Cardiovascular Considerations in Antidiabetic Therapies

Louis S. Christos, RPh: Cardiovascular (CV) benefits is now becoming part of that P & T [Pharmacy and Therapeutics] committee discussion. So, when we’re doing a clinical evaluation of new diabetic therapies, we are including that CV benefit as an actual section in our profile. What we look for in a CV benefit, is, obviously, relative risk reduction. But when we look at it, we look at the composite of a MACE [major adverse cardiac events] endpoint and also want to know exactly where those reductions are. Is it mortality? Is it hospitalizations? Is it stroke?

We are looking at the specific endpoint, a composite, but we’re also looking at the individual component. Now, there’s been a couple products that have shown CV benefit. The question is whether or not those products, or that benefit, is specific to those products within that category or that MOA [mechanism of action], or is it a class effect? And that’s something, right now, where we’re sort of taking a wait-and-see approach. Is one SGLT2 [sodium-glucose co-transporter-2] going to have similar CV benefits as another? Is one GLP-1 [glucagon-like peptide-1] going to have similar CV benefits to another GLP-1? So, that’s part of the discussion now. Do we think it’s going to be an individualized benefit or do we think it’s going to be a class effect?

We appreciate that now we are getting CV benefit data from these products, after so many years, because we do know that diabetes results in cardiovascular complications. And we’ve always been taught that an A1C reduction of 1% always led to a 10% reduction in events. Now, we’re getting the data to actually support that. And this helps us, too, because we also get pharmacoeconomic models, from manufacturers in diabetes, that were previously based on assumptions. Now, these models can be based on actual clinical data and actual outcomes data to show a reduction in events that could potentially lead to reduction in cost (because of the lower rate of hospitalizations and lower healthcare resource utilization).

We don’t know that it’s going to be impact physicians, or we don’t know how much it’s impacted physicians, yet, in terms of therapeutic choice for their patients. As more data come out, then, yes, there’s a potential that this could be used earlier on. Because of the CV benefits, there’s more potential that it could be used for a larger portion of the population—more than just one that’s at risk. But I think it’s too early to tell, specifically because we haven’t really seen a shift in prescribing patterns. We haven’t seen an increase in market share for one particular product because of that CV data. Again, it’s a wait-and-see approach because the data are relatively new. We just don’t know how much of an impact this is going to have in a real-world setting.