Alice Goodman

WASHINGTON – Urate-lowering therapy (ULT) with allopurinol does not appear to increase the risk of chronic kidney disease in patients with gout who have normal or near-normal kidney function at diagnosis, according to a large retrospective study presented at the annual meeting of the American College of Rheumatology.

The study was based on electronic health records from The Health Improvement Network (THIN), a database that includes patients treated by general practitioners in the United Kingdom.

“It is sad in my practice to see how many gout patients are not treated with ULT because patients fear the side effects of medication or just don’t want to be treated, especially when they are not in flare. Many general practitioners also don’t view gout as a serious condition requiring medication,” said lead author Ana Beatriz Vargas-Santos, PhD, a research fellow at Boston University and a rheumatologist at the State University of Rio de Janeiro in a video interview.

rhnews@frontlinemedcom.com

WASHINGTON – Urate-lowering therapy (ULT) with allopurinol does not appear to increase the risk of chronic kidney disease in patients with gout who have normal or near-normal kidney function at diagnosis, according to a large retrospective study presented at the annual meeting of the American College of Rheumatology.

The study was based on electronic health records from The Health Improvement Network (THIN), a database that includes patients treated by general practitioners in the United Kingdom.

“It is sad in my practice to see how many gout patients are not treated with ULT because patients fear the side effects of medication or just don’t want to be treated, especially when they are not in flare. Many general practitioners also don’t view gout as a serious condition requiring medication,” said lead author Ana Beatriz Vargas-Santos, PhD, a research fellow at Boston University and a rheumatologist at the State University of Rio de Janeiro in a video interview.

rhnews@frontlinemedcom.com

WASHINGTON – Urate-lowering therapy (ULT) with allopurinol does not appear to increase the risk of chronic kidney disease in patients with gout who have normal or near-normal kidney function at diagnosis, according to a large retrospective study presented at the annual meeting of the American College of Rheumatology.

The study was based on electronic health records from The Health Improvement Network (THIN), a database that includes patients treated by general practitioners in the United Kingdom.

“It is sad in my practice to see how many gout patients are not treated with ULT because patients fear the side effects of medication or just don’t want to be treated, especially when they are not in flare. Many general practitioners also don’t view gout as a serious condition requiring medication,” said lead author Ana Beatriz Vargas-Santos, PhD, a research fellow at Boston University and a rheumatologist at the State University of Rio de Janeiro in a video interview.

rhnews@frontlinemedcom.com

This year’s annual meeting of the American College of Rheumatology will feature cutting-edge research and results of studies that directly affect how attendees will manage patients once they are back in the clinical setting, according to both Richard Loeser, MD, program chair of the Annual Meeting Planning Committee (AMPC), and Gregory Gardner, MD, clinical subchair of the AMPC, who suggested special sessions of interest culled from the more than 450 sessions to be presented.

“It is an exciting time in rheumatology. Basic research is being translated into new therapies before our very eyes. Areas on the program this year that have translational potential include immunometabolism, blocking interleukin-1 (IL-1), T-cell receptor signaling, and meta-analysis of gene expression data. The meeting will also feature trials that refine and advance the management of rheumatologic diseases, including results on studies of new biologics,” Dr. Loeser said.

Hot sessions

Luke O’Neill, MD, will talk about immunometabolism Monday at 7:30 a.m. This session will explore a newly described connection between energy metabolism and the immune system and the link with inflammation.

Charles Dinarello, MD, will give the Philip Hensch Memorial Lecture Sunday at 8:30 a.m. on blocking IL-1 in inflammatory diseases. He will cover a host of diseases from gout to cancer, Dr. Loeser noted.

Another hot topic, T-cell receptor signaling in autoimmune diseases and the development of new therapies, will be discussed by Arthur Weiss, MD, Tuesday morning at 7:30 a.m.

Tuesday at 11:00 a.m., Peter Lipsky, MD, will tackle big data mining, presenting a meta-analysis of gene expression datasets to identify novel pathways and targets in systemic lupus erythematosus (SLE).

“SLE lags behind rheumatoid arthritis in therapeutic advances. A number of trials of biologics have failed in SLE, whereas they have been found effective in rheumatoid arthritis,” Dr. Loeser explained.

Clinical slant

Sunday’s Plenary session at 11:00 a.m. will feature several top-rated abstracts, among them results of a phase III study on tocilizumab in giant cell arteritis to be presented by John Stone, MD. “Tocilizumab is a major breakthrough as a steroid-sparing treatment for the most common form of vasculitis that affects older adults,” Dr. Loeser said.

At 2:30 p.m. on Sunday at The Great Debate, Paul Emery, MD, and Arthur Kavanaugh, MD, will tackle the very important clinical topic of “To Taper or Not to Taper? – Biologic DMARDs in Low Rheumatoid Arthritis Disease Activity.”

“People aren’t sure what to do. The fear with tapering is rebound, with the disease coming back even more forcefully. There is new evidence to suggest that tapering may be safe under certain circumstances. This session should inform attendees on how to make the decision to taper and on the best way to do it,” Dr. Loeser commented.

The Late-Breaking Abstract session on Tuesday at 4:30 p.m. will feature six clinical trials. Dr. Loeser singled out a study to be presented by Elaine Husni, MD, on “Vascular Safety of Celecoxib versus Ibuprofen or Naproxen” in more than 20,000 patients with osteoarthritis or rheumatoid arthritis.

“The fear is that COX-2 inhibitors have increased cardiovascular risk. The data from this study that will be presented at the meeting should answer the question of whether or not this is true in patients with arthritis,” Dr. Loeser explained.

Wednesday at 7:30 a.m. Candida Fratazzi, MD, will talk about “Emerging Biosimilars in Therapeutic Management,” a subject of great interest since they have the potential to be equally effective and less expensive than current biologics.

Two “bookends” of the meeting will frame the opening and closing. Sunday at 7:30 a.m., the “Year in Review” session will feature the best published studies on rheumatologic diseases from the past year, based on the judgment of two experts. Ingrid Lundberg, MD, will present the best clinical studies and Bruce Cronstein, MD, will present the best basic science studies. Wednesday at 7:30 a.m., John Cush, MD, and Dr. Kavanaugh will present the “Rheumatology Roundup” of the best abstracts and put them into context. “This session is usually quite entertaining,” Dr. Loeser said.

More sessions of clinical import

“In keeping with our meeting theme of fine-tuning our care of patients with rheumatic disease, I want to point out several sessions,” Dr. Gardner said.

Attendees interested in sessions on clinical applicability will have to choose between two different sessions Monday at 4:30 p.m.: one on dermatomyositis, a relatively rare but difficult-to-treat entity, and the other about treatment of the patient with rheumatoid arthritis when the patient is not well and suffering from comorbidities.

Monday at 8:30 a.m., an “Osteoporosis Update” will give listeners perspective on current and future therapies.

Sunday at 2:30 p.m., new guidelines for steroid-induced osteoporosis will be presented.

“Four or five sessions on the Tech Track will show rheumatologists how they can improve their practice by using technology,” Dr. Gardner said. “Several high-quality sessions are important to educators, including ‘Flipped Classroom, Technology, and Reflection’ [Monday at 12:30 p.m.] and ‘Year in Review’ [Sunday at 1:00 p.m.].”

Monday at 11:00 a.m., the Plenary session will feature Workforce Study results on how many rheumatologists will be needed in the year 2030, and in which geographic locations. This session will also include a discussion of the impact of part-time rheumatologists.

“Two sessions I am excited about are ‘Treat to Target in 2016,’ Tuesday at 4:30 p.m., and ‘Rheumatic Diseases in Native Americans,’ Sunday at 11:00 a.m.,” Dr. Gardner noted. “Concurrent abstract sessions throughout the meeting will feature discussions on new biologics, small molecules, and gene therapy.”

This year’s annual meeting of the American College of Rheumatology will feature cutting-edge research and results of studies that directly affect how attendees will manage patients once they are back in the clinical setting, according to both Richard Loeser, MD, program chair of the Annual Meeting Planning Committee (AMPC), and Gregory Gardner, MD, clinical subchair of the AMPC, who suggested special sessions of interest culled from the more than 450 sessions to be presented.

“It is an exciting time in rheumatology. Basic research is being translated into new therapies before our very eyes. Areas on the program this year that have translational potential include immunometabolism, blocking interleukin-1 (IL-1), T-cell receptor signaling, and meta-analysis of gene expression data. The meeting will also feature trials that refine and advance the management of rheumatologic diseases, including results on studies of new biologics,” Dr. Loeser said.

Hot sessions

Luke O’Neill, MD, will talk about immunometabolism Monday at 7:30 a.m. This session will explore a newly described connection between energy metabolism and the immune system and the link with inflammation.

Charles Dinarello, MD, will give the Philip Hensch Memorial Lecture Sunday at 8:30 a.m. on blocking IL-1 in inflammatory diseases. He will cover a host of diseases from gout to cancer, Dr. Loeser noted.

Another hot topic, T-cell receptor signaling in autoimmune diseases and the development of new therapies, will be discussed by Arthur Weiss, MD, Tuesday morning at 7:30 a.m.

Tuesday at 11:00 a.m., Peter Lipsky, MD, will tackle big data mining, presenting a meta-analysis of gene expression datasets to identify novel pathways and targets in systemic lupus erythematosus (SLE).

“SLE lags behind rheumatoid arthritis in therapeutic advances. A number of trials of biologics have failed in SLE, whereas they have been found effective in rheumatoid arthritis,” Dr. Loeser explained.

Clinical slant

Sunday’s Plenary session at 11:00 a.m. will feature several top-rated abstracts, among them results of a phase III study on tocilizumab in giant cell arteritis to be presented by John Stone, MD. “Tocilizumab is a major breakthrough as a steroid-sparing treatment for the most common form of vasculitis that affects older adults,” Dr. Loeser said.

At 2:30 p.m. on Sunday at The Great Debate, Paul Emery, MD, and Arthur Kavanaugh, MD, will tackle the very important clinical topic of “To Taper or Not to Taper? – Biologic DMARDs in Low Rheumatoid Arthritis Disease Activity.”

“People aren’t sure what to do. The fear with tapering is rebound, with the disease coming back even more forcefully. There is new evidence to suggest that tapering may be safe under certain circumstances. This session should inform attendees on how to make the decision to taper and on the best way to do it,” Dr. Loeser commented.

The Late-Breaking Abstract session on Tuesday at 4:30 p.m. will feature six clinical trials. Dr. Loeser singled out a study to be presented by Elaine Husni, MD, on “Vascular Safety of Celecoxib versus Ibuprofen or Naproxen” in more than 20,000 patients with osteoarthritis or rheumatoid arthritis.

“The fear is that COX-2 inhibitors have increased cardiovascular risk. The data from this study that will be presented at the meeting should answer the question of whether or not this is true in patients with arthritis,” Dr. Loeser explained.

Wednesday at 7:30 a.m. Candida Fratazzi, MD, will talk about “Emerging Biosimilars in Therapeutic Management,” a subject of great interest since they have the potential to be equally effective and less expensive than current biologics.

Two “bookends” of the meeting will frame the opening and closing. Sunday at 7:30 a.m., the “Year in Review” session will feature the best published studies on rheumatologic diseases from the past year, based on the judgment of two experts. Ingrid Lundberg, MD, will present the best clinical studies and Bruce Cronstein, MD, will present the best basic science studies. Wednesday at 7:30 a.m., John Cush, MD, and Dr. Kavanaugh will present the “Rheumatology Roundup” of the best abstracts and put them into context. “This session is usually quite entertaining,” Dr. Loeser said.

More sessions of clinical import

“In keeping with our meeting theme of fine-tuning our care of patients with rheumatic disease, I want to point out several sessions,” Dr. Gardner said.

Attendees interested in sessions on clinical applicability will have to choose between two different sessions Monday at 4:30 p.m.: one on dermatomyositis, a relatively rare but difficult-to-treat entity, and the other about treatment of the patient with rheumatoid arthritis when the patient is not well and suffering from comorbidities.

Monday at 8:30 a.m., an “Osteoporosis Update” will give listeners perspective on current and future therapies.

Sunday at 2:30 p.m., new guidelines for steroid-induced osteoporosis will be presented.

“Four or five sessions on the Tech Track will show rheumatologists how they can improve their practice by using technology,” Dr. Gardner said. “Several high-quality sessions are important to educators, including ‘Flipped Classroom, Technology, and Reflection’ [Monday at 12:30 p.m.] and ‘Year in Review’ [Sunday at 1:00 p.m.].”

Monday at 11:00 a.m., the Plenary session will feature Workforce Study results on how many rheumatologists will be needed in the year 2030, and in which geographic locations. This session will also include a discussion of the impact of part-time rheumatologists.

“Two sessions I am excited about are ‘Treat to Target in 2016,’ Tuesday at 4:30 p.m., and ‘Rheumatic Diseases in Native Americans,’ Sunday at 11:00 a.m.,” Dr. Gardner noted. “Concurrent abstract sessions throughout the meeting will feature discussions on new biologics, small molecules, and gene therapy.”

This year’s annual meeting of the American College of Rheumatology will feature cutting-edge research and results of studies that directly affect how attendees will manage patients once they are back in the clinical setting, according to both Richard Loeser, MD, program chair of the Annual Meeting Planning Committee (AMPC), and Gregory Gardner, MD, clinical subchair of the AMPC, who suggested special sessions of interest culled from the more than 450 sessions to be presented.

“It is an exciting time in rheumatology. Basic research is being translated into new therapies before our very eyes. Areas on the program this year that have translational potential include immunometabolism, blocking interleukin-1 (IL-1), T-cell receptor signaling, and meta-analysis of gene expression data. The meeting will also feature trials that refine and advance the management of rheumatologic diseases, including results on studies of new biologics,” Dr. Loeser said.

Hot sessions

Luke O’Neill, MD, will talk about immunometabolism Monday at 7:30 a.m. This session will explore a newly described connection between energy metabolism and the immune system and the link with inflammation.

Charles Dinarello, MD, will give the Philip Hensch Memorial Lecture Sunday at 8:30 a.m. on blocking IL-1 in inflammatory diseases. He will cover a host of diseases from gout to cancer, Dr. Loeser noted.

Another hot topic, T-cell receptor signaling in autoimmune diseases and the development of new therapies, will be discussed by Arthur Weiss, MD, Tuesday morning at 7:30 a.m.

Tuesday at 11:00 a.m., Peter Lipsky, MD, will tackle big data mining, presenting a meta-analysis of gene expression datasets to identify novel pathways and targets in systemic lupus erythematosus (SLE).

“SLE lags behind rheumatoid arthritis in therapeutic advances. A number of trials of biologics have failed in SLE, whereas they have been found effective in rheumatoid arthritis,” Dr. Loeser explained.

Clinical slant

Sunday’s Plenary session at 11:00 a.m. will feature several top-rated abstracts, among them results of a phase III study on tocilizumab in giant cell arteritis to be presented by John Stone, MD. “Tocilizumab is a major breakthrough as a steroid-sparing treatment for the most common form of vasculitis that affects older adults,” Dr. Loeser said.

At 2:30 p.m. on Sunday at The Great Debate, Paul Emery, MD, and Arthur Kavanaugh, MD, will tackle the very important clinical topic of “To Taper or Not to Taper? – Biologic DMARDs in Low Rheumatoid Arthritis Disease Activity.”

“People aren’t sure what to do. The fear with tapering is rebound, with the disease coming back even more forcefully. There is new evidence to suggest that tapering may be safe under certain circumstances. This session should inform attendees on how to make the decision to taper and on the best way to do it,” Dr. Loeser commented.

The Late-Breaking Abstract session on Tuesday at 4:30 p.m. will feature six clinical trials. Dr. Loeser singled out a study to be presented by Elaine Husni, MD, on “Vascular Safety of Celecoxib versus Ibuprofen or Naproxen” in more than 20,000 patients with osteoarthritis or rheumatoid arthritis.

“The fear is that COX-2 inhibitors have increased cardiovascular risk. The data from this study that will be presented at the meeting should answer the question of whether or not this is true in patients with arthritis,” Dr. Loeser explained.

Wednesday at 7:30 a.m. Candida Fratazzi, MD, will talk about “Emerging Biosimilars in Therapeutic Management,” a subject of great interest since they have the potential to be equally effective and less expensive than current biologics.

Two “bookends” of the meeting will frame the opening and closing. Sunday at 7:30 a.m., the “Year in Review” session will feature the best published studies on rheumatologic diseases from the past year, based on the judgment of two experts. Ingrid Lundberg, MD, will present the best clinical studies and Bruce Cronstein, MD, will present the best basic science studies. Wednesday at 7:30 a.m., John Cush, MD, and Dr. Kavanaugh will present the “Rheumatology Roundup” of the best abstracts and put them into context. “This session is usually quite entertaining,” Dr. Loeser said.

More sessions of clinical import

“In keeping with our meeting theme of fine-tuning our care of patients with rheumatic disease, I want to point out several sessions,” Dr. Gardner said.

Attendees interested in sessions on clinical applicability will have to choose between two different sessions Monday at 4:30 p.m.: one on dermatomyositis, a relatively rare but difficult-to-treat entity, and the other about treatment of the patient with rheumatoid arthritis when the patient is not well and suffering from comorbidities.

Monday at 8:30 a.m., an “Osteoporosis Update” will give listeners perspective on current and future therapies.

Sunday at 2:30 p.m., new guidelines for steroid-induced osteoporosis will be presented.

“Four or five sessions on the Tech Track will show rheumatologists how they can improve their practice by using technology,” Dr. Gardner said. “Several high-quality sessions are important to educators, including ‘Flipped Classroom, Technology, and Reflection’ [Monday at 12:30 p.m.] and ‘Year in Review’ [Sunday at 1:00 p.m.].”

Monday at 11:00 a.m., the Plenary session will feature Workforce Study results on how many rheumatologists will be needed in the year 2030, and in which geographic locations. This session will also include a discussion of the impact of part-time rheumatologists.

“Two sessions I am excited about are ‘Treat to Target in 2016,’ Tuesday at 4:30 p.m., and ‘Rheumatic Diseases in Native Americans,’ Sunday at 11:00 a.m.,” Dr. Gardner noted. “Concurrent abstract sessions throughout the meeting will feature discussions on new biologics, small molecules, and gene therapy.”

SAN DIEGO – Neither a proton pump inhibitor nor an H2 antagonist is an optimal choice for users of low-dose aspirin with previously confirmed ulcer bleeding, according to data from a 12-month randomized trial.

“This is one of the largest clinical trials focusing on aspirin users with a history of ulcer bleeding. Previous trials of aspirin users were mostly endoscopic trials. The important message here is that – while PPI may be useful as gastroprotection for patients with a history of ulcer bleed – it seems that neither treatment is sufficiently protective,” Dr. Francis Chan said at the annual Digestive Disease Week.

Findings from earlier research by the same investigators showed that cotreatment with aspirin and a PPI seemed to be effective as secondary prevention for aspirin-induced ulcer bleeding. He noted that PPIs have a warning for high-risk aspirin users, so alternatives are being sought.

In the present randomized trial, even with PPI prophylaxis, 7.9% of these high-risk aspirin users developed recurrent bleed or endoscopic ulcers versus 12.4% of the group treated with an H₂ antagonist, a nonsignificant difference.

The prospective, randomized double-blind trial randomized 270 patients in a 1:1 ratio to 1 year of treatment with either 20 mg rabeprazole (a PPI) once daily or 40 mg of the H₂ antagonist famotidine once daily. All patients’ ulcers had healed, and all tested negative for Helicobacter pylori prior to randomization. Study participants were taking 80 mg of aspirin daily.

Patients were followed for 12 months. Endoscopy was repeated if there was suspicion of recurrent bleed or they reached 12 months of treatment.

The primary endpoint was a composite of upper gastrointestinal bleed or recurrent ulcer. Secondary endpoints included a composite of recurrent bleed, ulcers visible on endoscopy, and early withdrawal due to severe dyspepsia; lower GI bleeding; and cardiothrombotic events.

Study participants had a mean age of 73 years. At baseline, all patients were negative for H. pylori and hepatitis B virus infection. Both treatment arms were comparable for indication for aspirin. A history of coronary disease was noted in 37% of the PPI group and 40.2% of the H₂ antagonist group. A history of cerebrovascular disease was present in 35.5% and 37.1%, respectively.

The source of previous bleeding was comparable in the two groups.

In an intent-to-treat analysis that included all patients who took at least one dose of study medication as well as those who underwent endoscopy at 12 months, 24 cases of suspected bleeding were found: 14 in the PPI group (1 confirmed) and 10 in the H₂ antagonist group (4 confirmed). The rate of recurrent bleeding was 5.1% for the PPI and 8.1% for the H₂ antagonist.

Lower GI bleeding was reported in 11 patients (8.9%) on the PPI and 6 patients (5%) on the H₂ antagonist.

Cardiothrombotic events were reported in five patients: two on the PPI (1.6%) and three on the H₂ antagonist (2.5%) .

“We didn’t see any trends for cardiovascular bleeding in either group,” Dr. Chan noted.

An audience member asked what the best way is to treat these patients, given that neither drug provided adequate protection against upper GI bleeding.

“The answer is, I don’t know. We need more study of high-risk patients, and we should study a combination of PPI plus misoprostol. In the absence of larger studies, I currently treat my patients with PPI plus low-dose misoprostol,” he said.

SAN DIEGO – Neither a proton pump inhibitor nor an H2 antagonist is an optimal choice for users of low-dose aspirin with previously confirmed ulcer bleeding, according to data from a 12-month randomized trial.

“This is one of the largest clinical trials focusing on aspirin users with a history of ulcer bleeding. Previous trials of aspirin users were mostly endoscopic trials. The important message here is that – while PPI may be useful as gastroprotection for patients with a history of ulcer bleed – it seems that neither treatment is sufficiently protective,” Dr. Francis Chan said at the annual Digestive Disease Week.

Findings from earlier research by the same investigators showed that cotreatment with aspirin and a PPI seemed to be effective as secondary prevention for aspirin-induced ulcer bleeding. He noted that PPIs have a warning for high-risk aspirin users, so alternatives are being sought.

In the present randomized trial, even with PPI prophylaxis, 7.9% of these high-risk aspirin users developed recurrent bleed or endoscopic ulcers versus 12.4% of the group treated with an H₂ antagonist, a nonsignificant difference.

The prospective, randomized double-blind trial randomized 270 patients in a 1:1 ratio to 1 year of treatment with either 20 mg rabeprazole (a PPI) once daily or 40 mg of the H₂ antagonist famotidine once daily. All patients’ ulcers had healed, and all tested negative for Helicobacter pylori prior to randomization. Study participants were taking 80 mg of aspirin daily.

Patients were followed for 12 months. Endoscopy was repeated if there was suspicion of recurrent bleed or they reached 12 months of treatment.

The primary endpoint was a composite of upper gastrointestinal bleed or recurrent ulcer. Secondary endpoints included a composite of recurrent bleed, ulcers visible on endoscopy, and early withdrawal due to severe dyspepsia; lower GI bleeding; and cardiothrombotic events.

Study participants had a mean age of 73 years. At baseline, all patients were negative for H. pylori and hepatitis B virus infection. Both treatment arms were comparable for indication for aspirin. A history of coronary disease was noted in 37% of the PPI group and 40.2% of the H₂ antagonist group. A history of cerebrovascular disease was present in 35.5% and 37.1%, respectively.

The source of previous bleeding was comparable in the two groups.

In an intent-to-treat analysis that included all patients who took at least one dose of study medication as well as those who underwent endoscopy at 12 months, 24 cases of suspected bleeding were found: 14 in the PPI group (1 confirmed) and 10 in the H₂ antagonist group (4 confirmed). The rate of recurrent bleeding was 5.1% for the PPI and 8.1% for the H₂ antagonist.

Lower GI bleeding was reported in 11 patients (8.9%) on the PPI and 6 patients (5%) on the H₂ antagonist.

Cardiothrombotic events were reported in five patients: two on the PPI (1.6%) and three on the H₂ antagonist (2.5%) .

“We didn’t see any trends for cardiovascular bleeding in either group,” Dr. Chan noted.

An audience member asked what the best way is to treat these patients, given that neither drug provided adequate protection against upper GI bleeding.

“The answer is, I don’t know. We need more study of high-risk patients, and we should study a combination of PPI plus misoprostol. In the absence of larger studies, I currently treat my patients with PPI plus low-dose misoprostol,” he said.

SAN DIEGO – Neither a proton pump inhibitor nor an H2 antagonist is an optimal choice for users of low-dose aspirin with previously confirmed ulcer bleeding, according to data from a 12-month randomized trial.

“This is one of the largest clinical trials focusing on aspirin users with a history of ulcer bleeding. Previous trials of aspirin users were mostly endoscopic trials. The important message here is that – while PPI may be useful as gastroprotection for patients with a history of ulcer bleed – it seems that neither treatment is sufficiently protective,” Dr. Francis Chan said at the annual Digestive Disease Week.

Findings from earlier research by the same investigators showed that cotreatment with aspirin and a PPI seemed to be effective as secondary prevention for aspirin-induced ulcer bleeding. He noted that PPIs have a warning for high-risk aspirin users, so alternatives are being sought.

In the present randomized trial, even with PPI prophylaxis, 7.9% of these high-risk aspirin users developed recurrent bleed or endoscopic ulcers versus 12.4% of the group treated with an H₂ antagonist, a nonsignificant difference.

The prospective, randomized double-blind trial randomized 270 patients in a 1:1 ratio to 1 year of treatment with either 20 mg rabeprazole (a PPI) once daily or 40 mg of the H₂ antagonist famotidine once daily. All patients’ ulcers had healed, and all tested negative for Helicobacter pylori prior to randomization. Study participants were taking 80 mg of aspirin daily.

Patients were followed for 12 months. Endoscopy was repeated if there was suspicion of recurrent bleed or they reached 12 months of treatment.

The primary endpoint was a composite of upper gastrointestinal bleed or recurrent ulcer. Secondary endpoints included a composite of recurrent bleed, ulcers visible on endoscopy, and early withdrawal due to severe dyspepsia; lower GI bleeding; and cardiothrombotic events.

Study participants had a mean age of 73 years. At baseline, all patients were negative for H. pylori and hepatitis B virus infection. Both treatment arms were comparable for indication for aspirin. A history of coronary disease was noted in 37% of the PPI group and 40.2% of the H₂ antagonist group. A history of cerebrovascular disease was present in 35.5% and 37.1%, respectively.

The source of previous bleeding was comparable in the two groups.

In an intent-to-treat analysis that included all patients who took at least one dose of study medication as well as those who underwent endoscopy at 12 months, 24 cases of suspected bleeding were found: 14 in the PPI group (1 confirmed) and 10 in the H₂ antagonist group (4 confirmed). The rate of recurrent bleeding was 5.1% for the PPI and 8.1% for the H₂ antagonist.

Lower GI bleeding was reported in 11 patients (8.9%) on the PPI and 6 patients (5%) on the H₂ antagonist.

Cardiothrombotic events were reported in five patients: two on the PPI (1.6%) and three on the H₂ antagonist (2.5%) .

“We didn’t see any trends for cardiovascular bleeding in either group,” Dr. Chan noted.

An audience member asked what the best way is to treat these patients, given that neither drug provided adequate protection against upper GI bleeding.

“The answer is, I don’t know. We need more study of high-risk patients, and we should study a combination of PPI plus misoprostol. In the absence of larger studies, I currently treat my patients with PPI plus low-dose misoprostol,” he said.

SAN DIEGO – Visceral hypersensitivity may be an independent contributor to gastrointestinal symptoms in patients with functional GI disorders, a study showed.

The association was independent of the subjects’ tendency to report non-GI symptoms and independent of psychological distress.

iStockphoto.com

“We found a gradual increase in GI symptom severity related to hypersensitivity tertiles in irritable bowel syndrome and dyspepsia, and small but significant correlations between pain/discomfort thresholds and GI symptom severity across several large patient groups from different countries,” said presenting author Dr. Magnus Simren. “This association was independent of the tendency to report GI symptoms or comorbid anxiety and depression.”

The relationship between visceral hypersensitivity and GI symptoms has been questionable, with some studies suggesting an association between visceral hypersensitivity and symptom severity and pain in irritable bowel syndrome (IBS), dyspepsia, and other GI disorders.

However, some negative studies have failed to confirm this association, explained Dr. Simren. “The thinking is that reporting GI symptoms and severity of symptoms may reflect a general tendency to report symptoms that [are] explained by comorbid psychological stress,” he noted.

The study Dr. Simren presented at the annual Digestive Disease Week sought to determine the association between visceral hypersensitivity and GI symptoms and symptom severity, adjusted for psychological distress (anxiety and depression) as well as a tendency to report symptoms.

The study enrolled five patient cohorts with functional GI disorders at three different centers. Subjects underwent balloon distension (a validated method to determine GI hypersensitivity) and completed questionnaires to assess GI symptom severity, somatization, anxiety, and depression.

The five cohorts were the Belgian functional dyspepsia cohort (n = 242), IBS cohort 1 in the United States (n = 243), U.S. IBS cohort 2 (n = 159), Swedish IBS cohort 1 (n = 353), and Swedish IBS cohort 2 (n = 147). Subjects were divided into sensitivity tertiles based on pain/discomfort thresholds.

Dr. Simren pointed out that the three different countries used questionnaires with subtle differences to measure GI symptoms, anxiety, and depression. Therefore, the total scores of all GI questionnaires were recalculated to z scores for comparisons.

The barostat protocols also differed among the three countries, and different pain thresholds were used, he noted.

For statistical analysis, sensitivity tertiles (low, medium, and high) were constructed based on pain/discomfort thresholds. GI symptom severity was compared between tertiles and adjusted for anxiety and depression as well as for non-GI symptom reporting.

Then GI hypersensitivity (high and low thresholds) was correlated with symptom severity total scores and pain/discomfort thresholds. Significant differences in GI symptom severity were found between high and low threshold hypersensitivity tertiles across all five cohorts. These differences remained after investigators controlled for the presence of anxiety or depression. The same association was seen when investigators controlled for reporting of non-GI symptoms.

Dr. Simren acknowledged that these barostat tests are used in a research setting. “But you can use this information in managing patients. We would need a simpler test for clinical utility,” he said.

“These findings confirm that visceral hypersensitivity is a contributor to symptom generation in functional GI disease,” Dr. Simren said.

SAN DIEGO – Visceral hypersensitivity may be an independent contributor to gastrointestinal symptoms in patients with functional GI disorders, a study showed.

The association was independent of the subjects’ tendency to report non-GI symptoms and independent of psychological distress.

iStockphoto.com

“We found a gradual increase in GI symptom severity related to hypersensitivity tertiles in irritable bowel syndrome and dyspepsia, and small but significant correlations between pain/discomfort thresholds and GI symptom severity across several large patient groups from different countries,” said presenting author Dr. Magnus Simren. “This association was independent of the tendency to report GI symptoms or comorbid anxiety and depression.”

The relationship between visceral hypersensitivity and GI symptoms has been questionable, with some studies suggesting an association between visceral hypersensitivity and symptom severity and pain in irritable bowel syndrome (IBS), dyspepsia, and other GI disorders.

However, some negative studies have failed to confirm this association, explained Dr. Simren. “The thinking is that reporting GI symptoms and severity of symptoms may reflect a general tendency to report symptoms that [are] explained by comorbid psychological stress,” he noted.

The study Dr. Simren presented at the annual Digestive Disease Week sought to determine the association between visceral hypersensitivity and GI symptoms and symptom severity, adjusted for psychological distress (anxiety and depression) as well as a tendency to report symptoms.

The study enrolled five patient cohorts with functional GI disorders at three different centers. Subjects underwent balloon distension (a validated method to determine GI hypersensitivity) and completed questionnaires to assess GI symptom severity, somatization, anxiety, and depression.

The five cohorts were the Belgian functional dyspepsia cohort (n = 242), IBS cohort 1 in the United States (n = 243), U.S. IBS cohort 2 (n = 159), Swedish IBS cohort 1 (n = 353), and Swedish IBS cohort 2 (n = 147). Subjects were divided into sensitivity tertiles based on pain/discomfort thresholds.

Dr. Simren pointed out that the three different countries used questionnaires with subtle differences to measure GI symptoms, anxiety, and depression. Therefore, the total scores of all GI questionnaires were recalculated to z scores for comparisons.

The barostat protocols also differed among the three countries, and different pain thresholds were used, he noted.

For statistical analysis, sensitivity tertiles (low, medium, and high) were constructed based on pain/discomfort thresholds. GI symptom severity was compared between tertiles and adjusted for anxiety and depression as well as for non-GI symptom reporting.

Then GI hypersensitivity (high and low thresholds) was correlated with symptom severity total scores and pain/discomfort thresholds. Significant differences in GI symptom severity were found between high and low threshold hypersensitivity tertiles across all five cohorts. These differences remained after investigators controlled for the presence of anxiety or depression. The same association was seen when investigators controlled for reporting of non-GI symptoms.

Dr. Simren acknowledged that these barostat tests are used in a research setting. “But you can use this information in managing patients. We would need a simpler test for clinical utility,” he said.

“These findings confirm that visceral hypersensitivity is a contributor to symptom generation in functional GI disease,” Dr. Simren said.

SAN DIEGO – Visceral hypersensitivity may be an independent contributor to gastrointestinal symptoms in patients with functional GI disorders, a study showed.

The association was independent of the subjects’ tendency to report non-GI symptoms and independent of psychological distress.

iStockphoto.com

“We found a gradual increase in GI symptom severity related to hypersensitivity tertiles in irritable bowel syndrome and dyspepsia, and small but significant correlations between pain/discomfort thresholds and GI symptom severity across several large patient groups from different countries,” said presenting author Dr. Magnus Simren. “This association was independent of the tendency to report GI symptoms or comorbid anxiety and depression.”

The relationship between visceral hypersensitivity and GI symptoms has been questionable, with some studies suggesting an association between visceral hypersensitivity and symptom severity and pain in irritable bowel syndrome (IBS), dyspepsia, and other GI disorders.

However, some negative studies have failed to confirm this association, explained Dr. Simren. “The thinking is that reporting GI symptoms and severity of symptoms may reflect a general tendency to report symptoms that [are] explained by comorbid psychological stress,” he noted.

The study Dr. Simren presented at the annual Digestive Disease Week sought to determine the association between visceral hypersensitivity and GI symptoms and symptom severity, adjusted for psychological distress (anxiety and depression) as well as a tendency to report symptoms.

The study enrolled five patient cohorts with functional GI disorders at three different centers. Subjects underwent balloon distension (a validated method to determine GI hypersensitivity) and completed questionnaires to assess GI symptom severity, somatization, anxiety, and depression.

The five cohorts were the Belgian functional dyspepsia cohort (n = 242), IBS cohort 1 in the United States (n = 243), U.S. IBS cohort 2 (n = 159), Swedish IBS cohort 1 (n = 353), and Swedish IBS cohort 2 (n = 147). Subjects were divided into sensitivity tertiles based on pain/discomfort thresholds.

Dr. Simren pointed out that the three different countries used questionnaires with subtle differences to measure GI symptoms, anxiety, and depression. Therefore, the total scores of all GI questionnaires were recalculated to z scores for comparisons.

The barostat protocols also differed among the three countries, and different pain thresholds were used, he noted.

For statistical analysis, sensitivity tertiles (low, medium, and high) were constructed based on pain/discomfort thresholds. GI symptom severity was compared between tertiles and adjusted for anxiety and depression as well as for non-GI symptom reporting.

Then GI hypersensitivity (high and low thresholds) was correlated with symptom severity total scores and pain/discomfort thresholds. Significant differences in GI symptom severity were found between high and low threshold hypersensitivity tertiles across all five cohorts. These differences remained after investigators controlled for the presence of anxiety or depression. The same association was seen when investigators controlled for reporting of non-GI symptoms.

Dr. Simren acknowledged that these barostat tests are used in a research setting. “But you can use this information in managing patients. We would need a simpler test for clinical utility,” he said.

“These findings confirm that visceral hypersensitivity is a contributor to symptom generation in functional GI disease,” Dr. Simren said.

SAN DIEGO – Monitored anesthesia care (MAC) for outpatient endoscopy is on the rise in the United States, presumably because of financial incentives for fee-for-service gastroenterology (GI) practices. However, a new study found that use of MAC is increasing in Veteran’s Health Administration (VHA) facilities, an environment free of financial incentives.

The increase in VHA hospitals is much smaller than in the country as a whole, but the study suggests that there are additional drivers for use of MAC that need to be more fully explored.

Over the past two decades, the rate of MAC use for outpatient endoscopy in fee-for-service practices has increased by at least 30%. Over the study period, the rate of MAC use for endoscopy procedures doubled in VHA facilities from 5.7% in 2000 to 11.1% in 2013, with a larger proportion of increase between 2011 and 2013.

“The increase in MAC use in fee-for-service practices is thought to be driven by financial gain. With an anesthesiologist on hand for an endoscopy procedure, the practice can bill double [duplicative billing with separate billing codes], essentially getting double reimbursement. The VHA has little incentive to increase use of MAC for financial gain. We wanted to study use of MAC in the VHA environment to determine if there are other factors involved,” explained Dr. Megan A. Adams of the University of Michigan, Ann Arbor.

In an interview, Dr. Adams explained that American Society for Gastrointestinal Endoscopy guidelines for MAC use are relatively broad and diffuse. They state that MAC should be considered for patients with anticipated intolerance to standard sedatives, certain cardiopulmonary morbidities, and the potential for airway compromise.

“These will need to be more specific in the future,” she said.

The retrospective cohort study she reported on at the annual Digestive Disease Week was based on national VHA data from more than 1,700 sites of care, with about 300,000 endoscopies performed each year.

“A large variation of MAC use was observed across study facilities, particularly in the later years of the study period,” Dr. Adams explained.

The investigators developed a model based on 122 VHA facilities, 2.1 million patient encounters, and the time of event to analyze patient-level and provider-level predictors of MAC using multilevel random effects logistical regression analysis.

Patient-level factors associated with the increased use of MAC included female gender (35% increase), body mass index greater than 35 kg/m² (20% increase), obstructive sleep apnea (50% increase), opioid use (17% increase), and benzodiazepine use (13%). Charlson comorbidity scores were associated with a significant increase, compared with healthy patients, with a score of 3 having a 30% increased likelihood of MAC use.

Provider-level predictors of MAC use were related to facilities. Outside of the GI endoscopy suite, endoscopy procedures were about four times more likely to be performed with MAC, and surgeons were about 50% more likely to use MAC.

“The variation in MAC use is largely explained by facility factors. Potential facility factors could be academic versus nonacademic setting, differences in how sites triage care, and differences in local policy. Patient-level factors were relatively weak influences. We will need to explore provider-level [facility] factors more fully to understand the specifics,” she said.

“We will need to align incentives to promote more appropriate use of MAC tailored to patient factors,” Dr. Adams said.

“Payment reforms are looming. CMS will probably remove duplicative reimbursement for MAC. The country will follow CMS. This will affect the financial drivers of MAC, but not necessarily the nonfinancial drivers,” she predicted.

Dr. Adams had no financial disclosures.

SAN DIEGO – Monitored anesthesia care (MAC) for outpatient endoscopy is on the rise in the United States, presumably because of financial incentives for fee-for-service gastroenterology (GI) practices. However, a new study found that use of MAC is increasing in Veteran’s Health Administration (VHA) facilities, an environment free of financial incentives.

The increase in VHA hospitals is much smaller than in the country as a whole, but the study suggests that there are additional drivers for use of MAC that need to be more fully explored.

Over the past two decades, the rate of MAC use for outpatient endoscopy in fee-for-service practices has increased by at least 30%. Over the study period, the rate of MAC use for endoscopy procedures doubled in VHA facilities from 5.7% in 2000 to 11.1% in 2013, with a larger proportion of increase between 2011 and 2013.

“The increase in MAC use in fee-for-service practices is thought to be driven by financial gain. With an anesthesiologist on hand for an endoscopy procedure, the practice can bill double [duplicative billing with separate billing codes], essentially getting double reimbursement. The VHA has little incentive to increase use of MAC for financial gain. We wanted to study use of MAC in the VHA environment to determine if there are other factors involved,” explained Dr. Megan A. Adams of the University of Michigan, Ann Arbor.

In an interview, Dr. Adams explained that American Society for Gastrointestinal Endoscopy guidelines for MAC use are relatively broad and diffuse. They state that MAC should be considered for patients with anticipated intolerance to standard sedatives, certain cardiopulmonary morbidities, and the potential for airway compromise.

“These will need to be more specific in the future,” she said.

The retrospective cohort study she reported on at the annual Digestive Disease Week was based on national VHA data from more than 1,700 sites of care, with about 300,000 endoscopies performed each year.

“A large variation of MAC use was observed across study facilities, particularly in the later years of the study period,” Dr. Adams explained.

The investigators developed a model based on 122 VHA facilities, 2.1 million patient encounters, and the time of event to analyze patient-level and provider-level predictors of MAC using multilevel random effects logistical regression analysis.

Patient-level factors associated with the increased use of MAC included female gender (35% increase), body mass index greater than 35 kg/m² (20% increase), obstructive sleep apnea (50% increase), opioid use (17% increase), and benzodiazepine use (13%). Charlson comorbidity scores were associated with a significant increase, compared with healthy patients, with a score of 3 having a 30% increased likelihood of MAC use.

Provider-level predictors of MAC use were related to facilities. Outside of the GI endoscopy suite, endoscopy procedures were about four times more likely to be performed with MAC, and surgeons were about 50% more likely to use MAC.

“The variation in MAC use is largely explained by facility factors. Potential facility factors could be academic versus nonacademic setting, differences in how sites triage care, and differences in local policy. Patient-level factors were relatively weak influences. We will need to explore provider-level [facility] factors more fully to understand the specifics,” she said.

“We will need to align incentives to promote more appropriate use of MAC tailored to patient factors,” Dr. Adams said.

“Payment reforms are looming. CMS will probably remove duplicative reimbursement for MAC. The country will follow CMS. This will affect the financial drivers of MAC, but not necessarily the nonfinancial drivers,” she predicted.

Dr. Adams had no financial disclosures.

SAN DIEGO – Monitored anesthesia care (MAC) for outpatient endoscopy is on the rise in the United States, presumably because of financial incentives for fee-for-service gastroenterology (GI) practices. However, a new study found that use of MAC is increasing in Veteran’s Health Administration (VHA) facilities, an environment free of financial incentives.

The increase in VHA hospitals is much smaller than in the country as a whole, but the study suggests that there are additional drivers for use of MAC that need to be more fully explored.

Over the past two decades, the rate of MAC use for outpatient endoscopy in fee-for-service practices has increased by at least 30%. Over the study period, the rate of MAC use for endoscopy procedures doubled in VHA facilities from 5.7% in 2000 to 11.1% in 2013, with a larger proportion of increase between 2011 and 2013.

“The increase in MAC use in fee-for-service practices is thought to be driven by financial gain. With an anesthesiologist on hand for an endoscopy procedure, the practice can bill double [duplicative billing with separate billing codes], essentially getting double reimbursement. The VHA has little incentive to increase use of MAC for financial gain. We wanted to study use of MAC in the VHA environment to determine if there are other factors involved,” explained Dr. Megan A. Adams of the University of Michigan, Ann Arbor.

In an interview, Dr. Adams explained that American Society for Gastrointestinal Endoscopy guidelines for MAC use are relatively broad and diffuse. They state that MAC should be considered for patients with anticipated intolerance to standard sedatives, certain cardiopulmonary morbidities, and the potential for airway compromise.

“These will need to be more specific in the future,” she said.

The retrospective cohort study she reported on at the annual Digestive Disease Week was based on national VHA data from more than 1,700 sites of care, with about 300,000 endoscopies performed each year.

“A large variation of MAC use was observed across study facilities, particularly in the later years of the study period,” Dr. Adams explained.

The investigators developed a model based on 122 VHA facilities, 2.1 million patient encounters, and the time of event to analyze patient-level and provider-level predictors of MAC using multilevel random effects logistical regression analysis.

Patient-level factors associated with the increased use of MAC included female gender (35% increase), body mass index greater than 35 kg/m² (20% increase), obstructive sleep apnea (50% increase), opioid use (17% increase), and benzodiazepine use (13%). Charlson comorbidity scores were associated with a significant increase, compared with healthy patients, with a score of 3 having a 30% increased likelihood of MAC use.

Provider-level predictors of MAC use were related to facilities. Outside of the GI endoscopy suite, endoscopy procedures were about four times more likely to be performed with MAC, and surgeons were about 50% more likely to use MAC.

“The variation in MAC use is largely explained by facility factors. Potential facility factors could be academic versus nonacademic setting, differences in how sites triage care, and differences in local policy. Patient-level factors were relatively weak influences. We will need to explore provider-level [facility] factors more fully to understand the specifics,” she said.

“We will need to align incentives to promote more appropriate use of MAC tailored to patient factors,” Dr. Adams said.

“Payment reforms are looming. CMS will probably remove duplicative reimbursement for MAC. The country will follow CMS. This will affect the financial drivers of MAC, but not necessarily the nonfinancial drivers,” she predicted.

Dr. Adams had no financial disclosures.

SAN DIEGO – A first-in-human study suggests that a novel technique holds promise for the treatment of diabetes, reducing the complications, associated morbidity, and economic burden of this disease. Duodenal mucosal resurfacing (DMR) achieved a significant reduction in hemoglobin A1c (HbA1c) levels as well as a robust reduction in the liver enzymes aspartate aminotransferase and alanine aminotransferase in patients with poorly controlled type 2 diabetes.

DMR entails thermal ablation of the duodenal mucosa via minimally invasive endoscopy. According to the pioneer behind this technique, Dr. Harith Rajagopalan, who is the founder and CEO of Fractyl Laboratories, in Waltham, Mass., DMR can be compared to laser resurfacing of the skin to remove actinic keratosis. The procedure removes the surface cells of the duodenum, which are insulin resistant, and they heal and become insulin sensitive.

The procedure does not involve surgery or implants, and takes about 60 minutes.

“We hope that once the procedure is done, patients will adopt lifestyle interventions. In the future, we plan to study whether DMR will have even greater potential if patients adapt to a healthy lifestyle,” he said.

Alice Goodman/Frontline Medical News

During the annual Digestive Disease Week, Dr. Rajagopalan detailed experience with the first 39 humans treated with DMR. All patients had poorly controlled type 2 diabetes and were taking at least one antidiabetic medication. The average age was 53 years, mean body mass index was 31 kg/m², and 50% were taking metformin. DMR was performed after 2 weeks of a low-calorie diet.

In this single-arm study, DMR reduced HbA_1c by 1.2%, reduced ALT from 40 to 27 IU/L, and reduced AST from 32 to 22 IU/L over a period of 6 months. Patients with the highest entry levels of AST and ALT had the greatest reductions.

Of the 39 patients, 28 had a 9-cm ablation of the duodenum, and in these patients, the metabolic benefits were even more robust. Thus, 9 cm was identified as the optimal surface area for ablation in future studies.

The procedure was well tolerated, with minimal gastrointestinal symptoms. Adverse events were mostly mild and mainly abdominal pain due to air for the first 2 days following DMR. Three episodes of duodenal stenosis were reported over the first 6 weeks post procedure.

“These resolved with endoscopic balloon dilatation. We have since improved the procedure, and have not seen subsequent events,” Dr Rajagopalan said.

“We know that bariatric surgeries, particularly those that prevent contact of nutrients with mucosa, improve metabolic measures of metabolism in type 2 diabetes, including indicators of fatty liver disease. Revita resurfaces the duodenal mucosa. We have shown in this first-in-human study that the procedure appears to be safe, that the optimal length of the segment to be resurfaced is 9 cm, and that the procedure is associated with metabolic benefits that persist through 6 months after the mucosa heals,” Dr Rajagopalan said.

Longer-term data are needed beyond 6 months, he noted. The investigators will have 12-month data from this study in a few months, and a multicenter trial is now being conducted in Europe in patients with type 2 diabetes treated with DMR and 9-cm resurfacing of the duodenal mucosa.

“These early results raise the intriguing possibility that our intervention might be used not only in type 2 diabetes, but also in patients with metabolic liver disease and other insulin resistance–mediated diseases,” he said.

Insulin resistance plays a central role across a range of disorders, affecting many different organs, including the liver and gastrointestinal tract. Insulin resistance leads to inherent complications and associated syndromes. Just as polycystic ovarian syndrome is now called metabolic reproductive syndrome, nonalcoholic fatty liver disease and nonalcoholic steatohepatitis could be called metabolic liver disease, he suggested.

“Although some patients treated with DMR lost a modest amount of weight, the liver enzyme levels were still reduced. The weight really didn’t budge, yet the liver enzymes were reduced, which was surprising. This forces the question whether obesity really causes type 2 diabetes, or is the cause of insulin resistance independent of weight and are there other contributing factors than obesity,” he said.

“This study shows the potential for a single-point upper GI intervention that can exert broad metabolic effects in glycemia and fatty liver disease,” he commented.

“Even though the duodenal mucosa regenerates over months 1-3, there appears to be a sustained effect of DMR. However, we need controlled studies that prevent medication adjustments that affect glycemic signals,” Dr Rajagopalan noted.

SAN DIEGO – A first-in-human study suggests that a novel technique holds promise for the treatment of diabetes, reducing the complications, associated morbidity, and economic burden of this disease. Duodenal mucosal resurfacing (DMR) achieved a significant reduction in hemoglobin A1c (HbA1c) levels as well as a robust reduction in the liver enzymes aspartate aminotransferase and alanine aminotransferase in patients with poorly controlled type 2 diabetes.

DMR entails thermal ablation of the duodenal mucosa via minimally invasive endoscopy. According to the pioneer behind this technique, Dr. Harith Rajagopalan, who is the founder and CEO of Fractyl Laboratories, in Waltham, Mass., DMR can be compared to laser resurfacing of the skin to remove actinic keratosis. The procedure removes the surface cells of the duodenum, which are insulin resistant, and they heal and become insulin sensitive.

The procedure does not involve surgery or implants, and takes about 60 minutes.

“We hope that once the procedure is done, patients will adopt lifestyle interventions. In the future, we plan to study whether DMR will have even greater potential if patients adapt to a healthy lifestyle,” he said.

Alice Goodman/Frontline Medical News

During the annual Digestive Disease Week, Dr. Rajagopalan detailed experience with the first 39 humans treated with DMR. All patients had poorly controlled type 2 diabetes and were taking at least one antidiabetic medication. The average age was 53 years, mean body mass index was 31 kg/m², and 50% were taking metformin. DMR was performed after 2 weeks of a low-calorie diet.

In this single-arm study, DMR reduced HbA_1c by 1.2%, reduced ALT from 40 to 27 IU/L, and reduced AST from 32 to 22 IU/L over a period of 6 months. Patients with the highest entry levels of AST and ALT had the greatest reductions.

Of the 39 patients, 28 had a 9-cm ablation of the duodenum, and in these patients, the metabolic benefits were even more robust. Thus, 9 cm was identified as the optimal surface area for ablation in future studies.

The procedure was well tolerated, with minimal gastrointestinal symptoms. Adverse events were mostly mild and mainly abdominal pain due to air for the first 2 days following DMR. Three episodes of duodenal stenosis were reported over the first 6 weeks post procedure.

“These resolved with endoscopic balloon dilatation. We have since improved the procedure, and have not seen subsequent events,” Dr Rajagopalan said.

“We know that bariatric surgeries, particularly those that prevent contact of nutrients with mucosa, improve metabolic measures of metabolism in type 2 diabetes, including indicators of fatty liver disease. Revita resurfaces the duodenal mucosa. We have shown in this first-in-human study that the procedure appears to be safe, that the optimal length of the segment to be resurfaced is 9 cm, and that the procedure is associated with metabolic benefits that persist through 6 months after the mucosa heals,” Dr Rajagopalan said.

Longer-term data are needed beyond 6 months, he noted. The investigators will have 12-month data from this study in a few months, and a multicenter trial is now being conducted in Europe in patients with type 2 diabetes treated with DMR and 9-cm resurfacing of the duodenal mucosa.

“These early results raise the intriguing possibility that our intervention might be used not only in type 2 diabetes, but also in patients with metabolic liver disease and other insulin resistance–mediated diseases,” he said.

Insulin resistance plays a central role across a range of disorders, affecting many different organs, including the liver and gastrointestinal tract. Insulin resistance leads to inherent complications and associated syndromes. Just as polycystic ovarian syndrome is now called metabolic reproductive syndrome, nonalcoholic fatty liver disease and nonalcoholic steatohepatitis could be called metabolic liver disease, he suggested.

“Although some patients treated with DMR lost a modest amount of weight, the liver enzyme levels were still reduced. The weight really didn’t budge, yet the liver enzymes were reduced, which was surprising. This forces the question whether obesity really causes type 2 diabetes, or is the cause of insulin resistance independent of weight and are there other contributing factors than obesity,” he said.

“This study shows the potential for a single-point upper GI intervention that can exert broad metabolic effects in glycemia and fatty liver disease,” he commented.

“Even though the duodenal mucosa regenerates over months 1-3, there appears to be a sustained effect of DMR. However, we need controlled studies that prevent medication adjustments that affect glycemic signals,” Dr Rajagopalan noted.

SAN DIEGO – A first-in-human study suggests that a novel technique holds promise for the treatment of diabetes, reducing the complications, associated morbidity, and economic burden of this disease. Duodenal mucosal resurfacing (DMR) achieved a significant reduction in hemoglobin A1c (HbA1c) levels as well as a robust reduction in the liver enzymes aspartate aminotransferase and alanine aminotransferase in patients with poorly controlled type 2 diabetes.

DMR entails thermal ablation of the duodenal mucosa via minimally invasive endoscopy. According to the pioneer behind this technique, Dr. Harith Rajagopalan, who is the founder and CEO of Fractyl Laboratories, in Waltham, Mass., DMR can be compared to laser resurfacing of the skin to remove actinic keratosis. The procedure removes the surface cells of the duodenum, which are insulin resistant, and they heal and become insulin sensitive.

The procedure does not involve surgery or implants, and takes about 60 minutes.

“We hope that once the procedure is done, patients will adopt lifestyle interventions. In the future, we plan to study whether DMR will have even greater potential if patients adapt to a healthy lifestyle,” he said.

Alice Goodman/Frontline Medical News

During the annual Digestive Disease Week, Dr. Rajagopalan detailed experience with the first 39 humans treated with DMR. All patients had poorly controlled type 2 diabetes and were taking at least one antidiabetic medication. The average age was 53 years, mean body mass index was 31 kg/m², and 50% were taking metformin. DMR was performed after 2 weeks of a low-calorie diet.

In this single-arm study, DMR reduced HbA_1c by 1.2%, reduced ALT from 40 to 27 IU/L, and reduced AST from 32 to 22 IU/L over a period of 6 months. Patients with the highest entry levels of AST and ALT had the greatest reductions.

Of the 39 patients, 28 had a 9-cm ablation of the duodenum, and in these patients, the metabolic benefits were even more robust. Thus, 9 cm was identified as the optimal surface area for ablation in future studies.

The procedure was well tolerated, with minimal gastrointestinal symptoms. Adverse events were mostly mild and mainly abdominal pain due to air for the first 2 days following DMR. Three episodes of duodenal stenosis were reported over the first 6 weeks post procedure.

“These resolved with endoscopic balloon dilatation. We have since improved the procedure, and have not seen subsequent events,” Dr Rajagopalan said.

“We know that bariatric surgeries, particularly those that prevent contact of nutrients with mucosa, improve metabolic measures of metabolism in type 2 diabetes, including indicators of fatty liver disease. Revita resurfaces the duodenal mucosa. We have shown in this first-in-human study that the procedure appears to be safe, that the optimal length of the segment to be resurfaced is 9 cm, and that the procedure is associated with metabolic benefits that persist through 6 months after the mucosa heals,” Dr Rajagopalan said.

Longer-term data are needed beyond 6 months, he noted. The investigators will have 12-month data from this study in a few months, and a multicenter trial is now being conducted in Europe in patients with type 2 diabetes treated with DMR and 9-cm resurfacing of the duodenal mucosa.

“These early results raise the intriguing possibility that our intervention might be used not only in type 2 diabetes, but also in patients with metabolic liver disease and other insulin resistance–mediated diseases,” he said.

Insulin resistance plays a central role across a range of disorders, affecting many different organs, including the liver and gastrointestinal tract. Insulin resistance leads to inherent complications and associated syndromes. Just as polycystic ovarian syndrome is now called metabolic reproductive syndrome, nonalcoholic fatty liver disease and nonalcoholic steatohepatitis could be called metabolic liver disease, he suggested.

“Although some patients treated with DMR lost a modest amount of weight, the liver enzyme levels were still reduced. The weight really didn’t budge, yet the liver enzymes were reduced, which was surprising. This forces the question whether obesity really causes type 2 diabetes, or is the cause of insulin resistance independent of weight and are there other contributing factors than obesity,” he said.

“This study shows the potential for a single-point upper GI intervention that can exert broad metabolic effects in glycemia and fatty liver disease,” he commented.

“Even though the duodenal mucosa regenerates over months 1-3, there appears to be a sustained effect of DMR. However, we need controlled studies that prevent medication adjustments that affect glycemic signals,” Dr Rajagopalan noted.

SAN DIEGO – The experimental drug Metavert was effective in a mouse model of aggressive pancreatic cancer, and phase I trials in humans are expected to begin in early 2017.

“Metavert significantly slows tumor growth with less toxicity in preclinical trials. The drug prevents metastasis and reduces resistance to chemotherapy. Hopefully the drug will be a good partner with other drugs,” said presenting author Mouad Edderkaoui, Ph.D., of Cedars-Sinai, Los Angeles. “We hope this drug will improve the outcome of treatment of pancreatic cancer, knowing that the drugs now available are not effective and outcome is dismal. The last drug approved for pancreatic cancer – nab-paclitaxel – extended survival by only 7 weeks.”

Dr. Edderkaoui and Dr. Stephen Pandol, director, basic and translational pancreas research, gastroenterology, at Cedars-Sinai, are cofounders of Avenzoar Pharmaceuticals, the developer of Metavert.

Metavert is a small molecular dual inhibitor that targets two procancer pathways. Preclinical results show strong prevention of pancreatic cancer growth and metastasis with no significant toxicity, according to Dr. Edderkaoui, who explained that the novel agent has two linked moieties that target the glycogen synthase kinase–3 (GSK-3) beta and histone deacetylase (HDAC).

GSK-3 beta, which is highly expressed in pancreatic cancer, stimulates proliferation and resistance to apoptosis in cancer cells. HDAC inhibits epithelial cells. In combination, the two should simultaneously affect proliferation and metastasis.

The investigators studied pancreatic cell lines and KPC mice – an animal model of aggressive pancreatic cancer that carries KRAS and p53 mutations. Metavert reduced the survival of cancer cell lines but not of normal cells.

“The [combination] drug was more potent in cell lines than the two inhibitors separately,” he said. In dose-dependent fashion, Metavert inhibited GSK-3 beta and HDAC, decreased markers of epithelial to mesenchymal transition, and decreased migration of pancreatic cancer cells.

Further, Metavert sensitized pancreatic cancer cells to chemotherapy with gemcitabine and to radiation.

In KPC mice with advanced pancreatic cancer, treatment with Metavert increased survival by about 50%. At 6 months, all control mice had died, while 42% of Metavert-treated mice were still alive.

Tumor shrinkage was observed in Metavert-treated mice. Micrometastasis was seen in 29% of controls and in none of the Metavert-treated mice.

Fibrosis was not significantly affected by treatment, and the level of M2 macrophages significantly declined in treated mice.

SAN DIEGO – The experimental drug Metavert was effective in a mouse model of aggressive pancreatic cancer, and phase I trials in humans are expected to begin in early 2017.

“Metavert significantly slows tumor growth with less toxicity in preclinical trials. The drug prevents metastasis and reduces resistance to chemotherapy. Hopefully the drug will be a good partner with other drugs,” said presenting author Mouad Edderkaoui, Ph.D., of Cedars-Sinai, Los Angeles. “We hope this drug will improve the outcome of treatment of pancreatic cancer, knowing that the drugs now available are not effective and outcome is dismal. The last drug approved for pancreatic cancer – nab-paclitaxel – extended survival by only 7 weeks.”

Dr. Edderkaoui and Dr. Stephen Pandol, director, basic and translational pancreas research, gastroenterology, at Cedars-Sinai, are cofounders of Avenzoar Pharmaceuticals, the developer of Metavert.

Metavert is a small molecular dual inhibitor that targets two procancer pathways. Preclinical results show strong prevention of pancreatic cancer growth and metastasis with no significant toxicity, according to Dr. Edderkaoui, who explained that the novel agent has two linked moieties that target the glycogen synthase kinase–3 (GSK-3) beta and histone deacetylase (HDAC).

GSK-3 beta, which is highly expressed in pancreatic cancer, stimulates proliferation and resistance to apoptosis in cancer cells. HDAC inhibits epithelial cells. In combination, the two should simultaneously affect proliferation and metastasis.

The investigators studied pancreatic cell lines and KPC mice – an animal model of aggressive pancreatic cancer that carries KRAS and p53 mutations. Metavert reduced the survival of cancer cell lines but not of normal cells.

“The [combination] drug was more potent in cell lines than the two inhibitors separately,” he said. In dose-dependent fashion, Metavert inhibited GSK-3 beta and HDAC, decreased markers of epithelial to mesenchymal transition, and decreased migration of pancreatic cancer cells.

Further, Metavert sensitized pancreatic cancer cells to chemotherapy with gemcitabine and to radiation.

In KPC mice with advanced pancreatic cancer, treatment with Metavert increased survival by about 50%. At 6 months, all control mice had died, while 42% of Metavert-treated mice were still alive.

Tumor shrinkage was observed in Metavert-treated mice. Micrometastasis was seen in 29% of controls and in none of the Metavert-treated mice.

Fibrosis was not significantly affected by treatment, and the level of M2 macrophages significantly declined in treated mice.

SAN DIEGO – The experimental drug Metavert was effective in a mouse model of aggressive pancreatic cancer, and phase I trials in humans are expected to begin in early 2017.

“Metavert significantly slows tumor growth with less toxicity in preclinical trials. The drug prevents metastasis and reduces resistance to chemotherapy. Hopefully the drug will be a good partner with other drugs,” said presenting author Mouad Edderkaoui, Ph.D., of Cedars-Sinai, Los Angeles. “We hope this drug will improve the outcome of treatment of pancreatic cancer, knowing that the drugs now available are not effective and outcome is dismal. The last drug approved for pancreatic cancer – nab-paclitaxel – extended survival by only 7 weeks.”

Dr. Edderkaoui and Dr. Stephen Pandol, director, basic and translational pancreas research, gastroenterology, at Cedars-Sinai, are cofounders of Avenzoar Pharmaceuticals, the developer of Metavert.

Metavert is a small molecular dual inhibitor that targets two procancer pathways. Preclinical results show strong prevention of pancreatic cancer growth and metastasis with no significant toxicity, according to Dr. Edderkaoui, who explained that the novel agent has two linked moieties that target the glycogen synthase kinase–3 (GSK-3) beta and histone deacetylase (HDAC).

GSK-3 beta, which is highly expressed in pancreatic cancer, stimulates proliferation and resistance to apoptosis in cancer cells. HDAC inhibits epithelial cells. In combination, the two should simultaneously affect proliferation and metastasis.

The investigators studied pancreatic cell lines and KPC mice – an animal model of aggressive pancreatic cancer that carries KRAS and p53 mutations. Metavert reduced the survival of cancer cell lines but not of normal cells.

“The [combination] drug was more potent in cell lines than the two inhibitors separately,” he said. In dose-dependent fashion, Metavert inhibited GSK-3 beta and HDAC, decreased markers of epithelial to mesenchymal transition, and decreased migration of pancreatic cancer cells.

Further, Metavert sensitized pancreatic cancer cells to chemotherapy with gemcitabine and to radiation.

In KPC mice with advanced pancreatic cancer, treatment with Metavert increased survival by about 50%. At 6 months, all control mice had died, while 42% of Metavert-treated mice were still alive.

Tumor shrinkage was observed in Metavert-treated mice. Micrometastasis was seen in 29% of controls and in none of the Metavert-treated mice.

Fibrosis was not significantly affected by treatment, and the level of M2 macrophages significantly declined in treated mice.

The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.

Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.

More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.

“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”

The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.

In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).

As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).

Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).

These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.

Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.

Dr. Sutton had no relevant financial disclosures.

The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.

Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.

More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.

“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”

The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.

In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).

As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).

Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).

These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.

Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.

Dr. Sutton had no relevant financial disclosures.

The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.

Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.

More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.

“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”

The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.

In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).

As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).

Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).

These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.

Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.

Dr. Sutton had no relevant financial disclosures.

A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.

The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m² at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.

The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).

A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.

The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.

The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.

Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.

“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.

“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”

The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.

Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.

Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.

“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.

Dr. Sullivan received funding for this study from Obalon Therapeutics.

A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.

The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m² at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.

The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).

A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.

The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.

The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.

Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.

“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.

“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”

The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.

Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.

Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.

“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.

Dr. Sullivan received funding for this study from Obalon Therapeutics.

A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.

The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m² at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.

The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).

A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.

The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.

The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.

Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.

“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.

“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”

The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.

Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.

Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.

“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.

Dr. Sullivan received funding for this study from Obalon Therapeutics.