The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

The introduction of separate payment for the immediate postpartum implantation of long-acting reversible contraception was associated with increased use and a slow-down in the number of short-interval births in patients covered by South Carolina’s Medicaid program.

Immediate postpartum long-acting reversible contraception (IPP-LARC) is recommended to reduce the incidence of short pregnancy intervals – pregnancies within 6-24 months of each other. The global payment for hospital labor and delivery, however, may act as a disincentive to providing IPP-LARC, according to Maria W. Steenland of Brown University, Providence, R.I., and co-authors.

They looked at inpatient Medicaid claims data for 242,825 childbirth hospitalizations in South Carolina from 2010-2017; during that time the state Medicaid program began to provide an additional payment for IPP-LARC.

At the start of the study, just 0.07% of women received an IPP-LARC. After the change in reimbursement policy in March 2012, there was a steady 0.07 percentage point monthly increase in their use in adults and 0.1 percentage point increase per month in adolescents. In December 2017, 5.65% of adults and 10.48% of adolescents received an IPP-LARC (JAMA. 2019; doi: 10.1001/jama.2019.6854).

There was a corresponding, significant change in the trend of short-interval births among adolescents. Before the policy change, adolescent short-interval births had been increasing, but by March 2016 – 4 years after the payment change – the adolescent short-interval birth rate was 5.28 percentage points lower than what was expected had the increasing trend continued.

There was no significant change in the trend for short-interval births among adults.

“These findings suggest that IPP-LARC reimbursement could increase immediate postpartum contraceptive options and help adolescents avoid short-interval births,” the authors wrote, noting that as of February 2018, 36 other states’ Medicaid programs had began separately reimbursing for IPP-LARC.

They also raised the possibility that there may have been confounding due to other events that occurred at the same time as the policy changes.

The study was supported by the Eric M. Mindich Research Fund and one author was supported by National Institutes of Health. No conflicts of interest were declared.

SOURCE: Steenland M et al. JAMA 2019, DOI:10.1001/jama.2019.6854.

The introduction of separate payment for the immediate postpartum implantation of long-acting reversible contraception was associated with increased use and a slow-down in the number of short-interval births in patients covered by South Carolina’s Medicaid program.

Immediate postpartum long-acting reversible contraception (IPP-LARC) is recommended to reduce the incidence of short pregnancy intervals – pregnancies within 6-24 months of each other. The global payment for hospital labor and delivery, however, may act as a disincentive to providing IPP-LARC, according to Maria W. Steenland of Brown University, Providence, R.I., and co-authors.

They looked at inpatient Medicaid claims data for 242,825 childbirth hospitalizations in South Carolina from 2010-2017; during that time the state Medicaid program began to provide an additional payment for IPP-LARC.

At the start of the study, just 0.07% of women received an IPP-LARC. After the change in reimbursement policy in March 2012, there was a steady 0.07 percentage point monthly increase in their use in adults and 0.1 percentage point increase per month in adolescents. In December 2017, 5.65% of adults and 10.48% of adolescents received an IPP-LARC (JAMA. 2019; doi: 10.1001/jama.2019.6854).

There was a corresponding, significant change in the trend of short-interval births among adolescents. Before the policy change, adolescent short-interval births had been increasing, but by March 2016 – 4 years after the payment change – the adolescent short-interval birth rate was 5.28 percentage points lower than what was expected had the increasing trend continued.

There was no significant change in the trend for short-interval births among adults.

“These findings suggest that IPP-LARC reimbursement could increase immediate postpartum contraceptive options and help adolescents avoid short-interval births,” the authors wrote, noting that as of February 2018, 36 other states’ Medicaid programs had began separately reimbursing for IPP-LARC.

They also raised the possibility that there may have been confounding due to other events that occurred at the same time as the policy changes.

The study was supported by the Eric M. Mindich Research Fund and one author was supported by National Institutes of Health. No conflicts of interest were declared.

SOURCE: Steenland M et al. JAMA 2019, DOI:10.1001/jama.2019.6854.

The introduction of separate payment for the immediate postpartum implantation of long-acting reversible contraception was associated with increased use and a slow-down in the number of short-interval births in patients covered by South Carolina’s Medicaid program.

Immediate postpartum long-acting reversible contraception (IPP-LARC) is recommended to reduce the incidence of short pregnancy intervals – pregnancies within 6-24 months of each other. The global payment for hospital labor and delivery, however, may act as a disincentive to providing IPP-LARC, according to Maria W. Steenland of Brown University, Providence, R.I., and co-authors.

They looked at inpatient Medicaid claims data for 242,825 childbirth hospitalizations in South Carolina from 2010-2017; during that time the state Medicaid program began to provide an additional payment for IPP-LARC.

At the start of the study, just 0.07% of women received an IPP-LARC. After the change in reimbursement policy in March 2012, there was a steady 0.07 percentage point monthly increase in their use in adults and 0.1 percentage point increase per month in adolescents. In December 2017, 5.65% of adults and 10.48% of adolescents received an IPP-LARC (JAMA. 2019; doi: 10.1001/jama.2019.6854).

There was a corresponding, significant change in the trend of short-interval births among adolescents. Before the policy change, adolescent short-interval births had been increasing, but by March 2016 – 4 years after the payment change – the adolescent short-interval birth rate was 5.28 percentage points lower than what was expected had the increasing trend continued.

There was no significant change in the trend for short-interval births among adults.

“These findings suggest that IPP-LARC reimbursement could increase immediate postpartum contraceptive options and help adolescents avoid short-interval births,” the authors wrote, noting that as of February 2018, 36 other states’ Medicaid programs had began separately reimbursing for IPP-LARC.

They also raised the possibility that there may have been confounding due to other events that occurred at the same time as the policy changes.

The study was supported by the Eric M. Mindich Research Fund and one author was supported by National Institutes of Health. No conflicts of interest were declared.

SOURCE: Steenland M et al. JAMA 2019, DOI:10.1001/jama.2019.6854.

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

aotto@mdedge.com
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

aotto@mdedge.com
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

aotto@mdedge.com
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.

Frailty increasingly has been seen as a factor in procedural outcomes, including vascular surgery. Nutrition factors among older adults have also become an issue of concern, and older adults undergoing interventions for peripheral arterial disease (PAD) may be at risk for malnutrition. In Friday’s Scientific Session 6, Laura Drudi, MD, of McGill University, Montreal, will report on a study that she and her colleagues performed to determine the association between preprocedural nutritional status and all-cause mortality in patients being treated for PAD.

Dr. Drudi will report on their post hoc analysis of the FRAILED (Frailty Assessment in Lower Extremity arterial Disease) prospective cohort, which comprised two centers recruiting patients during July 1, 2015–Oct.1, 2016. Individuals who underwent vascular interventions for Rutherford class 3 or higher PAD were enrolled.

Trained observers used the Mini Nutritional Assessment (MNA)–Short Form to assess the patients before their procedures. Scores less than or equal to 7 on a 14-point scale were considered malnourished, with scores of 8-11 indicated that patients were at risk for malnutrition.

The modified Essential Frailty Toolset (mEFT) was simultaneously used to measure frailty, with scores of 3 or less on a 5-point scale considered frail. The primary endpoint of the study was all-cause mortality at 12 months after the procedure. Dr. Drudi will report on the results of the cohort of 148 patients (39.2% women) with a mean age of 70 years, and a mean body mass index of 26.7 kg/m². Among these patients, 59 (40%) had claudication and 89 (60%) had chronic limb-threatening ischemia. A total of 98 (66%) patients underwent endovascular revascularization and 50 (34%) underwent open or hybrid revascularization.

Overall, 3% of subjects were classified as malnourished and 33% were at risk for malnutrition. There were 9 (6%) deaths at 12 months. Mini Nutritional Assessment–Short Form scores were modestly but significantly correlated with the mEFT scores (Pearson’s R = –0.48; P less than .001).

”We found that patients with malnourishment or at risk of malnourishment had a 2.5-fold higher crude 1-year mortality, compared with those with normal nutritional status,” said Dr. Drudi.

In the 41% of patients deemed frail, malnutrition was associated with all-cause mortality (adjusted odds ratio, 2.08 per point decrease in MNA scores); whereas in the nonfrail patients, MNA scores had little or no effect on mortality (adjusted OR, 1.05).

“Preprocedural nutritional status is associated with mortality in frail older adults undergoing interventions for PAD. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable individuals,” Dr. Drudi concluded. 

Friday, June 21
1:30-3:00 p.m.
Gaylord National, Potomac A/B
S6: Scientific Session 6: RS16

Frailty increasingly has been seen as a factor in procedural outcomes, including vascular surgery. Nutrition factors among older adults have also become an issue of concern, and older adults undergoing interventions for peripheral arterial disease (PAD) may be at risk for malnutrition. In Friday’s Scientific Session 6, Laura Drudi, MD, of McGill University, Montreal, will report on a study that she and her colleagues performed to determine the association between preprocedural nutritional status and all-cause mortality in patients being treated for PAD.

Dr. Drudi will report on their post hoc analysis of the FRAILED (Frailty Assessment in Lower Extremity arterial Disease) prospective cohort, which comprised two centers recruiting patients during July 1, 2015–Oct.1, 2016. Individuals who underwent vascular interventions for Rutherford class 3 or higher PAD were enrolled.

Trained observers used the Mini Nutritional Assessment (MNA)–Short Form to assess the patients before their procedures. Scores less than or equal to 7 on a 14-point scale were considered malnourished, with scores of 8-11 indicated that patients were at risk for malnutrition.

The modified Essential Frailty Toolset (mEFT) was simultaneously used to measure frailty, with scores of 3 or less on a 5-point scale considered frail. The primary endpoint of the study was all-cause mortality at 12 months after the procedure. Dr. Drudi will report on the results of the cohort of 148 patients (39.2% women) with a mean age of 70 years, and a mean body mass index of 26.7 kg/m². Among these patients, 59 (40%) had claudication and 89 (60%) had chronic limb-threatening ischemia. A total of 98 (66%) patients underwent endovascular revascularization and 50 (34%) underwent open or hybrid revascularization.

Overall, 3% of subjects were classified as malnourished and 33% were at risk for malnutrition. There were 9 (6%) deaths at 12 months. Mini Nutritional Assessment–Short Form scores were modestly but significantly correlated with the mEFT scores (Pearson’s R = –0.48; P less than .001).

”We found that patients with malnourishment or at risk of malnourishment had a 2.5-fold higher crude 1-year mortality, compared with those with normal nutritional status,” said Dr. Drudi.

In the 41% of patients deemed frail, malnutrition was associated with all-cause mortality (adjusted odds ratio, 2.08 per point decrease in MNA scores); whereas in the nonfrail patients, MNA scores had little or no effect on mortality (adjusted OR, 1.05).

“Preprocedural nutritional status is associated with mortality in frail older adults undergoing interventions for PAD. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable individuals,” Dr. Drudi concluded. 

Friday, June 21
1:30-3:00 p.m.
Gaylord National, Potomac A/B
S6: Scientific Session 6: RS16

Frailty increasingly has been seen as a factor in procedural outcomes, including vascular surgery. Nutrition factors among older adults have also become an issue of concern, and older adults undergoing interventions for peripheral arterial disease (PAD) may be at risk for malnutrition. In Friday’s Scientific Session 6, Laura Drudi, MD, of McGill University, Montreal, will report on a study that she and her colleagues performed to determine the association between preprocedural nutritional status and all-cause mortality in patients being treated for PAD.

Dr. Drudi will report on their post hoc analysis of the FRAILED (Frailty Assessment in Lower Extremity arterial Disease) prospective cohort, which comprised two centers recruiting patients during July 1, 2015–Oct.1, 2016. Individuals who underwent vascular interventions for Rutherford class 3 or higher PAD were enrolled.

Trained observers used the Mini Nutritional Assessment (MNA)–Short Form to assess the patients before their procedures. Scores less than or equal to 7 on a 14-point scale were considered malnourished, with scores of 8-11 indicated that patients were at risk for malnutrition.

The modified Essential Frailty Toolset (mEFT) was simultaneously used to measure frailty, with scores of 3 or less on a 5-point scale considered frail. The primary endpoint of the study was all-cause mortality at 12 months after the procedure. Dr. Drudi will report on the results of the cohort of 148 patients (39.2% women) with a mean age of 70 years, and a mean body mass index of 26.7 kg/m². Among these patients, 59 (40%) had claudication and 89 (60%) had chronic limb-threatening ischemia. A total of 98 (66%) patients underwent endovascular revascularization and 50 (34%) underwent open or hybrid revascularization.

Overall, 3% of subjects were classified as malnourished and 33% were at risk for malnutrition. There were 9 (6%) deaths at 12 months. Mini Nutritional Assessment–Short Form scores were modestly but significantly correlated with the mEFT scores (Pearson’s R = –0.48; P less than .001).

”We found that patients with malnourishment or at risk of malnourishment had a 2.5-fold higher crude 1-year mortality, compared with those with normal nutritional status,” said Dr. Drudi.

In the 41% of patients deemed frail, malnutrition was associated with all-cause mortality (adjusted odds ratio, 2.08 per point decrease in MNA scores); whereas in the nonfrail patients, MNA scores had little or no effect on mortality (adjusted OR, 1.05).

“Preprocedural nutritional status is associated with mortality in frail older adults undergoing interventions for PAD. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable individuals,” Dr. Drudi concluded. 

Friday, June 21
1:30-3:00 p.m.
Gaylord National, Potomac A/B
S6: Scientific Session 6: RS16

After months of planning, the day is finally here! Friday evening, 500 people will be living the high life at the  “Vascular Spectacular” gala, celebrating the specialty and each other.

RUSSELLTATEdotCOM/DigitalVision Vectors

But everyone, no matter where they are in the world, may participate in the gala’s Silent Auction, right until it closes this evening.

In fact, bidding on nearly 70 items began in late May. Here’s how to join in the fun:

• Sign up on vam19gala.givesmart.com and peruse the selections.

• Place a bid. All bidders will be identified by name.

• If desired, monitor the bidding, by setting up notifications to learn when someone else ups the ante.

• Continue to bid until the auction closes during the gala itself.

• Wait for your prizes to be mailed to you — and know you have contributed to continuing the important work of the SVS Foundation.

The live auction takes place at the gala in its entirety and only those present can bid.

The Gala Committee is comprised of Drs. Cynthia Shortell and Benjamin Starnes, cochairs; and Enrico Ascher, William Jordan Jr., Melina Kibbe, Richard Lynn, Matthew Mell, Ben Pearce, Amy Reed, Russell Samson, William Shutze, Mal Sheahan, Maureen Sheehan and Anton Sidawy. 

What’s available? Dr. Clem Darling’s “Darling Magical Whiskery Tour” to sample top-tier whiskey in the mutually agreed-upon city; a stay in Lake Tahoe, a beach-front condo in Florida and a spacious townhome at the entrance to Rehoboth Beach, Del.; wildlife photos; fine art; jewelry; fine wine; portraits for people and pets; sports-related items; Maui Jim sunglasses; free admission to attractions from coast to coast and more. There are even one-on-one sessions with a number of vascular surgeons. 

In addition, Cydar Medical is offering a one-year subscription to Cydar EV Fusion Imaging, the world’s first AI-powered image fusion platform, valued at $50,000.  

All proceeds benefit the SVS Foundation.
 

After months of planning, the day is finally here! Friday evening, 500 people will be living the high life at the  “Vascular Spectacular” gala, celebrating the specialty and each other.

RUSSELLTATEdotCOM/DigitalVision Vectors

But everyone, no matter where they are in the world, may participate in the gala’s Silent Auction, right until it closes this evening.

In fact, bidding on nearly 70 items began in late May. Here’s how to join in the fun:

• Sign up on vam19gala.givesmart.com and peruse the selections.

• Place a bid. All bidders will be identified by name.

• If desired, monitor the bidding, by setting up notifications to learn when someone else ups the ante.

• Continue to bid until the auction closes during the gala itself.

• Wait for your prizes to be mailed to you — and know you have contributed to continuing the important work of the SVS Foundation.

The live auction takes place at the gala in its entirety and only those present can bid.

The Gala Committee is comprised of Drs. Cynthia Shortell and Benjamin Starnes, cochairs; and Enrico Ascher, William Jordan Jr., Melina Kibbe, Richard Lynn, Matthew Mell, Ben Pearce, Amy Reed, Russell Samson, William Shutze, Mal Sheahan, Maureen Sheehan and Anton Sidawy. 

What’s available? Dr. Clem Darling’s “Darling Magical Whiskery Tour” to sample top-tier whiskey in the mutually agreed-upon city; a stay in Lake Tahoe, a beach-front condo in Florida and a spacious townhome at the entrance to Rehoboth Beach, Del.; wildlife photos; fine art; jewelry; fine wine; portraits for people and pets; sports-related items; Maui Jim sunglasses; free admission to attractions from coast to coast and more. There are even one-on-one sessions with a number of vascular surgeons. 

In addition, Cydar Medical is offering a one-year subscription to Cydar EV Fusion Imaging, the world’s first AI-powered image fusion platform, valued at $50,000.  

All proceeds benefit the SVS Foundation.
 

After months of planning, the day is finally here! Friday evening, 500 people will be living the high life at the  “Vascular Spectacular” gala, celebrating the specialty and each other.

RUSSELLTATEdotCOM/DigitalVision Vectors

But everyone, no matter where they are in the world, may participate in the gala’s Silent Auction, right until it closes this evening.

In fact, bidding on nearly 70 items began in late May. Here’s how to join in the fun:

• Sign up on vam19gala.givesmart.com and peruse the selections.

• Place a bid. All bidders will be identified by name.

• If desired, monitor the bidding, by setting up notifications to learn when someone else ups the ante.

• Continue to bid until the auction closes during the gala itself.

• Wait for your prizes to be mailed to you — and know you have contributed to continuing the important work of the SVS Foundation.

The live auction takes place at the gala in its entirety and only those present can bid.

The Gala Committee is comprised of Drs. Cynthia Shortell and Benjamin Starnes, cochairs; and Enrico Ascher, William Jordan Jr., Melina Kibbe, Richard Lynn, Matthew Mell, Ben Pearce, Amy Reed, Russell Samson, William Shutze, Mal Sheahan, Maureen Sheehan and Anton Sidawy. 

What’s available? Dr. Clem Darling’s “Darling Magical Whiskery Tour” to sample top-tier whiskey in the mutually agreed-upon city; a stay in Lake Tahoe, a beach-front condo in Florida and a spacious townhome at the entrance to Rehoboth Beach, Del.; wildlife photos; fine art; jewelry; fine wine; portraits for people and pets; sports-related items; Maui Jim sunglasses; free admission to attractions from coast to coast and more. There are even one-on-one sessions with a number of vascular surgeons. 

In addition, Cydar Medical is offering a one-year subscription to Cydar EV Fusion Imaging, the world’s first AI-powered image fusion platform, valued at $50,000.  

All proceeds benefit the SVS Foundation.
 

Starting a vascular surgery integrated program or fellowship can be a daunting process. There exist a number of misconceptions about required case volume, program affiliations, and required number of faculty.

Requirements for creating such programs have recently been lightened. And the SVS and the Association of Program Directors in Vascular Surgery have a number of initiatives in place to help.

SVS will host an informational session for anyone interested in starting a program from 9:30 to 10:30 a.m. Friday, June 14, in National Harbor 4. Most of the session will be interactive, with experienced program directors offering participants useful information and practical advice. 

Starting a vascular surgery integrated program or fellowship can be a daunting process. There exist a number of misconceptions about required case volume, program affiliations, and required number of faculty.

Requirements for creating such programs have recently been lightened. And the SVS and the Association of Program Directors in Vascular Surgery have a number of initiatives in place to help.

SVS will host an informational session for anyone interested in starting a program from 9:30 to 10:30 a.m. Friday, June 14, in National Harbor 4. Most of the session will be interactive, with experienced program directors offering participants useful information and practical advice. 

Starting a vascular surgery integrated program or fellowship can be a daunting process. There exist a number of misconceptions about required case volume, program affiliations, and required number of faculty.

Requirements for creating such programs have recently been lightened. And the SVS and the Association of Program Directors in Vascular Surgery have a number of initiatives in place to help.

SVS will host an informational session for anyone interested in starting a program from 9:30 to 10:30 a.m. Friday, June 14, in National Harbor 4. Most of the session will be interactive, with experienced program directors offering participants useful information and practical advice. 

CHICAGO – Olanzapine plus aprepitant, palonosetron, and dexamethasone (APD) can be considered a new standard antiemetic therapy for patients receiving cisplatin-based chemotherapy, according to a speaker at the annual meeting of the American Society for Clinical Oncology.

A 5 mg dose of olanzapine plus APD produced significantly higher complete response (CR) rates than APD plus placebo in a phase 3 trial, said Hironobu Hashimoto, BPharm, of the National Cancer Center Hospital in Tokyo.

In addition, olanzapine plus APD had a significantly longer time to treatment failure and produced higher rates of complete control and total control. However, rates of somnolence, dizziness, and dry mouth were significantly higher with olanzapine plus APD.

In the phase 3 J-FORCE study, Mr. Hashimoto and his colleagues evaluated olanzapine at 5 mg plus standard antiemetic therapy (APD) for the prevention of chemotherapy-induced nausea and vomiting.

The trial enrolled 710 patients, ages 22-75 years, who had malignant solid tumors and were receiving cisplatin-based chemotherapy for the first time. The patients were randomized to olanzapine plus APD or APD plus placebo.

There were 354 patients evaluable for efficacy in the olanzapine arm and 351 in the placebo arm. The primary endpoint was CR, which was defined as no vomiting and no rescue medications, in the delayed phase (24 hours to 120 hours).

The CR rate in the delayed phase was 79% in the olanzapine arm and 66% in the placebo arm (P less than .001). The CR rate in the acute phase (0 to 24 hours) was 95% and 89%, respectively (P equal to .002), and the overall CR rate was 78% and 64%, respectively (P less than .001).

The time to treatment failure was significantly longer in the olanzapine arm (P less than .001).

The rate of complete control in the overall period (0 to 120 hours) was 76% in the olanzapine arm and 61% in the placebo arm (P less than .001). Complete control was defined as no emesis, no rescue medication, and no nausea or low-grade nausea.

The rate of total control in the overall period was 59% in the olanzapine arm and 48% in the placebo arm (P = .005). Total control was defined as no emesis, no rescue medication, and no nausea.

Treatment-related adverse events (in the olanzapine and placebo arms, respectively) included constipation (15% and 11%), hiccups (10% and 6%), somnolence (43% and 33%), insomnia (5% and 7%), dizziness (8% and 3%), and dry mouth (21% and 9%).

Adverse events that occurred significantly more often with olanzapine were somnolence (P = .011), dizziness (P = .004), and dry mouth (P  less than .001).

This study was sponsored by the Japan Agency for Medical Research and Development (AMED). Mr. Hashimoto said he had nothing to disclose. Other investigators involved in this study disclosed relationships with numerous pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Hashimoto H et al. ASCO 2019. Abstract 11503.

CHICAGO – Olanzapine plus aprepitant, palonosetron, and dexamethasone (APD) can be considered a new standard antiemetic therapy for patients receiving cisplatin-based chemotherapy, according to a speaker at the annual meeting of the American Society for Clinical Oncology.

A 5 mg dose of olanzapine plus APD produced significantly higher complete response (CR) rates than APD plus placebo in a phase 3 trial, said Hironobu Hashimoto, BPharm, of the National Cancer Center Hospital in Tokyo.

In addition, olanzapine plus APD had a significantly longer time to treatment failure and produced higher rates of complete control and total control. However, rates of somnolence, dizziness, and dry mouth were significantly higher with olanzapine plus APD.

In the phase 3 J-FORCE study, Mr. Hashimoto and his colleagues evaluated olanzapine at 5 mg plus standard antiemetic therapy (APD) for the prevention of chemotherapy-induced nausea and vomiting.

The trial enrolled 710 patients, ages 22-75 years, who had malignant solid tumors and were receiving cisplatin-based chemotherapy for the first time. The patients were randomized to olanzapine plus APD or APD plus placebo.

There were 354 patients evaluable for efficacy in the olanzapine arm and 351 in the placebo arm. The primary endpoint was CR, which was defined as no vomiting and no rescue medications, in the delayed phase (24 hours to 120 hours).

The CR rate in the delayed phase was 79% in the olanzapine arm and 66% in the placebo arm (P less than .001). The CR rate in the acute phase (0 to 24 hours) was 95% and 89%, respectively (P equal to .002), and the overall CR rate was 78% and 64%, respectively (P less than .001).

The time to treatment failure was significantly longer in the olanzapine arm (P less than .001).

The rate of complete control in the overall period (0 to 120 hours) was 76% in the olanzapine arm and 61% in the placebo arm (P less than .001). Complete control was defined as no emesis, no rescue medication, and no nausea or low-grade nausea.

The rate of total control in the overall period was 59% in the olanzapine arm and 48% in the placebo arm (P = .005). Total control was defined as no emesis, no rescue medication, and no nausea.

Treatment-related adverse events (in the olanzapine and placebo arms, respectively) included constipation (15% and 11%), hiccups (10% and 6%), somnolence (43% and 33%), insomnia (5% and 7%), dizziness (8% and 3%), and dry mouth (21% and 9%).

Adverse events that occurred significantly more often with olanzapine were somnolence (P = .011), dizziness (P = .004), and dry mouth (P  less than .001).

This study was sponsored by the Japan Agency for Medical Research and Development (AMED). Mr. Hashimoto said he had nothing to disclose. Other investigators involved in this study disclosed relationships with numerous pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Hashimoto H et al. ASCO 2019. Abstract 11503.

CHICAGO – Olanzapine plus aprepitant, palonosetron, and dexamethasone (APD) can be considered a new standard antiemetic therapy for patients receiving cisplatin-based chemotherapy, according to a speaker at the annual meeting of the American Society for Clinical Oncology.

A 5 mg dose of olanzapine plus APD produced significantly higher complete response (CR) rates than APD plus placebo in a phase 3 trial, said Hironobu Hashimoto, BPharm, of the National Cancer Center Hospital in Tokyo.

In addition, olanzapine plus APD had a significantly longer time to treatment failure and produced higher rates of complete control and total control. However, rates of somnolence, dizziness, and dry mouth were significantly higher with olanzapine plus APD.

In the phase 3 J-FORCE study, Mr. Hashimoto and his colleagues evaluated olanzapine at 5 mg plus standard antiemetic therapy (APD) for the prevention of chemotherapy-induced nausea and vomiting.

The trial enrolled 710 patients, ages 22-75 years, who had malignant solid tumors and were receiving cisplatin-based chemotherapy for the first time. The patients were randomized to olanzapine plus APD or APD plus placebo.

There were 354 patients evaluable for efficacy in the olanzapine arm and 351 in the placebo arm. The primary endpoint was CR, which was defined as no vomiting and no rescue medications, in the delayed phase (24 hours to 120 hours).

The CR rate in the delayed phase was 79% in the olanzapine arm and 66% in the placebo arm (P less than .001). The CR rate in the acute phase (0 to 24 hours) was 95% and 89%, respectively (P equal to .002), and the overall CR rate was 78% and 64%, respectively (P less than .001).

The time to treatment failure was significantly longer in the olanzapine arm (P less than .001).

The rate of complete control in the overall period (0 to 120 hours) was 76% in the olanzapine arm and 61% in the placebo arm (P less than .001). Complete control was defined as no emesis, no rescue medication, and no nausea or low-grade nausea.

The rate of total control in the overall period was 59% in the olanzapine arm and 48% in the placebo arm (P = .005). Total control was defined as no emesis, no rescue medication, and no nausea.

Treatment-related adverse events (in the olanzapine and placebo arms, respectively) included constipation (15% and 11%), hiccups (10% and 6%), somnolence (43% and 33%), insomnia (5% and 7%), dizziness (8% and 3%), and dry mouth (21% and 9%).

Adverse events that occurred significantly more often with olanzapine were somnolence (P = .011), dizziness (P = .004), and dry mouth (P  less than .001).

This study was sponsored by the Japan Agency for Medical Research and Development (AMED). Mr. Hashimoto said he had nothing to disclose. Other investigators involved in this study disclosed relationships with numerous pharmaceutical companies.

jensmith@mdedge.com

SOURCE: Hashimoto H et al. ASCO 2019. Abstract 11503.

Got an idea on how to reduce administrative burden to help reduce the cost of delivering health care? The Centers for Medicare & Medicaid Services wants to hear from you.

In a request for information published June 6, the agency seeks parties across the health care spectrum “to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and our health care system’s resources from needless paperwork to high-quality care that improves patient health,” CMS officials said in a statement.

The request for information, part of the agency’s Patients Over Paperwork initiative, seeks suggestions on how to reduce hassles associated with reporting and documentation, coding, prior authorization, rural issues, dual eligible patients, enrollment/eligibility determination and the agency’s own process for issuing regulations and policies.

“Patients over Paperwork has made great inroads in clearing away needlessly complex, outdated, or duplicative requirements that drain clinicians’ time but contribute little to quality of care or patient health,” CMS Administrator Seema Verma said in a statement. “Our goal is to ensure that doctors are spending more time with their patients and less time in administrative tasks.”

The request for information is scheduled to published in the Federal Register on June 11. Comments are due to the agency on Aug. 12. Comments can be made at www.regulations.gov and should refer to file code CMS-6082-NC.
 

gtwachtman@mdedge.com

SOURCE: Federal Register, CMS-6082-NC, https://federalregister.gov/d/2019-12215.

Got an idea on how to reduce administrative burden to help reduce the cost of delivering health care? The Centers for Medicare & Medicaid Services wants to hear from you.

In a request for information published June 6, the agency seeks parties across the health care spectrum “to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and our health care system’s resources from needless paperwork to high-quality care that improves patient health,” CMS officials said in a statement.

The request for information, part of the agency’s Patients Over Paperwork initiative, seeks suggestions on how to reduce hassles associated with reporting and documentation, coding, prior authorization, rural issues, dual eligible patients, enrollment/eligibility determination and the agency’s own process for issuing regulations and policies.

“Patients over Paperwork has made great inroads in clearing away needlessly complex, outdated, or duplicative requirements that drain clinicians’ time but contribute little to quality of care or patient health,” CMS Administrator Seema Verma said in a statement. “Our goal is to ensure that doctors are spending more time with their patients and less time in administrative tasks.”

The request for information is scheduled to published in the Federal Register on June 11. Comments are due to the agency on Aug. 12. Comments can be made at www.regulations.gov and should refer to file code CMS-6082-NC.
 

gtwachtman@mdedge.com

SOURCE: Federal Register, CMS-6082-NC, https://federalregister.gov/d/2019-12215.

Got an idea on how to reduce administrative burden to help reduce the cost of delivering health care? The Centers for Medicare & Medicaid Services wants to hear from you.

In a request for information published June 6, the agency seeks parties across the health care spectrum “to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and our health care system’s resources from needless paperwork to high-quality care that improves patient health,” CMS officials said in a statement.

The request for information, part of the agency’s Patients Over Paperwork initiative, seeks suggestions on how to reduce hassles associated with reporting and documentation, coding, prior authorization, rural issues, dual eligible patients, enrollment/eligibility determination and the agency’s own process for issuing regulations and policies.

“Patients over Paperwork has made great inroads in clearing away needlessly complex, outdated, or duplicative requirements that drain clinicians’ time but contribute little to quality of care or patient health,” CMS Administrator Seema Verma said in a statement. “Our goal is to ensure that doctors are spending more time with their patients and less time in administrative tasks.”

The request for information is scheduled to published in the Federal Register on June 11. Comments are due to the agency on Aug. 12. Comments can be made at www.regulations.gov and should refer to file code CMS-6082-NC.
 

gtwachtman@mdedge.com

SOURCE: Federal Register, CMS-6082-NC, https://federalregister.gov/d/2019-12215.