Louis S. Christos, RPh: We appreciate, now, that we’re getting head-to-head data (within this space) because, traditionally, it’s always been placebo-controlled data. So, just having comparative data is a step forward in diabetes. Having comparative data to show products that have comparable A1C reduction, but a potential better adverse event profile, is a benefit because, hopefully, you address some of those issues associated with the use of insulin. Now, the question is, who is the right patient for these ultra–long acting products versus your standard basal insulins? And I think, obviously, that goes back to the individualization from the provider perspective. But having, again, the data to show that we are potentially reducing hypoglycemic events with these ultra–long acting products is now providing a benefit, potentially, and addressing some of those concerns with insulin.
In the SWITCH 2 trial, when you look at the reduction in hypoglycemic events, the relative reduction is pretty significant in terms of the percentages. What we’ve done at the P&T [Pharmacy and Therapeutics] committee, though, is, when you look at the absolute reduction, these reductions are shown over the course of patient years. And things that are brought up in a P&T consider how significant of an absolute reduction it is (when you’re looking at absolute numbers and the reductions are only a matter of a couple of events over the course of a year), which is something that we’re still taking into consideration. So, again, even though the data are significant, we’re trying to translate (into a potential), what the real world experience would be and what the significance of these actual reductions are. Now, they are reductions and they’ve showed it in their comparative trial, so they are significant. But for us, that (to the provider) is a benefit because now they have an option. Potentially, if patients are on current therapies and they are having hypoglycemic events, they do have an option to switch now to a product that would potentially lower those risks.
In the DEVOTE trial, again, we saw a comparison versus glargine. What was shown was, again, comparable A1C, but we also saw comparable cardiovascular safety. We did, again, see a reduction in hypoglycemic events, which is where we think the ultra–long acting products are sort of trending toward—as the clinical value for those products is actually the hypoglycemic events reduction.