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Combined features of benign breast disease tied to breast cancer risk
“Benign breast disease is a key risk factor for breast cancer risk prediction,” commented presenting investigator Marta Román, PhD, of the Hospital del Mar Medical Research Institute in Barcelona. “Those women who have had a benign breast disease diagnosis have an increased risk that lasts for at least 20 years.”
To assess the combined influence of various attributes of benign breast disease, the investigators studied 629,087 women, aged 50-69 years, in Spain who underwent population-based mammographic breast cancer screening during 1994-2015 and did not have breast cancer at their prevalent (first) screen. The mean follow-up was 7.8 years.
Results showed that breast cancer risk was about three times higher for women with benign breast disease that was proliferative or that was detected on an incident screen, relative to peers with no benign breast disease. When combinations of factors were considered, breast cancer risk was most elevated – more than four times higher – for women with proliferative benign breast disease with atypia detected on an incident screen.
“We believe that these findings should be considered when discussing risk-based personalized screening strategies because these differences between prevalent and incident screens might be important if we want to personalize the screening, whether it’s the first time a woman comes to the screening program or a subsequent screen,” Dr. Román said.
Practice changing?
The study’s large size and population-based design, likely permitting capture of most biopsy results, are strengths, Mark David Pearlman, MD, of the University of Michigan, Ann Arbor, commented in an interview.
But its observational, retrospective nature opens the study up to biases, such as uncertainty as to how many women were symptomatic at the time of their mammogram and the likelihood of heightened monitoring after a biopsy showing hyperplasia, Dr. Pearlman cautioned.
“Moreover, the relative risk in this study for proliferative benign breast disease without atypia is substantially higher than prior observations of this group. This discrepancy was not discussed by the authors,” Dr. Pearlman said.
At present, women’s risk of breast cancer is predicted using well-validated models that include the question of prior breast biopsies, such as the Gail Model, the Tyrer-Cuzick model (IBIS tool), and the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm, Dr. Pearlman noted.
“This study, without further validation within a model, would not change risk assessment,” he said, disagreeing with the investigators’ conclusions. “What I would say is that further study to determine how to use this observation to decide if any change in screening or management should occur would be more appropriate.”
Study details
The 629,087 women studied underwent 2,327,384 screens, Dr. Román reported. In total, screening detected 9,184 cases of benign breast disease and 9,431 breast cancers.
Breast cancer was diagnosed in 2.4% and 3.0% of women with benign breast disease detected on prevalent and incident screens, respectively, compared with 1.5% of women without any benign breast disease detected.
Elevation of breast cancer risk varied across benign breast disease subtype. Relative to peers without any benign disease, risk was significantly elevated for women with nonproliferative disease (adjusted hazard ratio, 1.95), proliferative disease without atypia (aHR, 3.19), and proliferative disease with atypia (aHR, 3.82).
Similarly, elevation of risk varied depending on the screening at which the benign disease was detected. Risk was significantly elevated when the disease was found at prevalent screens (aHR, 1.87) and more so when it was found at incident screens (aHR, 2.67).
There was no significant interaction of these two factors (P = .83). However, when combinations were considered, risk was highest for women with proliferative benign breast disease with atypia detected on incident screens (aHR, 4.35) or prevalent screens (aHR, 3.35), and women with proliferative benign breast disease without atypia detected on incident screens (aHR, 3.83).
This study was supported by grants from Instituto de Salud Carlos III FEDER and by the Research Network on Health Services in Chronic Diseases. Dr. Román and Dr. Pearlman disclosed no conflicts of interest.
SOURCE: Román M et al. EBCC-12 Virtual Conference, Abstract 15.
“Benign breast disease is a key risk factor for breast cancer risk prediction,” commented presenting investigator Marta Román, PhD, of the Hospital del Mar Medical Research Institute in Barcelona. “Those women who have had a benign breast disease diagnosis have an increased risk that lasts for at least 20 years.”
To assess the combined influence of various attributes of benign breast disease, the investigators studied 629,087 women, aged 50-69 years, in Spain who underwent population-based mammographic breast cancer screening during 1994-2015 and did not have breast cancer at their prevalent (first) screen. The mean follow-up was 7.8 years.
Results showed that breast cancer risk was about three times higher for women with benign breast disease that was proliferative or that was detected on an incident screen, relative to peers with no benign breast disease. When combinations of factors were considered, breast cancer risk was most elevated – more than four times higher – for women with proliferative benign breast disease with atypia detected on an incident screen.
“We believe that these findings should be considered when discussing risk-based personalized screening strategies because these differences between prevalent and incident screens might be important if we want to personalize the screening, whether it’s the first time a woman comes to the screening program or a subsequent screen,” Dr. Román said.
Practice changing?
The study’s large size and population-based design, likely permitting capture of most biopsy results, are strengths, Mark David Pearlman, MD, of the University of Michigan, Ann Arbor, commented in an interview.
But its observational, retrospective nature opens the study up to biases, such as uncertainty as to how many women were symptomatic at the time of their mammogram and the likelihood of heightened monitoring after a biopsy showing hyperplasia, Dr. Pearlman cautioned.
“Moreover, the relative risk in this study for proliferative benign breast disease without atypia is substantially higher than prior observations of this group. This discrepancy was not discussed by the authors,” Dr. Pearlman said.
At present, women’s risk of breast cancer is predicted using well-validated models that include the question of prior breast biopsies, such as the Gail Model, the Tyrer-Cuzick model (IBIS tool), and the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm, Dr. Pearlman noted.
“This study, without further validation within a model, would not change risk assessment,” he said, disagreeing with the investigators’ conclusions. “What I would say is that further study to determine how to use this observation to decide if any change in screening or management should occur would be more appropriate.”
Study details
The 629,087 women studied underwent 2,327,384 screens, Dr. Román reported. In total, screening detected 9,184 cases of benign breast disease and 9,431 breast cancers.
Breast cancer was diagnosed in 2.4% and 3.0% of women with benign breast disease detected on prevalent and incident screens, respectively, compared with 1.5% of women without any benign breast disease detected.
Elevation of breast cancer risk varied across benign breast disease subtype. Relative to peers without any benign disease, risk was significantly elevated for women with nonproliferative disease (adjusted hazard ratio, 1.95), proliferative disease without atypia (aHR, 3.19), and proliferative disease with atypia (aHR, 3.82).
Similarly, elevation of risk varied depending on the screening at which the benign disease was detected. Risk was significantly elevated when the disease was found at prevalent screens (aHR, 1.87) and more so when it was found at incident screens (aHR, 2.67).
There was no significant interaction of these two factors (P = .83). However, when combinations were considered, risk was highest for women with proliferative benign breast disease with atypia detected on incident screens (aHR, 4.35) or prevalent screens (aHR, 3.35), and women with proliferative benign breast disease without atypia detected on incident screens (aHR, 3.83).
This study was supported by grants from Instituto de Salud Carlos III FEDER and by the Research Network on Health Services in Chronic Diseases. Dr. Román and Dr. Pearlman disclosed no conflicts of interest.
SOURCE: Román M et al. EBCC-12 Virtual Conference, Abstract 15.
“Benign breast disease is a key risk factor for breast cancer risk prediction,” commented presenting investigator Marta Román, PhD, of the Hospital del Mar Medical Research Institute in Barcelona. “Those women who have had a benign breast disease diagnosis have an increased risk that lasts for at least 20 years.”
To assess the combined influence of various attributes of benign breast disease, the investigators studied 629,087 women, aged 50-69 years, in Spain who underwent population-based mammographic breast cancer screening during 1994-2015 and did not have breast cancer at their prevalent (first) screen. The mean follow-up was 7.8 years.
Results showed that breast cancer risk was about three times higher for women with benign breast disease that was proliferative or that was detected on an incident screen, relative to peers with no benign breast disease. When combinations of factors were considered, breast cancer risk was most elevated – more than four times higher – for women with proliferative benign breast disease with atypia detected on an incident screen.
“We believe that these findings should be considered when discussing risk-based personalized screening strategies because these differences between prevalent and incident screens might be important if we want to personalize the screening, whether it’s the first time a woman comes to the screening program or a subsequent screen,” Dr. Román said.
Practice changing?
The study’s large size and population-based design, likely permitting capture of most biopsy results, are strengths, Mark David Pearlman, MD, of the University of Michigan, Ann Arbor, commented in an interview.
But its observational, retrospective nature opens the study up to biases, such as uncertainty as to how many women were symptomatic at the time of their mammogram and the likelihood of heightened monitoring after a biopsy showing hyperplasia, Dr. Pearlman cautioned.
“Moreover, the relative risk in this study for proliferative benign breast disease without atypia is substantially higher than prior observations of this group. This discrepancy was not discussed by the authors,” Dr. Pearlman said.
At present, women’s risk of breast cancer is predicted using well-validated models that include the question of prior breast biopsies, such as the Gail Model, the Tyrer-Cuzick model (IBIS tool), and the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm, Dr. Pearlman noted.
“This study, without further validation within a model, would not change risk assessment,” he said, disagreeing with the investigators’ conclusions. “What I would say is that further study to determine how to use this observation to decide if any change in screening or management should occur would be more appropriate.”
Study details
The 629,087 women studied underwent 2,327,384 screens, Dr. Román reported. In total, screening detected 9,184 cases of benign breast disease and 9,431 breast cancers.
Breast cancer was diagnosed in 2.4% and 3.0% of women with benign breast disease detected on prevalent and incident screens, respectively, compared with 1.5% of women without any benign breast disease detected.
Elevation of breast cancer risk varied across benign breast disease subtype. Relative to peers without any benign disease, risk was significantly elevated for women with nonproliferative disease (adjusted hazard ratio, 1.95), proliferative disease without atypia (aHR, 3.19), and proliferative disease with atypia (aHR, 3.82).
Similarly, elevation of risk varied depending on the screening at which the benign disease was detected. Risk was significantly elevated when the disease was found at prevalent screens (aHR, 1.87) and more so when it was found at incident screens (aHR, 2.67).
There was no significant interaction of these two factors (P = .83). However, when combinations were considered, risk was highest for women with proliferative benign breast disease with atypia detected on incident screens (aHR, 4.35) or prevalent screens (aHR, 3.35), and women with proliferative benign breast disease without atypia detected on incident screens (aHR, 3.83).
This study was supported by grants from Instituto de Salud Carlos III FEDER and by the Research Network on Health Services in Chronic Diseases. Dr. Román and Dr. Pearlman disclosed no conflicts of interest.
SOURCE: Román M et al. EBCC-12 Virtual Conference, Abstract 15.
FROM EBCC-12 VIRTUAL CONFERENCE
Fauci: Cautious optimism for COVID-19 vaccine by end of 2020
with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.
“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.
“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”
If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.
Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.
He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.
Rapid development gives reason for hope
Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.
“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”
“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”
COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.
Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.
As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.
Prioritizing COVID-19 vaccine distribution
Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.
Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.
COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.
Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.
Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.
with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.
“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.
“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”
If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.
Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.
He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.
Rapid development gives reason for hope
Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.
“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”
“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”
COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.
Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.
As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.
Prioritizing COVID-19 vaccine distribution
Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.
Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.
COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.
Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.
Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.
with distribution of first doses possible before the end of the year, according to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases, Bethesda, Md.
“Given the rate of infection that’s going on in this country, and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December,” Dr. Fauci said today in his virtual keynote address during the annual meeting of the American College of Chest Physicians.
“It may come earlier -- this month, in October,” he added in his remarks. “That is unlikely – it is more likely that we’ll have an answer in November and December.”
If that timing does come to pass, Dr. Fauci said, it’s possible that distribution of doses could start at the end of the year, continuing throughout the beginning and middle of 2021.
Although there are no guarantees, Dr. Fauci said he is “cautiously optimistic” regarding the timeline.
He said that his optimism is based in part on animal studies and phase 1 data that demonstrate robust neutralizing antibody responses to a vaccine that are equivalent to, if not greater than, natural infection with the SARS-CoV-2 virus that causes COVID-19.
Rapid development gives reason for hope
Ryan C. Maves, MD, FCCP, a critical care and infectious disease specialist at Naval Medical Center San Diego, said there is reason to be hopeful that a vaccine will be available by the end of the calendar year. He cautioned, however, that this timing is based on the assumption that one of the vaccines will be proven safe and effective very soon.
“We’re lucky to have multiple phase 3 trials using multiple vaccine technologies in different platforms,” Dr. Maves said in a panel discussion following Dr. Fauci’s remarks. “I think the odds are very high that one of them will be effective.”
“I’m hoping that multiple vaccines will be effective,” Dr. Maves added. “Then we’ll be in a good position of determining which is the best of several good options, as a society and as a world.”
COVID-19 vaccine development over the past year has been remarkably fast, especially given the previous record set by the mumps vaccine, which took about four years to go from initial steps to rollout, Dr. Maves noted.
Dr. Fauci said the federal government has taken a “strategic approach” to the COVID-19 vaccine that includes direct involvement in the research and development of six different vaccine candidates, five of which are now in phase 3 trials.
As part of that strategic approach, the study protocols are harmonized to have a common data and safety monitoring board, common primary and secondary endpoints, and an independent statistical group to determine correlates of protection, Dr. Fauci said.
Prioritizing COVID-19 vaccine distribution
Who gets COVID-19 vaccine first will be a challenge for governmental organizations as well as bioethicists, who have proposed different strategies for fairly prioritizing different groups for access.
Reaching communities of color will be an important consideration for prioritization, according to Dr. Maves, given the disproportionate burden of disease on Black and Hispanic individuals, among other such populations.
COVID-19–related hospitalization rates have been substantially higher in communities of color, Dr. Fauci said in his keynote address. Age-adjusted hospitalization rates for Hispanic/Latinx and Black populations are 375 to 368 per 100,000, respectively, compared with just 82 per 100,000 for White non-Hispanics, according to data from the Centers for Disease Control and Prevention.
Outreach to those communities should include building trust in those populations that they will benefit from a safe and effective vaccine, and making sure that the vaccine is available to those communities as quickly as possible, Dr. Maves said.
Dr. Fauci and Dr. Maves provided no disclosures related to their presentations.
FROM CHEST 2020
Calendar
For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.
UPCOMING EVENTS
Jan. 15-17, 2021
Gastrointestinal Cancers Symposium
Through an engaging lineup of novel science, education, and exhibits, the virtual 2021 Gastrointestinal (GI) Cancers Symposium offers new, innovative findings in GI cancer treatment, research, and care.
Early-bird deadline: Dec. 16, 2020.
Jan. 21-24, 2021
Crohn’s & Colitis Congress®Join health care professionals and researchers virtually at the Crohn’s & Colitis Congress® for the premier conference on IBD. Discover different perspectives, practical information you can immediately implement, and potential treatments on the horizon.
Early-bird deadline: Friday, Nov. 6, 2020.
May 21-23, 2021
Digestive Disease Week® (DDW)
Save the date for the world’s leading event in digestive disease. DDW® brings professionals in gastroenterology, hepatology, endoscopy, and GI surgery together. Experience growth when you share your research, converge with trailblazers, and improve the lives of patients suffering from GI and liver diseases.
Abstract submission window Oct. 15 to Dec. 3, 2020.
AWARD DEADLINES
American Gastroenterological Association (AGA) Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students,or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early-career (that is, 35 years of age or younger at the time of DDW) basic, translational or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations DDW. The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.
UPCOMING EVENTS
Jan. 15-17, 2021
Gastrointestinal Cancers Symposium
Through an engaging lineup of novel science, education, and exhibits, the virtual 2021 Gastrointestinal (GI) Cancers Symposium offers new, innovative findings in GI cancer treatment, research, and care.
Early-bird deadline: Dec. 16, 2020.
Jan. 21-24, 2021
Crohn’s & Colitis Congress®Join health care professionals and researchers virtually at the Crohn’s & Colitis Congress® for the premier conference on IBD. Discover different perspectives, practical information you can immediately implement, and potential treatments on the horizon.
Early-bird deadline: Friday, Nov. 6, 2020.
May 21-23, 2021
Digestive Disease Week® (DDW)
Save the date for the world’s leading event in digestive disease. DDW® brings professionals in gastroenterology, hepatology, endoscopy, and GI surgery together. Experience growth when you share your research, converge with trailblazers, and improve the lives of patients suffering from GI and liver diseases.
Abstract submission window Oct. 15 to Dec. 3, 2020.
AWARD DEADLINES
American Gastroenterological Association (AGA) Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students,or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early-career (that is, 35 years of age or younger at the time of DDW) basic, translational or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations DDW. The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.
UPCOMING EVENTS
Jan. 15-17, 2021
Gastrointestinal Cancers Symposium
Through an engaging lineup of novel science, education, and exhibits, the virtual 2021 Gastrointestinal (GI) Cancers Symposium offers new, innovative findings in GI cancer treatment, research, and care.
Early-bird deadline: Dec. 16, 2020.
Jan. 21-24, 2021
Crohn’s & Colitis Congress®Join health care professionals and researchers virtually at the Crohn’s & Colitis Congress® for the premier conference on IBD. Discover different perspectives, practical information you can immediately implement, and potential treatments on the horizon.
Early-bird deadline: Friday, Nov. 6, 2020.
May 21-23, 2021
Digestive Disease Week® (DDW)
Save the date for the world’s leading event in digestive disease. DDW® brings professionals in gastroenterology, hepatology, endoscopy, and GI surgery together. Experience growth when you share your research, converge with trailblazers, and improve the lives of patients suffering from GI and liver diseases.
Abstract submission window Oct. 15 to Dec. 3, 2020.
AWARD DEADLINES
American Gastroenterological Association (AGA) Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students,or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early-career (that is, 35 years of age or younger at the time of DDW) basic, translational or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations DDW. The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
Survey of Mohs surgeons highlights its use in invasive melanoma
of members of the American College of Mohs Surgery.
Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.
The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.
It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.
With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.
That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.
The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).
There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.
The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.
The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)
Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.
“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.
Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”
Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.
“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.
Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.
The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.
Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.
Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.
SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
of members of the American College of Mohs Surgery.
Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.
The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.
It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.
With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.
That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.
The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).
There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.
The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.
The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)
Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.
“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.
Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”
Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.
“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.
Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.
The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.
Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.
Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.
SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
of members of the American College of Mohs Surgery.
Of 513 survey participants, 40.9% reported using MMS to treat any subtype of melanoma. Most of these surgeons reported treating both lentigo maligna (97.5%) and other melanoma in situ (MIS) subtypes (91.4%). A slight majority – 58.6% – reported treating invasive T1 melanoma, and 20.5% reported treating invasive T2 and/or higher-stage melanoma with MMS.
The analysis, published in Dermatologic Surgery, was done by Spyros M. Siscos, MD, and a team of residents and faculty in the division of dermatology at the University of Kansas Medical Center, Kansas City.
It comes on the heels of an analysis of claims data for Mohs surgery, published last year in JAMA Dermatology, which showed a more than threefold increase in the use of Mohs surgery for melanoma from 2.6% of all surgical cases in 2001 to 7.9% in 2016.
With the increased use of MMS for treatment of melanoma, “Mohs surgeons who previously treated MIS with MMS may be increasingly doing so and/or expanding their scope of treatment to include invasive melanoma,” the University of Kansas investigators wrote.
That a slight majority now report treating invasive melanoma with MMS “may be due, in part, to upstaging during the MMS procedure and the increasing evidence demonstrating improved survival of early-invasive melanoma treated with MMS compared with [wide local excision],” as well as the advent of melanocytic immunohistochemical (IHC) stains, particularly melanoma antigen recognized by T-cells 1 (MART-1), they said. However, 29% of surveyed Mohs surgeons treating melanoma with MMS do not use IHC stains “despite growing evidence supporting” their use, the authors wrote.
The advent of IHC stains, particularly MART-1, has improved the accuracy of interpreting frozen sections of melanoma, they reported, noting that MMS without IHC has been associated with a recurrence rate as high as 33%. Of the 71% who reported using IHC stains, MART-1 was the primary IHC stain for virtually all of them (97.3%).
There was also variation in the number of surgeons who reported debulking MIS. Eighty-two percent take this approach, excising the clinically visible tumor before excising the initial Mohs stage – almost all with a scalpel. More than half of these surgeons – 58.5% – submit the entire debulked MIS specimen for permanent vertical sectioning (breadloafing) to evaluate for deeper tumor invasion.
The others reported submitting the entire debulked specimen for frozen vertical sectioning, or portions of the specimen for both permanent and frozen vertical sectioning. “It is unclear why a minority of surveyed Mohs surgeons reported not debulking MIS,” wrote Dr. Siscos and his colleagues.
The average margin size of the first Mohs stage for MIS was 4.96 ± 1.74 mm, which is at the lower end of the 0.5-1.0 cm range for wide local excision (WLE) recommended by the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology (AAD), according to a clinical practice guideline. (The survey did not investigate initial margins for invasive melanoma treated with MMS.)
Jeremy R. Etzhorn, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and an author of a 2019 claims data analysis of excisional surgery practices for melanoma, said that the new survey findings – like the prior analysis – highlight the variability in approaches to using MMS for melanoma.
“Mohs for melanoma [seems] like a one-liner ... but really, there are [a lot] of different techniques that fall under that umbrella, if you parse out all the variations,” he said in an interview.
Per the 2016 claims analysis, he noted, IHC was used in less than 40% of Mohs surgery cases for melanoma, and there were wide geographic variations. “The biggest critique of Mohs surgery for melanoma over the last two decades has been that it’s hard to see the tumor,” he said. “But with the advent of IHC, that challenge was overcome.”
Surgical excision practices are evolving without the development of best practice guidelines, said Dr. Etzkorn, who is director of clinical research for the University of Pennsylvania dermatologic oncology center. Multisociety guidelines published in 2012 on appropriate use criteria for Mohs surgery do not offer specific recommendations on the use of MMS for invasive melanoma. Nor do guidelines from the AAD and the NCCN, he said.
“What this [new] study highlights and what’s being discussed amongst Moh’s surgeons” is that Mohs for melanoma “has be to be standardized” to some extent and then clinical trials conducted comparing Mohs to conventional excision. The studies that have been published in recent years comparing MMS with WLE for MIS and invasive melanoma are “not gold standard studies,” he said.
Practice guidelines then can be informed by high-quality evidence on its safety and efficacy, he said.
The 513 participants in the newly published survey represent a 31.5% response rate. Invasive T2 and/or higher stage melanoma was more likely to be treated with MMS in academic hospitals, compared with other practice settings (30.2% v. 18.1%), Dr. Siscos and his coauthors reported.
Participants who reported treating melanoma with MMS were more likely to report fellowship exposure and more likely to have received fellowship training on melanocytic IHC stains. The study “highlights the importance of fellowship exposure to MMS and IHC staining for melanoma,” the authors wrote, adding that postfellowship training opportunities in MMS and IHC staining for melanoma may help broaden its use among Mohs surgeons who received inadequate fellowship exposure.
Dr. Siscos and his colleagues reported no significant interest with commercial supporters. Dr. Etzkorn had no disclosures.
SOURCE: Siscos S et al. Dermatol Surg. 2020 Oct;46(10):1267-71.
FROM DERMATOLOGIC SURGERY
Recall widens for diabetes drug metformin
The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.
The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.
Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.
The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.
The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).
The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.
The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.
The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
This article first appeared on WebMD.com.
The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.
The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.
Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.
The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.
The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).
The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.
The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.
The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
This article first appeared on WebMD.com.
The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.
The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.
Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.
The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.
The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).
The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.
The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.
The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
This article first appeared on WebMD.com.
Budesonide orodispersible tablets maintained remissions in EoE
Budesonide orodispersible tablets maintained remissions of eosinophilic esophagitis for 48 weeks in approximately 75% of patients and did not increase the risk for most adverse events, compared with placebo, according to the findings of a multicenter, randomized, double-blind trial.
While prior studies have shown that swallowed topical corticosteroids such as budesonide or fluticasone induce remission in EoE, this is the first multicenter phase 3 study of budesonide orodispersible tablets (BOTs) for maintaining remissions over the long term, wrote Alex Straumann, MD, of the Swiss EoE Research Group and University Hospital Zurich, and associates in Gastroenterology.
Eosinophilic esophagitis is the most common cause of esophageal dysphagia and food impaction. Swallowed topical corticosteroids improve symptoms and inflammation, but the off-label use of formulations developed for airway administration in asthma shows “suboptimal esophageal targeting and efficacy,” the researchers wrote. In the phase 3 EOS-2 trial, twice-daily treatment with 1.0 mg BOTs had induced clinicohistologic remissions in 58% of adults with EoE at 6 weeks and in 85% at 12 weeks.
To study long-term maintenance BOT therapy, the researchers randomly assigned 204 of the remitted patients to 48 weeks of twice-daily BOT 0.5 mg, BOT 1.0 mg, or placebo. There were 68 patients per group. A total of 141 patients completed this double-blind phase, but all 204 were evaluable for the primary analysis. The primary outcome was remission at week 48, defined as freedom from relapse (dysphagia or odynophagia rated as 4 or higher on a 10-point numeric rating scale), histologic relapse (≥48 eosinophils per mm2 high-power field), food impaction requiring endoscopic intervention, and dilation.
After 48 weeks, 51 patients in the 1-mg group (75%) and 50 patients in the 0.5-mg group (73.5%) remained in remission, compared with only three patients in the placebo group (4.4%; both P less than .0001). Patients in the placebo group relapsed after a median of 87 days off BOTs. Overall, BOT therapy was similarly efficacious regardless of factors such as history of allergic diseases, location of inflammation at the start of induction, or concomitant use of proton pump inhibitors. However, patients with inflammation of all three esophageal segments achieved “clinically relevant” greater rates of remission with twice-daily 1.0-mg BOT, compared with twice-daily 0.5-mg BOT (80% vs. 68%). In secondary analyses, rates of histologic relapse were 13.2% with 0.5-mg BOT twice daily, 10.3% with 1.0-mg BOT twice daily, and 90% with placebo, and rates of clinical relapse were 10.3%, 7.4%, and 60.3%, respectively. “Histological remission in the BOT 0.5 and 1.0mg twice daily group was independently maintained in all esophageal segments,” the researchers reported.
Rates of most adverse events were similar across treatment groups, and no serious treatment-emergent adverse events were reported. Average morning serum cortisol levels were similar among groups and did not change after treatment ended, but four patients on BOT therapy developed asymptomatic subnormal levels of morning cortisol. “Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5mg group and in 11.8% of patients in the BOT 1.0mg group; all infections resolved with treatment,” the researchers wrote.
The study and editorial support were funded by Dr. Falk Pharma GmbH, a pharmaceutical company in Germany. Dr. Falk Pharma was involved in the study design and data collection, analysis, and interpretation. Dr. Straumann disclosed fees from several pharmaceutical companies, including Dr. Falk Pharma and AstraZeneca, which makes budesonide. Several other coinvestigators also disclosed ties to Dr. Falk Pharma, AstraZeneca, and other pharmaceutical companies.
SOURCE: Straumann A et al. Gastroenterology. 2020 July 25. doi: 10.1053/j.gastro.2020.07.039.
Eosinophilic esophagitis (EoE) continues to rise in prevalence and prescription steroid therapy is limited to off-label use leading to a call for action for directed therapy for EoE and understanding long-term remission rates. In this phase 3 study, Straumann and colleagues studied budesonide orodispersible tablets (BOTs) and their ability to maintain remission, compared with placebo, at two doses specifically designed for EoE in adults with proton pump inhibitor–refractory EoE. Regardless of dose, at either 1.0 mg twice a day or 0.5 mg twice a day, there was an improvement in maintaining remission (73.5% for low dose and 75% for high dose, compared with 4.4% with placebo) at 48 weeks of therapy. Common side effects studied include an increase in candidiasis (12%-16% of patients), but there was no statistical change in morning cortisol.
Given the need for maintenance therapy for EoE, this study proves long-term efficacy and safety for the treatment of this chronic condition with a targeted esophageal formulation. We now have evidence of maintaining remission for EoE with a safe side-effect profile. Future research will be needed to look at long-term steroid use on bone health and immune dysregulation, especially in the pediatric population, which was not studied in this cohort. Moreover, future studies are needed to determine a minimally effective dose to help prevent potential side effects that can maintain remission while allowing discontinuation of all stable proton pump inhibitor doses to ensure no confounding effect.
Rishi D. Naik, MD, MSCI, is an assistant professor, department of medicine, section of gastroenterology & hepatology, Esophageal Center at Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Eosinophilic esophagitis (EoE) continues to rise in prevalence and prescription steroid therapy is limited to off-label use leading to a call for action for directed therapy for EoE and understanding long-term remission rates. In this phase 3 study, Straumann and colleagues studied budesonide orodispersible tablets (BOTs) and their ability to maintain remission, compared with placebo, at two doses specifically designed for EoE in adults with proton pump inhibitor–refractory EoE. Regardless of dose, at either 1.0 mg twice a day or 0.5 mg twice a day, there was an improvement in maintaining remission (73.5% for low dose and 75% for high dose, compared with 4.4% with placebo) at 48 weeks of therapy. Common side effects studied include an increase in candidiasis (12%-16% of patients), but there was no statistical change in morning cortisol.
Given the need for maintenance therapy for EoE, this study proves long-term efficacy and safety for the treatment of this chronic condition with a targeted esophageal formulation. We now have evidence of maintaining remission for EoE with a safe side-effect profile. Future research will be needed to look at long-term steroid use on bone health and immune dysregulation, especially in the pediatric population, which was not studied in this cohort. Moreover, future studies are needed to determine a minimally effective dose to help prevent potential side effects that can maintain remission while allowing discontinuation of all stable proton pump inhibitor doses to ensure no confounding effect.
Rishi D. Naik, MD, MSCI, is an assistant professor, department of medicine, section of gastroenterology & hepatology, Esophageal Center at Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Eosinophilic esophagitis (EoE) continues to rise in prevalence and prescription steroid therapy is limited to off-label use leading to a call for action for directed therapy for EoE and understanding long-term remission rates. In this phase 3 study, Straumann and colleagues studied budesonide orodispersible tablets (BOTs) and their ability to maintain remission, compared with placebo, at two doses specifically designed for EoE in adults with proton pump inhibitor–refractory EoE. Regardless of dose, at either 1.0 mg twice a day or 0.5 mg twice a day, there was an improvement in maintaining remission (73.5% for low dose and 75% for high dose, compared with 4.4% with placebo) at 48 weeks of therapy. Common side effects studied include an increase in candidiasis (12%-16% of patients), but there was no statistical change in morning cortisol.
Given the need for maintenance therapy for EoE, this study proves long-term efficacy and safety for the treatment of this chronic condition with a targeted esophageal formulation. We now have evidence of maintaining remission for EoE with a safe side-effect profile. Future research will be needed to look at long-term steroid use on bone health and immune dysregulation, especially in the pediatric population, which was not studied in this cohort. Moreover, future studies are needed to determine a minimally effective dose to help prevent potential side effects that can maintain remission while allowing discontinuation of all stable proton pump inhibitor doses to ensure no confounding effect.
Rishi D. Naik, MD, MSCI, is an assistant professor, department of medicine, section of gastroenterology & hepatology, Esophageal Center at Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.
Budesonide orodispersible tablets maintained remissions of eosinophilic esophagitis for 48 weeks in approximately 75% of patients and did not increase the risk for most adverse events, compared with placebo, according to the findings of a multicenter, randomized, double-blind trial.
While prior studies have shown that swallowed topical corticosteroids such as budesonide or fluticasone induce remission in EoE, this is the first multicenter phase 3 study of budesonide orodispersible tablets (BOTs) for maintaining remissions over the long term, wrote Alex Straumann, MD, of the Swiss EoE Research Group and University Hospital Zurich, and associates in Gastroenterology.
Eosinophilic esophagitis is the most common cause of esophageal dysphagia and food impaction. Swallowed topical corticosteroids improve symptoms and inflammation, but the off-label use of formulations developed for airway administration in asthma shows “suboptimal esophageal targeting and efficacy,” the researchers wrote. In the phase 3 EOS-2 trial, twice-daily treatment with 1.0 mg BOTs had induced clinicohistologic remissions in 58% of adults with EoE at 6 weeks and in 85% at 12 weeks.
To study long-term maintenance BOT therapy, the researchers randomly assigned 204 of the remitted patients to 48 weeks of twice-daily BOT 0.5 mg, BOT 1.0 mg, or placebo. There were 68 patients per group. A total of 141 patients completed this double-blind phase, but all 204 were evaluable for the primary analysis. The primary outcome was remission at week 48, defined as freedom from relapse (dysphagia or odynophagia rated as 4 or higher on a 10-point numeric rating scale), histologic relapse (≥48 eosinophils per mm2 high-power field), food impaction requiring endoscopic intervention, and dilation.
After 48 weeks, 51 patients in the 1-mg group (75%) and 50 patients in the 0.5-mg group (73.5%) remained in remission, compared with only three patients in the placebo group (4.4%; both P less than .0001). Patients in the placebo group relapsed after a median of 87 days off BOTs. Overall, BOT therapy was similarly efficacious regardless of factors such as history of allergic diseases, location of inflammation at the start of induction, or concomitant use of proton pump inhibitors. However, patients with inflammation of all three esophageal segments achieved “clinically relevant” greater rates of remission with twice-daily 1.0-mg BOT, compared with twice-daily 0.5-mg BOT (80% vs. 68%). In secondary analyses, rates of histologic relapse were 13.2% with 0.5-mg BOT twice daily, 10.3% with 1.0-mg BOT twice daily, and 90% with placebo, and rates of clinical relapse were 10.3%, 7.4%, and 60.3%, respectively. “Histological remission in the BOT 0.5 and 1.0mg twice daily group was independently maintained in all esophageal segments,” the researchers reported.
Rates of most adverse events were similar across treatment groups, and no serious treatment-emergent adverse events were reported. Average morning serum cortisol levels were similar among groups and did not change after treatment ended, but four patients on BOT therapy developed asymptomatic subnormal levels of morning cortisol. “Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5mg group and in 11.8% of patients in the BOT 1.0mg group; all infections resolved with treatment,” the researchers wrote.
The study and editorial support were funded by Dr. Falk Pharma GmbH, a pharmaceutical company in Germany. Dr. Falk Pharma was involved in the study design and data collection, analysis, and interpretation. Dr. Straumann disclosed fees from several pharmaceutical companies, including Dr. Falk Pharma and AstraZeneca, which makes budesonide. Several other coinvestigators also disclosed ties to Dr. Falk Pharma, AstraZeneca, and other pharmaceutical companies.
SOURCE: Straumann A et al. Gastroenterology. 2020 July 25. doi: 10.1053/j.gastro.2020.07.039.
Budesonide orodispersible tablets maintained remissions of eosinophilic esophagitis for 48 weeks in approximately 75% of patients and did not increase the risk for most adverse events, compared with placebo, according to the findings of a multicenter, randomized, double-blind trial.
While prior studies have shown that swallowed topical corticosteroids such as budesonide or fluticasone induce remission in EoE, this is the first multicenter phase 3 study of budesonide orodispersible tablets (BOTs) for maintaining remissions over the long term, wrote Alex Straumann, MD, of the Swiss EoE Research Group and University Hospital Zurich, and associates in Gastroenterology.
Eosinophilic esophagitis is the most common cause of esophageal dysphagia and food impaction. Swallowed topical corticosteroids improve symptoms and inflammation, but the off-label use of formulations developed for airway administration in asthma shows “suboptimal esophageal targeting and efficacy,” the researchers wrote. In the phase 3 EOS-2 trial, twice-daily treatment with 1.0 mg BOTs had induced clinicohistologic remissions in 58% of adults with EoE at 6 weeks and in 85% at 12 weeks.
To study long-term maintenance BOT therapy, the researchers randomly assigned 204 of the remitted patients to 48 weeks of twice-daily BOT 0.5 mg, BOT 1.0 mg, or placebo. There were 68 patients per group. A total of 141 patients completed this double-blind phase, but all 204 were evaluable for the primary analysis. The primary outcome was remission at week 48, defined as freedom from relapse (dysphagia or odynophagia rated as 4 or higher on a 10-point numeric rating scale), histologic relapse (≥48 eosinophils per mm2 high-power field), food impaction requiring endoscopic intervention, and dilation.
After 48 weeks, 51 patients in the 1-mg group (75%) and 50 patients in the 0.5-mg group (73.5%) remained in remission, compared with only three patients in the placebo group (4.4%; both P less than .0001). Patients in the placebo group relapsed after a median of 87 days off BOTs. Overall, BOT therapy was similarly efficacious regardless of factors such as history of allergic diseases, location of inflammation at the start of induction, or concomitant use of proton pump inhibitors. However, patients with inflammation of all three esophageal segments achieved “clinically relevant” greater rates of remission with twice-daily 1.0-mg BOT, compared with twice-daily 0.5-mg BOT (80% vs. 68%). In secondary analyses, rates of histologic relapse were 13.2% with 0.5-mg BOT twice daily, 10.3% with 1.0-mg BOT twice daily, and 90% with placebo, and rates of clinical relapse were 10.3%, 7.4%, and 60.3%, respectively. “Histological remission in the BOT 0.5 and 1.0mg twice daily group was independently maintained in all esophageal segments,” the researchers reported.
Rates of most adverse events were similar across treatment groups, and no serious treatment-emergent adverse events were reported. Average morning serum cortisol levels were similar among groups and did not change after treatment ended, but four patients on BOT therapy developed asymptomatic subnormal levels of morning cortisol. “Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5mg group and in 11.8% of patients in the BOT 1.0mg group; all infections resolved with treatment,” the researchers wrote.
The study and editorial support were funded by Dr. Falk Pharma GmbH, a pharmaceutical company in Germany. Dr. Falk Pharma was involved in the study design and data collection, analysis, and interpretation. Dr. Straumann disclosed fees from several pharmaceutical companies, including Dr. Falk Pharma and AstraZeneca, which makes budesonide. Several other coinvestigators also disclosed ties to Dr. Falk Pharma, AstraZeneca, and other pharmaceutical companies.
SOURCE: Straumann A et al. Gastroenterology. 2020 July 25. doi: 10.1053/j.gastro.2020.07.039.
FROM GASTROENTEROLOGY
NACMI: Clear benefit with PCI in STEMI COVID-19 patients
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
October 2020 Product News
Express Scripts Covers Rhofade on the National Preferred Formulary
EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.
MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream
MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.
Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis
Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Express Scripts Covers Rhofade on the National Preferred Formulary
EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.
MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream
MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.
Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis
Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Express Scripts Covers Rhofade on the National Preferred Formulary
EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.
MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream
MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.
Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis
Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Caring for patients who experience stillbirth: Dos and don’ts
As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”1 I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.
Inappropriate comments providers make
A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:
“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”
“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”
“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”
Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
Help parents make good memories
Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:
“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”
“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”
“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”
“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”
“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”
“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”
“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”
Don’t use the ‘silver lining’ theme
A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:
“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”
“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”
“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”
“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”
“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”
“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
Handling patient care after the loss
A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.
“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”
“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”
“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”
“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
When the patient returns to the office
The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.
“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”
“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”
“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”
“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”
“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”
“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”
“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
Continuing care in the office
The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.
“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”
“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”
“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”
“Saying nothing is worse than saying you don’t know what to say and you are sorry.”
“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”
Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].
Reference
1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.
As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”1 I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.
Inappropriate comments providers make
A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:
“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”
“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”
“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”
Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
Help parents make good memories
Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:
“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”
“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”
“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”
“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”
“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”
“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”
“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”
Don’t use the ‘silver lining’ theme
A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:
“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”
“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”
“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”
“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”
“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”
“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
Handling patient care after the loss
A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.
“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”
“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”
“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”
“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
When the patient returns to the office
The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.
“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”
“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”
“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”
“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”
“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”
“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”
“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
Continuing care in the office
The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.
“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”
“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”
“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”
“Saying nothing is worse than saying you don’t know what to say and you are sorry.”
“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”
Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].
Reference
1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.
As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”1 I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.
Inappropriate comments providers make
A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:
“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”
“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”
“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”
Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
Help parents make good memories
Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:
“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”
“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”
“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”
“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”
“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”
“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”
“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”
Don’t use the ‘silver lining’ theme
A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:
“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”
“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”
“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”
“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”
“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”
“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
Handling patient care after the loss
A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.
“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”
“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”
“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”
“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
When the patient returns to the office
The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.
“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”
“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”
“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”
“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”
“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”
“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”
“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
Continuing care in the office
The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.
“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”
“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”
“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”
“Saying nothing is worse than saying you don’t know what to say and you are sorry.”
“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”
Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].
Reference
1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.
FDA issues new NSAIDs warning for second half of pregnancy
The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.
Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.
The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.
Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.
Low-dose (81-mg) aspirin is excluded from this warning.
“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.
If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.
As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.
Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.
The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.
Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.
Low-dose (81-mg) aspirin is excluded from this warning.
“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.
If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.
As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.
Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.
The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.
Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.
Low-dose (81-mg) aspirin is excluded from this warning.
“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.
If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.
As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.