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Was the mortality disparity between the high-intensity and standard treatment arms in ACCORD an authentic finding?
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Protocol may have been too strictly followed
I am really hoping that [the correlation between lowering HbA1c levels and an increased risk of death] is not true. My emotions tell me that the phenomenon was just an artifact — one of those things that happened that really isn’t true — but I fear that it probably is [genuine].
One thing I wonder is whether the people [administering treatment] in the ACCORD study were treating HbA1c levels more than they were treating patients. Were they taking into consideration a patient’s background when they were making alterations of drugs? When a protocol is [strictly followed], you’re more likely to see adverse events.
A lot of times, someone other than an experienced diabetologist or endocrinologist is administering treatment in a clinical trial setting. These differences in personnel could potentially affect outcomes. It may be a matter of following protocol rather than treating individual patients.
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In the case of the ACCORD trial, the Data and Safety Monitoring Board did what they had to do. It would be negligent not to. They had to stop the study because of the mortality differences. Whether this [result] is real or not, we will find out.
David S. H. Bell, MD, FACE, FACP, is a Professor of Medicine at the University of Alabama School of Medicine, Birmingham, and is an Endocrine Today Editorial Board Member.
Media coverage caused hype
All of the hype surrounding the outcome differences between the ACCORD and ADVANCE trials is really being blown out of proportion. That kind of a study [ACCORD] has no causation, just associations.
This is an issue of trying to over-interpret statistical associations. This whole incident is an illustration of why it makes sense to try and interpret trials cautiously. Fuel is added to the fire when the lay press picks up on this kind of a study. Once past that, you just learn to take all the news with a good healthy dose of skepticism.
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We need more time and more data. We need an investigation that looks mechanistically at what rosiglitazone does and how it might increase the risk of cardiovascular events. Another option would be to have a trial designed from the outset to look at cardiovascular events that follows a usable population for an extended period of time to draw real conclusions.
Robert D. Blank, MD, PhD, is a Professor in the Department of Medicine, Section of Endocrinology, Diabetes and Metabolism at the University of Wisconsin, Madison, and is an Endocrine Today Editorial Board Member.