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Mole on forehead
The FP recognized this as a probable intradermal nevus. (Even benign nevi can grow in early adulthood and not be malignant.)
The features that suggested that this was a benign intradermal nevus included that it was a raised symmetrical papule on the face without suspicious signs of melanoma. Intradermal nevi are frequently skin colored because the melanocytes are deep in the dermis. The nevi may show small amounts of color, but are not likely to be dark, as might be seen in a compound nevus or melanoma. The differential diagnosis for a slightly pearly lesion like this, with small visible blood vessels, includes a nodular basal cell carcinoma.
The patient wanted to have the nevus removed to ease her anxiety and because she didn’t like the way it looked. While many insurance companies would reject payment for a cosmetic procedure, they are unlikely to reject payment with a diagnosis of a changing nevus.
The FP reviewed the risks and benefits of a shave biopsy with the patient. A shave biopsy with a sterile razor blade was performed after anesthetizing the area with 1% lidocaine and epinephrine by injection. (See the Watch and Learn video on shave biopsy.) Hemostasis was easily achieved with aluminum chloride in water.
At the 2-week follow-up, the biopsy site was healing well and the patient was reassured that it was only a benign intradermal nevus.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M, Usatine R. Benign nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:945-952.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
The FP recognized this as a probable intradermal nevus. (Even benign nevi can grow in early adulthood and not be malignant.)
The features that suggested that this was a benign intradermal nevus included that it was a raised symmetrical papule on the face without suspicious signs of melanoma. Intradermal nevi are frequently skin colored because the melanocytes are deep in the dermis. The nevi may show small amounts of color, but are not likely to be dark, as might be seen in a compound nevus or melanoma. The differential diagnosis for a slightly pearly lesion like this, with small visible blood vessels, includes a nodular basal cell carcinoma.
The patient wanted to have the nevus removed to ease her anxiety and because she didn’t like the way it looked. While many insurance companies would reject payment for a cosmetic procedure, they are unlikely to reject payment with a diagnosis of a changing nevus.
The FP reviewed the risks and benefits of a shave biopsy with the patient. A shave biopsy with a sterile razor blade was performed after anesthetizing the area with 1% lidocaine and epinephrine by injection. (See the Watch and Learn video on shave biopsy.) Hemostasis was easily achieved with aluminum chloride in water.
At the 2-week follow-up, the biopsy site was healing well and the patient was reassured that it was only a benign intradermal nevus.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M, Usatine R. Benign nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:945-952.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
The FP recognized this as a probable intradermal nevus. (Even benign nevi can grow in early adulthood and not be malignant.)
The features that suggested that this was a benign intradermal nevus included that it was a raised symmetrical papule on the face without suspicious signs of melanoma. Intradermal nevi are frequently skin colored because the melanocytes are deep in the dermis. The nevi may show small amounts of color, but are not likely to be dark, as might be seen in a compound nevus or melanoma. The differential diagnosis for a slightly pearly lesion like this, with small visible blood vessels, includes a nodular basal cell carcinoma.
The patient wanted to have the nevus removed to ease her anxiety and because she didn’t like the way it looked. While many insurance companies would reject payment for a cosmetic procedure, they are unlikely to reject payment with a diagnosis of a changing nevus.
The FP reviewed the risks and benefits of a shave biopsy with the patient. A shave biopsy with a sterile razor blade was performed after anesthetizing the area with 1% lidocaine and epinephrine by injection. (See the Watch and Learn video on shave biopsy.) Hemostasis was easily achieved with aluminum chloride in water.
At the 2-week follow-up, the biopsy site was healing well and the patient was reassured that it was only a benign intradermal nevus.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M, Usatine R. Benign nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:945-952.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.
Influenza update: A robust season but there's (some) good news
Resource
Centers for Disease Control and Prevention. Situation update: Summary of weekly Fluview report. February 9, 2018. Available at: https://www.cdc.gov/flu/weekly/summary.htm. Accessed February 12, 2018.
Resource
Centers for Disease Control and Prevention. Situation update: Summary of weekly Fluview report. February 9, 2018. Available at: https://www.cdc.gov/flu/weekly/summary.htm. Accessed February 12, 2018.
Resource
Centers for Disease Control and Prevention. Situation update: Summary of weekly Fluview report. February 9, 2018. Available at: https://www.cdc.gov/flu/weekly/summary.htm. Accessed February 12, 2018.
HM18 plenaries explore future of hospital medicine
The plenary sessions bookending the Society of Hospital Medicine’s HM18 conference will provide insight into the current state of hospital medicine and a glimpse at the directions in which it is evolving.
Opening the conference will be Kate Goodrich, MD, chief medical officer at the Centers for Medicare & Medicaid Services.
“What I want people to understand is the evolution within our health care system from one where we pay for volume to paying for value, and the role that Medicare can play in that,” Dr. Goodrich said in an interview. “Medicare has traditionally been sort of a passive payer, if you will, a passive payer of claims without a great deal of emphasis on the cost of care and the quality of care. [Now there is] a groundswell of concern nationally, not just here at CMS but nationwide, around the rising cost of care, and our quality of care is not as good as it should be for the amount that we spend.”
Dr. Goodrich said her plenary talk will look at how “that came to be, and then what CMS and other payers in the country are trying to do about it.” She said the United States is in a “truly transformative era in our health care system in changing how we pay for care, in service of better outcomes for patients and lower costs. I would like to give attendees the larger picture, of how we got here and what’s happening both at CMS and nationally to try and reverse some of those trends.”
Closing HM18, as has become tradition at the annual meeting, will be Robert Wachter, MD, MHM, of the University of California San Francisco, who will focus on the broader changes that must happen as the role of the hospitalist continues to evolve.
“I am going to talk about the changes in the world of hospital care and the importance of the field to innovate,” Dr. Wachter said. “To me, there are gravitational forces in the health care world that are making … patients who are in hospitals sicker than they were before. More and more patients are going to be cared for in outpatient settings and at home. We are going start to ... see things like sensors and telemedicine to enable more care outside of the hospital.”
Dr. Wachter said hospital medicine must evolve and mature, to continue to prove that hospitalists are indispensable staff members within the hospital.
“That was why the field became the fastest-growing profession in medical history. We can’t sit on our laurels. We have to continue to innovate,” he said. “Even as the system changes around us, I am confident that we will innovate. My talk will be a pep talk and include reflections on how the world of health care is changing, and what those changes will mean to hospitalists.”
As value-based purchasing programs – and the push to pay for value over volume in Medicare and the private sector – continue to become the norm, the expected trend of sicker, more complex patients entering the hospital is already happening, Dr. Goodrich said. She is experiencing it in her own clinical work, which continues in addition to her role at CMS.
“I can confirm from my own personal experience [that] I have absolutely encountered that exact trend,” she said. “I feel like every time I go in the hospital, my patients are sicker and more complex. That is the population of patients that hospitalists are dealing with. That’s why we are actually in that practice. We enjoy taking care of those types of patients and the challenges they bring, both on a clinical level but I would say also even on a social and economic level.”
Dr. Goodrich said that trend will present one of the key challenges hospitalists face in the future, especially as paying for value entails more two-sided risk.
“In a value-based purchasing world, transitioning to payments based on quality and cost is harder because by nature the sicker patients cost more and it is harder to improve their outcomes. They come to you already quite sick,” she said. “That’s a dilemma that a lot of hospitalists face, wondering ‘How is this going to affect me if I am already seeing the sickest of the sick?’ ”
Dr. Wachter noted that the trend of steering less sick patients to the outpatient setting, as well as other economic factors, would change the nature of hospitalist practice.
“It will be more acuity, more intensity, more complex relationships with your own hospital and often with partner hospitals,” he said. “More of the work will be digitally enabled than it would have been five or ten years ago.”
Integration of data and technology innovation will be a key to better serving this sicker population, Dr. Wachter predicted. We need “to take much fuller advantage than we have so far of the fact that we are all dealing with digital records and the decision support, the data analytics, the artificial intelligence that we get from our computer systems is pretty puny,” he said. “That is partly why physicians don’t love their computers so much. They spend huge amounts of time entering data into computers and don’t get much useful information out of it.”
Dr. Goodrich agreed that this is a challenge.
“How do we make it usable for the average front-line nurse or doctor who didn’t go to school to learn how to code and analyze data?” she asked. “How do we get platforms and analytics that are developed using human-centered design principles to make it very understandable and actionable to the front-end clinician, but also to patients and consumers? What is really needed to truly drive improvement is not just access to the data but usability.” She added that this problem is directly related to the usability of electronic health records. “That is a significant focus right now for the Office of the National Coordinator [of Health Information Technology] – to move away from just [adopting] EHRs, to promoting interoperability and also the usability aspects that exactly gets to the problems we’ve identified.”
Dr. Wachter also warned that too much data could have a negative impact on the delivery of care.
“One of the challenges we face is continuing to stay alert, not turn our brains off, and become increasingly dependent on the computer to give us information,” he said. “How do we avoid the challenges we’ve already seen from things like alert and alarm fatigue as the computer becomes more robust as an information source. There is always the risk it is going to overwhelm us with too much information, and we are going to fall asleep at the switch. Or when the computer says something that really is not right for a patient, we will not be thinking clearly enough to catch it.”
Despite the looming challenges and industry consolidation that are expected, Dr. Wachter doesn’t believe there will be any shortage of demand for hospitalists.
“I think in most circumstances, [hospitalists are a protected] profession, given the complexity, the high variations, and the dependence that it still has on seeing the patient, talking to the patient, and talking to multiple consultants,” he said. “It’s a pretty hard thing to replace with technology. Overall, the job situation is pretty bright.”
The plenary sessions bookending the Society of Hospital Medicine’s HM18 conference will provide insight into the current state of hospital medicine and a glimpse at the directions in which it is evolving.
Opening the conference will be Kate Goodrich, MD, chief medical officer at the Centers for Medicare & Medicaid Services.
“What I want people to understand is the evolution within our health care system from one where we pay for volume to paying for value, and the role that Medicare can play in that,” Dr. Goodrich said in an interview. “Medicare has traditionally been sort of a passive payer, if you will, a passive payer of claims without a great deal of emphasis on the cost of care and the quality of care. [Now there is] a groundswell of concern nationally, not just here at CMS but nationwide, around the rising cost of care, and our quality of care is not as good as it should be for the amount that we spend.”
Dr. Goodrich said her plenary talk will look at how “that came to be, and then what CMS and other payers in the country are trying to do about it.” She said the United States is in a “truly transformative era in our health care system in changing how we pay for care, in service of better outcomes for patients and lower costs. I would like to give attendees the larger picture, of how we got here and what’s happening both at CMS and nationally to try and reverse some of those trends.”
Closing HM18, as has become tradition at the annual meeting, will be Robert Wachter, MD, MHM, of the University of California San Francisco, who will focus on the broader changes that must happen as the role of the hospitalist continues to evolve.
“I am going to talk about the changes in the world of hospital care and the importance of the field to innovate,” Dr. Wachter said. “To me, there are gravitational forces in the health care world that are making … patients who are in hospitals sicker than they were before. More and more patients are going to be cared for in outpatient settings and at home. We are going start to ... see things like sensors and telemedicine to enable more care outside of the hospital.”
Dr. Wachter said hospital medicine must evolve and mature, to continue to prove that hospitalists are indispensable staff members within the hospital.
“That was why the field became the fastest-growing profession in medical history. We can’t sit on our laurels. We have to continue to innovate,” he said. “Even as the system changes around us, I am confident that we will innovate. My talk will be a pep talk and include reflections on how the world of health care is changing, and what those changes will mean to hospitalists.”
As value-based purchasing programs – and the push to pay for value over volume in Medicare and the private sector – continue to become the norm, the expected trend of sicker, more complex patients entering the hospital is already happening, Dr. Goodrich said. She is experiencing it in her own clinical work, which continues in addition to her role at CMS.
“I can confirm from my own personal experience [that] I have absolutely encountered that exact trend,” she said. “I feel like every time I go in the hospital, my patients are sicker and more complex. That is the population of patients that hospitalists are dealing with. That’s why we are actually in that practice. We enjoy taking care of those types of patients and the challenges they bring, both on a clinical level but I would say also even on a social and economic level.”
Dr. Goodrich said that trend will present one of the key challenges hospitalists face in the future, especially as paying for value entails more two-sided risk.
“In a value-based purchasing world, transitioning to payments based on quality and cost is harder because by nature the sicker patients cost more and it is harder to improve their outcomes. They come to you already quite sick,” she said. “That’s a dilemma that a lot of hospitalists face, wondering ‘How is this going to affect me if I am already seeing the sickest of the sick?’ ”
Dr. Wachter noted that the trend of steering less sick patients to the outpatient setting, as well as other economic factors, would change the nature of hospitalist practice.
“It will be more acuity, more intensity, more complex relationships with your own hospital and often with partner hospitals,” he said. “More of the work will be digitally enabled than it would have been five or ten years ago.”
Integration of data and technology innovation will be a key to better serving this sicker population, Dr. Wachter predicted. We need “to take much fuller advantage than we have so far of the fact that we are all dealing with digital records and the decision support, the data analytics, the artificial intelligence that we get from our computer systems is pretty puny,” he said. “That is partly why physicians don’t love their computers so much. They spend huge amounts of time entering data into computers and don’t get much useful information out of it.”
Dr. Goodrich agreed that this is a challenge.
“How do we make it usable for the average front-line nurse or doctor who didn’t go to school to learn how to code and analyze data?” she asked. “How do we get platforms and analytics that are developed using human-centered design principles to make it very understandable and actionable to the front-end clinician, but also to patients and consumers? What is really needed to truly drive improvement is not just access to the data but usability.” She added that this problem is directly related to the usability of electronic health records. “That is a significant focus right now for the Office of the National Coordinator [of Health Information Technology] – to move away from just [adopting] EHRs, to promoting interoperability and also the usability aspects that exactly gets to the problems we’ve identified.”
Dr. Wachter also warned that too much data could have a negative impact on the delivery of care.
“One of the challenges we face is continuing to stay alert, not turn our brains off, and become increasingly dependent on the computer to give us information,” he said. “How do we avoid the challenges we’ve already seen from things like alert and alarm fatigue as the computer becomes more robust as an information source. There is always the risk it is going to overwhelm us with too much information, and we are going to fall asleep at the switch. Or when the computer says something that really is not right for a patient, we will not be thinking clearly enough to catch it.”
Despite the looming challenges and industry consolidation that are expected, Dr. Wachter doesn’t believe there will be any shortage of demand for hospitalists.
“I think in most circumstances, [hospitalists are a protected] profession, given the complexity, the high variations, and the dependence that it still has on seeing the patient, talking to the patient, and talking to multiple consultants,” he said. “It’s a pretty hard thing to replace with technology. Overall, the job situation is pretty bright.”
The plenary sessions bookending the Society of Hospital Medicine’s HM18 conference will provide insight into the current state of hospital medicine and a glimpse at the directions in which it is evolving.
Opening the conference will be Kate Goodrich, MD, chief medical officer at the Centers for Medicare & Medicaid Services.
“What I want people to understand is the evolution within our health care system from one where we pay for volume to paying for value, and the role that Medicare can play in that,” Dr. Goodrich said in an interview. “Medicare has traditionally been sort of a passive payer, if you will, a passive payer of claims without a great deal of emphasis on the cost of care and the quality of care. [Now there is] a groundswell of concern nationally, not just here at CMS but nationwide, around the rising cost of care, and our quality of care is not as good as it should be for the amount that we spend.”
Dr. Goodrich said her plenary talk will look at how “that came to be, and then what CMS and other payers in the country are trying to do about it.” She said the United States is in a “truly transformative era in our health care system in changing how we pay for care, in service of better outcomes for patients and lower costs. I would like to give attendees the larger picture, of how we got here and what’s happening both at CMS and nationally to try and reverse some of those trends.”
Closing HM18, as has become tradition at the annual meeting, will be Robert Wachter, MD, MHM, of the University of California San Francisco, who will focus on the broader changes that must happen as the role of the hospitalist continues to evolve.
“I am going to talk about the changes in the world of hospital care and the importance of the field to innovate,” Dr. Wachter said. “To me, there are gravitational forces in the health care world that are making … patients who are in hospitals sicker than they were before. More and more patients are going to be cared for in outpatient settings and at home. We are going start to ... see things like sensors and telemedicine to enable more care outside of the hospital.”
Dr. Wachter said hospital medicine must evolve and mature, to continue to prove that hospitalists are indispensable staff members within the hospital.
“That was why the field became the fastest-growing profession in medical history. We can’t sit on our laurels. We have to continue to innovate,” he said. “Even as the system changes around us, I am confident that we will innovate. My talk will be a pep talk and include reflections on how the world of health care is changing, and what those changes will mean to hospitalists.”
As value-based purchasing programs – and the push to pay for value over volume in Medicare and the private sector – continue to become the norm, the expected trend of sicker, more complex patients entering the hospital is already happening, Dr. Goodrich said. She is experiencing it in her own clinical work, which continues in addition to her role at CMS.
“I can confirm from my own personal experience [that] I have absolutely encountered that exact trend,” she said. “I feel like every time I go in the hospital, my patients are sicker and more complex. That is the population of patients that hospitalists are dealing with. That’s why we are actually in that practice. We enjoy taking care of those types of patients and the challenges they bring, both on a clinical level but I would say also even on a social and economic level.”
Dr. Goodrich said that trend will present one of the key challenges hospitalists face in the future, especially as paying for value entails more two-sided risk.
“In a value-based purchasing world, transitioning to payments based on quality and cost is harder because by nature the sicker patients cost more and it is harder to improve their outcomes. They come to you already quite sick,” she said. “That’s a dilemma that a lot of hospitalists face, wondering ‘How is this going to affect me if I am already seeing the sickest of the sick?’ ”
Dr. Wachter noted that the trend of steering less sick patients to the outpatient setting, as well as other economic factors, would change the nature of hospitalist practice.
“It will be more acuity, more intensity, more complex relationships with your own hospital and often with partner hospitals,” he said. “More of the work will be digitally enabled than it would have been five or ten years ago.”
Integration of data and technology innovation will be a key to better serving this sicker population, Dr. Wachter predicted. We need “to take much fuller advantage than we have so far of the fact that we are all dealing with digital records and the decision support, the data analytics, the artificial intelligence that we get from our computer systems is pretty puny,” he said. “That is partly why physicians don’t love their computers so much. They spend huge amounts of time entering data into computers and don’t get much useful information out of it.”
Dr. Goodrich agreed that this is a challenge.
“How do we make it usable for the average front-line nurse or doctor who didn’t go to school to learn how to code and analyze data?” she asked. “How do we get platforms and analytics that are developed using human-centered design principles to make it very understandable and actionable to the front-end clinician, but also to patients and consumers? What is really needed to truly drive improvement is not just access to the data but usability.” She added that this problem is directly related to the usability of electronic health records. “That is a significant focus right now for the Office of the National Coordinator [of Health Information Technology] – to move away from just [adopting] EHRs, to promoting interoperability and also the usability aspects that exactly gets to the problems we’ve identified.”
Dr. Wachter also warned that too much data could have a negative impact on the delivery of care.
“One of the challenges we face is continuing to stay alert, not turn our brains off, and become increasingly dependent on the computer to give us information,” he said. “How do we avoid the challenges we’ve already seen from things like alert and alarm fatigue as the computer becomes more robust as an information source. There is always the risk it is going to overwhelm us with too much information, and we are going to fall asleep at the switch. Or when the computer says something that really is not right for a patient, we will not be thinking clearly enough to catch it.”
Despite the looming challenges and industry consolidation that are expected, Dr. Wachter doesn’t believe there will be any shortage of demand for hospitalists.
“I think in most circumstances, [hospitalists are a protected] profession, given the complexity, the high variations, and the dependence that it still has on seeing the patient, talking to the patient, and talking to multiple consultants,” he said. “It’s a pretty hard thing to replace with technology. Overall, the job situation is pretty bright.”
Make the Diagnosis - March 2018
Familial benign chronic pemphigus, also known as Hailey-Hailey disease, is an uncommon autosomal dominant genetic condition. A mutation in the calcium ATPase (ATP2C1) gene on chromosome 3q21 interferes with calcium signaling and results in a loss of keratinocyte adhesion. Generally, the onset of the condition is in the second or third decade. There are two clinical subtypes of the disease: segmental type 1 and segmental type 2.
Histology reveals groups of acantholytic cells that resemble a “dilapidated brick wall.” Direct immunofluorescence is negative, unlike pemphigus vulgaris.
As hyperhidrosis is a known aggravating factor, injection with botulinum toxin (this is off-label use not yet approved by the Food and Drug Administration) in affected areas to decrease sweating has been reported to be effective.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].
Familial benign chronic pemphigus, also known as Hailey-Hailey disease, is an uncommon autosomal dominant genetic condition. A mutation in the calcium ATPase (ATP2C1) gene on chromosome 3q21 interferes with calcium signaling and results in a loss of keratinocyte adhesion. Generally, the onset of the condition is in the second or third decade. There are two clinical subtypes of the disease: segmental type 1 and segmental type 2.
Histology reveals groups of acantholytic cells that resemble a “dilapidated brick wall.” Direct immunofluorescence is negative, unlike pemphigus vulgaris.
As hyperhidrosis is a known aggravating factor, injection with botulinum toxin (this is off-label use not yet approved by the Food and Drug Administration) in affected areas to decrease sweating has been reported to be effective.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].
Familial benign chronic pemphigus, also known as Hailey-Hailey disease, is an uncommon autosomal dominant genetic condition. A mutation in the calcium ATPase (ATP2C1) gene on chromosome 3q21 interferes with calcium signaling and results in a loss of keratinocyte adhesion. Generally, the onset of the condition is in the second or third decade. There are two clinical subtypes of the disease: segmental type 1 and segmental type 2.
Histology reveals groups of acantholytic cells that resemble a “dilapidated brick wall.” Direct immunofluorescence is negative, unlike pemphigus vulgaris.
As hyperhidrosis is a known aggravating factor, injection with botulinum toxin (this is off-label use not yet approved by the Food and Drug Administration) in affected areas to decrease sweating has been reported to be effective.
This case and photo were submitted by Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].
A 39-year-old healthy black woman presented with itchy, painful lesions in the bilateral axillae and groin. The lesions have come and gone for 15 years and flare when the patient perspires. Her mother and grandmother have the same condition.
VIDEO: Model supports endoscopic resection for some T1b esophageal adenocarcinomas
Endoscopic treatment of T1a esophageal adenocarcinoma outperformed esophagectomy across a range of ages and comorbidity levels in a Markov model.
Esophagectomy produced 0.16 more unadjusted life-years, but led to 0.27 fewer quality-adjusted life-years (QALYs), in the hypothetical case of a 75-year-old man with T1aN0M0 esophageal adenocarcinoma (EAC) and a Charlson comorbidity index score of 0, reported Jacqueline N. Chu, MD, of Massachusetts General Hospital, Boston, and her associates. “[We] believe QALYs are a more important endpoint because of the significant morbidity associated with esophagectomy,” they wrote in the March issue of Clinical Gastroenterology and Hepatology.
Source: American Gastroenterological Association
In contrast, the model portrayed the management of T1b EAC as “an individualized decision” – esophagectomy was preferable in 60- to 70-year-old patients with T1b EAC, but serial endoscopic treatment was better when patients were older, with more comorbidities, the researchers said. “For the sickest patients, those aged 80 and older with comorbidity index of 2, endoscopic treatment not only provided more QALYs but more unadjusted life years as well.”
Treatment of T1a EAC is transitioning from esophagectomy to serial endoscopic resection, which physicians still tend to regard as too risky in T1b EAC. The Markov model evaluated the efficacy and cost efficacy of the two approaches in hypothetical T1a and T1b patients of various ages and comorbidities, using cancer death data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database and published cost data converted to 2017 U.S. dollars based on the U.S. Bureau of Labor Statistics’ Consumer Price Index.
Like the T1a case, the T1b base case consisted of a 75-year-old man with a Charlson comorbidity index of 0. Esophagectomy produced 0.72 more unadjusted life years than did endoscopic treatment (5.73 vs. 5.01) while yielding 0.22 more QALYs (4.07 vs. 3.85, respectively). Esophagectomy cost $156,981 more, but the model did not account for costs of chemotherapy and radiation or palliative care, all of which are more likely with endoscopic resection than esophagectomy, the researchers noted.
In sensitivity analyses, endoscopic treatment optimized quality of life in T1b EAC patients who were older than 80 years and had a comorbidity index of 1 or 2. Beyond that, treatment choice depended on posttreatment variables. “[If] a patient considered his or her quality of life postesophagectomy nearly equal to, or preferable to, [that] postendoscopic treatment, esophagectomy would be the optimal treatment strategy,” the investigators wrote. “An example would be the patient who would rather have an esophagectomy than worry about recurrence with endoscopic treatment.”
Pathologic analysis of T1a EACs can be inconsistent, and the model did not test whether high versus low pathologic risk affected treatment preference, the researchers said. They added data on T1NOS (T1 not otherwise specified) EACs to the model because the SEER-Medicare database included so few T1b endoscopic cases, but T1NOS patients had the worst outcomes and were in fact probably higher stage than T1. Fully 31% of endoscopy patients were T1NOS, compared with only 11% of esophagectomy patients, which would have biased the model against endoscopic treatment, according to the investigators.
The National Institutes of Health provided funding. Dr. Chu reported having no conflicts of interest. Three coinvestigators disclosed ties to CSA Medical, Ninepoint, C2 Therapeutics, Medtronic, and Trio Medicines. The remaining coinvestigators had no conflicts.
SOURCE: Chu JN et al. Clin Gastroenterol Hepatol. 2017 Nov 24. doi: 10.1016/j.cgh.2017.10.024.
Endoscopic treatment of T1a esophageal adenocarcinoma outperformed esophagectomy across a range of ages and comorbidity levels in a Markov model.
Esophagectomy produced 0.16 more unadjusted life-years, but led to 0.27 fewer quality-adjusted life-years (QALYs), in the hypothetical case of a 75-year-old man with T1aN0M0 esophageal adenocarcinoma (EAC) and a Charlson comorbidity index score of 0, reported Jacqueline N. Chu, MD, of Massachusetts General Hospital, Boston, and her associates. “[We] believe QALYs are a more important endpoint because of the significant morbidity associated with esophagectomy,” they wrote in the March issue of Clinical Gastroenterology and Hepatology.
Source: American Gastroenterological Association
In contrast, the model portrayed the management of T1b EAC as “an individualized decision” – esophagectomy was preferable in 60- to 70-year-old patients with T1b EAC, but serial endoscopic treatment was better when patients were older, with more comorbidities, the researchers said. “For the sickest patients, those aged 80 and older with comorbidity index of 2, endoscopic treatment not only provided more QALYs but more unadjusted life years as well.”
Treatment of T1a EAC is transitioning from esophagectomy to serial endoscopic resection, which physicians still tend to regard as too risky in T1b EAC. The Markov model evaluated the efficacy and cost efficacy of the two approaches in hypothetical T1a and T1b patients of various ages and comorbidities, using cancer death data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database and published cost data converted to 2017 U.S. dollars based on the U.S. Bureau of Labor Statistics’ Consumer Price Index.
Like the T1a case, the T1b base case consisted of a 75-year-old man with a Charlson comorbidity index of 0. Esophagectomy produced 0.72 more unadjusted life years than did endoscopic treatment (5.73 vs. 5.01) while yielding 0.22 more QALYs (4.07 vs. 3.85, respectively). Esophagectomy cost $156,981 more, but the model did not account for costs of chemotherapy and radiation or palliative care, all of which are more likely with endoscopic resection than esophagectomy, the researchers noted.
In sensitivity analyses, endoscopic treatment optimized quality of life in T1b EAC patients who were older than 80 years and had a comorbidity index of 1 or 2. Beyond that, treatment choice depended on posttreatment variables. “[If] a patient considered his or her quality of life postesophagectomy nearly equal to, or preferable to, [that] postendoscopic treatment, esophagectomy would be the optimal treatment strategy,” the investigators wrote. “An example would be the patient who would rather have an esophagectomy than worry about recurrence with endoscopic treatment.”
Pathologic analysis of T1a EACs can be inconsistent, and the model did not test whether high versus low pathologic risk affected treatment preference, the researchers said. They added data on T1NOS (T1 not otherwise specified) EACs to the model because the SEER-Medicare database included so few T1b endoscopic cases, but T1NOS patients had the worst outcomes and were in fact probably higher stage than T1. Fully 31% of endoscopy patients were T1NOS, compared with only 11% of esophagectomy patients, which would have biased the model against endoscopic treatment, according to the investigators.
The National Institutes of Health provided funding. Dr. Chu reported having no conflicts of interest. Three coinvestigators disclosed ties to CSA Medical, Ninepoint, C2 Therapeutics, Medtronic, and Trio Medicines. The remaining coinvestigators had no conflicts.
SOURCE: Chu JN et al. Clin Gastroenterol Hepatol. 2017 Nov 24. doi: 10.1016/j.cgh.2017.10.024.
Endoscopic treatment of T1a esophageal adenocarcinoma outperformed esophagectomy across a range of ages and comorbidity levels in a Markov model.
Esophagectomy produced 0.16 more unadjusted life-years, but led to 0.27 fewer quality-adjusted life-years (QALYs), in the hypothetical case of a 75-year-old man with T1aN0M0 esophageal adenocarcinoma (EAC) and a Charlson comorbidity index score of 0, reported Jacqueline N. Chu, MD, of Massachusetts General Hospital, Boston, and her associates. “[We] believe QALYs are a more important endpoint because of the significant morbidity associated with esophagectomy,” they wrote in the March issue of Clinical Gastroenterology and Hepatology.
Source: American Gastroenterological Association
In contrast, the model portrayed the management of T1b EAC as “an individualized decision” – esophagectomy was preferable in 60- to 70-year-old patients with T1b EAC, but serial endoscopic treatment was better when patients were older, with more comorbidities, the researchers said. “For the sickest patients, those aged 80 and older with comorbidity index of 2, endoscopic treatment not only provided more QALYs but more unadjusted life years as well.”
Treatment of T1a EAC is transitioning from esophagectomy to serial endoscopic resection, which physicians still tend to regard as too risky in T1b EAC. The Markov model evaluated the efficacy and cost efficacy of the two approaches in hypothetical T1a and T1b patients of various ages and comorbidities, using cancer death data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database and published cost data converted to 2017 U.S. dollars based on the U.S. Bureau of Labor Statistics’ Consumer Price Index.
Like the T1a case, the T1b base case consisted of a 75-year-old man with a Charlson comorbidity index of 0. Esophagectomy produced 0.72 more unadjusted life years than did endoscopic treatment (5.73 vs. 5.01) while yielding 0.22 more QALYs (4.07 vs. 3.85, respectively). Esophagectomy cost $156,981 more, but the model did not account for costs of chemotherapy and radiation or palliative care, all of which are more likely with endoscopic resection than esophagectomy, the researchers noted.
In sensitivity analyses, endoscopic treatment optimized quality of life in T1b EAC patients who were older than 80 years and had a comorbidity index of 1 or 2. Beyond that, treatment choice depended on posttreatment variables. “[If] a patient considered his or her quality of life postesophagectomy nearly equal to, or preferable to, [that] postendoscopic treatment, esophagectomy would be the optimal treatment strategy,” the investigators wrote. “An example would be the patient who would rather have an esophagectomy than worry about recurrence with endoscopic treatment.”
Pathologic analysis of T1a EACs can be inconsistent, and the model did not test whether high versus low pathologic risk affected treatment preference, the researchers said. They added data on T1NOS (T1 not otherwise specified) EACs to the model because the SEER-Medicare database included so few T1b endoscopic cases, but T1NOS patients had the worst outcomes and were in fact probably higher stage than T1. Fully 31% of endoscopy patients were T1NOS, compared with only 11% of esophagectomy patients, which would have biased the model against endoscopic treatment, according to the investigators.
The National Institutes of Health provided funding. Dr. Chu reported having no conflicts of interest. Three coinvestigators disclosed ties to CSA Medical, Ninepoint, C2 Therapeutics, Medtronic, and Trio Medicines. The remaining coinvestigators had no conflicts.
SOURCE: Chu JN et al. Clin Gastroenterol Hepatol. 2017 Nov 24. doi: 10.1016/j.cgh.2017.10.024.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: A Markov model supports endoscopic resection for some T1b esophageal adenocarcinomas.
Major finding: Endoscopic resection was preferred in T1b patients who were more than 80 years old or had a Charlson comorbidity index of 1or 2.
Data source: A Markov model with Surveillance, Epidemiology, and End Results (SEER) Medicare mortality data and published cost data converted to 2017 U.S. dollars based on the national Consumer Price Index.
Disclosures: The National Institutes of Health provided funding. Dr. Chu reported having no conflicts of interest. Three coinvestigators disclosed ties to CSA Medical, Ninepoint, C2 Therapeutics, Medtronic, and Trio Medicines. The remaining coinvestigators had no conflicts.
Source: Chu JN et al. Clin Gastroenterol Hepatol .2017 Nov 24. doi: 10.1016/j.cgh.2017.10.024.
Ulcerative colitis is disabling over time
Between 70% and 80% of patients with ulcerative colitis relapsed within 10 years of diagnosis and 10%-15% had aggressive disease in a meta-analysis of 17 population-based cohorts spanning 1935 to 2016.
However, “contemporary population-based cohorts of patients diagnosed in the biologic era are lacking,” [and they] “may inform us of the population-level impact of paradigm shifts in approach to ulcerative colitis management during the last decade, such as early use of disease-modifying biologic therapy and treat-to-target [strategies],” wrote Mathurin Fumery, MD, of the University of California San Diego, La Jolla. The report was published in Clinical Gastroenterology and Hepatology (2017 Jun 16. doi: 10.1016/j.cgh.2017.06.016).
Population-based observational cohort studies follow an entire group in a geographic area over an extended time, which better characterizes the true natural history of disease outside highly controlled settings of clinical trials, the reviewers noted. They searched MEDLINE for population-based longitudinal studies of adults with newly diagnosed ulcerative colitis, whose medical records were reviewed, and who were followed for at least a year. They identified 60 such studies of 17 cohorts that included 15,316 patients in southern and northern Europe, Australia, Israel, the United States, Canada, China, Hong Kong, Indonesia, Sri Lanka, Macau, Malaysia, Singapore, and Thailand.
Left-sided colitis was most common (median, 40%; interquartile range, 33%-45%) and about 10%-30% of patients had disease extension. Patients tended to have mild to moderate disease that was most active at diagnosis and subsequently alternated between remission and mild activity. However, nearly half of patients were hospitalized at some point because of ulcerative colitis, and about half of that subgroup was rehospitalized within 5 years. Furthermore, up to 15% of patients with ulcerative colitis underwent colectomy within 10 years, a risk that mucosal healing helped mitigate. Use of corticosteroids dropped over time as the prevalence of immunomodulators and anti–tumor necrosis factor therapy rose.
“Although ulcerative colitis is not associated with an increased risk of mortality, it is associated with high morbidity and work disability, comparable to Crohn’s disease,” the reviewers concluded. Not only are contemporary population-level data lacking, but it also remains unclear whether treating patients with ulcerative colitis according to baseline risk affects the disease course, or whether the natural history of this disease differs in newly industrialized nations or the Asia-Oceania region, they added.
Dr. Fumery disclosed support from the French Society of Gastroenterology, AbbVie, MSD, Takeda, and Ferring. Coinvestigators disclosed ties to numerous pharmaceutical companies.
SOURCE: Fumery M et al. Clin Gastroenterol Hepatol. 2017 Jun 16. doi: 10.1016/j.cgh.2017.06.016.
Understanding the natural history of ulcerative colitis (UC) is imperative especially in view of emerging therapies that could have the potential to alter the natural course of disease. Dr. Fumery and his colleagues are to be congratulated for conducting a comprehensive review of different inception cohorts across the world and evaluating different facets of the disease. They found that the majority of patients had a mild-moderate disease course, which was most active at the time of diagnosis. Approximately half the patients require UC-related hospitalization at some time during the course of their disease. Similarly, 50% of patients received corticosteroids, and while almost all patients with UC were treated with mesalamine within 1 year of diagnosis, 30%-40% are not on mesalamine long term. They also identified consistent predictors of poor prognosis, including young age at diagnosis, extensive disease, early need for corticosteroids, and elevated biochemical markers.
These results are reassuring because they reinforce the previous observations that roughly half the patients with UC have an uncomplicated disease course and that the first few years of disease are the most aggressive. A good indicator was that the proportion of patients receiving corticosteroids decreased over time. The disheartening news was that the long-term colectomy rates have generally remained stable over time.
Nabeel Khan, MD, is assistant professor of clinical medicine, University of Pennsylvania, Philadelphia, and director of gastroenterology, Philadelphia Veterans Affairs Medical Center. He has received research grants from Takeda, Luitpold, and Pfizer.
Understanding the natural history of ulcerative colitis (UC) is imperative especially in view of emerging therapies that could have the potential to alter the natural course of disease. Dr. Fumery and his colleagues are to be congratulated for conducting a comprehensive review of different inception cohorts across the world and evaluating different facets of the disease. They found that the majority of patients had a mild-moderate disease course, which was most active at the time of diagnosis. Approximately half the patients require UC-related hospitalization at some time during the course of their disease. Similarly, 50% of patients received corticosteroids, and while almost all patients with UC were treated with mesalamine within 1 year of diagnosis, 30%-40% are not on mesalamine long term. They also identified consistent predictors of poor prognosis, including young age at diagnosis, extensive disease, early need for corticosteroids, and elevated biochemical markers.
These results are reassuring because they reinforce the previous observations that roughly half the patients with UC have an uncomplicated disease course and that the first few years of disease are the most aggressive. A good indicator was that the proportion of patients receiving corticosteroids decreased over time. The disheartening news was that the long-term colectomy rates have generally remained stable over time.
Nabeel Khan, MD, is assistant professor of clinical medicine, University of Pennsylvania, Philadelphia, and director of gastroenterology, Philadelphia Veterans Affairs Medical Center. He has received research grants from Takeda, Luitpold, and Pfizer.
Understanding the natural history of ulcerative colitis (UC) is imperative especially in view of emerging therapies that could have the potential to alter the natural course of disease. Dr. Fumery and his colleagues are to be congratulated for conducting a comprehensive review of different inception cohorts across the world and evaluating different facets of the disease. They found that the majority of patients had a mild-moderate disease course, which was most active at the time of diagnosis. Approximately half the patients require UC-related hospitalization at some time during the course of their disease. Similarly, 50% of patients received corticosteroids, and while almost all patients with UC were treated with mesalamine within 1 year of diagnosis, 30%-40% are not on mesalamine long term. They also identified consistent predictors of poor prognosis, including young age at diagnosis, extensive disease, early need for corticosteroids, and elevated biochemical markers.
These results are reassuring because they reinforce the previous observations that roughly half the patients with UC have an uncomplicated disease course and that the first few years of disease are the most aggressive. A good indicator was that the proportion of patients receiving corticosteroids decreased over time. The disheartening news was that the long-term colectomy rates have generally remained stable over time.
Nabeel Khan, MD, is assistant professor of clinical medicine, University of Pennsylvania, Philadelphia, and director of gastroenterology, Philadelphia Veterans Affairs Medical Center. He has received research grants from Takeda, Luitpold, and Pfizer.
Between 70% and 80% of patients with ulcerative colitis relapsed within 10 years of diagnosis and 10%-15% had aggressive disease in a meta-analysis of 17 population-based cohorts spanning 1935 to 2016.
However, “contemporary population-based cohorts of patients diagnosed in the biologic era are lacking,” [and they] “may inform us of the population-level impact of paradigm shifts in approach to ulcerative colitis management during the last decade, such as early use of disease-modifying biologic therapy and treat-to-target [strategies],” wrote Mathurin Fumery, MD, of the University of California San Diego, La Jolla. The report was published in Clinical Gastroenterology and Hepatology (2017 Jun 16. doi: 10.1016/j.cgh.2017.06.016).
Population-based observational cohort studies follow an entire group in a geographic area over an extended time, which better characterizes the true natural history of disease outside highly controlled settings of clinical trials, the reviewers noted. They searched MEDLINE for population-based longitudinal studies of adults with newly diagnosed ulcerative colitis, whose medical records were reviewed, and who were followed for at least a year. They identified 60 such studies of 17 cohorts that included 15,316 patients in southern and northern Europe, Australia, Israel, the United States, Canada, China, Hong Kong, Indonesia, Sri Lanka, Macau, Malaysia, Singapore, and Thailand.
Left-sided colitis was most common (median, 40%; interquartile range, 33%-45%) and about 10%-30% of patients had disease extension. Patients tended to have mild to moderate disease that was most active at diagnosis and subsequently alternated between remission and mild activity. However, nearly half of patients were hospitalized at some point because of ulcerative colitis, and about half of that subgroup was rehospitalized within 5 years. Furthermore, up to 15% of patients with ulcerative colitis underwent colectomy within 10 years, a risk that mucosal healing helped mitigate. Use of corticosteroids dropped over time as the prevalence of immunomodulators and anti–tumor necrosis factor therapy rose.
“Although ulcerative colitis is not associated with an increased risk of mortality, it is associated with high morbidity and work disability, comparable to Crohn’s disease,” the reviewers concluded. Not only are contemporary population-level data lacking, but it also remains unclear whether treating patients with ulcerative colitis according to baseline risk affects the disease course, or whether the natural history of this disease differs in newly industrialized nations or the Asia-Oceania region, they added.
Dr. Fumery disclosed support from the French Society of Gastroenterology, AbbVie, MSD, Takeda, and Ferring. Coinvestigators disclosed ties to numerous pharmaceutical companies.
SOURCE: Fumery M et al. Clin Gastroenterol Hepatol. 2017 Jun 16. doi: 10.1016/j.cgh.2017.06.016.
Between 70% and 80% of patients with ulcerative colitis relapsed within 10 years of diagnosis and 10%-15% had aggressive disease in a meta-analysis of 17 population-based cohorts spanning 1935 to 2016.
However, “contemporary population-based cohorts of patients diagnosed in the biologic era are lacking,” [and they] “may inform us of the population-level impact of paradigm shifts in approach to ulcerative colitis management during the last decade, such as early use of disease-modifying biologic therapy and treat-to-target [strategies],” wrote Mathurin Fumery, MD, of the University of California San Diego, La Jolla. The report was published in Clinical Gastroenterology and Hepatology (2017 Jun 16. doi: 10.1016/j.cgh.2017.06.016).
Population-based observational cohort studies follow an entire group in a geographic area over an extended time, which better characterizes the true natural history of disease outside highly controlled settings of clinical trials, the reviewers noted. They searched MEDLINE for population-based longitudinal studies of adults with newly diagnosed ulcerative colitis, whose medical records were reviewed, and who were followed for at least a year. They identified 60 such studies of 17 cohorts that included 15,316 patients in southern and northern Europe, Australia, Israel, the United States, Canada, China, Hong Kong, Indonesia, Sri Lanka, Macau, Malaysia, Singapore, and Thailand.
Left-sided colitis was most common (median, 40%; interquartile range, 33%-45%) and about 10%-30% of patients had disease extension. Patients tended to have mild to moderate disease that was most active at diagnosis and subsequently alternated between remission and mild activity. However, nearly half of patients were hospitalized at some point because of ulcerative colitis, and about half of that subgroup was rehospitalized within 5 years. Furthermore, up to 15% of patients with ulcerative colitis underwent colectomy within 10 years, a risk that mucosal healing helped mitigate. Use of corticosteroids dropped over time as the prevalence of immunomodulators and anti–tumor necrosis factor therapy rose.
“Although ulcerative colitis is not associated with an increased risk of mortality, it is associated with high morbidity and work disability, comparable to Crohn’s disease,” the reviewers concluded. Not only are contemporary population-level data lacking, but it also remains unclear whether treating patients with ulcerative colitis according to baseline risk affects the disease course, or whether the natural history of this disease differs in newly industrialized nations or the Asia-Oceania region, they added.
Dr. Fumery disclosed support from the French Society of Gastroenterology, AbbVie, MSD, Takeda, and Ferring. Coinvestigators disclosed ties to numerous pharmaceutical companies.
SOURCE: Fumery M et al. Clin Gastroenterol Hepatol. 2017 Jun 16. doi: 10.1016/j.cgh.2017.06.016.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Although usually mild to moderate in severity, ulcerative colitis is disabling over time.
Major finding: Cumulative risk of relapse was 70%-80% at 10 years.
Data source: A systematic review and analysis of 17 population-based cohorts.
Disclosures: Dr. Fumery disclosed support from the French Society of Gastroenterology, Abbvie, MSD, Takeda, and Ferring. Coinvestigators disclosed ties to numerous pharmaceutical companies.
Source: Fumery M et al. Clin Gastroenterol Hepatol. 2017 Jun 16. doi: 10.1016/j.cgh.2017.06.016.
VIDEO: No short-term link found between PPIs, myocardial infarction
in a large retrospective insurance claims study.
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Over a median follow-up of 2-3 months, estimated weighted risks of first-ever MI were low and similar regardless of whether patients started PPIs or histamine2 receptor antagonists (H2RAs), reported Suzanne N. Landi of the University of North Carolina at Chapel Hill, and her associates. “Contrary to prior literature, our analyses do not indicate increased risk of MI in PPI initiators compared to histamine2-receptor antagonist initiators,” they wrote in the March issue of Gastroenterology.
Epidemiologic studies have produced mixed findings on PPI use and MI risk. Animal models and ex vivo studies of human tissue indicate that PPIs might harm coronary vessels by increasing plasma levels of asymmetrical dimethylarginine, which counteracts the vasoprotective activity of endothelial nitrous oxide synthase, the investigators noted. To further assess PPIs and risk of MI while minimizing potential confounding, they studied new users of either prescription PPIs or an active comparator, prescription H2RAs. The dataset included administrative claims for more than 5 million patients with no MI history who were enrolled in commercial insurance plans or Medicare Supplemental Insurance plans. The study data spanned from 2001 to 2014, and patients were followed from their initial antacid prescription until they either developed a first-ever MI, stopped their medication, or left their insurance plan. Median follow-up times were 60 days in patients with commercial insurance and 96 days in patients with Medicare Supplemental Insurance, which employers provide for individuals who are at least 65 years old.
After controlling for numerous measurable clinical and demographic confounders, the estimated 12-month risk of MI was about 2 cases per 1,000 commercially insured patients and about 8 cases per 1,000 Medicare Supplemental Insurance enrollees. The estimated 12-month risk of MI did not significantly differ between users of PPIs and H2RAs, regardless of whether they were enrolled in commercial insurance plans (weighted risk difference per 1,000 users, –0.08; 95% confidence interval, –0.51 to 0.36) or Medicare Supplemental Insurance (weighted risk difference per 1,000 users, –0.45; 95% CI, –1.53 to 0.58) plans.
Each antacid class also conferred a similar estimated risk of MI at 36 months, with weighted risk differences of 0.44 (95% CI, –0.90 to 1.63) per 1,000 commercial plan enrollees and –0.33 (95% CI, –4.40 to 3.46) per 1,000 Medicare Supplemental Insurance plan enrollees, the researchers reported. Weighted estimated risk ratios also were similar between drug classes, ranging from 0.87 (95% CI, 0.76 to 0.99) at 3 months among Medicare Supplemental Insurance enrollees to 1.08 (95% CI, 0.87 to 1.35) at 36 months among commercial insurance plan members.
“Previous studies have examined the risk of MI in PPI users and compared directly to nonusers, which may have resulted in stronger confounding by indication and other risk factors, such as BMI [body mass index] and baseline cardiovascular disease,” the investigators wrote. “Physicians and patients should not avoid starting a PPI because of concerns related to MI risk.”
The researchers received no grant support for this study. Ms. Landi disclosed a student fellowship from UCB Biosciences.
SOURCE: Source: Landi SN et al. Gastroenterology. 2017 Nov 6. doi: 10.1053/j.gastro.2017.10.042.
In the late 2000s, several large epidemiologic studies suggested that proton pump inhibitors (PPIs) increase the risk for MI in users of clopidogrel. There was a proposed mechanism: PPIs competitively inhibit cytochrome P450 isoenzymes, which blocked clopidogrel activation and, ex vivo, increased platelet aggregation. It sounded scary – but fortunately, some reassuring data quickly emerged. In 2007, the COGENT trial randomized patients with cardiovascular disease to a PPI/clopidogrel versus a placebo/clopidogrel combination pill. After 3 years of follow-up, there was no difference in rates of death or cardiovascular events. In the glaring light of this randomized controlled trial data, earlier studies didn’t look so convincing.
So why won’t the PPI/MI issue die? In part because COGENT was a relatively small study. It included 3,761 patients, but the main result depended on 109 cardiovascular events. Naysayers have argued that perhaps if COGENT had been a bigger study, the result would have been different.
In this context, the epidemiologic study by Suzanne Landi and her associates provides further reassurance that PPIs do not cause MI. Two insurance cohorts comprising over 5 million patients were used to compare PPI users with histamine2-receptor antagonist users after adjusting for baseline differences between the two groups. The large size of the dataset allowed the authors to make precise estimates; we can say with confidence that there was no clinically relevant PPI/MI risk in these data.
Can we forget about PPIs and MI? These days, my patients worry more about dementia or chronic kidney disease. But the PPI/MI story is worth remembering. Large epidemiologic studies are sometimes contradicted by subsequent studies and need to be evaluated in context.
Daniel E. Freedberg, MD, MS, is an assistant professor of medicine at the Columbia University Medical Center, New York. He has consulted for Pfizer.
In the late 2000s, several large epidemiologic studies suggested that proton pump inhibitors (PPIs) increase the risk for MI in users of clopidogrel. There was a proposed mechanism: PPIs competitively inhibit cytochrome P450 isoenzymes, which blocked clopidogrel activation and, ex vivo, increased platelet aggregation. It sounded scary – but fortunately, some reassuring data quickly emerged. In 2007, the COGENT trial randomized patients with cardiovascular disease to a PPI/clopidogrel versus a placebo/clopidogrel combination pill. After 3 years of follow-up, there was no difference in rates of death or cardiovascular events. In the glaring light of this randomized controlled trial data, earlier studies didn’t look so convincing.
So why won’t the PPI/MI issue die? In part because COGENT was a relatively small study. It included 3,761 patients, but the main result depended on 109 cardiovascular events. Naysayers have argued that perhaps if COGENT had been a bigger study, the result would have been different.
In this context, the epidemiologic study by Suzanne Landi and her associates provides further reassurance that PPIs do not cause MI. Two insurance cohorts comprising over 5 million patients were used to compare PPI users with histamine2-receptor antagonist users after adjusting for baseline differences between the two groups. The large size of the dataset allowed the authors to make precise estimates; we can say with confidence that there was no clinically relevant PPI/MI risk in these data.
Can we forget about PPIs and MI? These days, my patients worry more about dementia or chronic kidney disease. But the PPI/MI story is worth remembering. Large epidemiologic studies are sometimes contradicted by subsequent studies and need to be evaluated in context.
Daniel E. Freedberg, MD, MS, is an assistant professor of medicine at the Columbia University Medical Center, New York. He has consulted for Pfizer.
In the late 2000s, several large epidemiologic studies suggested that proton pump inhibitors (PPIs) increase the risk for MI in users of clopidogrel. There was a proposed mechanism: PPIs competitively inhibit cytochrome P450 isoenzymes, which blocked clopidogrel activation and, ex vivo, increased platelet aggregation. It sounded scary – but fortunately, some reassuring data quickly emerged. In 2007, the COGENT trial randomized patients with cardiovascular disease to a PPI/clopidogrel versus a placebo/clopidogrel combination pill. After 3 years of follow-up, there was no difference in rates of death or cardiovascular events. In the glaring light of this randomized controlled trial data, earlier studies didn’t look so convincing.
So why won’t the PPI/MI issue die? In part because COGENT was a relatively small study. It included 3,761 patients, but the main result depended on 109 cardiovascular events. Naysayers have argued that perhaps if COGENT had been a bigger study, the result would have been different.
In this context, the epidemiologic study by Suzanne Landi and her associates provides further reassurance that PPIs do not cause MI. Two insurance cohorts comprising over 5 million patients were used to compare PPI users with histamine2-receptor antagonist users after adjusting for baseline differences between the two groups. The large size of the dataset allowed the authors to make precise estimates; we can say with confidence that there was no clinically relevant PPI/MI risk in these data.
Can we forget about PPIs and MI? These days, my patients worry more about dementia or chronic kidney disease. But the PPI/MI story is worth remembering. Large epidemiologic studies are sometimes contradicted by subsequent studies and need to be evaluated in context.
Daniel E. Freedberg, MD, MS, is an assistant professor of medicine at the Columbia University Medical Center, New York. He has consulted for Pfizer.
in a large retrospective insurance claims study.
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Over a median follow-up of 2-3 months, estimated weighted risks of first-ever MI were low and similar regardless of whether patients started PPIs or histamine2 receptor antagonists (H2RAs), reported Suzanne N. Landi of the University of North Carolina at Chapel Hill, and her associates. “Contrary to prior literature, our analyses do not indicate increased risk of MI in PPI initiators compared to histamine2-receptor antagonist initiators,” they wrote in the March issue of Gastroenterology.
Epidemiologic studies have produced mixed findings on PPI use and MI risk. Animal models and ex vivo studies of human tissue indicate that PPIs might harm coronary vessels by increasing plasma levels of asymmetrical dimethylarginine, which counteracts the vasoprotective activity of endothelial nitrous oxide synthase, the investigators noted. To further assess PPIs and risk of MI while minimizing potential confounding, they studied new users of either prescription PPIs or an active comparator, prescription H2RAs. The dataset included administrative claims for more than 5 million patients with no MI history who were enrolled in commercial insurance plans or Medicare Supplemental Insurance plans. The study data spanned from 2001 to 2014, and patients were followed from their initial antacid prescription until they either developed a first-ever MI, stopped their medication, or left their insurance plan. Median follow-up times were 60 days in patients with commercial insurance and 96 days in patients with Medicare Supplemental Insurance, which employers provide for individuals who are at least 65 years old.
After controlling for numerous measurable clinical and demographic confounders, the estimated 12-month risk of MI was about 2 cases per 1,000 commercially insured patients and about 8 cases per 1,000 Medicare Supplemental Insurance enrollees. The estimated 12-month risk of MI did not significantly differ between users of PPIs and H2RAs, regardless of whether they were enrolled in commercial insurance plans (weighted risk difference per 1,000 users, –0.08; 95% confidence interval, –0.51 to 0.36) or Medicare Supplemental Insurance (weighted risk difference per 1,000 users, –0.45; 95% CI, –1.53 to 0.58) plans.
Each antacid class also conferred a similar estimated risk of MI at 36 months, with weighted risk differences of 0.44 (95% CI, –0.90 to 1.63) per 1,000 commercial plan enrollees and –0.33 (95% CI, –4.40 to 3.46) per 1,000 Medicare Supplemental Insurance plan enrollees, the researchers reported. Weighted estimated risk ratios also were similar between drug classes, ranging from 0.87 (95% CI, 0.76 to 0.99) at 3 months among Medicare Supplemental Insurance enrollees to 1.08 (95% CI, 0.87 to 1.35) at 36 months among commercial insurance plan members.
“Previous studies have examined the risk of MI in PPI users and compared directly to nonusers, which may have resulted in stronger confounding by indication and other risk factors, such as BMI [body mass index] and baseline cardiovascular disease,” the investigators wrote. “Physicians and patients should not avoid starting a PPI because of concerns related to MI risk.”
The researchers received no grant support for this study. Ms. Landi disclosed a student fellowship from UCB Biosciences.
SOURCE: Source: Landi SN et al. Gastroenterology. 2017 Nov 6. doi: 10.1053/j.gastro.2017.10.042.
in a large retrospective insurance claims study.
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Over a median follow-up of 2-3 months, estimated weighted risks of first-ever MI were low and similar regardless of whether patients started PPIs or histamine2 receptor antagonists (H2RAs), reported Suzanne N. Landi of the University of North Carolina at Chapel Hill, and her associates. “Contrary to prior literature, our analyses do not indicate increased risk of MI in PPI initiators compared to histamine2-receptor antagonist initiators,” they wrote in the March issue of Gastroenterology.
Epidemiologic studies have produced mixed findings on PPI use and MI risk. Animal models and ex vivo studies of human tissue indicate that PPIs might harm coronary vessels by increasing plasma levels of asymmetrical dimethylarginine, which counteracts the vasoprotective activity of endothelial nitrous oxide synthase, the investigators noted. To further assess PPIs and risk of MI while minimizing potential confounding, they studied new users of either prescription PPIs or an active comparator, prescription H2RAs. The dataset included administrative claims for more than 5 million patients with no MI history who were enrolled in commercial insurance plans or Medicare Supplemental Insurance plans. The study data spanned from 2001 to 2014, and patients were followed from their initial antacid prescription until they either developed a first-ever MI, stopped their medication, or left their insurance plan. Median follow-up times were 60 days in patients with commercial insurance and 96 days in patients with Medicare Supplemental Insurance, which employers provide for individuals who are at least 65 years old.
After controlling for numerous measurable clinical and demographic confounders, the estimated 12-month risk of MI was about 2 cases per 1,000 commercially insured patients and about 8 cases per 1,000 Medicare Supplemental Insurance enrollees. The estimated 12-month risk of MI did not significantly differ between users of PPIs and H2RAs, regardless of whether they were enrolled in commercial insurance plans (weighted risk difference per 1,000 users, –0.08; 95% confidence interval, –0.51 to 0.36) or Medicare Supplemental Insurance (weighted risk difference per 1,000 users, –0.45; 95% CI, –1.53 to 0.58) plans.
Each antacid class also conferred a similar estimated risk of MI at 36 months, with weighted risk differences of 0.44 (95% CI, –0.90 to 1.63) per 1,000 commercial plan enrollees and –0.33 (95% CI, –4.40 to 3.46) per 1,000 Medicare Supplemental Insurance plan enrollees, the researchers reported. Weighted estimated risk ratios also were similar between drug classes, ranging from 0.87 (95% CI, 0.76 to 0.99) at 3 months among Medicare Supplemental Insurance enrollees to 1.08 (95% CI, 0.87 to 1.35) at 36 months among commercial insurance plan members.
“Previous studies have examined the risk of MI in PPI users and compared directly to nonusers, which may have resulted in stronger confounding by indication and other risk factors, such as BMI [body mass index] and baseline cardiovascular disease,” the investigators wrote. “Physicians and patients should not avoid starting a PPI because of concerns related to MI risk.”
The researchers received no grant support for this study. Ms. Landi disclosed a student fellowship from UCB Biosciences.
SOURCE: Source: Landi SN et al. Gastroenterology. 2017 Nov 6. doi: 10.1053/j.gastro.2017.10.042.
FROM GASTROENTEROLOGY
Key clinical point: Starting a PPI did not appear to increase the short-term risk of MI.
Major finding: Over a median follow-up time of 2-3 months, the estimated risk of first-ever MI did not statistically differ between initiators of PPIs and initiators of histamine2-receptor antagonists.
Data source: Analyses of commercial and Medicare Supplemental Insurance claims for more than 5 million patients from 2001-2014.
Disclosures: The researchers received no grant support for this study. Ms. Landi disclosed a student fellowship from UCB Biosciences.
Source: Landi SN et al. Gastroenterology. 2017 Nov 6. doi: 10.1053/j.gastro.2017.10.042.
AGA Guideline: Use goal-directed fluid therapy, early oral feeding in acute pancreatitis
Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.
In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).
The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).
The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.
The guideline strongly recommends early oral feeding and enteral rather than parenteral nutrition for all patients with acute pancreatitis. In 11 randomized controlled trials, early and delayed feeding led to similar rates of mortality, but delayed feeding produced a 2.5-fold higher risk of necrosis (95% CI for OR, 1.4-4.4) and tended to increase the risk of infected peripancreatic necrosis, multiorgan failure, and total necrotizing pancreatitis, the authors wrote. In another 12 trials, enteral nutrition significantly reduced the risk of infected peripancreatic necrosis, single-organ failure, and multiorgan failure compared with parenteral nutrition.
Clinicians continue to debate cholecystectomy timing in patients with biliary or gallstone pancreatitis. The guidelines strongly recommend same-admission cholecystectomy, citing a randomized controlled trial in which this approach markedly reduced the combined risk of mortality and gallstone-related complications (OR, 0.2, 95% CI, 0.1-0.6), readmission for recurrent pancreatitis (OR, 0.3, 95% CI, 0.1-0.9), and pancreaticobiliary complications (OR, 0.2, 95% CI, 0.1-0.6). “The AGA issued a strong recommendation due to the quality of available evidence and the high likelihood of benefit from early versus delayed cholecystectomy in this patient population,” the experts stated.
Patients with biliary pancreatitis should be evaluated for cholecystectomy during the same admission, while those with alcohol-induced pancreatitis should receive a brief alcohol intervention, according to the guidelines, which also call for better studies of how alcohol and tobacco cessation measures affect risk of recurrent acute pancreatitis, chronic pancreatitis, and pancreatic cancer, as well as quality of life, health care utilization, and mortality.
The authors also noted knowledge gaps concerning the relative benefits of risk stratification tools, the use of prophylactic antibiotics in patients with severe acute pancreatitis or necrotizing pancreatitis, and the timing of ERCP in patients with severe biliary pancreatitis with persistent biliary obstruction.
The guideline was developed with sole funding by the AGA Institute with no external funding. The authors disclosed no relevant conflicts of interest.
Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.
Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.
In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).
The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).
The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.
The guideline strongly recommends early oral feeding and enteral rather than parenteral nutrition for all patients with acute pancreatitis. In 11 randomized controlled trials, early and delayed feeding led to similar rates of mortality, but delayed feeding produced a 2.5-fold higher risk of necrosis (95% CI for OR, 1.4-4.4) and tended to increase the risk of infected peripancreatic necrosis, multiorgan failure, and total necrotizing pancreatitis, the authors wrote. In another 12 trials, enteral nutrition significantly reduced the risk of infected peripancreatic necrosis, single-organ failure, and multiorgan failure compared with parenteral nutrition.
Clinicians continue to debate cholecystectomy timing in patients with biliary or gallstone pancreatitis. The guidelines strongly recommend same-admission cholecystectomy, citing a randomized controlled trial in which this approach markedly reduced the combined risk of mortality and gallstone-related complications (OR, 0.2, 95% CI, 0.1-0.6), readmission for recurrent pancreatitis (OR, 0.3, 95% CI, 0.1-0.9), and pancreaticobiliary complications (OR, 0.2, 95% CI, 0.1-0.6). “The AGA issued a strong recommendation due to the quality of available evidence and the high likelihood of benefit from early versus delayed cholecystectomy in this patient population,” the experts stated.
Patients with biliary pancreatitis should be evaluated for cholecystectomy during the same admission, while those with alcohol-induced pancreatitis should receive a brief alcohol intervention, according to the guidelines, which also call for better studies of how alcohol and tobacco cessation measures affect risk of recurrent acute pancreatitis, chronic pancreatitis, and pancreatic cancer, as well as quality of life, health care utilization, and mortality.
The authors also noted knowledge gaps concerning the relative benefits of risk stratification tools, the use of prophylactic antibiotics in patients with severe acute pancreatitis or necrotizing pancreatitis, and the timing of ERCP in patients with severe biliary pancreatitis with persistent biliary obstruction.
The guideline was developed with sole funding by the AGA Institute with no external funding. The authors disclosed no relevant conflicts of interest.
Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.
Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.
In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).
The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).
The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.
The guideline strongly recommends early oral feeding and enteral rather than parenteral nutrition for all patients with acute pancreatitis. In 11 randomized controlled trials, early and delayed feeding led to similar rates of mortality, but delayed feeding produced a 2.5-fold higher risk of necrosis (95% CI for OR, 1.4-4.4) and tended to increase the risk of infected peripancreatic necrosis, multiorgan failure, and total necrotizing pancreatitis, the authors wrote. In another 12 trials, enteral nutrition significantly reduced the risk of infected peripancreatic necrosis, single-organ failure, and multiorgan failure compared with parenteral nutrition.
Clinicians continue to debate cholecystectomy timing in patients with biliary or gallstone pancreatitis. The guidelines strongly recommend same-admission cholecystectomy, citing a randomized controlled trial in which this approach markedly reduced the combined risk of mortality and gallstone-related complications (OR, 0.2, 95% CI, 0.1-0.6), readmission for recurrent pancreatitis (OR, 0.3, 95% CI, 0.1-0.9), and pancreaticobiliary complications (OR, 0.2, 95% CI, 0.1-0.6). “The AGA issued a strong recommendation due to the quality of available evidence and the high likelihood of benefit from early versus delayed cholecystectomy in this patient population,” the experts stated.
Patients with biliary pancreatitis should be evaluated for cholecystectomy during the same admission, while those with alcohol-induced pancreatitis should receive a brief alcohol intervention, according to the guidelines, which also call for better studies of how alcohol and tobacco cessation measures affect risk of recurrent acute pancreatitis, chronic pancreatitis, and pancreatic cancer, as well as quality of life, health care utilization, and mortality.
The authors also noted knowledge gaps concerning the relative benefits of risk stratification tools, the use of prophylactic antibiotics in patients with severe acute pancreatitis or necrotizing pancreatitis, and the timing of ERCP in patients with severe biliary pancreatitis with persistent biliary obstruction.
The guideline was developed with sole funding by the AGA Institute with no external funding. The authors disclosed no relevant conflicts of interest.
Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.
FROM GASTROENTEROLOGY
Hydrocortisone-fludrocortisone cuts deaths in septic shock
Hydrocortisone in combination with fludrocortisone significantly reduced 90-day mortality in septic shock patients in a double-blind, randomized, controlled trial.
Prior to this study, two large trials had displayed that corticosteroids were beneficial in improving hemodynamic status and organ function, but little was known about corticosteroids’ ability to increase survival in sepsis patients.
The study, named the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial, was designed to assess the benefit/risk ratio of using activated protein C – drotrecogin alfa (activated) – and corticosteroids together or separately in septic shock patients. The original design of the study included Xigris (drotrecogin alfa) and was composed of four parallel groups, but Xigris was removed from the market in October of 2011, so the study continued with only two parallel groups.
A total of 1,241 patients experiencing chronic septic shock were recruited into the two double-blind, parallel groups, with patients in one group receiving hydrocortisone plus fludrocortisone and the other receiving placebos. The placebos used in this study were similar in appearance to the actual treatment drugs. The placebos for hydrocortisone and fludrocortisone were either parenteral mannitol (133.6 mg), disodium phosphate (8.73 mg), and sodium phosphate (0.92 mg) or tablets of microcrystalline cellulose (59.098 mg), respectively.
Hydrocortisone was given intravenously every 6 hours as a 50-mg intravenous bolus, and fludrocortisone was given once a day as a 50-mcg tablet through a nasogastric tube. Patients in ICUs who had septic shock for less than 24 hours were included in the study. Septic shock was identified by the presence of a clinically or microbiologically documented infection, a Sequential Organ Failure Assessment score of 3 or 4 for at least two organs and for at least 6 hours, and receipt of vasopressor therapy for at least 6 hours.
After 90 days, 264 of 614 of the patients (43%) in the hydrocortisone/fludrocortisone group and almost half (49.1%) of 627 patients in the placebo group had died (P = .03). The relative risk of death was 0.88 (95% confidence interval, 0.78-0.99), which favored the hydrocortisone/fludrocortisone group. The researchers also observed that death was significantly lower in the hydrocortisone/fludrocortisone group, compared with the placebo group, at time of ICU discharge (35.4% vs. 41.0%, respectively; P = .04).
While mortality was reduced, patients still experienced adverse events. 326 of 614 (53.1%) patients in the hydrocortisone/fludrocortisone group and 363 of 626 patients (58.0%) in the placebo group experienced at least one serious adverse event by day 180 (P = 0.08).
“Seven-day treatment with a 50-mg intravenous bolus of hydrocortisone every 6 hours and a daily dose of 50 mcg of oral fludrocortisone resulted in lower mortality at day 90 and at ICU and hospital discharge than placebo among adults with septic shock,” concluded Dr. Annane and his coauthors.
The majority of researchers had no relevant financial disclosures to report, while some doctors received grants and personal fees unrelated to this study. This study was funded in part by public grants from the French Ministry of Health.
SOURCE: Annana A et al. NEJM. 2018 Feb 28. doi: 10.1056/NEJMoa1705716.
The results of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial and the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL), both reported in the latest issue of NEJM, are landmark studies detailing the largest analyses of hydrocortisone use in patients with septic shock.
Both of these trials were massive, with over 5,000 patients combined, which is much larger than all previous studies according to Anthony Suffredini, MD, of the National Institutes of Health. An additional useful feature of these trials was that they had clear criteria for entry into the study. These criteria included: “vasopressor-dependent shock and respiratory failure leading to the use of mechanical ventilation, details of antimicrobial therapy, assessment of survival at 90 days, and well-defined secondary outcomes and analyses of adverse events.”
The ADRENAL and APROCCHSS had vastly different 90-day mortality rates: ADRENAL had mortality rates of 27.9% with hydrocortisone and 28.8% with placebo (P = .50), while APROACCHSS had mortality rates of 43.0% with hydrocortisone plus fludrocortisone and 49.1% with placebo (P = .03). Despite this, they both display the beneficial effect anti-inflammatory therapies, such as hydrocortisone, have on secondary outcomes of shock reversal and the reduction in duration of mechanical ventilation. “It is unlikely that in the near future sufficiently powered trials will provide us with better data” than the ADRENAL and APROCCHSS trials, Dr. Suffredini wrote.
Dr. Suffredini made these comments in an editorial accompanying this study in the New England Journal of Medicine. He is the deputy chief of the critical care medicine department at the National Institutes of Health Clinical Center, and he has served on the executive committee of the Department of Veteran Affairs Cooperative Studies Program. He has no other relevant financial disclosures to report.
The results of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial and the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL), both reported in the latest issue of NEJM, are landmark studies detailing the largest analyses of hydrocortisone use in patients with septic shock.
Both of these trials were massive, with over 5,000 patients combined, which is much larger than all previous studies according to Anthony Suffredini, MD, of the National Institutes of Health. An additional useful feature of these trials was that they had clear criteria for entry into the study. These criteria included: “vasopressor-dependent shock and respiratory failure leading to the use of mechanical ventilation, details of antimicrobial therapy, assessment of survival at 90 days, and well-defined secondary outcomes and analyses of adverse events.”
The ADRENAL and APROCCHSS had vastly different 90-day mortality rates: ADRENAL had mortality rates of 27.9% with hydrocortisone and 28.8% with placebo (P = .50), while APROACCHSS had mortality rates of 43.0% with hydrocortisone plus fludrocortisone and 49.1% with placebo (P = .03). Despite this, they both display the beneficial effect anti-inflammatory therapies, such as hydrocortisone, have on secondary outcomes of shock reversal and the reduction in duration of mechanical ventilation. “It is unlikely that in the near future sufficiently powered trials will provide us with better data” than the ADRENAL and APROCCHSS trials, Dr. Suffredini wrote.
Dr. Suffredini made these comments in an editorial accompanying this study in the New England Journal of Medicine. He is the deputy chief of the critical care medicine department at the National Institutes of Health Clinical Center, and he has served on the executive committee of the Department of Veteran Affairs Cooperative Studies Program. He has no other relevant financial disclosures to report.
The results of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial and the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL), both reported in the latest issue of NEJM, are landmark studies detailing the largest analyses of hydrocortisone use in patients with septic shock.
Both of these trials were massive, with over 5,000 patients combined, which is much larger than all previous studies according to Anthony Suffredini, MD, of the National Institutes of Health. An additional useful feature of these trials was that they had clear criteria for entry into the study. These criteria included: “vasopressor-dependent shock and respiratory failure leading to the use of mechanical ventilation, details of antimicrobial therapy, assessment of survival at 90 days, and well-defined secondary outcomes and analyses of adverse events.”
The ADRENAL and APROCCHSS had vastly different 90-day mortality rates: ADRENAL had mortality rates of 27.9% with hydrocortisone and 28.8% with placebo (P = .50), while APROACCHSS had mortality rates of 43.0% with hydrocortisone plus fludrocortisone and 49.1% with placebo (P = .03). Despite this, they both display the beneficial effect anti-inflammatory therapies, such as hydrocortisone, have on secondary outcomes of shock reversal and the reduction in duration of mechanical ventilation. “It is unlikely that in the near future sufficiently powered trials will provide us with better data” than the ADRENAL and APROCCHSS trials, Dr. Suffredini wrote.
Dr. Suffredini made these comments in an editorial accompanying this study in the New England Journal of Medicine. He is the deputy chief of the critical care medicine department at the National Institutes of Health Clinical Center, and he has served on the executive committee of the Department of Veteran Affairs Cooperative Studies Program. He has no other relevant financial disclosures to report.
Hydrocortisone in combination with fludrocortisone significantly reduced 90-day mortality in septic shock patients in a double-blind, randomized, controlled trial.
Prior to this study, two large trials had displayed that corticosteroids were beneficial in improving hemodynamic status and organ function, but little was known about corticosteroids’ ability to increase survival in sepsis patients.
The study, named the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial, was designed to assess the benefit/risk ratio of using activated protein C – drotrecogin alfa (activated) – and corticosteroids together or separately in septic shock patients. The original design of the study included Xigris (drotrecogin alfa) and was composed of four parallel groups, but Xigris was removed from the market in October of 2011, so the study continued with only two parallel groups.
A total of 1,241 patients experiencing chronic septic shock were recruited into the two double-blind, parallel groups, with patients in one group receiving hydrocortisone plus fludrocortisone and the other receiving placebos. The placebos used in this study were similar in appearance to the actual treatment drugs. The placebos for hydrocortisone and fludrocortisone were either parenteral mannitol (133.6 mg), disodium phosphate (8.73 mg), and sodium phosphate (0.92 mg) or tablets of microcrystalline cellulose (59.098 mg), respectively.
Hydrocortisone was given intravenously every 6 hours as a 50-mg intravenous bolus, and fludrocortisone was given once a day as a 50-mcg tablet through a nasogastric tube. Patients in ICUs who had septic shock for less than 24 hours were included in the study. Septic shock was identified by the presence of a clinically or microbiologically documented infection, a Sequential Organ Failure Assessment score of 3 or 4 for at least two organs and for at least 6 hours, and receipt of vasopressor therapy for at least 6 hours.
After 90 days, 264 of 614 of the patients (43%) in the hydrocortisone/fludrocortisone group and almost half (49.1%) of 627 patients in the placebo group had died (P = .03). The relative risk of death was 0.88 (95% confidence interval, 0.78-0.99), which favored the hydrocortisone/fludrocortisone group. The researchers also observed that death was significantly lower in the hydrocortisone/fludrocortisone group, compared with the placebo group, at time of ICU discharge (35.4% vs. 41.0%, respectively; P = .04).
While mortality was reduced, patients still experienced adverse events. 326 of 614 (53.1%) patients in the hydrocortisone/fludrocortisone group and 363 of 626 patients (58.0%) in the placebo group experienced at least one serious adverse event by day 180 (P = 0.08).
“Seven-day treatment with a 50-mg intravenous bolus of hydrocortisone every 6 hours and a daily dose of 50 mcg of oral fludrocortisone resulted in lower mortality at day 90 and at ICU and hospital discharge than placebo among adults with septic shock,” concluded Dr. Annane and his coauthors.
The majority of researchers had no relevant financial disclosures to report, while some doctors received grants and personal fees unrelated to this study. This study was funded in part by public grants from the French Ministry of Health.
SOURCE: Annana A et al. NEJM. 2018 Feb 28. doi: 10.1056/NEJMoa1705716.
Hydrocortisone in combination with fludrocortisone significantly reduced 90-day mortality in septic shock patients in a double-blind, randomized, controlled trial.
Prior to this study, two large trials had displayed that corticosteroids were beneficial in improving hemodynamic status and organ function, but little was known about corticosteroids’ ability to increase survival in sepsis patients.
The study, named the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial, was designed to assess the benefit/risk ratio of using activated protein C – drotrecogin alfa (activated) – and corticosteroids together or separately in septic shock patients. The original design of the study included Xigris (drotrecogin alfa) and was composed of four parallel groups, but Xigris was removed from the market in October of 2011, so the study continued with only two parallel groups.
A total of 1,241 patients experiencing chronic septic shock were recruited into the two double-blind, parallel groups, with patients in one group receiving hydrocortisone plus fludrocortisone and the other receiving placebos. The placebos used in this study were similar in appearance to the actual treatment drugs. The placebos for hydrocortisone and fludrocortisone were either parenteral mannitol (133.6 mg), disodium phosphate (8.73 mg), and sodium phosphate (0.92 mg) or tablets of microcrystalline cellulose (59.098 mg), respectively.
Hydrocortisone was given intravenously every 6 hours as a 50-mg intravenous bolus, and fludrocortisone was given once a day as a 50-mcg tablet through a nasogastric tube. Patients in ICUs who had septic shock for less than 24 hours were included in the study. Septic shock was identified by the presence of a clinically or microbiologically documented infection, a Sequential Organ Failure Assessment score of 3 or 4 for at least two organs and for at least 6 hours, and receipt of vasopressor therapy for at least 6 hours.
After 90 days, 264 of 614 of the patients (43%) in the hydrocortisone/fludrocortisone group and almost half (49.1%) of 627 patients in the placebo group had died (P = .03). The relative risk of death was 0.88 (95% confidence interval, 0.78-0.99), which favored the hydrocortisone/fludrocortisone group. The researchers also observed that death was significantly lower in the hydrocortisone/fludrocortisone group, compared with the placebo group, at time of ICU discharge (35.4% vs. 41.0%, respectively; P = .04).
While mortality was reduced, patients still experienced adverse events. 326 of 614 (53.1%) patients in the hydrocortisone/fludrocortisone group and 363 of 626 patients (58.0%) in the placebo group experienced at least one serious adverse event by day 180 (P = 0.08).
“Seven-day treatment with a 50-mg intravenous bolus of hydrocortisone every 6 hours and a daily dose of 50 mcg of oral fludrocortisone resulted in lower mortality at day 90 and at ICU and hospital discharge than placebo among adults with septic shock,” concluded Dr. Annane and his coauthors.
The majority of researchers had no relevant financial disclosures to report, while some doctors received grants and personal fees unrelated to this study. This study was funded in part by public grants from the French Ministry of Health.
SOURCE: Annana A et al. NEJM. 2018 Feb 28. doi: 10.1056/NEJMoa1705716.
FROM NEJM
Key clinical point: Hydrocortisone in combination with fludrocortisone significantly reduced 90-day mortality in septic shock patients.
Major finding: Mortality rates were lower in patients treated with hydrocortisone plus fludrocortisone, compared with patients treated with placebos (43% vs. 49.1%, respectively; P = .03).
Study details: A randomized, double-blind study of 1,241 patients with septic shock.
Disclosures: The majority of researchers had no relevant financial disclosures to report, while some doctors received grants and personal fees unrelated to this study. This study was funded in part by public grants from the French Ministry of Health.
Source: Annane A et al. NEJM. 2018 Feb 28. doi: 10.1056/NEJMoa1705716.
On-demand nebulization in ICU equivalent to standard
SAN ANTONIO – with both medications, according to the results of a randomized clinical trial presented by Frederique Paulus, RN, PhD.
In this study, adverse events such as tachyarrhythmia and agitation were less frequent with the on-demand approach, in which patients receive nebulization based on strict clinical indications, Dr. Paulus reported at the Critical Care Congress sponsored by the Society for Critical Care Medicine. The study was published simultaneously in JAMA.
The on-demand approach may also be cost saving, she noted, citing an economic analysis underway that is not yet ready for publication.
“In our ICU, it will save us 350,000 Euros a year,” she said. “In the Netherlands, 40,000 patients will be mechanically ventilated in a year, so it will save us millions in the Netherlands alone.”
The study included adult ICU patients who were expected not to be extubated for at least 24 hours. Dr. Paulus presented the primary analysis of the study, which included data for 922 patients who were randomized either to the on-demand group (n = 455) or the routine nebulization group (n = 467) and completed follow-up.
Patients assigned to the on-demand group received acetylcysteine-containing solutions if they had thick or tenacious secretions, or salbutamol-containing solutions if wheezing was observed or suspected or when findings were suggestive of lower-airway obstruction, according to the paper, published in JAMA.
The primary outcome, number of ventilator-free days at day 28 of the study, was noninferior in the on-demand group versus the routine group, Dr. Paulus said.
The median number of ventilator-free days was 21 for the on-demand group and 20 for the routine group, said the paper.
The length of stay, mortality, and proportion of patients developing pulmonary complications did not differ between the two study arms, the investigators also reported in JAMA.
However, adverse events occurred in just 13.8% of the on-demand group, compared with 29.3% of the routine group (P less than .001), with the difference in adverse events mainly attributable to less tachyarrhythmia and agitation in the experimental group, according to the researchers.
Dr. Paulus and coauthors reported no conflicts of interest related to the study.
SOURCE: Paulus F et al. (van Meenen DMP et al.) JAMA. 2018 Feb. doi: 10.1001/jama.2018.0949.
I would suspect local practice patterns with nebulized acytylcysteine to vary even more widely than bronchodilator administration strategies.
I would suspect local practice patterns with nebulized acytylcysteine to vary even more widely than bronchodilator administration strategies.
I would suspect local practice patterns with nebulized acytylcysteine to vary even more widely than bronchodilator administration strategies.
SAN ANTONIO – with both medications, according to the results of a randomized clinical trial presented by Frederique Paulus, RN, PhD.
In this study, adverse events such as tachyarrhythmia and agitation were less frequent with the on-demand approach, in which patients receive nebulization based on strict clinical indications, Dr. Paulus reported at the Critical Care Congress sponsored by the Society for Critical Care Medicine. The study was published simultaneously in JAMA.
The on-demand approach may also be cost saving, she noted, citing an economic analysis underway that is not yet ready for publication.
“In our ICU, it will save us 350,000 Euros a year,” she said. “In the Netherlands, 40,000 patients will be mechanically ventilated in a year, so it will save us millions in the Netherlands alone.”
The study included adult ICU patients who were expected not to be extubated for at least 24 hours. Dr. Paulus presented the primary analysis of the study, which included data for 922 patients who were randomized either to the on-demand group (n = 455) or the routine nebulization group (n = 467) and completed follow-up.
Patients assigned to the on-demand group received acetylcysteine-containing solutions if they had thick or tenacious secretions, or salbutamol-containing solutions if wheezing was observed or suspected or when findings were suggestive of lower-airway obstruction, according to the paper, published in JAMA.
The primary outcome, number of ventilator-free days at day 28 of the study, was noninferior in the on-demand group versus the routine group, Dr. Paulus said.
The median number of ventilator-free days was 21 for the on-demand group and 20 for the routine group, said the paper.
The length of stay, mortality, and proportion of patients developing pulmonary complications did not differ between the two study arms, the investigators also reported in JAMA.
However, adverse events occurred in just 13.8% of the on-demand group, compared with 29.3% of the routine group (P less than .001), with the difference in adverse events mainly attributable to less tachyarrhythmia and agitation in the experimental group, according to the researchers.
Dr. Paulus and coauthors reported no conflicts of interest related to the study.
SOURCE: Paulus F et al. (van Meenen DMP et al.) JAMA. 2018 Feb. doi: 10.1001/jama.2018.0949.
SAN ANTONIO – with both medications, according to the results of a randomized clinical trial presented by Frederique Paulus, RN, PhD.
In this study, adverse events such as tachyarrhythmia and agitation were less frequent with the on-demand approach, in which patients receive nebulization based on strict clinical indications, Dr. Paulus reported at the Critical Care Congress sponsored by the Society for Critical Care Medicine. The study was published simultaneously in JAMA.
The on-demand approach may also be cost saving, she noted, citing an economic analysis underway that is not yet ready for publication.
“In our ICU, it will save us 350,000 Euros a year,” she said. “In the Netherlands, 40,000 patients will be mechanically ventilated in a year, so it will save us millions in the Netherlands alone.”
The study included adult ICU patients who were expected not to be extubated for at least 24 hours. Dr. Paulus presented the primary analysis of the study, which included data for 922 patients who were randomized either to the on-demand group (n = 455) or the routine nebulization group (n = 467) and completed follow-up.
Patients assigned to the on-demand group received acetylcysteine-containing solutions if they had thick or tenacious secretions, or salbutamol-containing solutions if wheezing was observed or suspected or when findings were suggestive of lower-airway obstruction, according to the paper, published in JAMA.
The primary outcome, number of ventilator-free days at day 28 of the study, was noninferior in the on-demand group versus the routine group, Dr. Paulus said.
The median number of ventilator-free days was 21 for the on-demand group and 20 for the routine group, said the paper.
The length of stay, mortality, and proportion of patients developing pulmonary complications did not differ between the two study arms, the investigators also reported in JAMA.
However, adverse events occurred in just 13.8% of the on-demand group, compared with 29.3% of the routine group (P less than .001), with the difference in adverse events mainly attributable to less tachyarrhythmia and agitation in the experimental group, according to the researchers.
Dr. Paulus and coauthors reported no conflicts of interest related to the study.
SOURCE: Paulus F et al. (van Meenen DMP et al.) JAMA. 2018 Feb. doi: 10.1001/jama.2018.0949.
REPORTING FROM CCC47
Key clinical point: Compared with routine nebulization with acetylcysteine or salbutamol, on-demand nebulization with acetylcysteine or salbutamol was noninferior among patients receiving invasive ventilation in the ICU.
Major finding: At day 28, the median number of ventilator-free days was 21 in the on-demand group and 20 in the routine care group.
Data source: Primary analysis of a randomized clinical trial including 922 adult patients who were expected to need at least 24 hours of invasive ventilation at one of seven ICUs in the Netherlands.
Disclosures: Authors reported no conflicts of interest related to the study.
Source: Paulus F et al. (van Meenen DMP et al.) JAMA. 2018 Feb. doi: 10.1001/jama.2018.0949.