Gastrohepatic Disorders

Novel <i>H. pylori</i> Eradication Therapy Effective in Phase 3 Trial

By December 04, 2018

The ERADICATE Hp2 trial enrolled 455 dyspepsia patients at 55 sites across the US and randomized them to receive 4 capsules, 3 times daily, of either Talicia or the active comparator (amoxicillin 250mg and omeprazole 10mg), for a period of 14 days.

Hypnotherapy vs Education for Relief of IBS Symptoms

November 30, 2018

A total of 354 participants were randomly assigned to individual hypnotherapy, group hypnotherapy, and educational supportive therapy; after excluding ineligible participants, 142, 146, and 54 participants, respectively.

Novel NASH Treatment Gets FDA's Fast Track Designation

By November 28, 2018

The Company has completed a first in human study in healthy volunteers; a Phase 2 trial in adults with NASH is due to begin soon in the US.

Probiotics Show No Benefits for Pediatric Acute Gastroenteritis

November 26, 2018

No benefits seen with Lactobacillus rhamnosus GG or L. rhamnosus R0011 and L. helveticus R0052

FDA Approves Longer Shelf Life for Nityr Tablets

By November 20, 2018

HT-1 is a rare genetic disease that can cause hepatic, renal and peripheral nerve damage.

DAA Treatment and Hepatic Fibrosis Improvement in HCV: What's the Link?

By November 13, 2018

The study aimed to determine whether direct-acting antiviral therapy reduced fibrosis and assessed whether any predictors of treatment failure existed at 1-year follow-up.

Avocado Implicated in Several Food Protein-Induced Enterocolitis Syndrome Cases

By October 29, 2018

FPIES is a gastrointestinal food-associated hypersensitivity that often affects infants and toddlers and is marked by vomiting, diarrhea, fatigue, and pallor.

Opiate-Free Surgery Feasible for Elective Colectomy

October 23, 2018

The researchers found that 83% of the patients required no narcotic medication postoperatively. Preoperative opioid use significantly predicted postoperative narcotic requirement.

Palonosetron Available in Prefilled Syringe for Chemotherapy-Induced Nausea, Vomiting

By October 22, 2018

The prefilled syringe is part of the Company's Simplist portfolio and is the first FDA-approved prefilled delivery version of palonosetron hydrochloride (HCI) to become available.

FDA Panel Votes on Prucalopride for Chronic Idiopathic Constipation

By October 19, 2018

The panel's decision was made based on data from from five Phase 3 studies and one Phase 4 trial which evaluated the safety and efficacy of prucalopride in patients with chronic constipation.

AGA: New Opioid-Induced Constipation Management Guidelines Available

By October 18, 2018

The recommendations have been published in the AGA's official journal, Gastroenterology.

Posttransplant Outcomes Assessed in Patients Who Resumed TNFi Therapy

By October 18, 2018

Of the 5256 patients who received a renal transplant in the study window (1/1/1998 - 12/31/2017), 14 met inclusion criteria.

Treatment for Alagille Syndrome Granted Orphan Drug Designation

By October 17, 2018

Alagille syndrome affects approximately 1 in 70,000 newborns.

Novel Blood Test for Irritable Bowel Syndrome Now Available

By October 10, 2018

The test works by measuring levels of anti-cytolethal distending toxin B (CdtB) and anti-vinculin, 2 biomarkers of post-infectious IBS-D and IBS-M.

Ustekinumab Induces Clinical Remission After One Dose in Ulcerative Colitis Study

By October 10, 2018

Study authors at the American College of Gastroenterology (ACG) Scientific Meeting 2018 presented late-breaking data from the induction phase of the Phase 3 UNIFI study.

Rituximab Linked to HBV Reactivation in Patients With Prior Functional Cure

By October 09, 2018

The study authors searched MEDLINE from inception through July 2018 to obtain relevant cohort studies and randomized trials assessing HBVr incidence secondary to pharmaceutical agents.

Probiotic Use May Not Protect Against <i>Clostridium Difficile</i> Infection

October 05, 2018

In patients taking multiple antibiotics, proton pump inhibitors, or histamine receptor antagonists, the concurrent use of probiotics was associated with an increased incidence of Clostridium difficile infection

Sucraid Supply Restored for Patients With Genetic Sucrase-Isomaltase Deficiency

By October 02, 2018

The Company stated that they are now able to meet all prescription demands for Sucraid without informed consent.

Proton Pump Inhibitor Use Tied to Hip Fracture in Dialysis Patients

September 28, 2018

The researchers found that a larger proportion of cases than controls had prior PPI use (70 vs 63%) or histamine-2 receptor antagonist use (25 vs 23%).

Reflux Band Now Available OTC for Reducing Laryngopharyngeal Reflux

By September 26, 2018

In one study, 86% of patients clinically diagnosed with esophagopharyngeal reflux reported significant reduction in symptoms after 2 weeks of use.

Antibiotic Tx Appears to Be a Reasonable Option for Uncomplicated Acute Appendicitis

By September 26, 2018

The study included 530 patients, aged 18 to 60 years, with computed tomography-confirmed uncomplicated acute appendicitis.

On-Demand PPI Use Examined in Non-Erosive Reflux Disease, Mild Erosive Esophagitis

By September 20, 2018

Results of the study found on-demand PPI use to be superior to daily administration of a PPI (pooled OR: 0.50; 95% CI: 0.35, 0.72).

Infant PPI Use and Lung Infection Risk: Is There a Link?

By September 20, 2018

The data showed matched odds ratio for current vs past use of PPIs to be 0.88 (95% CI, 0.36 to 2.16) when comparing cases and their controls for community-acquired pneumonia. With regard to lower respiratory tract infections, the matched odds ratio between cases and their controls was 1.13 (95% CI, 0.87 to 1.48).

Tenapanor NDA Submitted for Irritable Bowel Syndrome With Constipation

By September 14, 2018

Tenapanor, a minimally-systemic small molecule, inhibits the sodium transporter NHE3 and reduces sodium absorption in the gastrointestinal tract, thus increasing intestinal fluid.

Out-of-Pocket Costs Similar for Infliximab, Infliximab-Dyyb

September 05, 2018

"Although biosimilar gap discounts begin in 2019, infliximab-dyyb may still not significantly reduce Part D beneficiaries' out-of-pocket costs given its high price and coinsurance cost-sharing similar to infliximab," the authors write.

FDA Warns of Dangers of Liquid Nitrogen in Food, Drinks

September 04, 2018

Liquid nitrogen isn't toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release.

Drinking Water Turned Off in All Detroit's Public Schools

August 31, 2018

Recent tests revealed "higher than acceptable levels... (of) copper and/or lead" in at least 1 water source - such as a fountain or sink - at 16 of 24 schools, Vitti said.

Secretagogues Compared in Irritable Bowel Syndrome With Constipation

By August 29, 2018

While several secretagogues have been recently approved by the Food and Drug Administration (FDA), a lack of head-to-head trials led researchers to conduct a systematic review to compare the effectiveness of these agents in patients with IBS-C.

Odds of Marijuana Use Up With Nausea, Vomiting in Pregnancy

August 27, 2018

The prevalence of prenatal marijuana use was 5.3% by self-report or toxicologic test findings; prevalence was greater among females with severe and mild versus no NVP (11.3 and 8.4, respectively, vs 4.5%).