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Irritable Bowel Syndrome: HELP
Articles from New Jersey
Based on 43 articles published since 2010
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These are the 43 published articles about Irritable Bowel Syndrome that originated from New Jersey during 2010-2020.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Editorial Safety of Eluxadoline in Patients With IBS-D Without a Gallbladder. 2017

Cash, Brooks D / Lacy, Brian E / Schoenfeld, Philip S / Dove, Leonard S / Covington, Paul S. ·University of South Alabama, Mobile, Alabama, USA. · Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA. · University of Michigan School of Medicine, Ann Arbor, Michigan, USA. · Allergan plc, Parsippany, New Jersey, USA. · Furiex Pharmaceuticals, Allergan plc, Parsippany, New Jersey, USA. ·Am J Gastroenterol · Pubmed #28978951.

ABSTRACT: -- No abstract --

2 Review Elimination of Fermentable Carbohydrates to Reduce Gastrointestinal Symptoms in Pediatric Patients With Irritable Bowel Syndrome: A Narrative Review. 2020

Fisher, Kelly / Hutcheon, Deborah / Ziegler, Jane. ·Department of Clinical and Preventive Nutrition Sciences, School of Health Professions, Rutgers University, Newark, New Jersey, USA. ·Nutr Clin Pract · Pubmed #30937981.

ABSTRACT: Irritable bowel syndrome (IBS) is classified as a functional gastrointestinal (GI) disorder characterized by abdominal pain, bloating, and changes in bowel function. Although the pathophysiology of IBS is incompletely understood, fermentable carbohydrates are implicated as a potential cause of symptoms. An elimination diet, such as a low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet, represents a potential intervention for reducing GI symptoms in patients with IBS. The role of fermentable carbohydrates in symptom onset is well studied in adult patients with IBS; however, less research exists in the pediatric population. This review sought to explore evidence for the role of dietary fermentable carbohydrate elimination to reduce GI symptoms (abdominal pain, stool changes, abdominal bloating) in children and adolescents (4-19 years of age) diagnosed with IBS based on Rome III or IV criteria. Five studies of neutral to positive quality rating were identified and analyzed using the Academy of Nutrition and Dietetics Evidence Analysis Process. These studies demonstrate that dietary elimination of fermentable carbohydrates, such as through a low-FODMAP diet, reduces the severity of 1 or more GI symptoms in about one-quarter to one-half of pediatric patients with IBS. Patients without improvement are considered "nonresponders" and may require an alternative intervention. More research is needed to establish the best way to identify patients who would respond to elimination diets vs other IBS treatment strategies.

3 Review Beyond O&P Times Three. 2018

Mohapatra, Sonmoon / Singh, Dhruv Pratap / Alcid, David / Pitchumoni, Capecomorin S. ·Department of Internal Medicine, Saint Peter's University Hospital - Rutgers Robert Wood Johnson School of Medicine, New Brunswick, NJ, USA. Department of Infectious Diseases, Saint Peter's University Hospital - Rutgers Robert Wood Johnson School of Medicine, New Brunswick, NJ, USA. 3Department of Gastroenterology, Hepatology and Clinical Nutrition Saint Peter's University Hospital - Rutgers Robert Wood Johnson School of Medicine, New Brunswick, NJ, USA. ·Am J Gastroenterol · Pubmed #29867172.

ABSTRACT: Although examination of the stool for ova and parasites times three (O&P ×3) is routinely performed in the United States (US) for the evaluation of persistent and/or chronic diarrhea, the result is almost always negative. This has contributed to the perception that parasitic diseases are nearly non-existent in the country unless there is a history of travel to an endemic area. The increasing number of immigrants from third-world countries, tourists, and students who present with symptoms of parasitic diseases are often misdiagnosed as having irritable bowel syndrome or inflammatory bowel disease. The consequences of such misdiagnosis need no explanation. However, certain parasitic diseases are endemic to the US and other developed nations and affect both immunocompetent and immunocompromised patients. Testing for parasitic diseases either with O&P or with other diagnostic tests, followed by the recommended treatment, is quite rewarding when appropriate. Most parasitic diseases are easily treatable and should not be confused with other chronic gastrointestinal (GI) disorders. In this review, we critically evaluate the symptomatology of luminal parasitic diseases, their differential diagnoses, appropriate diagnostic tests, and management.

4 Review Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. 2017

Özdener, Ayşe Elif / Rivkin, Anastasia. ·School of Pharmacy and Health Sciences, Fairleigh Dickinson University, Florham Park, NJ, USA. ·Drug Des Devel Ther · Pubmed #29033544.

ABSTRACT: Eluxadoline is a novel drug approved for the management of diarrhea predominant irritable bowel syndrome (IBS-D). It has unique pharmacology and works on three different opioid receptors. Several Phase II and III clinical trials have demonstrated eluxadoline's efficacy in reducing symptoms related to IBS-D. Clinical trial results and postmarketing reports show a risk of pancreatitis in patients without a gallbladder or those abusing alcohol. This review article will include information on clinical trial results related to IBS-D management as well as eluxadoline's limitations.

5 Review Irritable Bowel Syndrome: Clinical Manifestations, Dietary Influences, and Management. 2017

Ikechi, Ronald / Fischer, Bradford D / DeSipio, Joshua / Phadtare, Sangita. ·Department of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USA. ikechir0@rowan.edu. · Department of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USA. fischerb@rowan.edu. · Department of Medicine, Gastroenterology/Liver Diseases Division, Cooper Medical School of Rowan University, Camden, NJ 08103, USA. DeSipio-Joshua@CooperHealth.edu. · Department of Biomedical Sciences, Cooper Medical School of Rowan University, Camden, NJ 08103, USA. phadtare@rowan.edu. ·Healthcare (Basel) · Pubmed #28445436.

ABSTRACT: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder that is characterized by symptoms of chronic abdominal pain and altered bowel habits in the absence of an overtly identifiable cause. It is the most commonly diagnosed functional gastrointestinal disorder, accounting for about one third of gastroenterology visits. It generally presents as a complex of symptoms, including psychological dysfunction. Hypersensitivity to certain foods, especially foods that contain high amounts of fructose, plays a role in the pathophysiology of IBS. Elevated consumption of high-fructose corn syrup (HFCS) has been discussed in this aspect. The treatment options for IBS are challenging and varied. In addition to dietary restrictions for HFCS-induced IBS, such as low-FODMAP (Fermentable Oligosaccharides, Disaccharide, Monosaccharides, and Polyols) diets, existing drug therapies are administered based on the predominant symptoms and IBS

6 Review Complementary, Integrative, and Holistic Medicine: Integrative Approaches to Pediatric Irritable Bowel Syndrome. 2016

Leiby, Alycia / Vazirani, Minal. ·Department of Pediatrics, Division of Pediatric Gastroenterology and Nutrition, Goryeb Children's Hospital, Atlantic Health System, Morristown, NJ. Department of Pediatrics, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA. · Siegler Center for Integrative Medicine, Barnabas Health ACC Barnabas Health System, Livingston, NJ. Rutgers - New Jersey Medical School, Newark, NJ. ·Pediatr Rev · Pubmed #27037108.

ABSTRACT: -- No abstract --

7 Review Update on the Management of Diarrhea-Predominant Irritable Bowel Syndrome: Focus on Rifaximin and Eluxadoline. 2016

Rivkin, Anastasia / Rybalov, Sergey. ·Fairleigh Dickinson University School of Pharmacy, Florham Park, New Jersey. · Division of Gastroenterology, Saint Clare's Hospital Dover/General, Dover, New Jersey. ·Pharmacotherapy · Pubmed #26971716.

ABSTRACT: Diarrhea-predominant irritable bowel syndrome (IBS-D) is one of the most common diagnoses made by gastroenterologists. Current pharmacologic treatments for IBS-D include fiber supplements, antidiarrheal over-the-counter medications, probiotics, antispasmodics, antidepressants, and a 5-hydroxytryptophan 3 receptor antagonist. All of these options have limited efficacy in managing IBS-D. Rifaximin, a nonabsorbable antibiotic, has been evaluated in patients with IBS-D. In two randomized, double-blind, placebo-controlled phase III trials evaluating rifaximin 550 mg by mouth 3 times/day for 14 days, the primary efficacy end point was achieved by 9% more patients randomized to the rifaximin group compared with placebo (40.7% vs 31.7%, p<0.001, number needed to treat ~11). The primary efficacy end point was defined as the proportion of patients having adequate relief of global IBS symptoms for at least 2 of the 4 weeks during the primary follow-up period (weeks 3-6). In the phase III trial examining the efficacy and safety of repeated courses of rifaximin in patients who responded to the initial 2-week course, rifaximin given for up to two additional courses provided a statistically significant incremental benefit (33% vs 25%, p=0.02). Eluxadoline is a gut-targeting μ and κ opioid receptor agonist and a δ opioid receptor antagonist. The dual mechanism of eluxadoline may explain the antidiarrheal and abdominal pain-modulating properties and lack of profound constipation. In two identically designed randomized, double-blind, placebo-controlled phase III studies, 10.3% more patients in an eluxadoline 100 mg by mouth twice/day group met the primary efficacy end point during the follow-up 1-12 week period compared with placebo (p<0.001). The primary efficacy end point was a composite response, defined as improvement in worst abdominal pain and stool consistency at the same time on most (50% or more) days during the follow-up period. This review evaluates evidence for the use of rifaximin and eluxadoline in patients with IBS-D. Rifaximin provides an additional modality for the management of IBS-D patients; it has mild to moderate efficacy similar to other currently available treatment options. Rifaximin is relatively safe, lacks significant drug-drug interactions, and can be used for up to two additional retreatment courses. This may make rifaximin a possible initial or second-line treatment option. Eluxadoline can also offer relief to patients with IBS-D. While effective, because of several limitations, including drug-drug interactions and drug disease contraindications, as well as current lack of clinical experience, it may be tried as a second- or third-line agent.

8 Review Rifaximin therapy of irritable bowel syndrome. 2012

Koo, Hoonmo L / Sabounchi, Saman / Huang, David B / DuPont, Herbert L. ·Baylor College of Medicine, Houston, TX. ; University of Texas at Houston School of Public Health, Houston, TX. · Baylor College of Medicine, Houston, TX. · Veterans Affairs Medical Center, East Orange, NJ. · Baylor College of Medicine, Houston, TX. ; University of Texas at Houston School of Public Health, Houston, TX. ; St. Luke's Episcopal Hospital. ·Clin Med Insights Gastroenterol · Pubmed #24833932.

ABSTRACT: Irritable bowel syndrome (IBS) is a common gastrointestinal disorder characterized by abdominal pain and altered bowel habits in the absence of specific organic pathology. Although the underlying pathogenesis of IBS is not well-understood, small intestinal bacterial overgrowth (SIBO) or other abnormalities in the gut flora is believed to contribute to the development of a subset of IBS cases. Rifaximin is a poorly absorbed antimicrobial with activity against enteric pathogens. A number of studies have shown a significant improvement in IBS symptoms with antibiotic therapy including rifaximin. In this review, we discuss the pharmacokinetics, in vitro susceptibility profile, and efficacy and safety data from clinical trials of rifaximin treatment of IBS.

9 Clinical Trial Efficacy and Safety of Eluxadoline in Patients With Irritable Bowel Syndrome With Diarrhea Who Report Inadequate Symptom Control With Loperamide: RELIEF Phase 4 Study. 2019

Brenner, Darren M / Sayuk, Gregory S / Gutman, Catherine R / Jo, Esther / Elmes, Steven J R / Liu, Louis W C / Cash, Brooks D. ·Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA. · Washington University School of Medicine, St. Louis, Missouri, USA. · St. Louis VA Medical Center, St Louis, Missouri, USA. · Allergan plc, Madison, New Jersey, USA. · Allergan plc, Irvine, California, USA. · Toronto Western Hospital, University Health Network, Department of Medicine, University of Toronto, Toronto, Ontario, Canada. · McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA. ·Am J Gastroenterol · Pubmed #31356229.

ABSTRACT: OBJECTIVES: Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder with limited effective treatment options. We evaluated the efficacy and safety of eluxadoline in patients with IBS-D who reported inadequate symptom control with prior loperamide. METHODS: Three hundred forty-six adults with IBS-D (Rome III criteria) were randomly assigned to placebo or eluxadoline 100 mg twice daily for 12 weeks. Patients recorded daily IBS-D symptoms, including worst abdominal pain (WAP) and stool consistency (through Bristol Stool Scale). The primary endpoint was proportion of composite responders, defined as patients who met daily composite response criteria (≥40% WAP improvement and <5 Bristol Stool Scale score) for at least 50% of treatment days, and recorded ≥60 days of diary entries over the 12-week period. RESULTS: Over 12 weeks, a significantly greater proportion of eluxadoline patients achieved the primary composite responder endpoint compared to placebo (22.7% vs 10.3%, P = 0.002), and component endpoints of improvements in stool consistency (27.9% vs 16.7%, P = 0.01) and WAP (43.6% vs 31.0%, P = 0.02). Additionally, a greater proportion of eluxadoline patients met the composite responder endpoint assessed at monthly intervals compared to placebo (weeks 1-4: 14.0% vs 6.9%, P = 0.03; weeks 5-8: 26.7% vs 14.9%, P = 0.006; weeks 9-12: 30.8% vs 16.7%, P = 0.002). Rates of adverse events were comparable in both groups (37.4% vs 35.3%); no treatment-related serious adverse event, cases of sphincter of Oddi spasm, or pancreatitis were reported. DISCUSSION: Eluxadoline appears safe and effective for treating IBS-D symptoms in patients with an intact gallbladder reporting inadequate relief with prior loperamide use.

10 Clinical Trial Rifaximin is associated with modest, transient decreases in multiple taxa in the gut microbiota of patients with diarrhoea-predominant irritable bowel syndrome. 2019

Fodor, Anthony A / Pimentel, Mark / Chey, William D / Lembo, Anthony / Golden, Pamela L / Israel, Robert J / Carroll, Ian M. ·a Department of Bioinformatics and Genomics , University of North Carolina at Charlotte , Charlotte , North Carolina , USA. · b Division of Gastroenterology, Cedars-Sinai Medical Center , Los Angeles , California , USA. · c Division of Gastroenterology, Michigan Medicine , Ann Arbor , Michigan , USA. · d Division of Gastroenterology, Beth Israel Deaconess Medical Center , Boston , Massachusetts , USA. · e Nonclinical and Clinical Pharmacology, Clinical and Medical Affairs, Salix Pharmaceuticals , Bridgewater , New Jersey , USA*. · f Department of Nutrition and Division of Gastroenterology and Hepatology , University of North Carolina , Chapel Hill , North Carolina , USA. ·Gut Microbes · Pubmed #29708822.

ABSTRACT: Rifaximin, a non-systemic antibiotic, is efficacious for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D). Given the emerging association between the gut microbiota and IBS, this study examined potential effects of rifaximin on the gastrointestinal microbial community in patients with IBS-D. TARGET 3 was a randomised, double-blind, placebo-controlled, phase 3 study. Patients with IBS-D initially received open-label rifaximin 550 mg 3 times daily (TID) for 2 weeks. Patients who responded to the initial treatment and then relapsed were randomised to receive 2 repeat courses of rifaximin 550 mg TID or placebo for 2 weeks, with each course separated by 10 weeks. Stool samples were collected at the beginning and end of open-label treatment, at the beginning and end of the first double-blind treatment, and at the end of the study. As a secondary analysis to the TARGET 3 trial, the composition and diversity of the gut microbiota were assessed, from a random subset of patients, using variable 4 hypervariable region 16S ribosomal RNA gene sequencing. Samples from 103 patients were included. After open-label rifaximin treatment for 2 weeks, 7 taxa (e.g. Peptostreptococcaceae, Verrucomicrobiaceae, Enterobacteriaceae) had significantly lower relative abundance at a 10% false discovery rate threshold. The effects of rifaximin were generally short-term, as there was little evidence of significantly different changes in taxa relative abundance at the end of the study (up to 46 weeks) versus baseline. The results suggest that rifaximin has a modest, largely transient effect across a broad range of stool microbes. Future research may determine whether the taxa affected by rifaximin are causally linked to IBS-D. ClinicalTrials.gov identifier number: NCT01543178.

11 Clinical Trial Eluxadoline Efficacy in IBS-D Patients Who Report Prior Loperamide Use. 2017

Lacy, Brian E / Chey, William D / Cash, Brooks D / Lembo, Anthony J / Dove, Leonard S / Covington, Paul S. ·Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA. · Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA. · Division of Gastroenterology and Hepatology, University of South Alabama, Mobile, Alabama, USA. · Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. · Furiex Pharmaceuticals, an affiliate of Allergan plc, Parsippany, New Jersey, USA. ·Am J Gastroenterol · Pubmed #28417992.

ABSTRACT: OBJECTIVES: Irritable bowel syndrome with diarrhea (IBS-D) is often managed with over-the-counter therapies such as loperamide, though with limited success. This analysis evaluated the efficacy of eluxadoline in patients previously treated with loperamide in two phase 3 studies. METHODS: Adults with IBS-D (Rome III criteria) were enrolled and randomized to placebo or eluxadoline (75 or 100 mg) twice daily for 26 (IBS-3002) or 52 (IBS-3001) weeks. Patients reported loperamide use over the previous year and recorded their rescue loperamide use during the studies. The primary efficacy end point was the proportion of patients with a composite response of simultaneous improvement in abdominal pain and reduction in diarrhea. RESULTS: A total of 2,428 patients were enrolled; 36.0% reported prior loperamide use, of whom 61.8% reported prior inadequate IBS-D symptom control with loperamide. Among patients with prior loperamide use, a greater proportion treated with eluxadoline (75 and 100 mg) were composite responders vs. those treated with placebo with inadequate prior symptom control, over weeks 1-12 (26.3% (P=0.001) and 27.0% (P<0.001) vs. 12.7%, respectively); similar results were observed over weeks 1-26. When daily rescue loperamide use was imputed as a nonresponse day, the composite responder rate was still higher in patients receiving eluxadoline (75 and 100 mg) vs. placebo over weeks 1-12 (P<0.001) and weeks 1-26 (P<0.001). Adverse events included nausea and abdominal pain. CONCLUSIONS: Eluxadoline effectively and safely treats IBS-D symptoms of abdominal pain and diarrhea in patients who self-report either adequate or inadequate control of their symptoms with prior loperamide treatment, with comparable efficacy and safety irrespective of the use of loperamide as a rescue medication during eluxadoline treatment.

12 Clinical Trial Early response predicts a sustained response to eluxadoline in patients with irritable bowel syndrome with diarrhoea in two Phase 3 studies. 2017

Chey, W D / Dove, L S / Andrae, D A / Covington, P S. ·University of Michigan, Ann Arbor, MI, USA. · Former employee of Furiex Pharmaceuticals, Inc., an affiliate of Allergan plc, Parsippany, NJ, USA. · Allergan plc, Parsippany, NJ, USA. ·Aliment Pharmacol Ther · Pubmed #28326568.

ABSTRACT: BACKGROUND: The mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, eluxadoline, is licensed in the USA for the treatment of irritable bowel syndrome with diarrhoea (IBS-D), based on the results of two large Phase 3 clinical trials. AIM: To understand the time course of treatment benefits with eluxadoline by comparing responder rates over the first month of treatment with responder rates over longer treatment intervals. METHODS: In this post hoc analysis of two Phase 3 studies, composite and adequate relief (AR) responder rates were calculated over month 1 and patients were stratified by their responder status. Cumulative counts over subsequent intervals (months 1-3, months 1-6, months 2 through 6) were tallied. RESULTS: The studies randomised 2428 patients. Over month 1, 24.6%, 22.8% and 12.5% of patients were composite responders with eluxadoline 100 mg, eluxadoline 75 mg and placebo respectively. For month 1 responders, 77.8% and 81.5% (over months 1-3) and 70.7% and 73.9% (over months 1-6) showed a continuous response with eluxadoline 100 mg and 75 mg respectively. [Correction added on 5 April 2017, after first online publication: The percentage for the responders over months 1-3 was previously wrong and has been corrected.] Of the month 1 nonresponders, <20% showed a response over months 1-3 or months 1-6. Similar results were seen for the analysis of proportions of AR responders over these time intervals. CONCLUSIONS: Over two-thirds of patients who respond over the first month retain a positive response over 6 months of treatment with eluxadoline, indicating that early clinical response to eluxadoline is associated with sustained benefits for up to 6 months in patients with IBS-D.

13 Clinical Trial Safety of Eluxadoline in Patients with Irritable Bowel Syndrome with Diarrhea. 2017

Cash, Brooks D / Lacy, Brian E / Schoenfeld, Philip S / Dove, Leonard S / Covington, Paul S. ·Department of Medicine, University of South Alabama, Mobile, Alabama, USA. · Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA. · University of Michigan School of Medicine, Ann Arbor, Michigan, USA. · Furiex Pharmaceuticals, Inc., an affiliate of Allergan plc, Parsippany, New Jersey, USA. ·Am J Gastroenterol · Pubmed #27922029.

ABSTRACT: OBJECTIVES: Eluxadoline is a mixed μ-opioid receptor (OR) and κ-OR agonist and δ-OR antagonist, approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D). This analysis evaluated the safety and tolerability of eluxadoline 75 and 100 mg twice daily (BID) in one Phase 2 (IBS-2001) and two Phase 3 (IBS-3001 and IBS-3002) studies. METHODS: Adults with IBS-D (Rome III criteria) were randomized to placebo or eluxadoline (75 or 100 mg) BID for 12 (IBS-2001), 26 (IBS-3002), or 52 (IBS-3001) weeks. Safety data were pooled. Adverse events (AEs) were assessed, with special focus on opioid-related AEs, including suspected sphincter of Oddi spasm (SOS) events. RESULTS: 2,776 patients were included in the enrolled set; the safety set comprised 2,814 patients, based on actual treatments received. The most frequent AEs in the placebo and eluxadoline 75 and 100 mg groups were constipation (2.5, 7.4, and 8.1%, respectively) and nausea (5.0, 8.1, and 7.1%, respectively); discontinuation due to constipation was uncommon (0.3, 1.1, and 1.5%, respectively). Ten SOS events (10/1,839; 0.5%) occurred in eluxadoline-treated patients, manifesting as acute abdominal pain with elevated aminotransferases or lipase, or pancreatitis; all occurred in patients without a gallbladder. Eight of these events occurred with the higher dose of eluxadoline, within 1 week of initiation of therapy, and all resolved with eluxadoline discontinuation. There were five events independently adjudicated as pancreatitis not associated with SOS, three of which were associated with heavy alcohol use. CONCLUSIONS: Eluxadoline was well tolerated in Phase 2 and 3 trials, with constipation and nausea the most common AEs. Consistent with the known adverse effects of opioid agonists, clinically apparent SOS events were observed in eluxadoline-treated patients. All occurred in patients without a gallbladder and the majority were observed in patients on the higher dose of eluxadoline, suggesting a possible association.

14 Clinical Trial Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. 2014

Rao, Satish S C / Quigley, Eamonn M M / Shiff, Steven J / Lavins, Bernard J / Kurtz, Caroline B / MacDougall, James E / Currie, Mark G / Johnston, Jeffrey M. ·Section of Gastroenterology and Hepatology, Georgia Regents University, Augusta, Georgia. · Gastroenterology Division, Houston Methodist Hospital and Weill Cornell Medical College, Houston, Texas. · Forest Research Institute, Jersey City, New Jersey. · Ironwood Pharmaceuticals, Cambridge, Massachusetts. · Ironwood Pharmaceuticals, Cambridge, Massachusetts. Electronic address: jjohnston@ironwoodpharma.com. ·Clin Gastroenterol Hepatol · Pubmed #24075889.

ABSTRACT: BACKGROUND & AIMS: Patients with irritable bowel syndrome with constipation (IBS-C) have abdominal symptoms that vary in severity. Linaclotide, a guanylate cyclase-C agonist, improves abdominal and bowel symptoms in these patients. We examined the prevalence of severe abdominal symptoms in patients with IBS-C and assessed the effects of linaclotide on abdominal symptoms, global measures, and quality of life (QOL). METHODS: In two phase 3 trials, patients who met modified Rome II criteria for IBS-C were randomly assigned to groups given oral, once-daily linaclotide (290 μg) or placebo for 12 weeks. During the baseline (2 weeks prior to treatment) and treatment periods, patients rated abdominal pain, discomfort, bloating, fullness, and cramping daily (from 0 = none to 10 = very severe). Linaclotide's effects on abdominal symptoms, global measures, and IBS-related QOL were assessed in subpopulations of patients who rated specific individual abdominal symptoms as severe (≥ 7.0) at baseline. RESULTS: In the intent-to-treat population (1602 patients; 797 receiving placebo and 805 receiving linaclotide), baseline prevalence values for severe abdominal symptoms were 44% for bloating, 44% for fullness, 32% for discomfort, 23% for pain, and 22% for cramping, with considerable overlap among symptoms. In patients with severe symptoms, linaclotide reduced all abdominal symptoms; mean changes from baseline severity scores ranged from -2.7 to -3.4 for linaclotide vs -1.4 to -1.9 for placebo (P < .0001). Linaclotide improved global measures (P < .0001) and IBS-QOL scores (P < .01) compared with placebo. Diarrhea was the most common adverse event of linaclotide in patients with severe abdominal symptoms (18.8%-21.0%). CONCLUSIONS: Of 5 severe abdominal symptoms assessed, bloating and fullness were most prevalent in patients with IBS-C. Linaclotide significantly improved all abdominal symptoms, global measures, and IBS-QOL in subpopulations of IBS-C patients with severe abdominal symptoms. Clinicaltrials.gov NUMBERS: NCT00938717, NCT00948818.

15 Article Effects of treatment with eluxadoline on abdominal pain in patients with IBS-D: Additional post hoc analyses of Phase 3 trials. 2020

Lembo, Anthony J / Covington, Paul S / Dove, Leonard S / Andrae, David A. ·Harvard Medical School, Boston, MA, USA. · Former employee of Furiex Pharmaceuticals, Inc., an affiliate of Allergan plc, Madison, NJ, USA. · Former employee of Allergan plc, Madison, NJ, USA. ·Neurogastroenterol Motil · Pubmed #31984655.

ABSTRACT: BACKGROUND: Recurring abdominal pain is a characteristic and often unpredictable and debilitating symptom of irritable bowel syndrome with diarrhea (IBS-D). Measuring the effects of IBS-D treatments on abdominal pain remains a significant challenge in clinical trials. Here, we aimed to examine the effect of eluxadoline through various post hoc analyses. METHODS: Data from two eluxadoline Phase 3 trials were pooled over 26 weeks, comparing eluxadoline 100 mg twice daily to placebo. Worst abdominal pain (WAP) was measured daily on a 0-10 scale. WAP responder criteria were prospectively defined as a ≥30% improvement in daily WAP score on ≥50% of days. Pairwise, two-sided Cochran-Mantel-Haenszel tests assessed treatment effects. Cumulative distribution functions were used to plot WAP response rates using variations on the response criteria. KEY RESULTS: Of 1615 patients with IBS-D (66% female, mean age 46 years), 806 received eluxadoline and 809 received placebo; 48.3% and 44.0% were WAP responders (≥30% improvement), respectively (P value not significant). When the response threshold was increased to 50% daily WAP improvement from baseline, a significantly greater percentage of eluxadoline-treated patients versus placebo-treated patients were WAP responders (38.7% vs 32.5%, respectively; P = .009). At Week 26, average WAP changes from baseline were -3.4 and -3.0 points, respectively (P = .002). CONCLUSIONS AND INFERENCES: Despite small effect sizes, eluxadoline demonstrated consistent and sustained improvement in WAP compared to placebo across a range of prospective and post hoc analyses. Assessing WAP response across a range of measures is important for fully understanding a treatment's efficacy.

16 Article Impact of patient and disease characteristics on the efficacy and safety of eluxadoline for IBS-D: a subgroup analysis of phase III trials. 2019

Lacy, Brian E / Harris, Lucinda A / Chang, Lin / Lucak, Susan / Gutman, Catherine / Dove, Leonard S / Covington, Paul S / Lembo, Anthony. ·Division of Gastroenterology and Hepatology, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224, USA. · Mayo Clinic, Scottsdale, AZ, USA. · University of California, Los Angeles, CA, USA. · Weill Cornell Medical Center, New York, NY, USA. · Allergan plc, Madison, NJ, USA. · Former employees of Furiex Pharmaceuticals, Inc., an affiliate of Allergan plc, Madison, NJ, USA. · Beth Israel Deaconess Medical Center, Boston, MA, USA. ·Therap Adv Gastroenterol · Pubmed #31019552.

ABSTRACT: Background: Irritable bowel syndrome with diarrhea (IBS-D) is a prevalent gastrointestinal (GI) disorder with a varied presentation, often overlapping with other GI and non-GI disorders. Eluxadoline is a locally active mixed µ- and κ-opioid receptor agonist and δ-opioid receptor antagonist approved for the treatment of IBS-D in adults. As IBS-D is a heterogeneous disease, factors such as patient demographics, symptom severity, and symptom pattern history can potentially inform treatment selection. Methods: Here, we report additional prospectively planned analyses of two large double-blind, placebo-controlled studies (IBS-3001 and IBS-3002) enrolling patients meeting Rome III criteria for IBS-D. Patients were randomized 1:1:1 to receive placebo or eluxadoline 75 mg or 100 mg twice daily. Efficacy (abdominal pain, stool consistency, and composite, simultaneous improvement in both) and safety were assessed for prospectively defined patient subgroups stratified by age, sex, race, presence of comorbidities, and baseline disease characteristics. Results: Across all age, sex, race, comorbidity, and disease characteristic subgroups, a greater proportion of patients were composite responders with both eluxadoline doses as compared with placebo, including patients with a history of depression or a history of gastroesophageal reflux disease. Among patients aged ⩾65 years, a greater proportion of patients receiving eluxadoline 75 mg were composite, abdominal pain, and stool consistency responders compared with those receiving 100 mg. The proportion of patients with at least one adverse event was slightly higher in patients aged ⩾65 years and also in female patients. Conclusions: This analysis suggests that eluxadoline is effective in treating IBS-D across a range of commonly encountered patient types. In contrast to the overall population, patients aged ⩾65 years demonstrated a greater proportion of responders at the lower approved 75 mg eluxadoline dose.

17 Article The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea. 2019

Abel, Jessica L / Carson, Robyn T / Andrae, David A. ·Allergan plc, 5 Giralda Farms, Madison, NJ, 07940, USA. Jessica.Abel@allergan.com. · Allergan plc, 5 Giralda Farms, Madison, NJ, 07940, USA. ·Qual Life Res · Pubmed #30267294.

ABSTRACT: PURPOSE: Irritable bowel syndrome with diarrhea (IBS-D) significantly impacts health-related quality of life (HRQOL). This post hoc analysis of two phase III trials evaluated the effects of eluxadoline treatment on disease-specific HRQOL among patients with IBS-D. METHODS: Adult patients meeting Rome III criteria for IBS-D were randomized to oral eluxadoline (75 mg or 100 mg) or placebo twice daily in two phase III clinical trials for 52 weeks (IBS-3001) and 26 weeks (IBS-3002). The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire assessed disease-specific HRQOL throughout the study. Changes from baseline to Week 26 in IBS-QOL total and subscale scores were analyzed using an analysis of covariance model. Percentages of IBS-QOL responders with ≥ 14- and 20-point changes were evaluated for IBS-QOL total and subscale scores. A longitudinal mixed-effects model was fitted to evaluate mean IBS-QOL total scores. A cumulative distribution function for change from baseline to Week 26 in IBS-QOL total score was plotted. RESULTS: Mean changes from baseline to Week 26 for the IBS-QOL total and all subscale scores were significantly higher for patients treated with eluxadoline (both doses) compared to placebo. A significantly greater proportion of eluxadoline-treated patients were responders compared to placebo. Mean and mixed-effects model estimated mean IBS-QOL total scores were consistently higher for eluxadoline versus placebo over 52 weeks. CONCLUSIONS: Compared to placebo, twice-daily eluxadoline treatment significantly improved HRQOL among patients with IBS-D in two phase III trials.

18 Article None 2018

Majeed, Muhammed / Nagabhushanam, Kalyanam / Arumugam, Sivakumar / Majeed, Shaheen / Ali, Furqan. ·Sami Labs Limited, Bangalore, Karnataka, India. · Sabinsa Corporation, East Windsor, NJ, USA. · Sabinsa Corporation, Payson, UT, USA. · ClinWorld Private Limited, Bangalore, Karnataka, India. ·Food Nutr Res · Pubmed #29997457.

ABSTRACT: Background: The modification of microbial ecology in human gut by supplementing probiotics may be an alternative strategy to ameliorate or prevent depression. Objective: The current study was conducted to assess the safety and efficacy of the probiotic strain Method: Patients ( Results: Significant change (

19 Article Radar plots: A novel modality for displaying disparate data on the efficacy of eluxadoline for the treatment of irritable bowel syndrome with diarrhea. 2018

Brenner, D M / Dove, L S / Andrae, D A / Covington, P S / Gutman, C / Chey, W D. ·Northwestern University Feinberg School of Medicine, Chicago, IL, USA. · Consultant to Allergan plc, Madison, NJ, USA. · Former employee of Allergan plc, Madison, NJ, USA. · Former employee of Furiex Pharmaceuticals, Inc., an affiliate of Allergan plc, Madison, NJ, USA. · Allergan plc, Madison, NJ, USA. · University of Michigan, Ann Arbor, MI, USA. ·Neurogastroenterol Motil · Pubmed #29575372.

ABSTRACT: BACKGROUND: Patients with irritable bowel syndrome with diarrhea (IBS-D) experience a range of abdominal and bowel symptoms; successful management requires alleviation of this constellation of symptoms. Eluxadoline, a locally active mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, is approved for the treatment of IBS-D in adults based on the results of 2 Phase 3 studies. Radar plots can facilitate comprehensive, visual evaluation of diverse but interrelated efficacy endpoints. METHODS: Two double-blind, placebo-controlled, Phase 3 trials (IBS-3001 and IBS-3002) randomized patients meeting Rome III criteria for IBS-D to twice-daily eluxadoline 75 or 100 mg or placebo. Radar plots were prepared showing pooled Weeks 1-26 response rates for the primary efficacy composite endpoint (simultaneous improvement in abdominal pain and stool consistency), stool consistency, abdominal pain, urgency-free days, and adequate relief, and change from baseline to Week 26 in IBS-D global symptom score, abdominal discomfort, abdominal pain, abdominal bloating, and daily number of bowel movements. KEY RESULTS: The studies enrolled 2428 patients. Eluxadoline increased Weeks 1-26 responder proportions vs placebo for the composite endpoint, stool consistency, abdominal pain, urgency-free days, and adequate relief. Changes from baseline to Week 26 in IBS-D global symptom score, abdominal discomfort, abdominal pain, abdominal bloating, and number of bowel movements were greater with eluxadoline vs placebo. CONCLUSIONS AND INFERENCES: Data presentation in radar plot format facilitates interpretation across multiple domains, demonstrating that eluxadoline treatment led to improvements vs placebo across 13 endpoints representing the range of symptoms experienced by patients with IBS-D.

20 Article Research Design Characteristics of Published Pharmacologic Randomized Clinical Trials for Irritable Bowel Syndrome and Chronic Pelvic Pain Conditions: An ACTTION Systematic Review. 2018

Gewandter, Jennifer S / Chaudari, Jenna / Iwan, Katarzyna B / Kitt, Rachel / As-Sanie, Sawsan / Bachmann, Gloria / Clemens, Quentin / Lai, H Henry / Tu, Frank / Verne, G Nicholas / Vincent, Katy / Wesselmann, Ursula / Zhou, QiQi / Turk, Dennis C / Dworkin, Robert H / Smith, Shannon M. ·Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York. Electronic address: jennifer_gewandter@urmc.rochester.edu. · Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York. · Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan. · Department of Obstetrics, Gynecology, and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey. · Department of Urology, University of Michigan, Ann Arbor, Michigan. · Departments of Surgery and Anesthesiology, Washington University, St. Louis, Missouri. · Department of Obstetrics and Gynecology, North Shore University Health System Evanston and University of Chicago Pritzker School of Medicine, Chicago, Illinois. · Department of Medicine, Tulane University, New Orleans, Louisiana. · Nuffield Department of Obstetrics and Gynecology, University of Oxford, Oxford, United Kingdom. · Departments of Anesthesiology, Neurology, and Psychology, University of Alabama at Birmingham, Birmingham, Alabama. · Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington. ·J Pain · Pubmed #29412183.

ABSTRACT: Chronic pain conditions occurring in the lower abdomen and pelvis are common, often challenging to manage, and can negatively affect health-related quality of life. Methodological challenges in designing randomized clinical trials (RCTs) for these conditions likely contributes to the limited number of available treatments. The goal of this systematic review of RCTs of pharmacologic treatments for irritable bowel syndrome and 3 common chronic pelvic pain conditions are to: 1) summarize the primary end points and entry criteria, and 2) evaluate the clarity of reporting of important methodological details. In total, 127 RCTs were included in the analysis. The most common inclusion criteria were a minimum pain duration (81%), fulfilling an established diagnostic criteria (61%), and reporting a minimum pain intensity (42%). Primary end points were identified for only 57% of trials. These end points, summarized in this article, were highly variable. The results of this systematic review can be used to inform future research to optimize the entry criteria and outcome measures for pain conditions occurring in the lower abdomen and pelvis, to increase transparency in reporting to allow for proper interpretation of RCT results for clinical and policy applications, and to facilitate the aggregation of data in meta-analyses. PERSPECTIVE: This article summarizes entry criteria and outcome measures and the clarity of reporting of these important design features in RCTs of irritable bowel syndrome and 3 common chronic pelvic pain conditions. These results can be used to improve design of future trials of these largely unaddressed pain conditions.

21 Article Response to Croteau and Barkin. 2017

Cash, Brooks D / Lacy, Brian E / Schoenfeld, Philip S / Dove, Leonard S / Covington, Paul S. ·University of South Alabama, Mobile, Alabama, USA. · Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA. · University of Michigan School of Medicine, Ann Arbor, Michigan, USA. · Allergan plc, Parsippany, New Jersey, USA. · Furiex Pharmaceuticals, Allergan plc, Parsippany, New Jersey, USA. ·Am J Gastroenterol · Pubmed #28978962.

ABSTRACT: -- No abstract --

22 Article Repeat treatment with rifaximin improves irritable bowel syndrome-related quality of life: a secondary analysis of a randomized, double-blind, placebo-controlled trial. 2017

Cash, Brooks D / Pimentel, Mark / Rao, Satish S C / Weinstock, Leonard / Chang, Lin / Heimanson, Zeev / Lembo, Anthony. ·University of South Alabama, Digestive Health Center, 75 S. University Blvd, Suite 6000-B, Mobile, AL 36608, USA. · GI Motility Program, Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. · Section of Gastroenterology/Hepatology, Digestive Health Center, Medical College of Georgia Augusta University, Augusta, GA, USA. · Specialists in Gastroenterology, LLC, Washington University School of Medicine, St Louis, MO, USA. · Division of Digestive Diseases/Gastroenterology, David Geffen School of Medicine at UCLA, UCLA, Los Angeles, CA, USA. · Salix Pharmaceuticals, Bridgewater, NJ, USA. · Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA. ·Therap Adv Gastroenterol · Pubmed #28932270.

ABSTRACT: BACKGROUND: Diarrhea-predominant irritable bowel syndrome (IBS-D) impairs patient quality of life (QOL). Rifaximin is an oral, nonsystemic antibiotic indicated for IBS-D. The objective of this secondary analysis was to evaluate rifaximin retreatment on IBS-related QOL in patients with IBS-D. METHODS: Patients received open-label rifaximin 550 mg three times daily for 2 weeks. Clinical responders [simultaneously meeting weekly response criteria for abdominal pain (⩾30% improvement from baseline in mean weekly pain score) and stool consistency (⩾50% decrease from baseline in number of days/week with Bristol Stool Scale (BSS) type 6 or 7 stools) during ⩾2 of first 4 weeks posttreatment] who relapsed during an up to 18-week treatment-free observation phase were randomly assigned to receive two 2-week courses of double-blind rifaximin or placebo, separated by 10 weeks. A validated 34-item IBS-QOL questionnaire examined patient responses in 8 domains. RESULTS: The 2579 patients receiving open-label rifaximin experienced a mean improvement from baseline in IBS-QOL overall score of 54.9%. Responders to open-label rifaximin ( CONCLUSIONS: Open-label and blinded retreatment with a short course (2 weeks) of rifaximin improved IBS-QOL in patients with IBS-D [ClinicalTrials.gov identifier: NCT01543178].

23 Article Clopidogrel IBS Patients Have Higher Incidence of Gastrointestinal Symptoms Influenced by Age and Gender. 2017

Soghomonyan, Suren / Abdel-Rasoul, Mahmoud / Zuleta-Alarcon, Alix / Grants, Iveta / Davila, Victor / Yu, Jeffrey / Zhang, Cheng / Whitaker, Emmett E / Bergese, Sergio D / Stoicea, Nicoleta / Arsenescu, Razvan / Christofi, Fievos L. ·Department of Anesthesiology, The Wexner Medical Center, The Ohio State University, 420 West 12th Ave, Room 226, Columbus, OH, 43210, USA. · Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University, 1800 Cannon Drive, Room 320, Columbus, OH, 43210, USA. · Department of Internal Medicine, Wexner Medical Center, The Ohio State University, 395 West 12th Ave, Suite 200, Columbus, OH, 43210, USA. · Department of Anesthesiology and Pain Medicine, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA. · Atlantic Inflammatory Bowel Disease Center of Excellence, Atlantic Digestive Health Institute, 435 South Street, Suite 205, Morristown, NJ, 07960, USA. · Department of Anesthesiology, The Wexner Medical Center, The Ohio State University, 420 West 12th Ave, Room 226, Columbus, OH, 43210, USA. Fedias.Christofi@osumc.edu. ·Dig Dis Sci · Pubmed #28840395.

ABSTRACT: BACKGROUND: Clopidogrel is an irreversible antagonist of P2Y AIM: To evaluate if blockade of P2Y METHODS: A retrospective analysis of our institutional database was conducted for a 13-year period. IBS patients were identified, and their demographics, GI symptoms and clopidogrel therapy were collected. Logistic regression models were used to characterize symptoms in clopidogrel versus no-clopidogrel IBS-groups, adjusting for Age and Sex differences. An additional study characterized the P2Y RESULTS: The search identified 7217 IBS patients (6761 no-clopidogrel/456 clopidogrel). There were a higher proportion of patients with GI symptoms on clopidogrel (68%) compared to controls (60%, p = 0.0011) that were Females (70 vs. 60%, p = 0.0003) not Males (61 vs. 60%; p = 0.8312). In Females, clopidogrel was associated with higher incidence of GI symptoms (Age adjusted; p < 0.0001) for pain, constipation, gastroparesis (p ≤ 0.0001) and psychogenic pain (p = 0.0006). Age or Sex (adjusted models) influenced one or more GI symptoms (i.e., pain, p < 0.0001; constipation, p < 0.0001/p = 0.008; diarrhea, flatulence, p = 0.01). P2Y CONCLUSIONS: Irreversible blockade of P2Y

24 Article Effect of Hepatic Impairment on Eluxadoline Pharmacokinetics. 2017

Marbury, Thomas C / Berg, Jolene Kay / Dove, Leonard S / Covington, Paul S. ·Orlando Clinical Research Center, Orlando, FL, USA. · DaVita Clinical Research, Minneapolis, MN, USA. · Consultant to Allergan plc, Parsippany, NJ, USA. · Former employee of Furiex Pharmaceuticals, Inc, an affiliate of Allergan plc, Parsippany, NJ, USA. ·J Clin Pharmacol · Pubmed #28719721.

ABSTRACT: -- No abstract --

25 Article Isotretinoin in retrospect. 2017

Karadag, Ayse Serap / Parish, Lawrence Charles / Lambert, Wm Clark. ·Department of Dermatology, Istanbul Medeniyet University School of Medicine, Istanbul, Turkey. Electronic address: karadagaserap@gmail.com. · Department of Dermatology and Cutaneous Biology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania. · Departments of Dermatology and Pathology and Laboratory Medicine, Rutgers-New Jersey Medical School, Newark, New, Jersey. ·Clin Dermatol · Pubmed #28511833.

ABSTRACT: -- No abstract --

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