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New drugs provide new options in HCC
PHILADELPHIA – Recent approvals and investigations of targeted and immune treatments for advanced hepatocellular carcinoma (HCC) are encouraging, Nikolaos Pyrsopoulos, MD, MBA, said at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
“I am excited, because a few years ago, there was only one [Food and Drug Administration] approved medication,” Dr. Pyrsopoulos, division director for gastroenterology and hepatology at Rutgers New Jersey Medical School, Newark, said in an interview. “We are on the cusp where new compounds not only are being tested, but they are being approved.”
Median overall survival in CELESTIAL was 10.2 months for cabozantinib versus 8.0 for placebo (P = .0049), according to the published report, and investigators also reported significant improvements in progression-free survival and response versus placebo.
“It is very encouraging,” Dr. Pyrsopoulos said of the cabozantinib results in a presentation on advances in HCC that he gave at the conference.
For years, the only FDA-approved treatment for advanced HCC was sorafenib. In the randomized phase 3 SHARP trial, published in the New England Journal of Medicine in 2008, patients receiving the multikinase inhibitor had a median survival of 10.7 months, versus 7.9 months for placebo (P less than .001).
In April 2017, the FDA approved regorafenib for patients with HCC previously treated with sorafenib. In the randomized phase 3 RESORCE trial, published in The Lancet in 2017, median overall survival was 10.6 months for regorafenib-treated patients versus 7.8 months in the placebo group. Investigators reported that regorafenib improved overall survival with a hazard ratio of 0.63 (P less than .0001).
Dr. Pyrsopoulos noted that a strategy of sorafenib followed by regorafenib would combine two treatments, each of which in clinical trials had a median overall survival approaching 11 months.
“In essence, you have an approximate 2-year survival,” he said.
More agents are under investigation, including lenvatinib, another multikinase inhibitor. In results of a phase 3 randomized trial presented at the 2017 meeting of the American Society of Clinical Oncology, lenvatinib was noninferior to sorafenib in overall survival, with treatment-related adverse effects such as hypertension and diarrhea that were expected based on previous experience with the drug, investigators said.
Cancer immunotherapy is making inroads into HCC. Just a few months after approving regorafenib, the FDA granted approval to nivolumab, a PD-1 inhibitor, for patients with HCC previously treated with sorafenib. The September 2017 approval of this checkpoint inhibitor was based in part on data from the CheckMate-040 trial that included a 14.3% response rate in the 154-patient subgroup of patients who had progressive disease on sorafenib or were intolerant of the treatment.
Dr. Pyrsopoulos highlighted another checkpoint inhibitor, known as BGB-A317, or tislelizumab. In January, BeiGene announced the initiation of a global phase 3 trial of this anti-PD-1 antibody versus sorafenib as first-line treatment of patients with unresectable HCC.
Although cancer immunotherapy holds great promise for HCC and other cancers, the treatments are associated with unique immune-related adverse events (irAEs) including immune-related hepatitis that may require corticosteroid treatment, according to Dr. Pyrsopoulos.
Dr. Pyrsopoulos reported disclosures related to AbbVie, Bayer, Genfit, Gilead Sciences, Hologic, Merck, Prometheus, Shire, and Vital Therapies.
Global Academy for Medical Education and this news organization are owned by the same company.
PHILADELPHIA – Recent approvals and investigations of targeted and immune treatments for advanced hepatocellular carcinoma (HCC) are encouraging, Nikolaos Pyrsopoulos, MD, MBA, said at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
“I am excited, because a few years ago, there was only one [Food and Drug Administration] approved medication,” Dr. Pyrsopoulos, division director for gastroenterology and hepatology at Rutgers New Jersey Medical School, Newark, said in an interview. “We are on the cusp where new compounds not only are being tested, but they are being approved.”
Median overall survival in CELESTIAL was 10.2 months for cabozantinib versus 8.0 for placebo (P = .0049), according to the published report, and investigators also reported significant improvements in progression-free survival and response versus placebo.
“It is very encouraging,” Dr. Pyrsopoulos said of the cabozantinib results in a presentation on advances in HCC that he gave at the conference.
For years, the only FDA-approved treatment for advanced HCC was sorafenib. In the randomized phase 3 SHARP trial, published in the New England Journal of Medicine in 2008, patients receiving the multikinase inhibitor had a median survival of 10.7 months, versus 7.9 months for placebo (P less than .001).
In April 2017, the FDA approved regorafenib for patients with HCC previously treated with sorafenib. In the randomized phase 3 RESORCE trial, published in The Lancet in 2017, median overall survival was 10.6 months for regorafenib-treated patients versus 7.8 months in the placebo group. Investigators reported that regorafenib improved overall survival with a hazard ratio of 0.63 (P less than .0001).
Dr. Pyrsopoulos noted that a strategy of sorafenib followed by regorafenib would combine two treatments, each of which in clinical trials had a median overall survival approaching 11 months.
“In essence, you have an approximate 2-year survival,” he said.
More agents are under investigation, including lenvatinib, another multikinase inhibitor. In results of a phase 3 randomized trial presented at the 2017 meeting of the American Society of Clinical Oncology, lenvatinib was noninferior to sorafenib in overall survival, with treatment-related adverse effects such as hypertension and diarrhea that were expected based on previous experience with the drug, investigators said.
Cancer immunotherapy is making inroads into HCC. Just a few months after approving regorafenib, the FDA granted approval to nivolumab, a PD-1 inhibitor, for patients with HCC previously treated with sorafenib. The September 2017 approval of this checkpoint inhibitor was based in part on data from the CheckMate-040 trial that included a 14.3% response rate in the 154-patient subgroup of patients who had progressive disease on sorafenib or were intolerant of the treatment.
Dr. Pyrsopoulos highlighted another checkpoint inhibitor, known as BGB-A317, or tislelizumab. In January, BeiGene announced the initiation of a global phase 3 trial of this anti-PD-1 antibody versus sorafenib as first-line treatment of patients with unresectable HCC.
Although cancer immunotherapy holds great promise for HCC and other cancers, the treatments are associated with unique immune-related adverse events (irAEs) including immune-related hepatitis that may require corticosteroid treatment, according to Dr. Pyrsopoulos.
Dr. Pyrsopoulos reported disclosures related to AbbVie, Bayer, Genfit, Gilead Sciences, Hologic, Merck, Prometheus, Shire, and Vital Therapies.
Global Academy for Medical Education and this news organization are owned by the same company.
PHILADELPHIA – Recent approvals and investigations of targeted and immune treatments for advanced hepatocellular carcinoma (HCC) are encouraging, Nikolaos Pyrsopoulos, MD, MBA, said at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
“I am excited, because a few years ago, there was only one [Food and Drug Administration] approved medication,” Dr. Pyrsopoulos, division director for gastroenterology and hepatology at Rutgers New Jersey Medical School, Newark, said in an interview. “We are on the cusp where new compounds not only are being tested, but they are being approved.”
Median overall survival in CELESTIAL was 10.2 months for cabozantinib versus 8.0 for placebo (P = .0049), according to the published report, and investigators also reported significant improvements in progression-free survival and response versus placebo.
“It is very encouraging,” Dr. Pyrsopoulos said of the cabozantinib results in a presentation on advances in HCC that he gave at the conference.
For years, the only FDA-approved treatment for advanced HCC was sorafenib. In the randomized phase 3 SHARP trial, published in the New England Journal of Medicine in 2008, patients receiving the multikinase inhibitor had a median survival of 10.7 months, versus 7.9 months for placebo (P less than .001).
In April 2017, the FDA approved regorafenib for patients with HCC previously treated with sorafenib. In the randomized phase 3 RESORCE trial, published in The Lancet in 2017, median overall survival was 10.6 months for regorafenib-treated patients versus 7.8 months in the placebo group. Investigators reported that regorafenib improved overall survival with a hazard ratio of 0.63 (P less than .0001).
Dr. Pyrsopoulos noted that a strategy of sorafenib followed by regorafenib would combine two treatments, each of which in clinical trials had a median overall survival approaching 11 months.
“In essence, you have an approximate 2-year survival,” he said.
More agents are under investigation, including lenvatinib, another multikinase inhibitor. In results of a phase 3 randomized trial presented at the 2017 meeting of the American Society of Clinical Oncology, lenvatinib was noninferior to sorafenib in overall survival, with treatment-related adverse effects such as hypertension and diarrhea that were expected based on previous experience with the drug, investigators said.
Cancer immunotherapy is making inroads into HCC. Just a few months after approving regorafenib, the FDA granted approval to nivolumab, a PD-1 inhibitor, for patients with HCC previously treated with sorafenib. The September 2017 approval of this checkpoint inhibitor was based in part on data from the CheckMate-040 trial that included a 14.3% response rate in the 154-patient subgroup of patients who had progressive disease on sorafenib or were intolerant of the treatment.
Dr. Pyrsopoulos highlighted another checkpoint inhibitor, known as BGB-A317, or tislelizumab. In January, BeiGene announced the initiation of a global phase 3 trial of this anti-PD-1 antibody versus sorafenib as first-line treatment of patients with unresectable HCC.
Although cancer immunotherapy holds great promise for HCC and other cancers, the treatments are associated with unique immune-related adverse events (irAEs) including immune-related hepatitis that may require corticosteroid treatment, according to Dr. Pyrsopoulos.
Dr. Pyrsopoulos reported disclosures related to AbbVie, Bayer, Genfit, Gilead Sciences, Hologic, Merck, Prometheus, Shire, and Vital Therapies.
Global Academy for Medical Education and this news organization are owned by the same company.
REPORTING FROM DIGESTIVE DISEASES: NEW ADVANCES
Switching to tenofovir alafenamide may benefit HBV patients
PHILADELPHIA – Tenofovir alafenamide, the newest kid on the block for treatment of chronic hepatitis B, not only has less bone and renal effects than tenofovir disoproxil, but now also appears to improve those parameters in patients switched over from the older tenofovir formulation, according to Paul Kwo, MD.
“Renal function, as well as hip and spine bone mineral density measurements, all improve after you flip,” said Dr. Kwo, director of hepatology at Stanford (Calif.) University.
Dr. Kwo described some of the latest data on the newer tenofovir formulation in a hepatitis B update he gave at the conference, jointly provided by Rutgers and Global Academy for Medical Education.
Tenofovir alafenamide, a nucleoside analogue reverse transcriptase inhibitor, was approved in November 2016 for treatment of adults with chronic hepatitis B virus (HBV) infection and compensated liver disease.
It has similar efficacy to tenofovir disoproxil, with fewer bone and renal effects, according to results of two large international phase 3 trials.
Some of the latest data, presented in October 2017 at The Liver Meeting in Washington, show that switching patients from tenofovir disoproxil to tenofovir alafenamide improved creatinine clearance and increased rates of alanine aminotransferase normalization, with sustained rates of virologic control, over 48 weeks of treatment.
Similar results were seen for bone mineral density. “It goes up over time, and you approach bone mineral density levels that are similar to [levels in] those who are on tenofovir alafenamide long term,” Dr. Kwo said, commenting on results of the study.
Compared with tenofovir disoproxil, tenofovir alafenamide is a slightly different prodrug of tenofovir, according to Dr. Kwo.
The approved dose of tenofovir alafenamide is 25 mg, compared with 300 mg for tenofovir disoproxil. “It’s more stable in the serum, so you don’t need higher levels, and you have fewer off-target effects,” Dr. Kwo said.
The two agents are “Coke and Pepsi” in terms of efficacy, he added, noting that comparative studies showed similar efficacy on endpoints of percentage HBV DNA less than 29 IU/mL and log10 HBV DNA change.
Very low rates of resistance are seen with first-line therapies for chronic hepatitis B, including entecavir and tenofovir disoproxil. “We wouldn’t expect (tenofovir alafenamide) to be any different, but nonetheless the surveillance has to happen,” Dr. Kwo said.
Tenofovir alafenamide is not yet listed in the official recommendations of the American Association for the Study of Liver Diseases, but it is in current guidelines from the European Association for the Study of the Liver.
The published EASL guidelines provide guidance on how tenofovir alafenamide fits into the treatment armamentarium for HBV.
Going by the EASL recommendations, age greater than 60 years, bone disease, and renal alterations are all good reasons to use tenofovir alafenamide as first-line therapy for hepatitis B, according to Dr. Kwo.
Dr. Kwo reported disclosures related to AbbVie, Allergan, Bristol-Myers Squibb, Conatus Pharmaceuticals, Dova Pharmaceuticals, DURECT, Gilead Sciences, Merck, and Shionogi.
Global Academy and this news organization are owned by the same company.
PHILADELPHIA – Tenofovir alafenamide, the newest kid on the block for treatment of chronic hepatitis B, not only has less bone and renal effects than tenofovir disoproxil, but now also appears to improve those parameters in patients switched over from the older tenofovir formulation, according to Paul Kwo, MD.
“Renal function, as well as hip and spine bone mineral density measurements, all improve after you flip,” said Dr. Kwo, director of hepatology at Stanford (Calif.) University.
Dr. Kwo described some of the latest data on the newer tenofovir formulation in a hepatitis B update he gave at the conference, jointly provided by Rutgers and Global Academy for Medical Education.
Tenofovir alafenamide, a nucleoside analogue reverse transcriptase inhibitor, was approved in November 2016 for treatment of adults with chronic hepatitis B virus (HBV) infection and compensated liver disease.
It has similar efficacy to tenofovir disoproxil, with fewer bone and renal effects, according to results of two large international phase 3 trials.
Some of the latest data, presented in October 2017 at The Liver Meeting in Washington, show that switching patients from tenofovir disoproxil to tenofovir alafenamide improved creatinine clearance and increased rates of alanine aminotransferase normalization, with sustained rates of virologic control, over 48 weeks of treatment.
Similar results were seen for bone mineral density. “It goes up over time, and you approach bone mineral density levels that are similar to [levels in] those who are on tenofovir alafenamide long term,” Dr. Kwo said, commenting on results of the study.
Compared with tenofovir disoproxil, tenofovir alafenamide is a slightly different prodrug of tenofovir, according to Dr. Kwo.
The approved dose of tenofovir alafenamide is 25 mg, compared with 300 mg for tenofovir disoproxil. “It’s more stable in the serum, so you don’t need higher levels, and you have fewer off-target effects,” Dr. Kwo said.
The two agents are “Coke and Pepsi” in terms of efficacy, he added, noting that comparative studies showed similar efficacy on endpoints of percentage HBV DNA less than 29 IU/mL and log10 HBV DNA change.
Very low rates of resistance are seen with first-line therapies for chronic hepatitis B, including entecavir and tenofovir disoproxil. “We wouldn’t expect (tenofovir alafenamide) to be any different, but nonetheless the surveillance has to happen,” Dr. Kwo said.
Tenofovir alafenamide is not yet listed in the official recommendations of the American Association for the Study of Liver Diseases, but it is in current guidelines from the European Association for the Study of the Liver.
The published EASL guidelines provide guidance on how tenofovir alafenamide fits into the treatment armamentarium for HBV.
Going by the EASL recommendations, age greater than 60 years, bone disease, and renal alterations are all good reasons to use tenofovir alafenamide as first-line therapy for hepatitis B, according to Dr. Kwo.
Dr. Kwo reported disclosures related to AbbVie, Allergan, Bristol-Myers Squibb, Conatus Pharmaceuticals, Dova Pharmaceuticals, DURECT, Gilead Sciences, Merck, and Shionogi.
Global Academy and this news organization are owned by the same company.
PHILADELPHIA – Tenofovir alafenamide, the newest kid on the block for treatment of chronic hepatitis B, not only has less bone and renal effects than tenofovir disoproxil, but now also appears to improve those parameters in patients switched over from the older tenofovir formulation, according to Paul Kwo, MD.
“Renal function, as well as hip and spine bone mineral density measurements, all improve after you flip,” said Dr. Kwo, director of hepatology at Stanford (Calif.) University.
Dr. Kwo described some of the latest data on the newer tenofovir formulation in a hepatitis B update he gave at the conference, jointly provided by Rutgers and Global Academy for Medical Education.
Tenofovir alafenamide, a nucleoside analogue reverse transcriptase inhibitor, was approved in November 2016 for treatment of adults with chronic hepatitis B virus (HBV) infection and compensated liver disease.
It has similar efficacy to tenofovir disoproxil, with fewer bone and renal effects, according to results of two large international phase 3 trials.
Some of the latest data, presented in October 2017 at The Liver Meeting in Washington, show that switching patients from tenofovir disoproxil to tenofovir alafenamide improved creatinine clearance and increased rates of alanine aminotransferase normalization, with sustained rates of virologic control, over 48 weeks of treatment.
Similar results were seen for bone mineral density. “It goes up over time, and you approach bone mineral density levels that are similar to [levels in] those who are on tenofovir alafenamide long term,” Dr. Kwo said, commenting on results of the study.
Compared with tenofovir disoproxil, tenofovir alafenamide is a slightly different prodrug of tenofovir, according to Dr. Kwo.
The approved dose of tenofovir alafenamide is 25 mg, compared with 300 mg for tenofovir disoproxil. “It’s more stable in the serum, so you don’t need higher levels, and you have fewer off-target effects,” Dr. Kwo said.
The two agents are “Coke and Pepsi” in terms of efficacy, he added, noting that comparative studies showed similar efficacy on endpoints of percentage HBV DNA less than 29 IU/mL and log10 HBV DNA change.
Very low rates of resistance are seen with first-line therapies for chronic hepatitis B, including entecavir and tenofovir disoproxil. “We wouldn’t expect (tenofovir alafenamide) to be any different, but nonetheless the surveillance has to happen,” Dr. Kwo said.
Tenofovir alafenamide is not yet listed in the official recommendations of the American Association for the Study of Liver Diseases, but it is in current guidelines from the European Association for the Study of the Liver.
The published EASL guidelines provide guidance on how tenofovir alafenamide fits into the treatment armamentarium for HBV.
Going by the EASL recommendations, age greater than 60 years, bone disease, and renal alterations are all good reasons to use tenofovir alafenamide as first-line therapy for hepatitis B, according to Dr. Kwo.
Dr. Kwo reported disclosures related to AbbVie, Allergan, Bristol-Myers Squibb, Conatus Pharmaceuticals, Dova Pharmaceuticals, DURECT, Gilead Sciences, Merck, and Shionogi.
Global Academy and this news organization are owned by the same company.
EXPERT ANALYSIS FROM DIGESTIVE DISEASES: NEW ADVANCES
Medical treatment of perianal fistulae often warranted, despite limited evidence
PHILADELPHIA – Perianal fistulae are a common and difficult-to-treat complication of Crohn’s disease that may often require medical therapy, though not all treatment options have robust data supporting their use in this setting, according to Mark T. Osterman, MD.
“Most studies done on fistulae actually didn’t have that as the primary endpoint – it was a secondary endpoint, so they weren’t really designed to look at fistulae, specifically,” said Dr. Osterman, associate professor of medicine in the division of gastroenterology at the University of Pennsylvania in Philadelphia.
Dr. Osterman shared his own approach to medical treatment of perianal fistulae in a presentation he gave at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
For simple perianal fistula with no rectal inflammation, a fistulotomy is reasonable, but medical treatment may be preferable, Dr. Osterman said.
“I always favor medical therapy because it attacks the root of the problem, which is the immune system,” he explained.
Helpful treatments in this scenario include antibiotics, along with anti–tumor necrosis factor therapy with or without immunomodulators, he said.
Antibiotic use in this setting is based on uncontrolled data, and efficacy is modest at best, according to Dr. Osterman, who noted that the treatments may reduce fistula drainage but likely do not heal fistulae.
The most commonly used antibiotics are metronidazole and ciprofloxacin given for up to 2-4 months, he added.
Infliximab is the drug that has by far the most robust fistula data, and one of only two drugs where a fistula was the primary outcome of the studies, according to Dr. Osterman.
In a randomized trial, infliximab induction treatment more than doubled fistula-related response and remission rates, compared with placebo, he said.
Maintenance infliximab treatment likewise showed an approximate doubling of both response and remission of fistula versus placebo, he added.
While not designed to look at fistulae as a primary outcome, the randomized CHARM study of adalimumab versus placebo for maintenance of Crohn’s disease remission did demonstrate remission rates about twice as high with the use of adalimumab, compared with placebo, in 117 patients who had draining fistulae at baseline, Dr. Osterman recounted.
For patients with complex fistulae, as well as patients with rectal inflammation, a seton and aggressive medical therapy are likely needed, Dr. Osterman said in his presentation.
An advancement flap or medical therapies such as vedolizumab or tacrolimus might be warranted for patients who fail other medical approaches, he added.
Relevant vedolizumab data come from GEMINI 2, a large clinical trial for Crohn’s disease that included 57 patients who had draining fistulas at baseline.
“We see an improvement in remission rates with fistula with vedolizumab, compared to placebo, but again, (GEMINI 2) wasn’t designed to look at fistula, but we do use it,” said Dr. Osterman.
Tacrolimus is the only drug besides infliximab that has randomized data for fistula, according to Dr. Osterman.
In the small randomized study, 48 patients with Crohn’s disease and draining perianal or enterocutaneous fistulae were treated for 10 weeks with oral tacrolimus at 0.2 mg/kg per day or placebo.
Fistula improvement was seen in 43% of tacrolimus-treated patients and 8% of placebo-treated patients (P = .004), while remission was seen in 10% and 8% of those groups, respectively (P = .86), according to published data on the trial.
“[Tacrolimus] showed a nice improvement in response rates, but very similar remission rates,” Dr. Osterman said, “but it does represent an option for us, for our patients.”
Dr. Osterman reported grant/research support from UCB and serving as a consultant for AbbVie, Janssen, Lycera, Merck, Pfizer, Takeda, and UCB.
Global Academy and this news organization are owned by the same company.
PHILADELPHIA – Perianal fistulae are a common and difficult-to-treat complication of Crohn’s disease that may often require medical therapy, though not all treatment options have robust data supporting their use in this setting, according to Mark T. Osterman, MD.
“Most studies done on fistulae actually didn’t have that as the primary endpoint – it was a secondary endpoint, so they weren’t really designed to look at fistulae, specifically,” said Dr. Osterman, associate professor of medicine in the division of gastroenterology at the University of Pennsylvania in Philadelphia.
Dr. Osterman shared his own approach to medical treatment of perianal fistulae in a presentation he gave at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
For simple perianal fistula with no rectal inflammation, a fistulotomy is reasonable, but medical treatment may be preferable, Dr. Osterman said.
“I always favor medical therapy because it attacks the root of the problem, which is the immune system,” he explained.
Helpful treatments in this scenario include antibiotics, along with anti–tumor necrosis factor therapy with or without immunomodulators, he said.
Antibiotic use in this setting is based on uncontrolled data, and efficacy is modest at best, according to Dr. Osterman, who noted that the treatments may reduce fistula drainage but likely do not heal fistulae.
The most commonly used antibiotics are metronidazole and ciprofloxacin given for up to 2-4 months, he added.
Infliximab is the drug that has by far the most robust fistula data, and one of only two drugs where a fistula was the primary outcome of the studies, according to Dr. Osterman.
In a randomized trial, infliximab induction treatment more than doubled fistula-related response and remission rates, compared with placebo, he said.
Maintenance infliximab treatment likewise showed an approximate doubling of both response and remission of fistula versus placebo, he added.
While not designed to look at fistulae as a primary outcome, the randomized CHARM study of adalimumab versus placebo for maintenance of Crohn’s disease remission did demonstrate remission rates about twice as high with the use of adalimumab, compared with placebo, in 117 patients who had draining fistulae at baseline, Dr. Osterman recounted.
For patients with complex fistulae, as well as patients with rectal inflammation, a seton and aggressive medical therapy are likely needed, Dr. Osterman said in his presentation.
An advancement flap or medical therapies such as vedolizumab or tacrolimus might be warranted for patients who fail other medical approaches, he added.
Relevant vedolizumab data come from GEMINI 2, a large clinical trial for Crohn’s disease that included 57 patients who had draining fistulas at baseline.
“We see an improvement in remission rates with fistula with vedolizumab, compared to placebo, but again, (GEMINI 2) wasn’t designed to look at fistula, but we do use it,” said Dr. Osterman.
Tacrolimus is the only drug besides infliximab that has randomized data for fistula, according to Dr. Osterman.
In the small randomized study, 48 patients with Crohn’s disease and draining perianal or enterocutaneous fistulae were treated for 10 weeks with oral tacrolimus at 0.2 mg/kg per day or placebo.
Fistula improvement was seen in 43% of tacrolimus-treated patients and 8% of placebo-treated patients (P = .004), while remission was seen in 10% and 8% of those groups, respectively (P = .86), according to published data on the trial.
“[Tacrolimus] showed a nice improvement in response rates, but very similar remission rates,” Dr. Osterman said, “but it does represent an option for us, for our patients.”
Dr. Osterman reported grant/research support from UCB and serving as a consultant for AbbVie, Janssen, Lycera, Merck, Pfizer, Takeda, and UCB.
Global Academy and this news organization are owned by the same company.
PHILADELPHIA – Perianal fistulae are a common and difficult-to-treat complication of Crohn’s disease that may often require medical therapy, though not all treatment options have robust data supporting their use in this setting, according to Mark T. Osterman, MD.
“Most studies done on fistulae actually didn’t have that as the primary endpoint – it was a secondary endpoint, so they weren’t really designed to look at fistulae, specifically,” said Dr. Osterman, associate professor of medicine in the division of gastroenterology at the University of Pennsylvania in Philadelphia.
Dr. Osterman shared his own approach to medical treatment of perianal fistulae in a presentation he gave at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
For simple perianal fistula with no rectal inflammation, a fistulotomy is reasonable, but medical treatment may be preferable, Dr. Osterman said.
“I always favor medical therapy because it attacks the root of the problem, which is the immune system,” he explained.
Helpful treatments in this scenario include antibiotics, along with anti–tumor necrosis factor therapy with or without immunomodulators, he said.
Antibiotic use in this setting is based on uncontrolled data, and efficacy is modest at best, according to Dr. Osterman, who noted that the treatments may reduce fistula drainage but likely do not heal fistulae.
The most commonly used antibiotics are metronidazole and ciprofloxacin given for up to 2-4 months, he added.
Infliximab is the drug that has by far the most robust fistula data, and one of only two drugs where a fistula was the primary outcome of the studies, according to Dr. Osterman.
In a randomized trial, infliximab induction treatment more than doubled fistula-related response and remission rates, compared with placebo, he said.
Maintenance infliximab treatment likewise showed an approximate doubling of both response and remission of fistula versus placebo, he added.
While not designed to look at fistulae as a primary outcome, the randomized CHARM study of adalimumab versus placebo for maintenance of Crohn’s disease remission did demonstrate remission rates about twice as high with the use of adalimumab, compared with placebo, in 117 patients who had draining fistulae at baseline, Dr. Osterman recounted.
For patients with complex fistulae, as well as patients with rectal inflammation, a seton and aggressive medical therapy are likely needed, Dr. Osterman said in his presentation.
An advancement flap or medical therapies such as vedolizumab or tacrolimus might be warranted for patients who fail other medical approaches, he added.
Relevant vedolizumab data come from GEMINI 2, a large clinical trial for Crohn’s disease that included 57 patients who had draining fistulas at baseline.
“We see an improvement in remission rates with fistula with vedolizumab, compared to placebo, but again, (GEMINI 2) wasn’t designed to look at fistula, but we do use it,” said Dr. Osterman.
Tacrolimus is the only drug besides infliximab that has randomized data for fistula, according to Dr. Osterman.
In the small randomized study, 48 patients with Crohn’s disease and draining perianal or enterocutaneous fistulae were treated for 10 weeks with oral tacrolimus at 0.2 mg/kg per day or placebo.
Fistula improvement was seen in 43% of tacrolimus-treated patients and 8% of placebo-treated patients (P = .004), while remission was seen in 10% and 8% of those groups, respectively (P = .86), according to published data on the trial.
“[Tacrolimus] showed a nice improvement in response rates, but very similar remission rates,” Dr. Osterman said, “but it does represent an option for us, for our patients.”
Dr. Osterman reported grant/research support from UCB and serving as a consultant for AbbVie, Janssen, Lycera, Merck, Pfizer, Takeda, and UCB.
Global Academy and this news organization are owned by the same company.
EXPERT ANALYSIS FROM DIGESTIVE DISEASES: NEW ADVANCES
Step-up diet: Less-intensive way to ID eosinophilic esophagitis food triggers?
PHILADELPHIA – While traditional elimination diets for eosinophilic esophagitis are highly restrictive and endoscopically intensive, a new “step-up” approach may offer a superior empiric scheme for identifying food triggers, according to Stuart J. Spechler, MD.
The recently described step-up approach may be preferable to the standard empiric six-food elimination diet, which has a 72% success rate but is challenging to implement, according to Dr. Spechler, chief of the division of gastroenterology, Baylor University Medical Center at Dallas.
“That’s an extremely demanding, time-consuming, inconvenient, and expensive thing to do. It requires at least seven endoscopies, probably more, performed over a period of 42 weeks,” Dr. Spechler said here at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
In contrast, the step-up approach recently described by Molina-Infante et al. in the Journal of Allergy and Clinical Immunology (2018 Mar 6. doi: 10.1016/j.jaci.2018.02.028) consists of a two-food elimination diet escalated to a four- and six-food elimination diet as needed.
This diet, which the researchers described as a “2-4-6” approach, starts with elimination of milk and wheat, the two most common food triggers for eosinophilic esophagitis. If patients do not respond, eggs and soy/legumes are eliminated, and if that fails, nuts and seafood are eliminated.
Once patients do respond, foods are reintroduced one at a time over 6 weeks with repeat endoscopy and biopsy, according to the report.
Molina-Infante and coauthors further described results of the diet in 220 patients with eosinophilic esophagitis. Of that group, investigators said 90 patients refused dietary therapy.
However, for the remaining 130 patients, 74 responded to the diet, the investigators reported.
Of 74 responders, 56 (43%) achieved remission at the first step in which milk and wheat were eliminated, results show, while an additional 10 had remission after the step up to four-food elimination, and another 8 had remission after the final step up to six-food elimination.
Dr. Spechler said his current take on diet therapy for eosinophilic esophagitis would be to start with the two-food elimination diet.
That first step alone identified about three-quarters of the patients who eventually would respond to the step-up approach in the Molina-Infante study, he observed.
For patients who do not respond and are motivated to continue, Dr. Spechler said he would move up to the four-food elimination diet, which identified about 90% of patients who eventually responded.
However, Dr. Spechler said he would consider the final step-up only in “exceptionally highly motivated” patients, since that step seems to identify very few additional responders.
“They got very little benefit here from going all the way up to a six-food elimination diet,” Dr. Spechler said.
Patient acceptance may be one major barrier to any dietary approach to treatment of eosinophilic esophagitis, regardless of how intensive the approach is.
“Ninety patients just flat-out refused to try the diet, so this is not a popular form of therapy,” Dr. Spechler noted.
However, diet is one of three valid treatment options for patients who do have an established diagnosis of eosinophilic esophagitis, the other two being proton pump inhibitors (PPIs) or 6-8 weeks of topical steroids, according to Dr. Spechler.
“If you’re going to use diet, I think you begin with that two-food elimination diet,“ he said. “Fortunately, most of the patients who don’t respond to diet will respond to PPIs or steroids.”
Dr. Spechler reported disclosures related to Ironwood Pharmaceuticals and Takeda Pharmaceuticals.
Global Academy and this news organization are owned by the same company.
PHILADELPHIA – While traditional elimination diets for eosinophilic esophagitis are highly restrictive and endoscopically intensive, a new “step-up” approach may offer a superior empiric scheme for identifying food triggers, according to Stuart J. Spechler, MD.
The recently described step-up approach may be preferable to the standard empiric six-food elimination diet, which has a 72% success rate but is challenging to implement, according to Dr. Spechler, chief of the division of gastroenterology, Baylor University Medical Center at Dallas.
“That’s an extremely demanding, time-consuming, inconvenient, and expensive thing to do. It requires at least seven endoscopies, probably more, performed over a period of 42 weeks,” Dr. Spechler said here at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
In contrast, the step-up approach recently described by Molina-Infante et al. in the Journal of Allergy and Clinical Immunology (2018 Mar 6. doi: 10.1016/j.jaci.2018.02.028) consists of a two-food elimination diet escalated to a four- and six-food elimination diet as needed.
This diet, which the researchers described as a “2-4-6” approach, starts with elimination of milk and wheat, the two most common food triggers for eosinophilic esophagitis. If patients do not respond, eggs and soy/legumes are eliminated, and if that fails, nuts and seafood are eliminated.
Once patients do respond, foods are reintroduced one at a time over 6 weeks with repeat endoscopy and biopsy, according to the report.
Molina-Infante and coauthors further described results of the diet in 220 patients with eosinophilic esophagitis. Of that group, investigators said 90 patients refused dietary therapy.
However, for the remaining 130 patients, 74 responded to the diet, the investigators reported.
Of 74 responders, 56 (43%) achieved remission at the first step in which milk and wheat were eliminated, results show, while an additional 10 had remission after the step up to four-food elimination, and another 8 had remission after the final step up to six-food elimination.
Dr. Spechler said his current take on diet therapy for eosinophilic esophagitis would be to start with the two-food elimination diet.
That first step alone identified about three-quarters of the patients who eventually would respond to the step-up approach in the Molina-Infante study, he observed.
For patients who do not respond and are motivated to continue, Dr. Spechler said he would move up to the four-food elimination diet, which identified about 90% of patients who eventually responded.
However, Dr. Spechler said he would consider the final step-up only in “exceptionally highly motivated” patients, since that step seems to identify very few additional responders.
“They got very little benefit here from going all the way up to a six-food elimination diet,” Dr. Spechler said.
Patient acceptance may be one major barrier to any dietary approach to treatment of eosinophilic esophagitis, regardless of how intensive the approach is.
“Ninety patients just flat-out refused to try the diet, so this is not a popular form of therapy,” Dr. Spechler noted.
However, diet is one of three valid treatment options for patients who do have an established diagnosis of eosinophilic esophagitis, the other two being proton pump inhibitors (PPIs) or 6-8 weeks of topical steroids, according to Dr. Spechler.
“If you’re going to use diet, I think you begin with that two-food elimination diet,“ he said. “Fortunately, most of the patients who don’t respond to diet will respond to PPIs or steroids.”
Dr. Spechler reported disclosures related to Ironwood Pharmaceuticals and Takeda Pharmaceuticals.
Global Academy and this news organization are owned by the same company.
PHILADELPHIA – While traditional elimination diets for eosinophilic esophagitis are highly restrictive and endoscopically intensive, a new “step-up” approach may offer a superior empiric scheme for identifying food triggers, according to Stuart J. Spechler, MD.
The recently described step-up approach may be preferable to the standard empiric six-food elimination diet, which has a 72% success rate but is challenging to implement, according to Dr. Spechler, chief of the division of gastroenterology, Baylor University Medical Center at Dallas.
“That’s an extremely demanding, time-consuming, inconvenient, and expensive thing to do. It requires at least seven endoscopies, probably more, performed over a period of 42 weeks,” Dr. Spechler said here at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.
In contrast, the step-up approach recently described by Molina-Infante et al. in the Journal of Allergy and Clinical Immunology (2018 Mar 6. doi: 10.1016/j.jaci.2018.02.028) consists of a two-food elimination diet escalated to a four- and six-food elimination diet as needed.
This diet, which the researchers described as a “2-4-6” approach, starts with elimination of milk and wheat, the two most common food triggers for eosinophilic esophagitis. If patients do not respond, eggs and soy/legumes are eliminated, and if that fails, nuts and seafood are eliminated.
Once patients do respond, foods are reintroduced one at a time over 6 weeks with repeat endoscopy and biopsy, according to the report.
Molina-Infante and coauthors further described results of the diet in 220 patients with eosinophilic esophagitis. Of that group, investigators said 90 patients refused dietary therapy.
However, for the remaining 130 patients, 74 responded to the diet, the investigators reported.
Of 74 responders, 56 (43%) achieved remission at the first step in which milk and wheat were eliminated, results show, while an additional 10 had remission after the step up to four-food elimination, and another 8 had remission after the final step up to six-food elimination.
Dr. Spechler said his current take on diet therapy for eosinophilic esophagitis would be to start with the two-food elimination diet.
That first step alone identified about three-quarters of the patients who eventually would respond to the step-up approach in the Molina-Infante study, he observed.
For patients who do not respond and are motivated to continue, Dr. Spechler said he would move up to the four-food elimination diet, which identified about 90% of patients who eventually responded.
However, Dr. Spechler said he would consider the final step-up only in “exceptionally highly motivated” patients, since that step seems to identify very few additional responders.
“They got very little benefit here from going all the way up to a six-food elimination diet,” Dr. Spechler said.
Patient acceptance may be one major barrier to any dietary approach to treatment of eosinophilic esophagitis, regardless of how intensive the approach is.
“Ninety patients just flat-out refused to try the diet, so this is not a popular form of therapy,” Dr. Spechler noted.
However, diet is one of three valid treatment options for patients who do have an established diagnosis of eosinophilic esophagitis, the other two being proton pump inhibitors (PPIs) or 6-8 weeks of topical steroids, according to Dr. Spechler.
“If you’re going to use diet, I think you begin with that two-food elimination diet,“ he said. “Fortunately, most of the patients who don’t respond to diet will respond to PPIs or steroids.”
Dr. Spechler reported disclosures related to Ironwood Pharmaceuticals and Takeda Pharmaceuticals.
Global Academy and this news organization are owned by the same company.
EXPERT ANALYSIS FROM DIGESTIVE DISEASES: NEW ADVANCES
Pre-screening could help identify NAFLD biopsy candidates
PHILADELPHIA – When evaluating patients with established non-alcoholic fatty liver disease (NAFLD), using pre-screening criteria may help identify the subset of patients who should be subjected to liver biopsy, according to Vinod K. Rustgi, MD.
The recently described pre-screening criteria include a set of patient and disease characteristics that identify who might be at highest risk for non-alcoholic steatohepatitis (NASH) and fibrosis, said Dr. Rustgi, chief of hepatology at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.
“Eighty-five percent of the patients who fall into this category will actually have fibrosis on liver biopsy. So it’s a good way to screen out who you want to actually biopsy,” Dr. Rustgi said at the meeting, jointly provided by Rutgers and Global Academy for Medical Education.
Liver biopsy needs to be considered in patients with NAFLD who are at increased risk of having advanced fibrosis, according to the latest practice guidance on diagnosis and management of NAFLD (Hepatology. 2018 Jan;67[1]:328-57).
While it’s the most accurate means to diagnose and stage severity of NASH, biopsy is invasive, costly, and associated with potential complications, according to a recent Hepatology review article (2017 Dec 9. doi: 10.1002/hep.29721).
Criteria to pinpoint patients at highest risk for NASH and fibrosis could be useful for streamlining clinical trial enrollment and limiting screening failures, according to authors who recently described the pre-screening criteria in the Journal of Hepatology (2018 Feb. doi: 10.1016/j.jhep.2017.10.015).
, or who have a vibration controlled transient elastography (VCTE, FibroScan) score of kPa greater than 8.5, or an AST/ALT ratio greater than 1, among several other criteria described in the article.
“The patients who have a low likelihood of NASH and fibrosis are those who are under the age of 40, who may not be diabetic, who have a elastography score of kPa less than 7, or an AST less than 20,” Dr. Rustgi said of the pre-screening criteria.
In his presentation, Dr. Rustgi provided other notes on when to biopsy as described in the January 2018 practice guidance from Hepatology.
In particular, the guidance states that presence of metabolic syndrome, NAFLD fibrosis score or Fibrosis 4 Score, or liver stiffness measured by VCTE or magnetic resonance elastography might be used to help identify patients at risk for steatohepatitis or advanced fibrosis.
Liver biopsy also should be considered in NAFLD when competing etiologies cannot be excluded except by a liver biopsy, according to the recent guidance.
Dr. Rustgi reported disclosures related to AbbVie, Genfit, and Gilead Sciences.
Global Academy for Medical Education and this news organization are owned by the same company.
PHILADELPHIA – When evaluating patients with established non-alcoholic fatty liver disease (NAFLD), using pre-screening criteria may help identify the subset of patients who should be subjected to liver biopsy, according to Vinod K. Rustgi, MD.
The recently described pre-screening criteria include a set of patient and disease characteristics that identify who might be at highest risk for non-alcoholic steatohepatitis (NASH) and fibrosis, said Dr. Rustgi, chief of hepatology at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.
“Eighty-five percent of the patients who fall into this category will actually have fibrosis on liver biopsy. So it’s a good way to screen out who you want to actually biopsy,” Dr. Rustgi said at the meeting, jointly provided by Rutgers and Global Academy for Medical Education.
Liver biopsy needs to be considered in patients with NAFLD who are at increased risk of having advanced fibrosis, according to the latest practice guidance on diagnosis and management of NAFLD (Hepatology. 2018 Jan;67[1]:328-57).
While it’s the most accurate means to diagnose and stage severity of NASH, biopsy is invasive, costly, and associated with potential complications, according to a recent Hepatology review article (2017 Dec 9. doi: 10.1002/hep.29721).
Criteria to pinpoint patients at highest risk for NASH and fibrosis could be useful for streamlining clinical trial enrollment and limiting screening failures, according to authors who recently described the pre-screening criteria in the Journal of Hepatology (2018 Feb. doi: 10.1016/j.jhep.2017.10.015).
, or who have a vibration controlled transient elastography (VCTE, FibroScan) score of kPa greater than 8.5, or an AST/ALT ratio greater than 1, among several other criteria described in the article.
“The patients who have a low likelihood of NASH and fibrosis are those who are under the age of 40, who may not be diabetic, who have a elastography score of kPa less than 7, or an AST less than 20,” Dr. Rustgi said of the pre-screening criteria.
In his presentation, Dr. Rustgi provided other notes on when to biopsy as described in the January 2018 practice guidance from Hepatology.
In particular, the guidance states that presence of metabolic syndrome, NAFLD fibrosis score or Fibrosis 4 Score, or liver stiffness measured by VCTE or magnetic resonance elastography might be used to help identify patients at risk for steatohepatitis or advanced fibrosis.
Liver biopsy also should be considered in NAFLD when competing etiologies cannot be excluded except by a liver biopsy, according to the recent guidance.
Dr. Rustgi reported disclosures related to AbbVie, Genfit, and Gilead Sciences.
Global Academy for Medical Education and this news organization are owned by the same company.
PHILADELPHIA – When evaluating patients with established non-alcoholic fatty liver disease (NAFLD), using pre-screening criteria may help identify the subset of patients who should be subjected to liver biopsy, according to Vinod K. Rustgi, MD.
The recently described pre-screening criteria include a set of patient and disease characteristics that identify who might be at highest risk for non-alcoholic steatohepatitis (NASH) and fibrosis, said Dr. Rustgi, chief of hepatology at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.
“Eighty-five percent of the patients who fall into this category will actually have fibrosis on liver biopsy. So it’s a good way to screen out who you want to actually biopsy,” Dr. Rustgi said at the meeting, jointly provided by Rutgers and Global Academy for Medical Education.
Liver biopsy needs to be considered in patients with NAFLD who are at increased risk of having advanced fibrosis, according to the latest practice guidance on diagnosis and management of NAFLD (Hepatology. 2018 Jan;67[1]:328-57).
While it’s the most accurate means to diagnose and stage severity of NASH, biopsy is invasive, costly, and associated with potential complications, according to a recent Hepatology review article (2017 Dec 9. doi: 10.1002/hep.29721).
Criteria to pinpoint patients at highest risk for NASH and fibrosis could be useful for streamlining clinical trial enrollment and limiting screening failures, according to authors who recently described the pre-screening criteria in the Journal of Hepatology (2018 Feb. doi: 10.1016/j.jhep.2017.10.015).
, or who have a vibration controlled transient elastography (VCTE, FibroScan) score of kPa greater than 8.5, or an AST/ALT ratio greater than 1, among several other criteria described in the article.
“The patients who have a low likelihood of NASH and fibrosis are those who are under the age of 40, who may not be diabetic, who have a elastography score of kPa less than 7, or an AST less than 20,” Dr. Rustgi said of the pre-screening criteria.
In his presentation, Dr. Rustgi provided other notes on when to biopsy as described in the January 2018 practice guidance from Hepatology.
In particular, the guidance states that presence of metabolic syndrome, NAFLD fibrosis score or Fibrosis 4 Score, or liver stiffness measured by VCTE or magnetic resonance elastography might be used to help identify patients at risk for steatohepatitis or advanced fibrosis.
Liver biopsy also should be considered in NAFLD when competing etiologies cannot be excluded except by a liver biopsy, according to the recent guidance.
Dr. Rustgi reported disclosures related to AbbVie, Genfit, and Gilead Sciences.
Global Academy for Medical Education and this news organization are owned by the same company.
REPORTING FROM DIGESTIVE DISEASES: NEW ADVANCES
Do not miss cannabis use in gastroparesis patients
PHILADELPHIA – When evaluating potential causes of gastroparesis, cannabis use is a “do not miss” diagnosis that is easy to overlook and likely on the rise, according to Anthony J. Lembo, MD.
“This is not an infrequent problem, and I’ve even missed it a couple of times,” said Dr. Lembo, director of the GI Motility Laboratory at Beth Israel Deaconess Medical Center, Boston.
The rate of U.S. emergency department visits for vomiting with cannabis use disorder rose from 2.3 to 13.3 per 100,000 visits from 2006 to 2013, according to an analysis recently published by Dr. Lembo and colleagues (J Clin Gastroenterol. 2017 Oct 31. doi: 10.1097/MCG.0000000000000944).
The study showed that men between 20 and 29 years were the most common group presenting for vomiting with cannabis use disorder.
“Remember, 90% of people with chronic gastroparesis are women, so a young male is a red flag for cannabinoid use, whether or not you’ve got the right history,” Dr. Lembo told attendees at the meeting, jointly provided by Rutgers and Global Academy for Medical Education.
Dr. Lembo recounted an example from his own practice where a young male patient with recurrent nausea and vomiting denied cannabis use in the presence of family members.
“It was only after we managed to hospitalize him because he was losing so much weight that he came out and talked to one of the residents that he was an actually a daily pot smoker,” Dr. Lembo said. “Once we stopped it, the symptoms went away.”
Clinicians in states where cannabis use is increasing might need to be particularly alert for cannabis-related issues. According to the study by Dr. Lembo, the Midwest and West regions registered higher rates of vomiting with cannabis use disorder, compared with the Northeast and South.
Whether cannabinoids also can be a treatment for nausea or vomiting is a frequently asked question, Dr. Lembo said.
While there are no data for smoked marijuana, Dr. Lembo said, .
Dronabinol is indicated for adults for the treatment of chemotherapy-associated nausea and vomiting in patients who don’t respond adequately to conventional antiemetics, according to the agent’s prescribing information.
The cannabinoid medication is an isomer of tetrahydrocannabinol (THC), one of the active compounds in marijuana, according to Dr. Lembo.
“If you smoke marijuana, the levels go up high very quickly,” Dr. Lembo said. “If you take dronabinol, it takes 45 minutes to an hour. It’s a slower rise of it, so people are less likely to abuse dronabinol.”
In his talk, Dr. Lembo reported disclosures related to Allergan, Ironwood Pharmaceuticals, Salix Pharmaceuticals, and Takeda Pharmaceuticals.
Global Academy for Medical Education and this news organization are owned by the same company.
PHILADELPHIA – When evaluating potential causes of gastroparesis, cannabis use is a “do not miss” diagnosis that is easy to overlook and likely on the rise, according to Anthony J. Lembo, MD.
“This is not an infrequent problem, and I’ve even missed it a couple of times,” said Dr. Lembo, director of the GI Motility Laboratory at Beth Israel Deaconess Medical Center, Boston.
The rate of U.S. emergency department visits for vomiting with cannabis use disorder rose from 2.3 to 13.3 per 100,000 visits from 2006 to 2013, according to an analysis recently published by Dr. Lembo and colleagues (J Clin Gastroenterol. 2017 Oct 31. doi: 10.1097/MCG.0000000000000944).
The study showed that men between 20 and 29 years were the most common group presenting for vomiting with cannabis use disorder.
“Remember, 90% of people with chronic gastroparesis are women, so a young male is a red flag for cannabinoid use, whether or not you’ve got the right history,” Dr. Lembo told attendees at the meeting, jointly provided by Rutgers and Global Academy for Medical Education.
Dr. Lembo recounted an example from his own practice where a young male patient with recurrent nausea and vomiting denied cannabis use in the presence of family members.
“It was only after we managed to hospitalize him because he was losing so much weight that he came out and talked to one of the residents that he was an actually a daily pot smoker,” Dr. Lembo said. “Once we stopped it, the symptoms went away.”
Clinicians in states where cannabis use is increasing might need to be particularly alert for cannabis-related issues. According to the study by Dr. Lembo, the Midwest and West regions registered higher rates of vomiting with cannabis use disorder, compared with the Northeast and South.
Whether cannabinoids also can be a treatment for nausea or vomiting is a frequently asked question, Dr. Lembo said.
While there are no data for smoked marijuana, Dr. Lembo said, .
Dronabinol is indicated for adults for the treatment of chemotherapy-associated nausea and vomiting in patients who don’t respond adequately to conventional antiemetics, according to the agent’s prescribing information.
The cannabinoid medication is an isomer of tetrahydrocannabinol (THC), one of the active compounds in marijuana, according to Dr. Lembo.
“If you smoke marijuana, the levels go up high very quickly,” Dr. Lembo said. “If you take dronabinol, it takes 45 minutes to an hour. It’s a slower rise of it, so people are less likely to abuse dronabinol.”
In his talk, Dr. Lembo reported disclosures related to Allergan, Ironwood Pharmaceuticals, Salix Pharmaceuticals, and Takeda Pharmaceuticals.
Global Academy for Medical Education and this news organization are owned by the same company.
PHILADELPHIA – When evaluating potential causes of gastroparesis, cannabis use is a “do not miss” diagnosis that is easy to overlook and likely on the rise, according to Anthony J. Lembo, MD.
“This is not an infrequent problem, and I’ve even missed it a couple of times,” said Dr. Lembo, director of the GI Motility Laboratory at Beth Israel Deaconess Medical Center, Boston.
The rate of U.S. emergency department visits for vomiting with cannabis use disorder rose from 2.3 to 13.3 per 100,000 visits from 2006 to 2013, according to an analysis recently published by Dr. Lembo and colleagues (J Clin Gastroenterol. 2017 Oct 31. doi: 10.1097/MCG.0000000000000944).
The study showed that men between 20 and 29 years were the most common group presenting for vomiting with cannabis use disorder.
“Remember, 90% of people with chronic gastroparesis are women, so a young male is a red flag for cannabinoid use, whether or not you’ve got the right history,” Dr. Lembo told attendees at the meeting, jointly provided by Rutgers and Global Academy for Medical Education.
Dr. Lembo recounted an example from his own practice where a young male patient with recurrent nausea and vomiting denied cannabis use in the presence of family members.
“It was only after we managed to hospitalize him because he was losing so much weight that he came out and talked to one of the residents that he was an actually a daily pot smoker,” Dr. Lembo said. “Once we stopped it, the symptoms went away.”
Clinicians in states where cannabis use is increasing might need to be particularly alert for cannabis-related issues. According to the study by Dr. Lembo, the Midwest and West regions registered higher rates of vomiting with cannabis use disorder, compared with the Northeast and South.
Whether cannabinoids also can be a treatment for nausea or vomiting is a frequently asked question, Dr. Lembo said.
While there are no data for smoked marijuana, Dr. Lembo said, .
Dronabinol is indicated for adults for the treatment of chemotherapy-associated nausea and vomiting in patients who don’t respond adequately to conventional antiemetics, according to the agent’s prescribing information.
The cannabinoid medication is an isomer of tetrahydrocannabinol (THC), one of the active compounds in marijuana, according to Dr. Lembo.
“If you smoke marijuana, the levels go up high very quickly,” Dr. Lembo said. “If you take dronabinol, it takes 45 minutes to an hour. It’s a slower rise of it, so people are less likely to abuse dronabinol.”
In his talk, Dr. Lembo reported disclosures related to Allergan, Ironwood Pharmaceuticals, Salix Pharmaceuticals, and Takeda Pharmaceuticals.
Global Academy for Medical Education and this news organization are owned by the same company.
REPORTING FROM DIGESTIVE DISEASES: NEW ADVANCES