In patients with heart failure with reduced ejection fraction, the sodium glucose cotransporter-2 dapagliflozin reduced the incidence of new onset type 2 diabetes by 32% vs placebo. Dr Silvio Inzucchi explains.
I was a the endocrinologist on the executive committee and and we had the notion of assessing whether patients who did not have diabetes and that was about 55% of the original cohort so about 2,600 patients did not have diabetes at baseline so we we said well this is a great opportunity to see if going on this glucose lowering medication could prevent those
Individuals from developing diabetes during the trial why is that important well we know that patients with heart failure number one there are lots of individuals with diabetes and heart failure and when you look at the non diabetic individuals with heart failure lots of them have what was sometimes called pre-diabetes in other words glucose levels that are close
To the diagnostic threshold for diabetes but not not yet some use the term disc lycée mia suffice to say that it’s a high risk state meaning that those individuals when tracked for several years going forward tend to develop more diabetes than if their blood glucose was completely new or their hemoglobin a1c was would be completely normal so because we anticipated
That many of the patients in dap hf who didn’t have diabetes would have pre-diabetes we said this is a good opportunity to test this notion as to whether this sglt2 inhibitors debra frozen could potentially prevent them from getting diabetes so we pre specified an analysis those patients randomized to either davic alone or placebo would be tracked over the duration
Of the trial and we use the hemoglobin a1c is a very simple metric to assess for diabetes and this was measured periodically during the trial now to some degree we’re a victim of our own success with data hf the reason i say that is that the study was event-driven so it’s terminated when sufficient numbers of primary outcome events are ascertained and because the
Events were more freaked then had initially been anticipated and a large treatment effect of the dat book of data flows in the study only lasted about eighteen months now for those of you who may be used to reading diabetes prevention trials they typically go on for at least three years because it takes some time to develop diabetes so unfortunately we were not
Well fortunately for patients but unfortunately for the purposes of the tri of the sub study this diabetes prevention sub study we were curtailed at 18 months having said that we still had a significant treatment effect so the numbers of patients that develop diabetes who were randomized to dap ago closing the risk reduction for their developing type 2 diabetes
Was reduced by 32 percent so the hazard ratio being 0.68 32 percent relative risk reduction and what we also determined is that it was the patients who had pre-diabetes not surprisingly those individuals constituted more than 95 percent of the overall cohort that developed diabetes in other words the the non diabetic patients 2609 diabetic patients it was about
Two-thirds pre-diabetes one-third a normal hemoglobin a1c under 5.7 percent it was from the pool of the pre-diabetic individuals at 66 seven percent of the cohort with pre-diabetes that most of the diabetes events occurred so they contributed 95% of the not surprising because you know this is a it’s really a biochemical diagnosis and if you’re closer to the finish
Line you’re more apt to finish across that threshold if you will so so that those are the major results of the of the trial of the sub study that i presented this morning
Transcribed from video
DAPA-HF: Substudy shows dapagliflozin reduces T2D risk in HF By Patient Care Online
