Tenapanor treatment of patients with constipation-predominant irritable bowel syndrome: A phase 2, randomized, placebo-controlled efficacy and safety trial
The American Journal of Gastroenterology
March 03, 2017
Chey WD, et al.
This study was designed to assess the efficacy and safety of tenapanor in patients with constipation–predominant irritable bowel syndrome (IBS–C). Researchers reported that tenapanor (50 mg bid) significantly increased stool frequency and reduced abdominal symptoms in patients with IBS–C. They noted that further research into tenapanor as a potential treatment for these patients is justified.
Patients with IBS–C (Rome III criteria) were randomized (1:1:1:1) to receive tenapanor 5 mg, 20 mg, or 50 mg bid, or placebo bid for 12 weeks.
The primary end point was the complete spontaneous bowel movement (CSBM) responder rate, defined as the proportion of patients reporting an increase from baseline of ≥1 CSBM/week for ≥6/12 treatment weeks.
Secondary end points included abdominal symptom responder rates (≥30% score improvement from baseline for ≥6/12 weeks) and a composite responder rate (CSBM and abdominal pain response in the same week for ≥6/12 weeks).
A total of 356 patients were randomized (mean age: 45.7 years; 86.8% women) and 304 completed the study.
The CSBM responder rate was significantly higher in the tenapanor 50 mg bid group than in the placebo group (60.7 vs 33.7%; P<0.001), as was the composite responder rate (50.0 vs 23.6%; P<0.001).
Responder rates for abdominal symptoms (pain, discomfort, bloating, cramping, and fullness) were significantly higher in the tenapanor 50 mg bid group than in the placebo group (all P<0.05).
Diarrhea was the most frequent adverse event (tenapanor bid: 20 mg, 12.4%; 50 mg, 11.2%).
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