User login
Reflections on providing on-call overnight care for psychiatric patients
A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.
In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.
As part of yearlong monitoring research, I’ve asked my fellow residents at George Washington University, in Washington, to participate in a quality improvement survey. It collects information on the number of patients evaluated overnight while on call and also asks residents to rate their on-call experiences on an “emotional pain scale” with space for a qualitative comment. The emotional pain scale is a simple visual analog scale for pain, with a smiley face representing 0 pain and the sad face with tears representing the 10 out of 10, worst pain imaginable. Initially, the emotional pain scale seemed a lighthearted and somewhat silly way for residents to vent about their on-call experience. A year of data collection later, I consider the emotional pain scale an important acknowledgment to my fellow residents that being on call is physically and emotionally taxing.
At the 2018 American Psychiatric Association meeting in New York, I presented findings from this survey data, examining the quantitative information showing that sheer volume of patients correlates with higher emotional pain scores. But while compiling and analyzing the data for my presentation, I also found myself reading and rereading the comments left by my colleagues about their hardest nights. As I read, I reflected on my own 60 nights on call, and my personal experiences between the highs and lows of emotional pain.
As an homage to the educational and emotional power of being on call, I’d like to share a few vignettes from my years of overnight calls from across the emotional pain scale. (Key demographic details have been omitted to protect patients’ privacy.):
- 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.
- 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
- 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.
Dr. Jacqueline Posada - 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
- 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.
- 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.
Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.
A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.
In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.
As part of yearlong monitoring research, I’ve asked my fellow residents at George Washington University, in Washington, to participate in a quality improvement survey. It collects information on the number of patients evaluated overnight while on call and also asks residents to rate their on-call experiences on an “emotional pain scale” with space for a qualitative comment. The emotional pain scale is a simple visual analog scale for pain, with a smiley face representing 0 pain and the sad face with tears representing the 10 out of 10, worst pain imaginable. Initially, the emotional pain scale seemed a lighthearted and somewhat silly way for residents to vent about their on-call experience. A year of data collection later, I consider the emotional pain scale an important acknowledgment to my fellow residents that being on call is physically and emotionally taxing.
At the 2018 American Psychiatric Association meeting in New York, I presented findings from this survey data, examining the quantitative information showing that sheer volume of patients correlates with higher emotional pain scores. But while compiling and analyzing the data for my presentation, I also found myself reading and rereading the comments left by my colleagues about their hardest nights. As I read, I reflected on my own 60 nights on call, and my personal experiences between the highs and lows of emotional pain.
As an homage to the educational and emotional power of being on call, I’d like to share a few vignettes from my years of overnight calls from across the emotional pain scale. (Key demographic details have been omitted to protect patients’ privacy.):
- 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.
- 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
- 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.
Dr. Jacqueline Posada - 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
- 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.
- 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.
Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.
A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.
In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.
As part of yearlong monitoring research, I’ve asked my fellow residents at George Washington University, in Washington, to participate in a quality improvement survey. It collects information on the number of patients evaluated overnight while on call and also asks residents to rate their on-call experiences on an “emotional pain scale” with space for a qualitative comment. The emotional pain scale is a simple visual analog scale for pain, with a smiley face representing 0 pain and the sad face with tears representing the 10 out of 10, worst pain imaginable. Initially, the emotional pain scale seemed a lighthearted and somewhat silly way for residents to vent about their on-call experience. A year of data collection later, I consider the emotional pain scale an important acknowledgment to my fellow residents that being on call is physically and emotionally taxing.
At the 2018 American Psychiatric Association meeting in New York, I presented findings from this survey data, examining the quantitative information showing that sheer volume of patients correlates with higher emotional pain scores. But while compiling and analyzing the data for my presentation, I also found myself reading and rereading the comments left by my colleagues about their hardest nights. As I read, I reflected on my own 60 nights on call, and my personal experiences between the highs and lows of emotional pain.
As an homage to the educational and emotional power of being on call, I’d like to share a few vignettes from my years of overnight calls from across the emotional pain scale. (Key demographic details have been omitted to protect patients’ privacy.):
- 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.
- 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
- 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.
Dr. Jacqueline Posada - 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
- 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.
- 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.
Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.
In-hospital mortality predictors eyed in pneumonia patient subset
SAN DIEGO –, results from a large retrospective cohort study found.
In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.
In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.
A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.
They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.
Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.
[email protected]
SOURCE: Lodise T. et al. ATS 2018, Poster 272.
SAN DIEGO –, results from a large retrospective cohort study found.
In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.
In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.
A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.
They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.
Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.
[email protected]
SOURCE: Lodise T. et al. ATS 2018, Poster 272.
SAN DIEGO –, results from a large retrospective cohort study found.
In a poster abstract presented at an international conference of the American Thoracic Society, researchers led by Thomas P. Lodise Jr., PharmD, noted that ventilator-associated pneumonia is one of the most common hospital-acquired infections in intensive care units and affected an estimated 9%-27% of all intubated patients. “While data are readily available surrounding mortality associated with VAP, scant data are available on outcomes associated with any type of pneumonia requiring intubation and mechanical ventilation (MV) caused by gram-negative organisms,” they wrote.
In an effort to describe mortality rates and associated risk factors for intubated and MV patients diagnosed with gram-negative pneumonia, Dr. Lodise of the Albany (N.Y.) College of Pharmacy and Health Sciences and his associates conducted a retrospective cohort study of data from the Healthcare Cost and Utilization Project (HCUP) National Readmission Database (NRD). HCUP is the largest source of hospital care data in the United States, accounting for 49.3% of the total U.S. resident population and 49.1% of U.S. hospitalizations. The researchers included patients at least 18 years of age who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia between Feb. 1, 2013, and Nov. 30, 2013. They excluded index hospitalizations with a primary or secondary diagnosis of viral pneumonia, fungal pneumonia, atypical organisms, gram-positive bacterial pneumonia, or pneumonia occurring secondary to an infectious disease. They examined mortality rates descriptively and modeled them via adjusted multivariate logistic regression to evaluate the impact of baseline characteristics and comorbidities on risk of mortality. All analyses incorporated sample weights to increase generalizability and allow for extrapolation to the entire U.S. population.
A total of 32,683 patients met all study criteria. Of these, 2,323 (7.1%) had a primary diagnosis and 30,360 (92.9%) had a secondary diagnosis for gram-negative pneumonia. Their mean age was 64 years, and 61.1% were male. In all, 7,928 patients (24.3%) died during hospitalization. Multivariate analysis revealed that patients with concomitant sepsis had the highest risk of mortality (odds ratio, 2.60), followed by patients aged 65 years and older (OR, 1.88) and those with any prior hospitalization within 30 days (OR, 1.34). Comorbidities upon admission with highest risk of mortality included cancer (OR, 2.45), liver disease (OR, 1.91), AIDS/HIV (OR, 1.59), renal disease (OR, 1.33), and congestive heart failure (OR, 1.15). Diabetes was found to have a decreased risk of mortality, with an OR of 0.80. “However, a majority of patients with diabetes had no complications; thus, these patients may be representative of a less severe patient population,” Dr. Lodise and his associates noted in the poster.
They acknowledged certain limitations of the study, including the potential for coding errors. They also pointed out the HCUP NRD does not contain treatment-specific information, drugs administered or treatment patterns during hospitalization, the number of days patients spent in the ICU, or the number of days on ventilation, “which can influence outcomes in pneumonia patients.” In addition, the study did not attempt to determine cause of death. “Death may have been due to combinations of factors separate from pneumonia,” they wrote.
Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.
[email protected]
SOURCE: Lodise T. et al. ATS 2018, Poster 272.
AT ATS 2018
Key clinical point: Before this analysis, mortality and associated risk factors for intubated or mechanically ventilated patients diagnosed with gram-negative pneumonia were poorly understood.
Major finding: Among hospitalized, intubated or mechanically ventilated patients with gram-negative pneumonia, 24.3% died during their hospital stay.
Study details: A retrospective cohort study of data from 32,683 patients who were hospitalized with a primary or secondary diagnosis of gram-negative pneumonia.
Disclosures: Bayer Healthcare Pharmaceuticals funded the study. Dr. Lodise reported having no financial disclosures.
Source: Lodise T. et al. ATS 2018, Poster 272.
SAMHSA’s new general embarks on a new mission
Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.
Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.
Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. for their illnesses before they can begin to heal.
It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?
It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.
“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”
In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.
In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.
Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.
Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.
Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. for their illnesses before they can begin to heal.
It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?
It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.
“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”
In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.
In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.
Elinore F. McCance-Katz, MD, PhD, is by turns passionate and impatient, empathetic and brusquely no-nonsense. She is a person who knows what she wants to do and knows how to do it.
Accomplishing that on the idealogic battlefield of a presidential appointment is the focus of her considerable energy.
Dr. McCance-Katz carries the newly minted banner of assistant secretary for mental health and substance use. Her troops comprise more than 100 related federal agencies. Her charge is at once simple and mind-numbingly complex: Overhaul the nation’s mental health care system. for their illnesses before they can begin to heal.
It’s the precise opposite of the Substance Abuse and Mental Health Services Administration’s prior targeting, which focused heavily on providing healthy social support for patients with mental health and substance abuse disorders. To Dr. McCance-Katz’s way of thinking, dollars spent on such are largely wasted, because terribly ill people simply can’t function in healthy ways until they begin to get better. Why, she reasoned, should the government waste money on peer-support services while ignoring – or even openly rejecting – evidence-based psychiatric treatment paradigms that are proven to help heal?
It’s this philosophical dichotomy – combined with what she perceived as a palpable dismissal of psychiatric science – that drove her away from her first SAMHSA appointment as the agency’s first chief medical officer. She aired her frustration in an editorial, published 2 years ago in Psychiatric Times.
“There is a perceptible hostility toward psychiatric medicine: a resistance to addressing the treatment needs of those with serious mental illness and a questioning by some at SAMHSA as to whether mental disorders even exist – for example, is psychosis just a ‘different way of thinking for some experiencing stress?’ … Nowhere in SAMHSA’s strategic initiatives is psychiatric treatment of mental illness a priority. The occasional vague reference to treatment is no substitute for the urgent need for programs that address these issues.”
In the same letter, she outlined a new battle plan, one that includes funding for better outpatient treatments, more psychiatric hospital beds, clinician education and support, and money to beef up the dwindling supply of psychiatrists, advanced-practice psychiatric nurses, and psychologists.
In an exclusive video interview, Dr. McCance-Katz sat down with MDedge Psychiatry to discuss the path that brought her to this station and the long road ahead.
Alcohol abuse untreated in HCV patients, including HIV coinfected
Nearly 4% of Veterans Affairs patients who screened positive for unhealthy alcohol use were infected with hepatitis C virus, and 64% of these patients were diagnosed with alcohol use disorder, according to the results of a large database analysis.
Despite the fact that alcohol use at all levels can compound the adverse effects of HCV and lead to heightened risks of mortality, particularly among those coinfected with HIV, the majority of these patients did not receive specialty addiction treatment, according to Mandy D. Owens, PhD, and her colleagues at the VA Puget Sound Health Care System, Seattle.
In their study, published in Drug and Alcohol Dependence, the researchers queried the national VA health care system database, which is made up of 139 large facilities and more than 900 clinics throughout the United States, for all patients with a documented outpatient appointment between October 2009 and May 2013 to identify those with one or more with positive screens on the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) questionnaire. Those with AUDIT-C scores greater than or equal to 5 were considered positive, and each positive screen was tracked for up to 1 year to assess alcohol-related care outcomes. The four alcohol-related care outcomes measured were: receipt of brief intervention, specialty addiction treatment, alcohol use disorder (AUD) pharmacotherapy, and a composite measure of receiving any of these services.
Patients also were compared across HCV status in the entire sample of patients with positive screening as well as in the subsample with a clinically documented AUD.
During the study period, 830,825 VA patients screened positive for unhealthy alcohol use. Among those, 31,841 (3.8%) patients had a documented diagnosis for HCV, and of these 20,320 (64%) had an AUD. Two-thirds of these AUD patients did not receive specialty addiction treatment, and more than 90% did not receive pharmacotherapy that is approved by the Food and Drug Administration to treat AUD, according to the researchers. “These rates are concerning given the negative impact alcohol use can have on HCV,” they wrote.
They reiterated the importance of the 2016 change in policy adopted by the VA Health System, which updated its treatment guidelines to recommend that all patients with HCV be considered for treatment, regardless of substance use, and explicitly stated that alcohol use and length of abstinence should not be disqualifiers for receiving HCV treatment.
“All patients with HCV should be receiving evidence-based alcohol-related care given the risks of alcohol use in this population, particularly among those coinfected with HIV,” the researchers concluded.
The research was funded by a grant from the National Institute on Alcohol Abuse and Alcoholism. The authors reported that they had no conflicts of interest.
SOURCE: Owens MD et al. Drug Alcohol Depend. 2018;188:79-85.
Nearly 4% of Veterans Affairs patients who screened positive for unhealthy alcohol use were infected with hepatitis C virus, and 64% of these patients were diagnosed with alcohol use disorder, according to the results of a large database analysis.
Despite the fact that alcohol use at all levels can compound the adverse effects of HCV and lead to heightened risks of mortality, particularly among those coinfected with HIV, the majority of these patients did not receive specialty addiction treatment, according to Mandy D. Owens, PhD, and her colleagues at the VA Puget Sound Health Care System, Seattle.
In their study, published in Drug and Alcohol Dependence, the researchers queried the national VA health care system database, which is made up of 139 large facilities and more than 900 clinics throughout the United States, for all patients with a documented outpatient appointment between October 2009 and May 2013 to identify those with one or more with positive screens on the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) questionnaire. Those with AUDIT-C scores greater than or equal to 5 were considered positive, and each positive screen was tracked for up to 1 year to assess alcohol-related care outcomes. The four alcohol-related care outcomes measured were: receipt of brief intervention, specialty addiction treatment, alcohol use disorder (AUD) pharmacotherapy, and a composite measure of receiving any of these services.
Patients also were compared across HCV status in the entire sample of patients with positive screening as well as in the subsample with a clinically documented AUD.
During the study period, 830,825 VA patients screened positive for unhealthy alcohol use. Among those, 31,841 (3.8%) patients had a documented diagnosis for HCV, and of these 20,320 (64%) had an AUD. Two-thirds of these AUD patients did not receive specialty addiction treatment, and more than 90% did not receive pharmacotherapy that is approved by the Food and Drug Administration to treat AUD, according to the researchers. “These rates are concerning given the negative impact alcohol use can have on HCV,” they wrote.
They reiterated the importance of the 2016 change in policy adopted by the VA Health System, which updated its treatment guidelines to recommend that all patients with HCV be considered for treatment, regardless of substance use, and explicitly stated that alcohol use and length of abstinence should not be disqualifiers for receiving HCV treatment.
“All patients with HCV should be receiving evidence-based alcohol-related care given the risks of alcohol use in this population, particularly among those coinfected with HIV,” the researchers concluded.
The research was funded by a grant from the National Institute on Alcohol Abuse and Alcoholism. The authors reported that they had no conflicts of interest.
SOURCE: Owens MD et al. Drug Alcohol Depend. 2018;188:79-85.
Nearly 4% of Veterans Affairs patients who screened positive for unhealthy alcohol use were infected with hepatitis C virus, and 64% of these patients were diagnosed with alcohol use disorder, according to the results of a large database analysis.
Despite the fact that alcohol use at all levels can compound the adverse effects of HCV and lead to heightened risks of mortality, particularly among those coinfected with HIV, the majority of these patients did not receive specialty addiction treatment, according to Mandy D. Owens, PhD, and her colleagues at the VA Puget Sound Health Care System, Seattle.
In their study, published in Drug and Alcohol Dependence, the researchers queried the national VA health care system database, which is made up of 139 large facilities and more than 900 clinics throughout the United States, for all patients with a documented outpatient appointment between October 2009 and May 2013 to identify those with one or more with positive screens on the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) questionnaire. Those with AUDIT-C scores greater than or equal to 5 were considered positive, and each positive screen was tracked for up to 1 year to assess alcohol-related care outcomes. The four alcohol-related care outcomes measured were: receipt of brief intervention, specialty addiction treatment, alcohol use disorder (AUD) pharmacotherapy, and a composite measure of receiving any of these services.
Patients also were compared across HCV status in the entire sample of patients with positive screening as well as in the subsample with a clinically documented AUD.
During the study period, 830,825 VA patients screened positive for unhealthy alcohol use. Among those, 31,841 (3.8%) patients had a documented diagnosis for HCV, and of these 20,320 (64%) had an AUD. Two-thirds of these AUD patients did not receive specialty addiction treatment, and more than 90% did not receive pharmacotherapy that is approved by the Food and Drug Administration to treat AUD, according to the researchers. “These rates are concerning given the negative impact alcohol use can have on HCV,” they wrote.
They reiterated the importance of the 2016 change in policy adopted by the VA Health System, which updated its treatment guidelines to recommend that all patients with HCV be considered for treatment, regardless of substance use, and explicitly stated that alcohol use and length of abstinence should not be disqualifiers for receiving HCV treatment.
“All patients with HCV should be receiving evidence-based alcohol-related care given the risks of alcohol use in this population, particularly among those coinfected with HIV,” the researchers concluded.
The research was funded by a grant from the National Institute on Alcohol Abuse and Alcoholism. The authors reported that they had no conflicts of interest.
SOURCE: Owens MD et al. Drug Alcohol Depend. 2018;188:79-85.
FROM DRUG AND ALCOHOL DEPENDENCE
Key clinical point: Alcohol-use disorder therapy is underdelivered to patients with HCV who would benefit.
Major finding: Only 27% of patients with HCV plus alcohol-abuse disorder received AUD therapy.
Study details: National VA health care system database of 830,825 patients who screened positive for unhealthy alcohol use.
Disclosures: The research was funded by a grant from the National Institute on Alcohol Abuse and Alcoholism. The authors reported that they had no conflicts of interest.
Source: Owens MD et al. Drug Alcohol Depend. 2018;188:79-85.
Michael Alosco, PhD
Announcing the 2018 Section Research Mentor Award recipients
The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!
AGA Institute Council 2018 Section Research Mentor Award recipients
Basic & Clinical Intestinal Disorders
Gary D. Wu, MD
Cellular & Molecular Gastroenterology
Charalabos Pothoulakis, MD
Clinical Practice
Amnon Sonnenberg, MD, MSc
Esophageal, Gastric & Duodenal Disorders
Nicholas J. Shaheen, MD, MPH, AGAF
Gastrointestinal Oncology
Randall W. Burt, MD, AGAF
Growth, Development & Child Health
Deborah L. Gumucio, PhD
Imaging, Endoscopy & Advanced Technology
Michael B. Wallace, MD, MPH, AGAF
Immunology, Microbiology & Inflammatory Bowel Diseases
Claudio Fiocchi, MD
Liver & Biliary
Scott L. Friedman, MD
Microbiome & Microbial Diseases in the Gastrointestinal Tract
Jeffrey I. Gordon, MD
Neurogastroenterology & Motility
Richard W. McCallum, MD, AGAF
Obesity, Metabolism & Nutrition
Lee M. Kaplan, MD, PhD, AGAF
Pancreatic Disorders
Suresh T. Chari, MD
The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!
AGA Institute Council 2018 Section Research Mentor Award recipients
Basic & Clinical Intestinal Disorders
Gary D. Wu, MD
Cellular & Molecular Gastroenterology
Charalabos Pothoulakis, MD
Clinical Practice
Amnon Sonnenberg, MD, MSc
Esophageal, Gastric & Duodenal Disorders
Nicholas J. Shaheen, MD, MPH, AGAF
Gastrointestinal Oncology
Randall W. Burt, MD, AGAF
Growth, Development & Child Health
Deborah L. Gumucio, PhD
Imaging, Endoscopy & Advanced Technology
Michael B. Wallace, MD, MPH, AGAF
Immunology, Microbiology & Inflammatory Bowel Diseases
Claudio Fiocchi, MD
Liver & Biliary
Scott L. Friedman, MD
Microbiome & Microbial Diseases in the Gastrointestinal Tract
Jeffrey I. Gordon, MD
Neurogastroenterology & Motility
Richard W. McCallum, MD, AGAF
Obesity, Metabolism & Nutrition
Lee M. Kaplan, MD, PhD, AGAF
Pancreatic Disorders
Suresh T. Chari, MD
The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!
AGA Institute Council 2018 Section Research Mentor Award recipients
Basic & Clinical Intestinal Disorders
Gary D. Wu, MD
Cellular & Molecular Gastroenterology
Charalabos Pothoulakis, MD
Clinical Practice
Amnon Sonnenberg, MD, MSc
Esophageal, Gastric & Duodenal Disorders
Nicholas J. Shaheen, MD, MPH, AGAF
Gastrointestinal Oncology
Randall W. Burt, MD, AGAF
Growth, Development & Child Health
Deborah L. Gumucio, PhD
Imaging, Endoscopy & Advanced Technology
Michael B. Wallace, MD, MPH, AGAF
Immunology, Microbiology & Inflammatory Bowel Diseases
Claudio Fiocchi, MD
Liver & Biliary
Scott L. Friedman, MD
Microbiome & Microbial Diseases in the Gastrointestinal Tract
Jeffrey I. Gordon, MD
Neurogastroenterology & Motility
Richard W. McCallum, MD, AGAF
Obesity, Metabolism & Nutrition
Lee M. Kaplan, MD, PhD, AGAF
Pancreatic Disorders
Suresh T. Chari, MD
FDA advisory panelists reject Buvaya for acute pain
HYATTSVILLE, MD. – Two Food and Drug Administration advisory panels voted May 22 to reject buprenorphine sublingual spray for the treatment of moderate to severe postoperative pain.
At a joint meeting, advisers of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18 to 1 not to recommend the spray for approval. The proposed trade name for the spray is Buvaya.
“I think that if this were a standard schedule II opioid with the efficacy profile of this drug, we probably would not be here,”stated Steven Meisel, PharmD, system director of medication safety at Fairview Health Services, Minneapolis. “We would not be here, because the efficacy [is] so weak compared to what is already out there. It just does not work for acute postoperative pain.”
According to INSYS Therapeutics, developer of the buprenorphine sublingual spray, opioid painkillers remain one of the best treatment options in managing moderate to severe pain despite the risk of addiction. The sublingual spray formulation also has a lower abuse potential, according to the company. This was corroborated in a briefing document of currently marketed buprenorphine products by the FDA.
Buprenorphine, an opioid partial agonist-antagonist, is a long-acting Schedule III opioid. The sublingual spray was developed as part of the Buprenorphine Sublingual Spray clinical development program, consisting of 10 studies including 7 phase 1 studies, a phase 2 open label study, and two phase 3 efficacy studies. The company’s application was based on the results of those two efficacy studies. Both phase 3 studies had similar designs, randomizing patients to receive varying doses of the sublingual spray. They also shared the primary endpoint of assessing postoperative pain using the Numeric Rating Scale (NRS) Summed Pain and Intensity Difference 48 hours (SPID-48) after surgery. The similarities continued with secondary endpoints, with both phase 3 studies looking at NRS-SPID scores at 4, 8, and 24 hours after surgery, NRS pain intensity difference (NRS PID) and score at each time point, and total pain relief (TOTPAR) at 4, 8, 24, and 48 hours after surgery. The only difference between the studies were the doses of sublingual buprenorphine administered to patients.
One of the phase 3 trials was discontinued when several patients because of sedation events at higher doses, but that trial still was used to guide the dose selection for the pivotal phase 3 study. In that study, 40 patients postoperative bunionectomy patients were randomized to receive placebo, 0.5 mg, or 1.0 mg of sublingual buprenorphine (SBS) three times daily (t.i.d.) or 1.0 mg of SBS twice a day (b.i.d.). The study demonstrated that all doses were superior to placebo in reducing pain based on reductions in NRS SPID-48 scores. In fact, the mean NRS SPID-48 scores were 260%, 216%, and 236% higher for the 0.5-mg t.i.d., 1.0-mg b.i.d., and 1.0-mg t.i.d. doses, respectively, compared with placebo, indicating a decrease in pain. The study also found that sublingual buprenorphine doses of greater than 0.5 mg were not more effective in treating postoperative pain.
The pivotal phase 3 efficacy study randomized 322 patients after bunionectomy into one of four treatment groups: placebo, 0.5 mg t.i.d., 0.25 mg t.i.d., or 0.125 mg t.i.d. Sublingual buprenorphine was much more effective in reducing pain and SPID-48 scores, compared with placebo. Patients taking placebo had SPID-48 scores of 93.40, compared with 135.84, 125.75, and 182.81 for the 0.125-mg, 0.25-mg, and 0.5-mg SBS groups, respectively.
The most common adverse events were nausea, vomiting, and hypoxia. Specifically, in the pivotal study, nausea was reported at all three doses of 0.125 mg, 0.25 mg, and 0.50 mg in 43.9%, 58.8%, and 83.3% of patients.
Anne-Michelle Ruha, MD, of the University of Arizona, Phoenix, cited the risk of hypoxia as her biggest concern. “There’s so many factors that we can’t predict, like undiagnosed sleep apnea,” she said. “We just don’t know when the respiratory depression worsens, so I’m uncomfortable with the high rate of hypoxia.”
Although not directly related to this application, INSYS had been the subject of an investigation by the federal government in regard to an illegal marketing scheme that provided incentives for doctors to prescribe Subsys, a powerful and highly addictive synthetic opioid. Documents recently have been unsealed in federal court that prompted the federal government to investigate INSYS. The company has addressed the previous allegations of wrongdoing and states that INSYS has become a “... new and better company in many important respects across the organization,” according to a statement.The FDA usually follows the recommendations of its advisory panels, but they are not binding.
HYATTSVILLE, MD. – Two Food and Drug Administration advisory panels voted May 22 to reject buprenorphine sublingual spray for the treatment of moderate to severe postoperative pain.
At a joint meeting, advisers of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18 to 1 not to recommend the spray for approval. The proposed trade name for the spray is Buvaya.
“I think that if this were a standard schedule II opioid with the efficacy profile of this drug, we probably would not be here,”stated Steven Meisel, PharmD, system director of medication safety at Fairview Health Services, Minneapolis. “We would not be here, because the efficacy [is] so weak compared to what is already out there. It just does not work for acute postoperative pain.”
According to INSYS Therapeutics, developer of the buprenorphine sublingual spray, opioid painkillers remain one of the best treatment options in managing moderate to severe pain despite the risk of addiction. The sublingual spray formulation also has a lower abuse potential, according to the company. This was corroborated in a briefing document of currently marketed buprenorphine products by the FDA.
Buprenorphine, an opioid partial agonist-antagonist, is a long-acting Schedule III opioid. The sublingual spray was developed as part of the Buprenorphine Sublingual Spray clinical development program, consisting of 10 studies including 7 phase 1 studies, a phase 2 open label study, and two phase 3 efficacy studies. The company’s application was based on the results of those two efficacy studies. Both phase 3 studies had similar designs, randomizing patients to receive varying doses of the sublingual spray. They also shared the primary endpoint of assessing postoperative pain using the Numeric Rating Scale (NRS) Summed Pain and Intensity Difference 48 hours (SPID-48) after surgery. The similarities continued with secondary endpoints, with both phase 3 studies looking at NRS-SPID scores at 4, 8, and 24 hours after surgery, NRS pain intensity difference (NRS PID) and score at each time point, and total pain relief (TOTPAR) at 4, 8, 24, and 48 hours after surgery. The only difference between the studies were the doses of sublingual buprenorphine administered to patients.
One of the phase 3 trials was discontinued when several patients because of sedation events at higher doses, but that trial still was used to guide the dose selection for the pivotal phase 3 study. In that study, 40 patients postoperative bunionectomy patients were randomized to receive placebo, 0.5 mg, or 1.0 mg of sublingual buprenorphine (SBS) three times daily (t.i.d.) or 1.0 mg of SBS twice a day (b.i.d.). The study demonstrated that all doses were superior to placebo in reducing pain based on reductions in NRS SPID-48 scores. In fact, the mean NRS SPID-48 scores were 260%, 216%, and 236% higher for the 0.5-mg t.i.d., 1.0-mg b.i.d., and 1.0-mg t.i.d. doses, respectively, compared with placebo, indicating a decrease in pain. The study also found that sublingual buprenorphine doses of greater than 0.5 mg were not more effective in treating postoperative pain.
The pivotal phase 3 efficacy study randomized 322 patients after bunionectomy into one of four treatment groups: placebo, 0.5 mg t.i.d., 0.25 mg t.i.d., or 0.125 mg t.i.d. Sublingual buprenorphine was much more effective in reducing pain and SPID-48 scores, compared with placebo. Patients taking placebo had SPID-48 scores of 93.40, compared with 135.84, 125.75, and 182.81 for the 0.125-mg, 0.25-mg, and 0.5-mg SBS groups, respectively.
The most common adverse events were nausea, vomiting, and hypoxia. Specifically, in the pivotal study, nausea was reported at all three doses of 0.125 mg, 0.25 mg, and 0.50 mg in 43.9%, 58.8%, and 83.3% of patients.
Anne-Michelle Ruha, MD, of the University of Arizona, Phoenix, cited the risk of hypoxia as her biggest concern. “There’s so many factors that we can’t predict, like undiagnosed sleep apnea,” she said. “We just don’t know when the respiratory depression worsens, so I’m uncomfortable with the high rate of hypoxia.”
Although not directly related to this application, INSYS had been the subject of an investigation by the federal government in regard to an illegal marketing scheme that provided incentives for doctors to prescribe Subsys, a powerful and highly addictive synthetic opioid. Documents recently have been unsealed in federal court that prompted the federal government to investigate INSYS. The company has addressed the previous allegations of wrongdoing and states that INSYS has become a “... new and better company in many important respects across the organization,” according to a statement.The FDA usually follows the recommendations of its advisory panels, but they are not binding.
HYATTSVILLE, MD. – Two Food and Drug Administration advisory panels voted May 22 to reject buprenorphine sublingual spray for the treatment of moderate to severe postoperative pain.
At a joint meeting, advisers of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18 to 1 not to recommend the spray for approval. The proposed trade name for the spray is Buvaya.
“I think that if this were a standard schedule II opioid with the efficacy profile of this drug, we probably would not be here,”stated Steven Meisel, PharmD, system director of medication safety at Fairview Health Services, Minneapolis. “We would not be here, because the efficacy [is] so weak compared to what is already out there. It just does not work for acute postoperative pain.”
According to INSYS Therapeutics, developer of the buprenorphine sublingual spray, opioid painkillers remain one of the best treatment options in managing moderate to severe pain despite the risk of addiction. The sublingual spray formulation also has a lower abuse potential, according to the company. This was corroborated in a briefing document of currently marketed buprenorphine products by the FDA.
Buprenorphine, an opioid partial agonist-antagonist, is a long-acting Schedule III opioid. The sublingual spray was developed as part of the Buprenorphine Sublingual Spray clinical development program, consisting of 10 studies including 7 phase 1 studies, a phase 2 open label study, and two phase 3 efficacy studies. The company’s application was based on the results of those two efficacy studies. Both phase 3 studies had similar designs, randomizing patients to receive varying doses of the sublingual spray. They also shared the primary endpoint of assessing postoperative pain using the Numeric Rating Scale (NRS) Summed Pain and Intensity Difference 48 hours (SPID-48) after surgery. The similarities continued with secondary endpoints, with both phase 3 studies looking at NRS-SPID scores at 4, 8, and 24 hours after surgery, NRS pain intensity difference (NRS PID) and score at each time point, and total pain relief (TOTPAR) at 4, 8, 24, and 48 hours after surgery. The only difference between the studies were the doses of sublingual buprenorphine administered to patients.
One of the phase 3 trials was discontinued when several patients because of sedation events at higher doses, but that trial still was used to guide the dose selection for the pivotal phase 3 study. In that study, 40 patients postoperative bunionectomy patients were randomized to receive placebo, 0.5 mg, or 1.0 mg of sublingual buprenorphine (SBS) three times daily (t.i.d.) or 1.0 mg of SBS twice a day (b.i.d.). The study demonstrated that all doses were superior to placebo in reducing pain based on reductions in NRS SPID-48 scores. In fact, the mean NRS SPID-48 scores were 260%, 216%, and 236% higher for the 0.5-mg t.i.d., 1.0-mg b.i.d., and 1.0-mg t.i.d. doses, respectively, compared with placebo, indicating a decrease in pain. The study also found that sublingual buprenorphine doses of greater than 0.5 mg were not more effective in treating postoperative pain.
The pivotal phase 3 efficacy study randomized 322 patients after bunionectomy into one of four treatment groups: placebo, 0.5 mg t.i.d., 0.25 mg t.i.d., or 0.125 mg t.i.d. Sublingual buprenorphine was much more effective in reducing pain and SPID-48 scores, compared with placebo. Patients taking placebo had SPID-48 scores of 93.40, compared with 135.84, 125.75, and 182.81 for the 0.125-mg, 0.25-mg, and 0.5-mg SBS groups, respectively.
The most common adverse events were nausea, vomiting, and hypoxia. Specifically, in the pivotal study, nausea was reported at all three doses of 0.125 mg, 0.25 mg, and 0.50 mg in 43.9%, 58.8%, and 83.3% of patients.
Anne-Michelle Ruha, MD, of the University of Arizona, Phoenix, cited the risk of hypoxia as her biggest concern. “There’s so many factors that we can’t predict, like undiagnosed sleep apnea,” she said. “We just don’t know when the respiratory depression worsens, so I’m uncomfortable with the high rate of hypoxia.”
Although not directly related to this application, INSYS had been the subject of an investigation by the federal government in regard to an illegal marketing scheme that provided incentives for doctors to prescribe Subsys, a powerful and highly addictive synthetic opioid. Documents recently have been unsealed in federal court that prompted the federal government to investigate INSYS. The company has addressed the previous allegations of wrongdoing and states that INSYS has become a “... new and better company in many important respects across the organization,” according to a statement.The FDA usually follows the recommendations of its advisory panels, but they are not binding.
In abdominal myomectomy, cell salvage may reduce transfusions
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
REPORTING FROM SGS 2018
Key clinical point: Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy.
Major finding: Transfusion rates were similar (23% and 17%) despite greater blood loss in the cell salvage group.
Study details: A retrospective review of 138 patients’ charts.
Disclosures: Dr. Gingold reported having no disclosures.
Source: Gingold J et al. SGS 2018 Oral poster 18.
Recent studies of microbiota offer insights into digestive disease management
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
REPORTING FROM PERSPECTIVES IN DIGESTIVE DISEASES
FDA approves Doptelet for liver disease patients undergoing procedures
Doptelet (avatrombopag) is the first drug to be approved by the Food and Drug Administration for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, the FDA announced in a statement.
“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.”
The safety and efficacy of two different doses of Doptelet administered orally over 5 days, as compared with placebo, was studied in the ADAPT trials (ADAPT-1 and ADAPT-2) involving 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion. At both dose levels of Doptelet, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to 7 days following the procedure as compared with those treated with placebo.
The most common side effects reported by clinical trial participants who received Doptelet were fever, stomach (abdominal) pain, nausea, headache, fatigue and edema in the hands or feet. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots when taking Doptelet, the FDA said in a press release announcing the approval.
The FDA granted the Doptelet approval to AkaRx.
Doptelet (avatrombopag) is the first drug to be approved by the Food and Drug Administration for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, the FDA announced in a statement.
“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.”
The safety and efficacy of two different doses of Doptelet administered orally over 5 days, as compared with placebo, was studied in the ADAPT trials (ADAPT-1 and ADAPT-2) involving 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion. At both dose levels of Doptelet, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to 7 days following the procedure as compared with those treated with placebo.
The most common side effects reported by clinical trial participants who received Doptelet were fever, stomach (abdominal) pain, nausea, headache, fatigue and edema in the hands or feet. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots when taking Doptelet, the FDA said in a press release announcing the approval.
The FDA granted the Doptelet approval to AkaRx.
Doptelet (avatrombopag) is the first drug to be approved by the Food and Drug Administration for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, the FDA announced in a statement.
“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.”
The safety and efficacy of two different doses of Doptelet administered orally over 5 days, as compared with placebo, was studied in the ADAPT trials (ADAPT-1 and ADAPT-2) involving 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion. At both dose levels of Doptelet, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to 7 days following the procedure as compared with those treated with placebo.
The most common side effects reported by clinical trial participants who received Doptelet were fever, stomach (abdominal) pain, nausea, headache, fatigue and edema in the hands or feet. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots when taking Doptelet, the FDA said in a press release announcing the approval.
The FDA granted the Doptelet approval to AkaRx.