://www.bmj.com/cgi/content/full/340/may19-4/c2197. Accessed July 3, 2010.
11. Joy TR, Hegele RA. Narrative review: statin-related myopathy. Ann Intern Med. 2009;150(12):858-68. Available at: http://www.annals.org/content/150/12/ 858.full.pdf+html. Accessed July 2, 2010.
12. Cham S, Evans MA, Denenberg JO, Golomb BA. Statin-associated muscle-related adverse effects: a case series of 354 patients. Pharmacotherapy. 2010;30(6):541-53.
13. Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomized statin trials. Lancet. 2010;375(9716):735-42. Epub 2010 Feb 16.
14. Ridker PM, Danielson E, Fonseca FAH, et al.; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated c-reactive protein. N Engl J Med. 2008;359(21):2195-207. Published online ahead of print on Nov 9, 2008. Available at: http://content.nejm.org/cgi/reprint/ NEJMoa0807646v1.pdf. Accessed July 3, 2010.
15. Ridker PM; JUPITER Study Group. Rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity c-reactive protein: rationale and design of the JUPITER trial. Circulation. 2003;108(19):292-97.
16. Ridker PM. The JUPITER trial: Results, controversies, and implications for prevention. Circ Cardiovasc Qual Outcomes. 2009;2(3):279-85. Available at: http://circoutcomes.ahajournals.org/cgi/reprint/2/3/279. Accessed July 7, 2010.
17. Donner-Banzhoff N, Sönnichsen A. Statins and primary prevention of cardiovascular events - no change in strategy is needed despite the hype surrounding the recent JUPITER study. BMJ. 2008;337:1182-84. Online ahead of print 2008 Feb 9: a2576. Available at: http://www.bmj.com/cgi/section-pdf/337/ nov14-2/a2576.pdf. Accessed July 13, 2010.
18. Supplementary appendix to: Ridker PM, Danielson E, Fonseca FAH, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195-207. Available at: http://content.nejm.org/cgi/data/NEJMoa0807646/DC1/1. Accessed July 6, 2010.
19. Kjekshus J, Apetrei E, Barrios V, et al.; CORONA Group. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007;357(22):2248- 61. Available at: http://content.nejm.org/cgi/reprint/357/22/2248.pdf. Accessed July 7, 2010.
20. Kaul S, Morrissey RP, Diamond GA. By Jove! What is a clinician to make of JUPITER? Arch Intern Med. 2010;170(12):1073-77.
21. de Lorgeril M, Salen P, Abramson J, et al. Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy. A critical reappraisal. Arch Intern Med. 2010;170(12):1032-36.
22. JUPITER - Crestor 20 mg versus placebo in prevention of cardiovascular (CV) events. ClinicalTrials.gov. February 3, 2009. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00239681?term=JUPITER&rank=1. Accessed July 7, 2010.
23. O'Riordan M. JUPITER halted: rosuvastatin significantly reduces cardiovascular morbidity and mortality. Theheart.org. March 31, 2008. Available at: http://www.theheart.org/article/852735.do. Accessed July 7, 2010.
24. Helfand M, Buckley DI, Freeman M, et al. Emerging risk factors for coronary heart disease: a summary of systematic reviews conducted for the US Preventive Services Task Force. Ann Intern Med. 2009; 151(7):496-507. Available at: http://www.annals.org/content/151/7/496.full.pdf+html. Accessed July 7, 2010.
25. U.S. Department of Health and Human Services, United States Food and Drug Administration, Center for Drug Evaluation and Research. Transcript of meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. December 15, 2009. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM200611.pdf. Accessed July 7, 2010.
26. Bassler D, Briel M, Montori VM, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 2010;303(12):1180-87.
27. AstraZeneca. Annual report and form 20-F information 2009. Available at: http://www.astrazeneca-annualreports.com/2009/downloads/index.html. Accessed July 4, 2010.
28. Saha SA, Kizhakepunnur LG, Bahekar A, Arora RR. The role of fibrates in the prevention of cardiovascular disease - a pooled meta-analysis of long-term randomized placebo-controlled clinical trials. Am Heart J. 2007;154(5):943-53. (Pubitemid 350001283)
29. Peck P. FDA panel backs statin for primary prevention. Medpage today. December 15, 2009. Available at: http://www.medpagetoday.com/Cardiology/ Atherosclerosis/17569. Accessed July 3, 2010.
30. U.S. Food and Drug Administration. Supplemental approval, NDA 21366/S-016. February 8, 2010. Available at: http://www.accessdata.fda.gov/ drugsatfda-docs/appletter/2010/021366s016ltr.pdf. Accessed July 3, 2010.
31. Crestor (rosuvastatin calcium) prescribing information. June 2010. Available at: http://www1.astrazeneca-us.com/pi/crestor.pdf. Accessed July 3, 2010.
32. Woloshin S, Schwartz LM, Kerin K, Welch HG. Estimating the impact of adding c-reactive protein as a criterion for lipid lowering treatment in the United States. J Gen Intern Med. 2007;22(2):197-204. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1824732/pdf/11606-2006- Article-33.pdf. Accessed July 4, 2010.
33. Shah BM, Kemp R, Clearfield M. Using statins to treat 'healthy' patients: are we there yet? Expert Rev Pharmacoecon Outcomes Res. 2009;9(2):103-05. Available at: http://www.expert-reviews.com/doi/pdfplus/10.1586/erp.09.5. Accessed July 4, 2010.
34. ARUP's Laboratory Test Directory. C-reactive protein, high sensitivity. Available at: http://www.aruplab.com/guides/ug/tests/0050182.jsp. Accessed July 4, 2010.
35. Blue Cross Blue Shield of Tennessee. Treatment options - high sensitivity c-reactive protein testing for cardiovascular disease. August 11, 2009. Available at: http://www.bcbst.com/learn/treatment-options/crp.shtm. Accessed July 4, 2010.
36. Hlatky MA. Expanding the orbit of primary prevention - moving beyond JUPITER. N Engl J Med. 2008;359(21):2280-82.