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VIDEO: LINX magnetic band beats omeprazole for GERD regurgitation
CHICAGO – Persistent reflux symptoms resolved in 93% of patients who underwent laparoscopic deployment of a circlet of magnet beads to the lower esophageal juncture, but in just 9% of those who doubled their dose of omeprazole, Reginald Bell, MD, said at the annual Digestive Disease Week®.
In addition to bolstering positive device data, the results of this ongoing randomized study suggest that it may be time to rethink the treatment algorithm for patients who don’t respond optimally to medical therapy, Dr. Bell said in an interview.
“We found that relatively few patients respond well to the typical doubling of PPIs,” said Dr. Bell of the SOFI SurgOne Foregut Institute, Englewood, Colo. “In light of these strong results, it’s my opinion that we should consider going straight to surgery for at least some of these patients”
The LINX Reflux Management System (TORAX Medical; Shoreview, Minn.) is a small, flexible band of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads keeps them joined when the lower esophageal sphincter is at rest. It exerts just enough resistance, however, to keep the sphincter from opening under gastric pressures of less than about 20 mm Hg, preventing reflux into the esophagus. Reflux typically occurs at an opening pressure of 10-12 mm Hg. Swallowing pressures, however, generally exceed 20 mm Hg, Dr. Bell said, allowing the circlet to expand enough to allow free passage of the bolus. The magnetic forces then bring the beads back together, again keeping the sphincter in a closed position.
This variable pressure is a big advantage over the Nissen fundoplication, which creates a pseudoflap that isn’t as yielding to intragastric pressure, Dr. Bell said. Nissen patients frequently have trouble belching or vomiting, and can experience bloating and distention from a reduced ability to vent gases. That is generally not a problem with LINX patients. And while some do initially experience dysphagia, this is typically transient. In the pivotal trial, bloating occurred in 7% of patients by 24 months.
The study comprised 150 patients with persistent symptoms of gastroesophageal reflux disease (GERD), despite at least 8 weeks of taking 20 mg omeprazole daily. These patients were randomized on a 2:1 scheme to either a doubling of omeprazole (20 mg twice a day) or surgery with LINX. Dr. Bell reported 6-month outcomes on 80 patients, 25 of whom had the LINX procedure and 55 of whom began double-dose omeprazole.
These patients were a mean of 47 years old, and had used a proton pump inhibitor (PPI) for a mean of 8 years. Baseline work-ups confirmed moderate to severe GERD, with about 12% of gastric measurement times at less than pH 4. The mean DeMeester Score was about 40. On the GERD Health-Related Quality of Life Questionnaire, patients scored about 24 while on medical therapy and 31 while off. They reported moderate to severe heartburn and regurgitation.
The study’s primary endpoint was relief of moderate to severe regurgitation. This was reached in 93% of the LINX group and 9% of the double-dose PPI group – a significant difference. Significantly more LINX patients also achieved at least a 50% reduction in their baseline GERD-HRQL score (90% vs.7%). The mean score dropped from about 32-5 in the LINX group and 30-24 in the PPI group.
Mean scores on the Reflux Disease Questionnaire improved significantly more in the LINX group than in the PPI group, including regurgitation (4.2.-1.4; 4.4 at both time points), and heartburn (3.4-1.6; 3.6-3.9).
An independent, blinded laboratory conducted pH/impedance testing on the cohort; the normal values were less than 57 reflux episodes/24 hours. At 6 months, the LINX group experienced a mean of 30 episodes vs. 70 in the PPI group.
When the investigators examined a combined measure of the number of reflux episodes and the change in DeMeester scores, they found normal reflux in 92% of the LINX group and 36% of the PPI group.
There was one adverse event related to the LINX procedure. A 66-year-old man was hospitalized and medically treated for esophageal spasms. The incident resolved with no sequelae, Dr. Bell said. So far, one LINX patient has needed to add PPI therapy; other studies typically show that 2%-3% of patients with the device do so.
Dr. Bell disclosed that he is a consultant for TORAX.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
CHICAGO – Persistent reflux symptoms resolved in 93% of patients who underwent laparoscopic deployment of a circlet of magnet beads to the lower esophageal juncture, but in just 9% of those who doubled their dose of omeprazole, Reginald Bell, MD, said at the annual Digestive Disease Week®.
In addition to bolstering positive device data, the results of this ongoing randomized study suggest that it may be time to rethink the treatment algorithm for patients who don’t respond optimally to medical therapy, Dr. Bell said in an interview.
“We found that relatively few patients respond well to the typical doubling of PPIs,” said Dr. Bell of the SOFI SurgOne Foregut Institute, Englewood, Colo. “In light of these strong results, it’s my opinion that we should consider going straight to surgery for at least some of these patients”
The LINX Reflux Management System (TORAX Medical; Shoreview, Minn.) is a small, flexible band of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads keeps them joined when the lower esophageal sphincter is at rest. It exerts just enough resistance, however, to keep the sphincter from opening under gastric pressures of less than about 20 mm Hg, preventing reflux into the esophagus. Reflux typically occurs at an opening pressure of 10-12 mm Hg. Swallowing pressures, however, generally exceed 20 mm Hg, Dr. Bell said, allowing the circlet to expand enough to allow free passage of the bolus. The magnetic forces then bring the beads back together, again keeping the sphincter in a closed position.
This variable pressure is a big advantage over the Nissen fundoplication, which creates a pseudoflap that isn’t as yielding to intragastric pressure, Dr. Bell said. Nissen patients frequently have trouble belching or vomiting, and can experience bloating and distention from a reduced ability to vent gases. That is generally not a problem with LINX patients. And while some do initially experience dysphagia, this is typically transient. In the pivotal trial, bloating occurred in 7% of patients by 24 months.
The study comprised 150 patients with persistent symptoms of gastroesophageal reflux disease (GERD), despite at least 8 weeks of taking 20 mg omeprazole daily. These patients were randomized on a 2:1 scheme to either a doubling of omeprazole (20 mg twice a day) or surgery with LINX. Dr. Bell reported 6-month outcomes on 80 patients, 25 of whom had the LINX procedure and 55 of whom began double-dose omeprazole.
These patients were a mean of 47 years old, and had used a proton pump inhibitor (PPI) for a mean of 8 years. Baseline work-ups confirmed moderate to severe GERD, with about 12% of gastric measurement times at less than pH 4. The mean DeMeester Score was about 40. On the GERD Health-Related Quality of Life Questionnaire, patients scored about 24 while on medical therapy and 31 while off. They reported moderate to severe heartburn and regurgitation.
The study’s primary endpoint was relief of moderate to severe regurgitation. This was reached in 93% of the LINX group and 9% of the double-dose PPI group – a significant difference. Significantly more LINX patients also achieved at least a 50% reduction in their baseline GERD-HRQL score (90% vs.7%). The mean score dropped from about 32-5 in the LINX group and 30-24 in the PPI group.
Mean scores on the Reflux Disease Questionnaire improved significantly more in the LINX group than in the PPI group, including regurgitation (4.2.-1.4; 4.4 at both time points), and heartburn (3.4-1.6; 3.6-3.9).
An independent, blinded laboratory conducted pH/impedance testing on the cohort; the normal values were less than 57 reflux episodes/24 hours. At 6 months, the LINX group experienced a mean of 30 episodes vs. 70 in the PPI group.
When the investigators examined a combined measure of the number of reflux episodes and the change in DeMeester scores, they found normal reflux in 92% of the LINX group and 36% of the PPI group.
There was one adverse event related to the LINX procedure. A 66-year-old man was hospitalized and medically treated for esophageal spasms. The incident resolved with no sequelae, Dr. Bell said. So far, one LINX patient has needed to add PPI therapy; other studies typically show that 2%-3% of patients with the device do so.
Dr. Bell disclosed that he is a consultant for TORAX.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
CHICAGO – Persistent reflux symptoms resolved in 93% of patients who underwent laparoscopic deployment of a circlet of magnet beads to the lower esophageal juncture, but in just 9% of those who doubled their dose of omeprazole, Reginald Bell, MD, said at the annual Digestive Disease Week®.
In addition to bolstering positive device data, the results of this ongoing randomized study suggest that it may be time to rethink the treatment algorithm for patients who don’t respond optimally to medical therapy, Dr. Bell said in an interview.
“We found that relatively few patients respond well to the typical doubling of PPIs,” said Dr. Bell of the SOFI SurgOne Foregut Institute, Englewood, Colo. “In light of these strong results, it’s my opinion that we should consider going straight to surgery for at least some of these patients”
The LINX Reflux Management System (TORAX Medical; Shoreview, Minn.) is a small, flexible band of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads keeps them joined when the lower esophageal sphincter is at rest. It exerts just enough resistance, however, to keep the sphincter from opening under gastric pressures of less than about 20 mm Hg, preventing reflux into the esophagus. Reflux typically occurs at an opening pressure of 10-12 mm Hg. Swallowing pressures, however, generally exceed 20 mm Hg, Dr. Bell said, allowing the circlet to expand enough to allow free passage of the bolus. The magnetic forces then bring the beads back together, again keeping the sphincter in a closed position.
This variable pressure is a big advantage over the Nissen fundoplication, which creates a pseudoflap that isn’t as yielding to intragastric pressure, Dr. Bell said. Nissen patients frequently have trouble belching or vomiting, and can experience bloating and distention from a reduced ability to vent gases. That is generally not a problem with LINX patients. And while some do initially experience dysphagia, this is typically transient. In the pivotal trial, bloating occurred in 7% of patients by 24 months.
The study comprised 150 patients with persistent symptoms of gastroesophageal reflux disease (GERD), despite at least 8 weeks of taking 20 mg omeprazole daily. These patients were randomized on a 2:1 scheme to either a doubling of omeprazole (20 mg twice a day) or surgery with LINX. Dr. Bell reported 6-month outcomes on 80 patients, 25 of whom had the LINX procedure and 55 of whom began double-dose omeprazole.
These patients were a mean of 47 years old, and had used a proton pump inhibitor (PPI) for a mean of 8 years. Baseline work-ups confirmed moderate to severe GERD, with about 12% of gastric measurement times at less than pH 4. The mean DeMeester Score was about 40. On the GERD Health-Related Quality of Life Questionnaire, patients scored about 24 while on medical therapy and 31 while off. They reported moderate to severe heartburn and regurgitation.
The study’s primary endpoint was relief of moderate to severe regurgitation. This was reached in 93% of the LINX group and 9% of the double-dose PPI group – a significant difference. Significantly more LINX patients also achieved at least a 50% reduction in their baseline GERD-HRQL score (90% vs.7%). The mean score dropped from about 32-5 in the LINX group and 30-24 in the PPI group.
Mean scores on the Reflux Disease Questionnaire improved significantly more in the LINX group than in the PPI group, including regurgitation (4.2.-1.4; 4.4 at both time points), and heartburn (3.4-1.6; 3.6-3.9).
An independent, blinded laboratory conducted pH/impedance testing on the cohort; the normal values were less than 57 reflux episodes/24 hours. At 6 months, the LINX group experienced a mean of 30 episodes vs. 70 in the PPI group.
When the investigators examined a combined measure of the number of reflux episodes and the change in DeMeester scores, they found normal reflux in 92% of the LINX group and 36% of the PPI group.
There was one adverse event related to the LINX procedure. A 66-year-old man was hospitalized and medically treated for esophageal spasms. The incident resolved with no sequelae, Dr. Bell said. So far, one LINX patient has needed to add PPI therapy; other studies typically show that 2%-3% of patients with the device do so.
Dr. Bell disclosed that he is a consultant for TORAX.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
AT DDW 2017
Key clinical point:
Major finding: Symptoms resolved in 93% of patients, compared to 9% of those who took the proton pump inhibitor.
Data source: An ongoing randomized study of 150 patients; Dr. Bell reported 6-month outcomes on 80.
Disclosures: Dr. Bell is a consultant for TORAX Medical, which developed and manufactures the device.
VIDEO: Registry study will follow 4,000 fecal transplant patients for 10 years
CHICAGO – A 10-year registry study aims to gather clinical and patient-reported outcomes on 4,000 adult and pediatric patients who undergo fecal microbiota transplant in the United States, officials of the American Gastroenterological Association announced during Digestive Disease Week®.
The AGA Fecal Microbiota Transplantation National Registry will be the first study to assess both short- and long-term patient outcomes associated with fecal microbiota transplant (FMT) in both adults and children, Colleen Kelly, MD, said in an video interview. Most subjects will have received FMT for recurrent or refractory Clostridium difficile infections – the only indication for which Food and Drug Administration currently allows independent clinician action. But the investigational uses of FMT are expanding rapidly, and patients who undergo the procedure during any registered study will be eligible for enrollment, said Dr. Kelly, co-chair of the study’s steering committee.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The study’s primary objectives are short- and long-term safety outcomes, said Dr. Kelly of Brown University, Providence, R.I. While generally considered quite safe, short-term adverse events have been reported with FMT, and some of them have been serious – including one death from aspiration pneumonia in a patient who received donor stool via nasogastric tube (Clin Infect Dis. 2015 Mar;61[1]:136-7). Other adverse events are usually self-limited but can include low-grade fever, abdominal pain, distention, bloating, and diarrhea.
Researchers seek to illuminate many of the unknowns associated with this relatively new procedure. Scientists are only now beginning to unravel the myriad ways the human microbiome promotes both health and disease. Specific alterations, for example, have been associated with obesity and other conditions; there is concern that transplanting a new microbial population could induce a disease phenotype in a recipient who might not have otherwise been at risk.
With the planned cohort size and follow-up period, the study should be able to detect any unanticipated adverse events that occur in more than 1% of the population, Dr. Kelly said. It will include a comparator group of patients with recurrent or refractory C. difficile infection from a large insurance claims database to allow comparison between patients treated with FMT and those treated with antibiotics only.
The registry study also aims to discover which method or methods of transplant material delivery are best, she said. Right now, there are a number of methods (colonoscopy/sigmoidoscopy, enema, upper gastrointestinal endoscopy, nasogastric or nasoduodenal tube, and capsules), and no consensus on which is the best. As indications for FMT expand, there may be no single best method. The approach will probably be matched to the disorder being treated, and the study may help illuminate this as well.
For the first 2 years after a transplant, clinicians will follow patients and enter data into the registry. After that, an electronic patient-reported outcomes system will automatically contact the patient annually for follow-up information by email or text message. When patients enter their data, they can access educational material that will help keep them up-to-date on potential adverse events.
The study will also include a biobank of stool samples obtained during the procedures, hosted by the American Gut Project and the Microbiome Initiative at the University of California, San Diego. This arm of the project will analyze the microbiome of 3,000 stool samples from recipients, both before and after their transplant, as well as the corresponding donors whose material was used in the fecal transplant.
The registry study, a project of the AGA Center for Gut Microbiome Research and Education, is funded by a $3.3 million grant from the National Institute of Allergy and Infectious Diseases. It will be conducted in partnership with the Crohn’s and Colitis Foundation, Infectious Diseases Society, and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
The registry study currently is accepting applications. Physicians who perform FMT for C. difficile infections, and centers that conduct FMT research for other potential indications, can fill out a short survey to indicate their interest.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
This article was updated June 8, 2017.
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
CHICAGO – A 10-year registry study aims to gather clinical and patient-reported outcomes on 4,000 adult and pediatric patients who undergo fecal microbiota transplant in the United States, officials of the American Gastroenterological Association announced during Digestive Disease Week®.
The AGA Fecal Microbiota Transplantation National Registry will be the first study to assess both short- and long-term patient outcomes associated with fecal microbiota transplant (FMT) in both adults and children, Colleen Kelly, MD, said in an video interview. Most subjects will have received FMT for recurrent or refractory Clostridium difficile infections – the only indication for which Food and Drug Administration currently allows independent clinician action. But the investigational uses of FMT are expanding rapidly, and patients who undergo the procedure during any registered study will be eligible for enrollment, said Dr. Kelly, co-chair of the study’s steering committee.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The study’s primary objectives are short- and long-term safety outcomes, said Dr. Kelly of Brown University, Providence, R.I. While generally considered quite safe, short-term adverse events have been reported with FMT, and some of them have been serious – including one death from aspiration pneumonia in a patient who received donor stool via nasogastric tube (Clin Infect Dis. 2015 Mar;61[1]:136-7). Other adverse events are usually self-limited but can include low-grade fever, abdominal pain, distention, bloating, and diarrhea.
Researchers seek to illuminate many of the unknowns associated with this relatively new procedure. Scientists are only now beginning to unravel the myriad ways the human microbiome promotes both health and disease. Specific alterations, for example, have been associated with obesity and other conditions; there is concern that transplanting a new microbial population could induce a disease phenotype in a recipient who might not have otherwise been at risk.
With the planned cohort size and follow-up period, the study should be able to detect any unanticipated adverse events that occur in more than 1% of the population, Dr. Kelly said. It will include a comparator group of patients with recurrent or refractory C. difficile infection from a large insurance claims database to allow comparison between patients treated with FMT and those treated with antibiotics only.
The registry study also aims to discover which method or methods of transplant material delivery are best, she said. Right now, there are a number of methods (colonoscopy/sigmoidoscopy, enema, upper gastrointestinal endoscopy, nasogastric or nasoduodenal tube, and capsules), and no consensus on which is the best. As indications for FMT expand, there may be no single best method. The approach will probably be matched to the disorder being treated, and the study may help illuminate this as well.
For the first 2 years after a transplant, clinicians will follow patients and enter data into the registry. After that, an electronic patient-reported outcomes system will automatically contact the patient annually for follow-up information by email or text message. When patients enter their data, they can access educational material that will help keep them up-to-date on potential adverse events.
The study will also include a biobank of stool samples obtained during the procedures, hosted by the American Gut Project and the Microbiome Initiative at the University of California, San Diego. This arm of the project will analyze the microbiome of 3,000 stool samples from recipients, both before and after their transplant, as well as the corresponding donors whose material was used in the fecal transplant.
The registry study, a project of the AGA Center for Gut Microbiome Research and Education, is funded by a $3.3 million grant from the National Institute of Allergy and Infectious Diseases. It will be conducted in partnership with the Crohn’s and Colitis Foundation, Infectious Diseases Society, and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
The registry study currently is accepting applications. Physicians who perform FMT for C. difficile infections, and centers that conduct FMT research for other potential indications, can fill out a short survey to indicate their interest.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
This article was updated June 8, 2017.
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
CHICAGO – A 10-year registry study aims to gather clinical and patient-reported outcomes on 4,000 adult and pediatric patients who undergo fecal microbiota transplant in the United States, officials of the American Gastroenterological Association announced during Digestive Disease Week®.
The AGA Fecal Microbiota Transplantation National Registry will be the first study to assess both short- and long-term patient outcomes associated with fecal microbiota transplant (FMT) in both adults and children, Colleen Kelly, MD, said in an video interview. Most subjects will have received FMT for recurrent or refractory Clostridium difficile infections – the only indication for which Food and Drug Administration currently allows independent clinician action. But the investigational uses of FMT are expanding rapidly, and patients who undergo the procedure during any registered study will be eligible for enrollment, said Dr. Kelly, co-chair of the study’s steering committee.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The study’s primary objectives are short- and long-term safety outcomes, said Dr. Kelly of Brown University, Providence, R.I. While generally considered quite safe, short-term adverse events have been reported with FMT, and some of them have been serious – including one death from aspiration pneumonia in a patient who received donor stool via nasogastric tube (Clin Infect Dis. 2015 Mar;61[1]:136-7). Other adverse events are usually self-limited but can include low-grade fever, abdominal pain, distention, bloating, and diarrhea.
Researchers seek to illuminate many of the unknowns associated with this relatively new procedure. Scientists are only now beginning to unravel the myriad ways the human microbiome promotes both health and disease. Specific alterations, for example, have been associated with obesity and other conditions; there is concern that transplanting a new microbial population could induce a disease phenotype in a recipient who might not have otherwise been at risk.
With the planned cohort size and follow-up period, the study should be able to detect any unanticipated adverse events that occur in more than 1% of the population, Dr. Kelly said. It will include a comparator group of patients with recurrent or refractory C. difficile infection from a large insurance claims database to allow comparison between patients treated with FMT and those treated with antibiotics only.
The registry study also aims to discover which method or methods of transplant material delivery are best, she said. Right now, there are a number of methods (colonoscopy/sigmoidoscopy, enema, upper gastrointestinal endoscopy, nasogastric or nasoduodenal tube, and capsules), and no consensus on which is the best. As indications for FMT expand, there may be no single best method. The approach will probably be matched to the disorder being treated, and the study may help illuminate this as well.
For the first 2 years after a transplant, clinicians will follow patients and enter data into the registry. After that, an electronic patient-reported outcomes system will automatically contact the patient annually for follow-up information by email or text message. When patients enter their data, they can access educational material that will help keep them up-to-date on potential adverse events.
The study will also include a biobank of stool samples obtained during the procedures, hosted by the American Gut Project and the Microbiome Initiative at the University of California, San Diego. This arm of the project will analyze the microbiome of 3,000 stool samples from recipients, both before and after their transplant, as well as the corresponding donors whose material was used in the fecal transplant.
The registry study, a project of the AGA Center for Gut Microbiome Research and Education, is funded by a $3.3 million grant from the National Institute of Allergy and Infectious Diseases. It will be conducted in partnership with the Crohn’s and Colitis Foundation, Infectious Diseases Society, and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
The registry study currently is accepting applications. Physicians who perform FMT for C. difficile infections, and centers that conduct FMT research for other potential indications, can fill out a short survey to indicate their interest.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
This article was updated June 8, 2017.
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
AT DDW
VIDEO: Indomethacin slashes post-ERCP pancreatitis risk in primary sclerosing cholangitis
CHICAGO – Rectal indomethacin reduced by 90% the risk of post-procedural pancreatitis in patients with primary sclerosing cholangitis.
The anti-inflammatory has already been shown to reduce the risk of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in a general population, Nikhil Thiruvengadam, MD, said at the annual Digestive Disease Week®. Now, his retrospective study of almost 5,000 patients has shown the drug’s benefit in patients with primary sclerosing cholangitis (PSC), who are at particularly high risk of pancreatitis after the procedure.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“A prior history of PEP and a difficult initial cannulation were significant risk factors for developing PEP,” he said. “Indomethacin significantly reduced this risk, and our findings suggest that future prospective trials studying pharmacological prophylaxis of PEP – including rectal indomethacin – should be powered to be able detect a difference in PSC patients, and they should be included in such studies.”
In 2016 Dr. Thiruvengadam and his colleagues showed that rectal indomethacin significantly reduced the risk of PEP by about 65% in a diverse group of patients, including those with malignant biliary obstruction (Gastroenterology. 2016;151:288–97). The new study used an expanded patient-cohort but focused on patients with PSC, as they require multiple ERCPs for diagnosis and stenting of strictures and cholangiocarcinoma screening and thus may be more affected by post-procedural pancreatitis.
The study comprised 4,764 patients who underwent ERCP at the University of Pennsylvania from 2007-2015; of these, 200 had PSC. Rectal indomethacin was routinely administered to patients beginning in June 2012. The primary outcome of the study was post-ERCP pancreatitis. The secondary outcome was the severity of post-ERCP pancreatitis.
PEP was about twice as common in the PSC group as in the overall cohort (6.5% vs. 3.8%). Moderate-severe PEP also was twice as common (4% vs. 2%).
Dr. Thiruvengadam broke down the cohort by indication for ERCP. These included PSC as well as liver transplant, choledocholithiasis, benign pancreatic disease, bile leaks, and ampullary adenoma. PSC patients had the highest risk of developing PEP – almost 3 times more than those without the disorder (OR 2.7).
Among PSC patients, age, gender, and total bilirubin were not associated with increased risk. A history of prior PEP increased the risk by 17 times, and a difficult initial cannulation that required a pre-cut sphincterotomy increased it by 15 times.
“Interestingly, dilation of a common bile duct stricture reduced the odds of developing PEP by 81%,” Dr. Thiruvengadam said.
He then examined the impact of rectal indomethacin on the study subjects. Overall, PEP developed in 5% of those who didn’t receive indomethacin and 2% of those who did. In the PSC group, PEP developed in 11% of those who didn’t get indomethacin and less than 1% of those who did.
Indomethacin was particularly effective at preventing moderate-severe PEP, Dr. Thiruvengadam noted. In the overall cohort, moderate-severe PEP developed in 3% of unexposed patients compared to 0.6% of those who received the drug. The difference was more profound in the PSC group: None of those treated with indomethacin developed moderate-severe PEP, which occurred in 9.3% of the unexposed group.
Generally, patients who have previously undergone a sphincterotomy are at lower risk for PEP, Dr. Thiruvengadam said, and this was reflected in the findings for the overall group: PEP developed in 3% of the untreated patients and 0.5% of the treated patients. Post-sphincterotomy patients with PSC, however, were still at an increased risk of PEP. Indomethacin significantly mitigated this – no patient who got the drug developed PEP, compared with 10.5% of those who didn’t get it.
A series of regression analyses confirmed the consistency of these findings. In an unadjusted model, rectal indomethacin reduced the risk of post-ERCP PEP by 91% in patients with PSC. A model that adjusted for common bile duct brushing, type of sedation, and common bile duct dilation found a 90% risk reduction. Another model that controlled for classic risk factors for PEP (age, gender, total bilirubin, history of PEP, pancreatic duct injection and cannulation, and pre-cut sphincterotomy) found a 94% risk reduction.
“We additionally performed a propensity score matched analysis to account for potential unmeasured differences between the two cohorts, and it also confirmed the results found and demonstrated that indomethacin significantly reduced the odds of developing PEP by 89%,” Dr. Thiruvengadam said.
He had no financial conflicts of interest to disclosures.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
CHICAGO – Rectal indomethacin reduced by 90% the risk of post-procedural pancreatitis in patients with primary sclerosing cholangitis.
The anti-inflammatory has already been shown to reduce the risk of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in a general population, Nikhil Thiruvengadam, MD, said at the annual Digestive Disease Week®. Now, his retrospective study of almost 5,000 patients has shown the drug’s benefit in patients with primary sclerosing cholangitis (PSC), who are at particularly high risk of pancreatitis after the procedure.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“A prior history of PEP and a difficult initial cannulation were significant risk factors for developing PEP,” he said. “Indomethacin significantly reduced this risk, and our findings suggest that future prospective trials studying pharmacological prophylaxis of PEP – including rectal indomethacin – should be powered to be able detect a difference in PSC patients, and they should be included in such studies.”
In 2016 Dr. Thiruvengadam and his colleagues showed that rectal indomethacin significantly reduced the risk of PEP by about 65% in a diverse group of patients, including those with malignant biliary obstruction (Gastroenterology. 2016;151:288–97). The new study used an expanded patient-cohort but focused on patients with PSC, as they require multiple ERCPs for diagnosis and stenting of strictures and cholangiocarcinoma screening and thus may be more affected by post-procedural pancreatitis.
The study comprised 4,764 patients who underwent ERCP at the University of Pennsylvania from 2007-2015; of these, 200 had PSC. Rectal indomethacin was routinely administered to patients beginning in June 2012. The primary outcome of the study was post-ERCP pancreatitis. The secondary outcome was the severity of post-ERCP pancreatitis.
PEP was about twice as common in the PSC group as in the overall cohort (6.5% vs. 3.8%). Moderate-severe PEP also was twice as common (4% vs. 2%).
Dr. Thiruvengadam broke down the cohort by indication for ERCP. These included PSC as well as liver transplant, choledocholithiasis, benign pancreatic disease, bile leaks, and ampullary adenoma. PSC patients had the highest risk of developing PEP – almost 3 times more than those without the disorder (OR 2.7).
Among PSC patients, age, gender, and total bilirubin were not associated with increased risk. A history of prior PEP increased the risk by 17 times, and a difficult initial cannulation that required a pre-cut sphincterotomy increased it by 15 times.
“Interestingly, dilation of a common bile duct stricture reduced the odds of developing PEP by 81%,” Dr. Thiruvengadam said.
He then examined the impact of rectal indomethacin on the study subjects. Overall, PEP developed in 5% of those who didn’t receive indomethacin and 2% of those who did. In the PSC group, PEP developed in 11% of those who didn’t get indomethacin and less than 1% of those who did.
Indomethacin was particularly effective at preventing moderate-severe PEP, Dr. Thiruvengadam noted. In the overall cohort, moderate-severe PEP developed in 3% of unexposed patients compared to 0.6% of those who received the drug. The difference was more profound in the PSC group: None of those treated with indomethacin developed moderate-severe PEP, which occurred in 9.3% of the unexposed group.
Generally, patients who have previously undergone a sphincterotomy are at lower risk for PEP, Dr. Thiruvengadam said, and this was reflected in the findings for the overall group: PEP developed in 3% of the untreated patients and 0.5% of the treated patients. Post-sphincterotomy patients with PSC, however, were still at an increased risk of PEP. Indomethacin significantly mitigated this – no patient who got the drug developed PEP, compared with 10.5% of those who didn’t get it.
A series of regression analyses confirmed the consistency of these findings. In an unadjusted model, rectal indomethacin reduced the risk of post-ERCP PEP by 91% in patients with PSC. A model that adjusted for common bile duct brushing, type of sedation, and common bile duct dilation found a 90% risk reduction. Another model that controlled for classic risk factors for PEP (age, gender, total bilirubin, history of PEP, pancreatic duct injection and cannulation, and pre-cut sphincterotomy) found a 94% risk reduction.
“We additionally performed a propensity score matched analysis to account for potential unmeasured differences between the two cohorts, and it also confirmed the results found and demonstrated that indomethacin significantly reduced the odds of developing PEP by 89%,” Dr. Thiruvengadam said.
He had no financial conflicts of interest to disclosures.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
CHICAGO – Rectal indomethacin reduced by 90% the risk of post-procedural pancreatitis in patients with primary sclerosing cholangitis.
The anti-inflammatory has already been shown to reduce the risk of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in a general population, Nikhil Thiruvengadam, MD, said at the annual Digestive Disease Week®. Now, his retrospective study of almost 5,000 patients has shown the drug’s benefit in patients with primary sclerosing cholangitis (PSC), who are at particularly high risk of pancreatitis after the procedure.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“A prior history of PEP and a difficult initial cannulation were significant risk factors for developing PEP,” he said. “Indomethacin significantly reduced this risk, and our findings suggest that future prospective trials studying pharmacological prophylaxis of PEP – including rectal indomethacin – should be powered to be able detect a difference in PSC patients, and they should be included in such studies.”
In 2016 Dr. Thiruvengadam and his colleagues showed that rectal indomethacin significantly reduced the risk of PEP by about 65% in a diverse group of patients, including those with malignant biliary obstruction (Gastroenterology. 2016;151:288–97). The new study used an expanded patient-cohort but focused on patients with PSC, as they require multiple ERCPs for diagnosis and stenting of strictures and cholangiocarcinoma screening and thus may be more affected by post-procedural pancreatitis.
The study comprised 4,764 patients who underwent ERCP at the University of Pennsylvania from 2007-2015; of these, 200 had PSC. Rectal indomethacin was routinely administered to patients beginning in June 2012. The primary outcome of the study was post-ERCP pancreatitis. The secondary outcome was the severity of post-ERCP pancreatitis.
PEP was about twice as common in the PSC group as in the overall cohort (6.5% vs. 3.8%). Moderate-severe PEP also was twice as common (4% vs. 2%).
Dr. Thiruvengadam broke down the cohort by indication for ERCP. These included PSC as well as liver transplant, choledocholithiasis, benign pancreatic disease, bile leaks, and ampullary adenoma. PSC patients had the highest risk of developing PEP – almost 3 times more than those without the disorder (OR 2.7).
Among PSC patients, age, gender, and total bilirubin were not associated with increased risk. A history of prior PEP increased the risk by 17 times, and a difficult initial cannulation that required a pre-cut sphincterotomy increased it by 15 times.
“Interestingly, dilation of a common bile duct stricture reduced the odds of developing PEP by 81%,” Dr. Thiruvengadam said.
He then examined the impact of rectal indomethacin on the study subjects. Overall, PEP developed in 5% of those who didn’t receive indomethacin and 2% of those who did. In the PSC group, PEP developed in 11% of those who didn’t get indomethacin and less than 1% of those who did.
Indomethacin was particularly effective at preventing moderate-severe PEP, Dr. Thiruvengadam noted. In the overall cohort, moderate-severe PEP developed in 3% of unexposed patients compared to 0.6% of those who received the drug. The difference was more profound in the PSC group: None of those treated with indomethacin developed moderate-severe PEP, which occurred in 9.3% of the unexposed group.
Generally, patients who have previously undergone a sphincterotomy are at lower risk for PEP, Dr. Thiruvengadam said, and this was reflected in the findings for the overall group: PEP developed in 3% of the untreated patients and 0.5% of the treated patients. Post-sphincterotomy patients with PSC, however, were still at an increased risk of PEP. Indomethacin significantly mitigated this – no patient who got the drug developed PEP, compared with 10.5% of those who didn’t get it.
A series of regression analyses confirmed the consistency of these findings. In an unadjusted model, rectal indomethacin reduced the risk of post-ERCP PEP by 91% in patients with PSC. A model that adjusted for common bile duct brushing, type of sedation, and common bile duct dilation found a 90% risk reduction. Another model that controlled for classic risk factors for PEP (age, gender, total bilirubin, history of PEP, pancreatic duct injection and cannulation, and pre-cut sphincterotomy) found a 94% risk reduction.
“We additionally performed a propensity score matched analysis to account for potential unmeasured differences between the two cohorts, and it also confirmed the results found and demonstrated that indomethacin significantly reduced the odds of developing PEP by 89%,” Dr. Thiruvengadam said.
He had no financial conflicts of interest to disclosures.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
msullivan@frontlinemedcom.com
On Twitter @Alz_gal
AT DDW
Key clinical point:
Major finding: The anti-inflammatory reduced the risk in these patients by 90%.
Data source: A retrospective study of 4,764 patients with PSC who underwent ERCP at a single institution, Disclosures: Dr. Thiruvengadam had no financial disclosures.
VIDEO: Bile acid malabsorption as a cause of chronic diarrhea
CHICAGO – Bile acid malabsorption increasingly is recognized as a cause of persistent, chronic diarrhea, but patients often receive suboptimal treatment because medical and public awareness is low, Julian Walters, MD, of Imperial College London, said at Digestive Disease Week®.
Members of two patient support groups in the United Kingdom were invited to complete an online survey to provide information on how this condition affects them. The first 100 responses were analyzed. The majority of respondents were female (91). More than 35 respondents were diagnosed after the age of 50 years, and 35 felt their condition had not been taken seriously by multiple practitioners prior to their eventual diagnosis, Dr. Walters reported.
Two-thirds of respondents had been diagnosed with irritable bowel syndrome; the majority (68) of these had more than 10 interactions with medical professionals before being diagnosed with bile acid malabsorption.
Once appropriately diagnosed, most respondents reported doing very well on drugs such as cholestyramine and colesevelam, Dr. Walters said. He stressed that mental health issues are an important part of this condition because of its pervasive effects on daily life.
He discusses the survey and bile acid malabsorption in this video interview.
Dr. Walters disclosed that he has been a consultant to or has received research funds from GE Healthcare, Intercept, Albireo, and Novartis.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Bile acid malabsorption increasingly is recognized as a cause of persistent, chronic diarrhea, but patients often receive suboptimal treatment because medical and public awareness is low, Julian Walters, MD, of Imperial College London, said at Digestive Disease Week®.
Members of two patient support groups in the United Kingdom were invited to complete an online survey to provide information on how this condition affects them. The first 100 responses were analyzed. The majority of respondents were female (91). More than 35 respondents were diagnosed after the age of 50 years, and 35 felt their condition had not been taken seriously by multiple practitioners prior to their eventual diagnosis, Dr. Walters reported.
Two-thirds of respondents had been diagnosed with irritable bowel syndrome; the majority (68) of these had more than 10 interactions with medical professionals before being diagnosed with bile acid malabsorption.
Once appropriately diagnosed, most respondents reported doing very well on drugs such as cholestyramine and colesevelam, Dr. Walters said. He stressed that mental health issues are an important part of this condition because of its pervasive effects on daily life.
He discusses the survey and bile acid malabsorption in this video interview.
Dr. Walters disclosed that he has been a consultant to or has received research funds from GE Healthcare, Intercept, Albireo, and Novartis.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Bile acid malabsorption increasingly is recognized as a cause of persistent, chronic diarrhea, but patients often receive suboptimal treatment because medical and public awareness is low, Julian Walters, MD, of Imperial College London, said at Digestive Disease Week®.
Members of two patient support groups in the United Kingdom were invited to complete an online survey to provide information on how this condition affects them. The first 100 responses were analyzed. The majority of respondents were female (91). More than 35 respondents were diagnosed after the age of 50 years, and 35 felt their condition had not been taken seriously by multiple practitioners prior to their eventual diagnosis, Dr. Walters reported.
Two-thirds of respondents had been diagnosed with irritable bowel syndrome; the majority (68) of these had more than 10 interactions with medical professionals before being diagnosed with bile acid malabsorption.
Once appropriately diagnosed, most respondents reported doing very well on drugs such as cholestyramine and colesevelam, Dr. Walters said. He stressed that mental health issues are an important part of this condition because of its pervasive effects on daily life.
He discusses the survey and bile acid malabsorption in this video interview.
Dr. Walters disclosed that he has been a consultant to or has received research funds from GE Healthcare, Intercept, Albireo, and Novartis.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
AT DDW
VIDEO: Rifamycin matches ciprofloxacin’s efficacy in travelers’ diarrhea with less antibiotic resistance
CHICAGO – An investigational antibiotic was just as effective as ciprofloxacin at curing travelers’ diarrhea but was associated with a significantly lower rate of colonization with extended spectrum beta-lactam–resistant Escherichia coli, a phase III trial has determined.
“Rifamycin was noninferior to ciprofloxacin on every endpoint in this trial,” Robert Steffen, MD, said at the annual Digestive Disease Week. “However, there was no increase in extended spectrum beta-lactamase–producing Enterobacteriaceae (ESBL-E) associated with rifamycin, and significantly less new acquisition of these pathogens than in the ciprofloxacin group.”
Rifamycin is a poorly absorbed, broad-spectrum antibiotic in the same chemical family as rifaximin. It’s designed, both molecularly and in packaging, to become active only in the lower ileum and colon with limited systemic absorption. The drug is approved in Europe for infectious colitis, Clostridium difficile, diverticulitis, and also as supportive treatment of inflammatory bowel diseases and hepatic encephalopathy.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Subjects were randomized to 3 days of rifamycin 800 mg, or ciprofloxacin 1,000 mg. Follow-up visits occurred on days 2, 5, and 6, with a final follow-up by mail 4 weeks later. The primary endpoint was time to last unformed stool from the first dose of study medication. Secondary endpoints were clinical cure (24 hours with no clinical symptoms, fever, or watery stools, or 48 hours with no fever; and either no stools or only formed stools), need for rescue therapy, treatment failure, pathogen eradication in posttreatment stool, and the rate of ESBL-E colonization.
The time to last unformed stool was 43 hours in the rifamycin group and 37 hours in the ciprofloxacin group, which were not significantly different. The results were similar when broken down by infective organism, by gender, and by study location.
Rifamycin was also noninferior to ciprofloxacin in several secondary endpoints, including clinical cure (85% each), treatment failure (15% each), and need for rescue therapy (1% vs. 2.6%). The drugs were also virtually identical in the number of unformed stools per 24-hour interval, which fell precipitously from 5.5 on day 1, to 1 by day 5, and in complete resolution of gastrointestinal symptoms, which were about 75% resolved in each group by day 5.
Rifamycin was equally effective in eradicating all of the pathogens identified in the cohort. This included all pathogens in the E. coli group, all in the potentially invasive group (Shigella, Campylobacter, Salmonella, and Aeromonas), norovirus, giardia, and Cryptosporidium.
Treatment-emergent adverse events occurred in 12% of each group; none were serious. About 8% of each group experienced an adverse drug reaction.
Where the drugs did differ, and sharply so, was in antibiotic resistance, said Dr. Steffen, of the University of Zürich and the University of Texas School of Public Health, Houston. At baseline, about 16% of the group was infected with ESBL–E coli. At last follow-up, those species were present in 16% of the rifamycin group, but in 21% of the ciprofloxacin group. Similarly, there was less new ESBL–E. coli colonization in patients who had been negative at baseline (10% vs. 17%).
The findings are particularly important in light of the increasing worldwide emergence of antibiotic-resistant bacteria, Dr. Steffen said. In fact, new guidelines released April 29 by the International Society of Travel Medicine recommend that antibiotics be reserved for moderate to severe cases of traveler’s diarrhea and not be used at all in milder cases (J Travel Med. 2017 Apr 29;24[suppl. 1]:S57-S74).
“The widespread use of ciprofloxacin and other antibiotics for travelers’ diarrhea has contributed to the rise of these resistant bacteria,” Dr. Steffen said in an interview. “We need to rethink the way we use these drugs and to focus instead on drugs that are not systemically absorbed. If rifamycin is eventually approved for this indication, it would be a good alternative to systemic antibiotics, curing the acute illness, and not contributing as much to the emergence of these worrisome pathogens.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
In a video interview at the meeting, Dr. Steffen spoke about the trial and concerns about antibiotic resistance that are addressed in the new guidelines and by this new study.
Dr. Falk Pharma GmbH of Freiburg, Germany, is developing rifamycin and conducted the study. Dr. Steffen has received consulting and travel fees from the company.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
CHICAGO – An investigational antibiotic was just as effective as ciprofloxacin at curing travelers’ diarrhea but was associated with a significantly lower rate of colonization with extended spectrum beta-lactam–resistant Escherichia coli, a phase III trial has determined.
“Rifamycin was noninferior to ciprofloxacin on every endpoint in this trial,” Robert Steffen, MD, said at the annual Digestive Disease Week. “However, there was no increase in extended spectrum beta-lactamase–producing Enterobacteriaceae (ESBL-E) associated with rifamycin, and significantly less new acquisition of these pathogens than in the ciprofloxacin group.”
Rifamycin is a poorly absorbed, broad-spectrum antibiotic in the same chemical family as rifaximin. It’s designed, both molecularly and in packaging, to become active only in the lower ileum and colon with limited systemic absorption. The drug is approved in Europe for infectious colitis, Clostridium difficile, diverticulitis, and also as supportive treatment of inflammatory bowel diseases and hepatic encephalopathy.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Subjects were randomized to 3 days of rifamycin 800 mg, or ciprofloxacin 1,000 mg. Follow-up visits occurred on days 2, 5, and 6, with a final follow-up by mail 4 weeks later. The primary endpoint was time to last unformed stool from the first dose of study medication. Secondary endpoints were clinical cure (24 hours with no clinical symptoms, fever, or watery stools, or 48 hours with no fever; and either no stools or only formed stools), need for rescue therapy, treatment failure, pathogen eradication in posttreatment stool, and the rate of ESBL-E colonization.
The time to last unformed stool was 43 hours in the rifamycin group and 37 hours in the ciprofloxacin group, which were not significantly different. The results were similar when broken down by infective organism, by gender, and by study location.
Rifamycin was also noninferior to ciprofloxacin in several secondary endpoints, including clinical cure (85% each), treatment failure (15% each), and need for rescue therapy (1% vs. 2.6%). The drugs were also virtually identical in the number of unformed stools per 24-hour interval, which fell precipitously from 5.5 on day 1, to 1 by day 5, and in complete resolution of gastrointestinal symptoms, which were about 75% resolved in each group by day 5.
Rifamycin was equally effective in eradicating all of the pathogens identified in the cohort. This included all pathogens in the E. coli group, all in the potentially invasive group (Shigella, Campylobacter, Salmonella, and Aeromonas), norovirus, giardia, and Cryptosporidium.
Treatment-emergent adverse events occurred in 12% of each group; none were serious. About 8% of each group experienced an adverse drug reaction.
Where the drugs did differ, and sharply so, was in antibiotic resistance, said Dr. Steffen, of the University of Zürich and the University of Texas School of Public Health, Houston. At baseline, about 16% of the group was infected with ESBL–E coli. At last follow-up, those species were present in 16% of the rifamycin group, but in 21% of the ciprofloxacin group. Similarly, there was less new ESBL–E. coli colonization in patients who had been negative at baseline (10% vs. 17%).
The findings are particularly important in light of the increasing worldwide emergence of antibiotic-resistant bacteria, Dr. Steffen said. In fact, new guidelines released April 29 by the International Society of Travel Medicine recommend that antibiotics be reserved for moderate to severe cases of traveler’s diarrhea and not be used at all in milder cases (J Travel Med. 2017 Apr 29;24[suppl. 1]:S57-S74).
“The widespread use of ciprofloxacin and other antibiotics for travelers’ diarrhea has contributed to the rise of these resistant bacteria,” Dr. Steffen said in an interview. “We need to rethink the way we use these drugs and to focus instead on drugs that are not systemically absorbed. If rifamycin is eventually approved for this indication, it would be a good alternative to systemic antibiotics, curing the acute illness, and not contributing as much to the emergence of these worrisome pathogens.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
In a video interview at the meeting, Dr. Steffen spoke about the trial and concerns about antibiotic resistance that are addressed in the new guidelines and by this new study.
Dr. Falk Pharma GmbH of Freiburg, Germany, is developing rifamycin and conducted the study. Dr. Steffen has received consulting and travel fees from the company.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
CHICAGO – An investigational antibiotic was just as effective as ciprofloxacin at curing travelers’ diarrhea but was associated with a significantly lower rate of colonization with extended spectrum beta-lactam–resistant Escherichia coli, a phase III trial has determined.
“Rifamycin was noninferior to ciprofloxacin on every endpoint in this trial,” Robert Steffen, MD, said at the annual Digestive Disease Week. “However, there was no increase in extended spectrum beta-lactamase–producing Enterobacteriaceae (ESBL-E) associated with rifamycin, and significantly less new acquisition of these pathogens than in the ciprofloxacin group.”
Rifamycin is a poorly absorbed, broad-spectrum antibiotic in the same chemical family as rifaximin. It’s designed, both molecularly and in packaging, to become active only in the lower ileum and colon with limited systemic absorption. The drug is approved in Europe for infectious colitis, Clostridium difficile, diverticulitis, and also as supportive treatment of inflammatory bowel diseases and hepatic encephalopathy.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Subjects were randomized to 3 days of rifamycin 800 mg, or ciprofloxacin 1,000 mg. Follow-up visits occurred on days 2, 5, and 6, with a final follow-up by mail 4 weeks later. The primary endpoint was time to last unformed stool from the first dose of study medication. Secondary endpoints were clinical cure (24 hours with no clinical symptoms, fever, or watery stools, or 48 hours with no fever; and either no stools or only formed stools), need for rescue therapy, treatment failure, pathogen eradication in posttreatment stool, and the rate of ESBL-E colonization.
The time to last unformed stool was 43 hours in the rifamycin group and 37 hours in the ciprofloxacin group, which were not significantly different. The results were similar when broken down by infective organism, by gender, and by study location.
Rifamycin was also noninferior to ciprofloxacin in several secondary endpoints, including clinical cure (85% each), treatment failure (15% each), and need for rescue therapy (1% vs. 2.6%). The drugs were also virtually identical in the number of unformed stools per 24-hour interval, which fell precipitously from 5.5 on day 1, to 1 by day 5, and in complete resolution of gastrointestinal symptoms, which were about 75% resolved in each group by day 5.
Rifamycin was equally effective in eradicating all of the pathogens identified in the cohort. This included all pathogens in the E. coli group, all in the potentially invasive group (Shigella, Campylobacter, Salmonella, and Aeromonas), norovirus, giardia, and Cryptosporidium.
Treatment-emergent adverse events occurred in 12% of each group; none were serious. About 8% of each group experienced an adverse drug reaction.
Where the drugs did differ, and sharply so, was in antibiotic resistance, said Dr. Steffen, of the University of Zürich and the University of Texas School of Public Health, Houston. At baseline, about 16% of the group was infected with ESBL–E coli. At last follow-up, those species were present in 16% of the rifamycin group, but in 21% of the ciprofloxacin group. Similarly, there was less new ESBL–E. coli colonization in patients who had been negative at baseline (10% vs. 17%).
The findings are particularly important in light of the increasing worldwide emergence of antibiotic-resistant bacteria, Dr. Steffen said. In fact, new guidelines released April 29 by the International Society of Travel Medicine recommend that antibiotics be reserved for moderate to severe cases of traveler’s diarrhea and not be used at all in milder cases (J Travel Med. 2017 Apr 29;24[suppl. 1]:S57-S74).
“The widespread use of ciprofloxacin and other antibiotics for travelers’ diarrhea has contributed to the rise of these resistant bacteria,” Dr. Steffen said in an interview. “We need to rethink the way we use these drugs and to focus instead on drugs that are not systemically absorbed. If rifamycin is eventually approved for this indication, it would be a good alternative to systemic antibiotics, curing the acute illness, and not contributing as much to the emergence of these worrisome pathogens.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
In a video interview at the meeting, Dr. Steffen spoke about the trial and concerns about antibiotic resistance that are addressed in the new guidelines and by this new study.
Dr. Falk Pharma GmbH of Freiburg, Germany, is developing rifamycin and conducted the study. Dr. Steffen has received consulting and travel fees from the company.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT DDW
Key clinical point:
Major finding: Clinical cure occurred in 85% of each group, but new beta-lactam–resistant E. coli colonization occurred in 16% of the rifamycin group and 21% of the ciprofloxacin group.
Data source: The randomized study comprised 835 subjects.
Disclosures: Dr. Falk Pharma GmbH of Freiburg, Germany, is developing the drug and sponsored the study. Dr. Steffen has received consulting and travel fees from the company.
Amie Hiller, MD
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Anup Patel, MD
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VIDEO: Incoming AATS president outlines goals
BOSTON – Strengthening member engagement is a top goal for incoming AATS President Duke E. Cameron, MD.
In this video, Dr. Cameron, of Massachusetts General Hospital, Boston, shared his objectives as the next AATS leader and the direction he envisions for the specialty over the next 100 years. Dr. Cameron also discussed his hope for new online educational efforts and the importance of physician collaboration with other health professionals.
On Twitter @legal_med
BOSTON – Strengthening member engagement is a top goal for incoming AATS President Duke E. Cameron, MD.
In this video, Dr. Cameron, of Massachusetts General Hospital, Boston, shared his objectives as the next AATS leader and the direction he envisions for the specialty over the next 100 years. Dr. Cameron also discussed his hope for new online educational efforts and the importance of physician collaboration with other health professionals.
On Twitter @legal_med
BOSTON – Strengthening member engagement is a top goal for incoming AATS President Duke E. Cameron, MD.
In this video, Dr. Cameron, of Massachusetts General Hospital, Boston, shared his objectives as the next AATS leader and the direction he envisions for the specialty over the next 100 years. Dr. Cameron also discussed his hope for new online educational efforts and the importance of physician collaboration with other health professionals.
On Twitter @legal_med
AT THE AATS ANNUAL MEETING
