ADVERTISEMENT
Brian Lacy, MD, on Tenapanor for IBS-C
In this video, Dr Brian Lacy reviews his presentation on the use of tenapanor for the treatment of irritable bowel syndrome with constipation, which received the Outstanding Research Award in the Colon Category and was noted as a Newsworthy Abstract.
Brian Lacy, MD, is a professor of medicine at Mayo Clinic Florida in Jacksonville, Florida.
TRANSCRIPT:
Welcome. I'm Brian Lacy, professor of medicine at Mayo Clinic in Jacksonville, Florida, speaking from the annual ACG American College of Gastroenterology meeting in Vancouver, British Columbia. I'd like to spend the next few minutes talking about an interesting study we presented at ACG here in Vancouver about tenapanor, which is a first-in-class small agent used to treat symptoms of IBS with constipation. Although I don't like to usually wax poetic about good things, this actually received an award for ACG 2023 based on its novel findings. For many of our listeners today, you know that tenapanor is FDA-approved for the treatment of IBS with constipation in men and women, and it has a very unique mechanism of action and it blocks the sodium-hydrogen exchanger isoform 3. Now that's a mouthful, but by blocking that receptor, sodium stays in the GI lumen. It draws water into it, and this softens stool and increases intestinal permeability, which is why it improves IBS with constipation symptoms.
So what was our study? So we know that this medication improves IBS with constipation symptoms, but the goal of this was to look, really drill down on the data to date and identify when certain symptoms responded to this medication. So this was a post hoc analysis looking at nearly 1400 patients with IBS in constipation meeting Rome IV criteria. They were randomized to either the active drug 50 milligrams twice a day or placebo. There was a Phase 2b study, and then what's called the TEMPO 1 and TEMPO 3 studies. We looked at data from just 12 weeks, although many of our listeners will know that the TEMPO 3 study lasted 26 weeks and showed benefits.
What were the key findings? So we already know that this medication improved symptoms, but we found that at 2 weeks, patients had a significant improvement in their constipation symptoms—about 52% of people, and that's fairly impressive. We found more importantly though, and this is really the take-home message,—you don't want to give up too early on this medication—that your patients may continue to respond. What we found is, by the end of 12 weeks, 77% of patients had a significant improvement in their IBS symptoms, especially that of constipation.
So if you give up too early at the 2- to 3-week mark, you may miss 25%, or a quarter, of patients who may benefit from this novel medication. Importantly, we also found that abdominal pain or discomfort had a significant improvement compared to placebo at week 4 and we found that bloating, a very common symptom and difficult-to-treat symptom, generally had significant improvements at week 5.
So here we are again from Vancouver, talking about this novel medication, tenapanor, and its improvement for IBS-C symptoms, winning one of the awards here, and hoping that as a clinician, that you may want to incorporate this into your practice.