In part 3 of this Exclusive Interview, Dr. Thomas Seck talks with Diabetes in Control Publisher Steve Freed during the ADA 2017 Scientific Sessions in San Diego, CA about Empagliflozin precautions, patient responses to the latest medications and side effects.
Thomas Seck, MD, is VP of Clinical Development and Medical Affairs at Boehringer Ingelheim.
Transcript of this video segment:
Steve: The new drugs, the SGLT2 and the heart study, I think you really have to go back if you want to know your success….who do you have to thank for your success? I think you have to go to someone that I am sure you know, Dr Nissan.
Dr. Seck: Yes
Steve: What he tried to do in attempt caused the FDA to say that any new diabetes drugs has to do cardiovascular outcome studies because there is a cost to that and most companies would not do that because no body really knew. So I think we have to go back even though his issues with Avandia were incorrect that we know now but because of him your company has been very successful with this new drug and it’s kind of a breakthrough. I was talking to a physician just half hour ago and I said where is it as far as first line of therapy, second like of therapy…and it already has moved up to the second line of therapy, which is mind boggling when we have so many other alternatives. But its like anything else what good is it and I want to ask you about studies showing amputation possible. That information has just recently come out especially for the toes. I personally think that there is ways to prevent that if the patient is educated. What kind of response or what have you seen there?
Dr. Seck: So let me clarify, the information that came out that was announced by the FDA as a safety communication was for canagliflozin (invokana) but it did see imbalance in the CANVAS program that will result in a black box warning. So that’s related to that one end product. We looked as triggered by these findings, obviously outside of our data, we have a large data of empiric outcomes with high burden of peripheral artery disease and we could not identify imbalance in our data. That has also recently been published in Advances in Therapy available online and you can find these data and there is no difference between placebo and Empagliflozin.
Steve: What about other side effects of Empagliflozin?
Dr. Seck: Well, If you look at our prescribing information, there is a number of warning and precautions that can only be in detail under warning and precaution section. Clearly if you use Empagliflozin in combination with insulin, sulfonylurea it can be associated with hypoglycemia. We have hypovolemia is also a potential side effect. There is also something about diabetes ketoacidosis. You probably have heard about this topic over last couple of years. and I think these are the key warnings and precaution that we have as part of the labeling. I really encourage everybody to go back to labeling to get more information about safety information to make sure we have appropriate patients on Jardiance.