Rifaximin

The annual meeting of the American College of Gastroenterology was held from Oct. 25 to 30 in Philadelphia and attracted participants from around the world, including gastroenterology and digestive disease specialists and other health care professionals. The conference featured presentations focusing on clinical updates in gastroenterology and hepatology as well as the latest advances in digestive health and gastrointestinal disorders. In one study, Khaled Alsabbagh Alchirazi, M.D., of Aurora Healthcare in Brookfield, Wisconsin, and colleagues found that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are not associated with an increased risk for pancreatic cancer among patients with type 2 diabetes mellitus (T2DM). The authors evaluated the association between GLP-1 RAs and pancreatic cancer risk among T2DM patients. Deidentified electronic health records (EHRs) were used to identify patients with T2DM who were prescribed antidiabetic medications between 2005 and 2020 and had no prior antidiabetic drug use and no prior diagnosis of pancreatic cancer. The researchers compared GLP-1 RAs to other antidiabetic medications and found that T2DM patients on GLP-1 RAs did not have an increased incidence of pancreatic cancer. "Clinicians could consider GLP-1 RAs as a viable option for diabetes treatment, guiding more confident decision-making in long-term diabetes care," Alchirazi said. One author disclosed ties to Boston Scientific and Cook Endoscopy. Abstract No. 52 In another study, Temi Olasehinde, M.D., of Case Western Reserve University in Cleveland, and colleagues found that GLP-1 RAs may serve as protective agents against early-onset colorectal cancer (EO-CRC), which is relevant given the disease's rising incidence and mortality worldwide. The authors evaluated the impact of the use of GLP-1 RAs on EO-CRC among patients with T2DM. A retrospective cohort study was performed using data from deidentified EHRs. The researchers found that GLP-1 RA use was associated with a significantly decreased risk for EO-CRC development in patients with T2DM with or without obesity. "Our findings will need to be validated further in prospective studies," Olasehinde said. "However, it does show the potential for this agent to be used as a protective agent against EO-CRC, thereby adding to the growing body of research looking at preventative/risk-tailored strategies to decrease the risk of EO-CRC in this population." Abstract No. P2134 Jacqueline Khalil, D.O., of Case Western Reserve University/Metro Health in Beachwood, Ohio, and colleagues identified an association between hormone replacement therapy and an increased risk for developing irritable bowel syndrome (IBS), a risk that persisted over time. A population-based cohort study was performed using data from deidentified EHRs for postmenopausal women aged 50 years or older, with and without a prescription for hormone replacement therapy. The researchers found that hormone replacement therapy was associated with a higher risk for developing IBS. In addition, hormone replacement therapy correlated with elevated gastrointestinal symptoms, including abdominal distention and flatulence, increased medication utilization (particularly with medications prescribed to patients with IBS), and increased diagnostic testing. "These findings emphasize the importance of considering the potential consequences of hormone replacement therapy in postmenopausal women, particularly regarding IBS," Khalil said. "Clinicians should be cognizant about the gastrointestinal impact and effects when prescribing hormone replacement therapy." One author disclosed ties to Allurion, Bristol Myers Squibb, Johnson & Johnson, and Vibrant. Abstract No. P2357 Jasmohan S. Bajaj, M.D., of the Virginia Commonwealth University School of Medicine in Richmond, and colleagues found that rifaximin monotherapy is associated with a significantly lower rate of overt hepatic encephalopathy (OHE) recurrence and mortality among individuals with cirrhosis. The authors performed a post-hoc analysis of two randomized clinical trials involving patients with prior OHE. Specifically, they compared lactulose monotherapy and rifaximin monotherapy to each other; major outcomes were OHE recurrence, HE-related hospitalizations, and mortality at six months. The comparisons included cohorts of more than 280 patients across multiple centers worldwide. The researchers found that rifaximin monotherapy was tied to a lower rate of OHE recurrence and mortality. In addition, compared with the patients on rifaximin monotherapy, a greater proportion of patients on lactulose monotherapy had drug discontinuation due to diarrhea and other gastrointestinal-related adverse effects. "If confirmed, this could encourage the use of rifaximin alone rather than with lactulose therapy for prevention of HE recurrence and potentially a mortality benefit," Bajaj said. Several authors disclosed ties to pharmaceutical companies, including Salix Pharmaceuticals, which manufactures rifaximin. Abstract No. 9 ACG: GLP-1 RAs Tied to Lower Risk for Early-Onset Colorectal Cancer FRIDAY, Nov. 1, 2024 -- Glucagon-like peptide-1 receptor agonists can decrease the risk for developing early-onset colorectal cancer in patients with diabetes regardless of weight, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: 2000 to 2022 Saw Rise in Early-Onset CRC Mortality in the United States THURSDAY, Oct. 31, 2024 -- Early-onset colorectal cancer mortality rose in the United States over the past two decades, most notably in patients aged 20 to 44 years, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: Hormone Therapy Tied to Higher Risk for New Irritable Bowel Syndrome THURSDAY, Oct. 31, 2024 -- Hormone replacement therapy is associated with an increased risk for developing irritable bowel syndrome in postmenopausal women, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text ACG: Fewer Overt Hepatic Encephalopathy Episodes Seen With Rifaximin MONDAY, Oct. 28, 2024 -- For patients with a history of overt hepatic encephalopathy, rifaximin monotherapy results in significantly fewer overt hepatic encephalopathy episodes than lactulose monotherapy, according to a study presented at the annual meeting of the American College of Gastroenterology, held from Oct. 25 to 30 in Philadelphia. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Additional ACG presentation to focus on impact of Xifaxan on OHE rehospitalizations LAVAL, QC / ACCESSWIRE / October 27, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), announced that results of an analysis of Xifaxan® (rifaximin) monotherapy will be presented during a Presidential Plenary Session of The American College of Gastroenterology® 2024 Annual Scientific Meeting taking place October 25-30 in Philadelphia, PA. This post hoc analysis of data from two randomized trials evaluated the efficacy of Xifaxan monotherapy compared to lactulose monotherapy for risk reduction of overt hepatic encephalopathy (OHE) recurrence and all-cause mortality. During ACG, Salix will also present new data on the impact of Xifaxan use on rehospitalizations following an OHE hospitalization discharge in both commercially insured and Medicare patient populations. Two posters to be presented at the ACG meeting will also share findings for Plenvu® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) as a bowel preparation medication, including efficacy findings from colonoscopy patients who have either comorbid conditions or are taking concomitant medications that are known to impact bowel prep quality. "These presentations at ACG 2024 can give healthcare professionals confidence that treatments from Salix have potential to improve outcomes for their patients" said Aimee Lenar, Executive Vice President, US Pharma at Bausch Health. "Bausch Health remains dedicated to pursuing life-changing solutions and continues to invest in expanding the body of evidence for our medicines today and in the future." The complete list of Salix research and analyses to be presented at ACG 2024 is as follows: XIFAXAN Bajaj, Jasmohan S. et.al. Rifaximin Monotherapy Is More Effective Than Lactulose Monotherapy for Reducing the Risk of Overt Hepatic Encephalopathy (OHE) Recurrence and All-Cause Mortality: An Analysis of Two Randomized Trials Presidential Plenary Session 2; Presentation #9 Monday, October 28, 10:06 - 10:18 AM ET Jesudian, Arun B. et.al. Impact of Rifaximin Use on Overt Hepatic Encephalopathy (OHE) Rehospitalizations Post Discharge from an OHE Hospitalization in Commercially and Medicare Insured Patients Poster #P1162 Sunday, October 27, 3:30 PM - 7:00 PM ET Bajaj, Jasmohan S. et.al. Rifaximin Monotherapy Is More Effective Than Lactulose Monotherapy for Reducing the Risk of Overt Hepatic Encephalopathy (OHE) Recurrence and All-Cause Mortality: An Analysis of Two Randomized Trials Presidential Plenary Session 2; Presentation #9 Monday, October 28, 10:06 - 10:18 AM ET Presidential Plenary Session 2; Presentation #9 Monday, October 28, 10:06 - 10:18 AM ET Jesudian, Arun B. et.al. Impact of Rifaximin Use on Overt Hepatic Encephalopathy (OHE) Rehospitalizations Post Discharge from an OHE Hospitalization in Commercially and Medicare Insured Patients Poster #P1162 Sunday, October 27, 3:30 PM - 7:00 PM ET Poster #P1162 Sunday, October 27, 3:30 PM - 7:00 PM ET PLENVU Cash, Brooks D. et.al. Efficacy and Safety of the 1 Liter NER1006 Bowel Preparation for Colonoscopy in Adults With Comorbid Conditions That May Impact Prep Quality Poster #P3667 Tuesday, October 29, 10:30 AM - 4:00 PM ET Poppers, David. et.al. One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients Taking Concomitant Medications Known to Impact Prep Quality Poster #P3657 Tuesday, October 29, 10:30 AM - 4:00 PM ET Cash, Brooks D. et.al. Efficacy and Safety of the 1 Liter NER1006 Bowel Preparation for Colonoscopy in Adults With Comorbid Conditions That May Impact Prep Quality Poster #P3667 Tuesday, October 29, 10:30 AM - 4:00 PM ET Poster #P3667 Tuesday, October 29, 10:30 AM - 4:00 PM ET Poppers, David. et.al. One-Liter NER1006 Is Efficacious as a Bowel Preparation for Colonoscopy in Patients Taking Concomitant Medications Known to Impact Prep Quality Poster #P3657 Tuesday, October 29, 10:30 AM - 4:00 PM ET Poster #P3657 Tuesday, October 29, 10:30 AM - 4:00 PM ET About XIFAXAN INDICATION XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. IMPORTANT SAFETY INFORMATION XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients. Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin. In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were: HE (≥10%): Peripheral edema (17%), constipation (16%), nausea (15%), fatigue (14%), insomnia (14%), ascites (13%), dizziness (13%), urinary tract infection (12%), anemia (10%), and pruritus (10%) IBS-D (≥2%): Nausea (3%), ALT increased (2%) INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required. XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus. XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients. Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin. In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were: HE (≥10%): Peripheral edema (17%), constipation (16%), nausea (15%), fatigue (14%), insomnia (14%), ascites (13%), dizziness (13%), urinary tract infection (12%), anemia (10%), and pruritus (10%) IBS-D (≥2%): Nausea (3%), ALT increased (2%) INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required. XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus. To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click here for full Prescribing Information. About PLENVU INDICATION PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy. IMPORTANT SAFETY INFORMATION Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®. PLENVU® and other bowel preparations can cause serious side effects including loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause abnormal heartbeats that may result in death, seizures (even if you have never had a seizure), or kidney problems. Your chance of having fluid loss and changes in body salts with PLENVU® is higher if you have heart problems, kidney problems, or take water pills, high blood pressure medicine, or non-steroidal anti-inflammatory drugs (NSAIDS). Your healthcare provider may do blood tests after you take PLENVU® to check your blood for changes. Tell your healthcare provider right away if you have any symptoms of too much fluid loss (dehydration) including vomiting, dizziness, heart problems, kidney problems, seizures, dry mouth, urinating less often than normal; headache, or feel faint, weak, or lightheaded, especially when you stand up. PLENVU® can cause ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding. PLENVU® can cause serious allergic reactions that may include skin rash, itching, raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat; and kidney problems. The most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and stomach pain or discomfort. Tell your healthcare provider about all of your medical conditions and medicines you take, including prescription, nonprescription medicines, vitamins, and herbal supplements before you take PLENVU® Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®. PLENVU® and other bowel preparations can cause serious side effects including loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause abnormal heartbeats that may result in death, seizures (even if you have never had a seizure), or kidney problems. Your chance of having fluid loss and changes in body salts with PLENVU® is higher if you have heart problems, kidney problems, or take water pills, high blood pressure medicine, or non-steroidal anti-inflammatory drugs (NSAIDS). Your healthcare provider may do blood tests after you take PLENVU® to check your blood for changes. Tell your healthcare provider right away if you have any symptoms of too much fluid loss (dehydration) including vomiting, dizziness, heart problems, kidney problems, seizures, dry mouth, urinating less often than normal; headache, or feel faint, weak, or lightheaded, especially when you stand up. PLENVU® can cause ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding. PLENVU® can cause serious allergic reactions that may include skin rash, itching, raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat; and kidney problems. The most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and stomach pain or discomfort. Tell your healthcare provider about all of your medical conditions and medicines you take, including prescription, nonprescription medicines, vitamins, and herbal supplements before you take PLENVU® These are not all the possible side effects of PLENVU®. Ask your healthcare provider for more information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for full Prescribing Information. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.