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  1. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Constipation Lin Chang,1,*Shahnaz Sultan,2,3,*Anthony Lembo,4 G. Nicholas Verne,5 Walter Smalley,6 and Joel J. Heidelbaugh7 1Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California; 2Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Minneapolis, Minnesota; 3Veterans Affairs Healthcare System, Minneapolis, Minnesota; 4Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; 5Department of Medicine, University of Tennessee College of Medicine, Memphis, Tennessee; 6Department of Medicine, Division of Gastroenterology, Vanderbilt University, Nashville, Tennessee; and 7Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan Background & Aims Irritable bowel syndrome (IBS) is a common disorder of gut–brain interaction associated with significant disease burden. This American Gastroenterological Association guideline is intended to support practitioners in decisions about the use of medications for the pharmacological management of IBS-C and is an update of a prior technical review and guideline. Methods The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence and make recommendations. The technical review panel prioritized clinical questions and outcomes according to their importance for clinicians and patients and conducted an evidence review of the following agents: tenapanor, plecanatide, linaclotide, tegaserod, lubiprostone, polyethylene glycol laxatives, tricyclic antidepressants, selective serotonin reuptake inhibitors, and antispasmodics. The Guideline Panel reviewed the evidence and used the Evidence-to-Decision Framework to develop recommendations. Conclusions The panel agreed on 9 recommendations for the management of patients with IBS-C. The panel made a strong recommendation for linaclotide (high certainty) and conditional recommendations for tenapanor, plecanatide, tegaserod, and lubiprostone (moderate certainty), polyethylene glycol laxatives, tricyclic antidepressants, and antispasmodics (low certainty). The panel made a conditional recommendation against the use of selective serotonin reuptake inhibitors (low certainty). >> View the full guideline >> View a PDF of the guideline Copyright © 2022 Elsevier Inc. except certain content provided by third parties.
  2. Drug Treatment for Irritable Bowel Syndrome with Constipation Granted FDA Approval Pharmacy Times Drug Treatment for Irritable Bowel Syndrome with Constipation Granted FDA Approval SEPTEMBER 13, 2019 Officials with the FDA have approved tenapanor (Ibsrela, Ardelyx), a 50 mg, twice-daily oral medication for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults, according to a press release. Tenapanor, a novel treatment, is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3. Through this mechanism, treatment results in increased bowel movements and decreased abdominal pain for patients, according to Ardelyx. IBS-C, a subtype of IBS, can cause abdominal discomfort and bloating associated with constipation in patients and symptoms can be disruptive to daily life. “Ibsrela has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States,” Mike Raab, president and chief executive officer of Ardelyx, said in a statement. The approval is based on results from the phase 3 IBS-C program, which included 2 randomized trials: T3MPO-1 and T3MPO-2. The primary endpoint for both trials was the proportion of patients who responded during the 12-week treatment period. Both trials met the primary endpoint compared with a placebo: Trial 1: 37% versus 24%, tenapanor versus placebo, respectively. Trial 2: 27% versus 19%, tenapanor versus placebo, respectively. According to the results, in both trials, the proportion of responders for 9 out of the first 12 weeks, including at least 3 of the last 4 weeks, was greater in patients treated with tenapanor compared with patients treated with a placebo. Additionally, in trial 1, the proportion of responders for 13 out of 26 weeks was greater in tenapanor-treated patients compared with placebo-treated patients, according to the study. Both trials showed improvements from baseline in average weekly complete spontaneous bowel movements and abdominal pain by week 1, with improvement maintained through the end of treatment. In addition, a long-term safety extension trial, T3MPO-3, further supported the favorable safety profile of tenapanor, according to Ardelyx. This article was originally published by Specialty Pharmacy Times. Reference Ardelyx Receives FDA Approval for Ibsrela (Tenapanor), an NHE3 Sodium Transport Inhibitor, for the Treatment of Irritable Bowel Syndrome with Constipatin [news release]. Ardelyx. http://ir.ardelyx.com/news-releases/news-release-details/ardelyx-receives-fda-approval-ibsrelar-tenapanor-nhe3-sodium. Accessed September 13, 2019.
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