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Amitiza improves abdominal pain, bloating in IBS-C
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Researchers showed superiority of Amitiza over placebo for improving abdominal pain, bloating and composite endpoints including stool frequency in patients with constipation-predominant irritable bowel syndrome, according to post hoc analyses of two pivotal phase 3 randomized controlled trials.
Amitiza (lubiprostone, Sucampo/Takeda) is a novel type 2 chloride channel activator that was FDA-approved for use in women with IBS-C in 2008. Since then, the FDA has issued new guidance for clinical trials in IBS-C, recommending a composite endpoint that includes abdominal pain and stool frequency.
William D. Chey
Therefore, researchers including William D. Chey, MD, professor of medicine and nutrition sciences at the University of Michigan health system, director of the Digestive Diseases Center for Nutrition and Behavior at the University of Michigan, and Healio Gastroenterology Peer Perspective Board Member, retrospectively evaluated clinical trial data to assess the efficacy of lubiprostone in patients with baseline abdominal pain and bloating, and evaluated efficacy using the FDA-recommended composite endpoints including abdominal pain and stool frequency, as well as bloating and stool frequency. Composite endpoint responders were defined as those who had an average reduction of at least 30% in abdominal pain and an increase of at least one spontaneous bowel movement per week for at least half of the 12 treatment weeks.
Overall, 26.3% of the 325 patients treated with lubiprostone were responders based on the abdominal pain/stool frequency endpoint compared with 15.3% of the 180 patients who received placebo (P = .008).
Similarly, 23.8% of the treatment group were responders based on a composite endpoint of improved bloating and stool frequency compared with 12.6% of the placebo group (P = .012).
Patients treated with lubiprostone also had higher response rates for abdominal pain (P = .005) and bloating (P = .012) individually.
“These results were achieved despite the trials having been designed to apply a dose ... more suitable for treatment of pain; this dose was lower than one that would have been administered with the intention of showing a more profound effect on bowel movement frequency,” the researchers concluded. – by Adam Leitenberger
Disclosures: This study was funded by Sucampo and Takeda. Chey reports he has served as a consultant to Allergen, Ardelyx, AstraZeneca, Forest Laboratories, Ironwood Pharmaceuticals, Nestle, Prometheus Laboratories, SK Biopharmaceuticals, Sucampo and Takeda Pharmaceuticals, and has received research grant support from Ironwood Pharmaceuticals, Nestle, Prometheus, and Perrigo. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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