Marvin A. Konstam, MD, Chief Physician Executive, The CardioVascular Center, sat on a recent FDA advisory panel took up the findings of the EMPA-REG trial, examining the long-term cardiovascular effects of the newer diabetes drug, empagliflozin, a drug that reduces blood sugar by increasing removal in the urine. The trial showed a reduction in adverse cardiovascular outcomes in a population of patients at increased risk, and, in particular, suggested an unexpected substantial reduction in cardiovascular deaths. The panel debated whether the latter finding was real or could have been a “play of chance.” It came forward with a 50-50 split vote on the subject. The FDA will now need to determine whether or not to expand the drug’s indication to include this finding.
If the FDA accepts the finding as real and approves the new indication, then the drug becomes a “game-changer,” representing the first drug ever approved for treating type-2 diabetes offering the expectation of longer life expectancy. We need to await the final FDA decision, but this event could well represent the ushering in of a new era in treatment for diabetes.