番茄社区

At the American College of Gastroenterology annual meeting, researchers presented pooled data from two phase III trials to look closer at the effect of plecanatide (Trulance) on severe abdominal pain and severe bloating in adults with irritable bowel syndrome with constipation (IBS-C).

In this exclusive 番茄社区 video, , of Washington University School of Medicine in St. Louis, discusses the data.

Following is a transcript of his remarks:

So this was a study that actually looked at the previously conducted phase III clinical trials, examining the use of plecanatide as a treatment option for the management of irritable bowel syndrome with constipation. And what we did in this post-hoc analysis specifically was examine the subset of patients within these phase III trials that had severe abdominal pain, severe bloating, or a combination of both severe abdominal pain and severe bloating. The intent being to try to determine whether this subgroup of patients with more severe symptoms has comparable or better responses to plecanatide in terms of improvement of these abdominal symptoms.

And so what we did ultimately was identify this subset of patients. We defined a severe patient as an individual that had an abdominal pain or an abdominal bloating score at baseline of at least an 8 out of 10 (on a 0-10 scale). And then we looked at response, and response was defined as at least a 30% improvement in that baseline symptom score.

And what we found was actually that these patients with severe abdominal pain, severe bloating, or both severe pain and bloating, did respond well to plecanatide with significant improvements compared to placebo in all three of these subgroup analyses -- abdominal pain improvement, bloating improvement, and both abdominal pain and bloating in these severe patients. So we concluded that plecanatide was effective at decreasing symptom severity of these abdominal symptoms in patients with IBS-C.

The other thing that we were interested in exploring was the relationship of response in terms of improvement of both abdominal pain and bloating. And in order to evaluate this, what we did was we correlated the response of abdominal pain and response of bloating with plecanatide. And what we found here using both Spearman's correlation and Pearson's correlation coefficients, was that there was a very high correlation of improvement in one symptom with the other [symptom].

And so this suggested to us one of two possibilities. The first being that plecanatide could be a treatment that's effective in terms of not just abdominal pain, but other abdominal symptoms as well. That's one interpretation of this data. The other interpretation would be that patients perhaps are less critical in distinguishing between these individual abdominal symptoms, and if they feel that their symptoms have generally improved, they may endorse improvement across the spectrum of abdominal symptoms that they're experiencing to include abdominal pain and bloating in this case.

So it was an interesting study. I think it certainly inspires additional work to try to better understand this relationship of abdominal symptom responses. And as a clinician, it gives us confidence, I think, that plecanatide is a good option for treating these abdominal symptoms in individuals with more severe symptoms at baseline.

Comment