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One practice’s experience with obesity treatment
WASHINGTON – “We have heard about a lot of really interesting new things in therapy, but the reality is that they are just not economically viable at present,” said David Feldshon, MD, of Minnesota Gastroenterology (MNGI), speaking about his experience with offering obesity treatment in his practice.
One problem that Dr. Feldshon and MNGI faced was that they could never get enough patients into their weight loss program, a meal-replacement program priced at about $200 a month. Part of this program, Optifast, a commercially available low-calorie diet and behavior modification program, cost about $360 a month. Most patients found the cost to be prohibitive according to Dr. Feldshon. The program that MNGI offered was fairly competitive when compared with a number of other commercial diet programs like Nutrisystem and Medifast, which cost $300 and $329 a month, respectively.
Because of the economic pressure these programs can exert on patients, Dr. Feldshon spoke to the difficulty of recruiting patients with major metabolic and digestive disorders. “I work in the liver clinic, so I see people with NASH, NAFLD, cirrhosis, near-cirrhosis, diabetes. These are people that would really benefit from this type of program, and I could not get a single patient to sign up.”
For Dr. Feldshon’s program, patients were required to come to MNGI once a week, which led to higher dropout rates. This is troubling because it is important that patients meet with doctors and other patients as part of a weight loss program. But the inconvenience for patients and doctors is not just in physically attending meetings, but in the medical billing. The Affordable Care Act and Medicare cover obesity screening and counseling, but this is only for primary care physicians, nurse practitioners, physician assistants, or clinical nurse specialists. These limits may not extend into private insurance, but they remain a barrier for those covered by Medicare, according to Dr. Feldshon.
Another effective but ultimately expensive option is weight loss drugs. The cost of drugs can vary wildly. Even well-established drugs like phentermine can cost anywhere from $5 to $35 out of pocket a month, according to Dr. Feldshon. Some drugs, like Saxenda, can cost as much as $1,414 per month if paid for out of pocket. While Saxenda is effective, there is a catch in the prescribing and billing for this drug: “The moment you go above 2.4 mg per day, the insurance company says, ‘Aha! He’s treating obesity,’ and they stop covering it.” One drug that Dr. Feldshon recommends is topiramate because it is a multiuse drug. “Often, the insurance company can’t figure out why you’re prescribing it, so they’ll okay it,” said Dr. Feldshon.
One of the most effective nonsurgical methods of weight loss is intragastric balloon. From 2016 to 2017, MNGI used gastric balloons in 22 patients, resulting in 11.4% total body weight loss in these patients. Unfortunately, it was a “financial loser,” according to Dr. Feldshon. The global case rate charge for one balloon is $8,200. MNGI then incurred $2,000 per balloon, $3,000 in hospital charges, $750 for the medical weight loss program, $1,350 for office personnel and visits, and a calculated opportunity cost of $3,140 resulting in a net loss of $2,040 per balloon. The most important factor in this calculation is the opportunity cost, which includes travel to and from the hospital and phone encounters with patients, which took away Dr. Feldshon’s ability to conduct colonoscopies and GI consults.
In an attempt to make balloons cost effective, Dr. Feldshon committed to doing these procedures on his day off, which reduced the opportunity cost to $0. This made the balloon procedure profitable, at $1,100 per balloon, but the volume was too low to make it worthwhile.
Despite the challenges his group faced with treating obesity, Dr. Feldshon offered some cost-saving solutions to help keep costs down for both patients and doctors. He suggested avoiding manufacturer weight loss programs. Identify an internal program that is reasonably priced or an external program like Weight Watchers. Physicians can utilize video conferencing for weekly meetings; this helps patients interact with doctors, and products like AdobeConnect cost physicians only about $50 a month. Patients can use free online journaling products like MyFitnessPal to track diet and exercise. Physicians can also recommend using generic and over-the-counter drugs and consider enlisting the help of a life coach or dietitian.
“All obese patients benefit from weight loss but we should be targeting those with metabolic syndrome, diabetes, heart disease, hypercholesterolemia, hyperlipidemia, and increased abdominal girth,” said Dr. Feldshon.
Dr. Feldshon has served on advisory committees and review panels and has worked with United Health Group as well as Prime Therapeutics.
AGA Resource
AGA has created an Obesity Practice Guide to provide gastroenterologists with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management, including a model for how to operationalize business issues.
The increase in the proportion of people who are overweight and obese presents gastroenterologists with new challenges and opportunities. Our internal medicine background, experience in nutrition, and role as endoscopists puts us in a unique position to manage obesity. In addition, many GI conditions are directly affected by obesity, including NASH, GERD, pancreatic diseases, and colon cancer. Good nutrition will always be the cornerstone of healthy weight, but nutritional advice alone results in modest (2%-3%) total weight loss. This can be augmented with medications, meal replacement, endobariatrics, and combinations of these.
Having said this, there are significant challenges to managing obesity as a gastroenterologist, and these stem almost entirely from the fact that there is poor coverage for these therapeutic options, as emphasized by Dr. Feldshon. However, it is still important to bring weight loss interventions into our clinical practice – for many reasons.
First, unlike other obesity management programs, we are typically not managing obesity in isolation. Usually, we are managing obesity in the setting of a disease state such as NASH. When we manage patients with NASH and stage 3 fibrosis, the patients’ decision making on how much to invest to prevent further progression is different; they’re more likely to take on some costs. Second, the degree of coverage for medications is improving. Similarly, although endobariatrics is not currently covered, with time it likely will be under certain criteria.
We need to build the clinical experience necessary to manage obesity and do so now, or other specialties will have become the main providers of weight loss interventions. This will become a lost opportunity for both medical and endobariatric management of these patients by us.
So despite the challenges raised by Dr. Feldshon, I would suggest that a practicing gastroenterologist interested in weight loss management focus on patients with obesity-related diseases first and expand their focus incrementally.
Wahajat Mehal, MD, DPhil, is a hepatologist and director of the Yale Weight Loss Program at Yale University, New Haven, Conn. He is an associate editor for GI & Hepatology News.
The increase in the proportion of people who are overweight and obese presents gastroenterologists with new challenges and opportunities. Our internal medicine background, experience in nutrition, and role as endoscopists puts us in a unique position to manage obesity. In addition, many GI conditions are directly affected by obesity, including NASH, GERD, pancreatic diseases, and colon cancer. Good nutrition will always be the cornerstone of healthy weight, but nutritional advice alone results in modest (2%-3%) total weight loss. This can be augmented with medications, meal replacement, endobariatrics, and combinations of these.
Having said this, there are significant challenges to managing obesity as a gastroenterologist, and these stem almost entirely from the fact that there is poor coverage for these therapeutic options, as emphasized by Dr. Feldshon. However, it is still important to bring weight loss interventions into our clinical practice – for many reasons.
First, unlike other obesity management programs, we are typically not managing obesity in isolation. Usually, we are managing obesity in the setting of a disease state such as NASH. When we manage patients with NASH and stage 3 fibrosis, the patients’ decision making on how much to invest to prevent further progression is different; they’re more likely to take on some costs. Second, the degree of coverage for medications is improving. Similarly, although endobariatrics is not currently covered, with time it likely will be under certain criteria.
We need to build the clinical experience necessary to manage obesity and do so now, or other specialties will have become the main providers of weight loss interventions. This will become a lost opportunity for both medical and endobariatric management of these patients by us.
So despite the challenges raised by Dr. Feldshon, I would suggest that a practicing gastroenterologist interested in weight loss management focus on patients with obesity-related diseases first and expand their focus incrementally.
Wahajat Mehal, MD, DPhil, is a hepatologist and director of the Yale Weight Loss Program at Yale University, New Haven, Conn. He is an associate editor for GI & Hepatology News.
The increase in the proportion of people who are overweight and obese presents gastroenterologists with new challenges and opportunities. Our internal medicine background, experience in nutrition, and role as endoscopists puts us in a unique position to manage obesity. In addition, many GI conditions are directly affected by obesity, including NASH, GERD, pancreatic diseases, and colon cancer. Good nutrition will always be the cornerstone of healthy weight, but nutritional advice alone results in modest (2%-3%) total weight loss. This can be augmented with medications, meal replacement, endobariatrics, and combinations of these.
Having said this, there are significant challenges to managing obesity as a gastroenterologist, and these stem almost entirely from the fact that there is poor coverage for these therapeutic options, as emphasized by Dr. Feldshon. However, it is still important to bring weight loss interventions into our clinical practice – for many reasons.
First, unlike other obesity management programs, we are typically not managing obesity in isolation. Usually, we are managing obesity in the setting of a disease state such as NASH. When we manage patients with NASH and stage 3 fibrosis, the patients’ decision making on how much to invest to prevent further progression is different; they’re more likely to take on some costs. Second, the degree of coverage for medications is improving. Similarly, although endobariatrics is not currently covered, with time it likely will be under certain criteria.
We need to build the clinical experience necessary to manage obesity and do so now, or other specialties will have become the main providers of weight loss interventions. This will become a lost opportunity for both medical and endobariatric management of these patients by us.
So despite the challenges raised by Dr. Feldshon, I would suggest that a practicing gastroenterologist interested in weight loss management focus on patients with obesity-related diseases first and expand their focus incrementally.
Wahajat Mehal, MD, DPhil, is a hepatologist and director of the Yale Weight Loss Program at Yale University, New Haven, Conn. He is an associate editor for GI & Hepatology News.
WASHINGTON – “We have heard about a lot of really interesting new things in therapy, but the reality is that they are just not economically viable at present,” said David Feldshon, MD, of Minnesota Gastroenterology (MNGI), speaking about his experience with offering obesity treatment in his practice.
One problem that Dr. Feldshon and MNGI faced was that they could never get enough patients into their weight loss program, a meal-replacement program priced at about $200 a month. Part of this program, Optifast, a commercially available low-calorie diet and behavior modification program, cost about $360 a month. Most patients found the cost to be prohibitive according to Dr. Feldshon. The program that MNGI offered was fairly competitive when compared with a number of other commercial diet programs like Nutrisystem and Medifast, which cost $300 and $329 a month, respectively.
Because of the economic pressure these programs can exert on patients, Dr. Feldshon spoke to the difficulty of recruiting patients with major metabolic and digestive disorders. “I work in the liver clinic, so I see people with NASH, NAFLD, cirrhosis, near-cirrhosis, diabetes. These are people that would really benefit from this type of program, and I could not get a single patient to sign up.”
For Dr. Feldshon’s program, patients were required to come to MNGI once a week, which led to higher dropout rates. This is troubling because it is important that patients meet with doctors and other patients as part of a weight loss program. But the inconvenience for patients and doctors is not just in physically attending meetings, but in the medical billing. The Affordable Care Act and Medicare cover obesity screening and counseling, but this is only for primary care physicians, nurse practitioners, physician assistants, or clinical nurse specialists. These limits may not extend into private insurance, but they remain a barrier for those covered by Medicare, according to Dr. Feldshon.
Another effective but ultimately expensive option is weight loss drugs. The cost of drugs can vary wildly. Even well-established drugs like phentermine can cost anywhere from $5 to $35 out of pocket a month, according to Dr. Feldshon. Some drugs, like Saxenda, can cost as much as $1,414 per month if paid for out of pocket. While Saxenda is effective, there is a catch in the prescribing and billing for this drug: “The moment you go above 2.4 mg per day, the insurance company says, ‘Aha! He’s treating obesity,’ and they stop covering it.” One drug that Dr. Feldshon recommends is topiramate because it is a multiuse drug. “Often, the insurance company can’t figure out why you’re prescribing it, so they’ll okay it,” said Dr. Feldshon.
One of the most effective nonsurgical methods of weight loss is intragastric balloon. From 2016 to 2017, MNGI used gastric balloons in 22 patients, resulting in 11.4% total body weight loss in these patients. Unfortunately, it was a “financial loser,” according to Dr. Feldshon. The global case rate charge for one balloon is $8,200. MNGI then incurred $2,000 per balloon, $3,000 in hospital charges, $750 for the medical weight loss program, $1,350 for office personnel and visits, and a calculated opportunity cost of $3,140 resulting in a net loss of $2,040 per balloon. The most important factor in this calculation is the opportunity cost, which includes travel to and from the hospital and phone encounters with patients, which took away Dr. Feldshon’s ability to conduct colonoscopies and GI consults.
In an attempt to make balloons cost effective, Dr. Feldshon committed to doing these procedures on his day off, which reduced the opportunity cost to $0. This made the balloon procedure profitable, at $1,100 per balloon, but the volume was too low to make it worthwhile.
Despite the challenges his group faced with treating obesity, Dr. Feldshon offered some cost-saving solutions to help keep costs down for both patients and doctors. He suggested avoiding manufacturer weight loss programs. Identify an internal program that is reasonably priced or an external program like Weight Watchers. Physicians can utilize video conferencing for weekly meetings; this helps patients interact with doctors, and products like AdobeConnect cost physicians only about $50 a month. Patients can use free online journaling products like MyFitnessPal to track diet and exercise. Physicians can also recommend using generic and over-the-counter drugs and consider enlisting the help of a life coach or dietitian.
“All obese patients benefit from weight loss but we should be targeting those with metabolic syndrome, diabetes, heart disease, hypercholesterolemia, hyperlipidemia, and increased abdominal girth,” said Dr. Feldshon.
Dr. Feldshon has served on advisory committees and review panels and has worked with United Health Group as well as Prime Therapeutics.
AGA Resource
AGA has created an Obesity Practice Guide to provide gastroenterologists with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management, including a model for how to operationalize business issues.
WASHINGTON – “We have heard about a lot of really interesting new things in therapy, but the reality is that they are just not economically viable at present,” said David Feldshon, MD, of Minnesota Gastroenterology (MNGI), speaking about his experience with offering obesity treatment in his practice.
One problem that Dr. Feldshon and MNGI faced was that they could never get enough patients into their weight loss program, a meal-replacement program priced at about $200 a month. Part of this program, Optifast, a commercially available low-calorie diet and behavior modification program, cost about $360 a month. Most patients found the cost to be prohibitive according to Dr. Feldshon. The program that MNGI offered was fairly competitive when compared with a number of other commercial diet programs like Nutrisystem and Medifast, which cost $300 and $329 a month, respectively.
Because of the economic pressure these programs can exert on patients, Dr. Feldshon spoke to the difficulty of recruiting patients with major metabolic and digestive disorders. “I work in the liver clinic, so I see people with NASH, NAFLD, cirrhosis, near-cirrhosis, diabetes. These are people that would really benefit from this type of program, and I could not get a single patient to sign up.”
For Dr. Feldshon’s program, patients were required to come to MNGI once a week, which led to higher dropout rates. This is troubling because it is important that patients meet with doctors and other patients as part of a weight loss program. But the inconvenience for patients and doctors is not just in physically attending meetings, but in the medical billing. The Affordable Care Act and Medicare cover obesity screening and counseling, but this is only for primary care physicians, nurse practitioners, physician assistants, or clinical nurse specialists. These limits may not extend into private insurance, but they remain a barrier for those covered by Medicare, according to Dr. Feldshon.
Another effective but ultimately expensive option is weight loss drugs. The cost of drugs can vary wildly. Even well-established drugs like phentermine can cost anywhere from $5 to $35 out of pocket a month, according to Dr. Feldshon. Some drugs, like Saxenda, can cost as much as $1,414 per month if paid for out of pocket. While Saxenda is effective, there is a catch in the prescribing and billing for this drug: “The moment you go above 2.4 mg per day, the insurance company says, ‘Aha! He’s treating obesity,’ and they stop covering it.” One drug that Dr. Feldshon recommends is topiramate because it is a multiuse drug. “Often, the insurance company can’t figure out why you’re prescribing it, so they’ll okay it,” said Dr. Feldshon.
One of the most effective nonsurgical methods of weight loss is intragastric balloon. From 2016 to 2017, MNGI used gastric balloons in 22 patients, resulting in 11.4% total body weight loss in these patients. Unfortunately, it was a “financial loser,” according to Dr. Feldshon. The global case rate charge for one balloon is $8,200. MNGI then incurred $2,000 per balloon, $3,000 in hospital charges, $750 for the medical weight loss program, $1,350 for office personnel and visits, and a calculated opportunity cost of $3,140 resulting in a net loss of $2,040 per balloon. The most important factor in this calculation is the opportunity cost, which includes travel to and from the hospital and phone encounters with patients, which took away Dr. Feldshon’s ability to conduct colonoscopies and GI consults.
In an attempt to make balloons cost effective, Dr. Feldshon committed to doing these procedures on his day off, which reduced the opportunity cost to $0. This made the balloon procedure profitable, at $1,100 per balloon, but the volume was too low to make it worthwhile.
Despite the challenges his group faced with treating obesity, Dr. Feldshon offered some cost-saving solutions to help keep costs down for both patients and doctors. He suggested avoiding manufacturer weight loss programs. Identify an internal program that is reasonably priced or an external program like Weight Watchers. Physicians can utilize video conferencing for weekly meetings; this helps patients interact with doctors, and products like AdobeConnect cost physicians only about $50 a month. Patients can use free online journaling products like MyFitnessPal to track diet and exercise. Physicians can also recommend using generic and over-the-counter drugs and consider enlisting the help of a life coach or dietitian.
“All obese patients benefit from weight loss but we should be targeting those with metabolic syndrome, diabetes, heart disease, hypercholesterolemia, hyperlipidemia, and increased abdominal girth,” said Dr. Feldshon.
Dr. Feldshon has served on advisory committees and review panels and has worked with United Health Group as well as Prime Therapeutics.
AGA Resource
AGA has created an Obesity Practice Guide to provide gastroenterologists with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management, including a model for how to operationalize business issues.
EXPERT ANALYSIS FROM DDW 2018
Prolonged opioid use among U.S. IBD patients doubled during 2002-2016
WASHINGTON – based on statistics gathered in a database that included medical records from more than 40 million American patients.
Prolonged opioid treatment, defined as filling at least two prescriptions for an opioid at least 90 days apart in a calendar year, rose among patients diagnosed with either Crohn’s disease or ulcerative colitis from a low of 14% in 2002 to 26% in 2016, reaching a peak during the period of 29% in 2014, Marc Landsman, MD, said at the annual Digestive Disease Week.®
The sharpest rise during the 15-year period examined was an increase in this level of opioid use from 15% in 2004 to 21% in 2005. Prolonged opioid use remained at or above 26% of all U.S. patients identified with IBD in the database during each year from 2011 to 2016, said Dr. Landsman, a gastroenterologist at the MetroHealth Medical Center in Cleveland. He suggested that a multidisciplinary approach to pain relief including alternative approaches to pain management, “will be vital” for pain management in IBD patients.
“Pain is a very important symptom of IBD. Opioids have been easy to prescribe, but they may not be the correct drug to prescribe,” commented Gil Y. Melmed, MD, director of clinical inflammatory bowel disease at Cedars-Sinai Medical Center in Los Angeles. He agreed with Dr. Landsman that a more multidisciplinary approach to pain management, including behavioral interventions, might reduce reliance on opioids in these patients. In addition, good control of an IBD patient’s inflammatory disease with, for example, a tumor necrosis factor inhibitor often produces substantial pain reduction, although some patients may also need surgery to relieve obstructive pain, Dr. Melmed said in an interview.The analysis run by Dr. Landsman and his associates used data in the Explorys database that included 276,340 unique patients with a diagnosis in their insurance record of IBD who also underwent either flexible sigmoidoscopy or colonoscopy during the year when they first received the diagnosis.
The study also analyzed the type of medical insurance used by patients who received prolonged opioid treatment. During 2002, 43% of patients who received an opioid for a prolonged period had Medicare coverage, 35% had private insurance, and 20% had Medicaid coverage. The prevalence of Medicare and private insurance coverage among opioid recipients steadily shifted during the next 14 years, so that in 2016 private insurance was the most prevalent coverage among the IBD patients on prolonged opioid use, at 46%, with 33% on Medicare coverage and 15% covered by Medicaid. The changes in the prevalence of Medicare and private insurance coverage from 2002 to 2016 were statistically significant, Dr. Landsman said.
Dr. Landsman and Dr. Melmed had no relevant disclosures.
SOURCE: Landsman M et al. DDW 2018. Presentation 14.
WASHINGTON – based on statistics gathered in a database that included medical records from more than 40 million American patients.
Prolonged opioid treatment, defined as filling at least two prescriptions for an opioid at least 90 days apart in a calendar year, rose among patients diagnosed with either Crohn’s disease or ulcerative colitis from a low of 14% in 2002 to 26% in 2016, reaching a peak during the period of 29% in 2014, Marc Landsman, MD, said at the annual Digestive Disease Week.®
The sharpest rise during the 15-year period examined was an increase in this level of opioid use from 15% in 2004 to 21% in 2005. Prolonged opioid use remained at or above 26% of all U.S. patients identified with IBD in the database during each year from 2011 to 2016, said Dr. Landsman, a gastroenterologist at the MetroHealth Medical Center in Cleveland. He suggested that a multidisciplinary approach to pain relief including alternative approaches to pain management, “will be vital” for pain management in IBD patients.
“Pain is a very important symptom of IBD. Opioids have been easy to prescribe, but they may not be the correct drug to prescribe,” commented Gil Y. Melmed, MD, director of clinical inflammatory bowel disease at Cedars-Sinai Medical Center in Los Angeles. He agreed with Dr. Landsman that a more multidisciplinary approach to pain management, including behavioral interventions, might reduce reliance on opioids in these patients. In addition, good control of an IBD patient’s inflammatory disease with, for example, a tumor necrosis factor inhibitor often produces substantial pain reduction, although some patients may also need surgery to relieve obstructive pain, Dr. Melmed said in an interview.The analysis run by Dr. Landsman and his associates used data in the Explorys database that included 276,340 unique patients with a diagnosis in their insurance record of IBD who also underwent either flexible sigmoidoscopy or colonoscopy during the year when they first received the diagnosis.
The study also analyzed the type of medical insurance used by patients who received prolonged opioid treatment. During 2002, 43% of patients who received an opioid for a prolonged period had Medicare coverage, 35% had private insurance, and 20% had Medicaid coverage. The prevalence of Medicare and private insurance coverage among opioid recipients steadily shifted during the next 14 years, so that in 2016 private insurance was the most prevalent coverage among the IBD patients on prolonged opioid use, at 46%, with 33% on Medicare coverage and 15% covered by Medicaid. The changes in the prevalence of Medicare and private insurance coverage from 2002 to 2016 were statistically significant, Dr. Landsman said.
Dr. Landsman and Dr. Melmed had no relevant disclosures.
SOURCE: Landsman M et al. DDW 2018. Presentation 14.
WASHINGTON – based on statistics gathered in a database that included medical records from more than 40 million American patients.
Prolonged opioid treatment, defined as filling at least two prescriptions for an opioid at least 90 days apart in a calendar year, rose among patients diagnosed with either Crohn’s disease or ulcerative colitis from a low of 14% in 2002 to 26% in 2016, reaching a peak during the period of 29% in 2014, Marc Landsman, MD, said at the annual Digestive Disease Week.®
The sharpest rise during the 15-year period examined was an increase in this level of opioid use from 15% in 2004 to 21% in 2005. Prolonged opioid use remained at or above 26% of all U.S. patients identified with IBD in the database during each year from 2011 to 2016, said Dr. Landsman, a gastroenterologist at the MetroHealth Medical Center in Cleveland. He suggested that a multidisciplinary approach to pain relief including alternative approaches to pain management, “will be vital” for pain management in IBD patients.
“Pain is a very important symptom of IBD. Opioids have been easy to prescribe, but they may not be the correct drug to prescribe,” commented Gil Y. Melmed, MD, director of clinical inflammatory bowel disease at Cedars-Sinai Medical Center in Los Angeles. He agreed with Dr. Landsman that a more multidisciplinary approach to pain management, including behavioral interventions, might reduce reliance on opioids in these patients. In addition, good control of an IBD patient’s inflammatory disease with, for example, a tumor necrosis factor inhibitor often produces substantial pain reduction, although some patients may also need surgery to relieve obstructive pain, Dr. Melmed said in an interview.The analysis run by Dr. Landsman and his associates used data in the Explorys database that included 276,340 unique patients with a diagnosis in their insurance record of IBD who also underwent either flexible sigmoidoscopy or colonoscopy during the year when they first received the diagnosis.
The study also analyzed the type of medical insurance used by patients who received prolonged opioid treatment. During 2002, 43% of patients who received an opioid for a prolonged period had Medicare coverage, 35% had private insurance, and 20% had Medicaid coverage. The prevalence of Medicare and private insurance coverage among opioid recipients steadily shifted during the next 14 years, so that in 2016 private insurance was the most prevalent coverage among the IBD patients on prolonged opioid use, at 46%, with 33% on Medicare coverage and 15% covered by Medicaid. The changes in the prevalence of Medicare and private insurance coverage from 2002 to 2016 were statistically significant, Dr. Landsman said.
Dr. Landsman and Dr. Melmed had no relevant disclosures.
SOURCE: Landsman M et al. DDW 2018. Presentation 14.
REPORTING FROM DDW 2018
Key clinical point: Prolonged opioid use by IBD patients increased substantially during 2002-2016.
Major finding: The incidence of prolonged opioid use among U.S. IBD patients rose from 14% in 2002 to 26% in 2016.
Study details: Review of 276,340 U.S. patients diagnosed with IBD contained in a large insurance database.
Disclosures: Dr. Landsman and Dr. Melmed had no relevant disclosures.
Source: Landsman M et al. DDW 2018. Presentation 14.
Fecal transplantation suggests IBS efficacy in small, randomized studies
WASHINGTON –
In the more positive of the two studies, patients with “bloating-predominant” IBS received a freshly prepared FMT from either a selected donor or from their own stool as a placebo control. After 12 weeks, the percentage of patients reporting clinically meaningful improvements in both abdominal bloating and in IBS symptoms was roughly twice as high, about 56%, among the 43 actively treated patients as the 26% rate of patients reporting these changes among 19 controls, Tom Holvoet, MD, said at the annual Digestive Disease Week.®Further follow-up of 22 patients who had significant improvement of their IBS symptoms at 12 weeks after treatment showed that, 1 year later, 6 of the 22 (27%) maintained their improved state while the other 73% of patients relapsed, suggesting that retreatment may be necessary for many, said Dr. Holvoet, a gastroenterologist at Ghent (Belgium) University. Five of the six patients who showed a prolonged response had received a donor FMT, while the sixth patient was from the control group that received a transplant of material prepared from the patient’s own stool.
“I think some patients would be willing to have multiple treatments,” Dr. Holvoet said in an interview. “These are highly motivated patients; you need to be highly motivated to undergo this treatment, and if they see an effect they’ll be motivated for retreatment,” he predicted.
The single-center study enrolled patients 18-75 years old with refractory IBS, based on the Rome III criteria, with intermittent diarrhea and severe bloating. Each patient received a single FMT. Patients in the active-treatment arm received their FMT from either of two donors selected for their “rich microbial diversity,” and demonstrated efficacy in an earlier pilot study with 12 patients (Gut. 2017 May;66[5]:980-2). In addition to a higher rate of improvement of abdominal bloating and IBS symptoms, the donor FMT also led to a significantly better improvement in IBS-related quality of life. Preliminary analysis of the intestinal microbiome profile of patients in the study suggested that specific changes to the microbiome were linked with treatment success.
Dr. Holvoet highlighted that more research is needed to identify ideal patients to treat this way, and to simplify and streamline the FMT process.
“Our study is a good first step, but we need to figure out what is happening in these patients,” Dr. Holvoet said in an interview.
Results from the second study failed to show a statistically significant benefit from FMT, compared with placebo, for the primary endpoint, but it did show benefit in one secondary endpoint.
This study enrolled 48 patients 19-65 years old with moderate to severe, diarrhea-predominant IBS, based on the Rome III definitions, at any of three U.S. centers. The researchers randomized patients to either immediate treatment for 3 days with an encapsulated, frozen fecal preparation obtained from the OpenBiome stool bank or placebo capsules. After 12 weeks, the average change from baseline in the IBS–Symptom Severity Score (SSS), the study’s primary endpoint, was virtually identical in both arms of the study. In both treatment groups the average baseline IBS-SSS was nearly 300, and in both treatment groups the SSS dropped sharply after 1 week into the study and then remained stable at this lower level in both groups during the next 11 weeks. Patients then underwent a second round of treatment in a crossover design. During a second 12 weeks of follow-up the average IBS-SSS remained steady among the patients who received placebo as their second treatment, but the patients who received active treatment as their second dose showed a further significant decline in their SSS, so that after the second 12-week follow-up the average score was 76 points lower in patients who recently had active treatment than those who recently received placebo, a statistically significant difference for this clinically meaningful point difference, reported Lawrence J. Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine in New York.
In addition, the 12 patients in the study who had postinfection IBS showed the most dramatic reduction from baseline in their IBS-SSS 12 weeks after active treatment, compared with placebo. In contrast, 33 other patients in the study with noninfectious IBS etiologies showed on average no difference between active and placebo treatment in their 12-week change in SSS.
Preliminary findings in this study also showed some correlations between certain microbiome changes and better clinical responses to FMT, Dr. Brandt noted.
Dr. Holvoet and Dr. Brandt had no disclosures.
SOURCE: Holvoet T et al. DDW 2018. Presentation 617; Aroniadis OC et al. Presentation 742.
WASHINGTON –
In the more positive of the two studies, patients with “bloating-predominant” IBS received a freshly prepared FMT from either a selected donor or from their own stool as a placebo control. After 12 weeks, the percentage of patients reporting clinically meaningful improvements in both abdominal bloating and in IBS symptoms was roughly twice as high, about 56%, among the 43 actively treated patients as the 26% rate of patients reporting these changes among 19 controls, Tom Holvoet, MD, said at the annual Digestive Disease Week.®Further follow-up of 22 patients who had significant improvement of their IBS symptoms at 12 weeks after treatment showed that, 1 year later, 6 of the 22 (27%) maintained their improved state while the other 73% of patients relapsed, suggesting that retreatment may be necessary for many, said Dr. Holvoet, a gastroenterologist at Ghent (Belgium) University. Five of the six patients who showed a prolonged response had received a donor FMT, while the sixth patient was from the control group that received a transplant of material prepared from the patient’s own stool.
“I think some patients would be willing to have multiple treatments,” Dr. Holvoet said in an interview. “These are highly motivated patients; you need to be highly motivated to undergo this treatment, and if they see an effect they’ll be motivated for retreatment,” he predicted.
The single-center study enrolled patients 18-75 years old with refractory IBS, based on the Rome III criteria, with intermittent diarrhea and severe bloating. Each patient received a single FMT. Patients in the active-treatment arm received their FMT from either of two donors selected for their “rich microbial diversity,” and demonstrated efficacy in an earlier pilot study with 12 patients (Gut. 2017 May;66[5]:980-2). In addition to a higher rate of improvement of abdominal bloating and IBS symptoms, the donor FMT also led to a significantly better improvement in IBS-related quality of life. Preliminary analysis of the intestinal microbiome profile of patients in the study suggested that specific changes to the microbiome were linked with treatment success.
Dr. Holvoet highlighted that more research is needed to identify ideal patients to treat this way, and to simplify and streamline the FMT process.
“Our study is a good first step, but we need to figure out what is happening in these patients,” Dr. Holvoet said in an interview.
Results from the second study failed to show a statistically significant benefit from FMT, compared with placebo, for the primary endpoint, but it did show benefit in one secondary endpoint.
This study enrolled 48 patients 19-65 years old with moderate to severe, diarrhea-predominant IBS, based on the Rome III definitions, at any of three U.S. centers. The researchers randomized patients to either immediate treatment for 3 days with an encapsulated, frozen fecal preparation obtained from the OpenBiome stool bank or placebo capsules. After 12 weeks, the average change from baseline in the IBS–Symptom Severity Score (SSS), the study’s primary endpoint, was virtually identical in both arms of the study. In both treatment groups the average baseline IBS-SSS was nearly 300, and in both treatment groups the SSS dropped sharply after 1 week into the study and then remained stable at this lower level in both groups during the next 11 weeks. Patients then underwent a second round of treatment in a crossover design. During a second 12 weeks of follow-up the average IBS-SSS remained steady among the patients who received placebo as their second treatment, but the patients who received active treatment as their second dose showed a further significant decline in their SSS, so that after the second 12-week follow-up the average score was 76 points lower in patients who recently had active treatment than those who recently received placebo, a statistically significant difference for this clinically meaningful point difference, reported Lawrence J. Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine in New York.
In addition, the 12 patients in the study who had postinfection IBS showed the most dramatic reduction from baseline in their IBS-SSS 12 weeks after active treatment, compared with placebo. In contrast, 33 other patients in the study with noninfectious IBS etiologies showed on average no difference between active and placebo treatment in their 12-week change in SSS.
Preliminary findings in this study also showed some correlations between certain microbiome changes and better clinical responses to FMT, Dr. Brandt noted.
Dr. Holvoet and Dr. Brandt had no disclosures.
SOURCE: Holvoet T et al. DDW 2018. Presentation 617; Aroniadis OC et al. Presentation 742.
WASHINGTON –
In the more positive of the two studies, patients with “bloating-predominant” IBS received a freshly prepared FMT from either a selected donor or from their own stool as a placebo control. After 12 weeks, the percentage of patients reporting clinically meaningful improvements in both abdominal bloating and in IBS symptoms was roughly twice as high, about 56%, among the 43 actively treated patients as the 26% rate of patients reporting these changes among 19 controls, Tom Holvoet, MD, said at the annual Digestive Disease Week.®Further follow-up of 22 patients who had significant improvement of their IBS symptoms at 12 weeks after treatment showed that, 1 year later, 6 of the 22 (27%) maintained their improved state while the other 73% of patients relapsed, suggesting that retreatment may be necessary for many, said Dr. Holvoet, a gastroenterologist at Ghent (Belgium) University. Five of the six patients who showed a prolonged response had received a donor FMT, while the sixth patient was from the control group that received a transplant of material prepared from the patient’s own stool.
“I think some patients would be willing to have multiple treatments,” Dr. Holvoet said in an interview. “These are highly motivated patients; you need to be highly motivated to undergo this treatment, and if they see an effect they’ll be motivated for retreatment,” he predicted.
The single-center study enrolled patients 18-75 years old with refractory IBS, based on the Rome III criteria, with intermittent diarrhea and severe bloating. Each patient received a single FMT. Patients in the active-treatment arm received their FMT from either of two donors selected for their “rich microbial diversity,” and demonstrated efficacy in an earlier pilot study with 12 patients (Gut. 2017 May;66[5]:980-2). In addition to a higher rate of improvement of abdominal bloating and IBS symptoms, the donor FMT also led to a significantly better improvement in IBS-related quality of life. Preliminary analysis of the intestinal microbiome profile of patients in the study suggested that specific changes to the microbiome were linked with treatment success.
Dr. Holvoet highlighted that more research is needed to identify ideal patients to treat this way, and to simplify and streamline the FMT process.
“Our study is a good first step, but we need to figure out what is happening in these patients,” Dr. Holvoet said in an interview.
Results from the second study failed to show a statistically significant benefit from FMT, compared with placebo, for the primary endpoint, but it did show benefit in one secondary endpoint.
This study enrolled 48 patients 19-65 years old with moderate to severe, diarrhea-predominant IBS, based on the Rome III definitions, at any of three U.S. centers. The researchers randomized patients to either immediate treatment for 3 days with an encapsulated, frozen fecal preparation obtained from the OpenBiome stool bank or placebo capsules. After 12 weeks, the average change from baseline in the IBS–Symptom Severity Score (SSS), the study’s primary endpoint, was virtually identical in both arms of the study. In both treatment groups the average baseline IBS-SSS was nearly 300, and in both treatment groups the SSS dropped sharply after 1 week into the study and then remained stable at this lower level in both groups during the next 11 weeks. Patients then underwent a second round of treatment in a crossover design. During a second 12 weeks of follow-up the average IBS-SSS remained steady among the patients who received placebo as their second treatment, but the patients who received active treatment as their second dose showed a further significant decline in their SSS, so that after the second 12-week follow-up the average score was 76 points lower in patients who recently had active treatment than those who recently received placebo, a statistically significant difference for this clinically meaningful point difference, reported Lawrence J. Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine in New York.
In addition, the 12 patients in the study who had postinfection IBS showed the most dramatic reduction from baseline in their IBS-SSS 12 weeks after active treatment, compared with placebo. In contrast, 33 other patients in the study with noninfectious IBS etiologies showed on average no difference between active and placebo treatment in their 12-week change in SSS.
Preliminary findings in this study also showed some correlations between certain microbiome changes and better clinical responses to FMT, Dr. Brandt noted.
Dr. Holvoet and Dr. Brandt had no disclosures.
SOURCE: Holvoet T et al. DDW 2018. Presentation 617; Aroniadis OC et al. Presentation 742.
REPORTING FROM DDW 2018
Key clinical point: Results from two small randomized studies suggest that fecal microbiome transplantation may help some IBS patients.
Major finding: In one study, fecal transplantation linked with a doubling of patients having reduced IBS symptoms, compared with placebo, .
Study details: A single-center randomized study with 62 patients and a multicenter randomized crossover study with 48 patients.
Disclosures: Dr. Holvoet and Dr. Brandt had no disclosures.
Source: Holvoet T et al. DDW 2018. Presentation 617; Aroniadis OC et al. Presentation 742.
Machine learning software boosts colonoscopists’ adenoma detection rates
WASHINGTON –
When tested on 36,076 archived colonoscopy images, the polyp recognition program developed through machine learning had a sensitivity for polyp detection of 98%, a specificity of 93%, a positive predictive value of 0.758 and a negative predictive value of 0.995, Priyam V. Tripathi, MD, said at the annual Digestive Disease Week.® The program also showed an area under the receiver operator characteristic curve of 0.99, indicating nearly perfect ability to discriminate between images of polyps and normal colonic tissue, said Dr. Tripathi, a gastroenterologist at the University of California, Irvine.
She and her associates initially developed the polyp-recognition program with machine learning engineering that involved 4,088 images of polyps and 4,553 images of normal tissue drawn from the extensive colonoscopy video archive maintained at UC Irvine. Refinement of the program continues as it undergoes further use. The program can review 98 images a second, making it more than fast enough to aid during real-time colonoscopy examinations, Dr. Tripathi explained in a video interview. As an operator withdraws the colonoscope and views the images, the program is designed to monitor the pictures along with the operator and trigger alerts that flag high-probability lesions by framing them in a colored box on the screen. The operator can then examine these sites with more attention and decide whether they warrant biopsy or polypectomy.
A second validation study used the program to review 20 archived colonoscopy videos along with an expert panel. During the original examinations, the operators of these 20 procedures identified 28 polyps. The expert review confirmed these 28 and identified eight additional polyps. The researchers then assessed the same videos with the recognition program and confirmed the original 28 plus the added eight and also found nine additional polyps that had been missed twice by clinicians. Dr. Tripathi and her associates recently published results from this validation study (Gastroenterology. 2018 Jun 18. doi: 10.1053/j.gastro.2018.06.037).
The next step is a prospective, multicenter study to compare the adenoma detection rate of operators aided by the recognition program with their detection rate without the program, she said.
“The adenoma detection rate is the key marker,” noted William E. Karnes, MD, a gastroenterologist at UC Irvine and senior investigator on these studies. “If the adenoma detection rate rises, we won’t know whether it’s the artificial intelligence that’s the reason, or whether it’s the artificial intelligence watching the operator” and motivating the gastroenterologist to do a more thorough job, Dr. Karnes noted in an interview. “But it doesn’t matter as long as the software is easy to use. It can potentially close the gap in adenoma detection rates. There are a lot of missed polyps” in routine practice right now.
SOURCE: Tripathi PV et al. DDW 2018. Presentation 133.
WASHINGTON –
When tested on 36,076 archived colonoscopy images, the polyp recognition program developed through machine learning had a sensitivity for polyp detection of 98%, a specificity of 93%, a positive predictive value of 0.758 and a negative predictive value of 0.995, Priyam V. Tripathi, MD, said at the annual Digestive Disease Week.® The program also showed an area under the receiver operator characteristic curve of 0.99, indicating nearly perfect ability to discriminate between images of polyps and normal colonic tissue, said Dr. Tripathi, a gastroenterologist at the University of California, Irvine.
She and her associates initially developed the polyp-recognition program with machine learning engineering that involved 4,088 images of polyps and 4,553 images of normal tissue drawn from the extensive colonoscopy video archive maintained at UC Irvine. Refinement of the program continues as it undergoes further use. The program can review 98 images a second, making it more than fast enough to aid during real-time colonoscopy examinations, Dr. Tripathi explained in a video interview. As an operator withdraws the colonoscope and views the images, the program is designed to monitor the pictures along with the operator and trigger alerts that flag high-probability lesions by framing them in a colored box on the screen. The operator can then examine these sites with more attention and decide whether they warrant biopsy or polypectomy.
A second validation study used the program to review 20 archived colonoscopy videos along with an expert panel. During the original examinations, the operators of these 20 procedures identified 28 polyps. The expert review confirmed these 28 and identified eight additional polyps. The researchers then assessed the same videos with the recognition program and confirmed the original 28 plus the added eight and also found nine additional polyps that had been missed twice by clinicians. Dr. Tripathi and her associates recently published results from this validation study (Gastroenterology. 2018 Jun 18. doi: 10.1053/j.gastro.2018.06.037).
The next step is a prospective, multicenter study to compare the adenoma detection rate of operators aided by the recognition program with their detection rate without the program, she said.
“The adenoma detection rate is the key marker,” noted William E. Karnes, MD, a gastroenterologist at UC Irvine and senior investigator on these studies. “If the adenoma detection rate rises, we won’t know whether it’s the artificial intelligence that’s the reason, or whether it’s the artificial intelligence watching the operator” and motivating the gastroenterologist to do a more thorough job, Dr. Karnes noted in an interview. “But it doesn’t matter as long as the software is easy to use. It can potentially close the gap in adenoma detection rates. There are a lot of missed polyps” in routine practice right now.
SOURCE: Tripathi PV et al. DDW 2018. Presentation 133.
WASHINGTON –
When tested on 36,076 archived colonoscopy images, the polyp recognition program developed through machine learning had a sensitivity for polyp detection of 98%, a specificity of 93%, a positive predictive value of 0.758 and a negative predictive value of 0.995, Priyam V. Tripathi, MD, said at the annual Digestive Disease Week.® The program also showed an area under the receiver operator characteristic curve of 0.99, indicating nearly perfect ability to discriminate between images of polyps and normal colonic tissue, said Dr. Tripathi, a gastroenterologist at the University of California, Irvine.
She and her associates initially developed the polyp-recognition program with machine learning engineering that involved 4,088 images of polyps and 4,553 images of normal tissue drawn from the extensive colonoscopy video archive maintained at UC Irvine. Refinement of the program continues as it undergoes further use. The program can review 98 images a second, making it more than fast enough to aid during real-time colonoscopy examinations, Dr. Tripathi explained in a video interview. As an operator withdraws the colonoscope and views the images, the program is designed to monitor the pictures along with the operator and trigger alerts that flag high-probability lesions by framing them in a colored box on the screen. The operator can then examine these sites with more attention and decide whether they warrant biopsy or polypectomy.
A second validation study used the program to review 20 archived colonoscopy videos along with an expert panel. During the original examinations, the operators of these 20 procedures identified 28 polyps. The expert review confirmed these 28 and identified eight additional polyps. The researchers then assessed the same videos with the recognition program and confirmed the original 28 plus the added eight and also found nine additional polyps that had been missed twice by clinicians. Dr. Tripathi and her associates recently published results from this validation study (Gastroenterology. 2018 Jun 18. doi: 10.1053/j.gastro.2018.06.037).
The next step is a prospective, multicenter study to compare the adenoma detection rate of operators aided by the recognition program with their detection rate without the program, she said.
“The adenoma detection rate is the key marker,” noted William E. Karnes, MD, a gastroenterologist at UC Irvine and senior investigator on these studies. “If the adenoma detection rate rises, we won’t know whether it’s the artificial intelligence that’s the reason, or whether it’s the artificial intelligence watching the operator” and motivating the gastroenterologist to do a more thorough job, Dr. Karnes noted in an interview. “But it doesn’t matter as long as the software is easy to use. It can potentially close the gap in adenoma detection rates. There are a lot of missed polyps” in routine practice right now.
SOURCE: Tripathi PV et al. DDW 2018. Presentation 133.
REPORTING FROM DDW 2018
Key clinical point: New software provides real-time aid to colonoscopists for identifying adenomatous polyps.
Major finding: The software was 98% sensitive, 93% specific, and had a negative predictive value of 0.995 for ruling out adenomatous polyps.
Study details: Single-center review of 36,076 images of polyps and normal colonic tissue.
Disclosures: The software development has no commercial funding. Dr. Tripathi had no disclosures. Dr. Karnes is cofounder of Docbot/Qualoscopy, a company that markets colonoscopy software.
Source: Tripathi PV et al. DDW 2018. Presentation 133.
U.S. pancreatic insufficiency patients often get inadequate enzyme replacement
WASHINGTON – according to a recent analysis of insurance claims data from more than 48 million Americans.
Amid concerns that some people with nonspecific symptoms are overdiagnosed with exocrine pancreatic insufficiency (EPI) and hence getting unneeded treatment with pancreatic enzyme replacement therapy (PERT), it seems like substantial numbers of patients with legitimate pancreatic morbidity are often missed and are going untreated, Chris E. Forsmark, MD, said at the annual Digestive Disease Week®. This includes patients with chronic pancreatitis, pancreatic cancer, and patients who underwent pancreatic resection surgery.
Dr. Forsmark cited still-unpublished evidence that he has reported at meetings during the past year. At DDW 2017 he and his associates reported findings from an analysis of health insurance claims data collected in the PharMetrics database for more than 48 million Americans during 2006-2013, which included 37,061 insured adults diagnosed with chronic pancreatitis. Analysis of these data showed that just 7% had ever undergone testing for EPI and 30% had received a prescription for PERT, of which only 31% received an appropriate dosage (Gastroenterology. 2017 Apr;152[5, suppl 1]:S677). In other words, a scant 9% of insured U.S. adults with chronic pancreatitis during the studied period had received a minimally effective dosage of PERT.
Dr. Forsmark and his associates ran a second analysis using the same 2006-2013 insurance database, but this time looked at 32,461 insured American adults diagnosed with pancreatic cancer and reported similar findings: Fewer than 2% of patients underwent testing for EPI, 22% were prescribed PERT, and of these, 22% of patients per quarter received a minimally effective dosage of PERT, meaning that, overall, only 6% of pancreatic cancer patients received treatment that could be expected to resolve their presumed enzyme deficiency. Dr. Forsmark and his associates presented this report at the annual meeting of the American Pancreatic Association in San Diego in November 2017 (Pancreas. 2017 Nov/Dec;46[10]:1386-1448).
An irony is that PERT underuse comes at a time when some Internet sites promote PERT as a treatment for patients with nonspecific symptoms of EPI such as bloating, dyspepsia, and loose stools, Dr. Forsmark noted. “There is a possibility that patients with nonspecific gastrointestinal symptoms may request or receive PERT. Some patients may receive PERT who do not have EPI.” In 2015, clinicians had written roughly 746,000 prescriptions for PERT to U.S. patients, with the number of prescriptions steadily increasing during 2010-2015. Five different formulations for PERT are currently on the U.S. market, and a typical course of treatment costs about $1,500-$2,000 per month, he added.
Dr. Forsmark had no disclosures to report.
WASHINGTON – according to a recent analysis of insurance claims data from more than 48 million Americans.
Amid concerns that some people with nonspecific symptoms are overdiagnosed with exocrine pancreatic insufficiency (EPI) and hence getting unneeded treatment with pancreatic enzyme replacement therapy (PERT), it seems like substantial numbers of patients with legitimate pancreatic morbidity are often missed and are going untreated, Chris E. Forsmark, MD, said at the annual Digestive Disease Week®. This includes patients with chronic pancreatitis, pancreatic cancer, and patients who underwent pancreatic resection surgery.
Dr. Forsmark cited still-unpublished evidence that he has reported at meetings during the past year. At DDW 2017 he and his associates reported findings from an analysis of health insurance claims data collected in the PharMetrics database for more than 48 million Americans during 2006-2013, which included 37,061 insured adults diagnosed with chronic pancreatitis. Analysis of these data showed that just 7% had ever undergone testing for EPI and 30% had received a prescription for PERT, of which only 31% received an appropriate dosage (Gastroenterology. 2017 Apr;152[5, suppl 1]:S677). In other words, a scant 9% of insured U.S. adults with chronic pancreatitis during the studied period had received a minimally effective dosage of PERT.
Dr. Forsmark and his associates ran a second analysis using the same 2006-2013 insurance database, but this time looked at 32,461 insured American adults diagnosed with pancreatic cancer and reported similar findings: Fewer than 2% of patients underwent testing for EPI, 22% were prescribed PERT, and of these, 22% of patients per quarter received a minimally effective dosage of PERT, meaning that, overall, only 6% of pancreatic cancer patients received treatment that could be expected to resolve their presumed enzyme deficiency. Dr. Forsmark and his associates presented this report at the annual meeting of the American Pancreatic Association in San Diego in November 2017 (Pancreas. 2017 Nov/Dec;46[10]:1386-1448).
An irony is that PERT underuse comes at a time when some Internet sites promote PERT as a treatment for patients with nonspecific symptoms of EPI such as bloating, dyspepsia, and loose stools, Dr. Forsmark noted. “There is a possibility that patients with nonspecific gastrointestinal symptoms may request or receive PERT. Some patients may receive PERT who do not have EPI.” In 2015, clinicians had written roughly 746,000 prescriptions for PERT to U.S. patients, with the number of prescriptions steadily increasing during 2010-2015. Five different formulations for PERT are currently on the U.S. market, and a typical course of treatment costs about $1,500-$2,000 per month, he added.
Dr. Forsmark had no disclosures to report.
WASHINGTON – according to a recent analysis of insurance claims data from more than 48 million Americans.
Amid concerns that some people with nonspecific symptoms are overdiagnosed with exocrine pancreatic insufficiency (EPI) and hence getting unneeded treatment with pancreatic enzyme replacement therapy (PERT), it seems like substantial numbers of patients with legitimate pancreatic morbidity are often missed and are going untreated, Chris E. Forsmark, MD, said at the annual Digestive Disease Week®. This includes patients with chronic pancreatitis, pancreatic cancer, and patients who underwent pancreatic resection surgery.
Dr. Forsmark cited still-unpublished evidence that he has reported at meetings during the past year. At DDW 2017 he and his associates reported findings from an analysis of health insurance claims data collected in the PharMetrics database for more than 48 million Americans during 2006-2013, which included 37,061 insured adults diagnosed with chronic pancreatitis. Analysis of these data showed that just 7% had ever undergone testing for EPI and 30% had received a prescription for PERT, of which only 31% received an appropriate dosage (Gastroenterology. 2017 Apr;152[5, suppl 1]:S677). In other words, a scant 9% of insured U.S. adults with chronic pancreatitis during the studied period had received a minimally effective dosage of PERT.
Dr. Forsmark and his associates ran a second analysis using the same 2006-2013 insurance database, but this time looked at 32,461 insured American adults diagnosed with pancreatic cancer and reported similar findings: Fewer than 2% of patients underwent testing for EPI, 22% were prescribed PERT, and of these, 22% of patients per quarter received a minimally effective dosage of PERT, meaning that, overall, only 6% of pancreatic cancer patients received treatment that could be expected to resolve their presumed enzyme deficiency. Dr. Forsmark and his associates presented this report at the annual meeting of the American Pancreatic Association in San Diego in November 2017 (Pancreas. 2017 Nov/Dec;46[10]:1386-1448).
An irony is that PERT underuse comes at a time when some Internet sites promote PERT as a treatment for patients with nonspecific symptoms of EPI such as bloating, dyspepsia, and loose stools, Dr. Forsmark noted. “There is a possibility that patients with nonspecific gastrointestinal symptoms may request or receive PERT. Some patients may receive PERT who do not have EPI.” In 2015, clinicians had written roughly 746,000 prescriptions for PERT to U.S. patients, with the number of prescriptions steadily increasing during 2010-2015. Five different formulations for PERT are currently on the U.S. market, and a typical course of treatment costs about $1,500-$2,000 per month, he added.
Dr. Forsmark had no disclosures to report.
REPORTING FROM DDW 2018
Key clinical point: U.S. patients with presumed exocrine pancreatic insufficiency often appear undertreated.
Major finding: During 2006-2013, only 9% of U.S. adults with chronic pancreatitis and 6% with pancreatic cancer received adequate enzyme replacement.
Study details: A review of diagnosis and claims data from 48.67 million insured U.S. adults during 2006-2013.
Disclosures: Dr. Forsmark had no disclosures to report.
Female authorship trends in academic gastroenterology over 4 decades
WASHINGTON – Gastroenterology is still a majority male specialty, although women are entering the field at higher and higher rates. Female first authorship tripled from 1995 to 2010 (from 11% to 32%) and female senior authorship tripled from 2000 to 2010 (from 7% to 24%), but gains have not been equal in all areas and have not continued in all areas.
Eileen J. Benz, MD, of Beaumont Hospital, Dublin, described in a video interview at the annual Digestive Disease Week® a study she and her colleagues conducted to analyze published research in the journal Gastroenterology for the changing prevalence of female authorship over 4 decades.
The researchers reviewed all research published in the January and July issues of Gastroenterology during 1971-2010 (865 abstracts); animal trials were excluded. The sex of the first author and the last author (considered the senior author) of each paper was recorded, as was the type of study (basic science, clinical trials, or epidemiologic research). The increase in female senior authorship lagged behind the increase in first authorship, which likely reflects the promotion of female gastroenterologists over time into senior academic positions.
Also noted was that basic science and epidemiology research have the highest number of female authors overall, and these areas seem to continue to add female authors, whereas the number of female authors in clinical trials research seems to have stagnated since 1996. Dr. Benz hypothesizes that both bench science and epidemiology have research time built in, but that for a physician who may have other demands on her time, clinical trials research is an add-on for which there may not be protected time.
WASHINGTON – Gastroenterology is still a majority male specialty, although women are entering the field at higher and higher rates. Female first authorship tripled from 1995 to 2010 (from 11% to 32%) and female senior authorship tripled from 2000 to 2010 (from 7% to 24%), but gains have not been equal in all areas and have not continued in all areas.
Eileen J. Benz, MD, of Beaumont Hospital, Dublin, described in a video interview at the annual Digestive Disease Week® a study she and her colleagues conducted to analyze published research in the journal Gastroenterology for the changing prevalence of female authorship over 4 decades.
The researchers reviewed all research published in the January and July issues of Gastroenterology during 1971-2010 (865 abstracts); animal trials were excluded. The sex of the first author and the last author (considered the senior author) of each paper was recorded, as was the type of study (basic science, clinical trials, or epidemiologic research). The increase in female senior authorship lagged behind the increase in first authorship, which likely reflects the promotion of female gastroenterologists over time into senior academic positions.
Also noted was that basic science and epidemiology research have the highest number of female authors overall, and these areas seem to continue to add female authors, whereas the number of female authors in clinical trials research seems to have stagnated since 1996. Dr. Benz hypothesizes that both bench science and epidemiology have research time built in, but that for a physician who may have other demands on her time, clinical trials research is an add-on for which there may not be protected time.
WASHINGTON – Gastroenterology is still a majority male specialty, although women are entering the field at higher and higher rates. Female first authorship tripled from 1995 to 2010 (from 11% to 32%) and female senior authorship tripled from 2000 to 2010 (from 7% to 24%), but gains have not been equal in all areas and have not continued in all areas.
Eileen J. Benz, MD, of Beaumont Hospital, Dublin, described in a video interview at the annual Digestive Disease Week® a study she and her colleagues conducted to analyze published research in the journal Gastroenterology for the changing prevalence of female authorship over 4 decades.
The researchers reviewed all research published in the January and July issues of Gastroenterology during 1971-2010 (865 abstracts); animal trials were excluded. The sex of the first author and the last author (considered the senior author) of each paper was recorded, as was the type of study (basic science, clinical trials, or epidemiologic research). The increase in female senior authorship lagged behind the increase in first authorship, which likely reflects the promotion of female gastroenterologists over time into senior academic positions.
Also noted was that basic science and epidemiology research have the highest number of female authors overall, and these areas seem to continue to add female authors, whereas the number of female authors in clinical trials research seems to have stagnated since 1996. Dr. Benz hypothesizes that both bench science and epidemiology have research time built in, but that for a physician who may have other demands on her time, clinical trials research is an add-on for which there may not be protected time.
Reporting from DDW 2018
Primary cirrhotic prophylaxis of bacterial peritonitis falls short
WASHINGTON –
The mortality rate during follow-up of cirrhotic patients hospitalized while on primary prophylaxis against spontaneous bacterial peritonitis (SBP) was 19%, compared with a 9% death rate among cirrhotic patients hospitalized while on secondary prophylaxis, Jasmohan S. Bajaj, MD, said at the annual Digestive Disease Week®.
Although the findings raised questions about the value of primary prophylaxis with an antibiotic in cirrhotic patients for preventing a first episode of SBP, secondary prophylaxis remains an important precaution.
“There is clear benefit from secondary prophylaxis; please use it. The data supporting it are robust,” said Dr. Bajaj, a hepatologist at Virginia Commonwealth University, Richmond. In contrast, the evidence supporting benefits from primary prophylaxis is weaker, he said. The findings were also counterintuitive, because patients who experience repeat episodes of SBP might be expected to fare worse than those hit by SBP just once.
Dr. Bajaj also acknowledged the substantial confounding that distinguishes patients with cirrhosis receiving primary or secondary prophylaxis, and the difficulty of fully adjusting for all this confounding by statistical analyses. “There is selective bias for secondary prevention, and there is no way to correct for this,” he explained. Patients who need secondary prophylaxis have “weathered the storm” of a first episode of SBP, which might have exerted selection pressure, and might have triggered important immunologic changes, Dr. Bajaj suggested.
The findings also raised concerns about the appropriateness of existing antibiotic prophylaxis for SBP. The patients included in the study all received similar regimens regardless of whether they were on primary or secondary prophylaxis. Three-quarters of primary prophylaxis patients received a fluoroquinolone, as did 81% on secondary prophylaxis. All other patients received trimethoprim-sulfamethoxazole. These regimens are aimed at preventing gram-negative infections; however, an increasing number of SBP episodes are caused by either gram-positive pathogens or strains of gram-negative bacteria or fungi resistant to standard antibiotics.
Clinicians “absolutely” need to rethink their approach to both primary and secondary prophylaxis, Dr. Bajaj said. “As fast as treatment evolves, bacteria evolve 20 times faster. We need to find ways to prevent infections without antibiotic prophylaxis, whatever that might be.”
The study used data collected prospectively from patients with cirrhosis at any of 12 U.S. and 2 Canadian centers that belonged to the North American Consortium for the Study of End-Stage Liver Disease. Among 2,731 cirrhotic patients admitted nonelectively, 492 (18%) were on antibiotic prophylaxis at the time of their admission, 305 for primary prophylaxis and 187 for secondary prophylaxis. Dr. Bajaj and his associates used both the baseline model for end-stage liver disease score and serum albumin level of each patient to focus on a group of 154 primary prophylaxis and 154 secondary prophylaxis patients who were similar by these two criteria. Despite this matching, the two subgroups showed statistically significant differences at the time of their index hospitalization for several important clinical measures.
The secondary prophylaxis patients were significantly more likely to have been hospitalized within the previous 6 months, significantly more likely to be on treatment for hepatic encephalopathy at the time of their index admission, and significantly less likely to have systemic inflammatory response syndrome on admission.
Also, at the time of admission, secondary prophylaxis patients were significantly more likely to have an infection of any type at a rate of 40%, compared with 24% among those on primary prophylaxis, as well as a significantly higher rate of SBP at 16%, compared with a 9% rate among the primary prophylaxis patients. During hospitalization, nosocomial SBP occurred significantly more often among the secondary prophylaxis patients at a rate of 6%, compared with a 0.5% rate among those on primary prophylaxis.
Despite these between-group differences, the average duration of hospitalization, and the average incidence of acute-on-chronic liver failure during follow-up out to 30 days post discharge was similar in the two subgroups. And the patients on secondary prophylaxis showed better outcomes by two important parameters: mortality during hospitalization and 30 days post discharge; and the incidence of ICU admission during hospitalization, which was significantly greater for primary prophylaxis patients at 31%, compared with 21% among the secondary prophylaxis patients, Dr. Bajaj reported.
Dr. Bajaj has been a consultant for Norgine and Salix Pharmaceuticals and has received research support from Grifols and Salix Pharmaceuticals.
WASHINGTON –
The mortality rate during follow-up of cirrhotic patients hospitalized while on primary prophylaxis against spontaneous bacterial peritonitis (SBP) was 19%, compared with a 9% death rate among cirrhotic patients hospitalized while on secondary prophylaxis, Jasmohan S. Bajaj, MD, said at the annual Digestive Disease Week®.
Although the findings raised questions about the value of primary prophylaxis with an antibiotic in cirrhotic patients for preventing a first episode of SBP, secondary prophylaxis remains an important precaution.
“There is clear benefit from secondary prophylaxis; please use it. The data supporting it are robust,” said Dr. Bajaj, a hepatologist at Virginia Commonwealth University, Richmond. In contrast, the evidence supporting benefits from primary prophylaxis is weaker, he said. The findings were also counterintuitive, because patients who experience repeat episodes of SBP might be expected to fare worse than those hit by SBP just once.
Dr. Bajaj also acknowledged the substantial confounding that distinguishes patients with cirrhosis receiving primary or secondary prophylaxis, and the difficulty of fully adjusting for all this confounding by statistical analyses. “There is selective bias for secondary prevention, and there is no way to correct for this,” he explained. Patients who need secondary prophylaxis have “weathered the storm” of a first episode of SBP, which might have exerted selection pressure, and might have triggered important immunologic changes, Dr. Bajaj suggested.
The findings also raised concerns about the appropriateness of existing antibiotic prophylaxis for SBP. The patients included in the study all received similar regimens regardless of whether they were on primary or secondary prophylaxis. Three-quarters of primary prophylaxis patients received a fluoroquinolone, as did 81% on secondary prophylaxis. All other patients received trimethoprim-sulfamethoxazole. These regimens are aimed at preventing gram-negative infections; however, an increasing number of SBP episodes are caused by either gram-positive pathogens or strains of gram-negative bacteria or fungi resistant to standard antibiotics.
Clinicians “absolutely” need to rethink their approach to both primary and secondary prophylaxis, Dr. Bajaj said. “As fast as treatment evolves, bacteria evolve 20 times faster. We need to find ways to prevent infections without antibiotic prophylaxis, whatever that might be.”
The study used data collected prospectively from patients with cirrhosis at any of 12 U.S. and 2 Canadian centers that belonged to the North American Consortium for the Study of End-Stage Liver Disease. Among 2,731 cirrhotic patients admitted nonelectively, 492 (18%) were on antibiotic prophylaxis at the time of their admission, 305 for primary prophylaxis and 187 for secondary prophylaxis. Dr. Bajaj and his associates used both the baseline model for end-stage liver disease score and serum albumin level of each patient to focus on a group of 154 primary prophylaxis and 154 secondary prophylaxis patients who were similar by these two criteria. Despite this matching, the two subgroups showed statistically significant differences at the time of their index hospitalization for several important clinical measures.
The secondary prophylaxis patients were significantly more likely to have been hospitalized within the previous 6 months, significantly more likely to be on treatment for hepatic encephalopathy at the time of their index admission, and significantly less likely to have systemic inflammatory response syndrome on admission.
Also, at the time of admission, secondary prophylaxis patients were significantly more likely to have an infection of any type at a rate of 40%, compared with 24% among those on primary prophylaxis, as well as a significantly higher rate of SBP at 16%, compared with a 9% rate among the primary prophylaxis patients. During hospitalization, nosocomial SBP occurred significantly more often among the secondary prophylaxis patients at a rate of 6%, compared with a 0.5% rate among those on primary prophylaxis.
Despite these between-group differences, the average duration of hospitalization, and the average incidence of acute-on-chronic liver failure during follow-up out to 30 days post discharge was similar in the two subgroups. And the patients on secondary prophylaxis showed better outcomes by two important parameters: mortality during hospitalization and 30 days post discharge; and the incidence of ICU admission during hospitalization, which was significantly greater for primary prophylaxis patients at 31%, compared with 21% among the secondary prophylaxis patients, Dr. Bajaj reported.
Dr. Bajaj has been a consultant for Norgine and Salix Pharmaceuticals and has received research support from Grifols and Salix Pharmaceuticals.
WASHINGTON –
The mortality rate during follow-up of cirrhotic patients hospitalized while on primary prophylaxis against spontaneous bacterial peritonitis (SBP) was 19%, compared with a 9% death rate among cirrhotic patients hospitalized while on secondary prophylaxis, Jasmohan S. Bajaj, MD, said at the annual Digestive Disease Week®.
Although the findings raised questions about the value of primary prophylaxis with an antibiotic in cirrhotic patients for preventing a first episode of SBP, secondary prophylaxis remains an important precaution.
“There is clear benefit from secondary prophylaxis; please use it. The data supporting it are robust,” said Dr. Bajaj, a hepatologist at Virginia Commonwealth University, Richmond. In contrast, the evidence supporting benefits from primary prophylaxis is weaker, he said. The findings were also counterintuitive, because patients who experience repeat episodes of SBP might be expected to fare worse than those hit by SBP just once.
Dr. Bajaj also acknowledged the substantial confounding that distinguishes patients with cirrhosis receiving primary or secondary prophylaxis, and the difficulty of fully adjusting for all this confounding by statistical analyses. “There is selective bias for secondary prevention, and there is no way to correct for this,” he explained. Patients who need secondary prophylaxis have “weathered the storm” of a first episode of SBP, which might have exerted selection pressure, and might have triggered important immunologic changes, Dr. Bajaj suggested.
The findings also raised concerns about the appropriateness of existing antibiotic prophylaxis for SBP. The patients included in the study all received similar regimens regardless of whether they were on primary or secondary prophylaxis. Three-quarters of primary prophylaxis patients received a fluoroquinolone, as did 81% on secondary prophylaxis. All other patients received trimethoprim-sulfamethoxazole. These regimens are aimed at preventing gram-negative infections; however, an increasing number of SBP episodes are caused by either gram-positive pathogens or strains of gram-negative bacteria or fungi resistant to standard antibiotics.
Clinicians “absolutely” need to rethink their approach to both primary and secondary prophylaxis, Dr. Bajaj said. “As fast as treatment evolves, bacteria evolve 20 times faster. We need to find ways to prevent infections without antibiotic prophylaxis, whatever that might be.”
The study used data collected prospectively from patients with cirrhosis at any of 12 U.S. and 2 Canadian centers that belonged to the North American Consortium for the Study of End-Stage Liver Disease. Among 2,731 cirrhotic patients admitted nonelectively, 492 (18%) were on antibiotic prophylaxis at the time of their admission, 305 for primary prophylaxis and 187 for secondary prophylaxis. Dr. Bajaj and his associates used both the baseline model for end-stage liver disease score and serum albumin level of each patient to focus on a group of 154 primary prophylaxis and 154 secondary prophylaxis patients who were similar by these two criteria. Despite this matching, the two subgroups showed statistically significant differences at the time of their index hospitalization for several important clinical measures.
The secondary prophylaxis patients were significantly more likely to have been hospitalized within the previous 6 months, significantly more likely to be on treatment for hepatic encephalopathy at the time of their index admission, and significantly less likely to have systemic inflammatory response syndrome on admission.
Also, at the time of admission, secondary prophylaxis patients were significantly more likely to have an infection of any type at a rate of 40%, compared with 24% among those on primary prophylaxis, as well as a significantly higher rate of SBP at 16%, compared with a 9% rate among the primary prophylaxis patients. During hospitalization, nosocomial SBP occurred significantly more often among the secondary prophylaxis patients at a rate of 6%, compared with a 0.5% rate among those on primary prophylaxis.
Despite these between-group differences, the average duration of hospitalization, and the average incidence of acute-on-chronic liver failure during follow-up out to 30 days post discharge was similar in the two subgroups. And the patients on secondary prophylaxis showed better outcomes by two important parameters: mortality during hospitalization and 30 days post discharge; and the incidence of ICU admission during hospitalization, which was significantly greater for primary prophylaxis patients at 31%, compared with 21% among the secondary prophylaxis patients, Dr. Bajaj reported.
Dr. Bajaj has been a consultant for Norgine and Salix Pharmaceuticals and has received research support from Grifols and Salix Pharmaceuticals.
REPORTING FROM DDW 2018
Key clinical point: Antibiotic prophylaxis for bacterial peritonitis showed limitations, especially for primary prophylaxis.
Major finding: Mortality was 19% among primary prophylaxis patients and 9% among secondary prophylaxis patients during hospitalization and 30 days following.
Study details: An analysis of data from 308 cirrhotic patients on antibiotic prophylaxis at 14 North American centers.
Disclosures: Dr. Bajaj has been a consultant for Norgine and Salix Pharmaceuticals and has received research support from Grifols and Salix Pharmaceuticals.
Screen sooner and more often for those with family history of CRC
WASHINGTON – The number of first- and second-degree relatives with colorectal cancer can increase an individual’s risk for CRC, which could require screening to be done more frequently.
“There have been multiple guidelines reported as to what should be done for these individuals,” Harminder Singh, MD, of the University of Manitoba and his associates stated. “However, for the most part, they have not systematically analyzed the data.” He went on to say that, “more importantly, there’s been no recent AGA [American Gastroenterological Association] or Canadian Association of Gastroenterology statement, which led the development of this guideline.”
To address this issue, Dr. Singh and his colleagues conducted a systematic review of 10 literature searches to answer the following five questions concerning colorectal risk and screening practices: What is the effect of a family history of CRC on an individual’s risk of CRC? What is the effect of a family history of adenoma on an individual’s risk of CRC? At what age should CRC screening begin? Which screening tests are optimal? What are the optimal testing intervals for people with a family history of CRC or adenoma?
These questions were developed via an iterative online platform and then further developed and voted on by a team of specialists. GRADE (Grading of Recommendation Assessment, Development and Evaluation) was used to assess the quality of evidence to support these questions.
Similarly, individuals with two or more first-degree relatives with CRC had a two- to fourfold increased risk of developing CRC, compared with the general population. The review also found that, of the 20 recommendation statements from the review panel, there was consensus about 19 of them.
Colorectal cancer screening is recommended for all individuals with a family history of CRC or documented adenoma. Similarly, colonoscopy is recommended as the preferred test for individuals at the highest risk– those with one or more affected first-degree relatives. Fecal immunochemistry tests are considered a viable alternative except in patients with two or more first-degree relatives.
If a patient is considered to have an elevated risk of CRC because of family history, then screening should begin when they are aged 10 years younger than when that first-degree relative was diagnosed, and a 5-year screening interval should be followed after that.
Dr. Singh pointed out that the age of the affected first-degree relative should be considered when weighing an individual’s related risk of developing CRC. For example, having an first-degree relative who is diagnosed after the age of 75 is not likely to elevate an individual’s risk of developing CRC. Individuals with one or more second-degree relatives with CRC or nonadvanced adenoma do not appear to have an elevated risk of developing CRC and should be screened according to average-risk guidelines.
Dr. Singh reported receiving funding for from Merck Canada.
SOURCE: Leddin D. Gastroenterology. 2018 Jun. doi: 10.1016/S0016-5085(18)31083-7.
WASHINGTON – The number of first- and second-degree relatives with colorectal cancer can increase an individual’s risk for CRC, which could require screening to be done more frequently.
“There have been multiple guidelines reported as to what should be done for these individuals,” Harminder Singh, MD, of the University of Manitoba and his associates stated. “However, for the most part, they have not systematically analyzed the data.” He went on to say that, “more importantly, there’s been no recent AGA [American Gastroenterological Association] or Canadian Association of Gastroenterology statement, which led the development of this guideline.”
To address this issue, Dr. Singh and his colleagues conducted a systematic review of 10 literature searches to answer the following five questions concerning colorectal risk and screening practices: What is the effect of a family history of CRC on an individual’s risk of CRC? What is the effect of a family history of adenoma on an individual’s risk of CRC? At what age should CRC screening begin? Which screening tests are optimal? What are the optimal testing intervals for people with a family history of CRC or adenoma?
These questions were developed via an iterative online platform and then further developed and voted on by a team of specialists. GRADE (Grading of Recommendation Assessment, Development and Evaluation) was used to assess the quality of evidence to support these questions.
Similarly, individuals with two or more first-degree relatives with CRC had a two- to fourfold increased risk of developing CRC, compared with the general population. The review also found that, of the 20 recommendation statements from the review panel, there was consensus about 19 of them.
Colorectal cancer screening is recommended for all individuals with a family history of CRC or documented adenoma. Similarly, colonoscopy is recommended as the preferred test for individuals at the highest risk– those with one or more affected first-degree relatives. Fecal immunochemistry tests are considered a viable alternative except in patients with two or more first-degree relatives.
If a patient is considered to have an elevated risk of CRC because of family history, then screening should begin when they are aged 10 years younger than when that first-degree relative was diagnosed, and a 5-year screening interval should be followed after that.
Dr. Singh pointed out that the age of the affected first-degree relative should be considered when weighing an individual’s related risk of developing CRC. For example, having an first-degree relative who is diagnosed after the age of 75 is not likely to elevate an individual’s risk of developing CRC. Individuals with one or more second-degree relatives with CRC or nonadvanced adenoma do not appear to have an elevated risk of developing CRC and should be screened according to average-risk guidelines.
Dr. Singh reported receiving funding for from Merck Canada.
SOURCE: Leddin D. Gastroenterology. 2018 Jun. doi: 10.1016/S0016-5085(18)31083-7.
WASHINGTON – The number of first- and second-degree relatives with colorectal cancer can increase an individual’s risk for CRC, which could require screening to be done more frequently.
“There have been multiple guidelines reported as to what should be done for these individuals,” Harminder Singh, MD, of the University of Manitoba and his associates stated. “However, for the most part, they have not systematically analyzed the data.” He went on to say that, “more importantly, there’s been no recent AGA [American Gastroenterological Association] or Canadian Association of Gastroenterology statement, which led the development of this guideline.”
To address this issue, Dr. Singh and his colleagues conducted a systematic review of 10 literature searches to answer the following five questions concerning colorectal risk and screening practices: What is the effect of a family history of CRC on an individual’s risk of CRC? What is the effect of a family history of adenoma on an individual’s risk of CRC? At what age should CRC screening begin? Which screening tests are optimal? What are the optimal testing intervals for people with a family history of CRC or adenoma?
These questions were developed via an iterative online platform and then further developed and voted on by a team of specialists. GRADE (Grading of Recommendation Assessment, Development and Evaluation) was used to assess the quality of evidence to support these questions.
Similarly, individuals with two or more first-degree relatives with CRC had a two- to fourfold increased risk of developing CRC, compared with the general population. The review also found that, of the 20 recommendation statements from the review panel, there was consensus about 19 of them.
Colorectal cancer screening is recommended for all individuals with a family history of CRC or documented adenoma. Similarly, colonoscopy is recommended as the preferred test for individuals at the highest risk– those with one or more affected first-degree relatives. Fecal immunochemistry tests are considered a viable alternative except in patients with two or more first-degree relatives.
If a patient is considered to have an elevated risk of CRC because of family history, then screening should begin when they are aged 10 years younger than when that first-degree relative was diagnosed, and a 5-year screening interval should be followed after that.
Dr. Singh pointed out that the age of the affected first-degree relative should be considered when weighing an individual’s related risk of developing CRC. For example, having an first-degree relative who is diagnosed after the age of 75 is not likely to elevate an individual’s risk of developing CRC. Individuals with one or more second-degree relatives with CRC or nonadvanced adenoma do not appear to have an elevated risk of developing CRC and should be screened according to average-risk guidelines.
Dr. Singh reported receiving funding for from Merck Canada.
SOURCE: Leddin D. Gastroenterology. 2018 Jun. doi: 10.1016/S0016-5085(18)31083-7.
REPORTING FROM DDW 2018
Key clinical point: Patients with 1 or more first-degree relative with CRC should be screened more often.
Major finding: Patients with one or more first-degree relatives with CRC or adenoma had a twofold greater risk of developing CRC, compared with those without a family history of these diseases.
Study details: A systematic review of 10 literature searches assessing risk of CRC in those with a family history of CRC.
Disclosures: Dr. Singh has received funding from Merck Canada.
Source: Leddin D. Gastroenterology. 2018 Jun. doi: 10.1016/S0016-5085(18)31083-7.
Pancreatic cancer has a pancreatopathy distinct from type 2 diabetes
WASHINGTON –
“The endocrinopathies associated with type 2 diabetes mellitus and pancreatic cancer are distinct, the former represented by an increase in glucagon and the latter characterized by a reduction in islet size,” said Sajan Nagpal, MD, of the Mayo Clinic in Rochester, Minn., at Digestive Disease Week 2018®. “These data lend insight to a unique pathophysiology of diabetes that results from pancreatic cancer.”
Prior to presenting his results, Dr. Nagpal pointed out an interesting relationship between pancreatic cancer and diabetes.
“Pancreatic cancer and diabetes have a very unique, two-way relationship. While long-standing diabetes [LSDM] increases the risk of developing pancreatic cancer by 1.5-2 times over a person’s lifetime, pancreatic cancer itself causes a paraneoplastic form of diabetes. A person with a new diagnosis of diabetes mellitus has a five to eight times increased risk of being diagnosed with pancreatic cancer as compared to the general population within 3 years.“
This form of diabetes is referred to as pancreatic cancer–induced new onset diabetes (PC-NOD).
Dr. Nagpal and his team conducted a study that included 46 patients: 16 patients with pancreatic cancer (5 with LSDM, 5 NOD, and 6 without diabetes mellitus), 15 patients with T2DM (9 LSDM, 6 NOD), and 15 controls matched for age and body mass index. NOD was defined as a diabetes mellitus diagnosis less than 3 years from the date of autopsy or pancreatic cancer diagnosis. All pancreatic specimens were resected from pancreatic cancer patients or obtained as autopsy specimens. Researchers performed islet morphometric studies utilizing immunofluorescence analysis with specific insulin and glucagon antibodies.
The results of the study showed that patients with pancreatic cancer had islet sizes that were about a third smaller than those in the patients with T2DM and the healthy controls (P = .005). This held true for both LSDM and NOD pancreatic cancer patients, compared with the T2DM and healthy control groups. Researchers also found that insulin to glucagon (I:G) ratios were preserved in pancreatic cancer patients, whereas they were lower in patients with T2DM because of a higher percentage of glucagon in the islets (P = .08). Additionally, islet amyloid was much higher in T2DM patients (66.7%) versus patients with diabetes associated with pancreatic cancer (55.6%) and healthy controls (13.3%; P = .01).
There were several limitations to this study, including the small number of patients in each group and how pancreatic islet characteristics can vary based on their location. Finally, ductal obstruction can cause changes to islet morphology.
Along with the pathological changes found by Dr. Nagpal and his research team, PC-NOD and T2DM also have unique clinical profiles. As patients with pancreatic cancer approach their diagnosis, they begin to lose weight. This begins about 1 year before the patient’s diagnosis of pancreatic cancer. Conversely, these patients have worsening fasting glucose levels despite the fact that they are losing weight. The paradoxical relationship between weight loss and hyperglycemia are what distinguishes PC-NOD from T2DM, according to Dr. Nagpal. In patients with PC-NOD, worsening hyperglycemia happens over a periods of months, compared with the gradual increase over the course of years seen in T2DM.
The differences between these diseases may be caused by differences in their pancreatopathy.
When discussing the pancreatopathy associated with T2DM, Dr. Nagpal pointed out that there is a decrease in the I:G ratio, compared with those seen in patients without diabetes. The prevailing theory is that this decrease in the I:G ratio is caused by beta-cell apoptosis and transdifferentiation to alpha-cells. T2DM patients also have increased amyloid deposits, the result of increased islet amyloid polypeptide.
”Pancreatic cancer provides subtle metabolic clues, such as worsening glucose tolerance and weight loss, that can serve as potential targets for its early detection.”
According to Dr. Nagpal, more research is needed on pathogenesis of PC-NOD. Identification of biomarkers for screening may be possible in patients with new onset diabetes.
Dr. Nagpal had no financial conflicts of interest to report.
SOURCE: Nagpal S et al. DDW 2018, Abstract 392.
WASHINGTON –
“The endocrinopathies associated with type 2 diabetes mellitus and pancreatic cancer are distinct, the former represented by an increase in glucagon and the latter characterized by a reduction in islet size,” said Sajan Nagpal, MD, of the Mayo Clinic in Rochester, Minn., at Digestive Disease Week 2018®. “These data lend insight to a unique pathophysiology of diabetes that results from pancreatic cancer.”
Prior to presenting his results, Dr. Nagpal pointed out an interesting relationship between pancreatic cancer and diabetes.
“Pancreatic cancer and diabetes have a very unique, two-way relationship. While long-standing diabetes [LSDM] increases the risk of developing pancreatic cancer by 1.5-2 times over a person’s lifetime, pancreatic cancer itself causes a paraneoplastic form of diabetes. A person with a new diagnosis of diabetes mellitus has a five to eight times increased risk of being diagnosed with pancreatic cancer as compared to the general population within 3 years.“
This form of diabetes is referred to as pancreatic cancer–induced new onset diabetes (PC-NOD).
Dr. Nagpal and his team conducted a study that included 46 patients: 16 patients with pancreatic cancer (5 with LSDM, 5 NOD, and 6 without diabetes mellitus), 15 patients with T2DM (9 LSDM, 6 NOD), and 15 controls matched for age and body mass index. NOD was defined as a diabetes mellitus diagnosis less than 3 years from the date of autopsy or pancreatic cancer diagnosis. All pancreatic specimens were resected from pancreatic cancer patients or obtained as autopsy specimens. Researchers performed islet morphometric studies utilizing immunofluorescence analysis with specific insulin and glucagon antibodies.
The results of the study showed that patients with pancreatic cancer had islet sizes that were about a third smaller than those in the patients with T2DM and the healthy controls (P = .005). This held true for both LSDM and NOD pancreatic cancer patients, compared with the T2DM and healthy control groups. Researchers also found that insulin to glucagon (I:G) ratios were preserved in pancreatic cancer patients, whereas they were lower in patients with T2DM because of a higher percentage of glucagon in the islets (P = .08). Additionally, islet amyloid was much higher in T2DM patients (66.7%) versus patients with diabetes associated with pancreatic cancer (55.6%) and healthy controls (13.3%; P = .01).
There were several limitations to this study, including the small number of patients in each group and how pancreatic islet characteristics can vary based on their location. Finally, ductal obstruction can cause changes to islet morphology.
Along with the pathological changes found by Dr. Nagpal and his research team, PC-NOD and T2DM also have unique clinical profiles. As patients with pancreatic cancer approach their diagnosis, they begin to lose weight. This begins about 1 year before the patient’s diagnosis of pancreatic cancer. Conversely, these patients have worsening fasting glucose levels despite the fact that they are losing weight. The paradoxical relationship between weight loss and hyperglycemia are what distinguishes PC-NOD from T2DM, according to Dr. Nagpal. In patients with PC-NOD, worsening hyperglycemia happens over a periods of months, compared with the gradual increase over the course of years seen in T2DM.
The differences between these diseases may be caused by differences in their pancreatopathy.
When discussing the pancreatopathy associated with T2DM, Dr. Nagpal pointed out that there is a decrease in the I:G ratio, compared with those seen in patients without diabetes. The prevailing theory is that this decrease in the I:G ratio is caused by beta-cell apoptosis and transdifferentiation to alpha-cells. T2DM patients also have increased amyloid deposits, the result of increased islet amyloid polypeptide.
”Pancreatic cancer provides subtle metabolic clues, such as worsening glucose tolerance and weight loss, that can serve as potential targets for its early detection.”
According to Dr. Nagpal, more research is needed on pathogenesis of PC-NOD. Identification of biomarkers for screening may be possible in patients with new onset diabetes.
Dr. Nagpal had no financial conflicts of interest to report.
SOURCE: Nagpal S et al. DDW 2018, Abstract 392.
WASHINGTON –
“The endocrinopathies associated with type 2 diabetes mellitus and pancreatic cancer are distinct, the former represented by an increase in glucagon and the latter characterized by a reduction in islet size,” said Sajan Nagpal, MD, of the Mayo Clinic in Rochester, Minn., at Digestive Disease Week 2018®. “These data lend insight to a unique pathophysiology of diabetes that results from pancreatic cancer.”
Prior to presenting his results, Dr. Nagpal pointed out an interesting relationship between pancreatic cancer and diabetes.
“Pancreatic cancer and diabetes have a very unique, two-way relationship. While long-standing diabetes [LSDM] increases the risk of developing pancreatic cancer by 1.5-2 times over a person’s lifetime, pancreatic cancer itself causes a paraneoplastic form of diabetes. A person with a new diagnosis of diabetes mellitus has a five to eight times increased risk of being diagnosed with pancreatic cancer as compared to the general population within 3 years.“
This form of diabetes is referred to as pancreatic cancer–induced new onset diabetes (PC-NOD).
Dr. Nagpal and his team conducted a study that included 46 patients: 16 patients with pancreatic cancer (5 with LSDM, 5 NOD, and 6 without diabetes mellitus), 15 patients with T2DM (9 LSDM, 6 NOD), and 15 controls matched for age and body mass index. NOD was defined as a diabetes mellitus diagnosis less than 3 years from the date of autopsy or pancreatic cancer diagnosis. All pancreatic specimens were resected from pancreatic cancer patients or obtained as autopsy specimens. Researchers performed islet morphometric studies utilizing immunofluorescence analysis with specific insulin and glucagon antibodies.
The results of the study showed that patients with pancreatic cancer had islet sizes that were about a third smaller than those in the patients with T2DM and the healthy controls (P = .005). This held true for both LSDM and NOD pancreatic cancer patients, compared with the T2DM and healthy control groups. Researchers also found that insulin to glucagon (I:G) ratios were preserved in pancreatic cancer patients, whereas they were lower in patients with T2DM because of a higher percentage of glucagon in the islets (P = .08). Additionally, islet amyloid was much higher in T2DM patients (66.7%) versus patients with diabetes associated with pancreatic cancer (55.6%) and healthy controls (13.3%; P = .01).
There were several limitations to this study, including the small number of patients in each group and how pancreatic islet characteristics can vary based on their location. Finally, ductal obstruction can cause changes to islet morphology.
Along with the pathological changes found by Dr. Nagpal and his research team, PC-NOD and T2DM also have unique clinical profiles. As patients with pancreatic cancer approach their diagnosis, they begin to lose weight. This begins about 1 year before the patient’s diagnosis of pancreatic cancer. Conversely, these patients have worsening fasting glucose levels despite the fact that they are losing weight. The paradoxical relationship between weight loss and hyperglycemia are what distinguishes PC-NOD from T2DM, according to Dr. Nagpal. In patients with PC-NOD, worsening hyperglycemia happens over a periods of months, compared with the gradual increase over the course of years seen in T2DM.
The differences between these diseases may be caused by differences in their pancreatopathy.
When discussing the pancreatopathy associated with T2DM, Dr. Nagpal pointed out that there is a decrease in the I:G ratio, compared with those seen in patients without diabetes. The prevailing theory is that this decrease in the I:G ratio is caused by beta-cell apoptosis and transdifferentiation to alpha-cells. T2DM patients also have increased amyloid deposits, the result of increased islet amyloid polypeptide.
”Pancreatic cancer provides subtle metabolic clues, such as worsening glucose tolerance and weight loss, that can serve as potential targets for its early detection.”
According to Dr. Nagpal, more research is needed on pathogenesis of PC-NOD. Identification of biomarkers for screening may be possible in patients with new onset diabetes.
Dr. Nagpal had no financial conflicts of interest to report.
SOURCE: Nagpal S et al. DDW 2018, Abstract 392.
REPORTING FROM DDW 2018
Key clinical point: Pancreatic cancer has a distinct endocrine pancreatopathy.
Major finding: Patients with pancreatic cancer had islet sizes that were about a third smaller than those in patients with type 2 diabetes and healthy controls (P = .005).
Study details: Small study analyzing the pathology of pancreatic cancer resections and autopsy specimens.
Disclosures: The authors of this study had no financial conflicts to disclose.
Source: Nagpal S et al. DDW 2018, Abstract 392.
Fundoplication works best for true PPI-refractory heartburn
WASHINGTON – Less than a quarter of patients with heartburn that appears refractory to proton pump inhibitor treatment truly have reflux-related, drug-refractory heartburn with a high symptom–related probability, but patients who fall into this select subgroup often have significant symptom relief from surgical fundoplication, based on results from a randomized, multicenter, Department of Veterans Affairs study with 78 patients.
Although laparoscopic Nissen fundoplication relieved the heartburn symptoms of just two-thirds of patients who met the study’s definition of having true proton pump inhibitor (PPI)–refractory heartburn, this level of efficacy far exceeded the impact of drug therapy with baclofen or desipramine, which was little better than placebo, Stuart J. Spechler, MD, said at the annual Digestive Disease Week®.
“Fundoplication fell out of favor because of the success of PPI treatment, and because of complications from the surgery, but what our results show is that there is a subgroup of patients who can benefit from fundoplication. The challenge is identifying them,” said Dr. Spechler, a gastroenterologist and professor of medicine at the University of Texas, Dallas. “If you go through a careful work-up you will find the patients who have true PPI-refractory acid reflux and heartburn, and in the end we don’t have good medical treatments for these patients,” leaving fundoplication as their best hope for symptom relief.
The study he ran included 366 patients seen at about 30 VA Medical Centers across the United States who had been referred to his center because of presumed PPI-refractory heartburn. The careful work-up that Dr. Spechler and his associates ran included a closely supervised, 2-week trial of a standardized PPI regimen with omeprazole, careful symptom scoring on this treatment with a reflux-specific, health-related quality of life questionnaire, endoscopic esophageal manometry, and esophageal pH monitoring while on omeprazole.
This process placed patients into several distinct subgroups: About 19% dropped out of the study during this assessment, and another 15% left the study because of their intolerance of various stages of the work-up. Nearly 12% of patients wound up being responsive to the PPI regimen, about 6% had organic disorders not related to gastroesophageal reflux disease, and 27% had functional heartburn with a normal level of acid reflux, which left 78 patients (21%) who demonstrated true reflux-related, PPI-refractory heartburn symptoms.
The researchers then randomized this 78-patient subgroup into three treatment arms, with one group of 27 underwent fundoplication surgery. A group of 25 underwent active medical therapy with 20 mg omeprazole b.i.d. plus baclofen, which was started at 5 mg t.i.d. and increased to 20 mg t.i.d. In baclofen-intolerant or nonresponding patients, this treatment was followed up with desipramine, increasing from a starting dosage of 25 mg/day to 100 mg/day. A third group of 26 control patients received active omeprazole at the same dosage but placebo in place of the baclofen and desipramine. These three subgroups showed no statistically significant differences at baseline for all demographic and clinical parameters recorded.
The study’s primary endpoint was the percentage of patients in each treatment arm who had a “successful” outcome, defined as at least a 50% improvement in their gastroesophageal reflux health-related quality of life score (J Gastrointest Surg. 1998 Mar-Apr;2[2]:141-5) after 1 year on treatment, which occurred in 67% of the fundoplication patients, 28% in the active medical arm, and 12% in the control arm. The fundoplication-treated patients had a significantly higher rate of a successful outcome, compared with patients in each of the other two treatment groups, while the success rates among patients in the active medical group and the control group did not differ significantly, Dr. Spechler said.
Dr. Spechler had no disclosures to report.
WASHINGTON – Less than a quarter of patients with heartburn that appears refractory to proton pump inhibitor treatment truly have reflux-related, drug-refractory heartburn with a high symptom–related probability, but patients who fall into this select subgroup often have significant symptom relief from surgical fundoplication, based on results from a randomized, multicenter, Department of Veterans Affairs study with 78 patients.
Although laparoscopic Nissen fundoplication relieved the heartburn symptoms of just two-thirds of patients who met the study’s definition of having true proton pump inhibitor (PPI)–refractory heartburn, this level of efficacy far exceeded the impact of drug therapy with baclofen or desipramine, which was little better than placebo, Stuart J. Spechler, MD, said at the annual Digestive Disease Week®.
“Fundoplication fell out of favor because of the success of PPI treatment, and because of complications from the surgery, but what our results show is that there is a subgroup of patients who can benefit from fundoplication. The challenge is identifying them,” said Dr. Spechler, a gastroenterologist and professor of medicine at the University of Texas, Dallas. “If you go through a careful work-up you will find the patients who have true PPI-refractory acid reflux and heartburn, and in the end we don’t have good medical treatments for these patients,” leaving fundoplication as their best hope for symptom relief.
The study he ran included 366 patients seen at about 30 VA Medical Centers across the United States who had been referred to his center because of presumed PPI-refractory heartburn. The careful work-up that Dr. Spechler and his associates ran included a closely supervised, 2-week trial of a standardized PPI regimen with omeprazole, careful symptom scoring on this treatment with a reflux-specific, health-related quality of life questionnaire, endoscopic esophageal manometry, and esophageal pH monitoring while on omeprazole.
This process placed patients into several distinct subgroups: About 19% dropped out of the study during this assessment, and another 15% left the study because of their intolerance of various stages of the work-up. Nearly 12% of patients wound up being responsive to the PPI regimen, about 6% had organic disorders not related to gastroesophageal reflux disease, and 27% had functional heartburn with a normal level of acid reflux, which left 78 patients (21%) who demonstrated true reflux-related, PPI-refractory heartburn symptoms.
The researchers then randomized this 78-patient subgroup into three treatment arms, with one group of 27 underwent fundoplication surgery. A group of 25 underwent active medical therapy with 20 mg omeprazole b.i.d. plus baclofen, which was started at 5 mg t.i.d. and increased to 20 mg t.i.d. In baclofen-intolerant or nonresponding patients, this treatment was followed up with desipramine, increasing from a starting dosage of 25 mg/day to 100 mg/day. A third group of 26 control patients received active omeprazole at the same dosage but placebo in place of the baclofen and desipramine. These three subgroups showed no statistically significant differences at baseline for all demographic and clinical parameters recorded.
The study’s primary endpoint was the percentage of patients in each treatment arm who had a “successful” outcome, defined as at least a 50% improvement in their gastroesophageal reflux health-related quality of life score (J Gastrointest Surg. 1998 Mar-Apr;2[2]:141-5) after 1 year on treatment, which occurred in 67% of the fundoplication patients, 28% in the active medical arm, and 12% in the control arm. The fundoplication-treated patients had a significantly higher rate of a successful outcome, compared with patients in each of the other two treatment groups, while the success rates among patients in the active medical group and the control group did not differ significantly, Dr. Spechler said.
Dr. Spechler had no disclosures to report.
WASHINGTON – Less than a quarter of patients with heartburn that appears refractory to proton pump inhibitor treatment truly have reflux-related, drug-refractory heartburn with a high symptom–related probability, but patients who fall into this select subgroup often have significant symptom relief from surgical fundoplication, based on results from a randomized, multicenter, Department of Veterans Affairs study with 78 patients.
Although laparoscopic Nissen fundoplication relieved the heartburn symptoms of just two-thirds of patients who met the study’s definition of having true proton pump inhibitor (PPI)–refractory heartburn, this level of efficacy far exceeded the impact of drug therapy with baclofen or desipramine, which was little better than placebo, Stuart J. Spechler, MD, said at the annual Digestive Disease Week®.
“Fundoplication fell out of favor because of the success of PPI treatment, and because of complications from the surgery, but what our results show is that there is a subgroup of patients who can benefit from fundoplication. The challenge is identifying them,” said Dr. Spechler, a gastroenterologist and professor of medicine at the University of Texas, Dallas. “If you go through a careful work-up you will find the patients who have true PPI-refractory acid reflux and heartburn, and in the end we don’t have good medical treatments for these patients,” leaving fundoplication as their best hope for symptom relief.
The study he ran included 366 patients seen at about 30 VA Medical Centers across the United States who had been referred to his center because of presumed PPI-refractory heartburn. The careful work-up that Dr. Spechler and his associates ran included a closely supervised, 2-week trial of a standardized PPI regimen with omeprazole, careful symptom scoring on this treatment with a reflux-specific, health-related quality of life questionnaire, endoscopic esophageal manometry, and esophageal pH monitoring while on omeprazole.
This process placed patients into several distinct subgroups: About 19% dropped out of the study during this assessment, and another 15% left the study because of their intolerance of various stages of the work-up. Nearly 12% of patients wound up being responsive to the PPI regimen, about 6% had organic disorders not related to gastroesophageal reflux disease, and 27% had functional heartburn with a normal level of acid reflux, which left 78 patients (21%) who demonstrated true reflux-related, PPI-refractory heartburn symptoms.
The researchers then randomized this 78-patient subgroup into three treatment arms, with one group of 27 underwent fundoplication surgery. A group of 25 underwent active medical therapy with 20 mg omeprazole b.i.d. plus baclofen, which was started at 5 mg t.i.d. and increased to 20 mg t.i.d. In baclofen-intolerant or nonresponding patients, this treatment was followed up with desipramine, increasing from a starting dosage of 25 mg/day to 100 mg/day. A third group of 26 control patients received active omeprazole at the same dosage but placebo in place of the baclofen and desipramine. These three subgroups showed no statistically significant differences at baseline for all demographic and clinical parameters recorded.
The study’s primary endpoint was the percentage of patients in each treatment arm who had a “successful” outcome, defined as at least a 50% improvement in their gastroesophageal reflux health-related quality of life score (J Gastrointest Surg. 1998 Mar-Apr;2[2]:141-5) after 1 year on treatment, which occurred in 67% of the fundoplication patients, 28% in the active medical arm, and 12% in the control arm. The fundoplication-treated patients had a significantly higher rate of a successful outcome, compared with patients in each of the other two treatment groups, while the success rates among patients in the active medical group and the control group did not differ significantly, Dr. Spechler said.
Dr. Spechler had no disclosures to report.
REPORTING FROM DDW 2018
Key clinical point: Fundoplication produces the best outcomes in patients with true proton pump inhibitor–refractory heartburn.
Major finding: Two-thirds of patients treated with fundoplication had successful outcomes, compared with 28% in medical controls and 12% in placebo controls.
Study details: A multicenter, randomized study with 78 patients.
Disclosures: Dr. Spechler had no disclosures to report.