Lubiprostone was significantly more effective in improving abdominal pain or bloating than placebo, according to results from a post-hoc analysis published in Alimentary Pharmacology and Therapeutics.
Lubiprostone (Amitiza; Sucampo and Takeda), a gastrointestinal (GI) motility enhancer, was approved in 2008 for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) in women aged 18 years and older. The Food and Drug Administration (FDA) released new guidance for IBS-C clinical trials by recommending a composite endpoint including both abdominal pain and stool frequency.
Similar criteria were used in a post-hoc analysis of data from two, Phase 3, double-blind, randomized trials of lubiprostone in patients with IBS-C. Study patients had baseline spontaneous bowel movement (SBM) frequency of <3/week and abdominal pain or bloating ratings of ≥1.36 on a 5-point scale.
Responders (composite endpoint) had a mean pain reduction ≥30% vs. baseline, and an increase from baseline of ≥1 SBM/week for ≥6 of the 12 treatment weeks. Study authors assessed effects on abdominal pain alone, bloating alone, and in a composite endpoint with stool frequency.
Pooled data (n=505) showed higher response rates with the lubiprostone group vs. placebo group for the composite endpoint of improved pain and stool frequency (26.3% vs. 15.3%, respectively; P=0.008) as well as the composite endpoint of improved bloating and stool frequency (23.8% vs. 12.6%, respectively; P=0.012). Also, higher response rates were seen with the lubiprostone group for abdominal pain alone (P=0.005) and bloating alone (P=0.012) vs. the placebo group.
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