Itopride shows promise in functional dyspepsia

WASHINGTON — Itopride appeared to improve symptoms in patients with functional dyspepsia, including those with both postprandial distress and epigastric pain syndromes, according to a presenter here.

Perspective from Mark Pimentel, MD

Itopride is a D2 antagonist and cholinesterase inhibitor with prokinetic effects on gastric motility.

The study also validated the usefulness of a patient reported outcome measure called the Leuven Postprandial Distress Scale (LPDS) in both “pure” postprandial distress syndrome (PDS) and PDS-epigastric pain syndrome (EPS) overlap, Florencia Carbone, MD, of University of Leuven in Belgium, and colleagues noted.

“The LPDS is a sensitive and reliable instrument to assess severity of PDS symptoms on a daily basis, and we also validated this questionnaire in the overlap PDS-EPS subgroup,” Carbone said during her presentation. “We also showed improvement of PDS symptoms after treatment with itopride compared to baseline. Symptom benefit with itopride was also shown in the PDS-EPS subgroup.”

In a double-blind multicenter trial, Carbone and colleagues randomly assigned 45 patients with pure PDS and 55 patients with PDS-EPS overlap to receive 100 mg itopride or placebo twice daily for 8 weeks (79% women; mean age, 39 years). Patients did not take PPIs or other GI drugs during the study, and reported symptoms in diaries.

There was no significant difference between the effects of the study drug and placebo. However, the investigators found that the study drug significantly improved LPDS scores based on an average of postprandial fullness, early satiation and upper abdominal bloating (P = .0002). It also improved individual symptoms including postprandial fullness (P = .0007), abdominal bloating (P = .003), nausea (P = .04) and epigastric pain (P = .03). There was no significant improvement in the placebo group.

Future studies of itopride with larger numbers of patients are warranted based on these data, Carbone said. – by Adam Leitenberger

Reference:

Carbone F, et al. Abstract 383. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.

Disclosures: Carbone reports no relevant financial disclosures. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.

Perspective

Mark Pimentel, MD

Itopride is not currently available in the U.S. and my understanding is there is no plan to bring it here. But this is a good opportunity to discuss the prokinetics that are emerging in the next year.

The problem here, in the U.S., is that we don’t have a good prokinetic. Tegaserod was available in the last decade but was removed from the market. That drug was brilliant for some of these particular gut symptoms; even though it was approved for IBS-C, off-label use showed it was good for gastroparesis and other conditions. We miss those types of products.

Prucalopride (Resolor, Shire) is another one that is still available outside the U.S. There’s been some word that it might be coming to the U.S. and the FDA recently accepted a new drug application for it. It’s available almost everywhere else and is another promising drug in this category of agents.

We need a good prokinetic in the U.S., but we don’t have one right now. I hope this year brings one because we need it in practice.

Mark Pimentel, MD

Executive director

Medically Associated Science and Technology program

Cedars Sinai Medical Center

Los Angeles

Disclosures: Pimentel reports financial relationships with Synthetic Biologics, Salix, Naia Pharmaceuticals, Commonwealth Diagnostics International and Valeant.