The rosiglitazone story - Lessons from an FDA advisory committee meeting

New England Journal of Medicine

Volumn 357, Issue 9, 2007, Pages 844-846

  Rosen, Clifford J ^a,b  

^a ST JOSEPH HOSPITAL   (United States)

^b JACKSON LABORATORY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; METFORMIN; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SULFONYLUREA;

ATHEROSCLEROSIS; CARDIOVASCULAR RISK; CLINICAL TRIAL; CONFERENCE PAPER; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; HEART FAILURE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; META ANALYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STROKE; SYSTEMATIC REVIEW; UNSTABLE ANGINA PECTORIS;

EID: 34548303246     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp078167     Document Type: Conference Paper

References (5)

1. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356:2457-71. [Erratum, N Engl J Med 2007;357:100.]
2. Richter B, Bandeira-Echtler E, Bergerhoff K, Clar C, Ebrahim S. Rosiglitazone for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007;3:CD006063.
3. Gerrits CM, Bhattacharya M, Manthena S, Baran R, Perez A, Kupfer S. A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetics. Pharmacoepidemiol Drug Saf (DOI: 10.1002/pds.1470) (http://www3.interscience.wiley.com/cgi-bin/abstract/ 114300391/ABSTRACT).
4. Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355:2427-43. [Erratum, N Engl J Med 2007;356:1387-8.]
5. Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes - an interim analysis. N Engl J Med 2007;357:28-38.