Is rifaximin or tegaserod effective in the treatment of irritable bowel syndrome (IBS)?

Updated: Dec 11, 2019
  • Author: Jenifer K Lehrer, MD; Chief Editor: BS Anand, MD  more...
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Answer

Rifaximin was approved by the FDA in 2015 for IBS-D. [54] A total of 1260 patients with IBS without constipation were enrolled in the TARGET 1 and TARGET 2 phase III trials at 179 investigative sites in the United States and Canada. Results showed that treatment with rifaximin (550 mg PO tid for 14 d) provided better symptom relief (eg, bloating, abdominal pain, loose/watery stools) compared with placebo, although the placebo effect was tremendous. Similarly, a 2012 meta-analysis of five studies, incorporating 1,803 patients, determined that rifaximin is more effective than placebo for global symptom relief and bloating. Adverse event rates were similar to placebo. [55, 56]

Tegaserod was reintroduced in the United States in 2019 after it had been suspended from the market in 2007 because of cardiovascular (CV) safety concerns. [57, 58, 59] The reapproved tegaserod indication is for women younger than 65 years with IBS-C who are without a history of CV ischemic disease and who have a low risk of developing CV disease. FDA approval was based on three multicenter, double-blind, placebo-controlled trials that stratified data from women with IBS-C (N = 2470). [57, 58] Tegaserod has been "shown to improve symptoms, enhance gastric accommodation and significantly attenuate visceral pain arising from the colon in functional dyspepsia patients." [59] Evidence also exists in animal models that tegaserod may have a protective effect in inflamed colons. [59]


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