Rosiglitazone and the FDA [12]

New England Journal of Medicine

Volumn 357, Issue 17, 2007, Pages 1775-1777

  Joffe, Hylton V ^a   Parks, Mary H ^a   Meyer, Robert J ^a   Jenkins, John K ^a   Temple, Robert ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN; ROSIGLITAZONE; 2,4 THIAZOLIDINEDIONE DERIVATIVE;

CARDIOVASCULAR DISEASE; CARDIOVASCULAR SYMPTOM; CLINICAL TRIAL; DRUG APPROVAL; DRUG MECHANISM; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; LETTER; LONG TERM CARE; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RISK ASSESSMENT; TREATMENT OUTCOME; ADVISORY COMMITTEE; CHEMICALLY INDUCED DISORDER; NOTE; UNITED STATES;

ADVISORY COMMITTEES; CARDIOVASCULAR DISEASES; DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; THIAZOLIDINEDIONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 35548936523     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc076347     Document Type: Letter

References (4)

1. Rosen CJ. The rosiglitazone story - lessons from an FDA advisory committee meeting. N Engl J Med 2007;357:844-6.
2. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
3. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53. [Erratum, Lancet 1999;354:602.]
4. Idem. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854-65. [Erratum, Lancet 1998;352:1558.]