Watch the exclusive #ESOC2022 press presentation by Christopher Bladin on Treatment of Hyperglycaemia in Acute Stroke: Results from the Trial of Exenatide in Acute Ischaemic Stroke (TEXAIS).
Okay well thank you very much for the opportunity to uh do this interview for esoc in lyon we’re very much looking forward to coming over there and i’m going to be presenting this study which is the treatment of hyperglycemia in acute stroke and this is the results from the trial of exanatide in acute ischemic stroke study or what we known as the texas study and
One of the issues about the treatment of hyperglycemia in acute stroke is that it’s very common about up to 50 of patients at admission have hyperglycemia and indeed in the texas study was well over 40 percent had hyperglycemia on admission and one of the issues with hypoglycemia is that it causes significant problems it results in poorer outcomes for patients
With stroke and particularly in the context of patients who are getting mechanical thrombectomy and they also tend to have worse outcomes and we’ve been looking for different ways of treating hyperglycemia for quite some time and one of the obvious ways is to use insulin therapy but as we’ve seen from multiple studies including even the recently published shine
Study insulin therapy is difficult there’s problems of hypoglycemia and in some studies that can occur in up to 70 of patients getting insulin and of course it’s very resource intensive and indeed studies have shown that in fact even using insulin you don’t get any better outcomes and some studies have even suggested there are worse outcomes in terms of infarct
Growth on the mri so we decided to look at this from a different perspective and we looked at some of the newer diabetes drugs in particular the glp agonists and there’s a group of drugs known as the incretins and in the incretins are gut hormones that have a pretty unique feature in that they reduce blood glucose but their action is actually glucose dependent
So as the blood glucose level drops then the action of the drug diminishes so we looked at a particular drug called xenotide particularly the short acting version of xenotide and that has an action within two point hours of subcutaneous injection so it’s ideally situated for the use in acute stroke whereas some of the other diabetes drugs have longer mechanisms
Of action and they take hours to several days to to kick in short acting xenotide kicks in within just a few hours so the texas study was looking at using xenotide twice a day subcutaneously within nine hours of stroke onset in other words targeting the ischemic penumbra trying to improve stroke outcomes it’s a multi-center phase ii multi-center prospective
Randomized open label study a probe trial design ran over 15 sites including christchurch in new zealand and helsinki in europe and the primary primary hypothesis was an ambitious one we’re looking at the improvement in neurological outcome as an eight point improvement in nihss um or zero one at seven days and we also had a number of um secondary hypotheses
Particularly looking at 90 day nihss and 90 day rank and uh scores um so we recruited about 350 patients we initially were aiming at 528 but unfortunately as with many studies covert and time constraints caused significant problems for us and the study was finished at um 350 patients after about five years now um between the standard care and exercise groups
There are no major differences in all the key variables uh there was no difference in age sex there was no difference in a lot of the medical comorbidities in particular no difference in diabetes between the the two groups so in terms of the outcomes from this study um as i said it was an ambitious uh primary hypothesis and we showed that between standard care
And group and the exenatide group there was no significant difference in the primary outcome of improvement of eight points in nihss there was an improvement in 56.7 percent of the standard care group 61 percent of the xenotide group with an effect size with an adjusted odds ratio of 1.22 and while i would like to think there was certainly a trend there towards a
Better outcome in the xenotide group the p-value was 0.38 terms of secondary outcomes there was no significant differences in 90 day ranking scores nih nihss scores and there was no difference in death at 90 days between the the two groups now one of the interesting parts of this study the texas study was looking at the profile of hypoglycemia and hypoglycemia
And basically what we looked at was in each patient the mean daily frequency of either hypo or hyper glycemia we took all those values and generated a median score across the group so what we found interestingly was that there was a reduction in frequency of hyperglycemia in the xenotype group and that was certainly statistically significant importantly we
Found there was no occurrence of hypoglycemia in in either group now exanatide is a very easy drug to use but it does have a potential side effects of nausea and vomiting and fortunately we found that this was pretty uncommon it occurred about 3.5 percent in the xenotide group but was not overly severe and certainly was well able to be well controlled with
Antiometic therapy so in conclusion we found that in this phase two study there was no significant improvement across the two groups in the outcomes at nihss at seven days but we did demonstrate that there was significantly less hyperglycemia in the exercise group and that there were no episodes of hypoglycemia so clearly xenotide is having some benefit
In terms of keeping glucose under control reducing hypoglycemia and this certainly lends itself to a further phase three larger phase three study which can look at this uh more completely thank you
Transcribed from video
TEXAIS: Press presentation by Christopher Bladin By ESO European Stroke Organisation