However, new bowel preparations are emerging that can offer greater options for these patients.
NER1006 (Plenvu) is a low-volume polyethylene glycol-based bowel preparation that is indicated in the US for colon cleansing in preparation for colonoscopy. The drug’s efficacy and tolerability among adults were demonstrated in 2 randomized, phase 3 studies.
A recent post-hoc analysis of these trials was presented at the annual American College of Gastroenterology (ACG) 2020 conference. The study evaluated and compared the safety profile of 1 liter of NER1006 in adults with and without diabetes.
Overall, a total of 524 patients were included in the safety analysis. Of the total, 8.0% had diabetes, and 82.1% underwent screening or surveillance colonoscopy.
In Part 1 of an interview with HCPLive, lead investigator Brooks Cash, MD, of the University of Texas Health Science Center, discussed the study’s findings.
HCPLive: Can you talk a bit about your study? What were your motivations behind it, and what did you find?
Cash: What we did was a study of a relatively new bowel prep for colonoscopy. It’s a PEG-based prep called NER1006 (Plenvu). It’s a somewhat unique preparation in that it’s the lowest volume preparation that is on the market currently. It is only a liter of fluid intake that is required with this bowel prep.
What we did was that we analyzed data from some of the pivotal trials with this prep, looking specifically at patients with or without diabetes. Diabetes has been associated with worse prep scores in general. There are a number of different predictors for incomplete, or suboptimal bowel preparations, such as male gender or sex and chronic idiopathic constipation. The most important indicator is previous incomplete bowel preparation, and that stands to reason.
But diabetes is also one of those risk factors for inadequate bowel preparation. So, we looked at a post-hoc analysis of 2 phase 3, randomized-controlled trials. One of these trials was known as the NOCT trial, and the other was known as the MORA trial. They had other different preparations that NER1006 was compared to.
What we found was that this bowel preparation did just as well in patients with diabetes as without diabetes. It resulted in good-to-excellent bowel preps in the majority of patients. We found it to be an excellent choice for bowel preparation in those patients with diabetes. And there were no significant abnormalities with regards to safety or any safety signals.
It’s just more evidence that this bowel prep can work in an otherwise difficult group of patients.
In your study you had mentioned a dosing regimen approved by the US Food and Drug Administration? Can you say more on that and what that looked like?
We used a PM/AM dosing regimen. That means patients would do half the prep the night before the procedure, and then the other half the morning of the procedure. We call that split-dose prep. It has really become standard of care.
One of these studies looked at a same-day preparation as well. We didn’t analyze that in our study. We were only looking at the split-dose preparation, because we wanted to have as similar methods as we could with regards to those patients that took this prep. And so, it was important they actually did it the same way. So, we looked at a typical split-dose preparation.