Ibsrela Linked to Resolved IBS-Constipation Abdominal Pain

Credit: Pexels / Andrea Piacquadio

Analysis of previously published studies assessing tenapanor (Ibsrela) in patients with irritable bowel syndrome with constipation (IBS-C) show the drug can help to significant reduce key abdominal symptoms.

More specifically, the sodium/hydrogen exchanger 3 (NHE3) inhibitor was found to improve measures in the novel Abdominal Score test in treated patients across the three observed trial results.

Results published in The American Journal of Gastroenterology called attention to Ibsrela's early onset of action for significantly reducing average weekly scores for abdominal bloating, discomfort, cramping, and fullness versus placebo, with improvements observed as early as week one and sustained through week 12 of treatment.

“IBS-C is a clinically heterogeneous disorder, and available treatments may not simultaneously improve both bowel movements and the range of abdominal symptoms that patients experience,” investigators from the analysis wrote.

Although it is the most common disease diagnosed by gastroenterologists, few patients affected by IBS see a provider and receive a diagnosis, and even less report abdominal pain or discomfort resolution with treatment. Although changes in diet and exercise are widely recommended for management of symptoms, medication may also be necessary. However, the exact cause of IBS is unknown, hindering the effective management of its wide array of bothersome abdominal symptoms.

To determine the overall effectiveness of Ibsrela for IBS-associated abdominal symptoms, investigators conducted an analysis of data from three randomized, double-blind, placebo-controlled trials conducted in the United States that enrolled patients who met Rome III criteria for IBS-C.¹

In the present study, data were pooled from the intent-to-treat populations of patients with IBS-C who received Ibsrela 50 mg or placebo during the first 12 weeks of treatment. Patients were included in the analysis if they met the individual study eligibility criteria, were randomized, and received at least one dose of the study drug.

A total of 1372 participants were enrolled, 684 of whom were in the Ibsrela 50 mg twice a day group and 688 of whom were in the placebo group. Investigators noted most patients were female and White, and a mean age of 45.3 years old.

Weekly scores were calculated as the average score for all days during a week with four or more days of reporting of the given abdominal symptom. In the present analysis, the Abdominal Score was calculated as the average of weekly scores for abdominal pain, discomfort, and bloating. Investigators assessed the overall change from baseline to week 12 for each symptom weekly score and the corresponding Abdominal Score, as well as Abdominal Score 6/12-week and 9/12-week response rates (Abdominal Score improvement of at least points).¹

Upon analysis, the least squares mean Abdominal Score change from baseline in the pooled population was greater with tenapanor compared to placebo over the first 12 weeks of treatment.

Investigators noted weekly Abdominal Score response rates were consistently greater with Ibsrela compared with placebo in the pooled population over the first 12 weeks, and patients receiving Ibsrela had significantly increased six of 12-week and nine of 12-week response rates versus patients receiving placebo in the pooled population. Similar patterns were observed in the individual studies for the six of 12-week, nine of 12-week, and 13 of 26-week response rates.

Diarrhea was the most common event in the pooled population receiving Ibsrela. The first event of diarrhea occurred mostly within the first month of Ibsrela treatment, with a median time to onset of about four days.

"We demonstrate that tenapanor significantly improves abdominal symptoms, including pain, bloating, discomfort, cramping, and fullness, in patients with IBS-C, with an early onset of action that increases over time and is sustained throughout the treatment period," investigators concluded.

An original version of this article was published on sister site HCPLive.