Trends and opportunities in the metabolic syndrome

Metabolic Syndrome consists of a multifactoral set of indications and, unfortunately, definitions. There is, at present, no consensus definition for Metabolic Syndrome and physicians who recognize the syndrome use different definitions. Some of the major stakeholder associations do not believe that Metabolic Syndrome is an approvable indication and no regulatory agency has weighed in on the matter. This has been the cause of confusion among many physicians resulting in different emphasis on intervention. However, there is close agreement between physicians surveyed in major markets as to the top three indications. The largest unmet medical need among these indications is obesity and obesity represents the largest opportunity. However, any single NCE or combination of existing drugs that can treat 3 indications will be a major advance. Any therapy will be an intervention and will have to have a very clean safety profile. Morbidity and mortality studies with existing therapies and combinations will be needed to establish outcomes. Drug Dev. Res. 67:539–544, 2006. © 2006 Wiley‐Liss, Inc.