New guideline provides recommendations for the treatment of mild to moderate UC

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Most patients with ulcerative colitis (UC) have mild to moderate disease characterized by periods of activity or remission, but practice variations exist in disease management. A new clinical guideline from AGA published in Gastroenterology, the official journal of AGA, addresses the medical management of these patients, focusing on use of both oral and topical 5-aminosalicylates (5-ASA) medications, rectal corticosteroids, and oral budesonide, to promote high-quality care.

AGA’s new clinical guideline is meant to help with the management of patients with mild to moderate UC, but not all patients will effectively respond to the outlined therapies. In those cases, there may be a need to escalate treatment to systemic corticosteroids, immunomodulators, and/or biologic therapies for induction and maintenance of remission. However, the use of biologic therapies and/or immunomodulators are not specifically addressed within the guideline.

Mild to moderate UC was defined as patients with fewer than four to six bowel movements per day, mild or moderate rectal bleeding, absence of constitutional symptoms, low overall inflammatory burden, and absence of features suggestive of high inflammatory activity. Although disease activity exists on a spectrum, patients in the mild to moderate category who have more frequent bowel movements, more prominent rectal bleeding, or greater overall inflammatory burden should be considered to have moderate disease.

The guideline recommends the following for the medical management of mild-to-moderate ulcerative colitis:

1. Use either standard-dose mesalamine (2-3 grams/day) or diazo-bonded 5-ASA rather than low-dose mesalamine, sulfasalazine, or no treatment in patients with extensive mild-moderate UC. (Strong recommendation, moderate-quality evidence)

2. In patients with extensive or left-sided mild-moderate UC, add rectal mesalamine to oral 5-ASA. (Conditional recommendation, moderate quality evidence)

3. In patients with mild–moderate UC with suboptimal response to standard-dose mesalamine or diazo-bonded 5-ASA or with moderate disease activity, use high-dose mesalamine (more than 3 grams/day) with rectal mesalamine. (Conditional recommendation, moderate-quality evidence [induction of remission], low-quality evidence [maintenance of remission])

4. In patients with mild–moderate UC being treated with oral mesalamine, use once-daily dosing rather than multiple times per day dosing. (Conditional recommendation, moderate-quality evidence)

5. In patients with mild–moderate UC, use standard-dose oral mesalamine or diazo-bonded 5-ASA, rather than budesonide MMX or controlled ileal-release budesonide for induction of remission. (Conditional recommendation, low quality of evidence)

6. In patients with mild–moderate ulcerative proctosigmoiditis or proctitis, use mesalamine enemas (or suppositories) rather than oral mesalamine. (Conditional recommendation, very-low-quality evidence)

7. In patients with mild–moderate ulcerative proctosigmoiditis who choose rectal therapy over oral therapy, use mesalamine enemas rather than rectal corticosteroids.(Conditional recommendation, moderate-quality evidence)

8. In patients with mild–moderate ulcerative proctitis who choose rectal therapy over oral therapy, use mesalamine suppositories. (Strong recommendation, moderate-quality evidence)

9. In patients with mild–moderate ulcerative proctosigmoiditis or proctitis being treated with rectal therapy who are intolerant of or refractory to mesalamine suppositories, use rectal corticosteroid therapy rather than no therapy for induction of remission. (Conditional recommendation, low-quality evidence)

10. In patients with mild–moderate UC refractory to optimized oral and rectal 5-ASA, regardless of disease extent, add either oral prednisone or budesonide MMX. (Conditional recommendation, low-quality evidence)

11. In patients with mild–moderate UC, AGA makes no recommendation for use of probiotics. (No recommendation, knowledge gap)

12. In patients with mild–moderate UC despite 5-ASA therapy, AGA makes no recommendation for use of curcumin. (No recommendation, knowledge gap)

13. In patients with mild–moderate UC without Clostridium difficile infection, AGA recommends fecal microbiota transplantation be performed only in the context of a clinical trial. (No recommendation for treatment of ulcerative colitis, knowledge gap)
 

The guideline is accompanied by a technical review that is a compilation of the clinical evidence based on which these recommendations were framed.
 

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Most patients with ulcerative colitis (UC) have mild to moderate disease characterized by periods of activity or remission, but practice variations exist in disease management. A new clinical guideline from AGA published in Gastroenterology, the official journal of AGA, addresses the medical management of these patients, focusing on use of both oral and topical 5-aminosalicylates (5-ASA) medications, rectal corticosteroids, and oral budesonide, to promote high-quality care.

AGA’s new clinical guideline is meant to help with the management of patients with mild to moderate UC, but not all patients will effectively respond to the outlined therapies. In those cases, there may be a need to escalate treatment to systemic corticosteroids, immunomodulators, and/or biologic therapies for induction and maintenance of remission. However, the use of biologic therapies and/or immunomodulators are not specifically addressed within the guideline.

Mild to moderate UC was defined as patients with fewer than four to six bowel movements per day, mild or moderate rectal bleeding, absence of constitutional symptoms, low overall inflammatory burden, and absence of features suggestive of high inflammatory activity. Although disease activity exists on a spectrum, patients in the mild to moderate category who have more frequent bowel movements, more prominent rectal bleeding, or greater overall inflammatory burden should be considered to have moderate disease.

The guideline recommends the following for the medical management of mild-to-moderate ulcerative colitis:

1. Use either standard-dose mesalamine (2-3 grams/day) or diazo-bonded 5-ASA rather than low-dose mesalamine, sulfasalazine, or no treatment in patients with extensive mild-moderate UC. (Strong recommendation, moderate-quality evidence)

2. In patients with extensive or left-sided mild-moderate UC, add rectal mesalamine to oral 5-ASA. (Conditional recommendation, moderate quality evidence)

3. In patients with mild–moderate UC with suboptimal response to standard-dose mesalamine or diazo-bonded 5-ASA or with moderate disease activity, use high-dose mesalamine (more than 3 grams/day) with rectal mesalamine. (Conditional recommendation, moderate-quality evidence [induction of remission], low-quality evidence [maintenance of remission])

4. In patients with mild–moderate UC being treated with oral mesalamine, use once-daily dosing rather than multiple times per day dosing. (Conditional recommendation, moderate-quality evidence)

5. In patients with mild–moderate UC, use standard-dose oral mesalamine or diazo-bonded 5-ASA, rather than budesonide MMX or controlled ileal-release budesonide for induction of remission. (Conditional recommendation, low quality of evidence)

6. In patients with mild–moderate ulcerative proctosigmoiditis or proctitis, use mesalamine enemas (or suppositories) rather than oral mesalamine. (Conditional recommendation, very-low-quality evidence)

7. In patients with mild–moderate ulcerative proctosigmoiditis who choose rectal therapy over oral therapy, use mesalamine enemas rather than rectal corticosteroids.(Conditional recommendation, moderate-quality evidence)

8. In patients with mild–moderate ulcerative proctitis who choose rectal therapy over oral therapy, use mesalamine suppositories. (Strong recommendation, moderate-quality evidence)

9. In patients with mild–moderate ulcerative proctosigmoiditis or proctitis being treated with rectal therapy who are intolerant of or refractory to mesalamine suppositories, use rectal corticosteroid therapy rather than no therapy for induction of remission. (Conditional recommendation, low-quality evidence)

10. In patients with mild–moderate UC refractory to optimized oral and rectal 5-ASA, regardless of disease extent, add either oral prednisone or budesonide MMX. (Conditional recommendation, low-quality evidence)

11. In patients with mild–moderate UC, AGA makes no recommendation for use of probiotics. (No recommendation, knowledge gap)

12. In patients with mild–moderate UC despite 5-ASA therapy, AGA makes no recommendation for use of curcumin. (No recommendation, knowledge gap)

13. In patients with mild–moderate UC without Clostridium difficile infection, AGA recommends fecal microbiota transplantation be performed only in the context of a clinical trial. (No recommendation for treatment of ulcerative colitis, knowledge gap)
 

The guideline is accompanied by a technical review that is a compilation of the clinical evidence based on which these recommendations were framed.
 

Most patients with ulcerative colitis (UC) have mild to moderate disease characterized by periods of activity or remission, but practice variations exist in disease management. A new clinical guideline from AGA published in Gastroenterology, the official journal of AGA, addresses the medical management of these patients, focusing on use of both oral and topical 5-aminosalicylates (5-ASA) medications, rectal corticosteroids, and oral budesonide, to promote high-quality care.

AGA’s new clinical guideline is meant to help with the management of patients with mild to moderate UC, but not all patients will effectively respond to the outlined therapies. In those cases, there may be a need to escalate treatment to systemic corticosteroids, immunomodulators, and/or biologic therapies for induction and maintenance of remission. However, the use of biologic therapies and/or immunomodulators are not specifically addressed within the guideline.

Mild to moderate UC was defined as patients with fewer than four to six bowel movements per day, mild or moderate rectal bleeding, absence of constitutional symptoms, low overall inflammatory burden, and absence of features suggestive of high inflammatory activity. Although disease activity exists on a spectrum, patients in the mild to moderate category who have more frequent bowel movements, more prominent rectal bleeding, or greater overall inflammatory burden should be considered to have moderate disease.

The guideline recommends the following for the medical management of mild-to-moderate ulcerative colitis:

1. Use either standard-dose mesalamine (2-3 grams/day) or diazo-bonded 5-ASA rather than low-dose mesalamine, sulfasalazine, or no treatment in patients with extensive mild-moderate UC. (Strong recommendation, moderate-quality evidence)

2. In patients with extensive or left-sided mild-moderate UC, add rectal mesalamine to oral 5-ASA. (Conditional recommendation, moderate quality evidence)

3. In patients with mild–moderate UC with suboptimal response to standard-dose mesalamine or diazo-bonded 5-ASA or with moderate disease activity, use high-dose mesalamine (more than 3 grams/day) with rectal mesalamine. (Conditional recommendation, moderate-quality evidence [induction of remission], low-quality evidence [maintenance of remission])

4. In patients with mild–moderate UC being treated with oral mesalamine, use once-daily dosing rather than multiple times per day dosing. (Conditional recommendation, moderate-quality evidence)

5. In patients with mild–moderate UC, use standard-dose oral mesalamine or diazo-bonded 5-ASA, rather than budesonide MMX or controlled ileal-release budesonide for induction of remission. (Conditional recommendation, low quality of evidence)

6. In patients with mild–moderate ulcerative proctosigmoiditis or proctitis, use mesalamine enemas (or suppositories) rather than oral mesalamine. (Conditional recommendation, very-low-quality evidence)

7. In patients with mild–moderate ulcerative proctosigmoiditis who choose rectal therapy over oral therapy, use mesalamine enemas rather than rectal corticosteroids.(Conditional recommendation, moderate-quality evidence)

8. In patients with mild–moderate ulcerative proctitis who choose rectal therapy over oral therapy, use mesalamine suppositories. (Strong recommendation, moderate-quality evidence)

9. In patients with mild–moderate ulcerative proctosigmoiditis or proctitis being treated with rectal therapy who are intolerant of or refractory to mesalamine suppositories, use rectal corticosteroid therapy rather than no therapy for induction of remission. (Conditional recommendation, low-quality evidence)

10. In patients with mild–moderate UC refractory to optimized oral and rectal 5-ASA, regardless of disease extent, add either oral prednisone or budesonide MMX. (Conditional recommendation, low-quality evidence)

11. In patients with mild–moderate UC, AGA makes no recommendation for use of probiotics. (No recommendation, knowledge gap)

12. In patients with mild–moderate UC despite 5-ASA therapy, AGA makes no recommendation for use of curcumin. (No recommendation, knowledge gap)

13. In patients with mild–moderate UC without Clostridium difficile infection, AGA recommends fecal microbiota transplantation be performed only in the context of a clinical trial. (No recommendation for treatment of ulcerative colitis, knowledge gap)
 

The guideline is accompanied by a technical review that is a compilation of the clinical evidence based on which these recommendations were framed.
 

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Sesame allergy’s surprising threat

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U.S. sesame allergy prevalence tops some tree nut allergies’ rates. Teens are likely to mimic their parents’ opioid use. Smoking cessation could delay or prevent rheumatoid arthritis. And death data spur a boxed warning for the gout drug febuxistat.
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U.S. sesame allergy prevalence tops some tree nut allergies’ rates. Teens are likely to mimic their parents’ opioid use. Smoking cessation could delay or prevent rheumatoid arthritis. And death data spur a boxed warning for the gout drug febuxistat.
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U.S. sesame allergy prevalence tops some tree nut allergies’ rates. Teens are likely to mimic their parents’ opioid use. Smoking cessation could delay or prevent rheumatoid arthritis. And death data spur a boxed warning for the gout drug febuxistat.
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Masterclass: Marlene Freeman on treating bipolar disorder in women

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In this Masterclass episode of the MDedge Psychcast from the 2018 AACP Encore meeting in Las Vegas, Dr. Marlene Freeman discusses the latest studies on the risks of treating – and not treating – women with bipolar disorder during pregnancy. Dr. Freeman, associate professor of psychiatry at Harvard Medical School, also shares preliminary data on the impact of exposure to atypical antipsychotics from the National Pregnancy Registry for Psychiatric Medications at Massachusetts General Hospital, where she also serves as associate director of Women’s Mental Health.
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In this Masterclass episode of the MDedge Psychcast from the 2018 AACP Encore meeting in Las Vegas, Dr. Marlene Freeman discusses the latest studies on the risks of treating – and not treating – women with bipolar disorder during pregnancy. Dr. Freeman, associate professor of psychiatry at Harvard Medical School, also shares preliminary data on the impact of exposure to atypical antipsychotics from the National Pregnancy Registry for Psychiatric Medications at Massachusetts General Hospital, where she also serves as associate director of Women’s Mental Health.
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In this Masterclass episode of the MDedge Psychcast from the 2018 AACP Encore meeting in Las Vegas, Dr. Marlene Freeman discusses the latest studies on the risks of treating – and not treating – women with bipolar disorder during pregnancy. Dr. Freeman, associate professor of psychiatry at Harvard Medical School, also shares preliminary data on the impact of exposure to atypical antipsychotics from the National Pregnancy Registry for Psychiatric Medications at Massachusetts General Hospital, where she also serves as associate director of Women’s Mental Health.
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How Are Schizophrenic Patients Treated After Myocardial Infarction?

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Researchers find that patients with schizophrenia may be lacking needed cardiology treatment.

Patients with schizophrenia may not always get the cardiac treatment they should following a myocardial infarction (MI), according to researchers from Aalborg University Hospital, Denmark.

Studies have already established that patients with schizophrenia have a higher prevalence of cardiovascular disease (CVD) and that there is a strong correlation between MI and schizophrenia, the researchers say. Patients with schizophrenia also undergo fewer cardiac procedures compared with the general population. To try to find out why that might be, the researchers focused on the 4-stage process from initial admission following MI: offer of examination, acceptance of examination, offer of treatment, and acceptance of treatment.

Of 141 patients with a first MI, 47 also had a diagnosis of schizophrenia.

The researchers say their data show a “clear difference” between the 2 groups studied. Patients with schizophrenia were statistically significantly less likely to be offered and accept examination and to be offered and accept treatment than were the psychiatrically healthy controls. However, when the researchers analyzed each stage separately, none of the secondary results were statistically significant. Still they say, as a whole the stages contribute to the primary outcome of less cardiac treatment for these patients.

The researchers did find 2 significant differences between the 2 groups: Patients with schizophrenia were more likely to be smokers and have a lower familial predisposition to CVD. They also were less likely to be in treatment for diabetes, hypercholesterolemia and hypertension at the first MI, although that did not reach statistical significance. The 2 groups also differed in the treatments offered. Patients with schizophrenia were less often offered invasive coronary angiography (CAG) and more often offered exercise-ECG. In contrast, the controls were more likely to be offered CAG.

Without statistical significance, the researchers could not pinpoint whether physician bias, patients’ unwillingness to receive health care, or both were at the root of the discrepancies. They note that the clinical manifestations of schizophrenia “may be seen as a complication for postoperative care” and influence decisions about cardiac procedures. Those decisions may be based on “tacit assumptions rather than on standard guidelines based on medical outcomes,” the researchers  add. Three patients in the study reported that they had previously visited the hospital complaining of typical chest pain but were sent home without examination. The researchers cite another study that found patients with schizophrenia receive care only when their symptoms are “severe enough.”

However, patients with schizophrenia also are known to be more likely to decline treatment, perhaps in part because they do not understand the importance of treatment, the researchers say.

The researchers suggest that the way patients are handled by the treating doctor “needs to be reformed.” It is important, they say, that health care providers are aware of the limits of dealing with a double-diagnosed patient and of the possibility of unintentional bias. A “more personalized approach,” they conclude, might make patients with schizophrenia more willing to cooperate with offers of treatment.

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Researchers find that patients with schizophrenia may be lacking needed cardiology treatment.
Researchers find that patients with schizophrenia may be lacking needed cardiology treatment.

Patients with schizophrenia may not always get the cardiac treatment they should following a myocardial infarction (MI), according to researchers from Aalborg University Hospital, Denmark.

Studies have already established that patients with schizophrenia have a higher prevalence of cardiovascular disease (CVD) and that there is a strong correlation between MI and schizophrenia, the researchers say. Patients with schizophrenia also undergo fewer cardiac procedures compared with the general population. To try to find out why that might be, the researchers focused on the 4-stage process from initial admission following MI: offer of examination, acceptance of examination, offer of treatment, and acceptance of treatment.

Of 141 patients with a first MI, 47 also had a diagnosis of schizophrenia.

The researchers say their data show a “clear difference” between the 2 groups studied. Patients with schizophrenia were statistically significantly less likely to be offered and accept examination and to be offered and accept treatment than were the psychiatrically healthy controls. However, when the researchers analyzed each stage separately, none of the secondary results were statistically significant. Still they say, as a whole the stages contribute to the primary outcome of less cardiac treatment for these patients.

The researchers did find 2 significant differences between the 2 groups: Patients with schizophrenia were more likely to be smokers and have a lower familial predisposition to CVD. They also were less likely to be in treatment for diabetes, hypercholesterolemia and hypertension at the first MI, although that did not reach statistical significance. The 2 groups also differed in the treatments offered. Patients with schizophrenia were less often offered invasive coronary angiography (CAG) and more often offered exercise-ECG. In contrast, the controls were more likely to be offered CAG.

Without statistical significance, the researchers could not pinpoint whether physician bias, patients’ unwillingness to receive health care, or both were at the root of the discrepancies. They note that the clinical manifestations of schizophrenia “may be seen as a complication for postoperative care” and influence decisions about cardiac procedures. Those decisions may be based on “tacit assumptions rather than on standard guidelines based on medical outcomes,” the researchers  add. Three patients in the study reported that they had previously visited the hospital complaining of typical chest pain but were sent home without examination. The researchers cite another study that found patients with schizophrenia receive care only when their symptoms are “severe enough.”

However, patients with schizophrenia also are known to be more likely to decline treatment, perhaps in part because they do not understand the importance of treatment, the researchers say.

The researchers suggest that the way patients are handled by the treating doctor “needs to be reformed.” It is important, they say, that health care providers are aware of the limits of dealing with a double-diagnosed patient and of the possibility of unintentional bias. A “more personalized approach,” they conclude, might make patients with schizophrenia more willing to cooperate with offers of treatment.

Patients with schizophrenia may not always get the cardiac treatment they should following a myocardial infarction (MI), according to researchers from Aalborg University Hospital, Denmark.

Studies have already established that patients with schizophrenia have a higher prevalence of cardiovascular disease (CVD) and that there is a strong correlation between MI and schizophrenia, the researchers say. Patients with schizophrenia also undergo fewer cardiac procedures compared with the general population. To try to find out why that might be, the researchers focused on the 4-stage process from initial admission following MI: offer of examination, acceptance of examination, offer of treatment, and acceptance of treatment.

Of 141 patients with a first MI, 47 also had a diagnosis of schizophrenia.

The researchers say their data show a “clear difference” between the 2 groups studied. Patients with schizophrenia were statistically significantly less likely to be offered and accept examination and to be offered and accept treatment than were the psychiatrically healthy controls. However, when the researchers analyzed each stage separately, none of the secondary results were statistically significant. Still they say, as a whole the stages contribute to the primary outcome of less cardiac treatment for these patients.

The researchers did find 2 significant differences between the 2 groups: Patients with schizophrenia were more likely to be smokers and have a lower familial predisposition to CVD. They also were less likely to be in treatment for diabetes, hypercholesterolemia and hypertension at the first MI, although that did not reach statistical significance. The 2 groups also differed in the treatments offered. Patients with schizophrenia were less often offered invasive coronary angiography (CAG) and more often offered exercise-ECG. In contrast, the controls were more likely to be offered CAG.

Without statistical significance, the researchers could not pinpoint whether physician bias, patients’ unwillingness to receive health care, or both were at the root of the discrepancies. They note that the clinical manifestations of schizophrenia “may be seen as a complication for postoperative care” and influence decisions about cardiac procedures. Those decisions may be based on “tacit assumptions rather than on standard guidelines based on medical outcomes,” the researchers  add. Three patients in the study reported that they had previously visited the hospital complaining of typical chest pain but were sent home without examination. The researchers cite another study that found patients with schizophrenia receive care only when their symptoms are “severe enough.”

However, patients with schizophrenia also are known to be more likely to decline treatment, perhaps in part because they do not understand the importance of treatment, the researchers say.

The researchers suggest that the way patients are handled by the treating doctor “needs to be reformed.” It is important, they say, that health care providers are aware of the limits of dealing with a double-diagnosed patient and of the possibility of unintentional bias. A “more personalized approach,” they conclude, might make patients with schizophrenia more willing to cooperate with offers of treatment.

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GI leaders recognized by AGA’s prestigious recognition awards

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AGA has announced the 2019 recipients of the annual recognition awards, given in honor of outstanding contributions and achievements in gastroenterology.

“AGA members honor their colleagues and peers for outstanding contributions to the field of gastroenterology by nominating them for the AGA Recognition Awards,” said David A. Lieberman, MD, AGAF, president of the AGA Institute. “We are proud to announce the 2019 AGA Recognition Prize winners, who are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representative of AGA.”

The AGA Recognition Awards will be presented during Digestive Disease Week® 2019, May 18-21, 2019, in San Diego.
 

Julius Friedenwald Medal

AGA bequeaths its highest honor, the Julius Friedenwald Medal, to John I. Allen, MD, MBA, AGAF, for his incredible contributions to the field of gastroenterology and AGA over several decades. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.

Dr. Allen is internationally renowned for bringing unique and critical knowledge about health care delivery and health care economics to the field of gastroenterology, as well as for his decades of AGA leadership. His experience is unique within the national gastroenterology community, encompassing private practice, nonacademic health systems, and leadership within two academic medical centers. As AGA Institute President, he led the development of AGA’s 5-year strategic plan and made AGA a national player at the federal, state, and local levels during a time of massive health care delivery transformation. Dr. Allen is a clinical professor of medicine in the division of gastroenterology and hepatology and chief clinical officer of the University of Michigan Medical Group at the University of Michigan School of Medicine, Ann Arbor.
 

Distinguished Achievement Award In Basic Science

AGA honors Harry B. Greenberg, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly advanced the science and practice of gastroenterology. Throughout his career, Dr. Greenberg’s incredible contributions over several decades contributed to the development of rotavirus vaccines and increased physicians’ understanding of viral pathogenesis, particularly rotavirus, norovirus, and hepatitis. Dr. Greenberg is an associate dean for research at Stanford University School of Medicine, Palo Alto, California.

William Beaumont Prize

AGA honors Timothy C. Wang, MD, AGAF, with the William Beaumont Prize in gastroenterology, which recognizes an individual who has made a unique, outstanding contribution of major importance to the field of gastroenterology. Dr. Wang’s extraordinary contribution to the understanding and practice of modern gastroenterology and digestive science are exemplified through his work, which includes defining the mechanisms and cellular origins of Barrett’s esophagus and gastroesophageal cancer. Dr. Wang, who has served AGA in numerous positions, including as president of the AGA Institute, is currently chief of the division of digestive and liver diseases at Columbia University Medical Center and as the Dorothy L. and Daniel H. Silberberg Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, New York, New York.

 

 

Distinguished Educator Award

AGA recognizes and honors Deborah D. Proctor, MD, AGAF, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels, over a lifelong career. Dr. Proctor is a national expert in gastroenterology training and education who has taught and inspired generations of future gastroenterologists, nurses and physician assistants. Currently serving as the AGA Institute Education & Training Councillor, Dr. Proctor is a professor of medicine, and the medical director of the inflammatory bowel disease program, at Yale School of Medicine, New Haven, Connecticut.

Distinguished Clinician Awards

The AGA Distinguished Clinician Award recognizes members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.

AGA presents the Distinguished Clinician Award, Private Practice, to Naresh T. Gunaratnam, MD, AGAF. Dr. Gunaratnam has made a huge impact on patient care in his community and improved gastroenterology-oncology care by starting the endoscopic ultrasound & interventional GI program at St. Joseph Mercy Ann Arbor hospital in Ypsilanti, Michigan. Dr. Gunaratnam is a director of research and obesity management at Huron Gastro.

AGA is honored to present the Distinguished Clinician Award, Clinical Academic Practice, to Edward V. Loftus Jr., MD, AGAF. Dr. Loftus is an outstanding role model in practice, an effective researcher and a recognized leader who is devoted to treating patients with ulcerative colitis and Crohn’s disease with quality clinical care, including understanding the predictors of treatment response. Dr. Loftus is a practicing gastroenterologist at the Mayo Clinic and a professor of medicine at the Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
 

Distinguished Mentor Award

AGA bestows the Distinguished Mentor Award to Fred S. Gorelick, MD, which recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Gorelick has been an inspiration to generations of trainees, many of whom have gone on to successful academic careers as faculty members, section chiefs, program directors, department chairs, and institute directors. Dr. Gorelick is a professor of medicine and cell biology at Yale School of Medicine, and deputy director of the Yale MD-PhD Program, New Haven, Connecticut.

Research Service Award

AGA honors Ann G. Zauber, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterogical science and research. Dr. Zauber’s accomplishments have changed and advanced the practice of gastroenterology. Her work involving colorectal cancer screening and surveillance studies has had far-reaching effects on public policy. She is well-known for her leadership role in the development of colorectal cancer screening guidelines in the U.S., which has significantly reduced mortality and incidence rates. Dr. Zauber is an attending biostatistician in the department of epidemiology & biostatistics at the Memorial Sloan Kettering Cancer Center, New York, New York.

 

 

Young Investigator Awards

The AGA Young Investigator Award recognizes two young investigators, one in basic science and one in clinical science, for outstanding research achievements.

AGA honors Sonia S. Kupfer, MD, with the Young Investigator Award in Clinical Science. Dr. Kupfer is nationally and internationally recognized as an expert in colorectal cancer in high-risk populations including individuals with hereditary cancer syndromes and African Americans. During her clinical and translational research to better understand factors that increase the risk of colorectal cancer, Dr. Kupfer identified distinctions in African-American population compared with Caucasians. Dr. Kupfer is an associate professor of medicine at the University of Chicago, and director of the Gastrointestinal Cancer Risk and Prevention Clinic, Illinois.

AGA honors Costas A. Lyssiotis, PhD, with the Young Investigator Award in Basic Science. His research, work ethic, and innovative approaches have made Dr. Lyssiotis a distinguished leader in pancreatic cancer. His work has broad implications for harnessing the power of the immune system to treat the disease and his laboratory is working to develop new drug therapies that target a pancreatic cancer metabolism-specific enzyme. Dr. Lyssiotis is an assistant professor in the department of molecular and integrative physiology in the division of gastroenterology at University of Michigan Medical School, Ann Arbor.
 

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AGA has announced the 2019 recipients of the annual recognition awards, given in honor of outstanding contributions and achievements in gastroenterology.

“AGA members honor their colleagues and peers for outstanding contributions to the field of gastroenterology by nominating them for the AGA Recognition Awards,” said David A. Lieberman, MD, AGAF, president of the AGA Institute. “We are proud to announce the 2019 AGA Recognition Prize winners, who are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representative of AGA.”

The AGA Recognition Awards will be presented during Digestive Disease Week® 2019, May 18-21, 2019, in San Diego.
 

Julius Friedenwald Medal

AGA bequeaths its highest honor, the Julius Friedenwald Medal, to John I. Allen, MD, MBA, AGAF, for his incredible contributions to the field of gastroenterology and AGA over several decades. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.

Dr. Allen is internationally renowned for bringing unique and critical knowledge about health care delivery and health care economics to the field of gastroenterology, as well as for his decades of AGA leadership. His experience is unique within the national gastroenterology community, encompassing private practice, nonacademic health systems, and leadership within two academic medical centers. As AGA Institute President, he led the development of AGA’s 5-year strategic plan and made AGA a national player at the federal, state, and local levels during a time of massive health care delivery transformation. Dr. Allen is a clinical professor of medicine in the division of gastroenterology and hepatology and chief clinical officer of the University of Michigan Medical Group at the University of Michigan School of Medicine, Ann Arbor.
 

Distinguished Achievement Award In Basic Science

AGA honors Harry B. Greenberg, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly advanced the science and practice of gastroenterology. Throughout his career, Dr. Greenberg’s incredible contributions over several decades contributed to the development of rotavirus vaccines and increased physicians’ understanding of viral pathogenesis, particularly rotavirus, norovirus, and hepatitis. Dr. Greenberg is an associate dean for research at Stanford University School of Medicine, Palo Alto, California.

William Beaumont Prize

AGA honors Timothy C. Wang, MD, AGAF, with the William Beaumont Prize in gastroenterology, which recognizes an individual who has made a unique, outstanding contribution of major importance to the field of gastroenterology. Dr. Wang’s extraordinary contribution to the understanding and practice of modern gastroenterology and digestive science are exemplified through his work, which includes defining the mechanisms and cellular origins of Barrett’s esophagus and gastroesophageal cancer. Dr. Wang, who has served AGA in numerous positions, including as president of the AGA Institute, is currently chief of the division of digestive and liver diseases at Columbia University Medical Center and as the Dorothy L. and Daniel H. Silberberg Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, New York, New York.

 

 

Distinguished Educator Award

AGA recognizes and honors Deborah D. Proctor, MD, AGAF, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels, over a lifelong career. Dr. Proctor is a national expert in gastroenterology training and education who has taught and inspired generations of future gastroenterologists, nurses and physician assistants. Currently serving as the AGA Institute Education & Training Councillor, Dr. Proctor is a professor of medicine, and the medical director of the inflammatory bowel disease program, at Yale School of Medicine, New Haven, Connecticut.

Distinguished Clinician Awards

The AGA Distinguished Clinician Award recognizes members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.

AGA presents the Distinguished Clinician Award, Private Practice, to Naresh T. Gunaratnam, MD, AGAF. Dr. Gunaratnam has made a huge impact on patient care in his community and improved gastroenterology-oncology care by starting the endoscopic ultrasound & interventional GI program at St. Joseph Mercy Ann Arbor hospital in Ypsilanti, Michigan. Dr. Gunaratnam is a director of research and obesity management at Huron Gastro.

AGA is honored to present the Distinguished Clinician Award, Clinical Academic Practice, to Edward V. Loftus Jr., MD, AGAF. Dr. Loftus is an outstanding role model in practice, an effective researcher and a recognized leader who is devoted to treating patients with ulcerative colitis and Crohn’s disease with quality clinical care, including understanding the predictors of treatment response. Dr. Loftus is a practicing gastroenterologist at the Mayo Clinic and a professor of medicine at the Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
 

Distinguished Mentor Award

AGA bestows the Distinguished Mentor Award to Fred S. Gorelick, MD, which recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Gorelick has been an inspiration to generations of trainees, many of whom have gone on to successful academic careers as faculty members, section chiefs, program directors, department chairs, and institute directors. Dr. Gorelick is a professor of medicine and cell biology at Yale School of Medicine, and deputy director of the Yale MD-PhD Program, New Haven, Connecticut.

Research Service Award

AGA honors Ann G. Zauber, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterogical science and research. Dr. Zauber’s accomplishments have changed and advanced the practice of gastroenterology. Her work involving colorectal cancer screening and surveillance studies has had far-reaching effects on public policy. She is well-known for her leadership role in the development of colorectal cancer screening guidelines in the U.S., which has significantly reduced mortality and incidence rates. Dr. Zauber is an attending biostatistician in the department of epidemiology & biostatistics at the Memorial Sloan Kettering Cancer Center, New York, New York.

 

 

Young Investigator Awards

The AGA Young Investigator Award recognizes two young investigators, one in basic science and one in clinical science, for outstanding research achievements.

AGA honors Sonia S. Kupfer, MD, with the Young Investigator Award in Clinical Science. Dr. Kupfer is nationally and internationally recognized as an expert in colorectal cancer in high-risk populations including individuals with hereditary cancer syndromes and African Americans. During her clinical and translational research to better understand factors that increase the risk of colorectal cancer, Dr. Kupfer identified distinctions in African-American population compared with Caucasians. Dr. Kupfer is an associate professor of medicine at the University of Chicago, and director of the Gastrointestinal Cancer Risk and Prevention Clinic, Illinois.

AGA honors Costas A. Lyssiotis, PhD, with the Young Investigator Award in Basic Science. His research, work ethic, and innovative approaches have made Dr. Lyssiotis a distinguished leader in pancreatic cancer. His work has broad implications for harnessing the power of the immune system to treat the disease and his laboratory is working to develop new drug therapies that target a pancreatic cancer metabolism-specific enzyme. Dr. Lyssiotis is an assistant professor in the department of molecular and integrative physiology in the division of gastroenterology at University of Michigan Medical School, Ann Arbor.
 

 

AGA has announced the 2019 recipients of the annual recognition awards, given in honor of outstanding contributions and achievements in gastroenterology.

“AGA members honor their colleagues and peers for outstanding contributions to the field of gastroenterology by nominating them for the AGA Recognition Awards,” said David A. Lieberman, MD, AGAF, president of the AGA Institute. “We are proud to announce the 2019 AGA Recognition Prize winners, who are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representative of AGA.”

The AGA Recognition Awards will be presented during Digestive Disease Week® 2019, May 18-21, 2019, in San Diego.
 

Julius Friedenwald Medal

AGA bequeaths its highest honor, the Julius Friedenwald Medal, to John I. Allen, MD, MBA, AGAF, for his incredible contributions to the field of gastroenterology and AGA over several decades. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.

Dr. Allen is internationally renowned for bringing unique and critical knowledge about health care delivery and health care economics to the field of gastroenterology, as well as for his decades of AGA leadership. His experience is unique within the national gastroenterology community, encompassing private practice, nonacademic health systems, and leadership within two academic medical centers. As AGA Institute President, he led the development of AGA’s 5-year strategic plan and made AGA a national player at the federal, state, and local levels during a time of massive health care delivery transformation. Dr. Allen is a clinical professor of medicine in the division of gastroenterology and hepatology and chief clinical officer of the University of Michigan Medical Group at the University of Michigan School of Medicine, Ann Arbor.
 

Distinguished Achievement Award In Basic Science

AGA honors Harry B. Greenberg, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly advanced the science and practice of gastroenterology. Throughout his career, Dr. Greenberg’s incredible contributions over several decades contributed to the development of rotavirus vaccines and increased physicians’ understanding of viral pathogenesis, particularly rotavirus, norovirus, and hepatitis. Dr. Greenberg is an associate dean for research at Stanford University School of Medicine, Palo Alto, California.

William Beaumont Prize

AGA honors Timothy C. Wang, MD, AGAF, with the William Beaumont Prize in gastroenterology, which recognizes an individual who has made a unique, outstanding contribution of major importance to the field of gastroenterology. Dr. Wang’s extraordinary contribution to the understanding and practice of modern gastroenterology and digestive science are exemplified through his work, which includes defining the mechanisms and cellular origins of Barrett’s esophagus and gastroesophageal cancer. Dr. Wang, who has served AGA in numerous positions, including as president of the AGA Institute, is currently chief of the division of digestive and liver diseases at Columbia University Medical Center and as the Dorothy L. and Daniel H. Silberberg Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, New York, New York.

 

 

Distinguished Educator Award

AGA recognizes and honors Deborah D. Proctor, MD, AGAF, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels, over a lifelong career. Dr. Proctor is a national expert in gastroenterology training and education who has taught and inspired generations of future gastroenterologists, nurses and physician assistants. Currently serving as the AGA Institute Education & Training Councillor, Dr. Proctor is a professor of medicine, and the medical director of the inflammatory bowel disease program, at Yale School of Medicine, New Haven, Connecticut.

Distinguished Clinician Awards

The AGA Distinguished Clinician Award recognizes members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.

AGA presents the Distinguished Clinician Award, Private Practice, to Naresh T. Gunaratnam, MD, AGAF. Dr. Gunaratnam has made a huge impact on patient care in his community and improved gastroenterology-oncology care by starting the endoscopic ultrasound & interventional GI program at St. Joseph Mercy Ann Arbor hospital in Ypsilanti, Michigan. Dr. Gunaratnam is a director of research and obesity management at Huron Gastro.

AGA is honored to present the Distinguished Clinician Award, Clinical Academic Practice, to Edward V. Loftus Jr., MD, AGAF. Dr. Loftus is an outstanding role model in practice, an effective researcher and a recognized leader who is devoted to treating patients with ulcerative colitis and Crohn’s disease with quality clinical care, including understanding the predictors of treatment response. Dr. Loftus is a practicing gastroenterologist at the Mayo Clinic and a professor of medicine at the Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
 

Distinguished Mentor Award

AGA bestows the Distinguished Mentor Award to Fred S. Gorelick, MD, which recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Gorelick has been an inspiration to generations of trainees, many of whom have gone on to successful academic careers as faculty members, section chiefs, program directors, department chairs, and institute directors. Dr. Gorelick is a professor of medicine and cell biology at Yale School of Medicine, and deputy director of the Yale MD-PhD Program, New Haven, Connecticut.

Research Service Award

AGA honors Ann G. Zauber, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterogical science and research. Dr. Zauber’s accomplishments have changed and advanced the practice of gastroenterology. Her work involving colorectal cancer screening and surveillance studies has had far-reaching effects on public policy. She is well-known for her leadership role in the development of colorectal cancer screening guidelines in the U.S., which has significantly reduced mortality and incidence rates. Dr. Zauber is an attending biostatistician in the department of epidemiology & biostatistics at the Memorial Sloan Kettering Cancer Center, New York, New York.

 

 

Young Investigator Awards

The AGA Young Investigator Award recognizes two young investigators, one in basic science and one in clinical science, for outstanding research achievements.

AGA honors Sonia S. Kupfer, MD, with the Young Investigator Award in Clinical Science. Dr. Kupfer is nationally and internationally recognized as an expert in colorectal cancer in high-risk populations including individuals with hereditary cancer syndromes and African Americans. During her clinical and translational research to better understand factors that increase the risk of colorectal cancer, Dr. Kupfer identified distinctions in African-American population compared with Caucasians. Dr. Kupfer is an associate professor of medicine at the University of Chicago, and director of the Gastrointestinal Cancer Risk and Prevention Clinic, Illinois.

AGA honors Costas A. Lyssiotis, PhD, with the Young Investigator Award in Basic Science. His research, work ethic, and innovative approaches have made Dr. Lyssiotis a distinguished leader in pancreatic cancer. His work has broad implications for harnessing the power of the immune system to treat the disease and his laboratory is working to develop new drug therapies that target a pancreatic cancer metabolism-specific enzyme. Dr. Lyssiotis is an assistant professor in the department of molecular and integrative physiology in the division of gastroenterology at University of Michigan Medical School, Ann Arbor.
 

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AGA Legacy Society members bolster research

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The AGA Research Foundation has funded more than $50 million in research funding since its inception in 1984. Gifts from AGA members have helped fuel discoveries in the GI field. The most generous of AGA members are our Legacy Society members.

Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $5,000 or more per year for 5 years ($25,000 total) or $50,000 or more in a planned gift, such as a bequest. Legacy Society member donations directly support young GI investigators as they establish independent research careers.

“The support of the AGA Research Foundation indicates that our peers share in our enthusiasm for research and gives me and my group added confidence to pursue questions about the pathology of IBD. Our overall plan is to translate this work into key components of larger federally funded grants in the near future,” states David L. Boone, PhD, Indiana University School of Medicine, Indianapolis, 2017 AGA Research Foundation Pilot Research Award grant recipient.

Donors, who make gifts at the Legacy Society level before Digestive Disease Week® (DDW), will receive an invitation to the annual Benefactors’ Dinner, which will be held at the San Diego Wine and Culinary Center this year. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at stuneski@gastro.org or via phone (301) 222-4005. More information on the AGA Legacy Society including the current roster and acceptance form is available on the foundation’s web site.

A celebration of research support

Beginning with a memorable gathering at the United States Library of Congress in 2007, the AGA Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The San Diego Wine and Culinary Center will be the location of the 2019 AGA Research Foundation Benefactors’ Dinner during DDW® in San Diego. Located near the convention center, the San Diego Wine and Culinary Center feels worlds away and will allow guests to relax and enjoy time with friends. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.

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The AGA Research Foundation has funded more than $50 million in research funding since its inception in 1984. Gifts from AGA members have helped fuel discoveries in the GI field. The most generous of AGA members are our Legacy Society members.

Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $5,000 or more per year for 5 years ($25,000 total) or $50,000 or more in a planned gift, such as a bequest. Legacy Society member donations directly support young GI investigators as they establish independent research careers.

“The support of the AGA Research Foundation indicates that our peers share in our enthusiasm for research and gives me and my group added confidence to pursue questions about the pathology of IBD. Our overall plan is to translate this work into key components of larger federally funded grants in the near future,” states David L. Boone, PhD, Indiana University School of Medicine, Indianapolis, 2017 AGA Research Foundation Pilot Research Award grant recipient.

Donors, who make gifts at the Legacy Society level before Digestive Disease Week® (DDW), will receive an invitation to the annual Benefactors’ Dinner, which will be held at the San Diego Wine and Culinary Center this year. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at stuneski@gastro.org or via phone (301) 222-4005. More information on the AGA Legacy Society including the current roster and acceptance form is available on the foundation’s web site.

A celebration of research support

Beginning with a memorable gathering at the United States Library of Congress in 2007, the AGA Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The San Diego Wine and Culinary Center will be the location of the 2019 AGA Research Foundation Benefactors’ Dinner during DDW® in San Diego. Located near the convention center, the San Diego Wine and Culinary Center feels worlds away and will allow guests to relax and enjoy time with friends. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.

 

The AGA Research Foundation has funded more than $50 million in research funding since its inception in 1984. Gifts from AGA members have helped fuel discoveries in the GI field. The most generous of AGA members are our Legacy Society members.

Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $5,000 or more per year for 5 years ($25,000 total) or $50,000 or more in a planned gift, such as a bequest. Legacy Society member donations directly support young GI investigators as they establish independent research careers.

“The support of the AGA Research Foundation indicates that our peers share in our enthusiasm for research and gives me and my group added confidence to pursue questions about the pathology of IBD. Our overall plan is to translate this work into key components of larger federally funded grants in the near future,” states David L. Boone, PhD, Indiana University School of Medicine, Indianapolis, 2017 AGA Research Foundation Pilot Research Award grant recipient.

Donors, who make gifts at the Legacy Society level before Digestive Disease Week® (DDW), will receive an invitation to the annual Benefactors’ Dinner, which will be held at the San Diego Wine and Culinary Center this year. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at stuneski@gastro.org or via phone (301) 222-4005. More information on the AGA Legacy Society including the current roster and acceptance form is available on the foundation’s web site.

A celebration of research support

Beginning with a memorable gathering at the United States Library of Congress in 2007, the AGA Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The San Diego Wine and Culinary Center will be the location of the 2019 AGA Research Foundation Benefactors’ Dinner during DDW® in San Diego. Located near the convention center, the San Diego Wine and Culinary Center feels worlds away and will allow guests to relax and enjoy time with friends. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.

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New online resource from the AGA IBD Parenthood Project provides guidance, dispels fears about pregnancy for women with IBD

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AGA launched the IBD Parenthood Project to address misperceptions and fears women with inflammatory bowel disease and their health care providers experience throughout all phases of family planning. This patient-directed initiative, which was created by gastroenterologists, maternal-fetal medicine subspecialists and patients, is led by AGA with support from the Society for Maternal-Fetal Medicine, the Crohn’s & Colitis Foundation, and patient support network, Girls With Guts.

Health care providers are encouraged to visit the program’s new website, www.IBDParenthoodProject.org, which houses medical facts about IBD and pregnancy and share it with their patients. The website provides answers to common questions and provides a downloadable patient toolkit that features visual and patient-friendly information. Resources include easy-to-digest lists of key questions to ask a provider as women are thinking of becoming pregnant, a flow diagram outlining the various HCPs potentially involved in a woman’s care, a guide to postnatal care and provider locator tools. These tools are a direct response to AGA survey findings that reported women with IBD want more and better information about managing their disease (BabyCenter. 2018. IBD and Preconception, Pregnancy, Early Motherhood).

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AGA launched the IBD Parenthood Project to address misperceptions and fears women with inflammatory bowel disease and their health care providers experience throughout all phases of family planning. This patient-directed initiative, which was created by gastroenterologists, maternal-fetal medicine subspecialists and patients, is led by AGA with support from the Society for Maternal-Fetal Medicine, the Crohn’s & Colitis Foundation, and patient support network, Girls With Guts.

Health care providers are encouraged to visit the program’s new website, www.IBDParenthoodProject.org, which houses medical facts about IBD and pregnancy and share it with their patients. The website provides answers to common questions and provides a downloadable patient toolkit that features visual and patient-friendly information. Resources include easy-to-digest lists of key questions to ask a provider as women are thinking of becoming pregnant, a flow diagram outlining the various HCPs potentially involved in a woman’s care, a guide to postnatal care and provider locator tools. These tools are a direct response to AGA survey findings that reported women with IBD want more and better information about managing their disease (BabyCenter. 2018. IBD and Preconception, Pregnancy, Early Motherhood).

AGA launched the IBD Parenthood Project to address misperceptions and fears women with inflammatory bowel disease and their health care providers experience throughout all phases of family planning. This patient-directed initiative, which was created by gastroenterologists, maternal-fetal medicine subspecialists and patients, is led by AGA with support from the Society for Maternal-Fetal Medicine, the Crohn’s & Colitis Foundation, and patient support network, Girls With Guts.

Health care providers are encouraged to visit the program’s new website, www.IBDParenthoodProject.org, which houses medical facts about IBD and pregnancy and share it with their patients. The website provides answers to common questions and provides a downloadable patient toolkit that features visual and patient-friendly information. Resources include easy-to-digest lists of key questions to ask a provider as women are thinking of becoming pregnant, a flow diagram outlining the various HCPs potentially involved in a woman’s care, a guide to postnatal care and provider locator tools. These tools are a direct response to AGA survey findings that reported women with IBD want more and better information about managing their disease (BabyCenter. 2018. IBD and Preconception, Pregnancy, Early Motherhood).

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Selinexor hits FDA stumbling block

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Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

FDA icon

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

 

 


Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.

This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.

Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.

The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.

Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.

However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.

These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.

Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”

Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.

Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.

Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”

Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.

“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”

msullivan@mdege.com

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Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

FDA icon

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

 

 


Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.

This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.

Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.

The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.

Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.

However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.

These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.

Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”

Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.

Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.

Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”

Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.

“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”

msullivan@mdege.com

 



Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

FDA icon

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

 

 


Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.

This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.

Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.

The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.

Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.

However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.

These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.

Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”

Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.

Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.

Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”

Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.

“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”

msullivan@mdege.com

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Paclitaxel drug-coated balloons appear safe for PAD treatment

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Tue, 05/03/2022 - 15:15

 

Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

Dr. Peter A. Schneider is a vascular surgeon at Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu
Dr. Peter A. Schneider

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

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Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

Dr. Peter A. Schneider is a vascular surgeon at Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu
Dr. Peter A. Schneider

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

 

Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

Dr. Peter A. Schneider is a vascular surgeon at Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu
Dr. Peter A. Schneider

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

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FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

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Online vitriol’s expansion into doctor discussion sites

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Changed
Tue, 02/26/2019 - 17:47

 

The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.

Doctor using social media
cyano66/Thinkstock

Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.

I don’t do that anymore.

This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.

Anonymous websites, by their very nature, tend to attract nastiness since the writers can’t be held accountable. As a result, many of them have turned from medical sites to political vitriol.

Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.

Makes it hard to actually kick around thoughts on Ocrevus (or whatever).

Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.

So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.

Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.

Doctor using social media
cyano66/Thinkstock

Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.

I don’t do that anymore.

This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.

Anonymous websites, by their very nature, tend to attract nastiness since the writers can’t be held accountable. As a result, many of them have turned from medical sites to political vitriol.

Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.

Makes it hard to actually kick around thoughts on Ocrevus (or whatever).

Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.

So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.

Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.

Doctor using social media
cyano66/Thinkstock

Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.

I don’t do that anymore.

This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.

Anonymous websites, by their very nature, tend to attract nastiness since the writers can’t be held accountable. As a result, many of them have turned from medical sites to political vitriol.

Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.

Makes it hard to actually kick around thoughts on Ocrevus (or whatever).

Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.

So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.

Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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