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Focus on lifestyle to manage menopause symptoms after breast cancer
Lifestyle modification, rather than hormone therapy, should form the basis for managing estrogen-depletion symptoms and associated clinical problems in breast cancer survivors, according to a review of available evidence.
The review, conducted by the writing group for the Endocrine Society’s guidelines on management of menopausal symptoms, was prompted by the paucity of both randomized controlled trials in breast cancer survivors with estrogen deficiency issues and guidelines that sufficiently focus on treatment of this subgroup of women.
“A large proportion of women experience menopausal symptoms or clinical manifestations of estrogen deficiency during treatment of their breast cancer or after completion of therapy. The specific symptoms and clinical challenges differ based on menopausal status prior to initiation of cancer treatment and therapeutic agents used,” the researchers wrote in a report published in the Journal of Clinical Endocrinology & Metabolism (2017 Aug 2. doi: 10.1210/jc.2017-01138).
For instance, among premenopausal women treated with chemotherapy, ovarian insufficiency, severe menopausal symptoms, and infertility can result. Postmenopasual women treated with aromatase inhibitors may experience arthralgia, accelerated bone loss, and osteoporotic fractures, as well as severe vulvovaginal atrophy, they explained, noting that both premenopausal and postmenopausal survivors can experience moderate-to-severe vasomotor symptoms and sleep disturbance with related fatigue, depressive symptoms, and mood changes.
“Less common problems include weight gain, symptomatic osteoarthritis and intervertebral disk degeneration, degenerative skin changes, radiation and chemotherapy-related cardiovascular disease, and reduced quality of life,” the researchers wrote.
Based on a review of randomized controlled clinical trials, observational studies, evidence-based guidelines, and expert opinion from professional societies, the writing group concluded that individualized lifestyle modifications and nonpharmacologic therapies are recommended for the treatment of these symptoms.
Specifically, the writing group recommended smoking cessation, weight loss when indicated, limited alcohol intake, maintenance of adequate vitamin D and calcium levels, a healthy diet, and regular physical activity for all women with prior breast cancer.
They also recommended nonpharmacologic therapies for vasomotor symptoms, and noted that cognitive behavioral therapy, hypnosis, and acupuncture are among the approaches that may be helpful.
Vaginal lubricants and moisturizers can also be helpful for mild vulvovaginal atrophy, they wrote. For women with more severe symptoms or signs of estrogen deficiency, pharmacologic agents are available to relieve vasomotor symptoms and vulvovaginal atrophy, and to prevent and treat fractures, they wrote, adding that “therapy must be individualized based on each woman’s needs and goals for therapy.”
Among emerging approaches to treatment of symptoms are selective estrogen receptor modulators (SERMs), tissue selective estrogen complex (TSEC) therapy, estetrol, and neurokinin B inhibitors, which show promise for expanding options for symptom relief with less breast cancer risk. However, these have not yet been tested in women with prior breast cancer, the researchers noted.
Dr. Santen reported receiving research funding from Panterhei Bioscience. Other authors received research funding from Therapeutics MD and Lawley Pharmaceuticals, and honoraria from Abbott, Besins Health Care, and Pfizer.
Lifestyle modification, rather than hormone therapy, should form the basis for managing estrogen-depletion symptoms and associated clinical problems in breast cancer survivors, according to a review of available evidence.
The review, conducted by the writing group for the Endocrine Society’s guidelines on management of menopausal symptoms, was prompted by the paucity of both randomized controlled trials in breast cancer survivors with estrogen deficiency issues and guidelines that sufficiently focus on treatment of this subgroup of women.
“A large proportion of women experience menopausal symptoms or clinical manifestations of estrogen deficiency during treatment of their breast cancer or after completion of therapy. The specific symptoms and clinical challenges differ based on menopausal status prior to initiation of cancer treatment and therapeutic agents used,” the researchers wrote in a report published in the Journal of Clinical Endocrinology & Metabolism (2017 Aug 2. doi: 10.1210/jc.2017-01138).
For instance, among premenopausal women treated with chemotherapy, ovarian insufficiency, severe menopausal symptoms, and infertility can result. Postmenopasual women treated with aromatase inhibitors may experience arthralgia, accelerated bone loss, and osteoporotic fractures, as well as severe vulvovaginal atrophy, they explained, noting that both premenopausal and postmenopausal survivors can experience moderate-to-severe vasomotor symptoms and sleep disturbance with related fatigue, depressive symptoms, and mood changes.
“Less common problems include weight gain, symptomatic osteoarthritis and intervertebral disk degeneration, degenerative skin changes, radiation and chemotherapy-related cardiovascular disease, and reduced quality of life,” the researchers wrote.
Based on a review of randomized controlled clinical trials, observational studies, evidence-based guidelines, and expert opinion from professional societies, the writing group concluded that individualized lifestyle modifications and nonpharmacologic therapies are recommended for the treatment of these symptoms.
Specifically, the writing group recommended smoking cessation, weight loss when indicated, limited alcohol intake, maintenance of adequate vitamin D and calcium levels, a healthy diet, and regular physical activity for all women with prior breast cancer.
They also recommended nonpharmacologic therapies for vasomotor symptoms, and noted that cognitive behavioral therapy, hypnosis, and acupuncture are among the approaches that may be helpful.
Vaginal lubricants and moisturizers can also be helpful for mild vulvovaginal atrophy, they wrote. For women with more severe symptoms or signs of estrogen deficiency, pharmacologic agents are available to relieve vasomotor symptoms and vulvovaginal atrophy, and to prevent and treat fractures, they wrote, adding that “therapy must be individualized based on each woman’s needs and goals for therapy.”
Among emerging approaches to treatment of symptoms are selective estrogen receptor modulators (SERMs), tissue selective estrogen complex (TSEC) therapy, estetrol, and neurokinin B inhibitors, which show promise for expanding options for symptom relief with less breast cancer risk. However, these have not yet been tested in women with prior breast cancer, the researchers noted.
Dr. Santen reported receiving research funding from Panterhei Bioscience. Other authors received research funding from Therapeutics MD and Lawley Pharmaceuticals, and honoraria from Abbott, Besins Health Care, and Pfizer.
Lifestyle modification, rather than hormone therapy, should form the basis for managing estrogen-depletion symptoms and associated clinical problems in breast cancer survivors, according to a review of available evidence.
The review, conducted by the writing group for the Endocrine Society’s guidelines on management of menopausal symptoms, was prompted by the paucity of both randomized controlled trials in breast cancer survivors with estrogen deficiency issues and guidelines that sufficiently focus on treatment of this subgroup of women.
“A large proportion of women experience menopausal symptoms or clinical manifestations of estrogen deficiency during treatment of their breast cancer or after completion of therapy. The specific symptoms and clinical challenges differ based on menopausal status prior to initiation of cancer treatment and therapeutic agents used,” the researchers wrote in a report published in the Journal of Clinical Endocrinology & Metabolism (2017 Aug 2. doi: 10.1210/jc.2017-01138).
For instance, among premenopausal women treated with chemotherapy, ovarian insufficiency, severe menopausal symptoms, and infertility can result. Postmenopasual women treated with aromatase inhibitors may experience arthralgia, accelerated bone loss, and osteoporotic fractures, as well as severe vulvovaginal atrophy, they explained, noting that both premenopausal and postmenopausal survivors can experience moderate-to-severe vasomotor symptoms and sleep disturbance with related fatigue, depressive symptoms, and mood changes.
“Less common problems include weight gain, symptomatic osteoarthritis and intervertebral disk degeneration, degenerative skin changes, radiation and chemotherapy-related cardiovascular disease, and reduced quality of life,” the researchers wrote.
Based on a review of randomized controlled clinical trials, observational studies, evidence-based guidelines, and expert opinion from professional societies, the writing group concluded that individualized lifestyle modifications and nonpharmacologic therapies are recommended for the treatment of these symptoms.
Specifically, the writing group recommended smoking cessation, weight loss when indicated, limited alcohol intake, maintenance of adequate vitamin D and calcium levels, a healthy diet, and regular physical activity for all women with prior breast cancer.
They also recommended nonpharmacologic therapies for vasomotor symptoms, and noted that cognitive behavioral therapy, hypnosis, and acupuncture are among the approaches that may be helpful.
Vaginal lubricants and moisturizers can also be helpful for mild vulvovaginal atrophy, they wrote. For women with more severe symptoms or signs of estrogen deficiency, pharmacologic agents are available to relieve vasomotor symptoms and vulvovaginal atrophy, and to prevent and treat fractures, they wrote, adding that “therapy must be individualized based on each woman’s needs and goals for therapy.”
Among emerging approaches to treatment of symptoms are selective estrogen receptor modulators (SERMs), tissue selective estrogen complex (TSEC) therapy, estetrol, and neurokinin B inhibitors, which show promise for expanding options for symptom relief with less breast cancer risk. However, these have not yet been tested in women with prior breast cancer, the researchers noted.
Dr. Santen reported receiving research funding from Panterhei Bioscience. Other authors received research funding from Therapeutics MD and Lawley Pharmaceuticals, and honoraria from Abbott, Besins Health Care, and Pfizer.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
CDC: Flu vaccine recommendations broaden for pregnant women and children
, 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.
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
, 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.
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
, 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.
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
FROM MMWR
ASCO issues new guideline on stage IV NSCLC
The American Society of Clinical Oncology has updated its clinical practice guideline on systemic therapy for stage IV non–small-cell lung cancer (NSCLC), incorporating recommendations on using checkpoint inhibitors in these patients.
The guideline was published recently on the Journal of Clinical Oncology website (J Clin Oncol. 2017 Aug 14. doi: 10.1200/JCO.2017.74.6065).
Among the recommendations is that, for patients with non–squamous cell carcinoma or squamous cell carcinoma without positive markers such as epidermal growth factor receptor who have high programmed death ligand 1 (PD-L1) expression, first-line treatment should be pembrolizumab alone. For those with low PD-L1 expression, standard chemotherapy should be used.
For second-line treatment in patients who received first-line chemotherapy without prior immune checkpoint treatment, if the NSCLC tumor is positive for PD-L1 expression, single-agent nivolumab, pembrolizumab, or atezolizumab should be used.
The guideline is an update of its 2015 recommendations. An expert panel made the changes after a systematic review of randomized controlled trials from February 2014 to December 2016.
Panelists said that there’s still a lot to learn about the use of checkpoint inhibitors in these patients.
“Cancer immunotherapy allows some patients to live longer with a better quality of life than chemotherapy; however, not all patients respond to this treatment,” panelists wrote. “Many factors remain unknown in the understanding of optimal sequencing of immune checkpoint therapy and other agents previously recommended in ASCO guidelines. Contraindications to receiving immune checkpoint therapy are not yet well defined.”
Several panelists report receiving research funding and/or consulting fees from Merck, Bristol-Meyers Squibb, Peloton Therapeutics, Genentech, and other companies.
The American Society of Clinical Oncology has updated its clinical practice guideline on systemic therapy for stage IV non–small-cell lung cancer (NSCLC), incorporating recommendations on using checkpoint inhibitors in these patients.
The guideline was published recently on the Journal of Clinical Oncology website (J Clin Oncol. 2017 Aug 14. doi: 10.1200/JCO.2017.74.6065).
Among the recommendations is that, for patients with non–squamous cell carcinoma or squamous cell carcinoma without positive markers such as epidermal growth factor receptor who have high programmed death ligand 1 (PD-L1) expression, first-line treatment should be pembrolizumab alone. For those with low PD-L1 expression, standard chemotherapy should be used.
For second-line treatment in patients who received first-line chemotherapy without prior immune checkpoint treatment, if the NSCLC tumor is positive for PD-L1 expression, single-agent nivolumab, pembrolizumab, or atezolizumab should be used.
The guideline is an update of its 2015 recommendations. An expert panel made the changes after a systematic review of randomized controlled trials from February 2014 to December 2016.
Panelists said that there’s still a lot to learn about the use of checkpoint inhibitors in these patients.
“Cancer immunotherapy allows some patients to live longer with a better quality of life than chemotherapy; however, not all patients respond to this treatment,” panelists wrote. “Many factors remain unknown in the understanding of optimal sequencing of immune checkpoint therapy and other agents previously recommended in ASCO guidelines. Contraindications to receiving immune checkpoint therapy are not yet well defined.”
Several panelists report receiving research funding and/or consulting fees from Merck, Bristol-Meyers Squibb, Peloton Therapeutics, Genentech, and other companies.
The American Society of Clinical Oncology has updated its clinical practice guideline on systemic therapy for stage IV non–small-cell lung cancer (NSCLC), incorporating recommendations on using checkpoint inhibitors in these patients.
The guideline was published recently on the Journal of Clinical Oncology website (J Clin Oncol. 2017 Aug 14. doi: 10.1200/JCO.2017.74.6065).
Among the recommendations is that, for patients with non–squamous cell carcinoma or squamous cell carcinoma without positive markers such as epidermal growth factor receptor who have high programmed death ligand 1 (PD-L1) expression, first-line treatment should be pembrolizumab alone. For those with low PD-L1 expression, standard chemotherapy should be used.
For second-line treatment in patients who received first-line chemotherapy without prior immune checkpoint treatment, if the NSCLC tumor is positive for PD-L1 expression, single-agent nivolumab, pembrolizumab, or atezolizumab should be used.
The guideline is an update of its 2015 recommendations. An expert panel made the changes after a systematic review of randomized controlled trials from February 2014 to December 2016.
Panelists said that there’s still a lot to learn about the use of checkpoint inhibitors in these patients.
“Cancer immunotherapy allows some patients to live longer with a better quality of life than chemotherapy; however, not all patients respond to this treatment,” panelists wrote. “Many factors remain unknown in the understanding of optimal sequencing of immune checkpoint therapy and other agents previously recommended in ASCO guidelines. Contraindications to receiving immune checkpoint therapy are not yet well defined.”
Several panelists report receiving research funding and/or consulting fees from Merck, Bristol-Meyers Squibb, Peloton Therapeutics, Genentech, and other companies.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: The American Society of Clinical Oncology has issued its latest clinical practice guideline on the systemic treatment of non–small-cell lung cancer, an update of its 2015 guideline.
Major finding: For patients with non–squamous cell carcinoma or squamous cell carcinoma without positive markers such as epidermal growth factor receptor (EGFR), if a patient has high programmed death ligand 1 (PD-L1) expression, first-line treatment should be pembrolizumab alone. For those with low PD-L1 expression, standard chemotherapy should be used.
Data source: A systematic review of randomized controlled trials from February 2014 to December 2016.
Disclosures: Several panelists report receiving research funding and/or consulting fees from Merck, Bristol-Meyers Squibb, Peloton Therapeutics, Genentech, and other companies.
Treating women with opioid use disorders poses unique challenges
The opioid epidemic in the United States is reaching a boiling point, with President Trump calling it a “national emergency” and instructing his administration to use all appropriate authority to respond. Experts say that women are disproportionately affected and require unique treatment approaches.
The rate of prescription opioid–related overdoses increased by 471% among women in 2015, compared with an increase of 218% among men. Heroin deaths among women have risen at more than twice the rate among men, according to a report from the Office of Women’s Health (OWH), part of the U.S. Department of Health & Human Services.
The OWH report, released in July, paints a different picture of addiction for women than for men. Women are more likely to experience chronic pain and turn to prescription opioids for longer periods of time and in higher doses. But women also become dependent at smaller doses and in a shorter period of time. Add to this the fact that psychological and emotional distress are risk factors for opioid abuse among women, but not among men, according to the report.
ACOG guidance
In August, the American College of Obstetricians and Gynecologists (ACOG) updated its recommendations for treatments and best practices related to opioid use among pregnant women (Obstet Gynecol. 2017;130:e81-94).
The committee opinion, developed with the American Society of Addiction Medicine, focuses on tearing down stereotypes about women with substance use disorders that could cause patients to slip through the cracks. ACOG recommended universal screening as a part of regular obstetric care, starting with the first prenatal visit.
While screening can involve laboratory testing, the recommendations focus more on creating a comfortable environment for pregnant women to share substance use history and to have a frank conversation about what treatment options are available.
“The document highlights the use of a verbal screening tool which enables the obstetric provider to have a direct conversation with the patient about their answers,” Maria Mascola, MD, an ob.gyn. at the Marshfield (Wis.) Clinic and lead author of the ACOG committee opinion, said in an interview. “It talks about substance use and then provides an opportunity to understand what substances and how much, why these substances might be bad, why this behavior should be changed, and how obstetricians can try to help the person make those changes.”
ACOG continues to recommend medication-assisted treatment (MAT) – typically with methadone or buprenorphine – as the most effective pathway for pregnant women to deal with substance use disorders. However, in cases in which the patient does not accept treatment with an opioid agonist or the treatment is unavailable, medically supervised withdrawal can be considered. ACOG cautions that relapse rates are high (from 59% to more than 90%) and that withdrawal often involves inpatient care and intensive outpatient follow-up. But recent evidence suggests medically supervised withdrawal is not associated with fetal death or preterm delivery.
“There have been some studies looking at smaller groups that have shown pregnant women going through medically supervised withdrawals and there have been some data from those studies that indicate women may be able to successfully go through this withdrawal without harm to the baby,” Dr. Mascola said. “The information we have on medically supervised withdrawal is a small amount of data, and we definitely need more before this is a primary approach.”
Access to care
Regardless of the treatment approach, the larger issue may be accessibility of care. Just 20% of adults with an opioid use disorder get the treatment and care they need each year, according to the OWH, with access and cost cited as the primary barriers to care. This problem is likely worse in rural areas.
“Rural health care is tougher. There is less access; that is an absolute truth, and it’s a burden then for those women to travel long distances to get the care they need,” Dr. Mascola said. “I think ob.gyns. should advocate for more attention in those areas where patients are underserved.”
One potential solution is for ob.gyns. to become certified in providing buprenorphine, which would allow physicians in rural areas to dispense these approved pharmacotherapies to patients who would otherwise be unable to have the proper treatment and follow-up necessary to prevent relapse, Dr. Mascola said.
There is already some federal funding available for this approach. In 2016, the Health Resources and Services Administration awarded $94 million to health centers across the country to expand substance use services, specifically increasing screening for substance use disorders, improving access to medication-assisted treatment, and training clinicians. Similarly, the Substance Abuse and Mental Health Services Administration recently announced it will allocate an additional $485 million to states through the State Targeted Response to the Opioid Crisis Grants to fund medication-assisted treatment and other services.
Unique challenges
Treating women with opioid use disorder isn’t just about identifying the best treatment approach. Social factors appear to play a larger role among women.
“Another difference with women over men is the prevalence of sexual trauma, as well as being in unhealthy relationships where the women are more likely to be enticed into leaving treatment,” she added.
Trauma among women with substance abuse disorders is prevalent, with 55%-99% of women reporting experiencing some form of trauma, compared with 36%-51% of the general population, according to the OWH report.
Beyond exploratory research, there needs to be a major shift in the public perception of opioid substance use, which currently does not approach the disorder as a chronic disease, according to Dr. Jones.
“The treatment process cannot just involve a detoxification program and then send patients off because that will commonly just end in relapse.” Dr. Jones said. “We need to approach substance use disorders with a recovery-oriented system of care in order to create a true safety net they can rely on.”
[email protected]
On Twitter @eaztweets
The opioid epidemic in the United States is reaching a boiling point, with President Trump calling it a “national emergency” and instructing his administration to use all appropriate authority to respond. Experts say that women are disproportionately affected and require unique treatment approaches.
The rate of prescription opioid–related overdoses increased by 471% among women in 2015, compared with an increase of 218% among men. Heroin deaths among women have risen at more than twice the rate among men, according to a report from the Office of Women’s Health (OWH), part of the U.S. Department of Health & Human Services.
The OWH report, released in July, paints a different picture of addiction for women than for men. Women are more likely to experience chronic pain and turn to prescription opioids for longer periods of time and in higher doses. But women also become dependent at smaller doses and in a shorter period of time. Add to this the fact that psychological and emotional distress are risk factors for opioid abuse among women, but not among men, according to the report.
ACOG guidance
In August, the American College of Obstetricians and Gynecologists (ACOG) updated its recommendations for treatments and best practices related to opioid use among pregnant women (Obstet Gynecol. 2017;130:e81-94).
The committee opinion, developed with the American Society of Addiction Medicine, focuses on tearing down stereotypes about women with substance use disorders that could cause patients to slip through the cracks. ACOG recommended universal screening as a part of regular obstetric care, starting with the first prenatal visit.
While screening can involve laboratory testing, the recommendations focus more on creating a comfortable environment for pregnant women to share substance use history and to have a frank conversation about what treatment options are available.
“The document highlights the use of a verbal screening tool which enables the obstetric provider to have a direct conversation with the patient about their answers,” Maria Mascola, MD, an ob.gyn. at the Marshfield (Wis.) Clinic and lead author of the ACOG committee opinion, said in an interview. “It talks about substance use and then provides an opportunity to understand what substances and how much, why these substances might be bad, why this behavior should be changed, and how obstetricians can try to help the person make those changes.”
ACOG continues to recommend medication-assisted treatment (MAT) – typically with methadone or buprenorphine – as the most effective pathway for pregnant women to deal with substance use disorders. However, in cases in which the patient does not accept treatment with an opioid agonist or the treatment is unavailable, medically supervised withdrawal can be considered. ACOG cautions that relapse rates are high (from 59% to more than 90%) and that withdrawal often involves inpatient care and intensive outpatient follow-up. But recent evidence suggests medically supervised withdrawal is not associated with fetal death or preterm delivery.
“There have been some studies looking at smaller groups that have shown pregnant women going through medically supervised withdrawals and there have been some data from those studies that indicate women may be able to successfully go through this withdrawal without harm to the baby,” Dr. Mascola said. “The information we have on medically supervised withdrawal is a small amount of data, and we definitely need more before this is a primary approach.”
Access to care
Regardless of the treatment approach, the larger issue may be accessibility of care. Just 20% of adults with an opioid use disorder get the treatment and care they need each year, according to the OWH, with access and cost cited as the primary barriers to care. This problem is likely worse in rural areas.
“Rural health care is tougher. There is less access; that is an absolute truth, and it’s a burden then for those women to travel long distances to get the care they need,” Dr. Mascola said. “I think ob.gyns. should advocate for more attention in those areas where patients are underserved.”
One potential solution is for ob.gyns. to become certified in providing buprenorphine, which would allow physicians in rural areas to dispense these approved pharmacotherapies to patients who would otherwise be unable to have the proper treatment and follow-up necessary to prevent relapse, Dr. Mascola said.
There is already some federal funding available for this approach. In 2016, the Health Resources and Services Administration awarded $94 million to health centers across the country to expand substance use services, specifically increasing screening for substance use disorders, improving access to medication-assisted treatment, and training clinicians. Similarly, the Substance Abuse and Mental Health Services Administration recently announced it will allocate an additional $485 million to states through the State Targeted Response to the Opioid Crisis Grants to fund medication-assisted treatment and other services.
Unique challenges
Treating women with opioid use disorder isn’t just about identifying the best treatment approach. Social factors appear to play a larger role among women.
“Another difference with women over men is the prevalence of sexual trauma, as well as being in unhealthy relationships where the women are more likely to be enticed into leaving treatment,” she added.
Trauma among women with substance abuse disorders is prevalent, with 55%-99% of women reporting experiencing some form of trauma, compared with 36%-51% of the general population, according to the OWH report.
Beyond exploratory research, there needs to be a major shift in the public perception of opioid substance use, which currently does not approach the disorder as a chronic disease, according to Dr. Jones.
“The treatment process cannot just involve a detoxification program and then send patients off because that will commonly just end in relapse.” Dr. Jones said. “We need to approach substance use disorders with a recovery-oriented system of care in order to create a true safety net they can rely on.”
[email protected]
On Twitter @eaztweets
The opioid epidemic in the United States is reaching a boiling point, with President Trump calling it a “national emergency” and instructing his administration to use all appropriate authority to respond. Experts say that women are disproportionately affected and require unique treatment approaches.
The rate of prescription opioid–related overdoses increased by 471% among women in 2015, compared with an increase of 218% among men. Heroin deaths among women have risen at more than twice the rate among men, according to a report from the Office of Women’s Health (OWH), part of the U.S. Department of Health & Human Services.
The OWH report, released in July, paints a different picture of addiction for women than for men. Women are more likely to experience chronic pain and turn to prescription opioids for longer periods of time and in higher doses. But women also become dependent at smaller doses and in a shorter period of time. Add to this the fact that psychological and emotional distress are risk factors for opioid abuse among women, but not among men, according to the report.
ACOG guidance
In August, the American College of Obstetricians and Gynecologists (ACOG) updated its recommendations for treatments and best practices related to opioid use among pregnant women (Obstet Gynecol. 2017;130:e81-94).
The committee opinion, developed with the American Society of Addiction Medicine, focuses on tearing down stereotypes about women with substance use disorders that could cause patients to slip through the cracks. ACOG recommended universal screening as a part of regular obstetric care, starting with the first prenatal visit.
While screening can involve laboratory testing, the recommendations focus more on creating a comfortable environment for pregnant women to share substance use history and to have a frank conversation about what treatment options are available.
“The document highlights the use of a verbal screening tool which enables the obstetric provider to have a direct conversation with the patient about their answers,” Maria Mascola, MD, an ob.gyn. at the Marshfield (Wis.) Clinic and lead author of the ACOG committee opinion, said in an interview. “It talks about substance use and then provides an opportunity to understand what substances and how much, why these substances might be bad, why this behavior should be changed, and how obstetricians can try to help the person make those changes.”
ACOG continues to recommend medication-assisted treatment (MAT) – typically with methadone or buprenorphine – as the most effective pathway for pregnant women to deal with substance use disorders. However, in cases in which the patient does not accept treatment with an opioid agonist or the treatment is unavailable, medically supervised withdrawal can be considered. ACOG cautions that relapse rates are high (from 59% to more than 90%) and that withdrawal often involves inpatient care and intensive outpatient follow-up. But recent evidence suggests medically supervised withdrawal is not associated with fetal death or preterm delivery.
“There have been some studies looking at smaller groups that have shown pregnant women going through medically supervised withdrawals and there have been some data from those studies that indicate women may be able to successfully go through this withdrawal without harm to the baby,” Dr. Mascola said. “The information we have on medically supervised withdrawal is a small amount of data, and we definitely need more before this is a primary approach.”
Access to care
Regardless of the treatment approach, the larger issue may be accessibility of care. Just 20% of adults with an opioid use disorder get the treatment and care they need each year, according to the OWH, with access and cost cited as the primary barriers to care. This problem is likely worse in rural areas.
“Rural health care is tougher. There is less access; that is an absolute truth, and it’s a burden then for those women to travel long distances to get the care they need,” Dr. Mascola said. “I think ob.gyns. should advocate for more attention in those areas where patients are underserved.”
One potential solution is for ob.gyns. to become certified in providing buprenorphine, which would allow physicians in rural areas to dispense these approved pharmacotherapies to patients who would otherwise be unable to have the proper treatment and follow-up necessary to prevent relapse, Dr. Mascola said.
There is already some federal funding available for this approach. In 2016, the Health Resources and Services Administration awarded $94 million to health centers across the country to expand substance use services, specifically increasing screening for substance use disorders, improving access to medication-assisted treatment, and training clinicians. Similarly, the Substance Abuse and Mental Health Services Administration recently announced it will allocate an additional $485 million to states through the State Targeted Response to the Opioid Crisis Grants to fund medication-assisted treatment and other services.
Unique challenges
Treating women with opioid use disorder isn’t just about identifying the best treatment approach. Social factors appear to play a larger role among women.
“Another difference with women over men is the prevalence of sexual trauma, as well as being in unhealthy relationships where the women are more likely to be enticed into leaving treatment,” she added.
Trauma among women with substance abuse disorders is prevalent, with 55%-99% of women reporting experiencing some form of trauma, compared with 36%-51% of the general population, according to the OWH report.
Beyond exploratory research, there needs to be a major shift in the public perception of opioid substance use, which currently does not approach the disorder as a chronic disease, according to Dr. Jones.
“The treatment process cannot just involve a detoxification program and then send patients off because that will commonly just end in relapse.” Dr. Jones said. “We need to approach substance use disorders with a recovery-oriented system of care in order to create a true safety net they can rely on.”
[email protected]
On Twitter @eaztweets
AGA Guideline: Therapeutic drug monitoring in IBD
Physicians should perform reactive therapeutic drug monitoring to guide changes in anti–tumor necrosis factor (TNF) therapy in patients with active inflammatory bowel disease and should consider target trough concentrations of at least 5 mcg/mL for infliximab, at least 7.5 mcg/mL for adalimumab, and at least 20 mcg/mL for certolizumab pegol, according to a guideline from the AGA Institute, published in the September 2017 issue of Gastroenterology (Gastroenterology. doi: 10.1053/j.gastro.2017.07.032).
Therapeutic drug monitoring can help guide whether to ramp up a dose (if the trough level is below the threshold) or switch therapy (if the trough level is above the threshold) when patients are not responding adequately to maintenance treatment. A nonresponder with optimal trough concentrations might need to switch drug classes, the guideline noted. A patient with low trough levels and no antidrug antibodies is probably experiencing rapid drug clearance in the setting of high inflammation. A patient with low or undetectable trough levels and high antidrug antibody titers has developed neutralizing antidrug antibodies. However, trough concentrations can vary for many other reasons, ranging from disease severity and inflammation to body mass index and sex. Therefore, target levels also vary and can be challenging to set.
The AGA makes no recommendation about routine, proactive TDM in patients with quiescent IBD who are on anti-TNF agents. While proactive TDM can shed light on endoscopic response and drug clearance, it might also trigger a premature switch of therapies; this is particularly likely because physicians have sparse data on either target trough levels for asymptomatic patients or the clinical significance of “low-titer” antidrug antibodies. The optimal frequency of proactive TDM also remains unclear.
Pending better data, the AGA recommended checking infliximab or adalimumab trough levels as close to the next dose as possible – that is, within 24 hours. Drug trough levels are consistent across commercial assays, but antidrug antibody titers are not, and there are no uniform thresholds for clinically relevant antidrug antibody titers. “Therefore, it may be beneficial to utilize the same assay when checking for trough concentration and antidrug antibodies,” the guideline stated.
For patients on a thiopurine, routine testing of thiopurine methyltransferase (TPMT) enzyme or genotype is recommended to guide dosing. In three pooled studies comprising 1,145 patients, only two patients were homozygous; further, rates of hematologic adverse events, clinical remission, and treatment discontinuation did not differ based on TPMT testing itself. However, using TPMT testing to guide dosing was associated with an 89% decrease in the risk of hematologic adverse events among patients who had a homozygous genotype or had low or absent TPMT enzymatic activity. “While this risk may be mitigated by routine laboratory CBC checking, adherence to regular monitoring in clinical practice is suboptimal,” the guideline stated. “It is important to continue to perform routine lab monitoring [of] CBC and liver enzymes after starting a thiopurine, regardless of the TPMT testing results.”
The AGA also conditionally supported reactive monitoring of thiopurine metabolites to guide treatment changes if patients develop breakthrough symptoms or treatment-related adverse effects. For active IBD symptoms in spite of thiopurine monotherapy, a target 6-thioguanine (6-TGN) cutoff between 230 and 450 pmol per 8 x 108 RBC is recommended. Again, supporting evidence is of “very low quality” – in a retrospective, observational study, patients who received treatment according to a TDM algorithm were five times more likely to respond to a change in therapy (relative risk, 5.2). The guideline recommended against monitoring thiopurine metabolites in quiescent IBD. Studies did not support this practice, compared with standard dosing, although no study of thiopurine metabolites included patients on thiopurine/anti-TNF combination therapy, the guideline’s authors noted.
The guideline includes clinical-decision support tools on when to perform TDM and how to interpret results when patients are taking an anti-TNF agent or a thiopurine. The guideline does not cover vedolizumab or ustekinumab because data are sparse. Other knowledge gaps include when best to measure trough concentrations; whether empiric dose escalation or TDM is preferred if response to induction is suboptimal; how target trough concentrations vary based on disease phenotype, disease state, or treatment goals; which levels and durations of antidrug antibody titers are clinically significant; and whether to suppress antidrug antibodies before changing therapy. Future studies should compare routine proactive and reactive TDM, investigate how often to perform proactive TDM, and characterize TDM of newly approved biologic agents, the guideline concluded.
The authors of the guideline document disclosed no conflicts related to the guideline topic.
Physicians should perform reactive therapeutic drug monitoring to guide changes in anti–tumor necrosis factor (TNF) therapy in patients with active inflammatory bowel disease and should consider target trough concentrations of at least 5 mcg/mL for infliximab, at least 7.5 mcg/mL for adalimumab, and at least 20 mcg/mL for certolizumab pegol, according to a guideline from the AGA Institute, published in the September 2017 issue of Gastroenterology (Gastroenterology. doi: 10.1053/j.gastro.2017.07.032).
Therapeutic drug monitoring can help guide whether to ramp up a dose (if the trough level is below the threshold) or switch therapy (if the trough level is above the threshold) when patients are not responding adequately to maintenance treatment. A nonresponder with optimal trough concentrations might need to switch drug classes, the guideline noted. A patient with low trough levels and no antidrug antibodies is probably experiencing rapid drug clearance in the setting of high inflammation. A patient with low or undetectable trough levels and high antidrug antibody titers has developed neutralizing antidrug antibodies. However, trough concentrations can vary for many other reasons, ranging from disease severity and inflammation to body mass index and sex. Therefore, target levels also vary and can be challenging to set.
The AGA makes no recommendation about routine, proactive TDM in patients with quiescent IBD who are on anti-TNF agents. While proactive TDM can shed light on endoscopic response and drug clearance, it might also trigger a premature switch of therapies; this is particularly likely because physicians have sparse data on either target trough levels for asymptomatic patients or the clinical significance of “low-titer” antidrug antibodies. The optimal frequency of proactive TDM also remains unclear.
Pending better data, the AGA recommended checking infliximab or adalimumab trough levels as close to the next dose as possible – that is, within 24 hours. Drug trough levels are consistent across commercial assays, but antidrug antibody titers are not, and there are no uniform thresholds for clinically relevant antidrug antibody titers. “Therefore, it may be beneficial to utilize the same assay when checking for trough concentration and antidrug antibodies,” the guideline stated.
For patients on a thiopurine, routine testing of thiopurine methyltransferase (TPMT) enzyme or genotype is recommended to guide dosing. In three pooled studies comprising 1,145 patients, only two patients were homozygous; further, rates of hematologic adverse events, clinical remission, and treatment discontinuation did not differ based on TPMT testing itself. However, using TPMT testing to guide dosing was associated with an 89% decrease in the risk of hematologic adverse events among patients who had a homozygous genotype or had low or absent TPMT enzymatic activity. “While this risk may be mitigated by routine laboratory CBC checking, adherence to regular monitoring in clinical practice is suboptimal,” the guideline stated. “It is important to continue to perform routine lab monitoring [of] CBC and liver enzymes after starting a thiopurine, regardless of the TPMT testing results.”
The AGA also conditionally supported reactive monitoring of thiopurine metabolites to guide treatment changes if patients develop breakthrough symptoms or treatment-related adverse effects. For active IBD symptoms in spite of thiopurine monotherapy, a target 6-thioguanine (6-TGN) cutoff between 230 and 450 pmol per 8 x 108 RBC is recommended. Again, supporting evidence is of “very low quality” – in a retrospective, observational study, patients who received treatment according to a TDM algorithm were five times more likely to respond to a change in therapy (relative risk, 5.2). The guideline recommended against monitoring thiopurine metabolites in quiescent IBD. Studies did not support this practice, compared with standard dosing, although no study of thiopurine metabolites included patients on thiopurine/anti-TNF combination therapy, the guideline’s authors noted.
The guideline includes clinical-decision support tools on when to perform TDM and how to interpret results when patients are taking an anti-TNF agent or a thiopurine. The guideline does not cover vedolizumab or ustekinumab because data are sparse. Other knowledge gaps include when best to measure trough concentrations; whether empiric dose escalation or TDM is preferred if response to induction is suboptimal; how target trough concentrations vary based on disease phenotype, disease state, or treatment goals; which levels and durations of antidrug antibody titers are clinically significant; and whether to suppress antidrug antibodies before changing therapy. Future studies should compare routine proactive and reactive TDM, investigate how often to perform proactive TDM, and characterize TDM of newly approved biologic agents, the guideline concluded.
The authors of the guideline document disclosed no conflicts related to the guideline topic.
Physicians should perform reactive therapeutic drug monitoring to guide changes in anti–tumor necrosis factor (TNF) therapy in patients with active inflammatory bowel disease and should consider target trough concentrations of at least 5 mcg/mL for infliximab, at least 7.5 mcg/mL for adalimumab, and at least 20 mcg/mL for certolizumab pegol, according to a guideline from the AGA Institute, published in the September 2017 issue of Gastroenterology (Gastroenterology. doi: 10.1053/j.gastro.2017.07.032).
Therapeutic drug monitoring can help guide whether to ramp up a dose (if the trough level is below the threshold) or switch therapy (if the trough level is above the threshold) when patients are not responding adequately to maintenance treatment. A nonresponder with optimal trough concentrations might need to switch drug classes, the guideline noted. A patient with low trough levels and no antidrug antibodies is probably experiencing rapid drug clearance in the setting of high inflammation. A patient with low or undetectable trough levels and high antidrug antibody titers has developed neutralizing antidrug antibodies. However, trough concentrations can vary for many other reasons, ranging from disease severity and inflammation to body mass index and sex. Therefore, target levels also vary and can be challenging to set.
The AGA makes no recommendation about routine, proactive TDM in patients with quiescent IBD who are on anti-TNF agents. While proactive TDM can shed light on endoscopic response and drug clearance, it might also trigger a premature switch of therapies; this is particularly likely because physicians have sparse data on either target trough levels for asymptomatic patients or the clinical significance of “low-titer” antidrug antibodies. The optimal frequency of proactive TDM also remains unclear.
Pending better data, the AGA recommended checking infliximab or adalimumab trough levels as close to the next dose as possible – that is, within 24 hours. Drug trough levels are consistent across commercial assays, but antidrug antibody titers are not, and there are no uniform thresholds for clinically relevant antidrug antibody titers. “Therefore, it may be beneficial to utilize the same assay when checking for trough concentration and antidrug antibodies,” the guideline stated.
For patients on a thiopurine, routine testing of thiopurine methyltransferase (TPMT) enzyme or genotype is recommended to guide dosing. In three pooled studies comprising 1,145 patients, only two patients were homozygous; further, rates of hematologic adverse events, clinical remission, and treatment discontinuation did not differ based on TPMT testing itself. However, using TPMT testing to guide dosing was associated with an 89% decrease in the risk of hematologic adverse events among patients who had a homozygous genotype or had low or absent TPMT enzymatic activity. “While this risk may be mitigated by routine laboratory CBC checking, adherence to regular monitoring in clinical practice is suboptimal,” the guideline stated. “It is important to continue to perform routine lab monitoring [of] CBC and liver enzymes after starting a thiopurine, regardless of the TPMT testing results.”
The AGA also conditionally supported reactive monitoring of thiopurine metabolites to guide treatment changes if patients develop breakthrough symptoms or treatment-related adverse effects. For active IBD symptoms in spite of thiopurine monotherapy, a target 6-thioguanine (6-TGN) cutoff between 230 and 450 pmol per 8 x 108 RBC is recommended. Again, supporting evidence is of “very low quality” – in a retrospective, observational study, patients who received treatment according to a TDM algorithm were five times more likely to respond to a change in therapy (relative risk, 5.2). The guideline recommended against monitoring thiopurine metabolites in quiescent IBD. Studies did not support this practice, compared with standard dosing, although no study of thiopurine metabolites included patients on thiopurine/anti-TNF combination therapy, the guideline’s authors noted.
The guideline includes clinical-decision support tools on when to perform TDM and how to interpret results when patients are taking an anti-TNF agent or a thiopurine. The guideline does not cover vedolizumab or ustekinumab because data are sparse. Other knowledge gaps include when best to measure trough concentrations; whether empiric dose escalation or TDM is preferred if response to induction is suboptimal; how target trough concentrations vary based on disease phenotype, disease state, or treatment goals; which levels and durations of antidrug antibody titers are clinically significant; and whether to suppress antidrug antibodies before changing therapy. Future studies should compare routine proactive and reactive TDM, investigate how often to perform proactive TDM, and characterize TDM of newly approved biologic agents, the guideline concluded.
The authors of the guideline document disclosed no conflicts related to the guideline topic.
FROM GASTROENTEROLOGY
AGA Clinical Practice Update: Opioids in gastroenterology
Physicians should consistently rule out opioid therapy as the cause of gastrointestinal symptoms, states a new clinical practice update published in the September 2017 issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2017.05.014).
About 4% of Americans receive long-term opioid therapy, primarily for musculoskeletal, postsurgical, or vascular pain, as well as nonsurgical abdominal pain, writes Michael Camilleri, MD, AGAF, of Mayo Clinic in Rochester, Minn., and his associates. Because opioid receptors thickly populate the gastrointestinal tract, exogenous opioids can trigger a variety of gastrointestinal symptoms. Examples include achalasia, gastroparesis, nausea, postsurgical ileus, constipation, and narcotic bowel syndrome.
In the stomach, opioid use can cause gastroparesis, early satiety, and postprandial nausea and emesis, especially in the postoperative setting. Even novel opioid agents that are less likely to cause constipation can retard gastric emptying. For example, tapentadol, a mu-opioid agonist and norepinephrine reuptake inhibitor, delays emptying to the same extent as oxycodone. Tramadol also appears to slow overall orocecal transit. Although gastroparesis itself can cause nausea and emesis, opioids also directly stimulate the chemoreceptor trigger zone in the area postrema in the floor of the fourth ventricle. Options for preventive therapy include using a prokinetic, such as metoclopramide, prochlorperazine, or a 5-hydroxytryptamine3 antagonist, especially if patients are receiving opioids for postoperative pain control.
Exogenous opioids also can cause ileus, especially after abdominal surgery. These patients are already at risk of ileus because of surgical stress from bowel handling, secretion of inflammatory mediators and endogenous opioids, and fluctuating hormone and electrolyte levels. Postoperative analgesia with mu-opioids adds to the risk of ileus by increasing fluid absorption and inhibiting colonic motility.
Both postsurgical and nonsurgical opioid use also can trigger opioid-induced constipation (OIC), in which patients have less than three spontaneous bowel movements a week, harder stools, increased straining, and a feeling of incomplete evacuation. Patients may also report nausea, emesis, and gastroesophageal reflux. Even low-dose and short-term opioid therapy can lead to OIC. Symptoms and treatment response can be assessed with the bowel function index, in which patients rate ease of defecation, completeness of bowel evacuation, and severity of constipation over the past week on a scale of 0-100. Scores of 0-29 suggest no OIC. Patients who score above 30 despite over-the-counter laxatives are candidates for stepped-up treatments, including prolonged-release naloxone and oxycodone, the intestinal secretagogue lubiprostone, or peripherally acting mu-opioid receptor antagonists (PAMORAs), such as methylnaltrexone (12 mg subcutaneously) and naloxegol (12.5 mg or 25 mg per day orally). Additionally, tapentadol controls pain at lower doses than oxycodone and is less likely to cause constipation.
Narcotic bowel syndrome typically presents as moderate to severe daily abdominal pain lasting more than 3 months in patients on long-term opioids equating to a dosage of more than 100 mg morphine daily. Typically, patients report generalized, persistent, colicky abdominal pain that does not respond to dose escalation and worsens with dose tapering. Work-up is negative for differentials such as kidney stones or bowel obstruction. One epidemiological study estimated that 4% of patients on long-term opiates develop narcotic bowel syndrome, but the true prevalence may be higher according to the experts who authored this update. Mechanisms remain unclear but may include neuroplastic changes that favor the facilitation of pain signals rather than their inhibition, inflammation of spinal glial cells through activation of toll-like receptors, abnormal function of the N-methyl-D aspartate receptor at the level of the spinal cord, and central nociceptive abnormalities related to certain psychological traits or a history of trauma.
Treating narcotic bowel syndrome requires detoxification with appropriate nonopioid therapies for pain, anxiety, and withdrawal symptoms, including the use of clonidine. “This is best handled through specialists or centers with expertise in opiate dependence,” the experts stated. Patients who are able to stay off narcotics report improvements in pain, but the recidivism rate is about 50%.
The practice update also covers opioid therapy for gastrointestinal disorders. The PAMORA alvimopan shortens time to first postoperative stool without counteracting opioid analgesia during recovery. Alvimopan also has been found to hasten recovery of gastrointestinal function in patients with postoperative ileus after bowel resection. There is no evidence for using mu-opioid agonists for pain associated with irritable bowel syndrome (IBS), but the synthetic peripheral mu-opioid receptor agonist loperamide can improve stool consistency and urgency. A typical dose is 2 mg after each loose bowel movement or 2-4 mg before eating in cases of postprandial diarrhea. The mixed mu- and kappa-opioid receptor agonist and delta-opioid receptor antagonist eluxadoline also can potentially improve stool consistency and urgency, global IBS symptoms, IBS symptom severity score, and quality of life. However, the FDA warns against using eluxadoline in patients who do not have a gallbladder because of the risk of severe outcomes – including death – related to sphincter of Oddi spasm and pancreatitis. Eluxadoline has been linked to at least two such fatalities in cholecystectomized patients. In each case, symptoms began after a single dose.
Dr. Camilleri is funded by the National Institutes of Health. He disclosed ties to AstraZeneca and Shionogi. The two coauthors disclosed ties to Forest Research Labs, Ironwood Pharmaceuticals, Prometheus, and Salix.
Physicians should consistently rule out opioid therapy as the cause of gastrointestinal symptoms, states a new clinical practice update published in the September 2017 issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2017.05.014).
About 4% of Americans receive long-term opioid therapy, primarily for musculoskeletal, postsurgical, or vascular pain, as well as nonsurgical abdominal pain, writes Michael Camilleri, MD, AGAF, of Mayo Clinic in Rochester, Minn., and his associates. Because opioid receptors thickly populate the gastrointestinal tract, exogenous opioids can trigger a variety of gastrointestinal symptoms. Examples include achalasia, gastroparesis, nausea, postsurgical ileus, constipation, and narcotic bowel syndrome.
In the stomach, opioid use can cause gastroparesis, early satiety, and postprandial nausea and emesis, especially in the postoperative setting. Even novel opioid agents that are less likely to cause constipation can retard gastric emptying. For example, tapentadol, a mu-opioid agonist and norepinephrine reuptake inhibitor, delays emptying to the same extent as oxycodone. Tramadol also appears to slow overall orocecal transit. Although gastroparesis itself can cause nausea and emesis, opioids also directly stimulate the chemoreceptor trigger zone in the area postrema in the floor of the fourth ventricle. Options for preventive therapy include using a prokinetic, such as metoclopramide, prochlorperazine, or a 5-hydroxytryptamine3 antagonist, especially if patients are receiving opioids for postoperative pain control.
Exogenous opioids also can cause ileus, especially after abdominal surgery. These patients are already at risk of ileus because of surgical stress from bowel handling, secretion of inflammatory mediators and endogenous opioids, and fluctuating hormone and electrolyte levels. Postoperative analgesia with mu-opioids adds to the risk of ileus by increasing fluid absorption and inhibiting colonic motility.
Both postsurgical and nonsurgical opioid use also can trigger opioid-induced constipation (OIC), in which patients have less than three spontaneous bowel movements a week, harder stools, increased straining, and a feeling of incomplete evacuation. Patients may also report nausea, emesis, and gastroesophageal reflux. Even low-dose and short-term opioid therapy can lead to OIC. Symptoms and treatment response can be assessed with the bowel function index, in which patients rate ease of defecation, completeness of bowel evacuation, and severity of constipation over the past week on a scale of 0-100. Scores of 0-29 suggest no OIC. Patients who score above 30 despite over-the-counter laxatives are candidates for stepped-up treatments, including prolonged-release naloxone and oxycodone, the intestinal secretagogue lubiprostone, or peripherally acting mu-opioid receptor antagonists (PAMORAs), such as methylnaltrexone (12 mg subcutaneously) and naloxegol (12.5 mg or 25 mg per day orally). Additionally, tapentadol controls pain at lower doses than oxycodone and is less likely to cause constipation.
Narcotic bowel syndrome typically presents as moderate to severe daily abdominal pain lasting more than 3 months in patients on long-term opioids equating to a dosage of more than 100 mg morphine daily. Typically, patients report generalized, persistent, colicky abdominal pain that does not respond to dose escalation and worsens with dose tapering. Work-up is negative for differentials such as kidney stones or bowel obstruction. One epidemiological study estimated that 4% of patients on long-term opiates develop narcotic bowel syndrome, but the true prevalence may be higher according to the experts who authored this update. Mechanisms remain unclear but may include neuroplastic changes that favor the facilitation of pain signals rather than their inhibition, inflammation of spinal glial cells through activation of toll-like receptors, abnormal function of the N-methyl-D aspartate receptor at the level of the spinal cord, and central nociceptive abnormalities related to certain psychological traits or a history of trauma.
Treating narcotic bowel syndrome requires detoxification with appropriate nonopioid therapies for pain, anxiety, and withdrawal symptoms, including the use of clonidine. “This is best handled through specialists or centers with expertise in opiate dependence,” the experts stated. Patients who are able to stay off narcotics report improvements in pain, but the recidivism rate is about 50%.
The practice update also covers opioid therapy for gastrointestinal disorders. The PAMORA alvimopan shortens time to first postoperative stool without counteracting opioid analgesia during recovery. Alvimopan also has been found to hasten recovery of gastrointestinal function in patients with postoperative ileus after bowel resection. There is no evidence for using mu-opioid agonists for pain associated with irritable bowel syndrome (IBS), but the synthetic peripheral mu-opioid receptor agonist loperamide can improve stool consistency and urgency. A typical dose is 2 mg after each loose bowel movement or 2-4 mg before eating in cases of postprandial diarrhea. The mixed mu- and kappa-opioid receptor agonist and delta-opioid receptor antagonist eluxadoline also can potentially improve stool consistency and urgency, global IBS symptoms, IBS symptom severity score, and quality of life. However, the FDA warns against using eluxadoline in patients who do not have a gallbladder because of the risk of severe outcomes – including death – related to sphincter of Oddi spasm and pancreatitis. Eluxadoline has been linked to at least two such fatalities in cholecystectomized patients. In each case, symptoms began after a single dose.
Dr. Camilleri is funded by the National Institutes of Health. He disclosed ties to AstraZeneca and Shionogi. The two coauthors disclosed ties to Forest Research Labs, Ironwood Pharmaceuticals, Prometheus, and Salix.
Physicians should consistently rule out opioid therapy as the cause of gastrointestinal symptoms, states a new clinical practice update published in the September 2017 issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2017.05.014).
About 4% of Americans receive long-term opioid therapy, primarily for musculoskeletal, postsurgical, or vascular pain, as well as nonsurgical abdominal pain, writes Michael Camilleri, MD, AGAF, of Mayo Clinic in Rochester, Minn., and his associates. Because opioid receptors thickly populate the gastrointestinal tract, exogenous opioids can trigger a variety of gastrointestinal symptoms. Examples include achalasia, gastroparesis, nausea, postsurgical ileus, constipation, and narcotic bowel syndrome.
In the stomach, opioid use can cause gastroparesis, early satiety, and postprandial nausea and emesis, especially in the postoperative setting. Even novel opioid agents that are less likely to cause constipation can retard gastric emptying. For example, tapentadol, a mu-opioid agonist and norepinephrine reuptake inhibitor, delays emptying to the same extent as oxycodone. Tramadol also appears to slow overall orocecal transit. Although gastroparesis itself can cause nausea and emesis, opioids also directly stimulate the chemoreceptor trigger zone in the area postrema in the floor of the fourth ventricle. Options for preventive therapy include using a prokinetic, such as metoclopramide, prochlorperazine, or a 5-hydroxytryptamine3 antagonist, especially if patients are receiving opioids for postoperative pain control.
Exogenous opioids also can cause ileus, especially after abdominal surgery. These patients are already at risk of ileus because of surgical stress from bowel handling, secretion of inflammatory mediators and endogenous opioids, and fluctuating hormone and electrolyte levels. Postoperative analgesia with mu-opioids adds to the risk of ileus by increasing fluid absorption and inhibiting colonic motility.
Both postsurgical and nonsurgical opioid use also can trigger opioid-induced constipation (OIC), in which patients have less than three spontaneous bowel movements a week, harder stools, increased straining, and a feeling of incomplete evacuation. Patients may also report nausea, emesis, and gastroesophageal reflux. Even low-dose and short-term opioid therapy can lead to OIC. Symptoms and treatment response can be assessed with the bowel function index, in which patients rate ease of defecation, completeness of bowel evacuation, and severity of constipation over the past week on a scale of 0-100. Scores of 0-29 suggest no OIC. Patients who score above 30 despite over-the-counter laxatives are candidates for stepped-up treatments, including prolonged-release naloxone and oxycodone, the intestinal secretagogue lubiprostone, or peripherally acting mu-opioid receptor antagonists (PAMORAs), such as methylnaltrexone (12 mg subcutaneously) and naloxegol (12.5 mg or 25 mg per day orally). Additionally, tapentadol controls pain at lower doses than oxycodone and is less likely to cause constipation.
Narcotic bowel syndrome typically presents as moderate to severe daily abdominal pain lasting more than 3 months in patients on long-term opioids equating to a dosage of more than 100 mg morphine daily. Typically, patients report generalized, persistent, colicky abdominal pain that does not respond to dose escalation and worsens with dose tapering. Work-up is negative for differentials such as kidney stones or bowel obstruction. One epidemiological study estimated that 4% of patients on long-term opiates develop narcotic bowel syndrome, but the true prevalence may be higher according to the experts who authored this update. Mechanisms remain unclear but may include neuroplastic changes that favor the facilitation of pain signals rather than their inhibition, inflammation of spinal glial cells through activation of toll-like receptors, abnormal function of the N-methyl-D aspartate receptor at the level of the spinal cord, and central nociceptive abnormalities related to certain psychological traits or a history of trauma.
Treating narcotic bowel syndrome requires detoxification with appropriate nonopioid therapies for pain, anxiety, and withdrawal symptoms, including the use of clonidine. “This is best handled through specialists or centers with expertise in opiate dependence,” the experts stated. Patients who are able to stay off narcotics report improvements in pain, but the recidivism rate is about 50%.
The practice update also covers opioid therapy for gastrointestinal disorders. The PAMORA alvimopan shortens time to first postoperative stool without counteracting opioid analgesia during recovery. Alvimopan also has been found to hasten recovery of gastrointestinal function in patients with postoperative ileus after bowel resection. There is no evidence for using mu-opioid agonists for pain associated with irritable bowel syndrome (IBS), but the synthetic peripheral mu-opioid receptor agonist loperamide can improve stool consistency and urgency. A typical dose is 2 mg after each loose bowel movement or 2-4 mg before eating in cases of postprandial diarrhea. The mixed mu- and kappa-opioid receptor agonist and delta-opioid receptor antagonist eluxadoline also can potentially improve stool consistency and urgency, global IBS symptoms, IBS symptom severity score, and quality of life. However, the FDA warns against using eluxadoline in patients who do not have a gallbladder because of the risk of severe outcomes – including death – related to sphincter of Oddi spasm and pancreatitis. Eluxadoline has been linked to at least two such fatalities in cholecystectomized patients. In each case, symptoms began after a single dose.
Dr. Camilleri is funded by the National Institutes of Health. He disclosed ties to AstraZeneca and Shionogi. The two coauthors disclosed ties to Forest Research Labs, Ironwood Pharmaceuticals, Prometheus, and Salix.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
AADE: New standards for diabetes self-management programs
New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).
The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.
The standards focus on a sort of nuts-and-bolts approach and may be directed toward health care providers who operate in areas with relatively few resources to turn to for help. “It seems it’s answering what to do if you don’t have backup and support, and perhaps that is what it’s for, but the standards should be good in any setting, whether totally integrated or separate. I do think in the future they need to address that large group of people in an integrated setting, and also talk about people with behavioral health expertise. Both are very important,” said Dr. Hellman.
One recommendation he praised in particular was the call for oversight from a quality coordinator. The document calls for the quality coordinator to ensure that the standards are properly implemented, including evidence-based practice, service design, evaluation, and quality improvement. That’s a key consideration because many patients may have disabilities that interfere with comprehension, such as hearing loss or cognitive dysfunction. Such impediments may prevent patients from learning key skills, such as properly checking blood glucose. “That can have a profound effect on diabetes control,” said Dr. Hellman.
He pointed out that quality control can play a wider role in medicine. “Checking your own work isn’t something people always like to do, but it’s really essential. If you think you’re giving high quality care, why don’t you just check your work to see that it’s getting the results that you thought it would?” said Dr. Hellman.
The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.
From AADE: 10 standards
Diabetes self-management education and support service providers should:
• Adopt a mission statement and goals.
• Adopt ongoing input from stakeholders and experts to improve quality and participation.
• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.
• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.
• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).
• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.
• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.
• Provide options and resources for ongoing support that participants can choose.
• Monitor participants’ progress toward self-management goals and other outcomes.
• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.
New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).
The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.
The standards focus on a sort of nuts-and-bolts approach and may be directed toward health care providers who operate in areas with relatively few resources to turn to for help. “It seems it’s answering what to do if you don’t have backup and support, and perhaps that is what it’s for, but the standards should be good in any setting, whether totally integrated or separate. I do think in the future they need to address that large group of people in an integrated setting, and also talk about people with behavioral health expertise. Both are very important,” said Dr. Hellman.
One recommendation he praised in particular was the call for oversight from a quality coordinator. The document calls for the quality coordinator to ensure that the standards are properly implemented, including evidence-based practice, service design, evaluation, and quality improvement. That’s a key consideration because many patients may have disabilities that interfere with comprehension, such as hearing loss or cognitive dysfunction. Such impediments may prevent patients from learning key skills, such as properly checking blood glucose. “That can have a profound effect on diabetes control,” said Dr. Hellman.
He pointed out that quality control can play a wider role in medicine. “Checking your own work isn’t something people always like to do, but it’s really essential. If you think you’re giving high quality care, why don’t you just check your work to see that it’s getting the results that you thought it would?” said Dr. Hellman.
The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.
From AADE: 10 standards
Diabetes self-management education and support service providers should:
• Adopt a mission statement and goals.
• Adopt ongoing input from stakeholders and experts to improve quality and participation.
• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.
• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.
• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).
• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.
• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.
• Provide options and resources for ongoing support that participants can choose.
• Monitor participants’ progress toward self-management goals and other outcomes.
• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.
New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).
The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.
The standards focus on a sort of nuts-and-bolts approach and may be directed toward health care providers who operate in areas with relatively few resources to turn to for help. “It seems it’s answering what to do if you don’t have backup and support, and perhaps that is what it’s for, but the standards should be good in any setting, whether totally integrated or separate. I do think in the future they need to address that large group of people in an integrated setting, and also talk about people with behavioral health expertise. Both are very important,” said Dr. Hellman.
One recommendation he praised in particular was the call for oversight from a quality coordinator. The document calls for the quality coordinator to ensure that the standards are properly implemented, including evidence-based practice, service design, evaluation, and quality improvement. That’s a key consideration because many patients may have disabilities that interfere with comprehension, such as hearing loss or cognitive dysfunction. Such impediments may prevent patients from learning key skills, such as properly checking blood glucose. “That can have a profound effect on diabetes control,” said Dr. Hellman.
He pointed out that quality control can play a wider role in medicine. “Checking your own work isn’t something people always like to do, but it’s really essential. If you think you’re giving high quality care, why don’t you just check your work to see that it’s getting the results that you thought it would?” said Dr. Hellman.
The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.
From AADE: 10 standards
Diabetes self-management education and support service providers should:
• Adopt a mission statement and goals.
• Adopt ongoing input from stakeholders and experts to improve quality and participation.
• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.
• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.
• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).
• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.
• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.
• Provide options and resources for ongoing support that participants can choose.
• Monitor participants’ progress toward self-management goals and other outcomes.
• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.
FROM DIABETES CARE
New guidelines highlight rapid, interdisciplinary treatment of PANS/PANDAS
Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.
Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.
Clinical management of PANS/PANDAS includes psychoeducational, psychotherapeutic, behavioral, family- and school-based, and pharmacologic interventions, Dr. Thienemann and her associates wrote. Starting CBT (exposure-response prevention) has the best chance of halting OCD behaviors. Acutely ill children might not be ready for CBT, but parents still can learn to “hold the line” to avoid accommodating and worsening irrational fears.
Options for psychoactive medications include benzodiazepines for anxiety; aripiprazole, risperidone, olanzapine, haloperidol, or quetiapine for psychosis; and SSRIs, such as fluoxetine, sertraline, and fluvoxamine for depression and OCD. Severe depression merits both psychotherapy and an SSRI. Antipsychotics are not indicated for OCD unless children are incapacitated and only if their QTc interval does not exceed 450 milliseconds. Because PANS/PANDAS patients can react severely to psychotropics, clinicians should “start low” at about a quarter of a typical dose and “go slow,” gradually titrating up.
It’s best to rule out other medical disorders first when patients refuse or restrict food or fluids. Next, clinicians should assess medical stability and support nutrition and hydration while treating underlying brain inflammation. “Feeding tubes may be necessary, at least during the acute phases of the illness,” the authors wrote. Chronic symptoms can warrant treatments for eating disorders.
Bouts of aggression or irritability are classic and can be especially challenging for families. Parents can refocus the child with toys or by dancing, singing, or acting silly but should also make a safety plan, such as calling 911, if aggressive behaviors are endangering the patient or family members. Pharmacologic options for aggression include diphenhydramine, benzodiazepines, and antipsychotics.
For tics, options include comprehensive behavioral intervention for tics, habit reversal training, and cautiously monitored pharmacotherapy with alpha-2 adrenergic agonists, clonidine, guanfacine, or short-course antipsychotics. Symptoms of attention-deficit/hyperactivity disorder merit classroom accommodations; methylphenidate compounds can be added if needed. For children with sleep disturbances, the best strategy is to focus on sleep hygiene before considering low-dose diphenhydramine, melatonin, cyproheptadine, clonidine, trazodone, or zolpidem. Pain, however, needs early treatment to stop it from becoming refractory. Pain and stiffness after awakening can signal arthritis, enthesitis, or inflammatory back pain and warrant physical therapy and evaluation by a pediatric rheumatologist or pain specialist.
Part II of the guidelines covers immunomodulators. As in other severe brain disorders, early treatment improves outcomes and helps prevent relapses, wrote Jennifer Frankovich, MD, also of Stanford University, and her associates. Clinicians should start second-line therapies if first-line treatment fails. Acute impairment can remit with NSAIDs or a short course of oral corticosteroids, but chronic symptoms often need more aggressive and prolonged immunotherapy. Children with moderate to severe impairment should receive intravenous immunoglobulins, and those with severe, chronic impairment may need bursts of high-dose corticosteroids or longer-term corticosteroids with taper. Patients with extreme or life-threatening impairment should receive first-line therapeutic plasma exchange alone or with intravenous immunoglobulins, high-dose intravenous corticosteroids, and rituximab.
Part III of the guidelines covers infections. Most cases involve group A streptococci (GAS), but other culprits include Mycoplasma pneumoniae and viruses, such as influenza, wrote Michael S. Cooperstock, MD, MPH, of the University of Missouri-Columbia and his associates. They recommend antistreptococcal treatment for “essentially all” newly diagnosed cases. They also suggest secondary antistreptococcal prophylaxis for severe neuropsychiatric symptoms or intermittent exacerbations associated with GAS. “For all other [cases], vigilance for GAS infection in both the patient and close contacts is recommended,” they wrote. “Since any intercurrent infection may induce a symptom flare, close observation with appropriate therapy for any treatable intercurrent infection is warranted.” They also recommend standard childhood immunizations and monitoring vitamin D levels.
The National Institutes of Health supported the research summarized in the guidelines. Dr. Thienemann disclosed grants from Auspex, Shire, Pfizer, F. Hoffmann-La Roche, AstraZeneca, Sunovion, Neurocrine Biosciences, Psyadon, and the PANDAS Network, as well as personal fees from the International OCD Foundation and the Tourette Syndrome Association. Dr. Frankovich and Dr. Cooperstock had no relevant disclosures.
Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.
Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.
Clinical management of PANS/PANDAS includes psychoeducational, psychotherapeutic, behavioral, family- and school-based, and pharmacologic interventions, Dr. Thienemann and her associates wrote. Starting CBT (exposure-response prevention) has the best chance of halting OCD behaviors. Acutely ill children might not be ready for CBT, but parents still can learn to “hold the line” to avoid accommodating and worsening irrational fears.
Options for psychoactive medications include benzodiazepines for anxiety; aripiprazole, risperidone, olanzapine, haloperidol, or quetiapine for psychosis; and SSRIs, such as fluoxetine, sertraline, and fluvoxamine for depression and OCD. Severe depression merits both psychotherapy and an SSRI. Antipsychotics are not indicated for OCD unless children are incapacitated and only if their QTc interval does not exceed 450 milliseconds. Because PANS/PANDAS patients can react severely to psychotropics, clinicians should “start low” at about a quarter of a typical dose and “go slow,” gradually titrating up.
It’s best to rule out other medical disorders first when patients refuse or restrict food or fluids. Next, clinicians should assess medical stability and support nutrition and hydration while treating underlying brain inflammation. “Feeding tubes may be necessary, at least during the acute phases of the illness,” the authors wrote. Chronic symptoms can warrant treatments for eating disorders.
Bouts of aggression or irritability are classic and can be especially challenging for families. Parents can refocus the child with toys or by dancing, singing, or acting silly but should also make a safety plan, such as calling 911, if aggressive behaviors are endangering the patient or family members. Pharmacologic options for aggression include diphenhydramine, benzodiazepines, and antipsychotics.
For tics, options include comprehensive behavioral intervention for tics, habit reversal training, and cautiously monitored pharmacotherapy with alpha-2 adrenergic agonists, clonidine, guanfacine, or short-course antipsychotics. Symptoms of attention-deficit/hyperactivity disorder merit classroom accommodations; methylphenidate compounds can be added if needed. For children with sleep disturbances, the best strategy is to focus on sleep hygiene before considering low-dose diphenhydramine, melatonin, cyproheptadine, clonidine, trazodone, or zolpidem. Pain, however, needs early treatment to stop it from becoming refractory. Pain and stiffness after awakening can signal arthritis, enthesitis, or inflammatory back pain and warrant physical therapy and evaluation by a pediatric rheumatologist or pain specialist.
Part II of the guidelines covers immunomodulators. As in other severe brain disorders, early treatment improves outcomes and helps prevent relapses, wrote Jennifer Frankovich, MD, also of Stanford University, and her associates. Clinicians should start second-line therapies if first-line treatment fails. Acute impairment can remit with NSAIDs or a short course of oral corticosteroids, but chronic symptoms often need more aggressive and prolonged immunotherapy. Children with moderate to severe impairment should receive intravenous immunoglobulins, and those with severe, chronic impairment may need bursts of high-dose corticosteroids or longer-term corticosteroids with taper. Patients with extreme or life-threatening impairment should receive first-line therapeutic plasma exchange alone or with intravenous immunoglobulins, high-dose intravenous corticosteroids, and rituximab.
Part III of the guidelines covers infections. Most cases involve group A streptococci (GAS), but other culprits include Mycoplasma pneumoniae and viruses, such as influenza, wrote Michael S. Cooperstock, MD, MPH, of the University of Missouri-Columbia and his associates. They recommend antistreptococcal treatment for “essentially all” newly diagnosed cases. They also suggest secondary antistreptococcal prophylaxis for severe neuropsychiatric symptoms or intermittent exacerbations associated with GAS. “For all other [cases], vigilance for GAS infection in both the patient and close contacts is recommended,” they wrote. “Since any intercurrent infection may induce a symptom flare, close observation with appropriate therapy for any treatable intercurrent infection is warranted.” They also recommend standard childhood immunizations and monitoring vitamin D levels.
The National Institutes of Health supported the research summarized in the guidelines. Dr. Thienemann disclosed grants from Auspex, Shire, Pfizer, F. Hoffmann-La Roche, AstraZeneca, Sunovion, Neurocrine Biosciences, Psyadon, and the PANDAS Network, as well as personal fees from the International OCD Foundation and the Tourette Syndrome Association. Dr. Frankovich and Dr. Cooperstock had no relevant disclosures.
Prompt, symptomatic, multidisciplinary treatment is the best way to curtail the symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS) and pediatric autoimmune neuropsychiatric syndrome associated with streptococcal infection (PANDAS), according to new guidelines.
Clinicians should tailor treatment to symptoms, wrote Margo Thienemann, MD, of Stanford (Calif.) University and her coauthors in the clinical management section of the guidelines. For example, children with mild psychiatric symptoms might only need cognitive-behavioral therapy (CBT), while more severe symptoms can merit a slow up-titration of psychoactive medications.
Clinical management of PANS/PANDAS includes psychoeducational, psychotherapeutic, behavioral, family- and school-based, and pharmacologic interventions, Dr. Thienemann and her associates wrote. Starting CBT (exposure-response prevention) has the best chance of halting OCD behaviors. Acutely ill children might not be ready for CBT, but parents still can learn to “hold the line” to avoid accommodating and worsening irrational fears.
Options for psychoactive medications include benzodiazepines for anxiety; aripiprazole, risperidone, olanzapine, haloperidol, or quetiapine for psychosis; and SSRIs, such as fluoxetine, sertraline, and fluvoxamine for depression and OCD. Severe depression merits both psychotherapy and an SSRI. Antipsychotics are not indicated for OCD unless children are incapacitated and only if their QTc interval does not exceed 450 milliseconds. Because PANS/PANDAS patients can react severely to psychotropics, clinicians should “start low” at about a quarter of a typical dose and “go slow,” gradually titrating up.
It’s best to rule out other medical disorders first when patients refuse or restrict food or fluids. Next, clinicians should assess medical stability and support nutrition and hydration while treating underlying brain inflammation. “Feeding tubes may be necessary, at least during the acute phases of the illness,” the authors wrote. Chronic symptoms can warrant treatments for eating disorders.
Bouts of aggression or irritability are classic and can be especially challenging for families. Parents can refocus the child with toys or by dancing, singing, or acting silly but should also make a safety plan, such as calling 911, if aggressive behaviors are endangering the patient or family members. Pharmacologic options for aggression include diphenhydramine, benzodiazepines, and antipsychotics.
For tics, options include comprehensive behavioral intervention for tics, habit reversal training, and cautiously monitored pharmacotherapy with alpha-2 adrenergic agonists, clonidine, guanfacine, or short-course antipsychotics. Symptoms of attention-deficit/hyperactivity disorder merit classroom accommodations; methylphenidate compounds can be added if needed. For children with sleep disturbances, the best strategy is to focus on sleep hygiene before considering low-dose diphenhydramine, melatonin, cyproheptadine, clonidine, trazodone, or zolpidem. Pain, however, needs early treatment to stop it from becoming refractory. Pain and stiffness after awakening can signal arthritis, enthesitis, or inflammatory back pain and warrant physical therapy and evaluation by a pediatric rheumatologist or pain specialist.
Part II of the guidelines covers immunomodulators. As in other severe brain disorders, early treatment improves outcomes and helps prevent relapses, wrote Jennifer Frankovich, MD, also of Stanford University, and her associates. Clinicians should start second-line therapies if first-line treatment fails. Acute impairment can remit with NSAIDs or a short course of oral corticosteroids, but chronic symptoms often need more aggressive and prolonged immunotherapy. Children with moderate to severe impairment should receive intravenous immunoglobulins, and those with severe, chronic impairment may need bursts of high-dose corticosteroids or longer-term corticosteroids with taper. Patients with extreme or life-threatening impairment should receive first-line therapeutic plasma exchange alone or with intravenous immunoglobulins, high-dose intravenous corticosteroids, and rituximab.
Part III of the guidelines covers infections. Most cases involve group A streptococci (GAS), but other culprits include Mycoplasma pneumoniae and viruses, such as influenza, wrote Michael S. Cooperstock, MD, MPH, of the University of Missouri-Columbia and his associates. They recommend antistreptococcal treatment for “essentially all” newly diagnosed cases. They also suggest secondary antistreptococcal prophylaxis for severe neuropsychiatric symptoms or intermittent exacerbations associated with GAS. “For all other [cases], vigilance for GAS infection in both the patient and close contacts is recommended,” they wrote. “Since any intercurrent infection may induce a symptom flare, close observation with appropriate therapy for any treatable intercurrent infection is warranted.” They also recommend standard childhood immunizations and monitoring vitamin D levels.
The National Institutes of Health supported the research summarized in the guidelines. Dr. Thienemann disclosed grants from Auspex, Shire, Pfizer, F. Hoffmann-La Roche, AstraZeneca, Sunovion, Neurocrine Biosciences, Psyadon, and the PANDAS Network, as well as personal fees from the International OCD Foundation and the Tourette Syndrome Association. Dr. Frankovich and Dr. Cooperstock had no relevant disclosures.
FROM JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY
Release nears for revised U.S. hypertension guidelines
Authoritative U.S. guidelines for managing high blood pressure have traveled a rocky and serpentine path ever since the expert group originally constituted as the Eighth Joint National Committee (JNC 8) released its controversial report in early 2014, when it relaxed the target blood pressure for most adults aged 60-79 years from less than 140 mm Hg to under 150/90 mm Hg (JAMA. 2014 Feb 5;3311[5]:507-20). A few months before those recommendations came out, the National Heart, Lung, and Blood Institute, which since 1977 had organized seven preceding iterations of U.S. blood pressure guidelines, handed off oversight of the project and any future updates to the American Heart Association, the American College of Cardiology, and the American Society of Hypertension. A year later, an expert panel organized by those three groups reset the blood pressure target for most U.S. adults with coronary artery disease back to a pressure of less than 140/90 mm Hg (Hypertension. 2015 Jun;65[6]:1372-1407), and that has been the prevailing U.S. standard in the 2-plus years since.
A few months later, in September 2015, data from the SPRINT trial in more than 9,000 patients with high cardiovascular risk first came out and showed that treating to a target systolic blood pressure of less than 120 mm Hg led to a significant 25% reduction in cardiovascular disease events, compared with controls treated to a systolic pressure of less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16). Ever since, the big question surrounding blood pressure targets in U.S. practice has been, when would new official guidelines emerge that took the SPRINT findings into consideration? It now looks like it will finally happen in September 2017.
That’s when the ASH and the AHA’s Hypertension Council will for the first time hold a joint annual meeting, after many years when each organization had its own, individual annual meeting. The ASH’s traditional spring meeting didn’t happen this year; early fall has traditionally been when the AHA’s Hypertension Council meets.
The Council’s posted preliminary program for the September meeting showed, as of late July, an opening session the morning of September 14 called a “Review of AHA Scientific Statement 2017.” On the ASH’s website is a virtual flier for a session the afternoon of September 15 on the “2017 Guidelines for Adult and Pediatric Hypertension.”
“I know that something will be discussed on September 14,” he told me recently. “I am not sure the full report will be ready then, but I think something will be presented that will at least describe the ‘attitude’ of the guidelines, if not the whole report. There will be more presented at the AHA Sessions in November.” Of course, there will also be “an accompanying evidence document describing the studies and evidence that generated the report, but I don’t know the release date,” he added.
Some of the suspense is already gone from the new guidelines, because the punch line – the new target blood pressure to treat toward for most U.S. adults with hypertension – is already known to be less than 130/80 mm Hg. That was the treatment goal set in April in updated guidelines for treating patients with heart failure by a panel of the ACC, the AHA, and the Heart Failure Society of America (J Am Coll Cardiol. 2017 Apr 30. doi: 10.1016/j.jacc.2017.04.025). Among the heart failure patients subject to this blood pressure target are adults with stage A heart failure, which the panel defined as any adult diagnosed with hypertension, as well as those with diabetes, coronary artery disease, or other risk factors that clearly predispose patients to develop heart failure.
Last April, the heart failure panel’s vice-chair, Mariell Jessup, MD, told me that the group chose a treatment target of less than 130/80 mm Hg to “harmonize” with the target that the hypertension guideline group had already selected.
So, in truth, an official U.S. hypertension treatment target of less than 130/80 mm Hg is already on the books for clinicians to follow that’s endorsed by the ACC and AHA. Unless the hypertension group throws a real curve ball its target will be identical.
But just knowing this lower target leaves important questions unanswered that presumably the hypertension panel will address. Questions like the best drug combinations to use to get blood pressures this low, and how aggressively to treat older patients with comorbidities who may need upward of four drugs to achieve a systolic blood pressure in this target range.
“I suspect some will say that the heart failure guidelines are for patients with heart failure, and thus the hypertension guidelines will complement them,” said Dr. Lackland. On the other hand, the SPRINT evidence is so persuasive that at least “some physicians will move to 130/80 mm Hg” readily, he predicted. “Others will probably wait and see, and some will wait even longer for follow-up comments” to come out.
Dr. Lackland also stressed the usual caveat about any medical guideline, that both the heart failure and hypertension statements simply give clinicians the recommended approach but “should not override clinical judgment for specific patients.”
But before the medical community can embrace or question the new hypertension guidelines it needs to at least see them. That finally seems ready to happen in September, and perhaps in November too.
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On Twitter @mitchelzoler
Authoritative U.S. guidelines for managing high blood pressure have traveled a rocky and serpentine path ever since the expert group originally constituted as the Eighth Joint National Committee (JNC 8) released its controversial report in early 2014, when it relaxed the target blood pressure for most adults aged 60-79 years from less than 140 mm Hg to under 150/90 mm Hg (JAMA. 2014 Feb 5;3311[5]:507-20). A few months before those recommendations came out, the National Heart, Lung, and Blood Institute, which since 1977 had organized seven preceding iterations of U.S. blood pressure guidelines, handed off oversight of the project and any future updates to the American Heart Association, the American College of Cardiology, and the American Society of Hypertension. A year later, an expert panel organized by those three groups reset the blood pressure target for most U.S. adults with coronary artery disease back to a pressure of less than 140/90 mm Hg (Hypertension. 2015 Jun;65[6]:1372-1407), and that has been the prevailing U.S. standard in the 2-plus years since.
A few months later, in September 2015, data from the SPRINT trial in more than 9,000 patients with high cardiovascular risk first came out and showed that treating to a target systolic blood pressure of less than 120 mm Hg led to a significant 25% reduction in cardiovascular disease events, compared with controls treated to a systolic pressure of less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16). Ever since, the big question surrounding blood pressure targets in U.S. practice has been, when would new official guidelines emerge that took the SPRINT findings into consideration? It now looks like it will finally happen in September 2017.
That’s when the ASH and the AHA’s Hypertension Council will for the first time hold a joint annual meeting, after many years when each organization had its own, individual annual meeting. The ASH’s traditional spring meeting didn’t happen this year; early fall has traditionally been when the AHA’s Hypertension Council meets.
The Council’s posted preliminary program for the September meeting showed, as of late July, an opening session the morning of September 14 called a “Review of AHA Scientific Statement 2017.” On the ASH’s website is a virtual flier for a session the afternoon of September 15 on the “2017 Guidelines for Adult and Pediatric Hypertension.”
“I know that something will be discussed on September 14,” he told me recently. “I am not sure the full report will be ready then, but I think something will be presented that will at least describe the ‘attitude’ of the guidelines, if not the whole report. There will be more presented at the AHA Sessions in November.” Of course, there will also be “an accompanying evidence document describing the studies and evidence that generated the report, but I don’t know the release date,” he added.
Some of the suspense is already gone from the new guidelines, because the punch line – the new target blood pressure to treat toward for most U.S. adults with hypertension – is already known to be less than 130/80 mm Hg. That was the treatment goal set in April in updated guidelines for treating patients with heart failure by a panel of the ACC, the AHA, and the Heart Failure Society of America (J Am Coll Cardiol. 2017 Apr 30. doi: 10.1016/j.jacc.2017.04.025). Among the heart failure patients subject to this blood pressure target are adults with stage A heart failure, which the panel defined as any adult diagnosed with hypertension, as well as those with diabetes, coronary artery disease, or other risk factors that clearly predispose patients to develop heart failure.
Last April, the heart failure panel’s vice-chair, Mariell Jessup, MD, told me that the group chose a treatment target of less than 130/80 mm Hg to “harmonize” with the target that the hypertension guideline group had already selected.
So, in truth, an official U.S. hypertension treatment target of less than 130/80 mm Hg is already on the books for clinicians to follow that’s endorsed by the ACC and AHA. Unless the hypertension group throws a real curve ball its target will be identical.
But just knowing this lower target leaves important questions unanswered that presumably the hypertension panel will address. Questions like the best drug combinations to use to get blood pressures this low, and how aggressively to treat older patients with comorbidities who may need upward of four drugs to achieve a systolic blood pressure in this target range.
“I suspect some will say that the heart failure guidelines are for patients with heart failure, and thus the hypertension guidelines will complement them,” said Dr. Lackland. On the other hand, the SPRINT evidence is so persuasive that at least “some physicians will move to 130/80 mm Hg” readily, he predicted. “Others will probably wait and see, and some will wait even longer for follow-up comments” to come out.
Dr. Lackland also stressed the usual caveat about any medical guideline, that both the heart failure and hypertension statements simply give clinicians the recommended approach but “should not override clinical judgment for specific patients.”
But before the medical community can embrace or question the new hypertension guidelines it needs to at least see them. That finally seems ready to happen in September, and perhaps in November too.
[email protected]
On Twitter @mitchelzoler
Authoritative U.S. guidelines for managing high blood pressure have traveled a rocky and serpentine path ever since the expert group originally constituted as the Eighth Joint National Committee (JNC 8) released its controversial report in early 2014, when it relaxed the target blood pressure for most adults aged 60-79 years from less than 140 mm Hg to under 150/90 mm Hg (JAMA. 2014 Feb 5;3311[5]:507-20). A few months before those recommendations came out, the National Heart, Lung, and Blood Institute, which since 1977 had organized seven preceding iterations of U.S. blood pressure guidelines, handed off oversight of the project and any future updates to the American Heart Association, the American College of Cardiology, and the American Society of Hypertension. A year later, an expert panel organized by those three groups reset the blood pressure target for most U.S. adults with coronary artery disease back to a pressure of less than 140/90 mm Hg (Hypertension. 2015 Jun;65[6]:1372-1407), and that has been the prevailing U.S. standard in the 2-plus years since.
A few months later, in September 2015, data from the SPRINT trial in more than 9,000 patients with high cardiovascular risk first came out and showed that treating to a target systolic blood pressure of less than 120 mm Hg led to a significant 25% reduction in cardiovascular disease events, compared with controls treated to a systolic pressure of less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16). Ever since, the big question surrounding blood pressure targets in U.S. practice has been, when would new official guidelines emerge that took the SPRINT findings into consideration? It now looks like it will finally happen in September 2017.
That’s when the ASH and the AHA’s Hypertension Council will for the first time hold a joint annual meeting, after many years when each organization had its own, individual annual meeting. The ASH’s traditional spring meeting didn’t happen this year; early fall has traditionally been when the AHA’s Hypertension Council meets.
The Council’s posted preliminary program for the September meeting showed, as of late July, an opening session the morning of September 14 called a “Review of AHA Scientific Statement 2017.” On the ASH’s website is a virtual flier for a session the afternoon of September 15 on the “2017 Guidelines for Adult and Pediatric Hypertension.”
“I know that something will be discussed on September 14,” he told me recently. “I am not sure the full report will be ready then, but I think something will be presented that will at least describe the ‘attitude’ of the guidelines, if not the whole report. There will be more presented at the AHA Sessions in November.” Of course, there will also be “an accompanying evidence document describing the studies and evidence that generated the report, but I don’t know the release date,” he added.
Some of the suspense is already gone from the new guidelines, because the punch line – the new target blood pressure to treat toward for most U.S. adults with hypertension – is already known to be less than 130/80 mm Hg. That was the treatment goal set in April in updated guidelines for treating patients with heart failure by a panel of the ACC, the AHA, and the Heart Failure Society of America (J Am Coll Cardiol. 2017 Apr 30. doi: 10.1016/j.jacc.2017.04.025). Among the heart failure patients subject to this blood pressure target are adults with stage A heart failure, which the panel defined as any adult diagnosed with hypertension, as well as those with diabetes, coronary artery disease, or other risk factors that clearly predispose patients to develop heart failure.
Last April, the heart failure panel’s vice-chair, Mariell Jessup, MD, told me that the group chose a treatment target of less than 130/80 mm Hg to “harmonize” with the target that the hypertension guideline group had already selected.
So, in truth, an official U.S. hypertension treatment target of less than 130/80 mm Hg is already on the books for clinicians to follow that’s endorsed by the ACC and AHA. Unless the hypertension group throws a real curve ball its target will be identical.
But just knowing this lower target leaves important questions unanswered that presumably the hypertension panel will address. Questions like the best drug combinations to use to get blood pressures this low, and how aggressively to treat older patients with comorbidities who may need upward of four drugs to achieve a systolic blood pressure in this target range.
“I suspect some will say that the heart failure guidelines are for patients with heart failure, and thus the hypertension guidelines will complement them,” said Dr. Lackland. On the other hand, the SPRINT evidence is so persuasive that at least “some physicians will move to 130/80 mm Hg” readily, he predicted. “Others will probably wait and see, and some will wait even longer for follow-up comments” to come out.
Dr. Lackland also stressed the usual caveat about any medical guideline, that both the heart failure and hypertension statements simply give clinicians the recommended approach but “should not override clinical judgment for specific patients.”
But before the medical community can embrace or question the new hypertension guidelines it needs to at least see them. That finally seems ready to happen in September, and perhaps in November too.
[email protected]
On Twitter @mitchelzoler
Bowel prep score helps predict missed polyps
“Several recent prospective studies of one-time colonoscopies have demonstrated an association between higher BBPS (Boston Bowel Preparation Scale) scores and higher polyp and adenoma detection rates,” wrote Matthew A. Kluge, MD, of Boston University Medical Center, and his colleagues.
“We hypothesized that the BBPS could predict the likelihood of missed polyps based on initial BBPS segment scores among a large consortium of gastroenterology practices throughout the United States, thereby providing evidence to inform recommendations for repeat colonoscopy after less-than-perfect bowel preparation,” they said.
The researchers reviewed data from 335 pairs of colonoscopy exams in which the second exam (C2) was performed within 3 years of the first exam (C1). The primary endpoint was the detection of polyps and advanced polyps among colon segments at C2 stratified by BBPS scores at C1 (Gastrointest Endosc. 2017 Jun 22. doi: 10.1016/j.gie.2017.06.012).
Overall, patients with inadequate bowel prep were significantly more likely than those with adequate prep to be male (71% vs. 60%) and younger (average age, 59 years vs. 61 years). *
In a multivariate model, the risk of advanced polyps at C2 was significantly higher for patients who had advanced polyps at C1 (odds ratio, 3.5), but inadequate BBPS scores at C1 had no significant impact on advanced polyp risk at C2. The risk of advanced polyps at C2 increased slightly with each year of age (OR, 1.1), but was not impacted by sex or time between C1 and C2 visits.
In addition, polyps at C2 were significantly more likely in patients with inadequate examinations at C1 vs. adequate C1 exams (18% vs. 7%).
The study’s strengths include the use of a large database, but limitations include lack of information about pathology and the use of surrogate measures of polyp size, the researchers noted. However, the results highlight the importance of proper bowel prep and support previous observations that “individuals with a BBPS segment score of 0 and 1 may be at increased risk for missed polyps, especially if advanced polyps are detected,” they said.
The study was supported in part by the Clinical Outcomes Research Initiative (CORI) and by the National Institutes of Health, and CORI has received infrastructure support from companies including AstraZeneca, Bard International, Endosoft, Ethicon, GIVEN Imaging, Pentax USA, and ProVation. Lead author Dr. Kluge had no financial conflicts to disclose.
* This story was updated on 7/26/2017
“Several recent prospective studies of one-time colonoscopies have demonstrated an association between higher BBPS (Boston Bowel Preparation Scale) scores and higher polyp and adenoma detection rates,” wrote Matthew A. Kluge, MD, of Boston University Medical Center, and his colleagues.
“We hypothesized that the BBPS could predict the likelihood of missed polyps based on initial BBPS segment scores among a large consortium of gastroenterology practices throughout the United States, thereby providing evidence to inform recommendations for repeat colonoscopy after less-than-perfect bowel preparation,” they said.
The researchers reviewed data from 335 pairs of colonoscopy exams in which the second exam (C2) was performed within 3 years of the first exam (C1). The primary endpoint was the detection of polyps and advanced polyps among colon segments at C2 stratified by BBPS scores at C1 (Gastrointest Endosc. 2017 Jun 22. doi: 10.1016/j.gie.2017.06.012).
Overall, patients with inadequate bowel prep were significantly more likely than those with adequate prep to be male (71% vs. 60%) and younger (average age, 59 years vs. 61 years). *
In a multivariate model, the risk of advanced polyps at C2 was significantly higher for patients who had advanced polyps at C1 (odds ratio, 3.5), but inadequate BBPS scores at C1 had no significant impact on advanced polyp risk at C2. The risk of advanced polyps at C2 increased slightly with each year of age (OR, 1.1), but was not impacted by sex or time between C1 and C2 visits.
In addition, polyps at C2 were significantly more likely in patients with inadequate examinations at C1 vs. adequate C1 exams (18% vs. 7%).
The study’s strengths include the use of a large database, but limitations include lack of information about pathology and the use of surrogate measures of polyp size, the researchers noted. However, the results highlight the importance of proper bowel prep and support previous observations that “individuals with a BBPS segment score of 0 and 1 may be at increased risk for missed polyps, especially if advanced polyps are detected,” they said.
The study was supported in part by the Clinical Outcomes Research Initiative (CORI) and by the National Institutes of Health, and CORI has received infrastructure support from companies including AstraZeneca, Bard International, Endosoft, Ethicon, GIVEN Imaging, Pentax USA, and ProVation. Lead author Dr. Kluge had no financial conflicts to disclose.
* This story was updated on 7/26/2017
“Several recent prospective studies of one-time colonoscopies have demonstrated an association between higher BBPS (Boston Bowel Preparation Scale) scores and higher polyp and adenoma detection rates,” wrote Matthew A. Kluge, MD, of Boston University Medical Center, and his colleagues.
“We hypothesized that the BBPS could predict the likelihood of missed polyps based on initial BBPS segment scores among a large consortium of gastroenterology practices throughout the United States, thereby providing evidence to inform recommendations for repeat colonoscopy after less-than-perfect bowel preparation,” they said.
The researchers reviewed data from 335 pairs of colonoscopy exams in which the second exam (C2) was performed within 3 years of the first exam (C1). The primary endpoint was the detection of polyps and advanced polyps among colon segments at C2 stratified by BBPS scores at C1 (Gastrointest Endosc. 2017 Jun 22. doi: 10.1016/j.gie.2017.06.012).
Overall, patients with inadequate bowel prep were significantly more likely than those with adequate prep to be male (71% vs. 60%) and younger (average age, 59 years vs. 61 years). *
In a multivariate model, the risk of advanced polyps at C2 was significantly higher for patients who had advanced polyps at C1 (odds ratio, 3.5), but inadequate BBPS scores at C1 had no significant impact on advanced polyp risk at C2. The risk of advanced polyps at C2 increased slightly with each year of age (OR, 1.1), but was not impacted by sex or time between C1 and C2 visits.
In addition, polyps at C2 were significantly more likely in patients with inadequate examinations at C1 vs. adequate C1 exams (18% vs. 7%).
The study’s strengths include the use of a large database, but limitations include lack of information about pathology and the use of surrogate measures of polyp size, the researchers noted. However, the results highlight the importance of proper bowel prep and support previous observations that “individuals with a BBPS segment score of 0 and 1 may be at increased risk for missed polyps, especially if advanced polyps are detected,” they said.
The study was supported in part by the Clinical Outcomes Research Initiative (CORI) and by the National Institutes of Health, and CORI has received infrastructure support from companies including AstraZeneca, Bard International, Endosoft, Ethicon, GIVEN Imaging, Pentax USA, and ProVation. Lead author Dr. Kluge had no financial conflicts to disclose.
* This story was updated on 7/26/2017
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: Individuals with a score of 0 or 1 on the Boston Bowel Preparation Scale may be at increased risk for missed polyps.
Major finding: Polyps at a second colonoscopy were significantly more likely in patients who had advanced polyps at an initial visit (odds ratio, 3.5).
Data source: The data come from a prospective, observational study of adults aged 50-75 years who had average risk screening colonoscopies.
Disclosures: The study was supported in part by the Clinical Outcomes Research Initiative (CORI) and by the National Institutes of Health, and CORI has received infrastructure support from companies including AstraZeneca, Bard International, Endosoft, Ethicon, GIVEN Imaging, Pentax USA, and ProVation. Dr. Kluge had no financial conflicts to disclose.