Critical illness-related corticosteroid insufficiency (CIRCI) was first introduced in 2008 by a task force convened by the Society of Critical Care Medicine (SCCM) to describe the impairment of the hypothalamic-pituitary-adrenal (HPA) axis during critical illness (Marik PE, et al. Crit Care Med. 2008;36(6):1937).

CIRCI is characterized by dysregulated systemic inflammation resulting from inadequate cellular corticosteroid activity for the severity of the patient’s critical illness. Signs and symptoms of CIRCI include hypotension poorly responsive to fluids, decreased sensitivity to catecholamines, fever, altered mental status, hypoxemia, and laboratory abnormalities such as hyponatremia and hypoglycemia. CIRCI can occur in a variety of acute conditions, such as sepsis and septic shock, acute respiratory distress syndrome (ARDS), severe community-acquired pneumonia, and non-septic systemic inflammatory response syndrome (SIRS) states associated with shock, such as trauma, cardiac arrest, and cardiopulmonary bypass surgery. Three major pathophysiologic events are considered to constitute CIRCI: dysregulation of the HPA axis, altered cortisol metabolism, and tissue resistance to glucocorticoids (Annane D, Pastores SM, et al. Crit Care Med. 2017;45(12):2089; Intensive Care Med. 2017;43(12):1781). Plasma clearance of cortisol is markedly reduced during critical illness, due to suppressed expression and activity of the primary cortisol-metabolizing enzymes in the liver and kidney. Furthermore, despite the elevated cortisol levels during critical illness, tissue resistance to glucocorticoids is believed to occur because of insufficient glucocorticoid receptor alpha-mediated anti-inflammatory activity.

Reviewing the Updated Guidelines

Against this background of recent insights into the understanding of CIRCI and the widespread use of corticosteroids in critically ill patients, an international panel of experts of the SCCM and the European Society of Intensive Care Medicine (ESICM) recently updated the guidelines for the diagnosis and management of CIRCI in a two-part guideline document (Annane D, Pastores SM, et al. Crit Care Med. 2017;45(12):2078; Intensive Care Med. 2017;43(12):1751; Pastores SM, Annane D, et al. Crit Care Med. 2018;46(1):146; Pastores SM, Annane D, et al. Intensive Care Med. 2018;44(4):474). For this update, the multidisciplinary task force used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to formulate actionable recommendations for the diagnosis and treatment of CIRCI. The recommendations and their strength (strong or conditional) required the agreement of at least 80% of the task force members. The task force spent considerable time and spirited discussions on the diagnosis of CIRCI and the use of corticosteroids for clinical disorders that most clinicians associate with CIRCI: sepsis/septic shock, ARDS, and major trauma.

Diagnosis

The task force was unable to reach agreement on a single test that can reliably diagnose CIRCI. However, they acknowledged that a delta cortisol less than 9 µg/dL at 60 minutes after administration of 250 µg of cosyntropin and a random plasma cortisol level of less than 10 µg/dL may be used by clinicians. They also suggested against the use of plasma-free cortisol or salivary cortisol level over plasma total cortisol. Unequivocally, the panel acknowledged the limitations of the current diagnostic tools to identify patients at risk for CIRCI and how this may impact the way corticosteroids are used in clinical practice.

Sepsis and Septic Shock

Despite dozens of observational studies and randomized controlled trials (RCTs) over several decades, the benefit-to-risk ratio of corticosteroids to treat sepsis and septic shock remains controversial with systematic reviews and meta-analyses either confirming (Annane D, et al. Cochrane Database Syst Rev. 2015;12:CD002243) or refuting (Volbeda M, et al. Intensive Care Med. 2015;41:1220) the survival benefit of corticosteroids. Based on the best available data, the task force recommended the use of corticosteroids in adult patients with septic shock that is not responsive to fluids and moderate-to-high vasopressor therapy but not for patients with sepsis who are not in shock. Intravenous hydrocortisone less than 400 mg/day for at least greater than or equal to 3 days at full dose was recommended rather than high dose and short course. The panel emphasized the consistent benefit of corticosteroids on shock reversal and the low risk for superinfection with low dose corticosteroids.

Since the publication of the updated CIRCI guidelines, two large RCTs (more than 5,000 combined patients) of low-dose corticosteroids in patients with septic shock were reported: The Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial (Venkatesh B, et al. N Engl J Med. 2018;378:797) and the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial (Annane D, et al. N Engl J Med. 2018;378:809). The ADRENAL trial included 3,800 patients in five countries and did not show a significant difference in 90-day mortality between the hydrocortisone group and the placebo group (27.9% vs 28.8%, respectively, P=.50). In contrast, the APROCCHSS trial, involving 1,241 patients in France, reported a lower 90-day mortality in the hydrocortisone-fludrocortisone group compared with the placebo group (43% vs 49.1%, P=.03). Both trials showed a beneficial effect of hydrocortisone in the number of vasopressor-free and mechanical ventilation-free days. Blood transfusions were less common in the in the hydrocortisone group than among those who received placebo in the ADRENAL trial. Besides hyperglycemia, which was more common in the hydrocortisone group in both trials, the overall rates of adverse events were relatively low.

It is important to highlight the key differences in study design between these two RCTs. First, in the APROCCHSS trial, oral fludrocortisone (50-μg once daily for 7 days) was added to hydrocortisone to provide additional mineralocorticoid potency, although a previous study had shown no added benefit (Annane D, et al. JAMA. 2010;303:341). Second, hydrocortisone was administered as a 50-mg IV bolus every 6 hours in APROCCHSS and given as a continuous infusion of 200 mg/day for 7 days or until death or ICU discharge in ADRENAL. It is noteworthy that the subjects in the ADRENAL trial had a higher rate of surgical admissions (31.5% vs 18.3%), a lower rate of renal-replacement therapy (12.7% vs 27.6%), lower rates of lung infection (35.2% vs 59.4%) and urinary tract infection (7.5% vs 17.7%), and a higher rate of abdominal infection (25.5% vs 11.5%). Patients in the APROCCHSS trial had high Sequential Organ Failure Assessment (SOFA) scores and Simplified Acute Physiology Score (SAPS) II values suggesting a sicker population and probably accounting for the higher mortality rates in both hydrocortisone and placebo groups compared with ADRENAL. In view of the current evidence, the author believes that survival benefit with corticosteroids in septic shock is dependent on several factors: dose (hydrocortisone greater than 400 mg/day), longer duration (at least 3 or more days), and severity of sepsis. “The more severe the sepsis, the more septic shock the patient is in, the more likely it is for corticosteroids to help these patients get off vasopressors and mechanical ventilation. I consider the addition of fludrocortisone as optional.”

ARDS

In patients with early moderate-to-severe ARDS (PaO2/FIO2 of less than 200 and within 14 days of onset), the task force recommended the use of IV methylprednisolone in a dose of 1 mg/kg/day followed by slow tapering over 2 weeks to prevent the development of a rebound inflammatory response, and adherence to infection surveillance. In patients with major trauma and influenza, the panel suggested against the use of corticosteroids. Corticosteroids were recommended for patients with severe community-acquired pneumonia (less than 400 mg/day of IV hydrocortisone or equivalent for 5 to 7 days), meningitis, adults undergoing cardiopulmonary bypass surgery, and adults who suffer a cardiac arrest. The task force highlighted that the quality of evidence for the use of corticosteroids in these disease states was often low and that additional well-designed RCTs with carefully selected patients were warranted.

To conclude, as with any clinical practice guideline, the task force reiterated that the updated CIRCI guidelines were not intended to define a standard of care and should not be interpreted as prescribing an exclusive course of management. Good clinical judgment should always prevail!

Dr. Pastores is Program Director, Critical Care Medicine, Vice-Chair of Education, Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center; Professor of Medicine and Anesthesiology, Weill Cornell Medical College, New York, NY.

Critical illness-related corticosteroid insufficiency (CIRCI) was first introduced in 2008 by a task force convened by the Society of Critical Care Medicine (SCCM) to describe the impairment of the hypothalamic-pituitary-adrenal (HPA) axis during critical illness (Marik PE, et al. Crit Care Med. 2008;36(6):1937).

CIRCI is characterized by dysregulated systemic inflammation resulting from inadequate cellular corticosteroid activity for the severity of the patient’s critical illness. Signs and symptoms of CIRCI include hypotension poorly responsive to fluids, decreased sensitivity to catecholamines, fever, altered mental status, hypoxemia, and laboratory abnormalities such as hyponatremia and hypoglycemia. CIRCI can occur in a variety of acute conditions, such as sepsis and septic shock, acute respiratory distress syndrome (ARDS), severe community-acquired pneumonia, and non-septic systemic inflammatory response syndrome (SIRS) states associated with shock, such as trauma, cardiac arrest, and cardiopulmonary bypass surgery. Three major pathophysiologic events are considered to constitute CIRCI: dysregulation of the HPA axis, altered cortisol metabolism, and tissue resistance to glucocorticoids (Annane D, Pastores SM, et al. Crit Care Med. 2017;45(12):2089; Intensive Care Med. 2017;43(12):1781). Plasma clearance of cortisol is markedly reduced during critical illness, due to suppressed expression and activity of the primary cortisol-metabolizing enzymes in the liver and kidney. Furthermore, despite the elevated cortisol levels during critical illness, tissue resistance to glucocorticoids is believed to occur because of insufficient glucocorticoid receptor alpha-mediated anti-inflammatory activity.

Reviewing the Updated Guidelines

Against this background of recent insights into the understanding of CIRCI and the widespread use of corticosteroids in critically ill patients, an international panel of experts of the SCCM and the European Society of Intensive Care Medicine (ESICM) recently updated the guidelines for the diagnosis and management of CIRCI in a two-part guideline document (Annane D, Pastores SM, et al. Crit Care Med. 2017;45(12):2078; Intensive Care Med. 2017;43(12):1751; Pastores SM, Annane D, et al. Crit Care Med. 2018;46(1):146; Pastores SM, Annane D, et al. Intensive Care Med. 2018;44(4):474). For this update, the multidisciplinary task force used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to formulate actionable recommendations for the diagnosis and treatment of CIRCI. The recommendations and their strength (strong or conditional) required the agreement of at least 80% of the task force members. The task force spent considerable time and spirited discussions on the diagnosis of CIRCI and the use of corticosteroids for clinical disorders that most clinicians associate with CIRCI: sepsis/septic shock, ARDS, and major trauma.

Diagnosis

The task force was unable to reach agreement on a single test that can reliably diagnose CIRCI. However, they acknowledged that a delta cortisol less than 9 µg/dL at 60 minutes after administration of 250 µg of cosyntropin and a random plasma cortisol level of less than 10 µg/dL may be used by clinicians. They also suggested against the use of plasma-free cortisol or salivary cortisol level over plasma total cortisol. Unequivocally, the panel acknowledged the limitations of the current diagnostic tools to identify patients at risk for CIRCI and how this may impact the way corticosteroids are used in clinical practice.

Sepsis and Septic Shock

Despite dozens of observational studies and randomized controlled trials (RCTs) over several decades, the benefit-to-risk ratio of corticosteroids to treat sepsis and septic shock remains controversial with systematic reviews and meta-analyses either confirming (Annane D, et al. Cochrane Database Syst Rev. 2015;12:CD002243) or refuting (Volbeda M, et al. Intensive Care Med. 2015;41:1220) the survival benefit of corticosteroids. Based on the best available data, the task force recommended the use of corticosteroids in adult patients with septic shock that is not responsive to fluids and moderate-to-high vasopressor therapy but not for patients with sepsis who are not in shock. Intravenous hydrocortisone less than 400 mg/day for at least greater than or equal to 3 days at full dose was recommended rather than high dose and short course. The panel emphasized the consistent benefit of corticosteroids on shock reversal and the low risk for superinfection with low dose corticosteroids.

Since the publication of the updated CIRCI guidelines, two large RCTs (more than 5,000 combined patients) of low-dose corticosteroids in patients with septic shock were reported: The Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial (Venkatesh B, et al. N Engl J Med. 2018;378:797) and the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial (Annane D, et al. N Engl J Med. 2018;378:809). The ADRENAL trial included 3,800 patients in five countries and did not show a significant difference in 90-day mortality between the hydrocortisone group and the placebo group (27.9% vs 28.8%, respectively, P=.50). In contrast, the APROCCHSS trial, involving 1,241 patients in France, reported a lower 90-day mortality in the hydrocortisone-fludrocortisone group compared with the placebo group (43% vs 49.1%, P=.03). Both trials showed a beneficial effect of hydrocortisone in the number of vasopressor-free and mechanical ventilation-free days. Blood transfusions were less common in the in the hydrocortisone group than among those who received placebo in the ADRENAL trial. Besides hyperglycemia, which was more common in the hydrocortisone group in both trials, the overall rates of adverse events were relatively low.

It is important to highlight the key differences in study design between these two RCTs. First, in the APROCCHSS trial, oral fludrocortisone (50-μg once daily for 7 days) was added to hydrocortisone to provide additional mineralocorticoid potency, although a previous study had shown no added benefit (Annane D, et al. JAMA. 2010;303:341). Second, hydrocortisone was administered as a 50-mg IV bolus every 6 hours in APROCCHSS and given as a continuous infusion of 200 mg/day for 7 days or until death or ICU discharge in ADRENAL. It is noteworthy that the subjects in the ADRENAL trial had a higher rate of surgical admissions (31.5% vs 18.3%), a lower rate of renal-replacement therapy (12.7% vs 27.6%), lower rates of lung infection (35.2% vs 59.4%) and urinary tract infection (7.5% vs 17.7%), and a higher rate of abdominal infection (25.5% vs 11.5%). Patients in the APROCCHSS trial had high Sequential Organ Failure Assessment (SOFA) scores and Simplified Acute Physiology Score (SAPS) II values suggesting a sicker population and probably accounting for the higher mortality rates in both hydrocortisone and placebo groups compared with ADRENAL. In view of the current evidence, the author believes that survival benefit with corticosteroids in septic shock is dependent on several factors: dose (hydrocortisone greater than 400 mg/day), longer duration (at least 3 or more days), and severity of sepsis. “The more severe the sepsis, the more septic shock the patient is in, the more likely it is for corticosteroids to help these patients get off vasopressors and mechanical ventilation. I consider the addition of fludrocortisone as optional.”

ARDS

In patients with early moderate-to-severe ARDS (PaO2/FIO2 of less than 200 and within 14 days of onset), the task force recommended the use of IV methylprednisolone in a dose of 1 mg/kg/day followed by slow tapering over 2 weeks to prevent the development of a rebound inflammatory response, and adherence to infection surveillance. In patients with major trauma and influenza, the panel suggested against the use of corticosteroids. Corticosteroids were recommended for patients with severe community-acquired pneumonia (less than 400 mg/day of IV hydrocortisone or equivalent for 5 to 7 days), meningitis, adults undergoing cardiopulmonary bypass surgery, and adults who suffer a cardiac arrest. The task force highlighted that the quality of evidence for the use of corticosteroids in these disease states was often low and that additional well-designed RCTs with carefully selected patients were warranted.

To conclude, as with any clinical practice guideline, the task force reiterated that the updated CIRCI guidelines were not intended to define a standard of care and should not be interpreted as prescribing an exclusive course of management. Good clinical judgment should always prevail!

Dr. Pastores is Program Director, Critical Care Medicine, Vice-Chair of Education, Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center; Professor of Medicine and Anesthesiology, Weill Cornell Medical College, New York, NY.

Critical illness-related corticosteroid insufficiency (CIRCI) was first introduced in 2008 by a task force convened by the Society of Critical Care Medicine (SCCM) to describe the impairment of the hypothalamic-pituitary-adrenal (HPA) axis during critical illness (Marik PE, et al. Crit Care Med. 2008;36(6):1937).

CIRCI is characterized by dysregulated systemic inflammation resulting from inadequate cellular corticosteroid activity for the severity of the patient’s critical illness. Signs and symptoms of CIRCI include hypotension poorly responsive to fluids, decreased sensitivity to catecholamines, fever, altered mental status, hypoxemia, and laboratory abnormalities such as hyponatremia and hypoglycemia. CIRCI can occur in a variety of acute conditions, such as sepsis and septic shock, acute respiratory distress syndrome (ARDS), severe community-acquired pneumonia, and non-septic systemic inflammatory response syndrome (SIRS) states associated with shock, such as trauma, cardiac arrest, and cardiopulmonary bypass surgery. Three major pathophysiologic events are considered to constitute CIRCI: dysregulation of the HPA axis, altered cortisol metabolism, and tissue resistance to glucocorticoids (Annane D, Pastores SM, et al. Crit Care Med. 2017;45(12):2089; Intensive Care Med. 2017;43(12):1781). Plasma clearance of cortisol is markedly reduced during critical illness, due to suppressed expression and activity of the primary cortisol-metabolizing enzymes in the liver and kidney. Furthermore, despite the elevated cortisol levels during critical illness, tissue resistance to glucocorticoids is believed to occur because of insufficient glucocorticoid receptor alpha-mediated anti-inflammatory activity.

Reviewing the Updated Guidelines

Against this background of recent insights into the understanding of CIRCI and the widespread use of corticosteroids in critically ill patients, an international panel of experts of the SCCM and the European Society of Intensive Care Medicine (ESICM) recently updated the guidelines for the diagnosis and management of CIRCI in a two-part guideline document (Annane D, Pastores SM, et al. Crit Care Med. 2017;45(12):2078; Intensive Care Med. 2017;43(12):1751; Pastores SM, Annane D, et al. Crit Care Med. 2018;46(1):146; Pastores SM, Annane D, et al. Intensive Care Med. 2018;44(4):474). For this update, the multidisciplinary task force used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to formulate actionable recommendations for the diagnosis and treatment of CIRCI. The recommendations and their strength (strong or conditional) required the agreement of at least 80% of the task force members. The task force spent considerable time and spirited discussions on the diagnosis of CIRCI and the use of corticosteroids for clinical disorders that most clinicians associate with CIRCI: sepsis/septic shock, ARDS, and major trauma.

Diagnosis

The task force was unable to reach agreement on a single test that can reliably diagnose CIRCI. However, they acknowledged that a delta cortisol less than 9 µg/dL at 60 minutes after administration of 250 µg of cosyntropin and a random plasma cortisol level of less than 10 µg/dL may be used by clinicians. They also suggested against the use of plasma-free cortisol or salivary cortisol level over plasma total cortisol. Unequivocally, the panel acknowledged the limitations of the current diagnostic tools to identify patients at risk for CIRCI and how this may impact the way corticosteroids are used in clinical practice.

Sepsis and Septic Shock

Despite dozens of observational studies and randomized controlled trials (RCTs) over several decades, the benefit-to-risk ratio of corticosteroids to treat sepsis and septic shock remains controversial with systematic reviews and meta-analyses either confirming (Annane D, et al. Cochrane Database Syst Rev. 2015;12:CD002243) or refuting (Volbeda M, et al. Intensive Care Med. 2015;41:1220) the survival benefit of corticosteroids. Based on the best available data, the task force recommended the use of corticosteroids in adult patients with septic shock that is not responsive to fluids and moderate-to-high vasopressor therapy but not for patients with sepsis who are not in shock. Intravenous hydrocortisone less than 400 mg/day for at least greater than or equal to 3 days at full dose was recommended rather than high dose and short course. The panel emphasized the consistent benefit of corticosteroids on shock reversal and the low risk for superinfection with low dose corticosteroids.

Since the publication of the updated CIRCI guidelines, two large RCTs (more than 5,000 combined patients) of low-dose corticosteroids in patients with septic shock were reported: The Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial (Venkatesh B, et al. N Engl J Med. 2018;378:797) and the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial (Annane D, et al. N Engl J Med. 2018;378:809). The ADRENAL trial included 3,800 patients in five countries and did not show a significant difference in 90-day mortality between the hydrocortisone group and the placebo group (27.9% vs 28.8%, respectively, P=.50). In contrast, the APROCCHSS trial, involving 1,241 patients in France, reported a lower 90-day mortality in the hydrocortisone-fludrocortisone group compared with the placebo group (43% vs 49.1%, P=.03). Both trials showed a beneficial effect of hydrocortisone in the number of vasopressor-free and mechanical ventilation-free days. Blood transfusions were less common in the in the hydrocortisone group than among those who received placebo in the ADRENAL trial. Besides hyperglycemia, which was more common in the hydrocortisone group in both trials, the overall rates of adverse events were relatively low.

It is important to highlight the key differences in study design between these two RCTs. First, in the APROCCHSS trial, oral fludrocortisone (50-μg once daily for 7 days) was added to hydrocortisone to provide additional mineralocorticoid potency, although a previous study had shown no added benefit (Annane D, et al. JAMA. 2010;303:341). Second, hydrocortisone was administered as a 50-mg IV bolus every 6 hours in APROCCHSS and given as a continuous infusion of 200 mg/day for 7 days or until death or ICU discharge in ADRENAL. It is noteworthy that the subjects in the ADRENAL trial had a higher rate of surgical admissions (31.5% vs 18.3%), a lower rate of renal-replacement therapy (12.7% vs 27.6%), lower rates of lung infection (35.2% vs 59.4%) and urinary tract infection (7.5% vs 17.7%), and a higher rate of abdominal infection (25.5% vs 11.5%). Patients in the APROCCHSS trial had high Sequential Organ Failure Assessment (SOFA) scores and Simplified Acute Physiology Score (SAPS) II values suggesting a sicker population and probably accounting for the higher mortality rates in both hydrocortisone and placebo groups compared with ADRENAL. In view of the current evidence, the author believes that survival benefit with corticosteroids in septic shock is dependent on several factors: dose (hydrocortisone greater than 400 mg/day), longer duration (at least 3 or more days), and severity of sepsis. “The more severe the sepsis, the more septic shock the patient is in, the more likely it is for corticosteroids to help these patients get off vasopressors and mechanical ventilation. I consider the addition of fludrocortisone as optional.”

ARDS

In patients with early moderate-to-severe ARDS (PaO2/FIO2 of less than 200 and within 14 days of onset), the task force recommended the use of IV methylprednisolone in a dose of 1 mg/kg/day followed by slow tapering over 2 weeks to prevent the development of a rebound inflammatory response, and adherence to infection surveillance. In patients with major trauma and influenza, the panel suggested against the use of corticosteroids. Corticosteroids were recommended for patients with severe community-acquired pneumonia (less than 400 mg/day of IV hydrocortisone or equivalent for 5 to 7 days), meningitis, adults undergoing cardiopulmonary bypass surgery, and adults who suffer a cardiac arrest. The task force highlighted that the quality of evidence for the use of corticosteroids in these disease states was often low and that additional well-designed RCTs with carefully selected patients were warranted.

To conclude, as with any clinical practice guideline, the task force reiterated that the updated CIRCI guidelines were not intended to define a standard of care and should not be interpreted as prescribing an exclusive course of management. Good clinical judgment should always prevail!

Dr. Pastores is Program Director, Critical Care Medicine, Vice-Chair of Education, Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center; Professor of Medicine and Anesthesiology, Weill Cornell Medical College, New York, NY.

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WASHINGTON – Hospital staffs often fail to treat malnourished, recently admitted patients with supplemental nutrition.

A retrospective review of more than 150,000 patients admitted during a single year at any center within a large, multicenter U.S. hospital system found that even when patients receive oral nutritional supplementation, there is often a substantial delay to its onset.

The data also suggested potential benefits from treating malnutrition with oral nutritional supplementation (ONS). Patients who received ONS had a 10% relative reduction in their rate of 30-day readmission, compared with malnourished patients who did not receive supplements after adjusting for several baseline demographic and clinical variables, Gerard Mullin, MD, said at the annual Digestive Disease Week. His analysis also showed that every doubling of the time from hospital admission to an order for ONS significantly linked with a 6% rise in hospital length of stay.

Mitchel L. Zoler/MDedge News

The study was sponsored by Abbott, which markets the oral nutritional supplement Ensure. Dr. Mullin had no additional disclosures.

[email protected]

On Twitter @mitchelzoler

SOURCE: Source: Mullin G et al. DDW 2018 presentation 883.

WASHINGTON – Hospital staffs often fail to treat malnourished, recently admitted patients with supplemental nutrition.

A retrospective review of more than 150,000 patients admitted during a single year at any center within a large, multicenter U.S. hospital system found that even when patients receive oral nutritional supplementation, there is often a substantial delay to its onset.

The data also suggested potential benefits from treating malnutrition with oral nutritional supplementation (ONS). Patients who received ONS had a 10% relative reduction in their rate of 30-day readmission, compared with malnourished patients who did not receive supplements after adjusting for several baseline demographic and clinical variables, Gerard Mullin, MD, said at the annual Digestive Disease Week. His analysis also showed that every doubling of the time from hospital admission to an order for ONS significantly linked with a 6% rise in hospital length of stay.

Mitchel L. Zoler/MDedge News

The study was sponsored by Abbott, which markets the oral nutritional supplement Ensure. Dr. Mullin had no additional disclosures.

[email protected]

On Twitter @mitchelzoler

SOURCE: Source: Mullin G et al. DDW 2018 presentation 883.

WASHINGTON – Hospital staffs often fail to treat malnourished, recently admitted patients with supplemental nutrition.

A retrospective review of more than 150,000 patients admitted during a single year at any center within a large, multicenter U.S. hospital system found that even when patients receive oral nutritional supplementation, there is often a substantial delay to its onset.

The data also suggested potential benefits from treating malnutrition with oral nutritional supplementation (ONS). Patients who received ONS had a 10% relative reduction in their rate of 30-day readmission, compared with malnourished patients who did not receive supplements after adjusting for several baseline demographic and clinical variables, Gerard Mullin, MD, said at the annual Digestive Disease Week. His analysis also showed that every doubling of the time from hospital admission to an order for ONS significantly linked with a 6% rise in hospital length of stay.

Mitchel L. Zoler/MDedge News

The study was sponsored by Abbott, which markets the oral nutritional supplement Ensure. Dr. Mullin had no additional disclosures.

[email protected]

On Twitter @mitchelzoler

SOURCE: Source: Mullin G et al. DDW 2018 presentation 883.

Photo courtesy of Abbvie

The US Food and Drug Administration (FDA) has approved venetoclax tablets (Venclexta ®) in combination with rituximab to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received 1 prior therapy.

The combination is approved for patients with or without deletion of 17p (del 17p).

The FDA based its approval on the phase 3 MURANO trial, in which venetoclax in combination with rituximab (VEN+R) significantly improved progression-free survival (PFS) in relapsed or refractory CLL patients compared to the chemoimmunotherapy regimen of bendamustine plus rituximab(B+R).

This approval, according to the drug’s developers, makes venetoclax plus rituximab the first oral-based, chemotherapy-free combination with a fixed treatment duration for CLL.

The FDA has also converted venetoclax's accelerated approval to a full approval. The drug was previously granted accelerated approval as a single agent for the treatment of people with CLL with 17p deletion.

Venetoclax is being developed by AbbVie and Roche and jointly commercialized by AbbVie and Genentech in the US and by AbbVie outside the US.

Phase 3 MURANO trial (NCT02005471)

The multicenter, open-label trial randomized 389 patients to VEN+R (194 patients) or B+R (195 patients). Median age of the patients was 65 years (range, 22 – 85).

Patients in the VEN+R arm completed a 5-week ramp-up of venetoclax followed by venetoclax 400 mg once daily for 24 months measured from the rituximab start date.

Tumor lysis syndrome (TLS), caused by a rapid reduction in tumor volume, is an identified risk with venetoclax treatment. The dose ramp-up was intended to mitigate this risk.

Rituximab was initiated after venetoclax ramp-up and given for 6 cycles (375 mg/m² intravenously on cycle 1 day 1 and 500 mg/m² intravenously on day 1 of cycles 2-6, with a 28-day cycle length).

Patients in the B+R arm received 6 cycles of B+R (bendamustine 70 mg/m² on days 1 and 2 of each 28-day cycle and rituximab at the above described dose and schedule).

Efficacy was based on PFS as assessed by an independent review committee.

After a median follow-up of 23 months, the median PFS was not reached in the VEN+R arm and was 18.1 months in the B+R arm (P<0.0001).

The overall response rate was 92% for patients treated with VEN+R compared to 72% for those treated with B+R.

Safety

The most common adverse events (AEs) in the VEN+R arms that occurred in 20% or more patients were neutropenia (65%), diarrhea (40%), upper respiratory tract infection (39%), fatigue (22%), cough (22%), and nausea (21%).

Grade 3 or 4 neutropenia developed in 64% of patients, and grade 4 neutropenia in 31%.

Serious adverse events (SAEs) developed in 46% of patients and serious infections in 21%, consisting most frequently of pneumonia (9%).

The incidence of TLS was 3%, occurring in 6 of  194 patients.

In the VEN+R arm, discontinuations due to any AEs occurred in 16% of patients, dose reductions in 15%, and dose interruptions in 71%.

Neutropenia led to dose interruptions in 46% of patients and discontinuations in 3%. Thrombocytopenia led to discontinuations in 3% of patients.

Fatal AEs that occurred in the absence of disease progression and within 30 days of the last VEN+R treatment and/or 90 days of the last rituximab infusion were reported in 2% (4/194) of patients.

In the B+R arm, AEs led to treatment discontinuations in 10% of patients, dose reductions in 15%, and dose interruptions in 40 %.

Investigators previously reported data from the phase 3 MURANO study as a late-breaking abstract at the 2017 ASH Annual Meeting and published the findings in NEJM.

John Seymour, MBBS, PhD, lead investigator of the MURANO study, said in the corporate release, the approval "validates the results seen in the phase 3 trial, including the significant improvement in progression-free survival over a standard of care comparator arm."

"Progression-free survival is considered a gold standard for demonstrating clinical benefit in oncology," he added.

Full prescribing information for venetoclax is available here. 

Photo courtesy of Abbvie

The US Food and Drug Administration (FDA) has approved venetoclax tablets (Venclexta ®) in combination with rituximab to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received 1 prior therapy.

The combination is approved for patients with or without deletion of 17p (del 17p).

The FDA based its approval on the phase 3 MURANO trial, in which venetoclax in combination with rituximab (VEN+R) significantly improved progression-free survival (PFS) in relapsed or refractory CLL patients compared to the chemoimmunotherapy regimen of bendamustine plus rituximab(B+R).

This approval, according to the drug’s developers, makes venetoclax plus rituximab the first oral-based, chemotherapy-free combination with a fixed treatment duration for CLL.

The FDA has also converted venetoclax's accelerated approval to a full approval. The drug was previously granted accelerated approval as a single agent for the treatment of people with CLL with 17p deletion.

Venetoclax is being developed by AbbVie and Roche and jointly commercialized by AbbVie and Genentech in the US and by AbbVie outside the US.

Phase 3 MURANO trial (NCT02005471)

The multicenter, open-label trial randomized 389 patients to VEN+R (194 patients) or B+R (195 patients). Median age of the patients was 65 years (range, 22 – 85).

Patients in the VEN+R arm completed a 5-week ramp-up of venetoclax followed by venetoclax 400 mg once daily for 24 months measured from the rituximab start date.

Tumor lysis syndrome (TLS), caused by a rapid reduction in tumor volume, is an identified risk with venetoclax treatment. The dose ramp-up was intended to mitigate this risk.

Rituximab was initiated after venetoclax ramp-up and given for 6 cycles (375 mg/m² intravenously on cycle 1 day 1 and 500 mg/m² intravenously on day 1 of cycles 2-6, with a 28-day cycle length).

Patients in the B+R arm received 6 cycles of B+R (bendamustine 70 mg/m² on days 1 and 2 of each 28-day cycle and rituximab at the above described dose and schedule).

Efficacy was based on PFS as assessed by an independent review committee.

After a median follow-up of 23 months, the median PFS was not reached in the VEN+R arm and was 18.1 months in the B+R arm (P<0.0001).

The overall response rate was 92% for patients treated with VEN+R compared to 72% for those treated with B+R.

Safety

The most common adverse events (AEs) in the VEN+R arms that occurred in 20% or more patients were neutropenia (65%), diarrhea (40%), upper respiratory tract infection (39%), fatigue (22%), cough (22%), and nausea (21%).

Grade 3 or 4 neutropenia developed in 64% of patients, and grade 4 neutropenia in 31%.

Serious adverse events (SAEs) developed in 46% of patients and serious infections in 21%, consisting most frequently of pneumonia (9%).

The incidence of TLS was 3%, occurring in 6 of  194 patients.

In the VEN+R arm, discontinuations due to any AEs occurred in 16% of patients, dose reductions in 15%, and dose interruptions in 71%.

Neutropenia led to dose interruptions in 46% of patients and discontinuations in 3%. Thrombocytopenia led to discontinuations in 3% of patients.

Fatal AEs that occurred in the absence of disease progression and within 30 days of the last VEN+R treatment and/or 90 days of the last rituximab infusion were reported in 2% (4/194) of patients.

In the B+R arm, AEs led to treatment discontinuations in 10% of patients, dose reductions in 15%, and dose interruptions in 40 %.

Investigators previously reported data from the phase 3 MURANO study as a late-breaking abstract at the 2017 ASH Annual Meeting and published the findings in NEJM.

John Seymour, MBBS, PhD, lead investigator of the MURANO study, said in the corporate release, the approval "validates the results seen in the phase 3 trial, including the significant improvement in progression-free survival over a standard of care comparator arm."

"Progression-free survival is considered a gold standard for demonstrating clinical benefit in oncology," he added.

Full prescribing information for venetoclax is available here. 

Photo courtesy of Abbvie

The US Food and Drug Administration (FDA) has approved venetoclax tablets (Venclexta ®) in combination with rituximab to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received 1 prior therapy.

The combination is approved for patients with or without deletion of 17p (del 17p).

The FDA based its approval on the phase 3 MURANO trial, in which venetoclax in combination with rituximab (VEN+R) significantly improved progression-free survival (PFS) in relapsed or refractory CLL patients compared to the chemoimmunotherapy regimen of bendamustine plus rituximab(B+R).

This approval, according to the drug’s developers, makes venetoclax plus rituximab the first oral-based, chemotherapy-free combination with a fixed treatment duration for CLL.

The FDA has also converted venetoclax's accelerated approval to a full approval. The drug was previously granted accelerated approval as a single agent for the treatment of people with CLL with 17p deletion.

Venetoclax is being developed by AbbVie and Roche and jointly commercialized by AbbVie and Genentech in the US and by AbbVie outside the US.

Phase 3 MURANO trial (NCT02005471)

The multicenter, open-label trial randomized 389 patients to VEN+R (194 patients) or B+R (195 patients). Median age of the patients was 65 years (range, 22 – 85).

Patients in the VEN+R arm completed a 5-week ramp-up of venetoclax followed by venetoclax 400 mg once daily for 24 months measured from the rituximab start date.

Tumor lysis syndrome (TLS), caused by a rapid reduction in tumor volume, is an identified risk with venetoclax treatment. The dose ramp-up was intended to mitigate this risk.

Rituximab was initiated after venetoclax ramp-up and given for 6 cycles (375 mg/m² intravenously on cycle 1 day 1 and 500 mg/m² intravenously on day 1 of cycles 2-6, with a 28-day cycle length).

Patients in the B+R arm received 6 cycles of B+R (bendamustine 70 mg/m² on days 1 and 2 of each 28-day cycle and rituximab at the above described dose and schedule).

Efficacy was based on PFS as assessed by an independent review committee.

After a median follow-up of 23 months, the median PFS was not reached in the VEN+R arm and was 18.1 months in the B+R arm (P<0.0001).

The overall response rate was 92% for patients treated with VEN+R compared to 72% for those treated with B+R.

Safety

The most common adverse events (AEs) in the VEN+R arms that occurred in 20% or more patients were neutropenia (65%), diarrhea (40%), upper respiratory tract infection (39%), fatigue (22%), cough (22%), and nausea (21%).

Grade 3 or 4 neutropenia developed in 64% of patients, and grade 4 neutropenia in 31%.

Serious adverse events (SAEs) developed in 46% of patients and serious infections in 21%, consisting most frequently of pneumonia (9%).

The incidence of TLS was 3%, occurring in 6 of  194 patients.

In the VEN+R arm, discontinuations due to any AEs occurred in 16% of patients, dose reductions in 15%, and dose interruptions in 71%.

Neutropenia led to dose interruptions in 46% of patients and discontinuations in 3%. Thrombocytopenia led to discontinuations in 3% of patients.

Fatal AEs that occurred in the absence of disease progression and within 30 days of the last VEN+R treatment and/or 90 days of the last rituximab infusion were reported in 2% (4/194) of patients.

In the B+R arm, AEs led to treatment discontinuations in 10% of patients, dose reductions in 15%, and dose interruptions in 40 %.

Investigators previously reported data from the phase 3 MURANO study as a late-breaking abstract at the 2017 ASH Annual Meeting and published the findings in NEJM.

John Seymour, MBBS, PhD, lead investigator of the MURANO study, said in the corporate release, the approval "validates the results seen in the phase 3 trial, including the significant improvement in progression-free survival over a standard of care comparator arm."

"Progression-free survival is considered a gold standard for demonstrating clinical benefit in oncology," he added.

Full prescribing information for venetoclax is available here. 

BOSTON – Though sleeve gastrectomy and Roux-en-Y gastric bypass are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.

A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.

One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.

In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.

The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”

A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.

In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.

[email protected]

SOURCE: McKenzie, T. AACE 2018, presentation SGS4.

BOSTON – Though sleeve gastrectomy and Roux-en-Y gastric bypass are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.

A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.

One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.

In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.

The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”

A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.

In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.

[email protected]

SOURCE: McKenzie, T. AACE 2018, presentation SGS4.

BOSTON – Though sleeve gastrectomy and Roux-en-Y gastric bypass are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.

A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.

One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.

In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.

The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”

A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.

In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.

[email protected]

SOURCE: McKenzie, T. AACE 2018, presentation SGS4.

SAN DIEGO – The use of aclidinium bromide 400 mcg b.i.d. did not increase the risk of major adverse cardiac events or mortality in patients with moderate to very severe COPD with significant cardiovascular risk factors, compared with placebo.

Those are two key findings from the ASCENT COPD trial presented by Robert A. Wise, MD, at an international conference of the American Thoracic Society. “Cardiovascular risk factors and comorbidities are prevalent in patients with COPD, and about 30% of COPD patients die of cardiovascular disease,” said Dr. Wise, who serves as director of research for the division of pulmonary and critical care medicine at the Johns Hopkins University School of Medicine, Baltimore. “However, patients who have cardiovascular disease are often excluded from, or not enrolled in, COPD clinical trials. Moreover, there has been controversy as to whether or not treatment with a long-acting muscarinic antagonist is associated with an increased risk of cardiovascular events. That’s been seen in randomized trials, meta-analyses, as well as in observational studies.”

Aclidinium bromide 400 mcg b.i.d., administered by the Pressair inhaler, is approved as a maintenance treatment for patients with COPD. However, during the registration studies, there were not an adequate number of cardiovascular events in order to ascertain clearly whether or not the drug was associated with increased risk, Dr. Wise said. Therefore, he and his associates in the ASCENT COPD study set out to assess the long-term cardiovascular safety profile of aclidinium 400 mcg b.i.d. in patients with moderate to very severe COPD at risk of major adverse cardiovascular events (MACE) for up to 3 years (Chronic Obstr Pulm Dis. 2018;5[1]:5-15). For the randomized, placebo-controlled, parallel-group study, patients received treatment with aclidinium bromide or a placebo inhaler of similar appearance. The study was designed to be terminated when at least 122 patients experienced an adjudicated MACE. The primary safety endpoint was time to first MACE during follow-up of up to 3 years, while the primary efficacy endpoint was the rate of moderate to severe exacerbations per patient per year during the first year of treatment.

To be included in the study, patients had to be at least 40 years of age with moderate to very severe stable COPD, have a smoking history of at least 10 pack-years, and have at least one of the following significant risk factors: cerebrovascular disease; coronary artery disease; peripheral vascular disease, or history of claudication; or at least two atherothrombotic risk factors (male at least 65 years of age, female at least 70 years of age; waist circumference of at least 40 inches among males or at least 38 inches among females; an estimated glomerular filtration rate of less than 60 mL/min and microalbuminuria; dyslipidemia; or hypertension).

The researchers randomized 1,791 patients to the aclidinium group and 1,798 to the placebo group. Their mean age was 67 years, and about 60% of patients had an exacerbation in the preceding year. Nearly two-thirds of patients (63%) were receiving concomitant long-acting beta 2-agonists (LABA) or LABA/inhaled corticosteroid therapy. In addition, 44% of patients entered the study with a history of a prior cardiovascular event plus at least two atherothrombotic risk factors, 52% reported at least two atherothrombotic risk factors without any prior cardiovascular events, and 4% had a history of a prior cardiovascular event only.

Dr. Wise reported that aclidinium did not increase the risk of MACE in patients with moderate to very severe COPD with significant cardiovascular risk factors, compared with placebo (hazard ratio 0.89; P = .469); non-inferiority was concluded as the upper bound of the 95% confidence interval was less than 1.8). In terms of all-cause mortality, aclidinium did not increase the risk of death, compared with placebo (HR 0.99; P = .929).

During the first year of treatment, Dr. Wise and his associates also observed a 22% reduction in COPD exacerbation rate for aclidinium vs. placebo groups (HR 0.44 vs. 0.57, respectively; P less than .001), and a 35% reduction in the rate of COPD exacerbations leading to hospitalizations (HR 0.07 vs. 0.10; P = .006). “The reduction in exacerbation risk was similar, whether or not patients had an exacerbation in the past year,” Dr. Wise said. He reported being a consultant to, and receiving research support from, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and ContraFect.

[email protected]

SOURCE: Wise, R., et al., Abstract 7711, ATS 2018.

SAN DIEGO – The use of aclidinium bromide 400 mcg b.i.d. did not increase the risk of major adverse cardiac events or mortality in patients with moderate to very severe COPD with significant cardiovascular risk factors, compared with placebo.

Those are two key findings from the ASCENT COPD trial presented by Robert A. Wise, MD, at an international conference of the American Thoracic Society. “Cardiovascular risk factors and comorbidities are prevalent in patients with COPD, and about 30% of COPD patients die of cardiovascular disease,” said Dr. Wise, who serves as director of research for the division of pulmonary and critical care medicine at the Johns Hopkins University School of Medicine, Baltimore. “However, patients who have cardiovascular disease are often excluded from, or not enrolled in, COPD clinical trials. Moreover, there has been controversy as to whether or not treatment with a long-acting muscarinic antagonist is associated with an increased risk of cardiovascular events. That’s been seen in randomized trials, meta-analyses, as well as in observational studies.”

Aclidinium bromide 400 mcg b.i.d., administered by the Pressair inhaler, is approved as a maintenance treatment for patients with COPD. However, during the registration studies, there were not an adequate number of cardiovascular events in order to ascertain clearly whether or not the drug was associated with increased risk, Dr. Wise said. Therefore, he and his associates in the ASCENT COPD study set out to assess the long-term cardiovascular safety profile of aclidinium 400 mcg b.i.d. in patients with moderate to very severe COPD at risk of major adverse cardiovascular events (MACE) for up to 3 years (Chronic Obstr Pulm Dis. 2018;5[1]:5-15). For the randomized, placebo-controlled, parallel-group study, patients received treatment with aclidinium bromide or a placebo inhaler of similar appearance. The study was designed to be terminated when at least 122 patients experienced an adjudicated MACE. The primary safety endpoint was time to first MACE during follow-up of up to 3 years, while the primary efficacy endpoint was the rate of moderate to severe exacerbations per patient per year during the first year of treatment.

To be included in the study, patients had to be at least 40 years of age with moderate to very severe stable COPD, have a smoking history of at least 10 pack-years, and have at least one of the following significant risk factors: cerebrovascular disease; coronary artery disease; peripheral vascular disease, or history of claudication; or at least two atherothrombotic risk factors (male at least 65 years of age, female at least 70 years of age; waist circumference of at least 40 inches among males or at least 38 inches among females; an estimated glomerular filtration rate of less than 60 mL/min and microalbuminuria; dyslipidemia; or hypertension).

The researchers randomized 1,791 patients to the aclidinium group and 1,798 to the placebo group. Their mean age was 67 years, and about 60% of patients had an exacerbation in the preceding year. Nearly two-thirds of patients (63%) were receiving concomitant long-acting beta 2-agonists (LABA) or LABA/inhaled corticosteroid therapy. In addition, 44% of patients entered the study with a history of a prior cardiovascular event plus at least two atherothrombotic risk factors, 52% reported at least two atherothrombotic risk factors without any prior cardiovascular events, and 4% had a history of a prior cardiovascular event only.

Dr. Wise reported that aclidinium did not increase the risk of MACE in patients with moderate to very severe COPD with significant cardiovascular risk factors, compared with placebo (hazard ratio 0.89; P = .469); non-inferiority was concluded as the upper bound of the 95% confidence interval was less than 1.8). In terms of all-cause mortality, aclidinium did not increase the risk of death, compared with placebo (HR 0.99; P = .929).

During the first year of treatment, Dr. Wise and his associates also observed a 22% reduction in COPD exacerbation rate for aclidinium vs. placebo groups (HR 0.44 vs. 0.57, respectively; P less than .001), and a 35% reduction in the rate of COPD exacerbations leading to hospitalizations (HR 0.07 vs. 0.10; P = .006). “The reduction in exacerbation risk was similar, whether or not patients had an exacerbation in the past year,” Dr. Wise said. He reported being a consultant to, and receiving research support from, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and ContraFect.

[email protected]

SOURCE: Wise, R., et al., Abstract 7711, ATS 2018.

SAN DIEGO – The use of aclidinium bromide 400 mcg b.i.d. did not increase the risk of major adverse cardiac events or mortality in patients with moderate to very severe COPD with significant cardiovascular risk factors, compared with placebo.

Those are two key findings from the ASCENT COPD trial presented by Robert A. Wise, MD, at an international conference of the American Thoracic Society. “Cardiovascular risk factors and comorbidities are prevalent in patients with COPD, and about 30% of COPD patients die of cardiovascular disease,” said Dr. Wise, who serves as director of research for the division of pulmonary and critical care medicine at the Johns Hopkins University School of Medicine, Baltimore. “However, patients who have cardiovascular disease are often excluded from, or not enrolled in, COPD clinical trials. Moreover, there has been controversy as to whether or not treatment with a long-acting muscarinic antagonist is associated with an increased risk of cardiovascular events. That’s been seen in randomized trials, meta-analyses, as well as in observational studies.”

Aclidinium bromide 400 mcg b.i.d., administered by the Pressair inhaler, is approved as a maintenance treatment for patients with COPD. However, during the registration studies, there were not an adequate number of cardiovascular events in order to ascertain clearly whether or not the drug was associated with increased risk, Dr. Wise said. Therefore, he and his associates in the ASCENT COPD study set out to assess the long-term cardiovascular safety profile of aclidinium 400 mcg b.i.d. in patients with moderate to very severe COPD at risk of major adverse cardiovascular events (MACE) for up to 3 years (Chronic Obstr Pulm Dis. 2018;5[1]:5-15). For the randomized, placebo-controlled, parallel-group study, patients received treatment with aclidinium bromide or a placebo inhaler of similar appearance. The study was designed to be terminated when at least 122 patients experienced an adjudicated MACE. The primary safety endpoint was time to first MACE during follow-up of up to 3 years, while the primary efficacy endpoint was the rate of moderate to severe exacerbations per patient per year during the first year of treatment.

To be included in the study, patients had to be at least 40 years of age with moderate to very severe stable COPD, have a smoking history of at least 10 pack-years, and have at least one of the following significant risk factors: cerebrovascular disease; coronary artery disease; peripheral vascular disease, or history of claudication; or at least two atherothrombotic risk factors (male at least 65 years of age, female at least 70 years of age; waist circumference of at least 40 inches among males or at least 38 inches among females; an estimated glomerular filtration rate of less than 60 mL/min and microalbuminuria; dyslipidemia; or hypertension).

The researchers randomized 1,791 patients to the aclidinium group and 1,798 to the placebo group. Their mean age was 67 years, and about 60% of patients had an exacerbation in the preceding year. Nearly two-thirds of patients (63%) were receiving concomitant long-acting beta 2-agonists (LABA) or LABA/inhaled corticosteroid therapy. In addition, 44% of patients entered the study with a history of a prior cardiovascular event plus at least two atherothrombotic risk factors, 52% reported at least two atherothrombotic risk factors without any prior cardiovascular events, and 4% had a history of a prior cardiovascular event only.

Dr. Wise reported that aclidinium did not increase the risk of MACE in patients with moderate to very severe COPD with significant cardiovascular risk factors, compared with placebo (hazard ratio 0.89; P = .469); non-inferiority was concluded as the upper bound of the 95% confidence interval was less than 1.8). In terms of all-cause mortality, aclidinium did not increase the risk of death, compared with placebo (HR 0.99; P = .929).

During the first year of treatment, Dr. Wise and his associates also observed a 22% reduction in COPD exacerbation rate for aclidinium vs. placebo groups (HR 0.44 vs. 0.57, respectively; P less than .001), and a 35% reduction in the rate of COPD exacerbations leading to hospitalizations (HR 0.07 vs. 0.10; P = .006). “The reduction in exacerbation risk was similar, whether or not patients had an exacerbation in the past year,” Dr. Wise said. He reported being a consultant to, and receiving research support from, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and ContraFect.

[email protected]

SOURCE: Wise, R., et al., Abstract 7711, ATS 2018.

A brief patient-directed education program delivered at the time of hospitalization for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) improved disease-specific knowledge, according to results of a pilot randomized trial.

Patients who participated in education sessions had a significant improvement in their scores on the Bristol COPD Knowledge Questionnaire (BCKQ), compared with control patients who received no education, study investigators reported in the journal Chest.

“Early education may be a bridge to more active approaches and could provide an important contribution to self-management interventions post-AECOPD,” wrote first author Tania Janaudis-Ferreira, PhD, of the School of Physical and Occupational Therapy, McGill University, Montreal, and her co-authors.

In the study, patients admitted to a community hospital with an AECOPD were randomized to standard care plus brief education or standard care alone. The education consisted of two 30-minute sessions delivered by a physiotherapist, either in the hospital or at home up to 2 weeks after the admission.

Before and after the intervention period, participant knowledge was measured using both the BCKQ and the Lung Information Needs Questionnaire (LINQ).

A total of 31 patients participated, including 15 in the intervention group and 16 in the control group, although 3 patients in the control group did not complete the follow-up testing, investigators said in their report.

The mean change in BCKQ was 8 points for the educational intervention group, and 3.4 for the control group (P = 0.02). That result was in keeping with findings of a previous randomized study noting an 8.3-point change in BCKQ scores for COPD patients who received education in the primary care setting, Dr. Janaudis-Ferreira and co-authors said.

“The change itself is relatively modest, suggesting more frequent sessions might result in greater improvements,” they wrote. For example, they said, an 8-week educational intervention delivered in the context of pulmonary rehabilitation program in one study yielded a mean change of 18.3 points on the BCKQ in the intervention group.

By contrast, the investigators found no significant difference in LINQ score changes between the intervention and control groups (P = .8).

That may indicate that two 30-minute sessions were not sufficient to attend to patients’ learning needs, authors said, though it could also have been an issue with the instrument itself in the setting of this study.

“The majority of the questions in the LINQ ask whether or not a doctor or nurse has explained a specific question to the patient,” authors explained. “Since a physiotherapist delivered the program, had the wording been altered to include physiotherapists or a more general term for healthcare professionals, we may have seen a change in these results.”

Dr. Janaudis-Ferreira and co-authors had no conflicts of interest to disclose. The study was funded by a grant from the Canadian Respiratory Health Professionals, which did not have input in research or manuscript development.

SOURCE: Janaudis-Ferreira T, et al.  Chest
 

A brief patient-directed education program delivered at the time of hospitalization for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) improved disease-specific knowledge, according to results of a pilot randomized trial.

Patients who participated in education sessions had a significant improvement in their scores on the Bristol COPD Knowledge Questionnaire (BCKQ), compared with control patients who received no education, study investigators reported in the journal Chest.

“Early education may be a bridge to more active approaches and could provide an important contribution to self-management interventions post-AECOPD,” wrote first author Tania Janaudis-Ferreira, PhD, of the School of Physical and Occupational Therapy, McGill University, Montreal, and her co-authors.

In the study, patients admitted to a community hospital with an AECOPD were randomized to standard care plus brief education or standard care alone. The education consisted of two 30-minute sessions delivered by a physiotherapist, either in the hospital or at home up to 2 weeks after the admission.

Before and after the intervention period, participant knowledge was measured using both the BCKQ and the Lung Information Needs Questionnaire (LINQ).

A total of 31 patients participated, including 15 in the intervention group and 16 in the control group, although 3 patients in the control group did not complete the follow-up testing, investigators said in their report.

The mean change in BCKQ was 8 points for the educational intervention group, and 3.4 for the control group (P = 0.02). That result was in keeping with findings of a previous randomized study noting an 8.3-point change in BCKQ scores for COPD patients who received education in the primary care setting, Dr. Janaudis-Ferreira and co-authors said.

“The change itself is relatively modest, suggesting more frequent sessions might result in greater improvements,” they wrote. For example, they said, an 8-week educational intervention delivered in the context of pulmonary rehabilitation program in one study yielded a mean change of 18.3 points on the BCKQ in the intervention group.

By contrast, the investigators found no significant difference in LINQ score changes between the intervention and control groups (P = .8).

That may indicate that two 30-minute sessions were not sufficient to attend to patients’ learning needs, authors said, though it could also have been an issue with the instrument itself in the setting of this study.

“The majority of the questions in the LINQ ask whether or not a doctor or nurse has explained a specific question to the patient,” authors explained. “Since a physiotherapist delivered the program, had the wording been altered to include physiotherapists or a more general term for healthcare professionals, we may have seen a change in these results.”

Dr. Janaudis-Ferreira and co-authors had no conflicts of interest to disclose. The study was funded by a grant from the Canadian Respiratory Health Professionals, which did not have input in research or manuscript development.

SOURCE: Janaudis-Ferreira T, et al.  Chest
 

A brief patient-directed education program delivered at the time of hospitalization for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) improved disease-specific knowledge, according to results of a pilot randomized trial.

Patients who participated in education sessions had a significant improvement in their scores on the Bristol COPD Knowledge Questionnaire (BCKQ), compared with control patients who received no education, study investigators reported in the journal Chest.

“Early education may be a bridge to more active approaches and could provide an important contribution to self-management interventions post-AECOPD,” wrote first author Tania Janaudis-Ferreira, PhD, of the School of Physical and Occupational Therapy, McGill University, Montreal, and her co-authors.

In the study, patients admitted to a community hospital with an AECOPD were randomized to standard care plus brief education or standard care alone. The education consisted of two 30-minute sessions delivered by a physiotherapist, either in the hospital or at home up to 2 weeks after the admission.

Before and after the intervention period, participant knowledge was measured using both the BCKQ and the Lung Information Needs Questionnaire (LINQ).

A total of 31 patients participated, including 15 in the intervention group and 16 in the control group, although 3 patients in the control group did not complete the follow-up testing, investigators said in their report.

The mean change in BCKQ was 8 points for the educational intervention group, and 3.4 for the control group (P = 0.02). That result was in keeping with findings of a previous randomized study noting an 8.3-point change in BCKQ scores for COPD patients who received education in the primary care setting, Dr. Janaudis-Ferreira and co-authors said.

“The change itself is relatively modest, suggesting more frequent sessions might result in greater improvements,” they wrote. For example, they said, an 8-week educational intervention delivered in the context of pulmonary rehabilitation program in one study yielded a mean change of 18.3 points on the BCKQ in the intervention group.

By contrast, the investigators found no significant difference in LINQ score changes between the intervention and control groups (P = .8).

That may indicate that two 30-minute sessions were not sufficient to attend to patients’ learning needs, authors said, though it could also have been an issue with the instrument itself in the setting of this study.

“The majority of the questions in the LINQ ask whether or not a doctor or nurse has explained a specific question to the patient,” authors explained. “Since a physiotherapist delivered the program, had the wording been altered to include physiotherapists or a more general term for healthcare professionals, we may have seen a change in these results.”

Dr. Janaudis-Ferreira and co-authors had no conflicts of interest to disclose. The study was funded by a grant from the Canadian Respiratory Health Professionals, which did not have input in research or manuscript development.

SOURCE: Janaudis-Ferreira T, et al.  Chest
 

When young people successfully complete an Indian Health Service (IHS) Youth Regional Treatment Center (YRTC) program, they often leave the structured environment to return to a community and family that cannot provide them with the necessary aftercare. The IHS has launched the YRTC Aftercare Pilot Project to fill that gap.

The 12 federal and tribal YRTCs provide a range of clinical services “rooted in culturally relevant, holistic models of care” to American Indian and Alaska Native (AI/AN) adolescents who abuse alcohol or drugs. But without aftercare and case management, the young people are at risk for falling back into old ways.

The YRTC project will identify transitional services that can be culturally adapted to meet the needs of AI/AN youth to support resiliency and coping skills and provide support systems. The project developers aim to establish community-based approaches to reduce relapse and encourage reintegration.

The IHS has awarded $1.62 million for YRTC Aftercare Pilot Projects to Healing Lodge of the Seven Nations in Spokane Valley, Washington, and Desert Sage Youth Wellness Center in Hemet, California. The awards are for 3 years. Both sites will develop innovative, collaborative strategies to improve the health of Native youth as they transition back to their communities.

When young people successfully complete an Indian Health Service (IHS) Youth Regional Treatment Center (YRTC) program, they often leave the structured environment to return to a community and family that cannot provide them with the necessary aftercare. The IHS has launched the YRTC Aftercare Pilot Project to fill that gap.

The 12 federal and tribal YRTCs provide a range of clinical services “rooted in culturally relevant, holistic models of care” to American Indian and Alaska Native (AI/AN) adolescents who abuse alcohol or drugs. But without aftercare and case management, the young people are at risk for falling back into old ways.

The YRTC project will identify transitional services that can be culturally adapted to meet the needs of AI/AN youth to support resiliency and coping skills and provide support systems. The project developers aim to establish community-based approaches to reduce relapse and encourage reintegration.

The IHS has awarded $1.62 million for YRTC Aftercare Pilot Projects to Healing Lodge of the Seven Nations in Spokane Valley, Washington, and Desert Sage Youth Wellness Center in Hemet, California. The awards are for 3 years. Both sites will develop innovative, collaborative strategies to improve the health of Native youth as they transition back to their communities.

When young people successfully complete an Indian Health Service (IHS) Youth Regional Treatment Center (YRTC) program, they often leave the structured environment to return to a community and family that cannot provide them with the necessary aftercare. The IHS has launched the YRTC Aftercare Pilot Project to fill that gap.

The 12 federal and tribal YRTCs provide a range of clinical services “rooted in culturally relevant, holistic models of care” to American Indian and Alaska Native (AI/AN) adolescents who abuse alcohol or drugs. But without aftercare and case management, the young people are at risk for falling back into old ways.

The YRTC project will identify transitional services that can be culturally adapted to meet the needs of AI/AN youth to support resiliency and coping skills and provide support systems. The project developers aim to establish community-based approaches to reduce relapse and encourage reintegration.

The IHS has awarded $1.62 million for YRTC Aftercare Pilot Projects to Healing Lodge of the Seven Nations in Spokane Valley, Washington, and Desert Sage Youth Wellness Center in Hemet, California. The awards are for 3 years. Both sites will develop innovative, collaborative strategies to improve the health of Native youth as they transition back to their communities.

The Food and Drug Administration on May 29 issued a set of recommendations to medical professionals and health care facility staff to reduce the occurrence of surgical fires on or near a patient.

Surgical fires most often occur when there is an oxygen-enriched environment (a concentration of greater than 30%). In addition to an oxygen source, the other two necessary elements of the “fire triangle” are an ignition source and a fuel source.

The recommendations discuss the safe use of devices or items that may serve as a source of any one of those three elements.

Oxygen: Evaluate if supplemental oxygen is needed. If it is, titrate to the minimum concentration needed for adequate saturation. Closed oxygen delivery systems (such as a laryngeal mask or endotracheal tube) are safer than open oxygen delivery systems (such as a nasal cannula or mask). If you must use an open system, take additional precautions to exclude oxygen and flammable/combustible gases from the operative field, such as draping techniques that avoid accumulation of oxygen.

[email protected]

The Food and Drug Administration on May 29 issued a set of recommendations to medical professionals and health care facility staff to reduce the occurrence of surgical fires on or near a patient.

Surgical fires most often occur when there is an oxygen-enriched environment (a concentration of greater than 30%). In addition to an oxygen source, the other two necessary elements of the “fire triangle” are an ignition source and a fuel source.

The recommendations discuss the safe use of devices or items that may serve as a source of any one of those three elements.

Oxygen: Evaluate if supplemental oxygen is needed. If it is, titrate to the minimum concentration needed for adequate saturation. Closed oxygen delivery systems (such as a laryngeal mask or endotracheal tube) are safer than open oxygen delivery systems (such as a nasal cannula or mask). If you must use an open system, take additional precautions to exclude oxygen and flammable/combustible gases from the operative field, such as draping techniques that avoid accumulation of oxygen.

[email protected]

The Food and Drug Administration on May 29 issued a set of recommendations to medical professionals and health care facility staff to reduce the occurrence of surgical fires on or near a patient.

Surgical fires most often occur when there is an oxygen-enriched environment (a concentration of greater than 30%). In addition to an oxygen source, the other two necessary elements of the “fire triangle” are an ignition source and a fuel source.

The recommendations discuss the safe use of devices or items that may serve as a source of any one of those three elements.

Oxygen: Evaluate if supplemental oxygen is needed. If it is, titrate to the minimum concentration needed for adequate saturation. Closed oxygen delivery systems (such as a laryngeal mask or endotracheal tube) are safer than open oxygen delivery systems (such as a nasal cannula or mask). If you must use an open system, take additional precautions to exclude oxygen and flammable/combustible gases from the operative field, such as draping techniques that avoid accumulation of oxygen.

[email protected]

BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes (T2D), it may be hard to best bariatric surgery for optimizing cardiovascular and metabolic health over the lifespan.

“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.

At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.

Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).

Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.

From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.

The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m² and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m² is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.

[email protected]

SOURCE: Hurley, D. AACE 2018, Session SGS-4.

BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes (T2D), it may be hard to best bariatric surgery for optimizing cardiovascular and metabolic health over the lifespan.

“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.

At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.

Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).

Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.

From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.

The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m² and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m² is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.

[email protected]

SOURCE: Hurley, D. AACE 2018, Session SGS-4.

BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes (T2D), it may be hard to best bariatric surgery for optimizing cardiovascular and metabolic health over the lifespan.

“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.

At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.

Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).

Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.

From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.

The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m² and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m² is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.

[email protected]

SOURCE: Hurley, D. AACE 2018, Session SGS-4.