Premature release of data from clinical trials of ezetimibe

New England Journal of Medicine

Volumn 361, Issue 7, 2009, Pages 712-

  Califf, Robert M ^a   Harrington, Robert A ^b   Blazing, Michael A ^b  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; EZETIMIBE; HIGH DENSITY LIPOPROTEIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN; PLACEBO; SIMVASTATIN; AZETIDINE DERIVATIVE; HYPOCHOLESTEROLEMIC AGENT; LOW DENSITY LIPOPROTEIN CHOLESTEROL;

ACUTE CORONARY SYNDROME; AORTA VALVE STENOSIS; ARTICLE; CANCER RISK; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DISEASE COURSE; DRUG EFFECT; DRUG EFFICACY; DRUG MARKETING; DRUG MONITORING; DRUG POTENTIATION; DRUG SAFETY; FOLLOW UP; HEART INFARCTION; HUMAN; INCIDENCE; PRIORITY JOURNAL; RISK ASSESSMENT; STROKE; TREATMENT OUTCOME; BLOOD; CARDIOVASCULAR DISEASE; CHEMICALLY INDUCED DISORDER; DATA BASE; DRUG APPROVAL; DRUG COMBINATION; DRUG SURVEILLANCE PROGRAM; ECONOMICS; HYPERCHOLESTEROLEMIA; NEOPLASM; RANDOMIZED CONTROLLED TRIAL; REGISTER; STANDARD; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTICHOLESTEREMIC AGENTS; AZETIDINES; CARDIOVASCULAR DISEASES; CHOLESTEROL, LDL; DATABASES AS TOPIC; DRUG APPROVAL; DRUG THERAPY, COMBINATION; HUMANS; HYPERCHOLESTEROLEMIA; INCIDENCE; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; SIMVASTATIN; UNITED STATES;

EID: 68849108178     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMsr0900910     Document Type: Article

References (16)

1. Rossebø AB, Pedersen TR, Boman K, et al. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med 2008;359:1343-56.
2. Fleming TR. Identifying and addressing safety signals in clinical trials. N Engl J Med 2008;359:1400-2.
3. Peto R, Emberson J, Landray M, et al. Analyses of cancer data from three ezetimibe trials. N Engl J Med 2008;359:1357-66.
4. Meng CQ. Ezetimibe (Schering-Plough). Curr Opin Investig Drugs 2001;2:389-92.
5. Clader JW. The discovery of ezetimibe: a view from outside the receptor. J Med Chem 2004;47:1-9.
6. Sager PT, Melani L, Lipka L, et al. Effect of coadministration of ezetimibe and simvastatin on high-sensitivity C-reactive protein. Am J Cardiol 2003;92:1414-8.
7. Casas JP, Shah T, Hingorani AD, Danesh J, Pepys MB. C-reactive protein and coronary heart disease: a critical review. J Intern Med 2008;264:295-314.
8. Ridker PM, Danielson E, Fonseca FA, et al. 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;373:1175-82.
9. Division of Metabolic and Endocrine Drug Products, Food and Drug Administration. Guidelines for the clinical evaluation of lipid-altering agents in adults and children. Center for Drug Evaluation and Research, September 1990. (Accessed July 23, 2009, at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM071586.pdf.)
10. Rossebø AB, Pedersen TR, Allen C, et al. Design and baseline characteristics of the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. Am J Cardiol 2007;99:970-3.
11. Baigent C, Landry M. Study of Heart and Renal Protection (SHARP). Kidney Int Suppl 2003;84:S207-S210.
12. ClinicalTrials.gov registry Web site. IMPROVE-IT: examining outcomes in subjects with acute coronary syndrome: Vytorin (ezetimibe/simvastatin) vs simvastatin (Study P04103). ClinicalTrials.gov identifier: NCT00202878. (Accessed July 23, 2009, at http://www.clinicaltrials.gov/ct2/show/NCT00202878? term=IMPROVE-IT&rank=1.)
13. DeMets DL, Fleming TR, Rockhold F, et al. Liability issues for data monitoring committee members. Clin Trials 2004;1:525-31.
14. Public Law 110-85. FDA Amendments Act of 2007 (FDAAA). (Accessed July 23, 2009, at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110-cong- public-laws&docid=f:publ085.110.pdf.)
15. Wood AJ. Progress and deficiencies in the registration of clinical trials. N Engl J Med 2009;360:824-30.
16. Taylor AJ, Nissen SE. Preliminary observations from preliminary trial results: have we finally had enough? Circ Cardiovasc Qual Outcomes 2008;1:54-7.