Prof. Marx (Aachen, Germany)

These data from the CARMELINA® trial, in this population with an advanced stage of T2D, showed CV safety for linagliptin compared to placebo, despite the fact that this was a population at very high CV risk, given [their] CKD.

If you look at the single endpoints here, they are all on the line of unity, no significant difference.

In addition, this is in line with other DPP4 inhibitors, like saxagliptin, alogliptin or sitagliptin, which also showed CV safety with respect to the primary outcome, which was the MACE outcome.

But if you look at the safety profile, at particular subgroups of patients, so – the elderly, patients with higher HbA_1c , patients with impaired kidney function – so, consistent safety profile in this trial.

In addition, you may remember that saxagliptin in SAVOR-TIMI 53 trial showed an increase in HHF compared to placebo, raising the question whether DPP4 inhibitors may, as a class, have a problem here. But our data from the CARMELINA® trial clearly showed that linagliptin does not increase the risk for HHF, as you can see here.

Even in the high-risk population of those with eGFR <60, for example, or albuminuria: no signal of an increase in HHF by linagliptin.

We looked at kidney endpoints, secondary endpoints, and as you can see there’s no safety signal and we could show a reduction in albuminuria progression here in patients treated with linagliptin compared to placebo.

Again, looking at the different patient populations, very consistent data here across the broad spectrum of subgroups.