Key clinical point: Calcitonin gene-related peptide-binding monoclonal antibody (CGRP mAb) is an effective and safe preventive treatment for episodic migraine.

Major finding: CGRP mAb therapy was associated with a significant reduction in monthly migraine days (weighted mean difference [WMD], −1.44; P less than .00001) and acute migraine-specific medication days (WMD, −1.28; P less than .00001), with an improvement in 50% responder rate (RR, 1.51; 95% CI,  1.37-1.66) compared with placebo. Adverse events and treatment withdrawal rates did not differ between groups.

Study details: Meta-analysis of 11 randomized controlled trials including 4,402 patients.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Wuhan science and technology plan project. The authors declared no conflicts of interest.

Citation: Deng H et al. BMC Neurol. 2020 Feb 15. doi: 10.1186/s12883-020-01633-3. 

Key clinical point: Calcitonin gene-related peptide-binding monoclonal antibody (CGRP mAb) is an effective and safe preventive treatment for episodic migraine.

Major finding: CGRP mAb therapy was associated with a significant reduction in monthly migraine days (weighted mean difference [WMD], −1.44; P less than .00001) and acute migraine-specific medication days (WMD, −1.28; P less than .00001), with an improvement in 50% responder rate (RR, 1.51; 95% CI,  1.37-1.66) compared with placebo. Adverse events and treatment withdrawal rates did not differ between groups.

Study details: Meta-analysis of 11 randomized controlled trials including 4,402 patients.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Wuhan science and technology plan project. The authors declared no conflicts of interest.

Citation: Deng H et al. BMC Neurol. 2020 Feb 15. doi: 10.1186/s12883-020-01633-3. 

Key clinical point: Calcitonin gene-related peptide-binding monoclonal antibody (CGRP mAb) is an effective and safe preventive treatment for episodic migraine.

Major finding: CGRP mAb therapy was associated with a significant reduction in monthly migraine days (weighted mean difference [WMD], −1.44; P less than .00001) and acute migraine-specific medication days (WMD, −1.28; P less than .00001), with an improvement in 50% responder rate (RR, 1.51; 95% CI,  1.37-1.66) compared with placebo. Adverse events and treatment withdrawal rates did not differ between groups.

Study details: Meta-analysis of 11 randomized controlled trials including 4,402 patients.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Wuhan science and technology plan project. The authors declared no conflicts of interest.

Citation: Deng H et al. BMC Neurol. 2020 Feb 15. doi: 10.1186/s12883-020-01633-3. 

No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.

The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).

Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.

Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.

For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).

Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.

While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)

“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.

Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.

“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.

“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.

Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”

As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.

Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.

All authors had no financial conflicts of interest to disclose.

Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.

Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.

SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.

No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.

The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).

Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.

Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.

For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).

Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.

While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)

“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.

Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.

“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.

“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.

Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”

As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.

Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.

All authors had no financial conflicts of interest to disclose.

Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.

Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.

SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.

No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.

The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).

Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.

Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.

For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).

Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.

While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)

“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.

Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.

“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.

“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.

Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”

As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.

Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.

All authors had no financial conflicts of interest to disclose.

Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.

Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.

SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.

Key clinical point: Long-term treatment with lasmiditan is associated with progressive and clinically meaningful reductions in migraine-related disability, including fewer missed days of work and school.

Major finding: Total scores of Migraine Disability Assessment (MIDAS) scale significantly reduced from baseline to months 3, 6, 9, and 12 for both 100 and 200 mg doses of lasmiditan, with no significant differences between the dose groups. Work and/or school absenteeism and presenteeism, monthly headache days, and mean headache pain intensity improved significantly with lasmiditan for up to 1 year.

Study details: Patients in GLADIATOR trial were randomly assigned to lasmiditan 100 mg (n=974) or 200 mg (n=1063).

Disclosures: The GLADIATOR study was funded by Eli Lilly and Company. The presenting author had received consultant fees, honoraria, and/or research grants from various pharmaceutical companies, including Eli Lilly and Company. Five of the authors were employees and minor stockholders of Eli Lilly and Company and one was an employee of Syneos Health, Inc., under contract to Eli Lilly and Company.

Citation: Lipton RB et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01088-4. 

Key clinical point: Long-term treatment with lasmiditan is associated with progressive and clinically meaningful reductions in migraine-related disability, including fewer missed days of work and school.

Major finding: Total scores of Migraine Disability Assessment (MIDAS) scale significantly reduced from baseline to months 3, 6, 9, and 12 for both 100 and 200 mg doses of lasmiditan, with no significant differences between the dose groups. Work and/or school absenteeism and presenteeism, monthly headache days, and mean headache pain intensity improved significantly with lasmiditan for up to 1 year.

Study details: Patients in GLADIATOR trial were randomly assigned to lasmiditan 100 mg (n=974) or 200 mg (n=1063).

Disclosures: The GLADIATOR study was funded by Eli Lilly and Company. The presenting author had received consultant fees, honoraria, and/or research grants from various pharmaceutical companies, including Eli Lilly and Company. Five of the authors were employees and minor stockholders of Eli Lilly and Company and one was an employee of Syneos Health, Inc., under contract to Eli Lilly and Company.

Citation: Lipton RB et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01088-4. 

Key clinical point: Long-term treatment with lasmiditan is associated with progressive and clinically meaningful reductions in migraine-related disability, including fewer missed days of work and school.

Major finding: Total scores of Migraine Disability Assessment (MIDAS) scale significantly reduced from baseline to months 3, 6, 9, and 12 for both 100 and 200 mg doses of lasmiditan, with no significant differences between the dose groups. Work and/or school absenteeism and presenteeism, monthly headache days, and mean headache pain intensity improved significantly with lasmiditan for up to 1 year.

Study details: Patients in GLADIATOR trial were randomly assigned to lasmiditan 100 mg (n=974) or 200 mg (n=1063).

Disclosures: The GLADIATOR study was funded by Eli Lilly and Company. The presenting author had received consultant fees, honoraria, and/or research grants from various pharmaceutical companies, including Eli Lilly and Company. Five of the authors were employees and minor stockholders of Eli Lilly and Company and one was an employee of Syneos Health, Inc., under contract to Eli Lilly and Company.

Citation: Lipton RB et al. J Headache Pain. 2020 Feb 24. doi: 10.1186/s10194-020-01088-4. 

Key clinical point: Increased subcutaneous abdominal fat is independently associated with cutaneous allodynia (CA), a marker of central sensitization in patients with migraine.

Major finding: Migraine patients with CA had a higher proportion of abdominal fat values than patients without CA (P = .04). The use of migraine prophylaxis (odds ratio [OR], 3.26), abdominal fat (OR, 1.13), and sleep disorders (OR, 1.13) were independent risk factors for the development of CA.

Study details: This prospective study investigated the association between CA and percentages of body fat and abdominal fat in 80 patients with migraine and 39 nonmigraine controls.

Disclosures: No study sponsor was identified. Allergan Inc. funded editorial assistance and statistical advice. María Rosario Luquin has received honoraria from TEVA, Zambon, AbbVie, and Bial for activities unrelated to the study. Pablo Irimia has received honoraria from Allergan, Novartis, Lilly, and Teva Pharmaceuticals as a consultant and speaker.

Citation: Mínguez-Olaondo A et al. J Headache Pain. 2020 Feb 4. doi: 10.1186/s10194-020-1082-0. 

Key clinical point: Increased subcutaneous abdominal fat is independently associated with cutaneous allodynia (CA), a marker of central sensitization in patients with migraine.

Major finding: Migraine patients with CA had a higher proportion of abdominal fat values than patients without CA (P = .04). The use of migraine prophylaxis (odds ratio [OR], 3.26), abdominal fat (OR, 1.13), and sleep disorders (OR, 1.13) were independent risk factors for the development of CA.

Study details: This prospective study investigated the association between CA and percentages of body fat and abdominal fat in 80 patients with migraine and 39 nonmigraine controls.

Disclosures: No study sponsor was identified. Allergan Inc. funded editorial assistance and statistical advice. María Rosario Luquin has received honoraria from TEVA, Zambon, AbbVie, and Bial for activities unrelated to the study. Pablo Irimia has received honoraria from Allergan, Novartis, Lilly, and Teva Pharmaceuticals as a consultant and speaker.

Citation: Mínguez-Olaondo A et al. J Headache Pain. 2020 Feb 4. doi: 10.1186/s10194-020-1082-0. 

Key clinical point: Increased subcutaneous abdominal fat is independently associated with cutaneous allodynia (CA), a marker of central sensitization in patients with migraine.

Major finding: Migraine patients with CA had a higher proportion of abdominal fat values than patients without CA (P = .04). The use of migraine prophylaxis (odds ratio [OR], 3.26), abdominal fat (OR, 1.13), and sleep disorders (OR, 1.13) were independent risk factors for the development of CA.

Study details: This prospective study investigated the association between CA and percentages of body fat and abdominal fat in 80 patients with migraine and 39 nonmigraine controls.

Disclosures: No study sponsor was identified. Allergan Inc. funded editorial assistance and statistical advice. María Rosario Luquin has received honoraria from TEVA, Zambon, AbbVie, and Bial for activities unrelated to the study. Pablo Irimia has received honoraria from Allergan, Novartis, Lilly, and Teva Pharmaceuticals as a consultant and speaker.

Citation: Mínguez-Olaondo A et al. J Headache Pain. 2020 Feb 4. doi: 10.1186/s10194-020-1082-0. 

PHOENIX, ARIZ. – Cardiovascular deaths and death rates related to atrial fibrillation have risen since 1999, with significant acceleration following 2009, results from a cross-sectional analysis of national data show.

Doug Brunk/MDedge News

“AFib is the most common arrhythmia disorder in the United States and it is estimated that it will effect more than 12 million Americans by 2030,” Yoshihiro Tanaka, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “The predicted lifetime risk ranges from 25% to 35%, and AFib is associated with an increased risk for heart failure, stroke, and death.”

A recent review reported that declines in total heart disease mortality rates in the United States have plateaued since 2011 (JAMA 2019;322[8]:780-2). However, it is not well understood what factors such as AFib contribute to this rate of plateau. In an effort to quantify U.S. trends in AFib-related CVD death rates, Dr. Tanaka and colleagues conducted a serial cross-sectional analysis of death certificate data from the Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research (WONDER) database during 1999-2017.

Outcomes included age-adjusted mortality per 100,000 based on the 2000 U.S. standard population. The researchers also used joinpoint regression to calculate the average annual percentage change over time and conducted subgroup analyses by race and sex and across two age groups: 35-64 years and 65-84 years.

In all, 522,104 AFib-related CVD deaths were identified during 1999-2017. Dr. Tanaka reported that age-adjusted mortality increased from 16.0 per 100,000 persons in 1999 to 22.2 per 100,000 person in 2017, with an acceleration following an inflection point in 2009. Specifically, the average annual percentage change in AFib-related CVD deaths rose from 0.4% in 2009 to 3.5% in 2017 (P < .001). “These increases were consistent across all race-sex subgroups,” said Dr. Tanaka, of the department of preventive medicine at Northwestern University, Chicago. “Relative increases were also greater in younger compared with older adults, although the absolute number of deaths in younger adults was less.”

The researchers observed that age-adjusted mortality increased across blacks and whites in both age groups, with a more pronounced increase among black and white men. Black men had the highest age-adjusted mortality among persons aged 35-64 (6.5 per 100,000 persons, compared with 4.2 among white men, 2.8 in black women, and 1.6 in white women 1.6 per 100,000). At the same time, white men had the highest age-adjusted mortality rate among those aged 65-84 years (112.5 per 100,000 persons, compared with 87.7 in black men, 77.4 in white women, and 61.3 in black women).

In an interview, one of the session’s moderators, Alvaro Alonso, MD, PhD, said that the study’s reliance on mortality data is a limitation. “You have to be careful with that, because it’s not the whole picture,” said Dr. Alonso, professor of epidemiology at the Rollins School of Public Health at Emory University, Atlanta. “It could be an underestimation of what is going on. The increase in recent years is probably due to a higher awareness of AFib as a risk factor for stroke; it’s more on the radar. Also, around 2009-2010, we started having new anticoagulants for AFib. It’s getting diagnosed more. When you look at coronary heart disease and stroke, there has been a decrease over time. In mortality and incidence of AFib, we don’t have that. That’s probably because we don’t know very much about what the risk factors for AFib are and how to prevent it.”

Dr. Tanaka said that the cause of increase in AFib-related CVD mortality can be classified into two major categories: a balance between case fatality of AFib and the prevalence of AFib. “The case fatality rate should have decreased over the last years,” he said at the meeting, which was sponsored by the American Heart Association. “In contrast, in the context of the aging of the population, the prevalence of AFib increased over the past years. Contributing factors include increasing awareness of AFib, a change in coding between ICD-9 and ICD-10, and a change in coding practices by physicians.”

Strengths of the study, he said, include its large sample size and the fact that the researchers were able to capture data from all death certificates filed in the United States. Limitations include the fact that the data “do not identify if changes in age-adjusted mortality rates are due to changing incidence or to case fatality rates,” he said. “CDC WONDER does not allow us to explore causes of these descriptive findings, but this would be an important next step.”

Dr. Tanaka reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Tanaka Y. EPI/Lifestyle 2020, Session 5, Abstract 15.

PHOENIX, ARIZ. – Cardiovascular deaths and death rates related to atrial fibrillation have risen since 1999, with significant acceleration following 2009, results from a cross-sectional analysis of national data show.

Doug Brunk/MDedge News

“AFib is the most common arrhythmia disorder in the United States and it is estimated that it will effect more than 12 million Americans by 2030,” Yoshihiro Tanaka, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “The predicted lifetime risk ranges from 25% to 35%, and AFib is associated with an increased risk for heart failure, stroke, and death.”

A recent review reported that declines in total heart disease mortality rates in the United States have plateaued since 2011 (JAMA 2019;322[8]:780-2). However, it is not well understood what factors such as AFib contribute to this rate of plateau. In an effort to quantify U.S. trends in AFib-related CVD death rates, Dr. Tanaka and colleagues conducted a serial cross-sectional analysis of death certificate data from the Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research (WONDER) database during 1999-2017.

Outcomes included age-adjusted mortality per 100,000 based on the 2000 U.S. standard population. The researchers also used joinpoint regression to calculate the average annual percentage change over time and conducted subgroup analyses by race and sex and across two age groups: 35-64 years and 65-84 years.

In all, 522,104 AFib-related CVD deaths were identified during 1999-2017. Dr. Tanaka reported that age-adjusted mortality increased from 16.0 per 100,000 persons in 1999 to 22.2 per 100,000 person in 2017, with an acceleration following an inflection point in 2009. Specifically, the average annual percentage change in AFib-related CVD deaths rose from 0.4% in 2009 to 3.5% in 2017 (P < .001). “These increases were consistent across all race-sex subgroups,” said Dr. Tanaka, of the department of preventive medicine at Northwestern University, Chicago. “Relative increases were also greater in younger compared with older adults, although the absolute number of deaths in younger adults was less.”

The researchers observed that age-adjusted mortality increased across blacks and whites in both age groups, with a more pronounced increase among black and white men. Black men had the highest age-adjusted mortality among persons aged 35-64 (6.5 per 100,000 persons, compared with 4.2 among white men, 2.8 in black women, and 1.6 in white women 1.6 per 100,000). At the same time, white men had the highest age-adjusted mortality rate among those aged 65-84 years (112.5 per 100,000 persons, compared with 87.7 in black men, 77.4 in white women, and 61.3 in black women).

In an interview, one of the session’s moderators, Alvaro Alonso, MD, PhD, said that the study’s reliance on mortality data is a limitation. “You have to be careful with that, because it’s not the whole picture,” said Dr. Alonso, professor of epidemiology at the Rollins School of Public Health at Emory University, Atlanta. “It could be an underestimation of what is going on. The increase in recent years is probably due to a higher awareness of AFib as a risk factor for stroke; it’s more on the radar. Also, around 2009-2010, we started having new anticoagulants for AFib. It’s getting diagnosed more. When you look at coronary heart disease and stroke, there has been a decrease over time. In mortality and incidence of AFib, we don’t have that. That’s probably because we don’t know very much about what the risk factors for AFib are and how to prevent it.”

Dr. Tanaka said that the cause of increase in AFib-related CVD mortality can be classified into two major categories: a balance between case fatality of AFib and the prevalence of AFib. “The case fatality rate should have decreased over the last years,” he said at the meeting, which was sponsored by the American Heart Association. “In contrast, in the context of the aging of the population, the prevalence of AFib increased over the past years. Contributing factors include increasing awareness of AFib, a change in coding between ICD-9 and ICD-10, and a change in coding practices by physicians.”

Strengths of the study, he said, include its large sample size and the fact that the researchers were able to capture data from all death certificates filed in the United States. Limitations include the fact that the data “do not identify if changes in age-adjusted mortality rates are due to changing incidence or to case fatality rates,” he said. “CDC WONDER does not allow us to explore causes of these descriptive findings, but this would be an important next step.”

Dr. Tanaka reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Tanaka Y. EPI/Lifestyle 2020, Session 5, Abstract 15.

PHOENIX, ARIZ. – Cardiovascular deaths and death rates related to atrial fibrillation have risen since 1999, with significant acceleration following 2009, results from a cross-sectional analysis of national data show.

Doug Brunk/MDedge News

“AFib is the most common arrhythmia disorder in the United States and it is estimated that it will effect more than 12 million Americans by 2030,” Yoshihiro Tanaka, MD, PhD, said at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting. “The predicted lifetime risk ranges from 25% to 35%, and AFib is associated with an increased risk for heart failure, stroke, and death.”

A recent review reported that declines in total heart disease mortality rates in the United States have plateaued since 2011 (JAMA 2019;322[8]:780-2). However, it is not well understood what factors such as AFib contribute to this rate of plateau. In an effort to quantify U.S. trends in AFib-related CVD death rates, Dr. Tanaka and colleagues conducted a serial cross-sectional analysis of death certificate data from the Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research (WONDER) database during 1999-2017.

Outcomes included age-adjusted mortality per 100,000 based on the 2000 U.S. standard population. The researchers also used joinpoint regression to calculate the average annual percentage change over time and conducted subgroup analyses by race and sex and across two age groups: 35-64 years and 65-84 years.

In all, 522,104 AFib-related CVD deaths were identified during 1999-2017. Dr. Tanaka reported that age-adjusted mortality increased from 16.0 per 100,000 persons in 1999 to 22.2 per 100,000 person in 2017, with an acceleration following an inflection point in 2009. Specifically, the average annual percentage change in AFib-related CVD deaths rose from 0.4% in 2009 to 3.5% in 2017 (P < .001). “These increases were consistent across all race-sex subgroups,” said Dr. Tanaka, of the department of preventive medicine at Northwestern University, Chicago. “Relative increases were also greater in younger compared with older adults, although the absolute number of deaths in younger adults was less.”

The researchers observed that age-adjusted mortality increased across blacks and whites in both age groups, with a more pronounced increase among black and white men. Black men had the highest age-adjusted mortality among persons aged 35-64 (6.5 per 100,000 persons, compared with 4.2 among white men, 2.8 in black women, and 1.6 in white women 1.6 per 100,000). At the same time, white men had the highest age-adjusted mortality rate among those aged 65-84 years (112.5 per 100,000 persons, compared with 87.7 in black men, 77.4 in white women, and 61.3 in black women).

In an interview, one of the session’s moderators, Alvaro Alonso, MD, PhD, said that the study’s reliance on mortality data is a limitation. “You have to be careful with that, because it’s not the whole picture,” said Dr. Alonso, professor of epidemiology at the Rollins School of Public Health at Emory University, Atlanta. “It could be an underestimation of what is going on. The increase in recent years is probably due to a higher awareness of AFib as a risk factor for stroke; it’s more on the radar. Also, around 2009-2010, we started having new anticoagulants for AFib. It’s getting diagnosed more. When you look at coronary heart disease and stroke, there has been a decrease over time. In mortality and incidence of AFib, we don’t have that. That’s probably because we don’t know very much about what the risk factors for AFib are and how to prevent it.”

Dr. Tanaka said that the cause of increase in AFib-related CVD mortality can be classified into two major categories: a balance between case fatality of AFib and the prevalence of AFib. “The case fatality rate should have decreased over the last years,” he said at the meeting, which was sponsored by the American Heart Association. “In contrast, in the context of the aging of the population, the prevalence of AFib increased over the past years. Contributing factors include increasing awareness of AFib, a change in coding between ICD-9 and ICD-10, and a change in coding practices by physicians.”

Strengths of the study, he said, include its large sample size and the fact that the researchers were able to capture data from all death certificates filed in the United States. Limitations include the fact that the data “do not identify if changes in age-adjusted mortality rates are due to changing incidence or to case fatality rates,” he said. “CDC WONDER does not allow us to explore causes of these descriptive findings, but this would be an important next step.”

Dr. Tanaka reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Tanaka Y. EPI/Lifestyle 2020, Session 5, Abstract 15.

Key clinical point: Galcanezumab is safe and effective in the prophylactic treatment of adult migraine.

Major finding: Compared with placebo, galcanezumab at doses of 120, 150, 240, and 300 mg significantly reduced monthly migraine days (mean difference [MD], −1.79, −1.20, −1.85, and –0.62, respectively). Reduction in migraine-specific medication days was statistically significant for galcanezumab doses of 120 and 240 mg vs. placebo. Total adverse events did not differ significantly between galcanezumab and placebo.

Study details: Meta-analysis of 5 studies evaluated the safety and efficacy of galcanezumab in the prophylactic treatment of adult migraine. 

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Citation: Zhao X et al. J Neurol. 2020 Jan 31. doi: 10.1007/s00415-020-09707-5. 

Key clinical point: Galcanezumab is safe and effective in the prophylactic treatment of adult migraine.

Major finding: Compared with placebo, galcanezumab at doses of 120, 150, 240, and 300 mg significantly reduced monthly migraine days (mean difference [MD], −1.79, −1.20, −1.85, and –0.62, respectively). Reduction in migraine-specific medication days was statistically significant for galcanezumab doses of 120 and 240 mg vs. placebo. Total adverse events did not differ significantly between galcanezumab and placebo.

Study details: Meta-analysis of 5 studies evaluated the safety and efficacy of galcanezumab in the prophylactic treatment of adult migraine. 

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Citation: Zhao X et al. J Neurol. 2020 Jan 31. doi: 10.1007/s00415-020-09707-5. 

Key clinical point: Galcanezumab is safe and effective in the prophylactic treatment of adult migraine.

Major finding: Compared with placebo, galcanezumab at doses of 120, 150, 240, and 300 mg significantly reduced monthly migraine days (mean difference [MD], −1.79, −1.20, −1.85, and –0.62, respectively). Reduction in migraine-specific medication days was statistically significant for galcanezumab doses of 120 and 240 mg vs. placebo. Total adverse events did not differ significantly between galcanezumab and placebo.

Study details: Meta-analysis of 5 studies evaluated the safety and efficacy of galcanezumab in the prophylactic treatment of adult migraine. 

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Citation: Zhao X et al. J Neurol. 2020 Jan 31. doi: 10.1007/s00415-020-09707-5. 

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

mlesney@mdedge.com

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

mlesney@mdedge.com

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.

“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.

In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.

Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.

Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.

The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
 

Specific advice for the gastroenterology profession

The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.

Patient concerns

In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.

Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.

“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.

In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .

Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
 

Protection of practitioners

Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.

“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.

“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.

Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.

The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.

In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week^® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
 

mlesney@mdedge.com

SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.

Key clinical point: Intravenous (IV) eptinezumab could be a safe and effective preventive therapy for adult patients with episodic migraine.

Main finding: Eptinezumab 100 and 300 mg significantly reduced monthly migraine days across weeks 1-12 compared with the placebo (difference from placebo for 100 and 300 mg: –0.69; P = .0182 and –1.11; P = .0001, respectively). Safety and tolerability of eptinezumab across doses were acceptable compared with placebo, with no dose-related trend in the nature, frequency, or severity of treatment-related adverse events.

Study details: In phase 3, multicenter, double-blind, parallel-group study, 888 patients were randomly assigned to IV eptinezumab (30, 100, and 300 mg) or placebo administered every 12 weeks. 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen, Denmark. Some of the authors were full-time employees of or contracted to Lundbeck Seattle BioPharmaceuticals, Inc. (previously known as Alder BioPharmaceuticals, Inc.), a subsidiary H. Lundbeck A/S. Some also were stockholders of Lundbeck Seattle BioPharmaceuticals, Inc.

Citation: Ashina M et al. Cephalalgia. 2020 Feb 19. doi: 10.1177/0333102420905132.

Key clinical point: Intravenous (IV) eptinezumab could be a safe and effective preventive therapy for adult patients with episodic migraine.

Main finding: Eptinezumab 100 and 300 mg significantly reduced monthly migraine days across weeks 1-12 compared with the placebo (difference from placebo for 100 and 300 mg: –0.69; P = .0182 and –1.11; P = .0001, respectively). Safety and tolerability of eptinezumab across doses were acceptable compared with placebo, with no dose-related trend in the nature, frequency, or severity of treatment-related adverse events.

Study details: In phase 3, multicenter, double-blind, parallel-group study, 888 patients were randomly assigned to IV eptinezumab (30, 100, and 300 mg) or placebo administered every 12 weeks. 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen, Denmark. Some of the authors were full-time employees of or contracted to Lundbeck Seattle BioPharmaceuticals, Inc. (previously known as Alder BioPharmaceuticals, Inc.), a subsidiary H. Lundbeck A/S. Some also were stockholders of Lundbeck Seattle BioPharmaceuticals, Inc.

Citation: Ashina M et al. Cephalalgia. 2020 Feb 19. doi: 10.1177/0333102420905132.

Key clinical point: Intravenous (IV) eptinezumab could be a safe and effective preventive therapy for adult patients with episodic migraine.

Main finding: Eptinezumab 100 and 300 mg significantly reduced monthly migraine days across weeks 1-12 compared with the placebo (difference from placebo for 100 and 300 mg: –0.69; P = .0182 and –1.11; P = .0001, respectively). Safety and tolerability of eptinezumab across doses were acceptable compared with placebo, with no dose-related trend in the nature, frequency, or severity of treatment-related adverse events.

Study details: In phase 3, multicenter, double-blind, parallel-group study, 888 patients were randomly assigned to IV eptinezumab (30, 100, and 300 mg) or placebo administered every 12 weeks. 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen, Denmark. Some of the authors were full-time employees of or contracted to Lundbeck Seattle BioPharmaceuticals, Inc. (previously known as Alder BioPharmaceuticals, Inc.), a subsidiary H. Lundbeck A/S. Some also were stockholders of Lundbeck Seattle BioPharmaceuticals, Inc.

Citation: Ashina M et al. Cephalalgia. 2020 Feb 19. doi: 10.1177/0333102420905132.

Key clinical point: Migraineurs with aura are more likely to show a higher anger response, but not impulsivity, compared with migraineurs without aura and healthy control individuals.

Main finding: Scores of anger symptoms were significantly higher migraineurs with aura than those without aura and control individuals (P less than .001); however, there was no significant difference in total Barratt impulsiveness scale-11 score, attentional impulsiveness, motor impulsiveness, and nonplanning impulsiveness between the 3 groups (P greater than .05).

Study details: The prospective cross-sectional study included 55 patients aged 18-55 years with episodic migraine (31 with aura and 24 without aura) and 40 healthy control individuals.

Disclosures: The authors declared no conflict of interest.

Citation: Tanik N et al. Neurol Res. 2020 Feb 5. doi: 10.1080/01616412.2020.1723974.

Key clinical point: Migraineurs with aura are more likely to show a higher anger response, but not impulsivity, compared with migraineurs without aura and healthy control individuals.

Main finding: Scores of anger symptoms were significantly higher migraineurs with aura than those without aura and control individuals (P less than .001); however, there was no significant difference in total Barratt impulsiveness scale-11 score, attentional impulsiveness, motor impulsiveness, and nonplanning impulsiveness between the 3 groups (P greater than .05).

Study details: The prospective cross-sectional study included 55 patients aged 18-55 years with episodic migraine (31 with aura and 24 without aura) and 40 healthy control individuals.

Disclosures: The authors declared no conflict of interest.

Citation: Tanik N et al. Neurol Res. 2020 Feb 5. doi: 10.1080/01616412.2020.1723974.

Key clinical point: Migraineurs with aura are more likely to show a higher anger response, but not impulsivity, compared with migraineurs without aura and healthy control individuals.

Main finding: Scores of anger symptoms were significantly higher migraineurs with aura than those without aura and control individuals (P less than .001); however, there was no significant difference in total Barratt impulsiveness scale-11 score, attentional impulsiveness, motor impulsiveness, and nonplanning impulsiveness between the 3 groups (P greater than .05).

Study details: The prospective cross-sectional study included 55 patients aged 18-55 years with episodic migraine (31 with aura and 24 without aura) and 40 healthy control individuals.

Disclosures: The authors declared no conflict of interest.

Citation: Tanik N et al. Neurol Res. 2020 Feb 5. doi: 10.1080/01616412.2020.1723974.

Key clinical point: Plasma glucose level increases during spontaneous migraine attacks, and the increase is independent of the presence of aura symptoms and pain intensity.

Main finding: Plasma glucose levels were higher in the ictal phase than in the interictal phase of migraine (mean, 98.83 vs. 88.63 mg/dL; P = .0014) after adjusting for diurnal variation. The attack-related elevation in plasma glucose level was not influenced by pain intensity or the presence of aura symptoms.

Study details: In this study, plasma glucose levels were measured during and outside of spontaneous attacks of migraine in 31 patients (13 with aura and 18 without aura).

Disclosures: The study was funded by the Lundbeck Foundation, the Novo Nordisk Foundation, the University of Copenhagen, the Research Foundation of the Capital Region of Denmark, and the Danish Council for Independent Research-Medical Sciences. Faisal Mohammad Amin and Anders Hougaard reported receiving personal fees and/or honoraria from multiple pharmaceutical companies. Messoud Ashina reported consultancy/advisory for multiple pharmaceutical companies. Other authors declared no disclosures. 

Citation: Zhang DG et al. Headache. 2020 Feb 7. doi: 10.1111/head.13760.

Key clinical point: Plasma glucose level increases during spontaneous migraine attacks, and the increase is independent of the presence of aura symptoms and pain intensity.

Main finding: Plasma glucose levels were higher in the ictal phase than in the interictal phase of migraine (mean, 98.83 vs. 88.63 mg/dL; P = .0014) after adjusting for diurnal variation. The attack-related elevation in plasma glucose level was not influenced by pain intensity or the presence of aura symptoms.

Study details: In this study, plasma glucose levels were measured during and outside of spontaneous attacks of migraine in 31 patients (13 with aura and 18 without aura).

Disclosures: The study was funded by the Lundbeck Foundation, the Novo Nordisk Foundation, the University of Copenhagen, the Research Foundation of the Capital Region of Denmark, and the Danish Council for Independent Research-Medical Sciences. Faisal Mohammad Amin and Anders Hougaard reported receiving personal fees and/or honoraria from multiple pharmaceutical companies. Messoud Ashina reported consultancy/advisory for multiple pharmaceutical companies. Other authors declared no disclosures. 

Citation: Zhang DG et al. Headache. 2020 Feb 7. doi: 10.1111/head.13760.

Key clinical point: Plasma glucose level increases during spontaneous migraine attacks, and the increase is independent of the presence of aura symptoms and pain intensity.

Main finding: Plasma glucose levels were higher in the ictal phase than in the interictal phase of migraine (mean, 98.83 vs. 88.63 mg/dL; P = .0014) after adjusting for diurnal variation. The attack-related elevation in plasma glucose level was not influenced by pain intensity or the presence of aura symptoms.

Study details: In this study, plasma glucose levels were measured during and outside of spontaneous attacks of migraine in 31 patients (13 with aura and 18 without aura).

Disclosures: The study was funded by the Lundbeck Foundation, the Novo Nordisk Foundation, the University of Copenhagen, the Research Foundation of the Capital Region of Denmark, and the Danish Council for Independent Research-Medical Sciences. Faisal Mohammad Amin and Anders Hougaard reported receiving personal fees and/or honoraria from multiple pharmaceutical companies. Messoud Ashina reported consultancy/advisory for multiple pharmaceutical companies. Other authors declared no disclosures. 

Citation: Zhang DG et al. Headache. 2020 Feb 7. doi: 10.1111/head.13760.