Help
Subscribe


GastroHep.com - the global online resource for all aspects of gastroenterology, hepatology and endoscopy

 21 October 2017

Advanced search
GastroHep.com - the global online resource for all aspects of gastroenterology, hepatology and endoscopy Profile of Roy Pounder

Home

News  
Journals
Review Articles
Slide Atlas
Video Clips
Online Books
Advanced Digestive Endoscopy
Classical Cases
Conference Diary
PubMed
International GH Links
USA GH Links
National GH Links
National GI Societies
Other Useful Links




Emails on Gastroenterology and Hepatology
the National AIDS Treatment Advocacy Project
Visit the gastroenterology section of the EUMS

News

Eluxadoline apears to be safe in patients with IBS-diarrhea

This month's issue of the American Journal of Gastroenterology examines the safety of eluxadoline in patients with IBS-diarrhea.

News image

Eluxadoline is a mixed µ-opioid receptor and ?-opioid receptor agonist and d-opioid receptor antagonist, approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Dr Brooks Cash and colleagues from Alabama, USA evaluated the safety and tolerability of eluxadoline 75 and 100mg twice daily (BID) in one Phase 2 (IBS-2001) and two Phase 3 (IBS-3001 and IBS-3002) studies.

Adults with IBS-D were randomized to placebo or eluxadoline BID for 12 (IBS-2001), 26 (IBS-3002), or 52 (IBS-3001) weeks.

Safety data were pooled.

Adverse events were assessed, with special focus on opioid-related adverse events, including suspected sphincter of Oddi spasm events.

The research team included 2,776 patients in the enrolled set.

The team reported that the safety set comprized 2,814 patients, based on actual treatments received.

The most frequent adverse events in the placebo and eluxadoline 75 and 100?mg groups were constipation, and nausea.

The team observed that discontinuation due to constipation was uncommon.

There were 10 SOS events that occurred in eluxadoline-treated patients, manifesting as acute abdominal pain with elevated aminotransferases or lipase, or pancreatitis; all occurred in patients without a gallbladder.

The researchers observed that 8 of these events occurred with the higher dose of eluxadoline, within 1 week of initiation of therapy, and all resolved with eluxadoline discontinuation.

The team found that there were 5 events independently adjudicated as pancreatitis not associated with SOS, three of which were associated with heavy alcohol use.

Dr Brooks' team comments, "Eluxadoline was well tolerated in Phase 2 and 3 trials, with constipation and nausea the most common adverse events."

"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."

Am J Gastroenterol 2017; 112:365–374
27 February 2017

Go to top of page Email this page Email this page to a colleague

 20 October 2017 
Food elimination diets for treatment of adults with eosinophilic esophagitis
 20 October 2017 
Conversion of planned colonoscopy to sigmoidoscopy
 20 October 2017 
Hospital readmissions reduction program
 19 October 2017 
Surgical anastomosis at 1-year colorectal cancer surveillance
 19 October 2017 
Fecal immunochemical tests in colorectal cancer screening
 19 October 2017 
Current management of chylous ascites
 18 October 2017 
Predicting recurrence after curative rectal cancer surgery
 18 October 2017 
Hep E seroprevalence and hemodialysis
 18 October 2017 
Prebiotic and changes in the human gut microbiota
 17 October 2017 
Laparoscopic surgery use in Medicare patients with colon cancer
 17 October 2017 
Medication nonadherence and health care costs
 17 October 2017 
Asthma and IBD development
 16 October 2017 
Colorectal cancer screening and postpolypectomy surveillance colonoscopy
 16 October 2017 
Continuity of care after colorectal surgery
 16 October 2017 
Breastfeeding and the risk of IBD
 13 October 2017 
Treating patients with HCV and severe renal impairment
 13 October 2017 
Blood pressure management during abdominal surgery
 13 October 2017 
Food elimination diets for eosinophilic esophagitis
 12 October 2017 
Global recurrence of H. pylori
 12 October 2017 
Colonoscopy in an organized colorectal cancer screening program 
 12 October 2017 
Predicting advanced fibrosis in chronic hepatitis B
 11 October 2017 
Fecal microbiota transplantation for ulcerative colitis
 11 October 2017 
Sexual functioning in Hep C
 11 October 2017 
Ulcerative proctitis in pediatric-onset UC
 10 October 2017 
Quality standards in upper gastrointestinal endoscopy
 10 October 2017 
Eosinophilic esophagitis and swallowed topical corticosteroids
 10 October 2017 
Follow-up of positive results on fecal blood tests
 09 October 2017 
Diverticulitis and emergency department burden
 09 October 2017 
Global recurrence rate of H. pylori
 09 October 2017 
Clostridium difficile infection after ileostomy reversal
 06 October 2017 
Predicting nontreatment for Hep C
 06 October 2017 
Cow's milk–based formula and development of celiac disease
 06 October 2017 
Propofol for outpatient colonoscopy
 05 October 2017 
Pediatric candidates on the transplant wait list
 05 October 2017 
Incidence of sepsis in the USA
 05 October 2017 
Quality of life after chemoradiation in rectal cancer
 04 October 2017 
Clinical practice guidelines in colon cancer
 04 October 2017 
Peptic ulcer disease diagnosed in acute upper endoscopy
 04 October 2017 
Rural residence and risk of IBD
 03 October 2017 
Novel candidate risk genes for IBD
 03 October 2017 
Antibody tests and detecting celiac disease
 03 October 2017 
Environmental factors and IBD
 02 October 2017 
Full publication of Gastroenerology abstracts
 02 October 2017 
Interferon-free therapy in advanced liver disease
 02 October 2017 
Burden of NAFLD with advanced fibrosis in the USA
 29 September 2017 
Inpatient Gastroenterology training experience
 29 September 2017 
Proteomic analysis of IBD
 28 September 2017 
Social networking-based discussion group by ERCP doctors
 28 September 2017 
Incidence of biopsy-verified celiac disease
 27 September 2017 
Predictors of nonadherence in IBD
 27 September 2017 
Hep C treatment in the era of direct-acting anti-viral agents
 27 September 2017 
Function of trypsin-3 in IBS
 26 September 2017 
Chronic pancreatitis and pancreatic cancer risk
 26 September 2017 
Factors associated with the risk of metachronous gastric neoplasm
 26 September 2017 
Treatment of hyperactive delirium in advanced cancer
 25 September 2017 
Lenalidomide for advanced liver cancer
 25 September 2017 
Silibinin nanoparticles inhibit HCV infection
 22 September 2017 
Perforation after colonic endoscopic mucosal resection
 22 September 2017 
Medical management and colectomy rates
 22 September 2017 
MRI for liver metastatic colorectal cancer

Blackwell Publishing


GastroHep.com is a Blackwell Publishing registered trademark
© 2017 Wiley-Blackwell and GastroHep.com and contributors
Privacy Statement
Disclaimer
About Us