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- W2912778832 abstract "Introduction: Irritable bowel syndrome with constipation (IBS-C) is a chronic condition that significantly impacts quality of life. Plecanatide, a uroguanylin analog, has been evaluated in two identicallydesigned phase 3, randomized, double-blind, placebo-controlled trials of adults with IBS-C in the United States. Methods: Patients (aged 18-85 yrs) meeting Rome III criteria for IBS-C were eligible to participate and were randomized to once-daily placebo (PBO), plecanatide 3 mg, or plecanatide 6 mg. The primary efficacy endpoint in both trials was the percentage of Overall Responders, defined as a patient who was both an Abdominal Pain Responder (≥30% decrease in worst abdominal pain vs baseline) and Stool Frequency Responder (increase ≥1 complete spontaneous bowel movement vs baseline) in the same week for ≥6 of 12 treatment weeks. Safety and tolerability were assessed by the incidence, nature, and severity of adverse events (AEs). Efficacy and safety data from these two 12-week trials were pooled. Results: A total of 1456 patients were included in the combined intention-to-treat population (PBO, N=733; 3 mg, N=728; 6 mg, N=728). Demographics were similar between treatment groups and across the studies. Plecanatide treatment resulted in a significantly greater percentage of Overall Responders than did placebo (PBO, 16.0%; 3 mg, 25.7%; 6 mg, 26.6%; PPP < 0.001 both doses) for ≥6 weeks of the 12-week studies. Plecanatide significantly improved patient-reported symptoms including stool consistency and straining severity. AE rates were similar in all 3 groups, with the only AE occurring in ≥2% of patients and with an incidence greater than PBO being diarrhea (PBO, 1.0%; 3 mg, 4.3%; 6 mg, 4.0%). There were low rates of discontinuation due to diarrhea (PBO, 0%; 3 mg, 1.2%; 6 mg, 1.4%). Conclusion: The hallmark symptoms of IBS-C, abdominal pain and reduced stool frequency, as well as secondary symptoms, were significantly improved with 12 weeks of once-daily plecanatide treatment compared with placebo. In plecanatide-treated patients, there were low AE and discontinuation rates, including diarrhea. Plecanatide offers a promising new treatment option for patients with IBS-C." @default.
- W2912778832 created "2019-02-21" @default.
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- W2912778832 date "2017-10-01" @default.
- W2912778832 modified "2023-09-24" @default.
- W2912778832 title "Efficacy and Safety of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation: Pooled Analysis of 2 Randomized Clinical Trials 2017 Presidential Poster Award" @default.
- W2912778832 doi "https://doi.org/10.14309/00000434-201710001-00480" @default.
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