Rosuvastatin: Winner in the statin wars, patients' health notwithstanding

BMJ (Online)

Volumn 350, Issue , 2015, Pages

  Wolfe, Sidney ^a  

^a Public Citizen Health Research Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; C REACTIVE PROTEIN; CREATINE KINASE; HEMOGLOBIN A1C; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; PLACEBO; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; FLUOROBENZENE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PYRIMIDINE DERIVATIVE; SULFONAMIDE;

ARTICLE; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CHOLESTEROL BLOOD LEVEL; CREATINE KINASE BLOOD LEVEL; DIABETES MELLITUS; DRUG COST; DRUG EFFICACY; DRUG LABELING; DRUG POTENCY; DRUG RESEARCH; DRUG SAFETY; ENZYME ACTIVITY; EVIDENCE BASED MEDICINE; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; GLOMERULUS FILTRATION RATE; HEART INFARCTION; HEMATURIA; HUMAN; HYPERCHOLESTEROLEMIA; INSULIN BLOOD LEVEL; INSULIN SENSITIVITY; PRIMARY PREVENTION; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; PROTEINURIA; RHABDOMYOLYSIS; RISK REDUCTION; ADVERTIZING; CHEMICALLY INDUCED; DRUG APPROVAL; KIDNEY DISEASE; RISK ASSESSMENT; UNITED STATES;

ADVERTISING AS TOPIC; DRUG APPROVAL; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; KIDNEY DISEASES; PYRIMIDINES; RHABDOMYOLYSIS; RISK ASSESSMENT; SULFONAMIDES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84926202021     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h1388     Document Type: Article

References (24)

1. IMS Health. 1October 2013 to 30 September 2014. IMS Health, 2014.
2. IMS Health. Top global products 2013. www.imshealth.com/deployedfiles/imshealth/ Global/Content/Corporate/Press%20Room/Global-2013/Top-20-Global-Products-2013. pdf.
3. Center for Drug Evaluation and Research. Crestor: clinical review. www.accessdata.fda. gov/drugsatfda-docs/nda/2010/021366s016MedR.pdf.
4. 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.
5. Morrissey RP, Diamond GA, Kaul S. The JUPITER trial: myth or reality? Curr Atheroscler Rep 2011;13:413-21.
6. 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;303:1180-7.
7. Freeman DJ, Norrie J, Sattar N, et al. Pravastatin and the development of diabetes. Evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation 2001;103:357-62.
8. FDA Advisory Committee, December 15, 2009 concerning JUPITER study. Comment by Ridker on reason for inclusion of diabetes as a prespecified outcome. www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM200611.pdf.
9. Navarese EP, Buffon A, Andreotti F, et al. Meta-analysis of impact of different types and doses of statins on new-onset diabetes mellitus. Am J Cardiol 2013;111:1123-30.
10. Zaharan NL, Williams D, Bennett K. Statins and risk of treated incident diabetes in a primary care population. Br J Clin Pharmacol 2013;75:1118-24.
11. Koh KK, Quon MJ, Sakuma I, et al. Differential metabolic effects of rosuvastatin and pravastatin in hypercholesterolemic patients. Int J Cardiol 2013;166:509-15.
12. Brault M, Ray J, Gomez Y, Mantzoros CS, Daskalopoulou SS. Statin treatment and new-onset diabetes: a review of proposed mechanisms. Metabolism 2014;63:735-45.
13. Food and Drug Administration. Drug labels. www.accessdata.fda.gov/scripts/cder/ drugsatfda/.
14. Public Citizen. FDA testimony opposing approval of Crestor. www.citizen.org/Page.aspx? pid=3287.
15. Public Citizen's Health Research Group. Petition to ban cholesterol-lowering drug rosuvastatin (Crestor). www.citizen.org/Page.aspx?pid=3212.
16. Van Staa TP, Carr DF, O'Meara H, McCann G, Pirmohamed M. Predictors and outcomes of increases in creatine phosphokinase concentrations or rhabdomyolysis risk during statin treatment. Br J Clin Pharmacol 2014;78:649-59.
17. FDA Center for Drug Evaluation and Research. Endocrinologic and metabolic drugs advisory committee meeting, July 9, 2003. Briefing information: Crestor: indicated for the treatment of hypercholesterolemia and mixed dyslipidemia. www.fda.gov/ohrms/dockets/ ac/03/briefing/3968B1-02-A-FDA-Clinical%20Review.pdf.
18. FDA. Petition denial. www.regulations.gov/#!documentDetail;D=FDA-2004-P-0009-0004.
19. De Zeeuw D, Anzalone DA, Cain VA, et al. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol 2015 Feb 4 [Epub ahead of print.]
20. The statin wars: why AstraZeneca must retreat. Lancet 2003;362:1341.
21. McKillop T. Letter to the editor: the statin wars.Lancet 2003;362:1498.
22. FDA. Letter to Mark R Szewczak, Astra Zeneca. www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm054657.pdf.
23. Kaufman M. Campaign waged against Crestor. Washington Post 2004 Nov 17. www. washingtonpost.com/wp-dyn/articles/A58493-2004Nov17.html.
24. FDA. Letter to Mark R Szewczak, Astra Zeneca. www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055672.pdf.