Diabetes Treatment and Cardiovascular Safety

This is the third of a series of articles based on presentations at the American Diabetes Association (ADA) 70th Scientific Sessions, held 25–29 June 2010 in Orlando, Florida, pertaining to the need for large-scale cardiovascular (CV) safety requirements for the treatment of diabetes. The term “contrarian” is defined in various ways as “a person who takes an opposing view,” as “one who rejects the majority opinion” (1), or as “an investor who goes against current market trends” (2). What might be characterized as a “contrarian” debate on diabetes discussed the new requirement for large-scale CV safety studies on all new glucose-lowering medications. There was also a discussion of an increasingly recognized issue, potential inaccuracies of capillary glucose test meters, and of point-of-care A1C testing technologies. At the symposium, Steven Nissen (Cleveland Clinic, Cleveland, OH) addressed the question of whether diabetes drugs should have a higher bar for CV safety than other drugs. He began with an acknowledgment of relationships with multiple pharmaceutical companies, although stating that all income from such went to “charity.” He then complained about the “ridiculous title for a debate,” to suggest that the outcome (presumably his) would be a foregone conclusion. He stated that “all drugs must be required to show a health outcomes benefit,” and that “diabetes drugs are being held to a standard that is neither greater nor less than other fields.” He acknowledged microvascular benefits of reduction in glycemia but stated that “some of the drugs that lower blood sugar actually increase the risk of macrovascular complications” and suggested this to override microvascular disease, as “CVD is the cause of death in most diabetic patients.” Furthermore, he questioned the use of biomarkers as “surrogate for real outcomes data” and termed the blood glucose concentration as simply a “biomarker.” “Blood glucose measurements,” he suggested, …