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Delaying flu vaccine didn’t drop fever rate for childhood immunizations
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
FROM PEDIATRICS
Key clinical point: Fevers were no less common when influenza vaccine was delayed for children receiving DTaP and pneumococcal vaccinations.
Major finding: There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87).
Study details: Randomized, nonblinded trial of 221 children aged 12-16 months receiving scheduled vaccinations.
Disclosures: The study was funded by the Centers for Disease Control and Prevention. One coauthor reported financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune.
Source: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
Cardiac arrest: Targeted temperature management a game changer
SNOWMASS, COLO. – Targeted temperature management maintained at 32-36 degrees Celsius is now a strong class I recommendation for all comatose patients who experience return of spontaneous circulation after out-of-hospital cardiac arrest, including those with nonshockable rhythms, Erin A. Bohula, MD, PhD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“Our practice is that ,” said Dr. Bohula, a cardiologist and critical care specialist at Brigham and Women’s Hospital and Harvard Medical School, Boston.
The current ACC/AHA guidelines declare: “There are essentially no patients for whom temperature control somewhere in the range between 32 degrees C [89.6 F) and 36 degrees C [96.8 F] is contraindicated.” The writing committee cited “recent clinical trial data enrolling patients with all rhythms, the rarity of adverse effects in trials, the high neurologic morbidity and mortality without any specific interventions, and the preponderance of data suggesting that temperature is an important variable for neurologic recovery” (Circulation. 2015 Nov 3;132[18 Suppl 2]:S465-82).
“That’s a pretty strong statement,” Dr. Bohula observed.
The current guidelines, which date back to 2015, give a class I, level of evidence B recommendation for targeted temperature management (TTM) in patients who are comatose with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest involving ventricular fibrillation or pulseless ventricular fibrillation. The bedside definition of comatose is lack of meaningful response to verbal commands to squeeze hands, blink, or move toes.
The current recommendation for TTM in patients resuscitated from out-of-hospital cardiac arrest with a nonshockable rhythm is class I, level of evidence C, meaning it’s based on expert consensus. However, that recommendation is now out of date and due for a level-of-evidence upgrade in light of the recent results of the French HYPERION trial, an open-label randomized trial of 584 patients resuscitated from cardiac arrest with a nonshockable rhythm. Although 90-day mortality was similarly high in the TTM and targeted normothermia groups, the rate of favorable neurologic outcome as assessed by a Cerebral Performance Category scale score of 1 or 2 was 10.2% in the TTM group, significantly better than the 5.7% rate in controls (N Engl J Med. 2019 Dec 12;381[24]:2327-37).
The 2010, ACC/AHA guidelines recommended a TTM range of 32-34 degrees C, but on the basis of subsequent persuasive randomized trial data, that range was broadened to 32-36 degrees C in the 2015 guidelines, with a class IB recommendation. Maintenance of TTM for at least 24 hours has a IIa, level of evidence C recommendation in the current guidelines.
The guidelines emphasize that specific features may favor selection of one temperature for TTM over another. For example, patients with seizures or cerebral edema might be better off with TTM at a lower temperature, while a higher temperature may be best for those with bleeding or severe bradycardia. At Brigham and Women’s Hospital, the default temperature is 33 degrees C. However, TTM with a goal of 36 degrees C is seriously considered in patients with recent head trauma, major surgery within the past 2 weeks, refractory hypotension, severe sepsis, pregnancy, or high bleeding risk. Rewarming is done at a rate of 0.25 degrees C per hour, with sedation maintained until the patient has been returned to 98.6 degrees F, according to Dr. Bohula.
Based on several negative studies of TTM using rapid infusion of chilled fluids in the ambulance en route to the hospital, the guidelines rate that practice class IIIA, meaning don’t do it. Avoidance of a systolic blood pressure below 90 mm Hg and a mean arterial pressure of less than 65 mm Hg gets a class IIb level of evidence C recommendation to lessen the risk of cerebral hypoxia.
TTM a major breakthrough
Prior to the introduction of TTM, comatose patients with ROSC after out-of-hospital cardiac arrest had a dreadful prognosis, with survival rates of 1%-10% in registry studies. In contrast, the survival rate in the landmark TTM clinical trials was 50%-60%. And while that’s a dramatic improvement, ROSC after cardiac arrest remains a high-mortality condition. Dr. Bohula was first author of a report by the Critical Care Cardiology Trials Network, composed of 16 tertiary cardiac intensive care units in the United States and Canada. Cardiac arrest was the primary indication for 8.7% of 3,049 consecutive admissions, and its 38% mortality rate was the highest of all cardiac critical care indications (JAMA Cardiol. 2019 Jul 24;4[9]:928-35).
TTM was developed in response to a recognition that two-thirds of deaths in patients who make it to the hospital after out-of-hospital cardiac arrest are neurologic – the result of brain anoxia – rather than being due to the myocardial ischemia that may have initially brought them to medical attention.
“Time is brain cells, the same way we think of time as cardiac muscle,” Dr. Bohula observed.
The main idea behind therapeutic hypothermia is that it lowers the cerebral metabolic rate of oxygen to reduce the consequences of ongoing anoxia. The brain doesn’t require as much perfusion when cooled.
TTM has other beneficial neurologic effects as well: It reduces cerebral blood volume via autoregulation, decreases intracranial pressure, and blunts the inflammatory response involved in the postcardiac arrest syndrome. In addition, TTM has anticonvulsant properties, an important effect because seizures and/or myoclonus occur in up to 15% of adults who achieve ROSC after cardiac arrest – and in even more of those who are comatose after doing so. And seizures increase the brain’s metabolic rate threefold, resulting in more cerebral ischemic injury, she explained.
Seizure activity can be difficult to distinguish from shivering in a patient on TTM. For this reason Dr. Bohula recommends putting patients on continuous EEG monitoring from the time of admission, as is the routine practice at the Brigham.
She reported serving as a consultant to Daiichi Sankyo, Servier, Lexicon, Kowa, Merck, Novartis, Novo Nordisk, and the National Institutes of Health. In addition, she generates institutional research grants provided by a half-dozen pharmaceutical companies.
SNOWMASS, COLO. – Targeted temperature management maintained at 32-36 degrees Celsius is now a strong class I recommendation for all comatose patients who experience return of spontaneous circulation after out-of-hospital cardiac arrest, including those with nonshockable rhythms, Erin A. Bohula, MD, PhD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“Our practice is that ,” said Dr. Bohula, a cardiologist and critical care specialist at Brigham and Women’s Hospital and Harvard Medical School, Boston.
The current ACC/AHA guidelines declare: “There are essentially no patients for whom temperature control somewhere in the range between 32 degrees C [89.6 F) and 36 degrees C [96.8 F] is contraindicated.” The writing committee cited “recent clinical trial data enrolling patients with all rhythms, the rarity of adverse effects in trials, the high neurologic morbidity and mortality without any specific interventions, and the preponderance of data suggesting that temperature is an important variable for neurologic recovery” (Circulation. 2015 Nov 3;132[18 Suppl 2]:S465-82).
“That’s a pretty strong statement,” Dr. Bohula observed.
The current guidelines, which date back to 2015, give a class I, level of evidence B recommendation for targeted temperature management (TTM) in patients who are comatose with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest involving ventricular fibrillation or pulseless ventricular fibrillation. The bedside definition of comatose is lack of meaningful response to verbal commands to squeeze hands, blink, or move toes.
The current recommendation for TTM in patients resuscitated from out-of-hospital cardiac arrest with a nonshockable rhythm is class I, level of evidence C, meaning it’s based on expert consensus. However, that recommendation is now out of date and due for a level-of-evidence upgrade in light of the recent results of the French HYPERION trial, an open-label randomized trial of 584 patients resuscitated from cardiac arrest with a nonshockable rhythm. Although 90-day mortality was similarly high in the TTM and targeted normothermia groups, the rate of favorable neurologic outcome as assessed by a Cerebral Performance Category scale score of 1 or 2 was 10.2% in the TTM group, significantly better than the 5.7% rate in controls (N Engl J Med. 2019 Dec 12;381[24]:2327-37).
The 2010, ACC/AHA guidelines recommended a TTM range of 32-34 degrees C, but on the basis of subsequent persuasive randomized trial data, that range was broadened to 32-36 degrees C in the 2015 guidelines, with a class IB recommendation. Maintenance of TTM for at least 24 hours has a IIa, level of evidence C recommendation in the current guidelines.
The guidelines emphasize that specific features may favor selection of one temperature for TTM over another. For example, patients with seizures or cerebral edema might be better off with TTM at a lower temperature, while a higher temperature may be best for those with bleeding or severe bradycardia. At Brigham and Women’s Hospital, the default temperature is 33 degrees C. However, TTM with a goal of 36 degrees C is seriously considered in patients with recent head trauma, major surgery within the past 2 weeks, refractory hypotension, severe sepsis, pregnancy, or high bleeding risk. Rewarming is done at a rate of 0.25 degrees C per hour, with sedation maintained until the patient has been returned to 98.6 degrees F, according to Dr. Bohula.
Based on several negative studies of TTM using rapid infusion of chilled fluids in the ambulance en route to the hospital, the guidelines rate that practice class IIIA, meaning don’t do it. Avoidance of a systolic blood pressure below 90 mm Hg and a mean arterial pressure of less than 65 mm Hg gets a class IIb level of evidence C recommendation to lessen the risk of cerebral hypoxia.
TTM a major breakthrough
Prior to the introduction of TTM, comatose patients with ROSC after out-of-hospital cardiac arrest had a dreadful prognosis, with survival rates of 1%-10% in registry studies. In contrast, the survival rate in the landmark TTM clinical trials was 50%-60%. And while that’s a dramatic improvement, ROSC after cardiac arrest remains a high-mortality condition. Dr. Bohula was first author of a report by the Critical Care Cardiology Trials Network, composed of 16 tertiary cardiac intensive care units in the United States and Canada. Cardiac arrest was the primary indication for 8.7% of 3,049 consecutive admissions, and its 38% mortality rate was the highest of all cardiac critical care indications (JAMA Cardiol. 2019 Jul 24;4[9]:928-35).
TTM was developed in response to a recognition that two-thirds of deaths in patients who make it to the hospital after out-of-hospital cardiac arrest are neurologic – the result of brain anoxia – rather than being due to the myocardial ischemia that may have initially brought them to medical attention.
“Time is brain cells, the same way we think of time as cardiac muscle,” Dr. Bohula observed.
The main idea behind therapeutic hypothermia is that it lowers the cerebral metabolic rate of oxygen to reduce the consequences of ongoing anoxia. The brain doesn’t require as much perfusion when cooled.
TTM has other beneficial neurologic effects as well: It reduces cerebral blood volume via autoregulation, decreases intracranial pressure, and blunts the inflammatory response involved in the postcardiac arrest syndrome. In addition, TTM has anticonvulsant properties, an important effect because seizures and/or myoclonus occur in up to 15% of adults who achieve ROSC after cardiac arrest – and in even more of those who are comatose after doing so. And seizures increase the brain’s metabolic rate threefold, resulting in more cerebral ischemic injury, she explained.
Seizure activity can be difficult to distinguish from shivering in a patient on TTM. For this reason Dr. Bohula recommends putting patients on continuous EEG monitoring from the time of admission, as is the routine practice at the Brigham.
She reported serving as a consultant to Daiichi Sankyo, Servier, Lexicon, Kowa, Merck, Novartis, Novo Nordisk, and the National Institutes of Health. In addition, she generates institutional research grants provided by a half-dozen pharmaceutical companies.
SNOWMASS, COLO. – Targeted temperature management maintained at 32-36 degrees Celsius is now a strong class I recommendation for all comatose patients who experience return of spontaneous circulation after out-of-hospital cardiac arrest, including those with nonshockable rhythms, Erin A. Bohula, MD, PhD, said at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
“Our practice is that ,” said Dr. Bohula, a cardiologist and critical care specialist at Brigham and Women’s Hospital and Harvard Medical School, Boston.
The current ACC/AHA guidelines declare: “There are essentially no patients for whom temperature control somewhere in the range between 32 degrees C [89.6 F) and 36 degrees C [96.8 F] is contraindicated.” The writing committee cited “recent clinical trial data enrolling patients with all rhythms, the rarity of adverse effects in trials, the high neurologic morbidity and mortality without any specific interventions, and the preponderance of data suggesting that temperature is an important variable for neurologic recovery” (Circulation. 2015 Nov 3;132[18 Suppl 2]:S465-82).
“That’s a pretty strong statement,” Dr. Bohula observed.
The current guidelines, which date back to 2015, give a class I, level of evidence B recommendation for targeted temperature management (TTM) in patients who are comatose with return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest involving ventricular fibrillation or pulseless ventricular fibrillation. The bedside definition of comatose is lack of meaningful response to verbal commands to squeeze hands, blink, or move toes.
The current recommendation for TTM in patients resuscitated from out-of-hospital cardiac arrest with a nonshockable rhythm is class I, level of evidence C, meaning it’s based on expert consensus. However, that recommendation is now out of date and due for a level-of-evidence upgrade in light of the recent results of the French HYPERION trial, an open-label randomized trial of 584 patients resuscitated from cardiac arrest with a nonshockable rhythm. Although 90-day mortality was similarly high in the TTM and targeted normothermia groups, the rate of favorable neurologic outcome as assessed by a Cerebral Performance Category scale score of 1 or 2 was 10.2% in the TTM group, significantly better than the 5.7% rate in controls (N Engl J Med. 2019 Dec 12;381[24]:2327-37).
The 2010, ACC/AHA guidelines recommended a TTM range of 32-34 degrees C, but on the basis of subsequent persuasive randomized trial data, that range was broadened to 32-36 degrees C in the 2015 guidelines, with a class IB recommendation. Maintenance of TTM for at least 24 hours has a IIa, level of evidence C recommendation in the current guidelines.
The guidelines emphasize that specific features may favor selection of one temperature for TTM over another. For example, patients with seizures or cerebral edema might be better off with TTM at a lower temperature, while a higher temperature may be best for those with bleeding or severe bradycardia. At Brigham and Women’s Hospital, the default temperature is 33 degrees C. However, TTM with a goal of 36 degrees C is seriously considered in patients with recent head trauma, major surgery within the past 2 weeks, refractory hypotension, severe sepsis, pregnancy, or high bleeding risk. Rewarming is done at a rate of 0.25 degrees C per hour, with sedation maintained until the patient has been returned to 98.6 degrees F, according to Dr. Bohula.
Based on several negative studies of TTM using rapid infusion of chilled fluids in the ambulance en route to the hospital, the guidelines rate that practice class IIIA, meaning don’t do it. Avoidance of a systolic blood pressure below 90 mm Hg and a mean arterial pressure of less than 65 mm Hg gets a class IIb level of evidence C recommendation to lessen the risk of cerebral hypoxia.
TTM a major breakthrough
Prior to the introduction of TTM, comatose patients with ROSC after out-of-hospital cardiac arrest had a dreadful prognosis, with survival rates of 1%-10% in registry studies. In contrast, the survival rate in the landmark TTM clinical trials was 50%-60%. And while that’s a dramatic improvement, ROSC after cardiac arrest remains a high-mortality condition. Dr. Bohula was first author of a report by the Critical Care Cardiology Trials Network, composed of 16 tertiary cardiac intensive care units in the United States and Canada. Cardiac arrest was the primary indication for 8.7% of 3,049 consecutive admissions, and its 38% mortality rate was the highest of all cardiac critical care indications (JAMA Cardiol. 2019 Jul 24;4[9]:928-35).
TTM was developed in response to a recognition that two-thirds of deaths in patients who make it to the hospital after out-of-hospital cardiac arrest are neurologic – the result of brain anoxia – rather than being due to the myocardial ischemia that may have initially brought them to medical attention.
“Time is brain cells, the same way we think of time as cardiac muscle,” Dr. Bohula observed.
The main idea behind therapeutic hypothermia is that it lowers the cerebral metabolic rate of oxygen to reduce the consequences of ongoing anoxia. The brain doesn’t require as much perfusion when cooled.
TTM has other beneficial neurologic effects as well: It reduces cerebral blood volume via autoregulation, decreases intracranial pressure, and blunts the inflammatory response involved in the postcardiac arrest syndrome. In addition, TTM has anticonvulsant properties, an important effect because seizures and/or myoclonus occur in up to 15% of adults who achieve ROSC after cardiac arrest – and in even more of those who are comatose after doing so. And seizures increase the brain’s metabolic rate threefold, resulting in more cerebral ischemic injury, she explained.
Seizure activity can be difficult to distinguish from shivering in a patient on TTM. For this reason Dr. Bohula recommends putting patients on continuous EEG monitoring from the time of admission, as is the routine practice at the Brigham.
She reported serving as a consultant to Daiichi Sankyo, Servier, Lexicon, Kowa, Merck, Novartis, Novo Nordisk, and the National Institutes of Health. In addition, she generates institutional research grants provided by a half-dozen pharmaceutical companies.
EXPERT ANALYSIS FROM ACC SNOWMASS 2020
CDC begins coronavirus diagnostic test kit distribution; new case confirmed in Wisconsin
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
The 2019 novel coronavirus: Case review IDs clinical characteristics
A group of physicians in Wuhan, China, who are treating patients with the 2019 novel coronavirus have gone the extra mile to share their clinical experiences with colleagues around the world.
Nanshan Chen, MD, of Jinyintan Hospital, Wuhan, and his team conducted a retrospective study on 99 cases and, in very short order, published their initial findings in the Lancet online on Jan. 29. These findings could guide action in other cases and help clinicians all over the world create treatment plans for patients of the 2019-nCoV.
The findings show that and characteristics of those with fatal infections align with the MuLBSTA score – an early warning model for predicting viral pneumonia–related mortality, according to a case review.
Of 99 patients who presented with 2019-nCoV pneumonia at Jinyintan Hospital between Jan. 1 and Jan. 20, 67 were men, the mean age was 55.5 years, and 50 patients had chronic diseases.
“All the data of included cases have been shared with [the World Health Organization]. The study was approved by Jinyintan Hospital Ethics Committee and written informed consent was obtained from patients involved before enrollment when data were collected retrospectively,” the researchers noted.
Nearly half of the patients (49%) lived or worked near a specific seafood market, suggesting disease clustering.
Clinical manifestations affecting the majority of patients included fever and cough in 83% and 82% of patients, respectively. Other symptoms included shortness of breath in 31%, muscle aches in 11%, confusion in 9%, headache in 8%, sore throat in 5%, and rhinorrhea, chest pain, diarrhea, and nausea and vomiting in 1%-4% of patients, the investigators found.
Imaging showed bilateral pneumonia in 75% of cases, multiple mottling and ground-glass opacity in 14%, and pneumothorax in 1%. Organ function damage was present in a third of patients at admission: 17% had acute respiratory distress syndrome (ARDS) – including 11 patients who worsened quickly and died of multiple organ failure. Eight percent had acute respiratory injury, 3% had acute renal injury, 4% had septic shock, and 1% had ventilator-associated pneumonia, they said, noting that all cases were confirmed by real-time polymerase chain reaction.
A notable laboratory finding was reduced absolute lymphocyte counts in most patients, the investigators said.
All patients were treated in isolation and 76% received antiviral treatment with oseltamivir, ganciclovir, lopinavir, or ritonavir for 3-14 days (median, 3 days). Most patients also received antibiotic treatment, including a single antibiotic in 25% of cases and combination therapy in 45%, with most antibiotics used to cover “common pathogens and some atypical pathogens,” they said, adding that “when secondary bacterial infection occurred, medication was administered according to the results of bacterial culture and drug sensitivity.”
Cephalosporins, quinolones, carbapenems, tigecycline against methicillin-resistant Staphylococcus aureus, linezolid, and antifungal drugs were used, and duration ranged from 3 to 17 days (median, 5 days).
Nineteen patients also received steroid treatments.
As of Jan. 25, 31 patients had been discharged and 57 remained hospitalized. Of the 11 who died, the first 2 were a 61-year-old man and a 69-year-old man, each diagnosed with severe pneumonia and ARDS. The first experienced sudden cardiac arrest and died on admission day 11, and the second died of severe pneumonia, septic shock, and respiratory failure on admission day 9. Neither had underlying disease, but both had a long history of smoking, the investigators noted.
“The deaths of these two patients were consistent with the MuLBSTA score,” they wrote, explaining that the scoring system takes into account multilobular infiltration, lymphopenia, bacterial coinfection, smoking history, hypertension, and age.
Eight of the nine other patients who died had lymphopenia, seven had bilateral pneumonia, five were over age 60 years, three had hypertension, and one was a heavy smoker, they added.
Most coronavirus infections cause mild symptoms and have good prognosis, but some patients with the 2019-nCoV, which was identified Jan. 7 following the development of several cases of pneumonia of unknown etiology in Wuhan, develop fatal disease. The paucity of data regarding epidemiology and clinical features of pneumonia associated with 2019-nCoV prompted the current retrospective study at the center where the first cases were admitted, the investigators explained.
They noted that the sequence of 2019-nCoV “is relatively different from the six other coronavirus subtypes, including the highly pathogenic severe acute respiratory syndrome (SARS)-CoV and Middle East Respiratory Syndrome (MERS)-CoV, as well as the human coronaviruses (HCoV)-OC43, -229E, -NL63, and -HKU1 that induce mild upper respiratory disease, but can be classified as a betacoronavirus with evidence of human-to-human transmission.
Mortality associated with SARS-CoV and MERS-CoV have been reported as more than 10% and more than 35%, respectively; at data cutoff for the current study, mortality among the 99 included cases was 11%, which is similar to that in another recent 2019-nCoV report, they said.
The finding of greater risk among older men also has been seen with SARS-CoV and MERS-CoV, and the high rate among individuals with chronic diseases, mainly cerebrovascular disease, cardiovascular disease, and diabetes, also has been reported with MERS-CoV, they added.
“Our results suggest that 2019-nCoV is more likely to infect older adult males with chronic comorbidities as a result of the weaker immune functions of these patients,” they wrote.
Coinfection with bacteria and fungi occurred in some patients, particularly those with severe illness, and cultures most often showed A. baumannii, K. pneumoniae, A. flavus, C. glabrata, and C. albicans, and the findings of reduced absolute lymphocyte values in most patients suggests that “2019-nCoV might mainly act on lymphocytes, especially T lymphocytes, as does SARS-CoV,” they noted.
Given the rapid progression with ARDS and septic shock in some patients in this review, “early identification and timely treatment of critical cases is of crucial importance,” they said.
“Use of intravenous immunoglobulin is recommended to enhance the ability of anti-infection for severely ill patients, and steroids (methylprednisolone 1-2 mg/kg per day) are recommended for patients with ARDS, for as short a duration of treatment as possible,” they added.
Further, since some studies suggest that a substantial decrease in lymphocyte count indicates consumption of many immune cells by coronavirus, thereby inhibiting cellular immune function, damage to T lymphocytes might be “an important factor leading to exacerbations of patients,” they wrote, adding that “[t]he low absolute value of lymphocytes could be used as a reference index in the diagnosis of new coronavirus infections in the clinic.”
The MuLBSTA score also should be investigated to determine its applicability for predicting mortality risk in patients with 2019-nCoV infection, they added.
The current study is limited by its small sample size; additional studies are needed to include “as many patients as possible in Wuhan, in other cities in China, and even in other countries to get a more comprehensive understanding of 2019-nCoV,” they said.
The National Key R&D Program of China funded the study. The authors reported having no conflicts of interest.
SOURCE: Chen N et al. Lancet. 2020 Jan 29. doi: 10.1016/S0140-6736(20)30211-7.
A group of physicians in Wuhan, China, who are treating patients with the 2019 novel coronavirus have gone the extra mile to share their clinical experiences with colleagues around the world.
Nanshan Chen, MD, of Jinyintan Hospital, Wuhan, and his team conducted a retrospective study on 99 cases and, in very short order, published their initial findings in the Lancet online on Jan. 29. These findings could guide action in other cases and help clinicians all over the world create treatment plans for patients of the 2019-nCoV.
The findings show that and characteristics of those with fatal infections align with the MuLBSTA score – an early warning model for predicting viral pneumonia–related mortality, according to a case review.
Of 99 patients who presented with 2019-nCoV pneumonia at Jinyintan Hospital between Jan. 1 and Jan. 20, 67 were men, the mean age was 55.5 years, and 50 patients had chronic diseases.
“All the data of included cases have been shared with [the World Health Organization]. The study was approved by Jinyintan Hospital Ethics Committee and written informed consent was obtained from patients involved before enrollment when data were collected retrospectively,” the researchers noted.
Nearly half of the patients (49%) lived or worked near a specific seafood market, suggesting disease clustering.
Clinical manifestations affecting the majority of patients included fever and cough in 83% and 82% of patients, respectively. Other symptoms included shortness of breath in 31%, muscle aches in 11%, confusion in 9%, headache in 8%, sore throat in 5%, and rhinorrhea, chest pain, diarrhea, and nausea and vomiting in 1%-4% of patients, the investigators found.
Imaging showed bilateral pneumonia in 75% of cases, multiple mottling and ground-glass opacity in 14%, and pneumothorax in 1%. Organ function damage was present in a third of patients at admission: 17% had acute respiratory distress syndrome (ARDS) – including 11 patients who worsened quickly and died of multiple organ failure. Eight percent had acute respiratory injury, 3% had acute renal injury, 4% had septic shock, and 1% had ventilator-associated pneumonia, they said, noting that all cases were confirmed by real-time polymerase chain reaction.
A notable laboratory finding was reduced absolute lymphocyte counts in most patients, the investigators said.
All patients were treated in isolation and 76% received antiviral treatment with oseltamivir, ganciclovir, lopinavir, or ritonavir for 3-14 days (median, 3 days). Most patients also received antibiotic treatment, including a single antibiotic in 25% of cases and combination therapy in 45%, with most antibiotics used to cover “common pathogens and some atypical pathogens,” they said, adding that “when secondary bacterial infection occurred, medication was administered according to the results of bacterial culture and drug sensitivity.”
Cephalosporins, quinolones, carbapenems, tigecycline against methicillin-resistant Staphylococcus aureus, linezolid, and antifungal drugs were used, and duration ranged from 3 to 17 days (median, 5 days).
Nineteen patients also received steroid treatments.
As of Jan. 25, 31 patients had been discharged and 57 remained hospitalized. Of the 11 who died, the first 2 were a 61-year-old man and a 69-year-old man, each diagnosed with severe pneumonia and ARDS. The first experienced sudden cardiac arrest and died on admission day 11, and the second died of severe pneumonia, septic shock, and respiratory failure on admission day 9. Neither had underlying disease, but both had a long history of smoking, the investigators noted.
“The deaths of these two patients were consistent with the MuLBSTA score,” they wrote, explaining that the scoring system takes into account multilobular infiltration, lymphopenia, bacterial coinfection, smoking history, hypertension, and age.
Eight of the nine other patients who died had lymphopenia, seven had bilateral pneumonia, five were over age 60 years, three had hypertension, and one was a heavy smoker, they added.
Most coronavirus infections cause mild symptoms and have good prognosis, but some patients with the 2019-nCoV, which was identified Jan. 7 following the development of several cases of pneumonia of unknown etiology in Wuhan, develop fatal disease. The paucity of data regarding epidemiology and clinical features of pneumonia associated with 2019-nCoV prompted the current retrospective study at the center where the first cases were admitted, the investigators explained.
They noted that the sequence of 2019-nCoV “is relatively different from the six other coronavirus subtypes, including the highly pathogenic severe acute respiratory syndrome (SARS)-CoV and Middle East Respiratory Syndrome (MERS)-CoV, as well as the human coronaviruses (HCoV)-OC43, -229E, -NL63, and -HKU1 that induce mild upper respiratory disease, but can be classified as a betacoronavirus with evidence of human-to-human transmission.
Mortality associated with SARS-CoV and MERS-CoV have been reported as more than 10% and more than 35%, respectively; at data cutoff for the current study, mortality among the 99 included cases was 11%, which is similar to that in another recent 2019-nCoV report, they said.
The finding of greater risk among older men also has been seen with SARS-CoV and MERS-CoV, and the high rate among individuals with chronic diseases, mainly cerebrovascular disease, cardiovascular disease, and diabetes, also has been reported with MERS-CoV, they added.
“Our results suggest that 2019-nCoV is more likely to infect older adult males with chronic comorbidities as a result of the weaker immune functions of these patients,” they wrote.
Coinfection with bacteria and fungi occurred in some patients, particularly those with severe illness, and cultures most often showed A. baumannii, K. pneumoniae, A. flavus, C. glabrata, and C. albicans, and the findings of reduced absolute lymphocyte values in most patients suggests that “2019-nCoV might mainly act on lymphocytes, especially T lymphocytes, as does SARS-CoV,” they noted.
Given the rapid progression with ARDS and septic shock in some patients in this review, “early identification and timely treatment of critical cases is of crucial importance,” they said.
“Use of intravenous immunoglobulin is recommended to enhance the ability of anti-infection for severely ill patients, and steroids (methylprednisolone 1-2 mg/kg per day) are recommended for patients with ARDS, for as short a duration of treatment as possible,” they added.
Further, since some studies suggest that a substantial decrease in lymphocyte count indicates consumption of many immune cells by coronavirus, thereby inhibiting cellular immune function, damage to T lymphocytes might be “an important factor leading to exacerbations of patients,” they wrote, adding that “[t]he low absolute value of lymphocytes could be used as a reference index in the diagnosis of new coronavirus infections in the clinic.”
The MuLBSTA score also should be investigated to determine its applicability for predicting mortality risk in patients with 2019-nCoV infection, they added.
The current study is limited by its small sample size; additional studies are needed to include “as many patients as possible in Wuhan, in other cities in China, and even in other countries to get a more comprehensive understanding of 2019-nCoV,” they said.
The National Key R&D Program of China funded the study. The authors reported having no conflicts of interest.
SOURCE: Chen N et al. Lancet. 2020 Jan 29. doi: 10.1016/S0140-6736(20)30211-7.
A group of physicians in Wuhan, China, who are treating patients with the 2019 novel coronavirus have gone the extra mile to share their clinical experiences with colleagues around the world.
Nanshan Chen, MD, of Jinyintan Hospital, Wuhan, and his team conducted a retrospective study on 99 cases and, in very short order, published their initial findings in the Lancet online on Jan. 29. These findings could guide action in other cases and help clinicians all over the world create treatment plans for patients of the 2019-nCoV.
The findings show that and characteristics of those with fatal infections align with the MuLBSTA score – an early warning model for predicting viral pneumonia–related mortality, according to a case review.
Of 99 patients who presented with 2019-nCoV pneumonia at Jinyintan Hospital between Jan. 1 and Jan. 20, 67 were men, the mean age was 55.5 years, and 50 patients had chronic diseases.
“All the data of included cases have been shared with [the World Health Organization]. The study was approved by Jinyintan Hospital Ethics Committee and written informed consent was obtained from patients involved before enrollment when data were collected retrospectively,” the researchers noted.
Nearly half of the patients (49%) lived or worked near a specific seafood market, suggesting disease clustering.
Clinical manifestations affecting the majority of patients included fever and cough in 83% and 82% of patients, respectively. Other symptoms included shortness of breath in 31%, muscle aches in 11%, confusion in 9%, headache in 8%, sore throat in 5%, and rhinorrhea, chest pain, diarrhea, and nausea and vomiting in 1%-4% of patients, the investigators found.
Imaging showed bilateral pneumonia in 75% of cases, multiple mottling and ground-glass opacity in 14%, and pneumothorax in 1%. Organ function damage was present in a third of patients at admission: 17% had acute respiratory distress syndrome (ARDS) – including 11 patients who worsened quickly and died of multiple organ failure. Eight percent had acute respiratory injury, 3% had acute renal injury, 4% had septic shock, and 1% had ventilator-associated pneumonia, they said, noting that all cases were confirmed by real-time polymerase chain reaction.
A notable laboratory finding was reduced absolute lymphocyte counts in most patients, the investigators said.
All patients were treated in isolation and 76% received antiviral treatment with oseltamivir, ganciclovir, lopinavir, or ritonavir for 3-14 days (median, 3 days). Most patients also received antibiotic treatment, including a single antibiotic in 25% of cases and combination therapy in 45%, with most antibiotics used to cover “common pathogens and some atypical pathogens,” they said, adding that “when secondary bacterial infection occurred, medication was administered according to the results of bacterial culture and drug sensitivity.”
Cephalosporins, quinolones, carbapenems, tigecycline against methicillin-resistant Staphylococcus aureus, linezolid, and antifungal drugs were used, and duration ranged from 3 to 17 days (median, 5 days).
Nineteen patients also received steroid treatments.
As of Jan. 25, 31 patients had been discharged and 57 remained hospitalized. Of the 11 who died, the first 2 were a 61-year-old man and a 69-year-old man, each diagnosed with severe pneumonia and ARDS. The first experienced sudden cardiac arrest and died on admission day 11, and the second died of severe pneumonia, septic shock, and respiratory failure on admission day 9. Neither had underlying disease, but both had a long history of smoking, the investigators noted.
“The deaths of these two patients were consistent with the MuLBSTA score,” they wrote, explaining that the scoring system takes into account multilobular infiltration, lymphopenia, bacterial coinfection, smoking history, hypertension, and age.
Eight of the nine other patients who died had lymphopenia, seven had bilateral pneumonia, five were over age 60 years, three had hypertension, and one was a heavy smoker, they added.
Most coronavirus infections cause mild symptoms and have good prognosis, but some patients with the 2019-nCoV, which was identified Jan. 7 following the development of several cases of pneumonia of unknown etiology in Wuhan, develop fatal disease. The paucity of data regarding epidemiology and clinical features of pneumonia associated with 2019-nCoV prompted the current retrospective study at the center where the first cases were admitted, the investigators explained.
They noted that the sequence of 2019-nCoV “is relatively different from the six other coronavirus subtypes, including the highly pathogenic severe acute respiratory syndrome (SARS)-CoV and Middle East Respiratory Syndrome (MERS)-CoV, as well as the human coronaviruses (HCoV)-OC43, -229E, -NL63, and -HKU1 that induce mild upper respiratory disease, but can be classified as a betacoronavirus with evidence of human-to-human transmission.
Mortality associated with SARS-CoV and MERS-CoV have been reported as more than 10% and more than 35%, respectively; at data cutoff for the current study, mortality among the 99 included cases was 11%, which is similar to that in another recent 2019-nCoV report, they said.
The finding of greater risk among older men also has been seen with SARS-CoV and MERS-CoV, and the high rate among individuals with chronic diseases, mainly cerebrovascular disease, cardiovascular disease, and diabetes, also has been reported with MERS-CoV, they added.
“Our results suggest that 2019-nCoV is more likely to infect older adult males with chronic comorbidities as a result of the weaker immune functions of these patients,” they wrote.
Coinfection with bacteria and fungi occurred in some patients, particularly those with severe illness, and cultures most often showed A. baumannii, K. pneumoniae, A. flavus, C. glabrata, and C. albicans, and the findings of reduced absolute lymphocyte values in most patients suggests that “2019-nCoV might mainly act on lymphocytes, especially T lymphocytes, as does SARS-CoV,” they noted.
Given the rapid progression with ARDS and septic shock in some patients in this review, “early identification and timely treatment of critical cases is of crucial importance,” they said.
“Use of intravenous immunoglobulin is recommended to enhance the ability of anti-infection for severely ill patients, and steroids (methylprednisolone 1-2 mg/kg per day) are recommended for patients with ARDS, for as short a duration of treatment as possible,” they added.
Further, since some studies suggest that a substantial decrease in lymphocyte count indicates consumption of many immune cells by coronavirus, thereby inhibiting cellular immune function, damage to T lymphocytes might be “an important factor leading to exacerbations of patients,” they wrote, adding that “[t]he low absolute value of lymphocytes could be used as a reference index in the diagnosis of new coronavirus infections in the clinic.”
The MuLBSTA score also should be investigated to determine its applicability for predicting mortality risk in patients with 2019-nCoV infection, they added.
The current study is limited by its small sample size; additional studies are needed to include “as many patients as possible in Wuhan, in other cities in China, and even in other countries to get a more comprehensive understanding of 2019-nCoV,” they said.
The National Key R&D Program of China funded the study. The authors reported having no conflicts of interest.
SOURCE: Chen N et al. Lancet. 2020 Jan 29. doi: 10.1016/S0140-6736(20)30211-7.
FROM THE LANCET
Trump takes on multiple health topics in State of the Union
President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.
Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”
That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.
A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.
But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.
“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.
A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.
The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.
The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.
“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”
Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.
Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.
Preexisting conditions
The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.
“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.
In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.
During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.
“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.
Socialist takeover
Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.
“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.
He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”
Added Mr. Trump: “We will never let socialism destroy American health care!”
Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.
Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
Opioids, the coronavirus, and abortion
In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.
He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.
Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.
The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.
“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.
Insulin costs?
In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.
At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.
But Mr. Trump never mentioned insulin in his speech.
This article first appeared on Medscape.com.
President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.
Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”
That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.
A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.
But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.
“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.
A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.
The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.
The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.
“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”
Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.
Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.
Preexisting conditions
The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.
“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.
In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.
During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.
“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.
Socialist takeover
Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.
“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.
He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”
Added Mr. Trump: “We will never let socialism destroy American health care!”
Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.
Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
Opioids, the coronavirus, and abortion
In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.
He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.
Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.
The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.
“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.
Insulin costs?
In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.
At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.
But Mr. Trump never mentioned insulin in his speech.
This article first appeared on Medscape.com.
President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.
Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”
That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.
A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.
But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.
“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.
A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.
The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.
The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.
“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”
Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.
Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.
Preexisting conditions
The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.
“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.
In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.
During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.
“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.
Socialist takeover
Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.
“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.
He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”
Added Mr. Trump: “We will never let socialism destroy American health care!”
Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.
Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
Opioids, the coronavirus, and abortion
In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.
He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.
Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.
The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.
“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.
Insulin costs?
In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.
At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.
But Mr. Trump never mentioned insulin in his speech.
This article first appeared on Medscape.com.
Home BP now a class Ia recommendation, with good reason
SNOWMASS, COLO. – The redefinition of hypertension as 130/80 mm Hg or higher introduced in the current American College of Cardiology/American Heart Association hypertension management guidelines has generated considerable controversy. Often overlooked, however, has been another major innovation included in the 2017 guidelines: the rise in the status of out-of-office 24-hour ambulatory blood pressure monitoring and home blood pressure self-measurement to a class I, level of evidence A recommendation, Andrew M. Kates, MD, observed at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
It’s a guideline he strongly endorses.
“We do a lot of this. It can be a challenge to get 24-hour ambulatory blood pressure monitoring covered by payers, so said Dr. Kates, professor of medicine and director of the cardiology fellowship program at Washington University, St. Louis.
He explained that one of the four key questions the guideline committee was tasked with answering at the outset of deliberations was this: What’s the evidence base for self-directed out-of-office blood pressure monitoring? Based on the panel’s systematic review of the literature, this practice wound up receiving the strongest possible class Ia recommendation, specifically for confirming the diagnosis of hypertension and for titration of antihypertensive medications. Moreover, the guidelines also endorsed home blood pressure monitoring for the detection of white-coat hypertension, this time as a Class IIa recommendation, as well as for identification of patients with masked hypertension, with class IIb status (Circulation. 2018 Oct 23;138[17]:e484-594).
The 2017 ACC/AHA guidelines include a detailed checklist for obtaining accurate measurements of office blood pressure. The suggestions include having the patient sit relaxed in a chair with both feet on the floor for at least 5 minutes before taking the measurement, no coffee or exercise for 30 minutes beforehand, empty the bladder, no talking, no clothing over the arm, and other recommendations. Many busy clinicians roll their eyes at the impracticality of doing all this on a routine basis.
“I don’t want to take an audience survey, but I’ll say that even in our office we are not successful in doing this. Patients run up the stairs to the office after dealing with traffic and the parking garage, they’re late for their appointment, in winter they’re wearing a sweater and don’t want to take it off. These are things we don’t do well, and they’re low-hanging fruit where we could do better,” Dr. Kates commented.
The challenges inherent in performing by-the-book office blood pressure measurement reinforce the importance of home self-monitoring of blood pressure in what is hopefully a more stress-free environment.
“We can give patients specific guidance about checking their blood pressure an hour after taking their medications, sitting for 5 minutes, and checking the pressures on a bare arm and not with the sleeve rolled up,” he noted.
The guidelines recommend using home blood pressure monitoring or ambulatory monitoring to detect white-coat hypertension in patients with an office blood pressure of 130/80 mm Hg or more, but less than 160/100 mm Hg, after a 3-month trial of lifestyle modification. If the home blood pressure is less than 130/80 mm Hg, that’s evidence of white-coat hypertension, for which the recommended treatment consists of continued lifestyle modification plus periodic monitoring of out-of-office blood pressures in order to promptly detect progression to hypertension. If, however, the out-of-office blood pressure is not less than 130/80 mm Hg, that’s hypertension, and the guidelines recommend starting dual-agent antihypertensive drug therapy while continuing lifestyle modification.
A confusing array of definitions of hypertension are now in use by various medical societies. While the 2017 ACC/AHA hypertension guidelines define hypertension as office blood pressure of 130/80 mm Hg or more, the 2018 European Society of Cardiology/European Society of Hypertension guidelines use a threshold of 140/90 mm Hg or more. Joint American Academy of Family Physicians/American College of Physicians guidelines recommend a treatment target of less than 150 mm Hg in hypertensive patients aged 60 years or older. And at the other end of the spectrum, the SPRINT trial showed a significant cardiovascular benefit for intensive treatment of hypertension to a target systolic blood pressure below 120 mm Hg, rather than less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
Dr. Kates believes the debate over the “right” treatment target misses the central point, which is that hypertension is staggeringly undertreated. Indeed, the Centers for Disease Control and Prevention estimates only one in four adults with hypertension have their disease under control. That’s a disconcerting statistic given that hypertension accounts for more cardiovascular deaths than any other modifiable cardiovascular risk factor.
“There’s been some concern raised that maybe too much weight has been put on the SPRINT trial in making the ACC/AHA recommendations, but I think it’s helpful to understand that we vastly undertreat patients with hypertension. So I think that, rather than being so concerned that we’re going to be treating people to too low a target or we’re being overly aggressive, it should give us some pause to think about the fact that we’re ordinarily not being aggressive enough with many of our patients as it is,” the cardiologist said.
Dr. Kates reported having no financial conflicts regarding his presentation.
SNOWMASS, COLO. – The redefinition of hypertension as 130/80 mm Hg or higher introduced in the current American College of Cardiology/American Heart Association hypertension management guidelines has generated considerable controversy. Often overlooked, however, has been another major innovation included in the 2017 guidelines: the rise in the status of out-of-office 24-hour ambulatory blood pressure monitoring and home blood pressure self-measurement to a class I, level of evidence A recommendation, Andrew M. Kates, MD, observed at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
It’s a guideline he strongly endorses.
“We do a lot of this. It can be a challenge to get 24-hour ambulatory blood pressure monitoring covered by payers, so said Dr. Kates, professor of medicine and director of the cardiology fellowship program at Washington University, St. Louis.
He explained that one of the four key questions the guideline committee was tasked with answering at the outset of deliberations was this: What’s the evidence base for self-directed out-of-office blood pressure monitoring? Based on the panel’s systematic review of the literature, this practice wound up receiving the strongest possible class Ia recommendation, specifically for confirming the diagnosis of hypertension and for titration of antihypertensive medications. Moreover, the guidelines also endorsed home blood pressure monitoring for the detection of white-coat hypertension, this time as a Class IIa recommendation, as well as for identification of patients with masked hypertension, with class IIb status (Circulation. 2018 Oct 23;138[17]:e484-594).
The 2017 ACC/AHA guidelines include a detailed checklist for obtaining accurate measurements of office blood pressure. The suggestions include having the patient sit relaxed in a chair with both feet on the floor for at least 5 minutes before taking the measurement, no coffee or exercise for 30 minutes beforehand, empty the bladder, no talking, no clothing over the arm, and other recommendations. Many busy clinicians roll their eyes at the impracticality of doing all this on a routine basis.
“I don’t want to take an audience survey, but I’ll say that even in our office we are not successful in doing this. Patients run up the stairs to the office after dealing with traffic and the parking garage, they’re late for their appointment, in winter they’re wearing a sweater and don’t want to take it off. These are things we don’t do well, and they’re low-hanging fruit where we could do better,” Dr. Kates commented.
The challenges inherent in performing by-the-book office blood pressure measurement reinforce the importance of home self-monitoring of blood pressure in what is hopefully a more stress-free environment.
“We can give patients specific guidance about checking their blood pressure an hour after taking their medications, sitting for 5 minutes, and checking the pressures on a bare arm and not with the sleeve rolled up,” he noted.
The guidelines recommend using home blood pressure monitoring or ambulatory monitoring to detect white-coat hypertension in patients with an office blood pressure of 130/80 mm Hg or more, but less than 160/100 mm Hg, after a 3-month trial of lifestyle modification. If the home blood pressure is less than 130/80 mm Hg, that’s evidence of white-coat hypertension, for which the recommended treatment consists of continued lifestyle modification plus periodic monitoring of out-of-office blood pressures in order to promptly detect progression to hypertension. If, however, the out-of-office blood pressure is not less than 130/80 mm Hg, that’s hypertension, and the guidelines recommend starting dual-agent antihypertensive drug therapy while continuing lifestyle modification.
A confusing array of definitions of hypertension are now in use by various medical societies. While the 2017 ACC/AHA hypertension guidelines define hypertension as office blood pressure of 130/80 mm Hg or more, the 2018 European Society of Cardiology/European Society of Hypertension guidelines use a threshold of 140/90 mm Hg or more. Joint American Academy of Family Physicians/American College of Physicians guidelines recommend a treatment target of less than 150 mm Hg in hypertensive patients aged 60 years or older. And at the other end of the spectrum, the SPRINT trial showed a significant cardiovascular benefit for intensive treatment of hypertension to a target systolic blood pressure below 120 mm Hg, rather than less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
Dr. Kates believes the debate over the “right” treatment target misses the central point, which is that hypertension is staggeringly undertreated. Indeed, the Centers for Disease Control and Prevention estimates only one in four adults with hypertension have their disease under control. That’s a disconcerting statistic given that hypertension accounts for more cardiovascular deaths than any other modifiable cardiovascular risk factor.
“There’s been some concern raised that maybe too much weight has been put on the SPRINT trial in making the ACC/AHA recommendations, but I think it’s helpful to understand that we vastly undertreat patients with hypertension. So I think that, rather than being so concerned that we’re going to be treating people to too low a target or we’re being overly aggressive, it should give us some pause to think about the fact that we’re ordinarily not being aggressive enough with many of our patients as it is,” the cardiologist said.
Dr. Kates reported having no financial conflicts regarding his presentation.
SNOWMASS, COLO. – The redefinition of hypertension as 130/80 mm Hg or higher introduced in the current American College of Cardiology/American Heart Association hypertension management guidelines has generated considerable controversy. Often overlooked, however, has been another major innovation included in the 2017 guidelines: the rise in the status of out-of-office 24-hour ambulatory blood pressure monitoring and home blood pressure self-measurement to a class I, level of evidence A recommendation, Andrew M. Kates, MD, observed at the annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
It’s a guideline he strongly endorses.
“We do a lot of this. It can be a challenge to get 24-hour ambulatory blood pressure monitoring covered by payers, so said Dr. Kates, professor of medicine and director of the cardiology fellowship program at Washington University, St. Louis.
He explained that one of the four key questions the guideline committee was tasked with answering at the outset of deliberations was this: What’s the evidence base for self-directed out-of-office blood pressure monitoring? Based on the panel’s systematic review of the literature, this practice wound up receiving the strongest possible class Ia recommendation, specifically for confirming the diagnosis of hypertension and for titration of antihypertensive medications. Moreover, the guidelines also endorsed home blood pressure monitoring for the detection of white-coat hypertension, this time as a Class IIa recommendation, as well as for identification of patients with masked hypertension, with class IIb status (Circulation. 2018 Oct 23;138[17]:e484-594).
The 2017 ACC/AHA guidelines include a detailed checklist for obtaining accurate measurements of office blood pressure. The suggestions include having the patient sit relaxed in a chair with both feet on the floor for at least 5 minutes before taking the measurement, no coffee or exercise for 30 minutes beforehand, empty the bladder, no talking, no clothing over the arm, and other recommendations. Many busy clinicians roll their eyes at the impracticality of doing all this on a routine basis.
“I don’t want to take an audience survey, but I’ll say that even in our office we are not successful in doing this. Patients run up the stairs to the office after dealing with traffic and the parking garage, they’re late for their appointment, in winter they’re wearing a sweater and don’t want to take it off. These are things we don’t do well, and they’re low-hanging fruit where we could do better,” Dr. Kates commented.
The challenges inherent in performing by-the-book office blood pressure measurement reinforce the importance of home self-monitoring of blood pressure in what is hopefully a more stress-free environment.
“We can give patients specific guidance about checking their blood pressure an hour after taking their medications, sitting for 5 minutes, and checking the pressures on a bare arm and not with the sleeve rolled up,” he noted.
The guidelines recommend using home blood pressure monitoring or ambulatory monitoring to detect white-coat hypertension in patients with an office blood pressure of 130/80 mm Hg or more, but less than 160/100 mm Hg, after a 3-month trial of lifestyle modification. If the home blood pressure is less than 130/80 mm Hg, that’s evidence of white-coat hypertension, for which the recommended treatment consists of continued lifestyle modification plus periodic monitoring of out-of-office blood pressures in order to promptly detect progression to hypertension. If, however, the out-of-office blood pressure is not less than 130/80 mm Hg, that’s hypertension, and the guidelines recommend starting dual-agent antihypertensive drug therapy while continuing lifestyle modification.
A confusing array of definitions of hypertension are now in use by various medical societies. While the 2017 ACC/AHA hypertension guidelines define hypertension as office blood pressure of 130/80 mm Hg or more, the 2018 European Society of Cardiology/European Society of Hypertension guidelines use a threshold of 140/90 mm Hg or more. Joint American Academy of Family Physicians/American College of Physicians guidelines recommend a treatment target of less than 150 mm Hg in hypertensive patients aged 60 years or older. And at the other end of the spectrum, the SPRINT trial showed a significant cardiovascular benefit for intensive treatment of hypertension to a target systolic blood pressure below 120 mm Hg, rather than less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
Dr. Kates believes the debate over the “right” treatment target misses the central point, which is that hypertension is staggeringly undertreated. Indeed, the Centers for Disease Control and Prevention estimates only one in four adults with hypertension have their disease under control. That’s a disconcerting statistic given that hypertension accounts for more cardiovascular deaths than any other modifiable cardiovascular risk factor.
“There’s been some concern raised that maybe too much weight has been put on the SPRINT trial in making the ACC/AHA recommendations, but I think it’s helpful to understand that we vastly undertreat patients with hypertension. So I think that, rather than being so concerned that we’re going to be treating people to too low a target or we’re being overly aggressive, it should give us some pause to think about the fact that we’re ordinarily not being aggressive enough with many of our patients as it is,” the cardiologist said.
Dr. Kates reported having no financial conflicts regarding his presentation.
EXPERT ANALYSIS FROM ACC SNOWMASS 2020
Statin, antihypertensive treatment don’t guarantee healthier lifestyles
When people learn they have enough cardiovascular disease risk to start treatment with a statin or antihypertensive drug, the impact on their healthy-lifestyle choices seems to often be a wash, based on findings from more than 40,000 Finland residents followed for at least 4 years after starting their primary-prevention regimen.
“Patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” wrote Maarit J. Korhonen, PhD, and associates in a report published in the Journal of the American Heart Association.
“Initiation of antihypertensive or statin therapy appears to be associated with lifestyle changes, some positive and others negative,” wrote Dr. Korhonen, a pharmacoepidemiologist at the University of Turku (Finland), and associates. This was the first reported study to assess a large-scale and prospectively followed cohort to look for associations between the use of medicines that prevent cardiovascular disease (CVD) and lifestyle changes. Most previous studies of these associations “have been cross sectional and provide no information on potential lifestyle changes during the time window around the initiation of medication use,” they added.
The new study specifically found that, on average, people who began treatment with at least one CVD-prevention medication for the first time were more likely to gain weight and more likely to become less active during the years following their treatment onset. But at the same time, these patients were also more likely to either quit or cut down on their smoking and alcohol consumption, the researchers found.
Their analysis used data from 41,225 people enrolled in the Finnish Public Sector Study, which prospectively began collecting data on a large number of Finland residents in the 1990s. They specifically focused on 81,772 completed questionnaires – collected at 4-year intervals – from people who completed at least two consecutive rounds of the survey during 2000-2013, and who were also at least 40 years old and free of prevalent CVD at the time of their first survey. The participants averaged nearly 53 years of age at their first survey, and 84% were women.
The researchers subdivided the survey responses into 8,837 (11%) people who began a statin, antihypertensive drug, or both during their participation; 26,914 (33%) already on a statin or antihypertensive drug when they completed their first questionnaire; and 46,021 response sets (56%) from people who never began treatment with either drug class. People who initiated a relevant drug began a median of 1.7 years following completion of their first survey, and a median of 2.4 years before their next survey. During follow-up, about 2% of all participants became newly diagnosed with some form of CVD.
The results showed that, after full adjustment for possible confounders, the mean increase in body mass index was larger among those who initiated a CVD-prevention drug, compared with those who did not. Among participants who were obese at entry, those who started a CVD drug had a statistically significant 37% increased rate of remaining obese, compared with those not starting these drugs. Among those who were not obese at baseline, those who began a CVD prevention drug had a statistically significant 82%% higher rate of becoming obese, compared with those not on a CVD-prevention drug. In addition, average daily energy expenditure, a measure of physical activity, showed a statistically significant decline among those who started a CVD drug, compared with those who did not. In contrast, CVD drug initiators had an average 1.85 gram/week decline in alcohol intake, compared with noninitiators, and those who were current smokers at the first survey and then started a CVD drug had a 26% relative drop in their smoking prevalence, compared with those who did not start a CVD drug, both statistically significant differences.
The findings suggest that “patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” the authors concluded. “This means that expansion of pharmacologic interventions toward populations at low CVD risk may not necessarily lead to expected benefits at the population level.”
The study received no commercial funding. Dr. Korhonen had no disclosures.
SOURCE: Korhonen MJ et al. J Am Heart Assoc. 2020 Feb 5. doi: 10.1161/JAHA.119.014.168.
When people learn they have enough cardiovascular disease risk to start treatment with a statin or antihypertensive drug, the impact on their healthy-lifestyle choices seems to often be a wash, based on findings from more than 40,000 Finland residents followed for at least 4 years after starting their primary-prevention regimen.
“Patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” wrote Maarit J. Korhonen, PhD, and associates in a report published in the Journal of the American Heart Association.
“Initiation of antihypertensive or statin therapy appears to be associated with lifestyle changes, some positive and others negative,” wrote Dr. Korhonen, a pharmacoepidemiologist at the University of Turku (Finland), and associates. This was the first reported study to assess a large-scale and prospectively followed cohort to look for associations between the use of medicines that prevent cardiovascular disease (CVD) and lifestyle changes. Most previous studies of these associations “have been cross sectional and provide no information on potential lifestyle changes during the time window around the initiation of medication use,” they added.
The new study specifically found that, on average, people who began treatment with at least one CVD-prevention medication for the first time were more likely to gain weight and more likely to become less active during the years following their treatment onset. But at the same time, these patients were also more likely to either quit or cut down on their smoking and alcohol consumption, the researchers found.
Their analysis used data from 41,225 people enrolled in the Finnish Public Sector Study, which prospectively began collecting data on a large number of Finland residents in the 1990s. They specifically focused on 81,772 completed questionnaires – collected at 4-year intervals – from people who completed at least two consecutive rounds of the survey during 2000-2013, and who were also at least 40 years old and free of prevalent CVD at the time of their first survey. The participants averaged nearly 53 years of age at their first survey, and 84% were women.
The researchers subdivided the survey responses into 8,837 (11%) people who began a statin, antihypertensive drug, or both during their participation; 26,914 (33%) already on a statin or antihypertensive drug when they completed their first questionnaire; and 46,021 response sets (56%) from people who never began treatment with either drug class. People who initiated a relevant drug began a median of 1.7 years following completion of their first survey, and a median of 2.4 years before their next survey. During follow-up, about 2% of all participants became newly diagnosed with some form of CVD.
The results showed that, after full adjustment for possible confounders, the mean increase in body mass index was larger among those who initiated a CVD-prevention drug, compared with those who did not. Among participants who were obese at entry, those who started a CVD drug had a statistically significant 37% increased rate of remaining obese, compared with those not starting these drugs. Among those who were not obese at baseline, those who began a CVD prevention drug had a statistically significant 82%% higher rate of becoming obese, compared with those not on a CVD-prevention drug. In addition, average daily energy expenditure, a measure of physical activity, showed a statistically significant decline among those who started a CVD drug, compared with those who did not. In contrast, CVD drug initiators had an average 1.85 gram/week decline in alcohol intake, compared with noninitiators, and those who were current smokers at the first survey and then started a CVD drug had a 26% relative drop in their smoking prevalence, compared with those who did not start a CVD drug, both statistically significant differences.
The findings suggest that “patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” the authors concluded. “This means that expansion of pharmacologic interventions toward populations at low CVD risk may not necessarily lead to expected benefits at the population level.”
The study received no commercial funding. Dr. Korhonen had no disclosures.
SOURCE: Korhonen MJ et al. J Am Heart Assoc. 2020 Feb 5. doi: 10.1161/JAHA.119.014.168.
When people learn they have enough cardiovascular disease risk to start treatment with a statin or antihypertensive drug, the impact on their healthy-lifestyle choices seems to often be a wash, based on findings from more than 40,000 Finland residents followed for at least 4 years after starting their primary-prevention regimen.
“Patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” wrote Maarit J. Korhonen, PhD, and associates in a report published in the Journal of the American Heart Association.
“Initiation of antihypertensive or statin therapy appears to be associated with lifestyle changes, some positive and others negative,” wrote Dr. Korhonen, a pharmacoepidemiologist at the University of Turku (Finland), and associates. This was the first reported study to assess a large-scale and prospectively followed cohort to look for associations between the use of medicines that prevent cardiovascular disease (CVD) and lifestyle changes. Most previous studies of these associations “have been cross sectional and provide no information on potential lifestyle changes during the time window around the initiation of medication use,” they added.
The new study specifically found that, on average, people who began treatment with at least one CVD-prevention medication for the first time were more likely to gain weight and more likely to become less active during the years following their treatment onset. But at the same time, these patients were also more likely to either quit or cut down on their smoking and alcohol consumption, the researchers found.
Their analysis used data from 41,225 people enrolled in the Finnish Public Sector Study, which prospectively began collecting data on a large number of Finland residents in the 1990s. They specifically focused on 81,772 completed questionnaires – collected at 4-year intervals – from people who completed at least two consecutive rounds of the survey during 2000-2013, and who were also at least 40 years old and free of prevalent CVD at the time of their first survey. The participants averaged nearly 53 years of age at their first survey, and 84% were women.
The researchers subdivided the survey responses into 8,837 (11%) people who began a statin, antihypertensive drug, or both during their participation; 26,914 (33%) already on a statin or antihypertensive drug when they completed their first questionnaire; and 46,021 response sets (56%) from people who never began treatment with either drug class. People who initiated a relevant drug began a median of 1.7 years following completion of their first survey, and a median of 2.4 years before their next survey. During follow-up, about 2% of all participants became newly diagnosed with some form of CVD.
The results showed that, after full adjustment for possible confounders, the mean increase in body mass index was larger among those who initiated a CVD-prevention drug, compared with those who did not. Among participants who were obese at entry, those who started a CVD drug had a statistically significant 37% increased rate of remaining obese, compared with those not starting these drugs. Among those who were not obese at baseline, those who began a CVD prevention drug had a statistically significant 82%% higher rate of becoming obese, compared with those not on a CVD-prevention drug. In addition, average daily energy expenditure, a measure of physical activity, showed a statistically significant decline among those who started a CVD drug, compared with those who did not. In contrast, CVD drug initiators had an average 1.85 gram/week decline in alcohol intake, compared with noninitiators, and those who were current smokers at the first survey and then started a CVD drug had a 26% relative drop in their smoking prevalence, compared with those who did not start a CVD drug, both statistically significant differences.
The findings suggest that “patients’ awareness of their risk factors alone seems not to be effective in improving health behaviors,” the authors concluded. “This means that expansion of pharmacologic interventions toward populations at low CVD risk may not necessarily lead to expected benefits at the population level.”
The study received no commercial funding. Dr. Korhonen had no disclosures.
SOURCE: Korhonen MJ et al. J Am Heart Assoc. 2020 Feb 5. doi: 10.1161/JAHA.119.014.168.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Chronic cough in COPD linked to more severe disease
, according to research published in CHEST.
The results indicate “that chronic cough in individuals with COPD is associated with a more severe disease phenotype, which could be helpful for stratifying management of COPD in the future,” wrote Eskild Landt, PhD, a research assistant at Zealand University Hospital in Køge, Denmark, and colleagues.
A study by published in the Journal of Allergy and Clinical Immunology: In Practice (2019;7[6]:1783-92.e8) indicated that in patients with asthma, chronic cough was associated with worse respiratory symptoms, more health care utilization, decreased lung function, and increased inflammatory markers in blood. Dr. Landt and colleagues hypothesized that patients with COPD and chronic cough had a similar pattern of disease severity.
To test their hypothesis, they identified individuals with COPD and chronic cough among 43,271 participants in the Copenhagen General Population Study, a population-based cohort study. The researchers defined COPD as a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) of less than 0.70 in individuals without asthma. Consecutive individuals answered questions about chronic cough, which was defined as a cough lasting more than 8 weeks, and responded to the Leicester Cough Questionnaire. They also underwent a physical health examination, including prebronchodilatory spirometry, and gave blood for biochemical analyses. The blood was analyzed for high-sensitive C-reactive protein, fibrinogen, leukocytes, eosinophils, neutrophils, and immunoglobulin E (i.e., inflammatory biomarkers).
Dr. Landt and colleagues identified 8,181 patients (19% of the population) with COPD, 796 (10%) of whom had chronic cough. Of the 33,364 participants without COPD, 1,585 (5%) had chronic cough. For patients with COPD and chronic cough, median total Leicester Cough Questionnaire score was 17.7, corresponding to 5.9 for the physical domain, 5.6 for the psychological domain, and 6.3 for the social domain.
Among participants with COPD, those with chronic cough had higher rates of sputum production (60% versus 8%), wheezing (46% versus 14%), dyspnea (66% versus 38%), chest pain or tightness (9% versus 4%), nighttime dyspnea (8% versus 3%), episodes of acute bronchitis or pneumonias in the past 10 years (45% versus 25%), and general practitioner visits in the past 12 months (53% versus 37%). In addition, these participants had lower FEV1% of predicted (81% versus 89%), lower ratio of FEV1 to FVC (0.64 versus 0.66), and higher levels of high-sensitive C-reactive protein, fibrinogen, leukocytes, neutrophils, eosinophils, and immunoglobulin E in blood.
“To our knowledge, this is the first study reporting Leicester Cough Questionnaire score for randomly selected individuals with COPD from a general population setting,” wrote Dr. Landt and colleagues. The study’s strengths include its randomly chosen population-based sample and investigator blinding to disease status and clinical outcome, they added. Some patients with the most severe types of COPD and chronic cough may not have attended the physical examination and participated in the study, however, and this factor could have biased the results. Furthermore, nearly the entire sample was white, so the results may not be generalizable to other ethnicities. “That said, we are not aware of results to suggest that our findings should not be relevant to individuals of all races,” wrote the investigators.
The study was funded by the private Lundbeck Foundation, as well as by the Danish Lung Association and the Danish Cancer Society. Several authors reported receiving grants and fees from AstraZeneca, GlaxoSmithKline, and Novartis that were unrelated to the study.
SOURCE: Landt E et al. CHEST. 2020 Jan 24. doi: 10.1016/j.chest.2019.12.038.
, according to research published in CHEST.
The results indicate “that chronic cough in individuals with COPD is associated with a more severe disease phenotype, which could be helpful for stratifying management of COPD in the future,” wrote Eskild Landt, PhD, a research assistant at Zealand University Hospital in Køge, Denmark, and colleagues.
A study by published in the Journal of Allergy and Clinical Immunology: In Practice (2019;7[6]:1783-92.e8) indicated that in patients with asthma, chronic cough was associated with worse respiratory symptoms, more health care utilization, decreased lung function, and increased inflammatory markers in blood. Dr. Landt and colleagues hypothesized that patients with COPD and chronic cough had a similar pattern of disease severity.
To test their hypothesis, they identified individuals with COPD and chronic cough among 43,271 participants in the Copenhagen General Population Study, a population-based cohort study. The researchers defined COPD as a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) of less than 0.70 in individuals without asthma. Consecutive individuals answered questions about chronic cough, which was defined as a cough lasting more than 8 weeks, and responded to the Leicester Cough Questionnaire. They also underwent a physical health examination, including prebronchodilatory spirometry, and gave blood for biochemical analyses. The blood was analyzed for high-sensitive C-reactive protein, fibrinogen, leukocytes, eosinophils, neutrophils, and immunoglobulin E (i.e., inflammatory biomarkers).
Dr. Landt and colleagues identified 8,181 patients (19% of the population) with COPD, 796 (10%) of whom had chronic cough. Of the 33,364 participants without COPD, 1,585 (5%) had chronic cough. For patients with COPD and chronic cough, median total Leicester Cough Questionnaire score was 17.7, corresponding to 5.9 for the physical domain, 5.6 for the psychological domain, and 6.3 for the social domain.
Among participants with COPD, those with chronic cough had higher rates of sputum production (60% versus 8%), wheezing (46% versus 14%), dyspnea (66% versus 38%), chest pain or tightness (9% versus 4%), nighttime dyspnea (8% versus 3%), episodes of acute bronchitis or pneumonias in the past 10 years (45% versus 25%), and general practitioner visits in the past 12 months (53% versus 37%). In addition, these participants had lower FEV1% of predicted (81% versus 89%), lower ratio of FEV1 to FVC (0.64 versus 0.66), and higher levels of high-sensitive C-reactive protein, fibrinogen, leukocytes, neutrophils, eosinophils, and immunoglobulin E in blood.
“To our knowledge, this is the first study reporting Leicester Cough Questionnaire score for randomly selected individuals with COPD from a general population setting,” wrote Dr. Landt and colleagues. The study’s strengths include its randomly chosen population-based sample and investigator blinding to disease status and clinical outcome, they added. Some patients with the most severe types of COPD and chronic cough may not have attended the physical examination and participated in the study, however, and this factor could have biased the results. Furthermore, nearly the entire sample was white, so the results may not be generalizable to other ethnicities. “That said, we are not aware of results to suggest that our findings should not be relevant to individuals of all races,” wrote the investigators.
The study was funded by the private Lundbeck Foundation, as well as by the Danish Lung Association and the Danish Cancer Society. Several authors reported receiving grants and fees from AstraZeneca, GlaxoSmithKline, and Novartis that were unrelated to the study.
SOURCE: Landt E et al. CHEST. 2020 Jan 24. doi: 10.1016/j.chest.2019.12.038.
, according to research published in CHEST.
The results indicate “that chronic cough in individuals with COPD is associated with a more severe disease phenotype, which could be helpful for stratifying management of COPD in the future,” wrote Eskild Landt, PhD, a research assistant at Zealand University Hospital in Køge, Denmark, and colleagues.
A study by published in the Journal of Allergy and Clinical Immunology: In Practice (2019;7[6]:1783-92.e8) indicated that in patients with asthma, chronic cough was associated with worse respiratory symptoms, more health care utilization, decreased lung function, and increased inflammatory markers in blood. Dr. Landt and colleagues hypothesized that patients with COPD and chronic cough had a similar pattern of disease severity.
To test their hypothesis, they identified individuals with COPD and chronic cough among 43,271 participants in the Copenhagen General Population Study, a population-based cohort study. The researchers defined COPD as a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) of less than 0.70 in individuals without asthma. Consecutive individuals answered questions about chronic cough, which was defined as a cough lasting more than 8 weeks, and responded to the Leicester Cough Questionnaire. They also underwent a physical health examination, including prebronchodilatory spirometry, and gave blood for biochemical analyses. The blood was analyzed for high-sensitive C-reactive protein, fibrinogen, leukocytes, eosinophils, neutrophils, and immunoglobulin E (i.e., inflammatory biomarkers).
Dr. Landt and colleagues identified 8,181 patients (19% of the population) with COPD, 796 (10%) of whom had chronic cough. Of the 33,364 participants without COPD, 1,585 (5%) had chronic cough. For patients with COPD and chronic cough, median total Leicester Cough Questionnaire score was 17.7, corresponding to 5.9 for the physical domain, 5.6 for the psychological domain, and 6.3 for the social domain.
Among participants with COPD, those with chronic cough had higher rates of sputum production (60% versus 8%), wheezing (46% versus 14%), dyspnea (66% versus 38%), chest pain or tightness (9% versus 4%), nighttime dyspnea (8% versus 3%), episodes of acute bronchitis or pneumonias in the past 10 years (45% versus 25%), and general practitioner visits in the past 12 months (53% versus 37%). In addition, these participants had lower FEV1% of predicted (81% versus 89%), lower ratio of FEV1 to FVC (0.64 versus 0.66), and higher levels of high-sensitive C-reactive protein, fibrinogen, leukocytes, neutrophils, eosinophils, and immunoglobulin E in blood.
“To our knowledge, this is the first study reporting Leicester Cough Questionnaire score for randomly selected individuals with COPD from a general population setting,” wrote Dr. Landt and colleagues. The study’s strengths include its randomly chosen population-based sample and investigator blinding to disease status and clinical outcome, they added. Some patients with the most severe types of COPD and chronic cough may not have attended the physical examination and participated in the study, however, and this factor could have biased the results. Furthermore, nearly the entire sample was white, so the results may not be generalizable to other ethnicities. “That said, we are not aware of results to suggest that our findings should not be relevant to individuals of all races,” wrote the investigators.
The study was funded by the private Lundbeck Foundation, as well as by the Danish Lung Association and the Danish Cancer Society. Several authors reported receiving grants and fees from AstraZeneca, GlaxoSmithKline, and Novartis that were unrelated to the study.
SOURCE: Landt E et al. CHEST. 2020 Jan 24. doi: 10.1016/j.chest.2019.12.038.
FROM CHEST
FDA approves novel pandemic influenza vaccine
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.
ACIP updates recommendations for adult vaccines
The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.
The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.
Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.
For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.
“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.
Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.
All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*
HPV
The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.
“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”
“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.
Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.
Influenza, hepatitis A and B
For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.
Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.
For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.
Meningitis B
Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.
Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.
Td/Tdap, varicella
The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.
Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.
Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”
In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.
Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.
As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.
The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.
The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine.
The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.
The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.
Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.
For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.
“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.
Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.
All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*
HPV
The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.
“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”
“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.
Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.
Influenza, hepatitis A and B
For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.
Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.
For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.
Meningitis B
Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.
Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.
Td/Tdap, varicella
The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.
Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.
Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”
In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.
Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.
As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.
The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.
The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine.
The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.
The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.
Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.
For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.
“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.
Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.
All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*
HPV
The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.
“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”
“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.
Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.
Influenza, hepatitis A and B
For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.
Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.
For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.
Meningitis B
Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.
Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.
Td/Tdap, varicella
The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.
Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.
Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”
In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.
Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.
As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.
The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.
The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine.