Kausik Ray, MD, on the ODYSSEY Trial
MD Mag: How does the ODYSSEY DM-INSULIN trial differ from previous trials of PCSK9 inhibitors?
Kausik Ray, MD: Previously, we’ve not specifically focused on a group of patients just with diabetes, and we’ve not focused on people treated just with insulin. The real question is, if you’ve got 2 injectables, do people comply with the medication? Is there an interaction? Is it safe? That was really the rationale
We had about 500 patients, all on insulin, of whom about 100 are type 1 diabetics. The other ones are type 2 on insulin, so they’re actually going to be much more advanced in their disease course because insulin is one of the last steps in these people
What we aimed for in that patient population, much like the other ODYSSEY trials, is to look at percentage change in LDL cholesterol from baseline compared to standard of care, or usual care in this case, with a background therapy of statins.
So that's the main difference actually. They’re a challenging group that we’ve not studied previously a priori, and its important because were able to show actually that you’ve got the same LDL reductions as the other studies, and it was tolerated well with the same safety profile.