Hello. I’m Ileana Piña from Thomas Jefferson University in Philadelphia. I’m the quality chief. This is my blog today from the European Society of Cardiology (ESC) Congress in Barcelona. It’s been an incredibly exciting meeting. Everyone is so happy to be together again in person, and you can really feel the energy in the rooms.
Hello i’m eliana pina from thomas jefferson university in philadelphia as the quality chief and this is my blog today from the esc in barcelona it’s been an incredibly exciting meeting everyone is so happy to be together again in person and you can really feel the energy in the rooms and given to that energy has been the awaited presentation of deliver the uh
Dapagliflozin preserved function study that’s been building and building and excitement and i’ve got scott solomon here who is the pi of the trial welcome scott solomon from the brigham uh and the pi and he’s been working very hard it’s been hard to reach him even in his office so give us like the the overall view of the trial from your standpoint yeah so i’m
Very excited first of all to have a chance to talk to you about this ileana and deliver as you know is the most the the largest and most inclusive trial in heart failure with mildly reduced and preserved ejection fractions both both we enrolled patients with an ejection fraction of 40 percent or uh above 40 percent uh and we also included patients who had heart
Failure with improved ejection fraction which is a group that had never been studied really before uh and these are people who had ef’s that had been below 40 but had risen to above which is a substantial number of patients we reverse we reverse in the clinic probably 35 of the patients we reverse them it’s true since we’ve gotten so much better with evidence-based
Therapies yep and then we say what do we do next you know so you’re going to tell me what to do next so tell me about the results so deliver overall showed an 18 reduction in the primary endpoint of cardiovascular death or worsening heart failure worsening heart failure consisting of heart failure hospitalization or an urgent heart failure visit but what was
Really remarkable about deliver was that we saw that benefit consistently across the spectrum of ejection fractions so the patients with an lvef over 60 percent had the same benefit as below and that was important because we had seen this attenuation in benefit with other studies other trials your other trial paragon paragon we saw it in top cat we saw it in
Charm and there was a hint of it a hint of it in emperor preserve presented at this meeting a year ago now i think we think based on the deliver results that that was probably play of chance in emperor preserved uh and that there is consistency across the spectrum in addition we saw benefit in every single one of our pre-specified subgroups including patients
Who were recently hospitalized or in hospital another group that had been excluded from emperor preserved in some of the earlier trials is that what you call the worsening heart failure group that is a group that this is sort of the sub-acute population those patients who are either hospitalized or within 30 days of hospitalization in the improved group we also
Saw a benefit that was similar to patients who had consistently greater than 40 percent ejection so do you have repeated echocardiography in that improved group we have no echocardiography in uh deliver patients who are enrolled based on uh clinical parameters we didn’t actually obtain echocardiograms but you didn’t see any worsening or going back into you know
Whatever it was that they were oh we didn’t measure these things so we don’t we don’t necessarily know but the outcomes in those patients were really remarkably good so the message to the clinicians that are watching us what do you want to tell them well i think that we now have a therapy that i think pretty definitively works across the spectrum of heart failure
And irrespective of care setting so um you know it’s been remarkable as you know sglt2 inhibitors drugs that were originally designed for diabetes now showing this kind of incredible benefit in heart failure with reduced ejection fraction heart failure with mildly reduced and heart failure preserved ejection fraction and our pooled analysis of dapa hf and deliver
Shows that the hazard ratio is essentially flat consistent that that wide spectrum so what’s this drug doing to the fpf patients ah that’s a great mechanism of action moa i mean we really we really don’t know but as you know do we really know the mechanism of action of all the drugs that we have used for years in heart but at least we thought we knew them before
We studied them and this has happened kind of the way we thought we knew but uh yeah i mean obviously there are lots of different effects there’s been a number that have been uh postulated there is a diuretic effect although we think that that’s very mild there may be a shift in the myocardial energetics that has been proposed but the bottom line is that we really
Don’t you know whatever happens happens awfully fast because those curves split apart within six months immediately we haven’t seen that you know we haven’t seen that kind of split not only do they split apart within six months but they split apart way earlier than that and we’re going to share some data at the heart failure society of america about how fast uh
We actually do see a benefit uh and it’s really i can just say it’s rapid so you have the application in at the fda already for the preserved uh the so you can get the coverage the uh the uh fda will review these data absolutely it’ll be it’ll be probably sooner rather than later because of the consistency with the uh empagliflozin preserve trial so i mean it’s
It’s exciting you know we need to redraw our slides now you know that we always did for half path make sure the blood pressure is controlled make sure you check for coronary disease and stick right in the middle there sglt2 and then work on all the other comorbidities which is going to be interesting to see what happens in this trial to those comorbidities that
Surround this population it’s very interesting in addition to our primary manuscript we actually published quite a few uh including um one about frailty one about uh the effect on older people so we showed consistent results regardless of how fail a patient was or their age so even the oldest frailest patients seem to benefit and more most importantly the
Safety which was basically very similar to placebo overall was also the case in even the most vulnerable patients that we have wow well thank you for coming i know it’s been a very busy meeting for you we appreciate it uh of you coming and sitting chatting with me great pleasure so i’m going to close with this i i want our clinicians to really pay attention to
This because you need to think about this drug and you need to think about it early that doesn’t mean you’re not going to treat the blood pressure and you’re not going to treat diabetes but you’ve got to get your patients on this drug and now you’ve heard that even the older the very old and the frail patient which many of these patients are particularly the women
That you can’t withhold the drug there’s absolutely no reason there’s no safety issue here it’s a pretty comfortable drug i’ve been using it in clinic and i’m quite quite happy with how well it goes and how little the side effect profile is thanks again thank you for joining me from the esc i hope you have a wonderful day ileana pina signing off you
Transcribed from video
DELIVERing the Details on Dapagliflozin in Heart Failure By Medscape
