endocrinologist Dr. Kevin Pantalone is making waves in the medical world with his recent findings concerning type 2 diabetes drugs and how they may actually increase the risk of mortality.
The study, titled “Increased Risk of Overall Mortality in Patients with Type 2 Diabetes Receiving Glipizide, Glyburide, and Glimepiride vs. Metformin. A Retrospective Analysis,” was published this past April, and according to Pantalone, his research applies to many of the 26 million Americans that are being treated for the disease.
“This study provides insight to a longstanding question regarding the potential risks of this commonly-used class of drugs, “said Dr. Zimmerman, Director of the Diabetes Center at Cleveland Clinic who co-authored the study. “Our findings will allow physicians to better assess which medications are right for treating diabetes patients.”
To find out more, Patch corresponded with Pantalone to ask some pressing questions, given the gravity of his findings.
Cuyahoga Falls Patch: What made you and your colleagues hone in on type 2 medications, in particular, to assess whether or not there were unknown risks?
Pantalone: The United States FDA (Food and Drug Administration) has made the approval process for type 2 diabetes medications much more difficult over the past few years. There has been a lot of concern regarding the cardiovascular safety of type 2 diabetes medications, and now, a drug’s cardiovascular safety must be demonstrated/studied prior to approval. Older drugs which have already been approved were not required to meet these new rigorous standards; thus, we decided to assess whether or not some unknown risks (mortality) existed among them.
Patch: Throughout your research, were there "smoking gun" findings that surfaced to help you and your colleagues conclude these widely prescribed drugs might raise mortality rates?
Pantalone: There has long been questions/concerns regarding the safety of sulfonylureas, but recent research (including our own) has suggested that some may be safer than others. Our previous research suggested that some sulfonylureas may be safer than others in those with coronary artery disesase. These findings led us to conduct the present study.
Patch: What causes of death could be connected to these medications?
Pantalone: The reason for the increased risk of mortality remains unclear. We were only able to assess overall mortality, we were not able to assess for the specific causes of death. This is a topic that requires further study.
Patch: If I'm being treated for type 2 diabetes, how important is it for me to work with my doctor and find out which medication is potentially the best one to take?
Pantalone: It is very important for patients to work with their doctors and discuss the risks vs. benefits of all medications, even those which have been around for a long time and are now available in generic formulations at a low cost.
Patch: Your findings are turning heads in the medical community on a global level. What sort of long-term ramifications might your research have on how type 2 diabetes drugs are studied, made and prescribed?
Pantalone: The long-term ramifications are unclear. The process regarding drug approval by the FDA has already become increasingly more strict over the past few years, and this will likely only continue. Assessing for drug safety prior to approval is clearly a good thing to do; however, one has to be cautious, as if the process/requirements for drug approval becomes too strict, this may limit the approval and availability of new medications which are clearly needed to treat patients with type 2 diabetes.
Our research suggests that older medications which have been approved long ago need to be continually assessed to identify any previously unknown concerns. Our results also suggest that it is important for doctors and patients to realize that all drugs have risks, even those which are generic/cheap. Patients need to talk to with their doctors about which drugs may be better/safer options, and this may vary considerably depending on their other health conditions.
Susana Arrigain, Dr. Ashish Atreja, Dr. Anil Jain, Dr. Michael W. Kattan, Dr. Brian J. Wells, Changhong Yu, all of the Cleveland Clinic, also contributed to the study. For additional information, refer to the attached PDF.