Antonio Ceriello gives his opinion on how the results of the outcome trials will effect current treatment paradigms.
FILMED AT THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES (EASD) ANNUAL MEETING, SEPTEMBER 2016
WHAT MECHANISMS MIGHT EXPLAIN THE RAPID EFFECT ON MORTALITY SEEN IN THE EMPA-REG TRIAL?
00:14 - Okay, this was an astonishing result. You know that the people were applauding finally. We got a positive result in a trial after some boring, flat results. It’s good news, of course, for finally, we have something positive. But equally, it’s impressive the effect in the short-term and particularly in the protective effect on heart failure which starts quite quickly. The mechanism must be clarified because, otherwise, it will be difficult to understand how this compound, or maybe these compounds, the class, could be so efficacious in preventing heart failure and cardiac death because, again, the only effect was shown on cardiac deaths, not on myocardial infarction, not on stroke. So this is good news, this is very interesting news, but in my opinion, and it’s not only my opinion, you know, that all the regulatory boards are discussing widely discussing these results. We need more clarification about the mechanism.
HOW WILL THE RESULTS OF THESE OUTCOME TRIALS AFFECT CURRENT TREATMENT PARADIGMS?
01:43 - It’s very complicated. So, on one side, you are more helped in personalising the treatment. You have now evidence that some drugs are more beneficial than others on cardiovascular outcomes. But on the other hand, it’s also true that one drug is not good for all, for everybody. Let’s say a practical example. Clearly, you can use empagliflozin in people at high risk of cardiovascular disease. But the drug has several contraindications meaning that, okay, if you have a renal failure… or not renal failure, renal function is not normal, you cannot use, at least as on the label. Meaning that it’s good that we have some more chance to protect other patients also against cardiovascular disease and while decreasing glycaemia. This is very good, but you need to personalise, you need to understand which is the right drug for the specific person in front of you.