Ibsrela improves abdominal symptoms in IBS-C
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Ibsrela helped reduce abdominal symptoms, like bloating, cramping and fullness, in patients with constipation-predominant irritable bowel syndrome, according to study results.
William D. Chey, MD, director of the GI Physiology Laboratory at University of Michigan Health System, and colleagues wrote that Ibsrela (tenapanor, Ardelyx) is a first-in-class, minimally absorbed, small molecule inhibitor of the gastrointestinal sodium/hydrogen exchanger isoform 3 (NHE3), which helps maintain salt and water balance through the electroneutral exchange of intestinal sodium ions for intracellular protons.
“NHE3 inhibition should therefore be expected to increase excretion of sodium and uid in stool,” they wrote. “Preclinical studies in rats and clinical studies have shown that tenapanor reduces sodium absorption, with minimal systemic drug exposure.”
Researchers conducted a phase 3, double-blind study to assess the efficacy and safety of tenapanor compared with placebo. They randomly assigned patients with IBS-C (n = 606) to receive either 50 mg of tenapanor or placebo twice daily for 12 weeks.
Ibsrela helped reduce abdominal symptoms, like bloating, cramping and fullness, in patients with constipation-predominant irritable bowel syndrome, according to study results.
The primary outcome of the study was the proportion of patients who reported a reduction in average weekly worst abdominal pain of at least 30% and an increase of at least one complete spontaneous bowel movement from baseline, both in the same week, for at least 6 weeks of the study.
Chey and colleagues found that a greater proportion of patients treated with tenapanor achieved the primary endpoint compared with patients who received placebo (27% vs. 18.7%; P = .02). Patients who received tenapanor also experience improvements in abdominal symptoms and global symptoms of IBS (P < .05 vs. placebo).
In their safety analysis, investigators found that the most common adverse event was diarrhea, which resulted in study discontinuation in 6.5% of patients in the tenapanor group and 0.7% in the placebo group.
“Tenapanor, with its unique mechanism of action, positive impact on key symptoms and satisfaction measures, and acceptable safety prole, could oer an exciting new treatment option for patients with IBS-C,” Chey and colleagues concluded. – by Alex Young
Disclosure: Chey reports consulting for Allergan, Biomerica, IM Health, Ironwood, Nestle, QOL Medical, Salix/Valeant, Vibrant and Zespri. Please see the full study for all other authors’ relevant financial disclosures.
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