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Editor's Correspondence |

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

Ronan Roussel, MD, PhD; Deepak L. Bhatt, MD, MPH; Philippe Gabriel Steg, MD; Reduction of Atherothrombosis for Continued  Health (REACH) Registry Investigators
Arch Intern Med. 2011;171(11):1042-1043. doi:10.1001/archinternmed.2011.225.
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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.

We are aware of previous well-conducted observational studies by Eurich and others evaluating the safety of metformin in patients with HF patients, and we believe that the changes in product monographs of metformin, down-toning the contraindication of the drug in diabetic patients with stable HF are welcome. Our results extend the basis of these labeling changes, but they also provide indications that other contraindications, such as renal insufficiency, may not be as justified as previously believed. Moreover, the issue is not only to mitigate contraindications, but possibly to switch some of them to indications—a tempting prospect for subjects with HF and diabetes, for example, that cannot be achieved without the highest level of evidence.

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June 13, 2011
Ronan Roussel, MD, PhD; Deepak L. Bhatt, MD, MPH; Philippe Gabriel Steg, MD; Reduction of Atherothrombosis for Continued  Health (REACH) Registry Investigators
Arch Intern Med. 2011;171(11):1042-1043. doi:10.1001/archinternmed.2011.225.
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