ADA chief scientific and medical officer Robert Ratner argued during the discussion of the results that the analysis failed to control for the very critical factor of insulin adherence.
"I am personally convinced, on the basis of zero data, and I have to emphasize that this is my speculation, that these people who are having sudden death are probably not taking their medication on a regular basis," Dr. Ratner said in an interview. "The protocol drives them to higher doses, so whenever they do take their medication, they have a higher risk of problems."
Session comoderator Marjorie Cypress, Ph.D., ADA health care and education president-elect and an adult nurse practitioner with Albuquerque Health Partners, agreed with Dr. Ratner’s concern.
"I’m a clinician, and if you start seeing [HbA1c numbers] going higher and higher, you do need to question adherence," she said. "I always question adherence with insulin."
As for whether mining the ACCORD data will ever reveal the cause of the excess deaths, Dr. Cypress said, "You keep doing post hoc analysis, and I guess at some point, there may be some tie-in."
Not so says Dr. Ratner.
"We’re never going to know," he said. "We can’t know because you can’t correlate hypoglycemia unless you have CGM [continuous glucose monitoring] for the entire length of study and you trust that it’s accurate."
In a later interview, Dr. Siraj said that the ACCORD study group will look into the adherence data and see whether it affects the association between insulin dose and CV mortality. And, the ACCORD leadership will decide the appropriateness of public release of the entire data set and its timing.
ACCORD was supported by grants from the National Heart, Lung, and Blood Institute. Dr. Siraj reported honoraria for speaking and/or consulting for Boehringer Ingelheim, Sanofi, and Merck and for serving as an advisory board member for Corcept.