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September 19, 2012

Cardiovascular Risk Assessment in the Development of New Drugs for Obesity

Author Affiliations

Author Affiliations: University of Colorado School of Medicine, Division of Cardiology and CPC Clinical Research, Aurora (Dr Hiatt); Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts (Dr Goldfine); and Division of Cardiology, Cedars Sinai Medical Center, University of California, Los Angeles (Dr Kaul).

JAMA. 2012;308(11):1099-1100. doi:10.1001/jama.2012.9931

The US Food and Drug Administration (FDA), Center for Drug Evaluation and Research, convened a meeting of the Division of Metabolism and Endocrinology Products on March 28-29, 2012, to consider cardiovascular safety requirements for approval of new drugs to treat obesity. The broader context at that time involved 4 recent individual drug product reviews, resulting in no new antiobesity drugs approved and 1 drug (sibutramine) withdrawn from the market.1 For pharmacologic weight loss to be more than cosmetic, it is essential to demonstrate measurable health benefits. Because obesity is associated with excess cardiovascular risk and weight loss treatments could potentially mitigate that risk, it is important to assess the effect of these drugs on cardiovascular morbidity and mortality.

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