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Editor's Correspondence
June 13, 2011

Levels of Evidence Needed for Changing Indications, Contraindications, and Food and Drug Administration Labeling: The Case of Metformin—Reply

Author Affiliations

Author Affiliations: INSERM, Unité 695 (Dr Roussel) and Unité 698 (Dr Steg), Université Paris 7, Assistance Publique–Hôpitaux de Paris, Paris, France; and Department of Cardiology, Veterans Affairs Boston Healthcare System, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (Dr Bhatt).Group Information: A list of the REACH Registry Investigators was published in JAMA (2006;295[2]:188) and can be found at http://jama.ama-assn.org/content/295/2/180.full.

Arch Intern Med. 2011;171(11):1042-1043. doi:10.1001/archinternmed.2011.225

In reply

Eurich et al note that observational data from Reduction of Atherothrombosis for Continued Health (REACH) that we published in the Archives1 complement previous studies, and they fear that obtaining a higher level of proof regarding the safety and perhaps the benefits of metformin in very high-risk patients is not achievable.

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