VANCOUVER—Patients with dementia with Lewy bodies have a high rate of hospitalization for hallucinations or confusion, falls, and infection, according to a study presented at the 21st International Congress of Parkinson’s Disease and Movement Disorders. Once these patients are hospitalized, they have a high rate of complications. Many patients require transition to a higher level of care.

“These results bring to light a need to educate caregivers on the hazards of hospitalization in this patient population,” said C. Chauncey Spears, MD, Senior Movement Disorders Fellow at the Center for Movement Disorders and Neurorestoration at the University of Florida in Gainesville. Hospitalization is associated with increased mortality in Parkinson’s disease and Alzheimer’s disease, but there are limited published data regarding hospitalization of patients with dementia with Lewy bodies.

To identify causes, complications, and outcomes of hospitalization in patients with dementia with Lewy bodies, the researchers conducted a cross-sectional chart review of patients who were hospitalized at the University of Florida Health Shands Hospital in 2014 and 2015.

The researchers included patients with a diagnosis of dementia with Lewy bodies by discharge who were older than 18. Patients with a diagnosis of other forms of parkinsonism were excluded.

The investigators reviewed 178 patient encounters with 117 patients. The mean age was 78, and 48 participants were women. In addition, there were 134 hospital complications. Patients with dementia with Lewy bodies were most commonly hospitalized for hallucinations or confusion, falls, and infection. This finding was independent of age, premorbid dementia, and home use of antipsychotic or anticholinergic agents. Further statistical analysis suggested a trend toward hospitalization for falls or hallucinations in older patients, said the researchers.

The median length of hospital stay was five days, with a trend toward longer admissions for patients admitted with hallucinations, confusion, or failure to cope. Prior to hospitalization, about 64% of patients were living at home, and 41% of patients were taking antipsychotics. During hospitalization, nearly half of patients experienced new or worsened confusion. “We found that haloperidol and risperidone are commonly used to treat these patients in the hospital, possibly due to their parenteral administration. This raises the concern of whether these medications could contribute to worse outcomes, as patients with dementia with Lewy bodies have a known risk of neuroleptic sensitivity,” said Dr. Spears.

Overall, patients with dementia with Lewy bodies had unfavorable hospital outcomes; 32.6% of patients transitioned to a higher level of care at discharge, relative to their baseline, and 15.2% of patients transitioned to hospice or died. “It will be important to identify variables to limit hospitalization and poor outcomes,” said Dr. Spears. “Further studies with large sample sizes are needed to evaluate for independent predictors of hospitalization, complications, and poorer outcomes, which may include ensuring optimal outpatient treatments for hallucinations [and] confusion, caregiver–provider awareness, and evaluating the risk versus benefit of antipsychotic and anticholinergic agents.”

—Erica Tricarico

VANCOUVER—Patients with dementia with Lewy bodies have a high rate of hospitalization for hallucinations or confusion, falls, and infection, according to a study presented at the 21st International Congress of Parkinson’s Disease and Movement Disorders. Once these patients are hospitalized, they have a high rate of complications. Many patients require transition to a higher level of care.

“These results bring to light a need to educate caregivers on the hazards of hospitalization in this patient population,” said C. Chauncey Spears, MD, Senior Movement Disorders Fellow at the Center for Movement Disorders and Neurorestoration at the University of Florida in Gainesville. Hospitalization is associated with increased mortality in Parkinson’s disease and Alzheimer’s disease, but there are limited published data regarding hospitalization of patients with dementia with Lewy bodies.

To identify causes, complications, and outcomes of hospitalization in patients with dementia with Lewy bodies, the researchers conducted a cross-sectional chart review of patients who were hospitalized at the University of Florida Health Shands Hospital in 2014 and 2015.

The researchers included patients with a diagnosis of dementia with Lewy bodies by discharge who were older than 18. Patients with a diagnosis of other forms of parkinsonism were excluded.

The investigators reviewed 178 patient encounters with 117 patients. The mean age was 78, and 48 participants were women. In addition, there were 134 hospital complications. Patients with dementia with Lewy bodies were most commonly hospitalized for hallucinations or confusion, falls, and infection. This finding was independent of age, premorbid dementia, and home use of antipsychotic or anticholinergic agents. Further statistical analysis suggested a trend toward hospitalization for falls or hallucinations in older patients, said the researchers.

The median length of hospital stay was five days, with a trend toward longer admissions for patients admitted with hallucinations, confusion, or failure to cope. Prior to hospitalization, about 64% of patients were living at home, and 41% of patients were taking antipsychotics. During hospitalization, nearly half of patients experienced new or worsened confusion. “We found that haloperidol and risperidone are commonly used to treat these patients in the hospital, possibly due to their parenteral administration. This raises the concern of whether these medications could contribute to worse outcomes, as patients with dementia with Lewy bodies have a known risk of neuroleptic sensitivity,” said Dr. Spears.

Overall, patients with dementia with Lewy bodies had unfavorable hospital outcomes; 32.6% of patients transitioned to a higher level of care at discharge, relative to their baseline, and 15.2% of patients transitioned to hospice or died. “It will be important to identify variables to limit hospitalization and poor outcomes,” said Dr. Spears. “Further studies with large sample sizes are needed to evaluate for independent predictors of hospitalization, complications, and poorer outcomes, which may include ensuring optimal outpatient treatments for hallucinations [and] confusion, caregiver–provider awareness, and evaluating the risk versus benefit of antipsychotic and anticholinergic agents.”

—Erica Tricarico

VANCOUVER—Patients with dementia with Lewy bodies have a high rate of hospitalization for hallucinations or confusion, falls, and infection, according to a study presented at the 21st International Congress of Parkinson’s Disease and Movement Disorders. Once these patients are hospitalized, they have a high rate of complications. Many patients require transition to a higher level of care.

“These results bring to light a need to educate caregivers on the hazards of hospitalization in this patient population,” said C. Chauncey Spears, MD, Senior Movement Disorders Fellow at the Center for Movement Disorders and Neurorestoration at the University of Florida in Gainesville. Hospitalization is associated with increased mortality in Parkinson’s disease and Alzheimer’s disease, but there are limited published data regarding hospitalization of patients with dementia with Lewy bodies.

To identify causes, complications, and outcomes of hospitalization in patients with dementia with Lewy bodies, the researchers conducted a cross-sectional chart review of patients who were hospitalized at the University of Florida Health Shands Hospital in 2014 and 2015.

The researchers included patients with a diagnosis of dementia with Lewy bodies by discharge who were older than 18. Patients with a diagnosis of other forms of parkinsonism were excluded.

The investigators reviewed 178 patient encounters with 117 patients. The mean age was 78, and 48 participants were women. In addition, there were 134 hospital complications. Patients with dementia with Lewy bodies were most commonly hospitalized for hallucinations or confusion, falls, and infection. This finding was independent of age, premorbid dementia, and home use of antipsychotic or anticholinergic agents. Further statistical analysis suggested a trend toward hospitalization for falls or hallucinations in older patients, said the researchers.

The median length of hospital stay was five days, with a trend toward longer admissions for patients admitted with hallucinations, confusion, or failure to cope. Prior to hospitalization, about 64% of patients were living at home, and 41% of patients were taking antipsychotics. During hospitalization, nearly half of patients experienced new or worsened confusion. “We found that haloperidol and risperidone are commonly used to treat these patients in the hospital, possibly due to their parenteral administration. This raises the concern of whether these medications could contribute to worse outcomes, as patients with dementia with Lewy bodies have a known risk of neuroleptic sensitivity,” said Dr. Spears.

Overall, patients with dementia with Lewy bodies had unfavorable hospital outcomes; 32.6% of patients transitioned to a higher level of care at discharge, relative to their baseline, and 15.2% of patients transitioned to hospice or died. “It will be important to identify variables to limit hospitalization and poor outcomes,” said Dr. Spears. “Further studies with large sample sizes are needed to evaluate for independent predictors of hospitalization, complications, and poorer outcomes, which may include ensuring optimal outpatient treatments for hallucinations [and] confusion, caregiver–provider awareness, and evaluating the risk versus benefit of antipsychotic and anticholinergic agents.”

—Erica Tricarico

COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Pregnant women may receive any licensed, recommended influenza vaccine at any time during pregnancy, according to new recommendations from the Centers for Disease Control and Prevention.
 

This change from the CDC’s previous guidance that pregnant women receive a seasonal inactivated influenza vaccine (IIV) was recommended by the Advisory Committee on Immunization Practices after some heated debate among committee members over evidence presented to support the change in wording (MMWR. 2017 Aug 25;66[(RR-2]:1-20).

The new update gives women the ability to choose between receiving an IIV and FluBlok, a recombinant influenza vaccine (RIV) that is not egg based and can be manufactured more quickly, making it ideal in cases of pandemic or supply shortages, according to the CDC.

Although pregnant women may choose to receive a vaccination during the first trimester, the CDC warns there may be some risk involved.

“Although experience with the use of IIVs is substantial, and data from observational studies are available to support the safety of these vaccines in pregnancy, data are more limited for vaccination during the first trimester,” according to the CDC. “Moreover, there is substantially less experience with more recently licensed IIV products (e.g., quadrivalent, cell culture-based, and adjuvanted vaccines) during pregnancy in general.”

Data also are limited regarding RIVs, the CDC said, with the data used to determine safety among pregnant women “limited to reports of pregnancies occurring incidentally during clinical trials, Vaccine Adverse Event Reporting System (VAERS) reports, and pregnancy registry reports.”

Changes for children

The CDC chose to accept ACIP recommendations regarding Afluria (IIV3), expanding the age of children who can receive the vaccine from 9 years and older to 5 years and older.

Similar labeling changes were accepted for FluLaval Quadrivalent (IIV4), which had previously been given to children 3 years and older but now but will be available for children starting at 6 months of age.

CAP53/iStockphoto.com

New products

Recent product licensures included in the MMWR report are Afluria Quadrivalent (IIV4) and Flublok Quadrivalent (RIV4), both for persons over 18 years.

According to the CDC, Flublok Quadrivalent (an RIV) met noninferiority measures, compared with a similar IIV quadrivalent vaccine, for the A(H3H2) and B/Yamagata viruses but not for A(H1N1) or B/Victoria viruses.

Vaccine composition for 2017-2018

Approved viruses for the 2017-2018 season trivalent vaccines are an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008–like virus (Victoria lineage), according to the MMWR. Quadrivalent vaccines will include those viruses, with the addition of an B/Phuket/3073/2013–like virus (Yamagata lineage).

The CDC continues to recommend that the quadrivalent live attenuated influenza vaccine FluMist not be used by anyone for the 2017-2018 season, a decision that was made after evidence showed poor effectiveness against influenza A(H1N1)pdm09 viruses in the 2013-2014 and 2015-2016 seasons.

Vaccine updates published in this report were recommended by ACIP during meetings held in October 2016 and February and June 2017.

[email protected]

On Twitter @eaztweets

Pregnant women may receive any licensed, recommended influenza vaccine at any time during pregnancy, according to new recommendations from the Centers for Disease Control and Prevention.
 

This change from the CDC’s previous guidance that pregnant women receive a seasonal inactivated influenza vaccine (IIV) was recommended by the Advisory Committee on Immunization Practices after some heated debate among committee members over evidence presented to support the change in wording (MMWR. 2017 Aug 25;66[(RR-2]:1-20).

The new update gives women the ability to choose between receiving an IIV and FluBlok, a recombinant influenza vaccine (RIV) that is not egg based and can be manufactured more quickly, making it ideal in cases of pandemic or supply shortages, according to the CDC.

Although pregnant women may choose to receive a vaccination during the first trimester, the CDC warns there may be some risk involved.

“Although experience with the use of IIVs is substantial, and data from observational studies are available to support the safety of these vaccines in pregnancy, data are more limited for vaccination during the first trimester,” according to the CDC. “Moreover, there is substantially less experience with more recently licensed IIV products (e.g., quadrivalent, cell culture-based, and adjuvanted vaccines) during pregnancy in general.”

Data also are limited regarding RIVs, the CDC said, with the data used to determine safety among pregnant women “limited to reports of pregnancies occurring incidentally during clinical trials, Vaccine Adverse Event Reporting System (VAERS) reports, and pregnancy registry reports.”

Changes for children

The CDC chose to accept ACIP recommendations regarding Afluria (IIV3), expanding the age of children who can receive the vaccine from 9 years and older to 5 years and older.

Similar labeling changes were accepted for FluLaval Quadrivalent (IIV4), which had previously been given to children 3 years and older but now but will be available for children starting at 6 months of age.

CAP53/iStockphoto.com

New products

Recent product licensures included in the MMWR report are Afluria Quadrivalent (IIV4) and Flublok Quadrivalent (RIV4), both for persons over 18 years.

According to the CDC, Flublok Quadrivalent (an RIV) met noninferiority measures, compared with a similar IIV quadrivalent vaccine, for the A(H3H2) and B/Yamagata viruses but not for A(H1N1) or B/Victoria viruses.

Vaccine composition for 2017-2018

Approved viruses for the 2017-2018 season trivalent vaccines are an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008–like virus (Victoria lineage), according to the MMWR. Quadrivalent vaccines will include those viruses, with the addition of an B/Phuket/3073/2013–like virus (Yamagata lineage).

The CDC continues to recommend that the quadrivalent live attenuated influenza vaccine FluMist not be used by anyone for the 2017-2018 season, a decision that was made after evidence showed poor effectiveness against influenza A(H1N1)pdm09 viruses in the 2013-2014 and 2015-2016 seasons.

Vaccine updates published in this report were recommended by ACIP during meetings held in October 2016 and February and June 2017.

[email protected]

On Twitter @eaztweets

Pregnant women may receive any licensed, recommended influenza vaccine at any time during pregnancy, according to new recommendations from the Centers for Disease Control and Prevention.
 

This change from the CDC’s previous guidance that pregnant women receive a seasonal inactivated influenza vaccine (IIV) was recommended by the Advisory Committee on Immunization Practices after some heated debate among committee members over evidence presented to support the change in wording (MMWR. 2017 Aug 25;66[(RR-2]:1-20).

The new update gives women the ability to choose between receiving an IIV and FluBlok, a recombinant influenza vaccine (RIV) that is not egg based and can be manufactured more quickly, making it ideal in cases of pandemic or supply shortages, according to the CDC.

Although pregnant women may choose to receive a vaccination during the first trimester, the CDC warns there may be some risk involved.

“Although experience with the use of IIVs is substantial, and data from observational studies are available to support the safety of these vaccines in pregnancy, data are more limited for vaccination during the first trimester,” according to the CDC. “Moreover, there is substantially less experience with more recently licensed IIV products (e.g., quadrivalent, cell culture-based, and adjuvanted vaccines) during pregnancy in general.”

Data also are limited regarding RIVs, the CDC said, with the data used to determine safety among pregnant women “limited to reports of pregnancies occurring incidentally during clinical trials, Vaccine Adverse Event Reporting System (VAERS) reports, and pregnancy registry reports.”

Changes for children

The CDC chose to accept ACIP recommendations regarding Afluria (IIV3), expanding the age of children who can receive the vaccine from 9 years and older to 5 years and older.

Similar labeling changes were accepted for FluLaval Quadrivalent (IIV4), which had previously been given to children 3 years and older but now but will be available for children starting at 6 months of age.

CAP53/iStockphoto.com

New products

Recent product licensures included in the MMWR report are Afluria Quadrivalent (IIV4) and Flublok Quadrivalent (RIV4), both for persons over 18 years.

According to the CDC, Flublok Quadrivalent (an RIV) met noninferiority measures, compared with a similar IIV quadrivalent vaccine, for the A(H3H2) and B/Yamagata viruses but not for A(H1N1) or B/Victoria viruses.

Vaccine composition for 2017-2018

Approved viruses for the 2017-2018 season trivalent vaccines are an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008–like virus (Victoria lineage), according to the MMWR. Quadrivalent vaccines will include those viruses, with the addition of an B/Phuket/3073/2013–like virus (Yamagata lineage).

The CDC continues to recommend that the quadrivalent live attenuated influenza vaccine FluMist not be used by anyone for the 2017-2018 season, a decision that was made after evidence showed poor effectiveness against influenza A(H1N1)pdm09 viruses in the 2013-2014 and 2015-2016 seasons.

Vaccine updates published in this report were recommended by ACIP during meetings held in October 2016 and February and June 2017.

[email protected]

On Twitter @eaztweets

All newborns with a birth weight of at least 2,000 grams (4.4 pounds) should receive the hepatitis B vaccine within 24 hours of birth, according to a new policy statement by the American Academy of Pediatrics that brings its recommendations in line with those of the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention.

“The birth dose can prevent infection of infants born to infected mothers in situations in which the mother’s results are never obtained, are misinterpreted, are falsely negative, are transcribed or reported to the infant care team inaccurately, or simply not communicated to the nursery,” announced the new statement from the AAP Committee on Infectious Diseases and the Committee on Fetus and Newborn (Pediatrics. 2017 Aug 28. doi: 10.1542/peds.2017-1870).

A dose of the hepatitis B vaccine within 24 hours of birth is 75%-95% effective at preventing perinatal hepatitis B transmission. “When postexposure prophylaxis with both hepatitis B vaccine and hepatitis B immune globulin (HBIG) is given, is timed appropriately, and is followed by completion of the infant hepatitis B immunization series, perinatal infection rates range from 0.7% to 1.1%,” according to the statement.

CDC/Dr. Erskine Palmer

Specific recommendations

• Infants born to mothers who test positive for hepatitis B surface antigen (HBsAg): Administer the hepatitis B vaccine and HBIG within 12 hours of birth.

• Infants weighing at least 2,000 g and born to mothers who are HBsAg negative: Administer the hepatitis B vaccine within 24 hours of birth.

• Infants weighing less than 2,000 g and born to mothers who are HBsAg negative: Administer the hepatitis B vaccine at hospital discharge or at age 1 month (whichever is first).

• Infants weighing at least 2,000 g and born to mothers with an unknown HBsAg status: Administer the hepatitis B vaccine within 12 hours of birth and HBIG by hospital discharge or age 7 days (whichever is first) if HBsAg status remains unknown or is confirmed positive.

• Infants weighing less than 2,000 g and born to mothers with an unknown HBsAg status: Administer the hepatitis B vaccine within 12 hours of birth and then HBIG within 12 hours unless the mother tests negative for HBsAg by then.

All newborns with a birth weight of at least 2,000 grams (4.4 pounds) should receive the hepatitis B vaccine within 24 hours of birth, according to a new policy statement by the American Academy of Pediatrics that brings its recommendations in line with those of the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention.

“The birth dose can prevent infection of infants born to infected mothers in situations in which the mother’s results are never obtained, are misinterpreted, are falsely negative, are transcribed or reported to the infant care team inaccurately, or simply not communicated to the nursery,” announced the new statement from the AAP Committee on Infectious Diseases and the Committee on Fetus and Newborn (Pediatrics. 2017 Aug 28. doi: 10.1542/peds.2017-1870).

A dose of the hepatitis B vaccine within 24 hours of birth is 75%-95% effective at preventing perinatal hepatitis B transmission. “When postexposure prophylaxis with both hepatitis B vaccine and hepatitis B immune globulin (HBIG) is given, is timed appropriately, and is followed by completion of the infant hepatitis B immunization series, perinatal infection rates range from 0.7% to 1.1%,” according to the statement.

CDC/Dr. Erskine Palmer

Specific recommendations

• Infants born to mothers who test positive for hepatitis B surface antigen (HBsAg): Administer the hepatitis B vaccine and HBIG within 12 hours of birth.

• Infants weighing at least 2,000 g and born to mothers who are HBsAg negative: Administer the hepatitis B vaccine within 24 hours of birth.

• Infants weighing less than 2,000 g and born to mothers who are HBsAg negative: Administer the hepatitis B vaccine at hospital discharge or at age 1 month (whichever is first).

• Infants weighing at least 2,000 g and born to mothers with an unknown HBsAg status: Administer the hepatitis B vaccine within 12 hours of birth and HBIG by hospital discharge or age 7 days (whichever is first) if HBsAg status remains unknown or is confirmed positive.

• Infants weighing less than 2,000 g and born to mothers with an unknown HBsAg status: Administer the hepatitis B vaccine within 12 hours of birth and then HBIG within 12 hours unless the mother tests negative for HBsAg by then.

All newborns with a birth weight of at least 2,000 grams (4.4 pounds) should receive the hepatitis B vaccine within 24 hours of birth, according to a new policy statement by the American Academy of Pediatrics that brings its recommendations in line with those of the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention.

“The birth dose can prevent infection of infants born to infected mothers in situations in which the mother’s results are never obtained, are misinterpreted, are falsely negative, are transcribed or reported to the infant care team inaccurately, or simply not communicated to the nursery,” announced the new statement from the AAP Committee on Infectious Diseases and the Committee on Fetus and Newborn (Pediatrics. 2017 Aug 28. doi: 10.1542/peds.2017-1870).

A dose of the hepatitis B vaccine within 24 hours of birth is 75%-95% effective at preventing perinatal hepatitis B transmission. “When postexposure prophylaxis with both hepatitis B vaccine and hepatitis B immune globulin (HBIG) is given, is timed appropriately, and is followed by completion of the infant hepatitis B immunization series, perinatal infection rates range from 0.7% to 1.1%,” according to the statement.

CDC/Dr. Erskine Palmer

Specific recommendations

• Infants born to mothers who test positive for hepatitis B surface antigen (HBsAg): Administer the hepatitis B vaccine and HBIG within 12 hours of birth.

• Infants weighing at least 2,000 g and born to mothers who are HBsAg negative: Administer the hepatitis B vaccine within 24 hours of birth.

• Infants weighing less than 2,000 g and born to mothers who are HBsAg negative: Administer the hepatitis B vaccine at hospital discharge or at age 1 month (whichever is first).

• Infants weighing at least 2,000 g and born to mothers with an unknown HBsAg status: Administer the hepatitis B vaccine within 12 hours of birth and HBIG by hospital discharge or age 7 days (whichever is first) if HBsAg status remains unknown or is confirmed positive.

• Infants weighing less than 2,000 g and born to mothers with an unknown HBsAg status: Administer the hepatitis B vaccine within 12 hours of birth and then HBIG within 12 hours unless the mother tests negative for HBsAg by then.

BOSTON—Insomnia with objective short sleep duration (ie, less than six hours) is not associated with an elevated risk of all-cause mortality, according to research presented at the 31st Annual Meeting of the Associated Professional Sleep Societies. Short sleep duration alone is associated with a higher risk of death, however.

To quantify the association between insomnia with objective short sleep duration and all-cause mortality, Suzanne Bertisch, MD, MPH, Assistant Professor of Medicine at Harvard Medical School and Clinical Investigator at Beth Israel Deaconess Medical Center in Boston, and colleagues conducted a time-to-event analysis of the Sleep Heart Health Study data. This prospective, community-based cohort study enrolled 6,441 participants age 40 and older between 1995 and 1998. At baseline, researchers administered questionnaires that queried participants about sleep symptoms, sleep patterns, medication, and medical history. In addition, participants underwent anthropometry and blood pressure measurements and had one night of unattended polysomnography at their home by certified and trained technicians. Researchers followed participants for a median of 11.6 years.

The primary exposure for Dr. Bertisch’s analysis was insomnia with short sleep duration. The investigators defined insomnia as self-report of difficulty falling asleep, difficulty getting back to sleep, early morning awakenings, or use of a sleeping pill for 16 to 30 nights/month. Short sleep duration was defined as total sleep time of less than six hours on single-night polysomnography. Covariates of interest included sex, race, smoking status, history of cardiovascular disease, apnea–hypopnea index, BMI, antidepressants used in the previous two weeks, hypertension, and diabetes.

Investigators used the propensity-score-adjusted Cox proportional hazards model to estimate the association between insomnia with short sleep duration and time to death. Researchers also performed a prespecified secondary analysis scoring hypertension and diabetes as potential mediators of an association between sleep variables and mortality. In addition, investigators stratified models by sex and examined insomnia with self-reported sleep duration. In secondary models, researchers used insomnia with self-reported duration as a secondary exposure.

Among 4,994 participants included in the study, researchers observed 1,163 deaths, of which 355 resulted from cardiovascular disease. The mean age of participants was 64. Participants with insomnia were more likely to be female, to smoke, and to use antidepressants, compared with those without insomnia.

Dr. Bertisch and colleagues also found that participants with short sleep duration had a 14% higher risk of mortality, compared with people without insomnia and with normal sleep duration. Insomnia with short sleep duration, however, was not associated with a higher risk of all-cause mortality. In the additional analysis, the researchers found no evidence that hypertension or diabetes mediated the association between sleep duration and mortality. Results also did not differ by sex, said Dr. Bertisch.

Limitations of this study include the fact that objective sleep duration was determined by a single night of polysomnography, and that researchers did not capture the duration of insomnia symptoms.

“Further work is needed to identify the mechanistic pathways by which insomnia with objective short sleep duration may confer increased risk for cardiovascular disease,” Dr. Bertisch concluded.

—Erica Tricarico

BOSTON—Insomnia with objective short sleep duration (ie, less than six hours) is not associated with an elevated risk of all-cause mortality, according to research presented at the 31st Annual Meeting of the Associated Professional Sleep Societies. Short sleep duration alone is associated with a higher risk of death, however.

To quantify the association between insomnia with objective short sleep duration and all-cause mortality, Suzanne Bertisch, MD, MPH, Assistant Professor of Medicine at Harvard Medical School and Clinical Investigator at Beth Israel Deaconess Medical Center in Boston, and colleagues conducted a time-to-event analysis of the Sleep Heart Health Study data. This prospective, community-based cohort study enrolled 6,441 participants age 40 and older between 1995 and 1998. At baseline, researchers administered questionnaires that queried participants about sleep symptoms, sleep patterns, medication, and medical history. In addition, participants underwent anthropometry and blood pressure measurements and had one night of unattended polysomnography at their home by certified and trained technicians. Researchers followed participants for a median of 11.6 years.

The primary exposure for Dr. Bertisch’s analysis was insomnia with short sleep duration. The investigators defined insomnia as self-report of difficulty falling asleep, difficulty getting back to sleep, early morning awakenings, or use of a sleeping pill for 16 to 30 nights/month. Short sleep duration was defined as total sleep time of less than six hours on single-night polysomnography. Covariates of interest included sex, race, smoking status, history of cardiovascular disease, apnea–hypopnea index, BMI, antidepressants used in the previous two weeks, hypertension, and diabetes.

Investigators used the propensity-score-adjusted Cox proportional hazards model to estimate the association between insomnia with short sleep duration and time to death. Researchers also performed a prespecified secondary analysis scoring hypertension and diabetes as potential mediators of an association between sleep variables and mortality. In addition, investigators stratified models by sex and examined insomnia with self-reported sleep duration. In secondary models, researchers used insomnia with self-reported duration as a secondary exposure.

Among 4,994 participants included in the study, researchers observed 1,163 deaths, of which 355 resulted from cardiovascular disease. The mean age of participants was 64. Participants with insomnia were more likely to be female, to smoke, and to use antidepressants, compared with those without insomnia.

Dr. Bertisch and colleagues also found that participants with short sleep duration had a 14% higher risk of mortality, compared with people without insomnia and with normal sleep duration. Insomnia with short sleep duration, however, was not associated with a higher risk of all-cause mortality. In the additional analysis, the researchers found no evidence that hypertension or diabetes mediated the association between sleep duration and mortality. Results also did not differ by sex, said Dr. Bertisch.

Limitations of this study include the fact that objective sleep duration was determined by a single night of polysomnography, and that researchers did not capture the duration of insomnia symptoms.

“Further work is needed to identify the mechanistic pathways by which insomnia with objective short sleep duration may confer increased risk for cardiovascular disease,” Dr. Bertisch concluded.

—Erica Tricarico

BOSTON—Insomnia with objective short sleep duration (ie, less than six hours) is not associated with an elevated risk of all-cause mortality, according to research presented at the 31st Annual Meeting of the Associated Professional Sleep Societies. Short sleep duration alone is associated with a higher risk of death, however.

To quantify the association between insomnia with objective short sleep duration and all-cause mortality, Suzanne Bertisch, MD, MPH, Assistant Professor of Medicine at Harvard Medical School and Clinical Investigator at Beth Israel Deaconess Medical Center in Boston, and colleagues conducted a time-to-event analysis of the Sleep Heart Health Study data. This prospective, community-based cohort study enrolled 6,441 participants age 40 and older between 1995 and 1998. At baseline, researchers administered questionnaires that queried participants about sleep symptoms, sleep patterns, medication, and medical history. In addition, participants underwent anthropometry and blood pressure measurements and had one night of unattended polysomnography at their home by certified and trained technicians. Researchers followed participants for a median of 11.6 years.

The primary exposure for Dr. Bertisch’s analysis was insomnia with short sleep duration. The investigators defined insomnia as self-report of difficulty falling asleep, difficulty getting back to sleep, early morning awakenings, or use of a sleeping pill for 16 to 30 nights/month. Short sleep duration was defined as total sleep time of less than six hours on single-night polysomnography. Covariates of interest included sex, race, smoking status, history of cardiovascular disease, apnea–hypopnea index, BMI, antidepressants used in the previous two weeks, hypertension, and diabetes.

Investigators used the propensity-score-adjusted Cox proportional hazards model to estimate the association between insomnia with short sleep duration and time to death. Researchers also performed a prespecified secondary analysis scoring hypertension and diabetes as potential mediators of an association between sleep variables and mortality. In addition, investigators stratified models by sex and examined insomnia with self-reported sleep duration. In secondary models, researchers used insomnia with self-reported duration as a secondary exposure.

Among 4,994 participants included in the study, researchers observed 1,163 deaths, of which 355 resulted from cardiovascular disease. The mean age of participants was 64. Participants with insomnia were more likely to be female, to smoke, and to use antidepressants, compared with those without insomnia.

Dr. Bertisch and colleagues also found that participants with short sleep duration had a 14% higher risk of mortality, compared with people without insomnia and with normal sleep duration. Insomnia with short sleep duration, however, was not associated with a higher risk of all-cause mortality. In the additional analysis, the researchers found no evidence that hypertension or diabetes mediated the association between sleep duration and mortality. Results also did not differ by sex, said Dr. Bertisch.

Limitations of this study include the fact that objective sleep duration was determined by a single night of polysomnography, and that researchers did not capture the duration of insomnia symptoms.

“Further work is needed to identify the mechanistic pathways by which insomnia with objective short sleep duration may confer increased risk for cardiovascular disease,” Dr. Bertisch concluded.

—Erica Tricarico

NEW YORK – Immobile patients are at a heightened risk for complications after bariatric surgery, a large retrospective study has shown.

“The importance of this study is to help us as an institution, but then also nationally, to try to focus on quality initiatives to improve the complication rate and safety profile of these patients, who are incredibly high risk for bariatric surgery,” said Rana Higgins, MD, a general surgeon at Froedtert Hospital and the Medical College of Wisconsin in Milwaukee.

Dr. Higgins and her colleagues compared 2,969 immobile patients with 145,741 who were ambulatory before surgery. The most common bariatric procedure was sleeve gastrectomy at 56%. Another 30% had gastric bypass, 3% had the gastric band, and the remaining 1% underwent other procedures, such as biliopancreatic diversion with duodenal switch. The MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) defines immobility as a patient with limited ambulation who requires assistive devices, such as a scooter or wheelchair, to ambulate most or all of the time. In addition, with regard to negotiating stairs, immobile patients need a home lift or an elevator.

[email protected]

NEW YORK – Immobile patients are at a heightened risk for complications after bariatric surgery, a large retrospective study has shown.

“The importance of this study is to help us as an institution, but then also nationally, to try to focus on quality initiatives to improve the complication rate and safety profile of these patients, who are incredibly high risk for bariatric surgery,” said Rana Higgins, MD, a general surgeon at Froedtert Hospital and the Medical College of Wisconsin in Milwaukee.

Dr. Higgins and her colleagues compared 2,969 immobile patients with 145,741 who were ambulatory before surgery. The most common bariatric procedure was sleeve gastrectomy at 56%. Another 30% had gastric bypass, 3% had the gastric band, and the remaining 1% underwent other procedures, such as biliopancreatic diversion with duodenal switch. The MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) defines immobility as a patient with limited ambulation who requires assistive devices, such as a scooter or wheelchair, to ambulate most or all of the time. In addition, with regard to negotiating stairs, immobile patients need a home lift or an elevator.

[email protected]

NEW YORK – Immobile patients are at a heightened risk for complications after bariatric surgery, a large retrospective study has shown.

“The importance of this study is to help us as an institution, but then also nationally, to try to focus on quality initiatives to improve the complication rate and safety profile of these patients, who are incredibly high risk for bariatric surgery,” said Rana Higgins, MD, a general surgeon at Froedtert Hospital and the Medical College of Wisconsin in Milwaukee.

Dr. Higgins and her colleagues compared 2,969 immobile patients with 145,741 who were ambulatory before surgery. The most common bariatric procedure was sleeve gastrectomy at 56%. Another 30% had gastric bypass, 3% had the gastric band, and the remaining 1% underwent other procedures, such as biliopancreatic diversion with duodenal switch. The MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) defines immobility as a patient with limited ambulation who requires assistive devices, such as a scooter or wheelchair, to ambulate most or all of the time. In addition, with regard to negotiating stairs, immobile patients need a home lift or an elevator.

[email protected]

ESTES PARK, COLO. – Close to 80% of men who have sex with men who had gonorrhea or chlamydia in a recent study were infected only at extragenital sites – and therein lies a tale for primary care physicians.

“Five or six years ago my infectious diseases colleagues were pushing extragenital testing in MSM, and I thought then it was a little over the top and excessive. But I now think this is something we should be doing. Two studies from last year highlight this. I think we’re probably missing a lot of infections if we’re only doing genitourinary testing,” John Koeppe, MD, said at a conference on internal medicine sponsored by the University of Colorado.

[email protected]

ESTES PARK, COLO. – Close to 80% of men who have sex with men who had gonorrhea or chlamydia in a recent study were infected only at extragenital sites – and therein lies a tale for primary care physicians.

“Five or six years ago my infectious diseases colleagues were pushing extragenital testing in MSM, and I thought then it was a little over the top and excessive. But I now think this is something we should be doing. Two studies from last year highlight this. I think we’re probably missing a lot of infections if we’re only doing genitourinary testing,” John Koeppe, MD, said at a conference on internal medicine sponsored by the University of Colorado.

[email protected]

ESTES PARK, COLO. – Close to 80% of men who have sex with men who had gonorrhea or chlamydia in a recent study were infected only at extragenital sites – and therein lies a tale for primary care physicians.

“Five or six years ago my infectious diseases colleagues were pushing extragenital testing in MSM, and I thought then it was a little over the top and excessive. But I now think this is something we should be doing. Two studies from last year highlight this. I think we’re probably missing a lot of infections if we’re only doing genitourinary testing,” John Koeppe, MD, said at a conference on internal medicine sponsored by the University of Colorado.

[email protected]

By 2030, the U.S. health care system could be facing a shortage of 19,800-29,000 surgeons, which means that things are looking up.

Last year, the Association of American Medical Colleges projected a shortage of 25,200-33,200 surgeons by the year 2025, which is larger than the 15,000- to 24,000-surgeon shortfall now projected for 2025 – larger even than the shortage that the AAMC is currently projecting for 2030.

[email protected]

By 2030, the U.S. health care system could be facing a shortage of 19,800-29,000 surgeons, which means that things are looking up.

Last year, the Association of American Medical Colleges projected a shortage of 25,200-33,200 surgeons by the year 2025, which is larger than the 15,000- to 24,000-surgeon shortfall now projected for 2025 – larger even than the shortage that the AAMC is currently projecting for 2030.

[email protected]

By 2030, the U.S. health care system could be facing a shortage of 19,800-29,000 surgeons, which means that things are looking up.

Last year, the Association of American Medical Colleges projected a shortage of 25,200-33,200 surgeons by the year 2025, which is larger than the 15,000- to 24,000-surgeon shortfall now projected for 2025 – larger even than the shortage that the AAMC is currently projecting for 2030.

[email protected]

BARCELONA – Prescription-strength ibuprofen has a bigger adverse effect on blood pressure than celecoxib or naproxen, a finding that suggests a likely mechanism for the worse cardiovascular event rate documented in ibuprofen-treated arthritis patients in the PRECISION trial, Frank Ruschitzka, MD, said at the annual congress of the European Society of Cardiology.

“Prescription-strength ibuprofen is under pressure – it has a high incidence of new-onset hypertension, particularly when compared to the more selective COX-2 inhibitor celecoxib. Before we did this study, many would have said it’s the other way around,” observed Dr. Ruschitzka, professor of cardiology at the University of Zurich.

He presented the results of PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement).

“These results will have impact on your daily practice when you go home,” the cardiologist promised.

PRECISION-ABPM was a prespecified double-blind, randomized, 60-center substudy of the published PRECISION trial, which included 24,081 U.S. patients who needed daily NSAIDs for arthritis and were also at increased cardiovascular risk. They were randomized to the COX-2 inhibitor celecoxib at 100-200 mg b.i.d. or the nonselective NSAIDs ibuprofen at 600-800 mg three times a day or naproxen at 375-500 mg twice daily. Participants also received a proton pump inhibitor to protect against NSAID-related GI bleeding. In the on-treatment analysis, the ibuprofen group was significantly more likely to experience cardiovascular and all-cause mortality and renal events than were those on celecoxib (N Engl J Med. 2016 Dec 29;375[26]:2519-29).

The PRECISION-ABPM substudy included 444 arthritis patients, 92% of whom had osteoarthritis. During the 4-month study, investigators amassed roughly 60,000 automated blood pressure measurements across the three study arms.

The primary outcome was change from baseline in mean 24-hour systolic blood pressure (SBP). It increased by 3.7 mm Hg in the ibuprofen group and declined by 0.3 mm Hg in the celecoxib group, while the naproxen group occupied the middle ground with a 1.6-mm Hg increase.

The nearly 4-mm Hg increase in mean 24-hour SBP at 4 months in the ibuprofen group is of sufficient magnitude to be clinically important, Dr. Ruschitzka noted. He noted that fully 23.2% of ibuprofen-treated patients who had normal baseline blood pressure developed hypertension as defined by a mean 24-hour SBP of at least 130 and/or a diastolic blood pressure of at least 80 mm Hg. In contrast, incident hypertension occurred in only 10.3% of the celecoxib group and 19% of naproxen-treated patients. Thus, the likelihood of developing hypertension was 61% less with celecoxib than ibuprofen and 51% less with celecoxib than naproxen.

Not treating chronic arthritic pain to avoid the cardiovascular risk of NSAIDs is not a legitimate option.

“Pain is a cardiovascular risk factor,” Dr. Ruschitzka emphasized. “It’s unethical not to treat it. If you don’t treat pain, the patient’s blood pressure goes up, heart rate goes up, and you’re driving patients into inactivity.”

Although he’s convinced there’s no such thing as a safe NSAID from a cardiovascular risk standpoint, the PRECISION and PRECISION-ABPM data show celecoxib is less unsafe than ibuprofen. And as for the oft-heard statement that naproxen is the safest NSAID for the heart, Dr. Ruschitzka snorted, “What an urban legend.”

Discussant Scott Solomon, MD, opined that, while PRECISION-ABPM doesn’t support the notion that conventional NSAIDs such as naproxen or ibuprofen are any safer than celecoxib, it would be wrong to conclude from the study that celecoxib doesn’t affect blood pressure and is safer than the others from a cardiovascular standpoint. That’s because the three study drugs weren’t compared in an equipotent way. Because of safety concerns, the Food and Drug Administration required that the daily dose of celecoxib be capped at the low end of the therapeutic range, while no such constraints were placed on the two nonselective NSAIDS.

“Compared to placebo, all NSAIDs likely raise blood pressure, especially in patients prone to hypertension, those with chronic kidney disease, the elderly – and this is exactly the type of patients who require NSAIDs for arthritis. Whichever NSAID is chosen, clinicians should be aware of this effect and treat hypertension according to guidelines,” said Dr. Solomon, director of noninvasive cardiology at Brigham and Women’s Hospital, Boston, and professor of medicine at Harvard Medical School.

Dr. Solomon has been a key figure in the COX-2 inhibitor controversy of the last decade. He was lead author of a 2005 review of data from clinical trials of COX-2 inhibitors for colorectal adenoma prevention, which concluded that the drugs had a cardiovascular safety issue in that setting (N Engl J Med. 2005 Mar 17;352[11]:1071-80).

“Our analysis of celecoxib concluded that a dose-dependent increase in cardiovascular events was there, was real, but notably occurred at doses which were substantially higher than what we typically use for patients with arthritis,” he said.

That report triggered a fevered reaction.

“Amid an enormous amount of hype, hyperbole, and hysteria, the safety of these agents was thrown into question, leading to the withdrawal of all but one of them from the market and a black-box warning around the one remaining agent, celecoxib,” he recalled.

Dr. Ruschitzka discussed his findings in a video interview.

PRECISION-ABPM was sponsored by Pfizer. Dr. Ruschitzka and Dr. Solomon reported having no financial conflicts of interest regarding their presentations.

[email protected]

BARCELONA – Prescription-strength ibuprofen has a bigger adverse effect on blood pressure than celecoxib or naproxen, a finding that suggests a likely mechanism for the worse cardiovascular event rate documented in ibuprofen-treated arthritis patients in the PRECISION trial, Frank Ruschitzka, MD, said at the annual congress of the European Society of Cardiology.

“Prescription-strength ibuprofen is under pressure – it has a high incidence of new-onset hypertension, particularly when compared to the more selective COX-2 inhibitor celecoxib. Before we did this study, many would have said it’s the other way around,” observed Dr. Ruschitzka, professor of cardiology at the University of Zurich.

He presented the results of PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement).

“These results will have impact on your daily practice when you go home,” the cardiologist promised.

PRECISION-ABPM was a prespecified double-blind, randomized, 60-center substudy of the published PRECISION trial, which included 24,081 U.S. patients who needed daily NSAIDs for arthritis and were also at increased cardiovascular risk. They were randomized to the COX-2 inhibitor celecoxib at 100-200 mg b.i.d. or the nonselective NSAIDs ibuprofen at 600-800 mg three times a day or naproxen at 375-500 mg twice daily. Participants also received a proton pump inhibitor to protect against NSAID-related GI bleeding. In the on-treatment analysis, the ibuprofen group was significantly more likely to experience cardiovascular and all-cause mortality and renal events than were those on celecoxib (N Engl J Med. 2016 Dec 29;375[26]:2519-29).

The PRECISION-ABPM substudy included 444 arthritis patients, 92% of whom had osteoarthritis. During the 4-month study, investigators amassed roughly 60,000 automated blood pressure measurements across the three study arms.

The primary outcome was change from baseline in mean 24-hour systolic blood pressure (SBP). It increased by 3.7 mm Hg in the ibuprofen group and declined by 0.3 mm Hg in the celecoxib group, while the naproxen group occupied the middle ground with a 1.6-mm Hg increase.

The nearly 4-mm Hg increase in mean 24-hour SBP at 4 months in the ibuprofen group is of sufficient magnitude to be clinically important, Dr. Ruschitzka noted. He noted that fully 23.2% of ibuprofen-treated patients who had normal baseline blood pressure developed hypertension as defined by a mean 24-hour SBP of at least 130 and/or a diastolic blood pressure of at least 80 mm Hg. In contrast, incident hypertension occurred in only 10.3% of the celecoxib group and 19% of naproxen-treated patients. Thus, the likelihood of developing hypertension was 61% less with celecoxib than ibuprofen and 51% less with celecoxib than naproxen.

Not treating chronic arthritic pain to avoid the cardiovascular risk of NSAIDs is not a legitimate option.

“Pain is a cardiovascular risk factor,” Dr. Ruschitzka emphasized. “It’s unethical not to treat it. If you don’t treat pain, the patient’s blood pressure goes up, heart rate goes up, and you’re driving patients into inactivity.”

Although he’s convinced there’s no such thing as a safe NSAID from a cardiovascular risk standpoint, the PRECISION and PRECISION-ABPM data show celecoxib is less unsafe than ibuprofen. And as for the oft-heard statement that naproxen is the safest NSAID for the heart, Dr. Ruschitzka snorted, “What an urban legend.”

Discussant Scott Solomon, MD, opined that, while PRECISION-ABPM doesn’t support the notion that conventional NSAIDs such as naproxen or ibuprofen are any safer than celecoxib, it would be wrong to conclude from the study that celecoxib doesn’t affect blood pressure and is safer than the others from a cardiovascular standpoint. That’s because the three study drugs weren’t compared in an equipotent way. Because of safety concerns, the Food and Drug Administration required that the daily dose of celecoxib be capped at the low end of the therapeutic range, while no such constraints were placed on the two nonselective NSAIDS.

“Compared to placebo, all NSAIDs likely raise blood pressure, especially in patients prone to hypertension, those with chronic kidney disease, the elderly – and this is exactly the type of patients who require NSAIDs for arthritis. Whichever NSAID is chosen, clinicians should be aware of this effect and treat hypertension according to guidelines,” said Dr. Solomon, director of noninvasive cardiology at Brigham and Women’s Hospital, Boston, and professor of medicine at Harvard Medical School.

Dr. Solomon has been a key figure in the COX-2 inhibitor controversy of the last decade. He was lead author of a 2005 review of data from clinical trials of COX-2 inhibitors for colorectal adenoma prevention, which concluded that the drugs had a cardiovascular safety issue in that setting (N Engl J Med. 2005 Mar 17;352[11]:1071-80).

“Our analysis of celecoxib concluded that a dose-dependent increase in cardiovascular events was there, was real, but notably occurred at doses which were substantially higher than what we typically use for patients with arthritis,” he said.

That report triggered a fevered reaction.

“Amid an enormous amount of hype, hyperbole, and hysteria, the safety of these agents was thrown into question, leading to the withdrawal of all but one of them from the market and a black-box warning around the one remaining agent, celecoxib,” he recalled.

Dr. Ruschitzka discussed his findings in a video interview.

PRECISION-ABPM was sponsored by Pfizer. Dr. Ruschitzka and Dr. Solomon reported having no financial conflicts of interest regarding their presentations.

[email protected]

BARCELONA – Prescription-strength ibuprofen has a bigger adverse effect on blood pressure than celecoxib or naproxen, a finding that suggests a likely mechanism for the worse cardiovascular event rate documented in ibuprofen-treated arthritis patients in the PRECISION trial, Frank Ruschitzka, MD, said at the annual congress of the European Society of Cardiology.

“Prescription-strength ibuprofen is under pressure – it has a high incidence of new-onset hypertension, particularly when compared to the more selective COX-2 inhibitor celecoxib. Before we did this study, many would have said it’s the other way around,” observed Dr. Ruschitzka, professor of cardiology at the University of Zurich.

He presented the results of PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement).

“These results will have impact on your daily practice when you go home,” the cardiologist promised.

PRECISION-ABPM was a prespecified double-blind, randomized, 60-center substudy of the published PRECISION trial, which included 24,081 U.S. patients who needed daily NSAIDs for arthritis and were also at increased cardiovascular risk. They were randomized to the COX-2 inhibitor celecoxib at 100-200 mg b.i.d. or the nonselective NSAIDs ibuprofen at 600-800 mg three times a day or naproxen at 375-500 mg twice daily. Participants also received a proton pump inhibitor to protect against NSAID-related GI bleeding. In the on-treatment analysis, the ibuprofen group was significantly more likely to experience cardiovascular and all-cause mortality and renal events than were those on celecoxib (N Engl J Med. 2016 Dec 29;375[26]:2519-29).

The PRECISION-ABPM substudy included 444 arthritis patients, 92% of whom had osteoarthritis. During the 4-month study, investigators amassed roughly 60,000 automated blood pressure measurements across the three study arms.

The primary outcome was change from baseline in mean 24-hour systolic blood pressure (SBP). It increased by 3.7 mm Hg in the ibuprofen group and declined by 0.3 mm Hg in the celecoxib group, while the naproxen group occupied the middle ground with a 1.6-mm Hg increase.

The nearly 4-mm Hg increase in mean 24-hour SBP at 4 months in the ibuprofen group is of sufficient magnitude to be clinically important, Dr. Ruschitzka noted. He noted that fully 23.2% of ibuprofen-treated patients who had normal baseline blood pressure developed hypertension as defined by a mean 24-hour SBP of at least 130 and/or a diastolic blood pressure of at least 80 mm Hg. In contrast, incident hypertension occurred in only 10.3% of the celecoxib group and 19% of naproxen-treated patients. Thus, the likelihood of developing hypertension was 61% less with celecoxib than ibuprofen and 51% less with celecoxib than naproxen.

Not treating chronic arthritic pain to avoid the cardiovascular risk of NSAIDs is not a legitimate option.

“Pain is a cardiovascular risk factor,” Dr. Ruschitzka emphasized. “It’s unethical not to treat it. If you don’t treat pain, the patient’s blood pressure goes up, heart rate goes up, and you’re driving patients into inactivity.”

Although he’s convinced there’s no such thing as a safe NSAID from a cardiovascular risk standpoint, the PRECISION and PRECISION-ABPM data show celecoxib is less unsafe than ibuprofen. And as for the oft-heard statement that naproxen is the safest NSAID for the heart, Dr. Ruschitzka snorted, “What an urban legend.”

Discussant Scott Solomon, MD, opined that, while PRECISION-ABPM doesn’t support the notion that conventional NSAIDs such as naproxen or ibuprofen are any safer than celecoxib, it would be wrong to conclude from the study that celecoxib doesn’t affect blood pressure and is safer than the others from a cardiovascular standpoint. That’s because the three study drugs weren’t compared in an equipotent way. Because of safety concerns, the Food and Drug Administration required that the daily dose of celecoxib be capped at the low end of the therapeutic range, while no such constraints were placed on the two nonselective NSAIDS.

“Compared to placebo, all NSAIDs likely raise blood pressure, especially in patients prone to hypertension, those with chronic kidney disease, the elderly – and this is exactly the type of patients who require NSAIDs for arthritis. Whichever NSAID is chosen, clinicians should be aware of this effect and treat hypertension according to guidelines,” said Dr. Solomon, director of noninvasive cardiology at Brigham and Women’s Hospital, Boston, and professor of medicine at Harvard Medical School.

Dr. Solomon has been a key figure in the COX-2 inhibitor controversy of the last decade. He was lead author of a 2005 review of data from clinical trials of COX-2 inhibitors for colorectal adenoma prevention, which concluded that the drugs had a cardiovascular safety issue in that setting (N Engl J Med. 2005 Mar 17;352[11]:1071-80).

“Our analysis of celecoxib concluded that a dose-dependent increase in cardiovascular events was there, was real, but notably occurred at doses which were substantially higher than what we typically use for patients with arthritis,” he said.

That report triggered a fevered reaction.

“Amid an enormous amount of hype, hyperbole, and hysteria, the safety of these agents was thrown into question, leading to the withdrawal of all but one of them from the market and a black-box warning around the one remaining agent, celecoxib,” he recalled.

Dr. Ruschitzka discussed his findings in a video interview.

PRECISION-ABPM was sponsored by Pfizer. Dr. Ruschitzka and Dr. Solomon reported having no financial conflicts of interest regarding their presentations.

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Gazyva (obinutuzumab) has been granted a Priority Review by the Food and Drug Administration for the treatment of previously untreated follicular lymphoma, according to a press release from Genentech.

FDA approval was based on results from the GALLIUM study, a phase 3 trial comparing Gazyva to Rituxan (rituximab). Patients who received Gazyva plus chemotherapy followed by Gazyva therapy alone for 2 years had a 32% improvement in progression-free survival during the 41.1 month follow-up period, compared with the patient group who received Rituxan plus chemotherapy followed by 2 years of Rituxan therapy alone. Median progression-free survival has not been reached in either arm of the study.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

Gazyva (obinutuzumab) has been granted a Priority Review by the Food and Drug Administration for the treatment of previously untreated follicular lymphoma, according to a press release from Genentech.

FDA approval was based on results from the GALLIUM study, a phase 3 trial comparing Gazyva to Rituxan (rituximab). Patients who received Gazyva plus chemotherapy followed by Gazyva therapy alone for 2 years had a 32% improvement in progression-free survival during the 41.1 month follow-up period, compared with the patient group who received Rituxan plus chemotherapy followed by 2 years of Rituxan therapy alone. Median progression-free survival has not been reached in either arm of the study.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

Gazyva (obinutuzumab) has been granted a Priority Review by the Food and Drug Administration for the treatment of previously untreated follicular lymphoma, according to a press release from Genentech.

FDA approval was based on results from the GALLIUM study, a phase 3 trial comparing Gazyva to Rituxan (rituximab). Patients who received Gazyva plus chemotherapy followed by Gazyva therapy alone for 2 years had a 32% improvement in progression-free survival during the 41.1 month follow-up period, compared with the patient group who received Rituxan plus chemotherapy followed by 2 years of Rituxan therapy alone. Median progression-free survival has not been reached in either arm of the study.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]