In part 2 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 new data on empagliflozin, the medications presented at the conference and the benefits of these treatments.
Thomas Seck, MD, is VP of Clinical Development and Medical Affairs at Boehringer Ingelheim.
Transcript of this video segment:
Steve: So what are you presenting here?
Dr. Seck: So in terms of what we follow up now, at this ADA meeting, is additional data on Empagliflozin. We have 20 abstracts on Empagliflozin only. We have 8 abstract on analysis of empiric outcomes. I think from my perspective really important data is we showed now that the effect of Empagliflozin compared to standard of care for cardiovascular death, for hospitalization of heart failure, for overall mortality independent of changes in blood pressure, in HbA1C and in blood lipids. We know that Empagliflozin has effects: it’s a glucose-lowering mediation, it lowers HbA1C. the question was, is that effect as well as blood pressure lowering effect that we know this compound has. Is that explaining most of of that reduction in cardiovascular death? And the analysis shows that this is independent of this effect. So it continues to be important to monitor and take care of HbA1C. It continues becomes important to manage your blood pressure and blood lipids. That is key in preventing cardiovascular disease. But you cannot mimic by doing the effect we saw in Empagliflozin in empiric outcome on cardiovascular death.
Steve: What are some of the other benefits that you are presenting?
Dr. Seck: We talked about hospitalization for heart failure. That was also major finding in empiric outcome. There was a 35% reduction in hospitalization for heart failure, which was highly statistically significant and another important aspect is the effect on renal complications. We defined an endpoint that was called worsening of nephropathy, which included increases in albuminuria, doubling of serum creatinine and end-stage renal disease such as dialysis or kidney transplantation. For all these endpoints, there was a clear reduction seen in Empagliflozin compared to placebo. We have an additional analysis here at ADA, that looked at what we call renal function slopes (eGFR slopes): we observed that in first dose, there is reduction in eGFR is what we saw in empiric outcome; small reduction is 2-3 mm/min, but then after the years to come, there is a stabilization of eGFR compared to placebo. That was causing lot of excitement for endocrinologists and also for nephrologists that this compound might have potential benefit on renal function over time.
Steve: And that’s not because of diuretic effect?
Dr. Seck: No, that is not due to diuretic effect. But if you have a diuretic, you clearly have no beneficial effect on renal function. And there is probably much more to Empagliflozin than just being a simple diuretic. It works in a very different way from mechanism perspective and has very different effect within the nephron of the kidney.
Steve: So what other products are you and Lilly presenting here at ADA?
Dr. Seck: We have 33 publications overall at ADA. 20 out of those are related to some extent to Empagliflozin. We have 11 abstracts related to linagliptin, which is a DPP4-inhibitor which does not need dose adjustment (Independent of renal function). And then we have additional abstract on basaglar- insulin glargine product. So that is also something we have as part of the alliance. We have new data here for that product showing comparability between that product and lantus in the element 5 study. For Linagliptin, we can share some of the highlights from those 11 publications as well. I think one important one to consider in the arena of cardiovascular outcome trials (this is dominating theme here at ADA again). We will publish and have a poster for the baseline characteristics for our linagliptin cardiovascular outcome trial. It is called CARMELINA. That is a trial that is really dedicated to assess the effects of linagliptin on cardiovascular outcomes as well as renal outcomes so that makes it a little different from other DPP4 cardiovascular outcome trials we have seen to date.