Javed Butler, MD
So my overall impression was that this trial like other ratio t 2 inhibitor trials again proved that there is substantial benefit in terms of reduction of heartfully hospitalization risk as you know there was a split a primary endpoint of this trial the maze endpoint did not reach statistical significance but the combined endpoint of cardiovascular death and
Heart failure hospitalization did reach the end point which was positive i think it’s adding in several ways so one issue obviously is that it further reinforces the issue of safety in this trial at least we did not see any differences in the risk of amputation so that was answered that was a big question that was in people’s mind the second question that was in
People’s mind was that this trial had the largest cohort of patients with risk factors but without doctors for the cardiovascular disease of all the ischial t’s whenever the truck so the question was was there any benefit in the primary prevention versus the secondary prevention of the cohort and then the third is just a overall body of literature regarding seo
Situ inhibitors and management of diabetes so for these reasons this is sort of the you know fulfills the picture and that’s another part that you can put in in the vast amount of literature we have so the limitations of the trial are that again so this is a randomized controlled trial that included patients either with cardiovascular risk factors or with adverse
Car to cardiovascular disease but a big proportion of patients with diabetes out there shorter duration of diabetes actually have no cardiac arrest factors and they were not included in any of the clinical trials per se so that is sort of one thing that we have to be careful about but other than that all of these trials what we’re learning from sglt2 inhibitors is
That the primary endpoint of maze which was primarily defined on the basis of the fda guidance the benefit is restricted to those would address chronic cardiovascular disease at baseline and there’s a modest benefit but there’s a bigger benefit for heart failure hospitalization and read benefit that we are seeing in these straws that goes across both the primary
Prevention and the secondary prevention cohort which really makes you think whether the definition for primary prevention and secondary prevention the way we define it for address chronic disease is really applicable for heart failure or chronic kidney disease i mean the biggest take-home message for the clinician is sort of stay tuned we have now three drugs that
Is showing significant impact of this therapy in reduction in heart failure risk which is one of the commonest complications of patients with diabetes so as things work through the regulatory agencies and the guidelines i would not be surprised that in the future irrespective of the benefit on mace just for heart failure prevention we probably will be using a lot
More of these agents in patients with diabetes at higher risk
Transcribed from video
DECLARE: The Dapagliflozin Effect on Cardiovascular Events – Medpage Today By MedPage Today
