Levels of evidence needed for changing indications, contraindications, and food and drug administration labeling: the case of metformin

Archives of Internal Medicine

Volumn 171, Issue 11, 2011, Pages 1042-1043

  Eurich, Dean T ^a   Majumdar, Sumit R ^a   McAlister, Finlay A ^a   Tsuyuki, Ross T ^a   Johnson, Jeffrey A ^a  

^a UNIVERSITY OF ALBERTA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

METFORMIN; PLACEBO;

ARTICLE; DRUG EFFICACY; DRUG LABELING; DRUG SAFETY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; FOOD PACKAGING; GLYCEMIC CONTROL; HEART FAILURE; HUMAN; LACTIC ACIDOSIS; MORTALITY; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT CONTRAINDICATION; TREATMENT INDICATION; DIABETES MELLITUS; HIGH RISK PATIENT; LETTER; MORBIDITY;

CANADA; CEREBROVASCULAR DISORDERS; CORONARY ARTERY DISEASE; DIABETES MELLITUS, TYPE 2; DRUG LABELING; HEART FAILURE; HUMANS; HYPOGLYCEMIC AGENTS; METFORMIN; PERIPHERAL ARTERIAL DISEASE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SECONDARY PREVENTION; UNITED STATES;

EID: 79959289763     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/archinternmed.2011.224     Document Type: Article

References (12)

1. Roussel R, Travert F, Pasquet B, et al; Reduction of Atherothrombosis for Continued Health (REACH) Registry Investigators. Metformin use and mortality among patients with diabetes and atherothrombosis. Arch Intern Med. 2010;170(21):1892-1899.
2. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352(9131):854-865.
3. Johnson JA, Majumdar SR, Simpson SH, Toth EL. Decreased mortality associated with the use of metformin compared with sulfonylurea mono-therapy in type 2 diabetes. Diabetes Care. 2002;25(12):2244-2248.
4. Misbin RI. The phantom of lactic acidosis due to metformin in patients with diabetes. Diabetes Care. 2004;27(7):1791-1793.
5. Eurich DT, Majumdar SR, McAlister FA, Tsuyuki RT, Johnson JA. Improved clinical outcomes associated with metformin in patients with diabetes and heart failure. Diabetes Care. 2005;28:2345-2351.
6. Masoudi FA, Inzucchi SE, Wang Y, Havranek EP, Foody JM, Krumholz HM. Thiazolidinediones, metformin, and outcomes in older patients with diabetes and heart failure: an observational study. Circulation. 2005;111(5): 583-590.
7. Inzucchi SE, Masoudi FA, Wang YF, et al. Insulin-sensitizing antihypergly-cemic drugs and mortality after acute myocardial infarction: insights from the National Heart Care Project. Diabetes Care. 2005;28(7):1680-1689.
8. Shah DD, Fonarow GC, Horwich TB. Metformin therapy and outcomes in patients with advanced systolic heart failure and diabetes. J Card Fail. 2010; 16(3):200-206.
9. Evans JM, Doney AS, AlZadjali MA, et al. Effect of metformin on mortality in patients with heart failure and type 2 diabetes mellitus. Am J Cardiol. 2010; 106(7):1006-1010.
10. MacDonald MR, Eurich DT, Majumdar SR, et al. Treatment of type 2 diabetes and outcomes in patients with heart failure: a nested case-control study from the UK General Practice Research Database. Diabetes Care. 2010; 33(6):1213-1218.
11. Aguilar D, Chan W, Bozkurt B, Ramasubbu K, Deswal A. Metformin use and mortality in ambulatory patients with diabetes and heart failure [published online October 15, 2010]. Circ Heart Fail. doi:10.1161/CIRCHEARTFAILURE.110.952556.
12. Eurich DT, Tsuyuki RT, Majumdar SR, et al. Metformin treatment in diabetes and heart failure: when academic equipoise meets clinical reality. Trials. February 9, 2009;10:12.