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EULAR Issues Vaccine Recommendations for Adults With AIIRD
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
FROM THE EUROPEAN LEAGUE AGAINST RHEUMATISM
EULAR Issues Vaccine Recommendations for Adults With AIIRD
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
FROM THE EUROPEAN LEAGUE AGAINST RHEUMATISM
EULAR Issues Vaccine Recommendations for Adults With AIIRD
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Due to the immune dysregulation seen inpatients with autoimmune inflammatory rheumatic disease, some vaccine-preventable infections seem to be more common or more severe. Yet the immunosuppressive therapies given to these patients can blunt the vaccine efficacy or, theoretically, be associated with primary infection from certain live and attenuated vaccines. There is only a limited amount of information obtained in the controlled-trial setting to provide guidance. Hence, a structured review of published data with expert discussion is of value in helping to provide guidance as to when specific vaccination is either appropriate or should be avoided. This is a common question from our patients: "Should I get [a specific vaccine]?"
The likelihood of a patient’s getting a severe infection with a vaccine, the degree of immunosuppression, and the safety of the vaccine are all factors that rheumatologists should consider when counseling patients about vaccinations. Influenza and pneumococcal vaccine decisions are easy: Efficacy may be blunted in some settings, but the vaccines are safe and any potential efficacy would be beneficial. A decision to vaccinate patients who are about to receive rituximab must take into consideration the data that B-cell–directed therapy clearly lowers the efficacy of the vaccine, so vaccination ideally should be given prior to this therapy. This takes some planning and careful review of the patient’s vaccination history in advance.
I believe we need outcome-based trials that study clinical – not just serologic – efficacy of certain vaccines in the setting of immunosuppression. I would particularly like to see formal studies on safety and efficacy of the zoster vaccine.
Brian F. Mandell, M.D., is a rheumatologist at the Cleveland Clinic, where he holds the position of professor and acting chair in the department of medicine. Dr. Mandell has served as a consultant or speaker for Merck and Takeda Pharmaceuticals.
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
Inactivated flu vaccine is an option for patients with autoimmune inflammatory rheumatic diseases, but any vaccination for these patients should occur during periods of stable disease, according to new recommendations from the European League Against Rheumatism.
Patients with autoimmune inflammatory rheumatic diseases (AIIRDs) are at increased risk for infections, but vaccination can cause flares of the disease, wrote Dr. Sander van Assen of the University Medical Center Groningen (the Netherlands), and colleagues. To help rheumatologists make informed decisions about patient vaccinations, EULAR convened a task force that developed eight key questions and 13 evidence-based recommendations (Ann. Rheum. Dis. 2011;70:414-22).
"For the most part, such recommendations have been lacking and the field has been changing very quickly as new drugs are developed and roll into the marketplace," according to infectious disease specialist Dr. Kevin Winthrop of the Oregon Health and Science University in Portland. "New drugs and new vaccines make these recommendations a moving target, and it was extremely important for the expert group to sit down, review the latest data, and codify their thoughts. For the most part, there is a lack of data regarding the efficacy and utility of many of these vaccines in these patients, and it is often unclear how their immunosuppressive medications and underlying diseases affect vaccine responsiveness. With certain biologics, we know that some vaccines are diminished in their immunogenicity and it is important to clarify for physicians when these vaccines can and should be given," he said.
The following were the committee’s questions:
• Is the risk of infections for which vaccines are available increased in patients with AIIRD in general, and specifically in those with active disease and in those using immunomodulation agents?
• Do vaccines decrease the risk of infections in patients with AIIRD in general, and specifically in those with unstable disease and in those using immunomodulating agents?
• Do vaccines cause significant harm in patients with AIIRD in general, and specifically in those with unstable disease or in those using immunomodulating agents?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect important harms of vaccination in patients with AIIRD?
• Does the timing of vaccination in relation to disease activity and treatment with immunomodulating agents affect the effectiveness of vaccination in patients with AIIRD?
• Does revaccination with any vaccines increase the effectiveness in patients with AIIRD?
• Does revaccination with any vaccine increase significant harms in patients with AIIRD?
• Is vaccination in patients with AIIRD cost effective?
The expert committee members represented 11 European countries. They reviewed studies from 1966 through October 2009, as well as abstracts presented at EULAR in 2008 and 2009 and at the American College of Rheumatology annual meeting in 2007 and 2008.
Their evidence-based recommendations for vaccination in patients with AIIRDs were the following:
• Assess vaccination status of an AIIRD patient at an initial work-up.
• Vaccinate patients during times of stable disease whenever possible.
• Avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Vaccinate patients before starting B-cell–depleting biologic therapy if possible, but vaccines can be given during the use of disease-modifying antirheumatic drugs and tumor necrosis factor–alpha–blocking agents.
• Strongly consider inactivated flu vaccine for patients with AIIRD.
• Strongly consider PPV23 (23-valent pneumococcal polysaccharide vaccination) for AIIRD patients.
• Vaccinate AIIRD patients for tetanus toxoid in accordance with recommendations for the general population.
• Consider herpes zoster vaccination in AIIRD patients.
• Consider human papillomavirus vaccination for selected patients with AIIRD (young women with systemic lupus erythematosus up to age 25 years).
• Vaccinate hyposplenic or asplenic patients with AIIRD with vaccines for influenza, pneumococcal, Haemophilus influenzae type b, and meningococcal C.
• Vaccinate only at-risk AIIRD patients for hepatitis A and/or B.
• Vaccinate traveling AIIRD patients according to the general rules for travelers, but avoid live, attenuated vaccines whenever possible in immunosuppressed patients.
• Do not vaccinate AIIRD patients with the BCG vaccine for tuberculosis.
"The exact implementation of the current recommendations may need to take into account local differences in specific countries and settings," the researchers noted. They added that more research is needed to continue to assess the effects of vaccination in AIIRDs patients.
In an interview, Dr. Winthrop noted that the "EULAR statement includes a thoughtful discussion of needed research. Clearly, we need better information regarding the risk of vaccine-preventable diseases in this population, as well as the outcomes of such infections and how these outcomes are modulated by certain immunosuppressive therapies. Such research would help better clarify the potential benefits of vaccination. On the adverse event side, further research is certainly necessary to better understand the risk of such vaccines (particularly live vaccines) and how that risk is modulated by immunosuppressive therapies, most notably biologic therapies. Lastly, studies evaluating the safety and efficacy of new vaccines [such as zoster vaccine and the new conjugated pneumococcal vaccine PCV13] in the context of existing and new biologic therapies remains an important area of study."
The study was funded by the European League Against Rheumatism. The researchers had no financial conflicts to disclose. Dr. Winthrop said he had no disclosures.
FROM THE EUROPEAN LEAGUE AGAINST RHEUMATISM
Contingent Test for Down Syndrome Tops for Cost-Effectiveness
Contingent screening for prenatal Down syndrome was the most cost-effective stratagem, compared with other screening protocols, based on data from a computer simulation study of 110,948 pregnancies published in the February issue of the American Journal of Obstetrics & Gynecology.
Several screening options are available in Canada and the United States, but data to help clinicians choose among the tests are limited, wrote Dr. Jean Gekas of the Centre Hospitalier de l’Université Laval in Quebec, Canada, and colleagues.
In this study, the researchers used a computer model to analyze a virtual population of 110,948 pregnant women based on the demographic, genetic, and Down syndrome (DS) phenotype characteristics of the local population in Quebec. The tests included in the study were the combined test, triple test, quadruple test, integrated test, serum integrated test, sequential screening test, contingent screening test, and amniocentesis for women aged 35 years and older (Am. J. Obstet. Gynecol. 2011;204:175.e1-8).
"The contingent strategy seems to be the most cost effective and is associated with an attractive rate of procedure-related euploid miscarriages and unnecessary terminations," the researchers wrote. "Moreover, this screening option provides a majority of women with reassurance early in gestation and may minimize costs by limiting retesting."
Overall, the contingent screening test showed a cost-effectiveness ratio of $26,833 Canadian dollars per case of DS. The next most cost-effective test was the serum integrated screening test, but the incremental cost-effectiveness ratio (ICER) between the serum integrated screening and contingent screening tests was $3,815 Canadian dollars for every DS birth detected.
The combined test, currently popular in the United States and Canada, had a slightly higher cost-effectiveness ratio of $47,358 Canadian dollars than does the contingent test, but it allowed 91% of women to be reassured in the first trimester, Dr. Gekas and associates noted.
Similar results on major outcomes including false positives, unnecessary terminations, and DS pregnancies were observed for contingent tests and several other screening tests. But the contingent screening test was associated with one of the lowest rates of procedure-related miscarriages (10). The contingent test also allowed 78% of patients to be reassured in the first trimester.
The combined test was associated with the highest rate of DS pregnancies in the first trimester (90%), and the highest rates of procedure-related euploid miscarriages (71) and unnecessary terminations (24). The combined test was the most expensive of the tests that followed screening strategies, most likely due to the requirement of a nuchal fold transparency test, and the high rate of false positives and subsequent unnecessary terminations associated with it, the researchers said.
The computer model showed that the integrated test had the lowest rate of procedure-related miscarriages. However, widespread use of the integrated test would prevent women from being reassured in the first trimester, the researchers noted.
"Our results should not be used to condemn any current practice of prenatal diagnosis of DS," the researchers said. Cost effectiveness is only part of the picture when choosing a screening strategy for any individual patient. The results suggest that a screening protocol that combines first- and second-trimester evaluation is beneficial for patients. But the findings also raise the question of who would cover the additional costs if tests of varying cost-effectiveness are available, the researchers said.
The study was limited by the lack of prospective data and the potential inability to generalize the results across countries, they said. However, "it is unlikely that a large-scale prospective clinical trial comparing these eight screening approaches could rapidly be organized across North America."
The journal did not provide any disclosure information.
Contingent screening for prenatal Down syndrome was the most cost-effective stratagem, compared with other screening protocols, based on data from a computer simulation study of 110,948 pregnancies published in the February issue of the American Journal of Obstetrics & Gynecology.
Several screening options are available in Canada and the United States, but data to help clinicians choose among the tests are limited, wrote Dr. Jean Gekas of the Centre Hospitalier de l’Université Laval in Quebec, Canada, and colleagues.
In this study, the researchers used a computer model to analyze a virtual population of 110,948 pregnant women based on the demographic, genetic, and Down syndrome (DS) phenotype characteristics of the local population in Quebec. The tests included in the study were the combined test, triple test, quadruple test, integrated test, serum integrated test, sequential screening test, contingent screening test, and amniocentesis for women aged 35 years and older (Am. J. Obstet. Gynecol. 2011;204:175.e1-8).
"The contingent strategy seems to be the most cost effective and is associated with an attractive rate of procedure-related euploid miscarriages and unnecessary terminations," the researchers wrote. "Moreover, this screening option provides a majority of women with reassurance early in gestation and may minimize costs by limiting retesting."
Overall, the contingent screening test showed a cost-effectiveness ratio of $26,833 Canadian dollars per case of DS. The next most cost-effective test was the serum integrated screening test, but the incremental cost-effectiveness ratio (ICER) between the serum integrated screening and contingent screening tests was $3,815 Canadian dollars for every DS birth detected.
The combined test, currently popular in the United States and Canada, had a slightly higher cost-effectiveness ratio of $47,358 Canadian dollars than does the contingent test, but it allowed 91% of women to be reassured in the first trimester, Dr. Gekas and associates noted.
Similar results on major outcomes including false positives, unnecessary terminations, and DS pregnancies were observed for contingent tests and several other screening tests. But the contingent screening test was associated with one of the lowest rates of procedure-related miscarriages (10). The contingent test also allowed 78% of patients to be reassured in the first trimester.
The combined test was associated with the highest rate of DS pregnancies in the first trimester (90%), and the highest rates of procedure-related euploid miscarriages (71) and unnecessary terminations (24). The combined test was the most expensive of the tests that followed screening strategies, most likely due to the requirement of a nuchal fold transparency test, and the high rate of false positives and subsequent unnecessary terminations associated with it, the researchers said.
The computer model showed that the integrated test had the lowest rate of procedure-related miscarriages. However, widespread use of the integrated test would prevent women from being reassured in the first trimester, the researchers noted.
"Our results should not be used to condemn any current practice of prenatal diagnosis of DS," the researchers said. Cost effectiveness is only part of the picture when choosing a screening strategy for any individual patient. The results suggest that a screening protocol that combines first- and second-trimester evaluation is beneficial for patients. But the findings also raise the question of who would cover the additional costs if tests of varying cost-effectiveness are available, the researchers said.
The study was limited by the lack of prospective data and the potential inability to generalize the results across countries, they said. However, "it is unlikely that a large-scale prospective clinical trial comparing these eight screening approaches could rapidly be organized across North America."
The journal did not provide any disclosure information.
Contingent screening for prenatal Down syndrome was the most cost-effective stratagem, compared with other screening protocols, based on data from a computer simulation study of 110,948 pregnancies published in the February issue of the American Journal of Obstetrics & Gynecology.
Several screening options are available in Canada and the United States, but data to help clinicians choose among the tests are limited, wrote Dr. Jean Gekas of the Centre Hospitalier de l’Université Laval in Quebec, Canada, and colleagues.
In this study, the researchers used a computer model to analyze a virtual population of 110,948 pregnant women based on the demographic, genetic, and Down syndrome (DS) phenotype characteristics of the local population in Quebec. The tests included in the study were the combined test, triple test, quadruple test, integrated test, serum integrated test, sequential screening test, contingent screening test, and amniocentesis for women aged 35 years and older (Am. J. Obstet. Gynecol. 2011;204:175.e1-8).
"The contingent strategy seems to be the most cost effective and is associated with an attractive rate of procedure-related euploid miscarriages and unnecessary terminations," the researchers wrote. "Moreover, this screening option provides a majority of women with reassurance early in gestation and may minimize costs by limiting retesting."
Overall, the contingent screening test showed a cost-effectiveness ratio of $26,833 Canadian dollars per case of DS. The next most cost-effective test was the serum integrated screening test, but the incremental cost-effectiveness ratio (ICER) between the serum integrated screening and contingent screening tests was $3,815 Canadian dollars for every DS birth detected.
The combined test, currently popular in the United States and Canada, had a slightly higher cost-effectiveness ratio of $47,358 Canadian dollars than does the contingent test, but it allowed 91% of women to be reassured in the first trimester, Dr. Gekas and associates noted.
Similar results on major outcomes including false positives, unnecessary terminations, and DS pregnancies were observed for contingent tests and several other screening tests. But the contingent screening test was associated with one of the lowest rates of procedure-related miscarriages (10). The contingent test also allowed 78% of patients to be reassured in the first trimester.
The combined test was associated with the highest rate of DS pregnancies in the first trimester (90%), and the highest rates of procedure-related euploid miscarriages (71) and unnecessary terminations (24). The combined test was the most expensive of the tests that followed screening strategies, most likely due to the requirement of a nuchal fold transparency test, and the high rate of false positives and subsequent unnecessary terminations associated with it, the researchers said.
The computer model showed that the integrated test had the lowest rate of procedure-related miscarriages. However, widespread use of the integrated test would prevent women from being reassured in the first trimester, the researchers noted.
"Our results should not be used to condemn any current practice of prenatal diagnosis of DS," the researchers said. Cost effectiveness is only part of the picture when choosing a screening strategy for any individual patient. The results suggest that a screening protocol that combines first- and second-trimester evaluation is beneficial for patients. But the findings also raise the question of who would cover the additional costs if tests of varying cost-effectiveness are available, the researchers said.
The study was limited by the lack of prospective data and the potential inability to generalize the results across countries, they said. However, "it is unlikely that a large-scale prospective clinical trial comparing these eight screening approaches could rapidly be organized across North America."
The journal did not provide any disclosure information.
FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Major Finding: Overall, the contingent screening test showed a cost-effectiveness ratio of $26,833 Canadian dollars per case of DS. The next most cost-effective test was the serum integrated screening test, but the incremental cost-effectiveness ratio (ICER) between the serum integrated screening and contingent screening tests was $3,815 Canadian dollars for every DS birth detected.
Data Source: A cost-effective study of Down syndrome screening tests based on a computer model including 110,948 pregnancies.
Disclosures: The journal did not provide any disclosure information.
Heart Associations Add Dabigatran to Atrial Fibrillation Guidelines
The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.
[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]
The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.
The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.
Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.
Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).
[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]
Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.
The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.
[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]
The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.
The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.
Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.
Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).
[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]
Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.
The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.
[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]
The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.
The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.
Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.
Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).
[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]
Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.
FROM CIRCULATION
Heart Associations Add Dabigatran to Atrial Fibrillation Guidelines
The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.
[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]
The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.
The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.
Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.
Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).
[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]
Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.
The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.
[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]
The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.
The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.
Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.
Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).
[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]
Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.
The direct thrombin inhibitor dabigatran can be used in atrial fibrillation patients as an alternative to warfarin, according to updated guidelines from the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society. The update was published online Feb. 14 in Circulation.
[Dabigatran, Rivaroxaban Vie as Warfarin Alternatives]
The guideline writing committee, which issued a focused update in December (Circulation 2011;123:104-23), noted that the approval of dabigatran by the Food and Drug Administration in October 2010 occurred too late for consideration.
The update to the guidelines summarizes the evidence supporting the FDA approval of dabigatran etexilate to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial – a noninferiority study of 18,113 patients with nonvalvular atrial fibrillation and at least one other risk factor for stroke – 150 mg of dabigatran twice daily reduced the risk of all types of stroke or systemic embolism by 34%. The average age of the patients in the study was 71 years.
Two dosing regimens (110 mg twice daily or 150 mg twice daily) were evaluated, and the 110-mg dose of dabigatran was noninferior to warfarin for the prevention of stroke or systemic embolism. The 110-mg dose of dabigatran was associated with significantly lower rates of major bleeding than was warfarin, and the rate of major bleeding at the 150-mg dose was noninferior to warfarin. Myocardial infarction was more common in dabigatran patients compared with warfarin patients, but the difference was not significant. The 110-mg dosage was not approved, however; the dosage for all patients except those with severe renal impairment is 150 mg twice daily.
Dr. L. Samuel Wann, a cardiologist at Wheaton Franciscan Healthcare in Wauwatosa, Wis., and chair of the 2011 Writing Group, and colleagues noted that dabigatran is not the best choice for all patients, given the twice-daily dosing regimen and increased risk of side effects. However, patients with atrial fibrillation and at least one additional risk factor for stroke might benefit from dabigatran depending on factors including cost, patient preferences, ability to comply with twice-daily dosing, and availability of an anticoagulation management program to help with routine maintenance, the reviewers wrote (Circulation 2011 Feb. 14 [doi:10.1161/CIR.0b013e31820f14c0]).
[FDA Panel Votes to Approve Dabigatran for Reduction of Stroke Risk]
Dr. Wann had no financial conflicts to disclose. Several of the writing group members disclosed serving as a speaker or consultant for, or receiving research funding from, multiple pharmaceutical companies including Medtronic, Boston Scientific, AstraZeneca, Sanofi-Aventis, and GlaxoSmithKline, as well as Boehringer Ingelheim, which markets dabigatran as Pradaxa.
FROM CIRCULATION
More Than One-Third of U.S. Could Have Cardiovascular Disease by 2030
WASHINGTON – Approximately 40% of the United States population could have some form of cardiovascular disease by the year 2030, based on data from a prediction model created by the American Heart Association. The findings were published online on Jan. 24 in an American Heart Association policy statement in Circulation.
If there’s a silver lining in these figures, it is that they are projections," Nancy Brown, chief executive officer of the AHA, said at a press conference. However, if current policies and prevention strategies go unchanged, the United States is facing "a cardiovascular crisis of alarming proportions," she said.
The aging U.S. population and the increase in medical spending are the main forces driving the disease prevalence and cost, wrote Dr. Paul Heidenreich, of the VA Palo Alto (Calif.) Health Care System, and colleagues.
Without changes in current prevention and treatment trends, the prevalence of cardiovascular disease in the United States will increase by about 10% over the next 20 years, and direct medical costs of cardiovascular disease will triple, from $273 billion to $818 billion, according to the policy statement.
The AHA statement projects an additional 27 million Americans with hypertension, 8 million with coronary heart disease, 4 million with stroke, and 3 million with heart failure between 2010 and 2030 (Circulation 2011 Jan. 24 [Epub doi: 10.1161/CIR.0b013e31820a55f5]).
According to the projections, hypertension will be the most expensive component of cardiovascular disease (CVD), with an estimated annual direct medical cost of $200 billion by 2030. The estimated direct medical cost for stroke is $96 billion, compared with $28 billion in 2010, but stroke represents the greatest relative increase in costs over the next 20 years (238%).
In addition, the indirect costs of all types of cardiovascular disease could increase by 61% (from $172 billion in 2010 to $276 billion in 2030).
However, previous studies have shown that many CVD cases are preventable, and individuals who maintain a healthy lifestyle and favorable levels of atherosclerotic risk are less likely to develop CVD. "Therefore, a greater focus on prevention may alter these CVD projections in the future," according to the statement.
Guidelines have been shown to have "a substantial impact on prevention and treatment and will be an important tool for limiting the burden of CVD," according to the statement. The AHA, the American College of Cardiology, and other organizations have previously published prevention-oriented CVD guidelines, but the implementation of such guidelines is often slow, the writing group noted.
Other factors that could hamper the improvement of CVD risk factors include a reported shortage of cardiologists, they added. Other shortages exist in nursing, pharmacy, and primary care, all of which are needed for a team approach to preventing CVD.
The take-home message for cardiologists is that they can "expect to see more demand for their services," Dr. Heidenreich said in an interview. In addition, primary care physicians will be seeing more patients with forms of heart disease. But the solution includes increasing the number of health professionals across all fields, not only cardiology, said Dr. Heidenreich. "The whole medical complex is insufficient to meet the demand" of the potential increases in CVD, he emphasized.
But, "through a combination of improved prevention of risk factors, and treatment of established risk factors, the dire projection of the health and economic impact of CVD can be diminished," the statement concluded.
The projections of CVD prevalence were based on data from the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2006 and Census Bureau projections from 2010 to 2030. Projections of direct medical costs of CVD were based on data from the Medical Expenditure Panel Survey from 2001 to 2005. Indirect costs of CVD included lost productivity from morbidity and early mortality.
Dr. Heidenreich, chair of the writing group, had no financial conflicts to disclose. Several members of the writing group disclosed research funding from pharmaceutical companies including Boston Scientific, Eli Lilly and Company, Pfizer, Procter & Gamble, and Medtronic. Some members disclosed serving as consultants or advisory board members to companies including Sanofi-Aventis, Bristol Myers Squibb, and Daiichi Sankyo. Some members of the group received research support from organizations including the National Institutes of Health and the National Heart, Lung and Blood Institute.
WASHINGTON – Approximately 40% of the United States population could have some form of cardiovascular disease by the year 2030, based on data from a prediction model created by the American Heart Association. The findings were published online on Jan. 24 in an American Heart Association policy statement in Circulation.
If there’s a silver lining in these figures, it is that they are projections," Nancy Brown, chief executive officer of the AHA, said at a press conference. However, if current policies and prevention strategies go unchanged, the United States is facing "a cardiovascular crisis of alarming proportions," she said.
The aging U.S. population and the increase in medical spending are the main forces driving the disease prevalence and cost, wrote Dr. Paul Heidenreich, of the VA Palo Alto (Calif.) Health Care System, and colleagues.
Without changes in current prevention and treatment trends, the prevalence of cardiovascular disease in the United States will increase by about 10% over the next 20 years, and direct medical costs of cardiovascular disease will triple, from $273 billion to $818 billion, according to the policy statement.
The AHA statement projects an additional 27 million Americans with hypertension, 8 million with coronary heart disease, 4 million with stroke, and 3 million with heart failure between 2010 and 2030 (Circulation 2011 Jan. 24 [Epub doi: 10.1161/CIR.0b013e31820a55f5]).
According to the projections, hypertension will be the most expensive component of cardiovascular disease (CVD), with an estimated annual direct medical cost of $200 billion by 2030. The estimated direct medical cost for stroke is $96 billion, compared with $28 billion in 2010, but stroke represents the greatest relative increase in costs over the next 20 years (238%).
In addition, the indirect costs of all types of cardiovascular disease could increase by 61% (from $172 billion in 2010 to $276 billion in 2030).
However, previous studies have shown that many CVD cases are preventable, and individuals who maintain a healthy lifestyle and favorable levels of atherosclerotic risk are less likely to develop CVD. "Therefore, a greater focus on prevention may alter these CVD projections in the future," according to the statement.
Guidelines have been shown to have "a substantial impact on prevention and treatment and will be an important tool for limiting the burden of CVD," according to the statement. The AHA, the American College of Cardiology, and other organizations have previously published prevention-oriented CVD guidelines, but the implementation of such guidelines is often slow, the writing group noted.
Other factors that could hamper the improvement of CVD risk factors include a reported shortage of cardiologists, they added. Other shortages exist in nursing, pharmacy, and primary care, all of which are needed for a team approach to preventing CVD.
The take-home message for cardiologists is that they can "expect to see more demand for their services," Dr. Heidenreich said in an interview. In addition, primary care physicians will be seeing more patients with forms of heart disease. But the solution includes increasing the number of health professionals across all fields, not only cardiology, said Dr. Heidenreich. "The whole medical complex is insufficient to meet the demand" of the potential increases in CVD, he emphasized.
But, "through a combination of improved prevention of risk factors, and treatment of established risk factors, the dire projection of the health and economic impact of CVD can be diminished," the statement concluded.
The projections of CVD prevalence were based on data from the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2006 and Census Bureau projections from 2010 to 2030. Projections of direct medical costs of CVD were based on data from the Medical Expenditure Panel Survey from 2001 to 2005. Indirect costs of CVD included lost productivity from morbidity and early mortality.
Dr. Heidenreich, chair of the writing group, had no financial conflicts to disclose. Several members of the writing group disclosed research funding from pharmaceutical companies including Boston Scientific, Eli Lilly and Company, Pfizer, Procter & Gamble, and Medtronic. Some members disclosed serving as consultants or advisory board members to companies including Sanofi-Aventis, Bristol Myers Squibb, and Daiichi Sankyo. Some members of the group received research support from organizations including the National Institutes of Health and the National Heart, Lung and Blood Institute.
WASHINGTON – Approximately 40% of the United States population could have some form of cardiovascular disease by the year 2030, based on data from a prediction model created by the American Heart Association. The findings were published online on Jan. 24 in an American Heart Association policy statement in Circulation.
If there’s a silver lining in these figures, it is that they are projections," Nancy Brown, chief executive officer of the AHA, said at a press conference. However, if current policies and prevention strategies go unchanged, the United States is facing "a cardiovascular crisis of alarming proportions," she said.
The aging U.S. population and the increase in medical spending are the main forces driving the disease prevalence and cost, wrote Dr. Paul Heidenreich, of the VA Palo Alto (Calif.) Health Care System, and colleagues.
Without changes in current prevention and treatment trends, the prevalence of cardiovascular disease in the United States will increase by about 10% over the next 20 years, and direct medical costs of cardiovascular disease will triple, from $273 billion to $818 billion, according to the policy statement.
The AHA statement projects an additional 27 million Americans with hypertension, 8 million with coronary heart disease, 4 million with stroke, and 3 million with heart failure between 2010 and 2030 (Circulation 2011 Jan. 24 [Epub doi: 10.1161/CIR.0b013e31820a55f5]).
According to the projections, hypertension will be the most expensive component of cardiovascular disease (CVD), with an estimated annual direct medical cost of $200 billion by 2030. The estimated direct medical cost for stroke is $96 billion, compared with $28 billion in 2010, but stroke represents the greatest relative increase in costs over the next 20 years (238%).
In addition, the indirect costs of all types of cardiovascular disease could increase by 61% (from $172 billion in 2010 to $276 billion in 2030).
However, previous studies have shown that many CVD cases are preventable, and individuals who maintain a healthy lifestyle and favorable levels of atherosclerotic risk are less likely to develop CVD. "Therefore, a greater focus on prevention may alter these CVD projections in the future," according to the statement.
Guidelines have been shown to have "a substantial impact on prevention and treatment and will be an important tool for limiting the burden of CVD," according to the statement. The AHA, the American College of Cardiology, and other organizations have previously published prevention-oriented CVD guidelines, but the implementation of such guidelines is often slow, the writing group noted.
Other factors that could hamper the improvement of CVD risk factors include a reported shortage of cardiologists, they added. Other shortages exist in nursing, pharmacy, and primary care, all of which are needed for a team approach to preventing CVD.
The take-home message for cardiologists is that they can "expect to see more demand for their services," Dr. Heidenreich said in an interview. In addition, primary care physicians will be seeing more patients with forms of heart disease. But the solution includes increasing the number of health professionals across all fields, not only cardiology, said Dr. Heidenreich. "The whole medical complex is insufficient to meet the demand" of the potential increases in CVD, he emphasized.
But, "through a combination of improved prevention of risk factors, and treatment of established risk factors, the dire projection of the health and economic impact of CVD can be diminished," the statement concluded.
The projections of CVD prevalence were based on data from the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2006 and Census Bureau projections from 2010 to 2030. Projections of direct medical costs of CVD were based on data from the Medical Expenditure Panel Survey from 2001 to 2005. Indirect costs of CVD included lost productivity from morbidity and early mortality.
Dr. Heidenreich, chair of the writing group, had no financial conflicts to disclose. Several members of the writing group disclosed research funding from pharmaceutical companies including Boston Scientific, Eli Lilly and Company, Pfizer, Procter & Gamble, and Medtronic. Some members disclosed serving as consultants or advisory board members to companies including Sanofi-Aventis, Bristol Myers Squibb, and Daiichi Sankyo. Some members of the group received research support from organizations including the National Institutes of Health and the National Heart, Lung and Blood Institute.
FROM THE AMERICAN HEART ASSOCIATION
CDC: Hypertension, Cholesterol Largely Uncontrolled in Adults
Approximately 68 million American adults have high blood pressure and 71 million have high cholesterol, and the conditions are uncontrolled in 37 million and 48 million, respectively, according to a Vital Signs report released by the Centers for Disease Control and Prevention.
"Heart disease is the leading killer in America, and the bottom line is that high blood pressure and high cholesterol are out of control for most Americans who have these conditions," CDC director Dr. Thomas R. Frieden said during a teleconference accompanying the report's release.
High blood pressure and high cholesterol remain top risk factors for life-threatening conditions including strokes, heart attacks, and vascular diseases, he added.
Dr. Frieden had a message for physicians: Controlling high blood pressure and cholesterol is one of the most important things you can do for your patients. Know how many of your patients have high blood pressure and high cholesterol, what proportion are controlled, and what can be done to help more patients get these conditions under control, he said.
"We have seen many examples of health systems, health programs, and doctors' offices using information technology to support patients and drastically improve the levels of control, and that's something that is needed throughout health care in this country," he added.
The report was based on data from the National Health and Nutrition Examination Survey (NHANES) on adults aged 18 years and older. The findings also indicate that approximately 20 million U.S. adults with high blood pressure and 37 million with high cholesterol are not being treated for these conditions.
The prevalence of control of high blood pressure was 29% among adults without health insurance, and the control of high cholesterol was less than 15% among those with limited access to health care. But at least 80% of individuals with uncontrolled high blood pressure and high cholesterol have health insurance, Dr. Frieden noted.
For those with health insurance, the characteristics of their specific plan are more likely to affect how likely they are to have high blood pressure or high cholesterol under control than are their personal characteristics, he said.
High blood pressure was defined as blood pressure greater than 140/90 mmHg or reported use of blood pressure–lowering medication. The national prevalence of high blood pressure remained stable over the past decade, although 70% of those with hypertension were being treated and 46% were being controlled, according to the report.
The criteria for high cholesterol included anyone taking cholesterol medication or having a LDL cholesterol level of 100 mg/dL or higher for high-risk individuals, 130 mg/dL or higher for intermediate-risk individuals, and 160 mg/dL for those at low risk.
The proportion of adults treated for high cholesterol increased from 28% to 48% over the past decade, and the proportion of those controlling their high cholesterol increased from less than 20% to more than 30%.
The findings were limited by the lack of data on individuals in nursing homes and other institutions that are not included in NHANES databases, the CDC researchers noted in the report.
"About 100,000 deaths [in the U.S.] are preventable by simple, low-cost improvements in our ability to control high blood pressure and high cholesterol," said Dr. Frieden. "Better control can save lives and save money."
The report is available online at www.cdc.gov/vitalsigns. More detailed information can be found in the Feb. 1 issue of the weekly Morbidity and Mortality Report (MMWR early release/vol. 60; Feb. 1, 2011).
Approximately 68 million American adults have high blood pressure and 71 million have high cholesterol, and the conditions are uncontrolled in 37 million and 48 million, respectively, according to a Vital Signs report released by the Centers for Disease Control and Prevention.
"Heart disease is the leading killer in America, and the bottom line is that high blood pressure and high cholesterol are out of control for most Americans who have these conditions," CDC director Dr. Thomas R. Frieden said during a teleconference accompanying the report's release.
High blood pressure and high cholesterol remain top risk factors for life-threatening conditions including strokes, heart attacks, and vascular diseases, he added.
Dr. Frieden had a message for physicians: Controlling high blood pressure and cholesterol is one of the most important things you can do for your patients. Know how many of your patients have high blood pressure and high cholesterol, what proportion are controlled, and what can be done to help more patients get these conditions under control, he said.
"We have seen many examples of health systems, health programs, and doctors' offices using information technology to support patients and drastically improve the levels of control, and that's something that is needed throughout health care in this country," he added.
The report was based on data from the National Health and Nutrition Examination Survey (NHANES) on adults aged 18 years and older. The findings also indicate that approximately 20 million U.S. adults with high blood pressure and 37 million with high cholesterol are not being treated for these conditions.
The prevalence of control of high blood pressure was 29% among adults without health insurance, and the control of high cholesterol was less than 15% among those with limited access to health care. But at least 80% of individuals with uncontrolled high blood pressure and high cholesterol have health insurance, Dr. Frieden noted.
For those with health insurance, the characteristics of their specific plan are more likely to affect how likely they are to have high blood pressure or high cholesterol under control than are their personal characteristics, he said.
High blood pressure was defined as blood pressure greater than 140/90 mmHg or reported use of blood pressure–lowering medication. The national prevalence of high blood pressure remained stable over the past decade, although 70% of those with hypertension were being treated and 46% were being controlled, according to the report.
The criteria for high cholesterol included anyone taking cholesterol medication or having a LDL cholesterol level of 100 mg/dL or higher for high-risk individuals, 130 mg/dL or higher for intermediate-risk individuals, and 160 mg/dL for those at low risk.
The proportion of adults treated for high cholesterol increased from 28% to 48% over the past decade, and the proportion of those controlling their high cholesterol increased from less than 20% to more than 30%.
The findings were limited by the lack of data on individuals in nursing homes and other institutions that are not included in NHANES databases, the CDC researchers noted in the report.
"About 100,000 deaths [in the U.S.] are preventable by simple, low-cost improvements in our ability to control high blood pressure and high cholesterol," said Dr. Frieden. "Better control can save lives and save money."
The report is available online at www.cdc.gov/vitalsigns. More detailed information can be found in the Feb. 1 issue of the weekly Morbidity and Mortality Report (MMWR early release/vol. 60; Feb. 1, 2011).
Approximately 68 million American adults have high blood pressure and 71 million have high cholesterol, and the conditions are uncontrolled in 37 million and 48 million, respectively, according to a Vital Signs report released by the Centers for Disease Control and Prevention.
"Heart disease is the leading killer in America, and the bottom line is that high blood pressure and high cholesterol are out of control for most Americans who have these conditions," CDC director Dr. Thomas R. Frieden said during a teleconference accompanying the report's release.
High blood pressure and high cholesterol remain top risk factors for life-threatening conditions including strokes, heart attacks, and vascular diseases, he added.
Dr. Frieden had a message for physicians: Controlling high blood pressure and cholesterol is one of the most important things you can do for your patients. Know how many of your patients have high blood pressure and high cholesterol, what proportion are controlled, and what can be done to help more patients get these conditions under control, he said.
"We have seen many examples of health systems, health programs, and doctors' offices using information technology to support patients and drastically improve the levels of control, and that's something that is needed throughout health care in this country," he added.
The report was based on data from the National Health and Nutrition Examination Survey (NHANES) on adults aged 18 years and older. The findings also indicate that approximately 20 million U.S. adults with high blood pressure and 37 million with high cholesterol are not being treated for these conditions.
The prevalence of control of high blood pressure was 29% among adults without health insurance, and the control of high cholesterol was less than 15% among those with limited access to health care. But at least 80% of individuals with uncontrolled high blood pressure and high cholesterol have health insurance, Dr. Frieden noted.
For those with health insurance, the characteristics of their specific plan are more likely to affect how likely they are to have high blood pressure or high cholesterol under control than are their personal characteristics, he said.
High blood pressure was defined as blood pressure greater than 140/90 mmHg or reported use of blood pressure–lowering medication. The national prevalence of high blood pressure remained stable over the past decade, although 70% of those with hypertension were being treated and 46% were being controlled, according to the report.
The criteria for high cholesterol included anyone taking cholesterol medication or having a LDL cholesterol level of 100 mg/dL or higher for high-risk individuals, 130 mg/dL or higher for intermediate-risk individuals, and 160 mg/dL for those at low risk.
The proportion of adults treated for high cholesterol increased from 28% to 48% over the past decade, and the proportion of those controlling their high cholesterol increased from less than 20% to more than 30%.
The findings were limited by the lack of data on individuals in nursing homes and other institutions that are not included in NHANES databases, the CDC researchers noted in the report.
"About 100,000 deaths [in the U.S.] are preventable by simple, low-cost improvements in our ability to control high blood pressure and high cholesterol," said Dr. Frieden. "Better control can save lives and save money."
The report is available online at www.cdc.gov/vitalsigns. More detailed information can be found in the Feb. 1 issue of the weekly Morbidity and Mortality Report (MMWR early release/vol. 60; Feb. 1, 2011).
New Dietary Guidelines Emphasize Calories, Exercise
WASHINGTON – The new Dietary Guidelines for Americans 2010, released Jan. 31, take a four-pronged approach focus to improving American’s dietary habits by recommending balancing calories and exercise to achieve a healthy body weight, restricting sodium and saturated fat, increasing consumption of whole grains and healthy fats, and developing mindful behaviors around eating and food preparation.
"We are putting some of the best information in people’s hands, and that’s a big step forward," said Health and Human Services Secretary Kathleen Sebelius, who presented the guidelines with Department of Agriculture Secretary Tom Vilsack. The guidelines are a joint effort of the U.S. Department of Health and Human Services and the Department of Agriculture.
The guidelines, intended for children aged 2 years and older and adults, include 23 recommendations in four categories, plus six additional recommendations for specific population groups. The guidelines are meant to include those at increased risk of chronic disease. The four categories are:
Balancing calories to reduce weight: Recommendations in this category include getting more exercise and balancing it against calorie intake as appropriate for weight maintenance or weight loss.
• Reducing certain foods and food components: The guidelines call for consuming less than 2,300 mg of sodium daily. The recommendation is no more than 1,500 mg for blacks, people aged 51 years and older, as well as anyone regardless of age who has hypertension, diabetes, or chronic kidney disease. Other recommended reductions include having saturated fats comprise less that 10% of daily calories, and consuming less than 300 mg of cholesterol daily.
• Increasing certain foods and nutrients: The recommendations repeat previous dietary guidelines that call for whole-grain foods to comprise half of Americans’ grain intake. Other recommendations include replacing solid fats , eating more seafood in favor of some red meat and poultry, replacing full-fat dairy products with low-fat or fat-free options, and consuming a variety of protein-rich foods including eggs, beans, nuts, and soy.
• Building healthy eating patterns and behaviors: In addition to 20 recommendations relating to diet and exercise, the new guidelines include 3 recommendations that are less food specific: Select an eating pattern that "meets nutrient needs over time at an appropriate calorie level;" and keep a food journal to assess how food and beverage choices fit into a healthy eating pattern; follow food safety recommendations when cooking and eating to reduce the risk of foodborne illness.
Women of child-bearing age should boost iron intake by eating foods with easily absorbed heme iron and vitamin C–rich foods that enhance iron absorption. Additional recommendations include adding 400 mcg of folic acid daily for women, in addition to the folate found in a healthy diet. Recommendations for women who are pregnant or breast-feeding include eating 8-12 ounces of seafood per week, but limiting tuna consumption to 6 ounces per week and avoiding tilefish, shark, swordfish, and king mackerel because of their high mercury content. Pregnant women also are advised to take an iron supplement as recommended by their health care providers.
One additional recommendation for individuals aged 50 years and older: Consume vitamin B12-fortified foods as part of a daily diet or as supplements. However, the guidelines did not recommend a specific amount of daily B12 for this population.
Over the next few months, USDA and HHS will release consumer tips and tools to help Americans follow the guidelines, including a revised food pyramid. The complete guidelines are available online at www.dietaryguidelines.gov.
WASHINGTON – The new Dietary Guidelines for Americans 2010, released Jan. 31, take a four-pronged approach focus to improving American’s dietary habits by recommending balancing calories and exercise to achieve a healthy body weight, restricting sodium and saturated fat, increasing consumption of whole grains and healthy fats, and developing mindful behaviors around eating and food preparation.
"We are putting some of the best information in people’s hands, and that’s a big step forward," said Health and Human Services Secretary Kathleen Sebelius, who presented the guidelines with Department of Agriculture Secretary Tom Vilsack. The guidelines are a joint effort of the U.S. Department of Health and Human Services and the Department of Agriculture.
The guidelines, intended for children aged 2 years and older and adults, include 23 recommendations in four categories, plus six additional recommendations for specific population groups. The guidelines are meant to include those at increased risk of chronic disease. The four categories are:
Balancing calories to reduce weight: Recommendations in this category include getting more exercise and balancing it against calorie intake as appropriate for weight maintenance or weight loss.
• Reducing certain foods and food components: The guidelines call for consuming less than 2,300 mg of sodium daily. The recommendation is no more than 1,500 mg for blacks, people aged 51 years and older, as well as anyone regardless of age who has hypertension, diabetes, or chronic kidney disease. Other recommended reductions include having saturated fats comprise less that 10% of daily calories, and consuming less than 300 mg of cholesterol daily.
• Increasing certain foods and nutrients: The recommendations repeat previous dietary guidelines that call for whole-grain foods to comprise half of Americans’ grain intake. Other recommendations include replacing solid fats , eating more seafood in favor of some red meat and poultry, replacing full-fat dairy products with low-fat or fat-free options, and consuming a variety of protein-rich foods including eggs, beans, nuts, and soy.
• Building healthy eating patterns and behaviors: In addition to 20 recommendations relating to diet and exercise, the new guidelines include 3 recommendations that are less food specific: Select an eating pattern that "meets nutrient needs over time at an appropriate calorie level;" and keep a food journal to assess how food and beverage choices fit into a healthy eating pattern; follow food safety recommendations when cooking and eating to reduce the risk of foodborne illness.
Women of child-bearing age should boost iron intake by eating foods with easily absorbed heme iron and vitamin C–rich foods that enhance iron absorption. Additional recommendations include adding 400 mcg of folic acid daily for women, in addition to the folate found in a healthy diet. Recommendations for women who are pregnant or breast-feeding include eating 8-12 ounces of seafood per week, but limiting tuna consumption to 6 ounces per week and avoiding tilefish, shark, swordfish, and king mackerel because of their high mercury content. Pregnant women also are advised to take an iron supplement as recommended by their health care providers.
One additional recommendation for individuals aged 50 years and older: Consume vitamin B12-fortified foods as part of a daily diet or as supplements. However, the guidelines did not recommend a specific amount of daily B12 for this population.
Over the next few months, USDA and HHS will release consumer tips and tools to help Americans follow the guidelines, including a revised food pyramid. The complete guidelines are available online at www.dietaryguidelines.gov.
WASHINGTON – The new Dietary Guidelines for Americans 2010, released Jan. 31, take a four-pronged approach focus to improving American’s dietary habits by recommending balancing calories and exercise to achieve a healthy body weight, restricting sodium and saturated fat, increasing consumption of whole grains and healthy fats, and developing mindful behaviors around eating and food preparation.
"We are putting some of the best information in people’s hands, and that’s a big step forward," said Health and Human Services Secretary Kathleen Sebelius, who presented the guidelines with Department of Agriculture Secretary Tom Vilsack. The guidelines are a joint effort of the U.S. Department of Health and Human Services and the Department of Agriculture.
The guidelines, intended for children aged 2 years and older and adults, include 23 recommendations in four categories, plus six additional recommendations for specific population groups. The guidelines are meant to include those at increased risk of chronic disease. The four categories are:
Balancing calories to reduce weight: Recommendations in this category include getting more exercise and balancing it against calorie intake as appropriate for weight maintenance or weight loss.
• Reducing certain foods and food components: The guidelines call for consuming less than 2,300 mg of sodium daily. The recommendation is no more than 1,500 mg for blacks, people aged 51 years and older, as well as anyone regardless of age who has hypertension, diabetes, or chronic kidney disease. Other recommended reductions include having saturated fats comprise less that 10% of daily calories, and consuming less than 300 mg of cholesterol daily.
• Increasing certain foods and nutrients: The recommendations repeat previous dietary guidelines that call for whole-grain foods to comprise half of Americans’ grain intake. Other recommendations include replacing solid fats , eating more seafood in favor of some red meat and poultry, replacing full-fat dairy products with low-fat or fat-free options, and consuming a variety of protein-rich foods including eggs, beans, nuts, and soy.
• Building healthy eating patterns and behaviors: In addition to 20 recommendations relating to diet and exercise, the new guidelines include 3 recommendations that are less food specific: Select an eating pattern that "meets nutrient needs over time at an appropriate calorie level;" and keep a food journal to assess how food and beverage choices fit into a healthy eating pattern; follow food safety recommendations when cooking and eating to reduce the risk of foodborne illness.
Women of child-bearing age should boost iron intake by eating foods with easily absorbed heme iron and vitamin C–rich foods that enhance iron absorption. Additional recommendations include adding 400 mcg of folic acid daily for women, in addition to the folate found in a healthy diet. Recommendations for women who are pregnant or breast-feeding include eating 8-12 ounces of seafood per week, but limiting tuna consumption to 6 ounces per week and avoiding tilefish, shark, swordfish, and king mackerel because of their high mercury content. Pregnant women also are advised to take an iron supplement as recommended by their health care providers.
One additional recommendation for individuals aged 50 years and older: Consume vitamin B12-fortified foods as part of a daily diet or as supplements. However, the guidelines did not recommend a specific amount of daily B12 for this population.
Over the next few months, USDA and HHS will release consumer tips and tools to help Americans follow the guidelines, including a revised food pyramid. The complete guidelines are available online at www.dietaryguidelines.gov.
New Options for Field Therapy: MAL-PDT Plus Red LED
ORLANDO - Limiting treatment of actinic keratoses to cryosurgery is a disservice to patients, according to Dr. Neil A. Fenske.
Every patient with AKs deserves consideration for field therapy, he said at the Orlando Dermatology Aesthetic and Clinical Conference. Mutated cells occur not only within the visible AKs, but also in the surrounding, normal-looking skin.
"Most patients don't have one AK," said Dr. Fenske of the Moffitt Cancer Center at the University of South Florida in Tampa. Data based on mathematical models suggest that 6%-10% of typical patients with an average of eight AKs will develop at least one squamous cell carcinoma over a 10-year period.
For more complete treatment, following cryosurgery with field therapy a week later. Field therapy using methyl aminolevulinate (MAL) plus a red light–emitting diode (LED) is an up-and-coming option.
MAL has a higher relative porphyrin enrichment in AKs than in normal skin, and is able to penetrate deeply compared with 5-aminolevulinic acid, Dr. Fenske explained. In addition, the red LED at 630 nm requires a lower light dose than other light options, so there is less heating of the skin.
Dr. Fenske cited a study of MAL-PDT plus red LED at 630 nm in which 14 patients with a total of 223 AKs on the scalp and face underwent two treatments. The total number of AKs decreased by 55% after the first treatment and by 62% after the second treatment. Although global photodamage scores improved, pain was an issue (J. Dermatolog. Treat. 2010;21:252-7).
Dr. Fenske said he often uses aminolevulinic acid plus blue light, but to treat and kill bacteria deep in the sebaceous glands, "I would use red light and [MAL]," he said.
Dr. Fenske disclosed serving as a consultant and speaker for Graceway Pharmaceuticals, and serving as a speaker for Sanofi-Aventis.
ORLANDO - Limiting treatment of actinic keratoses to cryosurgery is a disservice to patients, according to Dr. Neil A. Fenske.
Every patient with AKs deserves consideration for field therapy, he said at the Orlando Dermatology Aesthetic and Clinical Conference. Mutated cells occur not only within the visible AKs, but also in the surrounding, normal-looking skin.
"Most patients don't have one AK," said Dr. Fenske of the Moffitt Cancer Center at the University of South Florida in Tampa. Data based on mathematical models suggest that 6%-10% of typical patients with an average of eight AKs will develop at least one squamous cell carcinoma over a 10-year period.
For more complete treatment, following cryosurgery with field therapy a week later. Field therapy using methyl aminolevulinate (MAL) plus a red light–emitting diode (LED) is an up-and-coming option.
MAL has a higher relative porphyrin enrichment in AKs than in normal skin, and is able to penetrate deeply compared with 5-aminolevulinic acid, Dr. Fenske explained. In addition, the red LED at 630 nm requires a lower light dose than other light options, so there is less heating of the skin.
Dr. Fenske cited a study of MAL-PDT plus red LED at 630 nm in which 14 patients with a total of 223 AKs on the scalp and face underwent two treatments. The total number of AKs decreased by 55% after the first treatment and by 62% after the second treatment. Although global photodamage scores improved, pain was an issue (J. Dermatolog. Treat. 2010;21:252-7).
Dr. Fenske said he often uses aminolevulinic acid plus blue light, but to treat and kill bacteria deep in the sebaceous glands, "I would use red light and [MAL]," he said.
Dr. Fenske disclosed serving as a consultant and speaker for Graceway Pharmaceuticals, and serving as a speaker for Sanofi-Aventis.
ORLANDO - Limiting treatment of actinic keratoses to cryosurgery is a disservice to patients, according to Dr. Neil A. Fenske.
Every patient with AKs deserves consideration for field therapy, he said at the Orlando Dermatology Aesthetic and Clinical Conference. Mutated cells occur not only within the visible AKs, but also in the surrounding, normal-looking skin.
"Most patients don't have one AK," said Dr. Fenske of the Moffitt Cancer Center at the University of South Florida in Tampa. Data based on mathematical models suggest that 6%-10% of typical patients with an average of eight AKs will develop at least one squamous cell carcinoma over a 10-year period.
For more complete treatment, following cryosurgery with field therapy a week later. Field therapy using methyl aminolevulinate (MAL) plus a red light–emitting diode (LED) is an up-and-coming option.
MAL has a higher relative porphyrin enrichment in AKs than in normal skin, and is able to penetrate deeply compared with 5-aminolevulinic acid, Dr. Fenske explained. In addition, the red LED at 630 nm requires a lower light dose than other light options, so there is less heating of the skin.
Dr. Fenske cited a study of MAL-PDT plus red LED at 630 nm in which 14 patients with a total of 223 AKs on the scalp and face underwent two treatments. The total number of AKs decreased by 55% after the first treatment and by 62% after the second treatment. Although global photodamage scores improved, pain was an issue (J. Dermatolog. Treat. 2010;21:252-7).
Dr. Fenske said he often uses aminolevulinic acid plus blue light, but to treat and kill bacteria deep in the sebaceous glands, "I would use red light and [MAL]," he said.
Dr. Fenske disclosed serving as a consultant and speaker for Graceway Pharmaceuticals, and serving as a speaker for Sanofi-Aventis.
EXPERT ANALYSIS FROM THE ORLANDO DERMATOLOGY AESTHETIC AND CLINICAL CONFERENCE