BLINDNESS;
CARDIOVASCULAR RISK;
CLINICAL PRACTICE;
CLINICAL TRIAL;
DIABETES MELLITUS;
DRUG APPROVAL;
DRUG EFFECT;
DRUG EFFICACY;
DRUG RESEARCH;
DRUG SAFETY;
EDITORIAL;
FOOD AND DRUG ADMINISTRATION;
HEART INFARCTION;
HUMAN;
HYPERGLYCEMIA;
KIDNEY FAILURE;
MORTALITY;
NON INSULIN DEPENDENT DIABETES MELLITUS;
PRIORITY JOURNAL;
RISK BENEFIT ANALYSIS;
RISK REDUCTION;
SIDE EFFECT;
CARDIOVASCULAR DISEASES;
DIABETES MELLITUS, TYPE 2;
DRUG APPROVAL;
HUMANS;
HYPOGLYCEMIC AGENTS;
SAFETY-BASED DRUG WITHDRAWALS;
THIAZOLIDINEDIONES;
Food and Drug Administration. Briefing information for the July 13-14, 2010 joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. p556. www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs /EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm218491.htm.
Pooled analysis of rofecoxib placebo-controlled clinical trial data: Lessons for postmarket pharmaceutical safety surveillance
Abstract/FREE Full text
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance. Arch Intern Med 2009;169:1976-85. [Abstract/FREE Full text]
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)
UK Prospective Diabetes Study (UKPDS) Group. [CrossRef] [Medline] [Web of Science]
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. [CrossRef] [Medline] [Web of Science]
Effects of intensive glucose lowering in type 2 diabetes
Action to Control Cardiovascular Risk in Diabetes Study Group. [CrossRef] [Medline]
Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-59. [CrossRef] [Medline]
Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes
ADVANCE Collaborative Group. [CrossRef] [Medline]
ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560-72. [CrossRef] [Medline]
Glucose control and vascular complications in veterans with type 2 diabetes
[CrossRef] [Medline] [Web of Science]
Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven P, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med 2008;360:129-39. [CrossRef] [Medline] [Web of Science]
Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: An analysis of the ACCORD randomised trial
[CrossRef] [Medline] [Web of Science]
Ismail-Beigi F, Craven T, Banerji MA, Basile J, Calles J, Cohen RM, et al. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet 2010;376:419-30. [CrossRef] [Medline] [Web of Science]
Institute of Medicine of the National Academies. Evaluation of markers and surrogate endpoints in chronic disease. Consensus report, 2010. www.iom.edu/Reports /2010/Evaluation-of-Biomarkers-and-Surrogate-Endpoints-in- Chronic-Disease.aspx.
US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research DHHS
US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry. Diabetes mellitus - evaluating cardiovascular risk in antidiabetic therapies to treat type 2 diabetes. DHHS, 2009.