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Oral contraceptives may reduce ovarian and endometrial cancer risk 35 years after discontinuation
At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.
The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.
The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.
Reinforcing and extending knowledge
“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”
The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”
Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.
In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.
“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”
For certain patients, the association may be more relevant.
“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”
Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.
“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
Data from the U.K. Biobank
To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.
Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.
The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.
In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).
Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).
“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.
The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.
The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.
The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.
Reinforcing and extending knowledge
“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”
The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”
Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.
In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.
“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”
For certain patients, the association may be more relevant.
“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”
Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.
“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
Data from the U.K. Biobank
To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.
Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.
The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.
In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).
Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).
“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.
The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.
The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.
The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.
Reinforcing and extending knowledge
“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”
The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”
Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.
In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.
“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”
For certain patients, the association may be more relevant.
“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”
Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.
“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
Data from the U.K. Biobank
To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.
Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.
The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.
In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).
Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).
“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.
The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
FROM CANCER RESEARCH
Study flags cardiovascular disease in men with breast cancer
.
Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.
Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.
Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.
“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.
The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.
Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.
To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.
Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.
Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.
A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.
Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.
Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.
The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.
In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).
An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.
Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.
In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.
“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
.
Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.
Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.
Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.
“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.
The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.
Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.
To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.
Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.
Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.
A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.
Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.
Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.
The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.
In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).
An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.
Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.
In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.
“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
.
Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.
Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.
Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.
“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.
The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.
Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.
To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.
Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.
Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.
A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.
Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.
Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.
The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.
In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).
An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.
Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.
In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.
“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Plant-based or keto diet? Novel study yields surprising results
For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.
In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.
“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.
The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.
In this study, Dr. Hall and colleagues tested these two hypotheses head to head.
“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.
“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”
The study was published online Jan. 21, 2021 in Nature Medicine.
Pros and cons to both diets
For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m2.
The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g−1), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g−1) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.
Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.
One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.
They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d−1, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.
Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.
“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.
“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.
Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.
“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.
“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
Diet ‘tribes’
In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.
“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”
Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”
The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.
A version of this article first appeared on Medscape.com.
For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.
In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.
“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.
The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.
In this study, Dr. Hall and colleagues tested these two hypotheses head to head.
“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.
“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”
The study was published online Jan. 21, 2021 in Nature Medicine.
Pros and cons to both diets
For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m2.
The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g−1), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g−1) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.
Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.
One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.
They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d−1, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.
Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.
“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.
“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.
Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.
“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.
“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
Diet ‘tribes’
In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.
“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”
Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”
The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.
A version of this article first appeared on Medscape.com.
For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.
In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.
“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.
The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.
In this study, Dr. Hall and colleagues tested these two hypotheses head to head.
“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.
“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”
The study was published online Jan. 21, 2021 in Nature Medicine.
Pros and cons to both diets
For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m2.
The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g−1), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g−1) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.
Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.
One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.
They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d−1, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.
Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.
“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.
“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.
Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.
“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.
“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
Diet ‘tribes’
In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.
“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”
Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”
The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.
A version of this article first appeared on Medscape.com.
Algorithm trims time to treatment of acute hypertension in pregnancy
Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.
Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.
Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.
In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.
The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
Timely treatment improves with algorithm
Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.
The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.
However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
Algorithm may reduce disparities
The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.
In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.
In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.
“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
Need to create culture of safety
“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.
The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.
“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”
The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.
In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.
Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.
Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.
Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.
In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.
The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
Timely treatment improves with algorithm
Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.
The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.
However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
Algorithm may reduce disparities
The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.
In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.
In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.
“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
Need to create culture of safety
“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.
The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.
“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”
The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.
In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.
Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.
Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.
Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.
In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.
The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
Timely treatment improves with algorithm
Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.
The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.
However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
Algorithm may reduce disparities
The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.
In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.
In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.
“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
Need to create culture of safety
“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.
The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.
“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”
The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.
In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.
FROM OBSTETRICS & GYNECOLOGY
Obesity ‘clearly’ not tied to worse survival in metastatic breast cancer
First large cohort study
The relationship between obesity and overweight and breast cancer has some elements of mystery. But this is not one of them: in metastatic breast cancer (MBC), excess body weight does not negatively influence outcomes.
Multiple small studies have demonstrated this point, and now, for the first time, a large multicenter cohort analysis indicates the same.
Using medical records from 18 French comprehensive cancer centers, investigators reviewed body mass index (BMI) and overall survival (OS) data for nearly 13,000 women. The median OS was 47.4 months, and the median follow-up was about the same length of time. The team reports that obesity and overweight “were clearly not associated with prognosis.”
However, underweight was independently associated with worse OS (median, 33 months; hazard ratio, 1.14; 95% confidence interval, 1.02-1.27), report Khalil Saleh, MD, of Gustave Roussy in Villejuif, France, and colleagues.
In short, obesity or overweight had no effect on the primary outcome of OS, but underweight did.
“Underweight should be the subject of clinical attention at the time of diagnosis of MBC, and specific management should be implemented,” said study author Elise Deluche, MD, of CHU de Limoges, in an email to this news organization.
The study was published online Dec. 1 in The Breast.
“It’s really wonderful to have such a large cohort to look at this question,” said Jennifer Ligibel, MD, of the Dana-Farber Cancer Institute, Boston, who was asked for comment.
Is this another case of obesity paradox in cancer (as in renal cell carcinoma and melanoma, where excess weight is tied to better cancer-specific survival)?
No, said Dr. Ligibel: “There’s no hint at all [in this study] that people with obesity and overweight did better. … They just didn’t have worse outcomes.”
The study authors point out that the opposite is true in early-stage breast cancer. In this patient population, excess weight is associated with worse outcomes.
For example, in a 2014 meta-analysis of 82 follow-up studies in early-stage disease, obesity was associated with higher total mortality (relative risk, 1.41) and breast cancer–specific mortality (RR, 1.35) as compared to normal weight.
Why is there such a contrast between early- and late-stage disease?
“I don’t think we know exactly,” answered Dr. Ligibel. “It may be that, with breast cancer, as disease progresses, the pathways through which lifestyle may impact breast cancer may become less important.
“Obesity and overweight are associated with cancer risk in general,” said Dr. Ligibel, citing more than a dozen malignancies, including breast cancer.
But there is also an age element. Overweight or obesity is an independent predictor of breast cancer risk in postmenopausal women, but in premenopausal women, it appears to be protective. “Historically, there has been a lower risk of hormone receptor–positive breast cancer in women with obesity at younger ages that we don’t completely understand,” Dr. Ligibel noted.
That age-based difference is a conundrum, said Dr. Ligibel: “People have been trying to figure that out for a long time.”
Dr. Ligibel summarized as follows:
“There is a clear relationship between obesity and the risk of developing breast cancer; there is a clear relationship in early breast cancer that obesity is related to an increased risk of occurrence and mortality. What we are seeing from this study is that, by the time you get to metastatic breast cancer, body weight does not seem to play as important a role.”
More study details
The findings come from the French National Epidemiological Strategy and Medical Economics–Metastatic Breast Cancer observational cohort, which includes 22,000-plus consecutive patients who were newly diagnosed with metastatic disease between 2008 and 2016.
A total of 12,999 women for whom BMI data were available when they were diagnosed with metastatic breast cancer were selected for analysis. They were divided into four groups, according to World Health Organization classification: underweight (BMI <18.5 kg/m2), normal weight (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0).
A total of 20% of women were obese, which is a much lower percentage than the 40%-50% that would be expected in a comparable American cohort, said Dr. Ligibel. Also, 5% of the French cohort was underweight.
Multivariate Cox analyses were carried out for OS and for first-line progression-free survival (PFS).
As noted above, underweight was independently associated with a worse OS. It was also tied to worse first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight or obesity had no effect.
“Patients with a low BMI had more visceral metastases and a greater number of metastatic sites,” pointed out study author Dr. Deluche. “We attribute the fat loss in patients with metastatic breast cancer to aggressive tumor behavior with a higher energy requirement.”
The study authors also observe that in early-stage breast cancer, underweight is not associated with overall or breast cancer–specific survival. “Underweight at metastatic diagnosis seems to have a different significance and impact,” they write. The French team also observes that, in other cancers, underweight is also an adverse prognostic factor and has been associated with a higher risk for death.
The study authors acknowledge that BMI has limitations as a measure of body type. “BMI alone cannot estimate a woman’s muscle mass and adiposity,” they observe. The suggestion is that, among women with a similar BMI, some might be muscular, whereas others might have more body fat.
Multiple study authors report financial ties to industry, including pharmaceutical companies with drugs used in breast cancer. The database used in the study receives financial support from AstraZeneca, Daiichi Sankyo, Eisai, MSD, Pfizer, and Roche. Dr. Ligibel reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
First large cohort study
First large cohort study
The relationship between obesity and overweight and breast cancer has some elements of mystery. But this is not one of them: in metastatic breast cancer (MBC), excess body weight does not negatively influence outcomes.
Multiple small studies have demonstrated this point, and now, for the first time, a large multicenter cohort analysis indicates the same.
Using medical records from 18 French comprehensive cancer centers, investigators reviewed body mass index (BMI) and overall survival (OS) data for nearly 13,000 women. The median OS was 47.4 months, and the median follow-up was about the same length of time. The team reports that obesity and overweight “were clearly not associated with prognosis.”
However, underweight was independently associated with worse OS (median, 33 months; hazard ratio, 1.14; 95% confidence interval, 1.02-1.27), report Khalil Saleh, MD, of Gustave Roussy in Villejuif, France, and colleagues.
In short, obesity or overweight had no effect on the primary outcome of OS, but underweight did.
“Underweight should be the subject of clinical attention at the time of diagnosis of MBC, and specific management should be implemented,” said study author Elise Deluche, MD, of CHU de Limoges, in an email to this news organization.
The study was published online Dec. 1 in The Breast.
“It’s really wonderful to have such a large cohort to look at this question,” said Jennifer Ligibel, MD, of the Dana-Farber Cancer Institute, Boston, who was asked for comment.
Is this another case of obesity paradox in cancer (as in renal cell carcinoma and melanoma, where excess weight is tied to better cancer-specific survival)?
No, said Dr. Ligibel: “There’s no hint at all [in this study] that people with obesity and overweight did better. … They just didn’t have worse outcomes.”
The study authors point out that the opposite is true in early-stage breast cancer. In this patient population, excess weight is associated with worse outcomes.
For example, in a 2014 meta-analysis of 82 follow-up studies in early-stage disease, obesity was associated with higher total mortality (relative risk, 1.41) and breast cancer–specific mortality (RR, 1.35) as compared to normal weight.
Why is there such a contrast between early- and late-stage disease?
“I don’t think we know exactly,” answered Dr. Ligibel. “It may be that, with breast cancer, as disease progresses, the pathways through which lifestyle may impact breast cancer may become less important.
“Obesity and overweight are associated with cancer risk in general,” said Dr. Ligibel, citing more than a dozen malignancies, including breast cancer.
But there is also an age element. Overweight or obesity is an independent predictor of breast cancer risk in postmenopausal women, but in premenopausal women, it appears to be protective. “Historically, there has been a lower risk of hormone receptor–positive breast cancer in women with obesity at younger ages that we don’t completely understand,” Dr. Ligibel noted.
That age-based difference is a conundrum, said Dr. Ligibel: “People have been trying to figure that out for a long time.”
Dr. Ligibel summarized as follows:
“There is a clear relationship between obesity and the risk of developing breast cancer; there is a clear relationship in early breast cancer that obesity is related to an increased risk of occurrence and mortality. What we are seeing from this study is that, by the time you get to metastatic breast cancer, body weight does not seem to play as important a role.”
More study details
The findings come from the French National Epidemiological Strategy and Medical Economics–Metastatic Breast Cancer observational cohort, which includes 22,000-plus consecutive patients who were newly diagnosed with metastatic disease between 2008 and 2016.
A total of 12,999 women for whom BMI data were available when they were diagnosed with metastatic breast cancer were selected for analysis. They were divided into four groups, according to World Health Organization classification: underweight (BMI <18.5 kg/m2), normal weight (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0).
A total of 20% of women were obese, which is a much lower percentage than the 40%-50% that would be expected in a comparable American cohort, said Dr. Ligibel. Also, 5% of the French cohort was underweight.
Multivariate Cox analyses were carried out for OS and for first-line progression-free survival (PFS).
As noted above, underweight was independently associated with a worse OS. It was also tied to worse first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight or obesity had no effect.
“Patients with a low BMI had more visceral metastases and a greater number of metastatic sites,” pointed out study author Dr. Deluche. “We attribute the fat loss in patients with metastatic breast cancer to aggressive tumor behavior with a higher energy requirement.”
The study authors also observe that in early-stage breast cancer, underweight is not associated with overall or breast cancer–specific survival. “Underweight at metastatic diagnosis seems to have a different significance and impact,” they write. The French team also observes that, in other cancers, underweight is also an adverse prognostic factor and has been associated with a higher risk for death.
The study authors acknowledge that BMI has limitations as a measure of body type. “BMI alone cannot estimate a woman’s muscle mass and adiposity,” they observe. The suggestion is that, among women with a similar BMI, some might be muscular, whereas others might have more body fat.
Multiple study authors report financial ties to industry, including pharmaceutical companies with drugs used in breast cancer. The database used in the study receives financial support from AstraZeneca, Daiichi Sankyo, Eisai, MSD, Pfizer, and Roche. Dr. Ligibel reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The relationship between obesity and overweight and breast cancer has some elements of mystery. But this is not one of them: in metastatic breast cancer (MBC), excess body weight does not negatively influence outcomes.
Multiple small studies have demonstrated this point, and now, for the first time, a large multicenter cohort analysis indicates the same.
Using medical records from 18 French comprehensive cancer centers, investigators reviewed body mass index (BMI) and overall survival (OS) data for nearly 13,000 women. The median OS was 47.4 months, and the median follow-up was about the same length of time. The team reports that obesity and overweight “were clearly not associated with prognosis.”
However, underweight was independently associated with worse OS (median, 33 months; hazard ratio, 1.14; 95% confidence interval, 1.02-1.27), report Khalil Saleh, MD, of Gustave Roussy in Villejuif, France, and colleagues.
In short, obesity or overweight had no effect on the primary outcome of OS, but underweight did.
“Underweight should be the subject of clinical attention at the time of diagnosis of MBC, and specific management should be implemented,” said study author Elise Deluche, MD, of CHU de Limoges, in an email to this news organization.
The study was published online Dec. 1 in The Breast.
“It’s really wonderful to have such a large cohort to look at this question,” said Jennifer Ligibel, MD, of the Dana-Farber Cancer Institute, Boston, who was asked for comment.
Is this another case of obesity paradox in cancer (as in renal cell carcinoma and melanoma, where excess weight is tied to better cancer-specific survival)?
No, said Dr. Ligibel: “There’s no hint at all [in this study] that people with obesity and overweight did better. … They just didn’t have worse outcomes.”
The study authors point out that the opposite is true in early-stage breast cancer. In this patient population, excess weight is associated with worse outcomes.
For example, in a 2014 meta-analysis of 82 follow-up studies in early-stage disease, obesity was associated with higher total mortality (relative risk, 1.41) and breast cancer–specific mortality (RR, 1.35) as compared to normal weight.
Why is there such a contrast between early- and late-stage disease?
“I don’t think we know exactly,” answered Dr. Ligibel. “It may be that, with breast cancer, as disease progresses, the pathways through which lifestyle may impact breast cancer may become less important.
“Obesity and overweight are associated with cancer risk in general,” said Dr. Ligibel, citing more than a dozen malignancies, including breast cancer.
But there is also an age element. Overweight or obesity is an independent predictor of breast cancer risk in postmenopausal women, but in premenopausal women, it appears to be protective. “Historically, there has been a lower risk of hormone receptor–positive breast cancer in women with obesity at younger ages that we don’t completely understand,” Dr. Ligibel noted.
That age-based difference is a conundrum, said Dr. Ligibel: “People have been trying to figure that out for a long time.”
Dr. Ligibel summarized as follows:
“There is a clear relationship between obesity and the risk of developing breast cancer; there is a clear relationship in early breast cancer that obesity is related to an increased risk of occurrence and mortality. What we are seeing from this study is that, by the time you get to metastatic breast cancer, body weight does not seem to play as important a role.”
More study details
The findings come from the French National Epidemiological Strategy and Medical Economics–Metastatic Breast Cancer observational cohort, which includes 22,000-plus consecutive patients who were newly diagnosed with metastatic disease between 2008 and 2016.
A total of 12,999 women for whom BMI data were available when they were diagnosed with metastatic breast cancer were selected for analysis. They were divided into four groups, according to World Health Organization classification: underweight (BMI <18.5 kg/m2), normal weight (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0).
A total of 20% of women were obese, which is a much lower percentage than the 40%-50% that would be expected in a comparable American cohort, said Dr. Ligibel. Also, 5% of the French cohort was underweight.
Multivariate Cox analyses were carried out for OS and for first-line progression-free survival (PFS).
As noted above, underweight was independently associated with a worse OS. It was also tied to worse first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight or obesity had no effect.
“Patients with a low BMI had more visceral metastases and a greater number of metastatic sites,” pointed out study author Dr. Deluche. “We attribute the fat loss in patients with metastatic breast cancer to aggressive tumor behavior with a higher energy requirement.”
The study authors also observe that in early-stage breast cancer, underweight is not associated with overall or breast cancer–specific survival. “Underweight at metastatic diagnosis seems to have a different significance and impact,” they write. The French team also observes that, in other cancers, underweight is also an adverse prognostic factor and has been associated with a higher risk for death.
The study authors acknowledge that BMI has limitations as a measure of body type. “BMI alone cannot estimate a woman’s muscle mass and adiposity,” they observe. The suggestion is that, among women with a similar BMI, some might be muscular, whereas others might have more body fat.
Multiple study authors report financial ties to industry, including pharmaceutical companies with drugs used in breast cancer. The database used in the study receives financial support from AstraZeneca, Daiichi Sankyo, Eisai, MSD, Pfizer, and Roche. Dr. Ligibel reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Rapid shifts in radiotherapy for cancer in response to COVID-19
Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.
The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.
“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).
“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.
“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.
The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).
Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.
On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).
Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.
The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.
There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.
This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.
“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.
“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.
The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
Shorter radiotherapy regimen for breast cancer
In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.
One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.
These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.
Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.
The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.
“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”
The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.
What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.
“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.
“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
Radiotherapy remains reduced
Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.
“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.
“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”
By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”
The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.
No funding for the study was declared. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.
The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.
“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).
“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.
“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.
The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).
Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.
On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).
Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.
The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.
There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.
This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.
“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.
“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.
The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
Shorter radiotherapy regimen for breast cancer
In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.
One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.
These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.
Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.
The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.
“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”
The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.
What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.
“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.
“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
Radiotherapy remains reduced
Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.
“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.
“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”
By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”
The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.
No funding for the study was declared. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.
The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.
“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).
“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.
“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.
The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).
Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.
On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).
Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.
The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.
There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.
This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.
“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.
“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.
The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
Shorter radiotherapy regimen for breast cancer
In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.
One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.
These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.
Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.
The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.
“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”
The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.
What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.
“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.
“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
Radiotherapy remains reduced
Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.
“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.
“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”
By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”
The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.
No funding for the study was declared. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
‘Category 5’ COVID hurricane approaches, expert says
The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.
“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.
The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.
Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”
Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.
Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.
“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.
The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.
“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”
A version of this article first appeared on WebMD.com.
The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.
“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.
The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.
Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”
Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.
Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.
“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.
The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.
“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”
A version of this article first appeared on WebMD.com.
The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.
“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.
The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.
Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”
Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.
Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.
“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.
The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.
“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”
A version of this article first appeared on WebMD.com.
Tough pain relief choices in the COVID-19 pandemic
More people with fever and body aches are turning to NSAIDs to ease symptoms, but the drugs have come under new scrutiny as investigators work to determine whether they are a safe way to relieve the pain of COVID-19 vaccination or symptoms of the disease.
Early on in the pandemic, French health officials warned that NSAIDs, such as ibuprofen, could worsen coronavirus disease, and they recommended switching to acetaminophen instead.
The National Health Service in the United Kingdom followed with a similar recommendation for acetaminophen.
But the European Medicines Agency took a different approach, reporting “no scientific evidence” that NSAIDs could worsen COVID-19. The U.S. Food and Drug Administration also opted not to take a stance.
The debate prompted discussion on social media, with various reactions from around the world. It also inspired Craig Wilen, MD, PhD, from Yale University, New Haven, Conn., and associates to examine the effect of NSAIDs on COVID-19 infection and immune response. Their findings were published online Jan.20 in the Journal of Virology.
“It really bothered me that non–evidence-based decisions were driving the conversation,” Dr. Wilen said. “Millions of people are taking NSAIDs every day and clinical decisions about their care shouldn’t be made on a hypothesis.”
One theory is that NSAIDs alter susceptibility to infection by modifying ACE2. The drugs might also change the cell entry receptor for SARS-CoV-2, alter virus replication, or even modify the immune response.
British researchers, also questioning the safety of NSAIDs in patients with COVID-19, delved into National Health Service records to study two large groups of patients, some of whom were taking the pain relievers.
“We were watching the controversy and the lack of evidence and wanted to contribute,” lead investigator Angel Wong, PhD, from the London School of Hygiene and Tropical Medicine, said in an interview.
And with nearly 11 million NSAID prescriptions dispensed in primary care in England alone in the past 12 months, the inconsistency was concerning.
The team compared COVID-19–related deaths in two groups: one group of more than 700,000 people taking NSAIDs, including patients with rheumatoid arthritis and osteoarthritis; and another of almost 3.5 million people not on the medication.
NSAIDs work by inhibiting cyclooxygenase-1 and COX-2 enzymes in the body, which are crucial for the generation of prostaglandins. These lipid molecules play a role in inflammation and are blocked by NSAIDs.
The investigators found no evidence of a harmful effect of NSAIDs on COVID-19-related deaths; their results were published online Jan. 21 in the Annals of the Rheumatic Diseases.
The results, they pointed out, are in line with a Danish study that also showed no evidence of a higher risk for severe COVID-19 outcomes with NSAID use.
“It’s reassuring,” Dr. Wong said, “that patients can safely continue treatment.”
More new evidence
Dr. Wilen’s team found that SARS-CoV-2 infection stimulated COX-2 expression in human and mice cells. However, suppression of COX-2 by two commonly used NSAIDs, ibuprofen and meloxicam, had no effect on ACE2 expression, viral entry, or viral replication.
In their mouse model of SARS-CoV-2 infection, the investigators saw that NSAIDs impaired the production of proinflammatory cytokines and neutralizing antibodies. The findings suggest that NSAIDs influence COVID-19 outcomes by dampening the inflammatory response and production of protective antibodies, rather than modifying susceptibility to infection or viral replication.
Understanding the effect of NSAIDs on cytokine production is critical, Dr. Wilen pointed out, because they might be protective early in COVID-19 but pathologic at later stages.
Timing is crucial in the case of other immunomodulatory drugs. For example, dexamethasone lowers mortality in COVID-19 patients on respiratory support but is potentially harmful for those with milder disease.
There still is a lot to learn, Dr. Wilen acknowledged. “We may be seeing something similar going on with NSAIDs, where the timing of treatment is important.”
A version of this article first appeared on Medscape.com.
More people with fever and body aches are turning to NSAIDs to ease symptoms, but the drugs have come under new scrutiny as investigators work to determine whether they are a safe way to relieve the pain of COVID-19 vaccination or symptoms of the disease.
Early on in the pandemic, French health officials warned that NSAIDs, such as ibuprofen, could worsen coronavirus disease, and they recommended switching to acetaminophen instead.
The National Health Service in the United Kingdom followed with a similar recommendation for acetaminophen.
But the European Medicines Agency took a different approach, reporting “no scientific evidence” that NSAIDs could worsen COVID-19. The U.S. Food and Drug Administration also opted not to take a stance.
The debate prompted discussion on social media, with various reactions from around the world. It also inspired Craig Wilen, MD, PhD, from Yale University, New Haven, Conn., and associates to examine the effect of NSAIDs on COVID-19 infection and immune response. Their findings were published online Jan.20 in the Journal of Virology.
“It really bothered me that non–evidence-based decisions were driving the conversation,” Dr. Wilen said. “Millions of people are taking NSAIDs every day and clinical decisions about their care shouldn’t be made on a hypothesis.”
One theory is that NSAIDs alter susceptibility to infection by modifying ACE2. The drugs might also change the cell entry receptor for SARS-CoV-2, alter virus replication, or even modify the immune response.
British researchers, also questioning the safety of NSAIDs in patients with COVID-19, delved into National Health Service records to study two large groups of patients, some of whom were taking the pain relievers.
“We were watching the controversy and the lack of evidence and wanted to contribute,” lead investigator Angel Wong, PhD, from the London School of Hygiene and Tropical Medicine, said in an interview.
And with nearly 11 million NSAID prescriptions dispensed in primary care in England alone in the past 12 months, the inconsistency was concerning.
The team compared COVID-19–related deaths in two groups: one group of more than 700,000 people taking NSAIDs, including patients with rheumatoid arthritis and osteoarthritis; and another of almost 3.5 million people not on the medication.
NSAIDs work by inhibiting cyclooxygenase-1 and COX-2 enzymes in the body, which are crucial for the generation of prostaglandins. These lipid molecules play a role in inflammation and are blocked by NSAIDs.
The investigators found no evidence of a harmful effect of NSAIDs on COVID-19-related deaths; their results were published online Jan. 21 in the Annals of the Rheumatic Diseases.
The results, they pointed out, are in line with a Danish study that also showed no evidence of a higher risk for severe COVID-19 outcomes with NSAID use.
“It’s reassuring,” Dr. Wong said, “that patients can safely continue treatment.”
More new evidence
Dr. Wilen’s team found that SARS-CoV-2 infection stimulated COX-2 expression in human and mice cells. However, suppression of COX-2 by two commonly used NSAIDs, ibuprofen and meloxicam, had no effect on ACE2 expression, viral entry, or viral replication.
In their mouse model of SARS-CoV-2 infection, the investigators saw that NSAIDs impaired the production of proinflammatory cytokines and neutralizing antibodies. The findings suggest that NSAIDs influence COVID-19 outcomes by dampening the inflammatory response and production of protective antibodies, rather than modifying susceptibility to infection or viral replication.
Understanding the effect of NSAIDs on cytokine production is critical, Dr. Wilen pointed out, because they might be protective early in COVID-19 but pathologic at later stages.
Timing is crucial in the case of other immunomodulatory drugs. For example, dexamethasone lowers mortality in COVID-19 patients on respiratory support but is potentially harmful for those with milder disease.
There still is a lot to learn, Dr. Wilen acknowledged. “We may be seeing something similar going on with NSAIDs, where the timing of treatment is important.”
A version of this article first appeared on Medscape.com.
More people with fever and body aches are turning to NSAIDs to ease symptoms, but the drugs have come under new scrutiny as investigators work to determine whether they are a safe way to relieve the pain of COVID-19 vaccination or symptoms of the disease.
Early on in the pandemic, French health officials warned that NSAIDs, such as ibuprofen, could worsen coronavirus disease, and they recommended switching to acetaminophen instead.
The National Health Service in the United Kingdom followed with a similar recommendation for acetaminophen.
But the European Medicines Agency took a different approach, reporting “no scientific evidence” that NSAIDs could worsen COVID-19. The U.S. Food and Drug Administration also opted not to take a stance.
The debate prompted discussion on social media, with various reactions from around the world. It also inspired Craig Wilen, MD, PhD, from Yale University, New Haven, Conn., and associates to examine the effect of NSAIDs on COVID-19 infection and immune response. Their findings were published online Jan.20 in the Journal of Virology.
“It really bothered me that non–evidence-based decisions were driving the conversation,” Dr. Wilen said. “Millions of people are taking NSAIDs every day and clinical decisions about their care shouldn’t be made on a hypothesis.”
One theory is that NSAIDs alter susceptibility to infection by modifying ACE2. The drugs might also change the cell entry receptor for SARS-CoV-2, alter virus replication, or even modify the immune response.
British researchers, also questioning the safety of NSAIDs in patients with COVID-19, delved into National Health Service records to study two large groups of patients, some of whom were taking the pain relievers.
“We were watching the controversy and the lack of evidence and wanted to contribute,” lead investigator Angel Wong, PhD, from the London School of Hygiene and Tropical Medicine, said in an interview.
And with nearly 11 million NSAID prescriptions dispensed in primary care in England alone in the past 12 months, the inconsistency was concerning.
The team compared COVID-19–related deaths in two groups: one group of more than 700,000 people taking NSAIDs, including patients with rheumatoid arthritis and osteoarthritis; and another of almost 3.5 million people not on the medication.
NSAIDs work by inhibiting cyclooxygenase-1 and COX-2 enzymes in the body, which are crucial for the generation of prostaglandins. These lipid molecules play a role in inflammation and are blocked by NSAIDs.
The investigators found no evidence of a harmful effect of NSAIDs on COVID-19-related deaths; their results were published online Jan. 21 in the Annals of the Rheumatic Diseases.
The results, they pointed out, are in line with a Danish study that also showed no evidence of a higher risk for severe COVID-19 outcomes with NSAID use.
“It’s reassuring,” Dr. Wong said, “that patients can safely continue treatment.”
More new evidence
Dr. Wilen’s team found that SARS-CoV-2 infection stimulated COX-2 expression in human and mice cells. However, suppression of COX-2 by two commonly used NSAIDs, ibuprofen and meloxicam, had no effect on ACE2 expression, viral entry, or viral replication.
In their mouse model of SARS-CoV-2 infection, the investigators saw that NSAIDs impaired the production of proinflammatory cytokines and neutralizing antibodies. The findings suggest that NSAIDs influence COVID-19 outcomes by dampening the inflammatory response and production of protective antibodies, rather than modifying susceptibility to infection or viral replication.
Understanding the effect of NSAIDs on cytokine production is critical, Dr. Wilen pointed out, because they might be protective early in COVID-19 but pathologic at later stages.
Timing is crucial in the case of other immunomodulatory drugs. For example, dexamethasone lowers mortality in COVID-19 patients on respiratory support but is potentially harmful for those with milder disease.
There still is a lot to learn, Dr. Wilen acknowledged. “We may be seeing something similar going on with NSAIDs, where the timing of treatment is important.”
A version of this article first appeared on Medscape.com.
Dr. Fauci sees ‘wake-up call’ in emergence of new virus variants
New data on COVID-19 vaccines should serve as a “wake-up call” about the need to stop the spread of the SARS-CoV-2 virus among people and thus deprive it of opportunities to evolve its defenses, the top federal expert on infectious diseases said.
“The virus will continue to mutate and will mutate for its own selective advantage,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, at a Friday news conference organized by the White House.
The continued transmission of SARS-CoV-2 “gives the virus the chance to adapt to the forces, in this case the immune response, that’s trying to get rid of it,” Dr. Fauci said. “That’s where you get mutations.”
Federal health officials are working to boost the U.S. supply of COVID-19 vaccines, even as signals emerge about the extent that the virus is already evolving.
Data released this week about the Janssen/Johnson & Johnson (J&J) and Novavax COVID-19 vaccines in late-stage development provides further evidence that they may not protect as well against emerging variants, Dr. Fauci said.
“Mutations that lead to different lineage do have clinical consequences,” he said, while also emphasizing that the emerging vaccines appear to confer broad protection. Dr. Fauci earlier in the day addressed the “messaging challenge” for clinicians and researchers in discussing the results of the J&J vaccine trial, which appear to fall short of those reported for the two vaccines already approved and in use in the United States. He noted the benefits of possibly soon having more authorized vaccines to combat COVID-19. But continued community spread of the infection will foster conditions that can undermine the vaccines’ effectiveness.
“Even though the long-range effect in the sense of severe disease is still handled reasonably well by the vaccines, this is a wake-up call to all of us,” Dr. Fauci said.
Pharmaceutical scientists and executives and government health officials will need to work together to continue to develop vaccines that can outwit the emerging variants, he said.
On Jan. 29, J&J reported that its highly anticipated single-dose vaccine had shown its worst results in South Africa where many cases of COVID-19 were caused by infection with a SARS-CoV-2 variant from the B.1.351 lineage. The overall efficacy was 66% globally, 72% in the United States, and 57% in South Africa against moderate to severe SARS-CoV-2, J&J said.
Novavax on Jan. 28 reported an efficacy rate for its COVID-19 vaccine of 49.4% from a clinical trial conducted in South Africa, compared with an 89.3% rate from a U.K. study. There already have been attempts to estimate how well the Pfizer/BioNTech and Moderna vaccines can handle new variants of the virus. They both have been granted emergency-use authorization by the U.S. Food and Drug Administration.
‘Genomic surveillance’
The Centers for Disease Control and Prevention on Thursday reported the first U.S.-documented cases of the B.1.351 variant of SARS-CoV-2 in South Carolina. On Jan. 26, the first confirmed U.S. case of a highly transmissible Brazilian coronavirus variant was detected in Minnesota, state health officials said.
The CDC’s stepped-up “genomic surveillance” will help keep clinicians and researchers aware of how SARS-CoV-2 is changing, Dr. Fauci said.
Speaking at the same White House news conference, CDC director Rochelle Walensky, MD, MPH, said the two South Carolina cases of the B.1.351 variant were reported in different parts of the state and not believed to be epidemiologically linked. The people involved “did not have any travel history,” she added.
The SARS-CoV-2 mutations were expected to emerge at some point, as with any virus, but their appearance underscores the need for people to remain vigilant about precautions that can stop its spread, Dr. Walensky said.
She and Dr. Fauci both stressed the need for continued use of masks and social distancing and urged people to get COVID-19 vaccines as they become available. Continued community spread of the virus allows this global health threat to keep replicating, and thus increases its chances to thwart medical interventions, Dr. Fauci said.
“The virus has a playing field, as it were, to mutate,” Dr. Fauci said. “If you stop that and stop the replication, the viruses cannot mutate if they don’t replicate.”
A version of this article first appeared on Medscape.com.
New data on COVID-19 vaccines should serve as a “wake-up call” about the need to stop the spread of the SARS-CoV-2 virus among people and thus deprive it of opportunities to evolve its defenses, the top federal expert on infectious diseases said.
“The virus will continue to mutate and will mutate for its own selective advantage,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, at a Friday news conference organized by the White House.
The continued transmission of SARS-CoV-2 “gives the virus the chance to adapt to the forces, in this case the immune response, that’s trying to get rid of it,” Dr. Fauci said. “That’s where you get mutations.”
Federal health officials are working to boost the U.S. supply of COVID-19 vaccines, even as signals emerge about the extent that the virus is already evolving.
Data released this week about the Janssen/Johnson & Johnson (J&J) and Novavax COVID-19 vaccines in late-stage development provides further evidence that they may not protect as well against emerging variants, Dr. Fauci said.
“Mutations that lead to different lineage do have clinical consequences,” he said, while also emphasizing that the emerging vaccines appear to confer broad protection. Dr. Fauci earlier in the day addressed the “messaging challenge” for clinicians and researchers in discussing the results of the J&J vaccine trial, which appear to fall short of those reported for the two vaccines already approved and in use in the United States. He noted the benefits of possibly soon having more authorized vaccines to combat COVID-19. But continued community spread of the infection will foster conditions that can undermine the vaccines’ effectiveness.
“Even though the long-range effect in the sense of severe disease is still handled reasonably well by the vaccines, this is a wake-up call to all of us,” Dr. Fauci said.
Pharmaceutical scientists and executives and government health officials will need to work together to continue to develop vaccines that can outwit the emerging variants, he said.
On Jan. 29, J&J reported that its highly anticipated single-dose vaccine had shown its worst results in South Africa where many cases of COVID-19 were caused by infection with a SARS-CoV-2 variant from the B.1.351 lineage. The overall efficacy was 66% globally, 72% in the United States, and 57% in South Africa against moderate to severe SARS-CoV-2, J&J said.
Novavax on Jan. 28 reported an efficacy rate for its COVID-19 vaccine of 49.4% from a clinical trial conducted in South Africa, compared with an 89.3% rate from a U.K. study. There already have been attempts to estimate how well the Pfizer/BioNTech and Moderna vaccines can handle new variants of the virus. They both have been granted emergency-use authorization by the U.S. Food and Drug Administration.
‘Genomic surveillance’
The Centers for Disease Control and Prevention on Thursday reported the first U.S.-documented cases of the B.1.351 variant of SARS-CoV-2 in South Carolina. On Jan. 26, the first confirmed U.S. case of a highly transmissible Brazilian coronavirus variant was detected in Minnesota, state health officials said.
The CDC’s stepped-up “genomic surveillance” will help keep clinicians and researchers aware of how SARS-CoV-2 is changing, Dr. Fauci said.
Speaking at the same White House news conference, CDC director Rochelle Walensky, MD, MPH, said the two South Carolina cases of the B.1.351 variant were reported in different parts of the state and not believed to be epidemiologically linked. The people involved “did not have any travel history,” she added.
The SARS-CoV-2 mutations were expected to emerge at some point, as with any virus, but their appearance underscores the need for people to remain vigilant about precautions that can stop its spread, Dr. Walensky said.
She and Dr. Fauci both stressed the need for continued use of masks and social distancing and urged people to get COVID-19 vaccines as they become available. Continued community spread of the virus allows this global health threat to keep replicating, and thus increases its chances to thwart medical interventions, Dr. Fauci said.
“The virus has a playing field, as it were, to mutate,” Dr. Fauci said. “If you stop that and stop the replication, the viruses cannot mutate if they don’t replicate.”
A version of this article first appeared on Medscape.com.
New data on COVID-19 vaccines should serve as a “wake-up call” about the need to stop the spread of the SARS-CoV-2 virus among people and thus deprive it of opportunities to evolve its defenses, the top federal expert on infectious diseases said.
“The virus will continue to mutate and will mutate for its own selective advantage,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, at a Friday news conference organized by the White House.
The continued transmission of SARS-CoV-2 “gives the virus the chance to adapt to the forces, in this case the immune response, that’s trying to get rid of it,” Dr. Fauci said. “That’s where you get mutations.”
Federal health officials are working to boost the U.S. supply of COVID-19 vaccines, even as signals emerge about the extent that the virus is already evolving.
Data released this week about the Janssen/Johnson & Johnson (J&J) and Novavax COVID-19 vaccines in late-stage development provides further evidence that they may not protect as well against emerging variants, Dr. Fauci said.
“Mutations that lead to different lineage do have clinical consequences,” he said, while also emphasizing that the emerging vaccines appear to confer broad protection. Dr. Fauci earlier in the day addressed the “messaging challenge” for clinicians and researchers in discussing the results of the J&J vaccine trial, which appear to fall short of those reported for the two vaccines already approved and in use in the United States. He noted the benefits of possibly soon having more authorized vaccines to combat COVID-19. But continued community spread of the infection will foster conditions that can undermine the vaccines’ effectiveness.
“Even though the long-range effect in the sense of severe disease is still handled reasonably well by the vaccines, this is a wake-up call to all of us,” Dr. Fauci said.
Pharmaceutical scientists and executives and government health officials will need to work together to continue to develop vaccines that can outwit the emerging variants, he said.
On Jan. 29, J&J reported that its highly anticipated single-dose vaccine had shown its worst results in South Africa where many cases of COVID-19 were caused by infection with a SARS-CoV-2 variant from the B.1.351 lineage. The overall efficacy was 66% globally, 72% in the United States, and 57% in South Africa against moderate to severe SARS-CoV-2, J&J said.
Novavax on Jan. 28 reported an efficacy rate for its COVID-19 vaccine of 49.4% from a clinical trial conducted in South Africa, compared with an 89.3% rate from a U.K. study. There already have been attempts to estimate how well the Pfizer/BioNTech and Moderna vaccines can handle new variants of the virus. They both have been granted emergency-use authorization by the U.S. Food and Drug Administration.
‘Genomic surveillance’
The Centers for Disease Control and Prevention on Thursday reported the first U.S.-documented cases of the B.1.351 variant of SARS-CoV-2 in South Carolina. On Jan. 26, the first confirmed U.S. case of a highly transmissible Brazilian coronavirus variant was detected in Minnesota, state health officials said.
The CDC’s stepped-up “genomic surveillance” will help keep clinicians and researchers aware of how SARS-CoV-2 is changing, Dr. Fauci said.
Speaking at the same White House news conference, CDC director Rochelle Walensky, MD, MPH, said the two South Carolina cases of the B.1.351 variant were reported in different parts of the state and not believed to be epidemiologically linked. The people involved “did not have any travel history,” she added.
The SARS-CoV-2 mutations were expected to emerge at some point, as with any virus, but their appearance underscores the need for people to remain vigilant about precautions that can stop its spread, Dr. Walensky said.
She and Dr. Fauci both stressed the need for continued use of masks and social distancing and urged people to get COVID-19 vaccines as they become available. Continued community spread of the virus allows this global health threat to keep replicating, and thus increases its chances to thwart medical interventions, Dr. Fauci said.
“The virus has a playing field, as it were, to mutate,” Dr. Fauci said. “If you stop that and stop the replication, the viruses cannot mutate if they don’t replicate.”
A version of this article first appeared on Medscape.com.
The COVID-19 virus may prompt the body to attack itself
An international team of researchers studying COVID-19 has made a startling and pivotal discovery: The virus appears to cause the body to make weapons to attack its own tissues.
The finding could unlock a number of COVID-19’s clinical mysteries. They include the puzzling collection of symptoms that can come with the infection; the persistence of symptoms in some people for months after they clear the virus, a phenomenon dubbed long COVID-19; and why some children and adults have a serious inflammatory syndrome, called multisystem inflammatory syndrome in children (MIS-C) or MIS in adults (MIS-A), after their infections.
“It suggests that the virus might be directly causing autoimmunity, which would be fascinating,” says lead study author Paul Utz, MD, who studies immunology and autoimmunity at Stanford (Calif.) University.
The study also deepens the question of whether other respiratory viruses might also break the body’s tolerance to itself, setting people up for autoimmune diseases like multiple sclerosis, rheumatoid arthritis, and lupus later in life.
Dr. Utz said he and his team are next going to study flu patients to see if that virus might also cause this phenomenon.
“My prediction is that it isn’t going to be specific just to SARS-CoV-2. I’m willing to bet that we will find this with other respiratory viruses,” he said.
The study comes on the heels of a handful of smaller, detailed investigations that have come to similar conclusions.
The study included data from more than 300 patients from four hospitals: two in California, one in Pennsylvania, and another in Germany.
Researchers used blood tests to study their immune responses as their infections progressed. Researchers looked for autoantibodies – weapons of the immune system that go rogue and launch an attack against the body’s own tissues. They compared these autoantibodies with those found in people who were not infected with the virus that causes COVID.
As previous studies have found, autoantibodies were more common after COVID – 50% of people hospitalized for their infections had autoantibodies, compared with less than 15% of those who were healthy and uninfected.
Some people with autoantibodies had little change in them as their infections progressed. That suggests the autoantibodies were there to begin with, possibly allowing the infection to burn out of control in the body.
“Their body is set up to get bad COVID, and it’s probably caused by the autoantibodies,” Dr. Utz said.
But in others, about 20% of people who had them, the autoantibodies became more common as the infection progressed, suggesting they were directly related to the viral infection, instead of being a preexisting condition.
Some of these were antibodies that attack key components of the immune system’s weapons against the virus, like interferon. Interferons are proteins that help infected cells call for reinforcements and can also interfere with a virus’s ability to copy itself. Taking them out is a powerful evasive tactic, and previous studies have shown that people who are born with genes that cause them to have lower interferon function, or who make autoantibodies against these proteins, appear to be at higher risk for life-threatening COVID infections.
“It seems to give the virus a powerful advantage,” said study author, John Wherry, PhD, who directs the Institute for Immunology at the University of Pennsylvania, Philadelphia. “Now your immune system, instead of having a tiny little hill to climb, is staring at Mount Everest. That really is devious.”
In addition to those that sabotage the immune system, some people in the study had autoantibodies against muscles and connective tissues that are seen in some rare disorders.
Dr. Utz said they started the study after seeing COVID patients with strange collections of symptoms that looked more like autoimmune diseases than viral infections – skin rashes, joint pain, fatigue, aching muscles, brain swelling, dry eyes, blood that clots easily, and inflamed blood vessels.
“One thing that’s very important to note is that we don’t know if these patients are going to go on to develop autoimmune disease,” Dr. Utz said. “I think we’ll be able to answer that question in the next 6-12 months as we follow the long haulers and study their samples.”
Dr. Utz said it will be important to study autoantibodies in long haulers to see if they can identify exactly which ones seem to be at work in the condition. If you can catch them early, it might be possible to treat those at risk for enduring symptoms with drugs that suppress the immune system.
What this means, he said, is that COVID will be with us for a long, long time.
“We have to realize that there’s going to be long-term damage from this virus for the survivors. Not just the long haulers, but all the people who have lung damage and heart damage and everything else. We’re going to be studying this virus and it’s badness for decades,” Dr. Utz said.
A version of this article first appeared on WebMD.com.
An international team of researchers studying COVID-19 has made a startling and pivotal discovery: The virus appears to cause the body to make weapons to attack its own tissues.
The finding could unlock a number of COVID-19’s clinical mysteries. They include the puzzling collection of symptoms that can come with the infection; the persistence of symptoms in some people for months after they clear the virus, a phenomenon dubbed long COVID-19; and why some children and adults have a serious inflammatory syndrome, called multisystem inflammatory syndrome in children (MIS-C) or MIS in adults (MIS-A), after their infections.
“It suggests that the virus might be directly causing autoimmunity, which would be fascinating,” says lead study author Paul Utz, MD, who studies immunology and autoimmunity at Stanford (Calif.) University.
The study also deepens the question of whether other respiratory viruses might also break the body’s tolerance to itself, setting people up for autoimmune diseases like multiple sclerosis, rheumatoid arthritis, and lupus later in life.
Dr. Utz said he and his team are next going to study flu patients to see if that virus might also cause this phenomenon.
“My prediction is that it isn’t going to be specific just to SARS-CoV-2. I’m willing to bet that we will find this with other respiratory viruses,” he said.
The study comes on the heels of a handful of smaller, detailed investigations that have come to similar conclusions.
The study included data from more than 300 patients from four hospitals: two in California, one in Pennsylvania, and another in Germany.
Researchers used blood tests to study their immune responses as their infections progressed. Researchers looked for autoantibodies – weapons of the immune system that go rogue and launch an attack against the body’s own tissues. They compared these autoantibodies with those found in people who were not infected with the virus that causes COVID.
As previous studies have found, autoantibodies were more common after COVID – 50% of people hospitalized for their infections had autoantibodies, compared with less than 15% of those who were healthy and uninfected.
Some people with autoantibodies had little change in them as their infections progressed. That suggests the autoantibodies were there to begin with, possibly allowing the infection to burn out of control in the body.
“Their body is set up to get bad COVID, and it’s probably caused by the autoantibodies,” Dr. Utz said.
But in others, about 20% of people who had them, the autoantibodies became more common as the infection progressed, suggesting they were directly related to the viral infection, instead of being a preexisting condition.
Some of these were antibodies that attack key components of the immune system’s weapons against the virus, like interferon. Interferons are proteins that help infected cells call for reinforcements and can also interfere with a virus’s ability to copy itself. Taking them out is a powerful evasive tactic, and previous studies have shown that people who are born with genes that cause them to have lower interferon function, or who make autoantibodies against these proteins, appear to be at higher risk for life-threatening COVID infections.
“It seems to give the virus a powerful advantage,” said study author, John Wherry, PhD, who directs the Institute for Immunology at the University of Pennsylvania, Philadelphia. “Now your immune system, instead of having a tiny little hill to climb, is staring at Mount Everest. That really is devious.”
In addition to those that sabotage the immune system, some people in the study had autoantibodies against muscles and connective tissues that are seen in some rare disorders.
Dr. Utz said they started the study after seeing COVID patients with strange collections of symptoms that looked more like autoimmune diseases than viral infections – skin rashes, joint pain, fatigue, aching muscles, brain swelling, dry eyes, blood that clots easily, and inflamed blood vessels.
“One thing that’s very important to note is that we don’t know if these patients are going to go on to develop autoimmune disease,” Dr. Utz said. “I think we’ll be able to answer that question in the next 6-12 months as we follow the long haulers and study their samples.”
Dr. Utz said it will be important to study autoantibodies in long haulers to see if they can identify exactly which ones seem to be at work in the condition. If you can catch them early, it might be possible to treat those at risk for enduring symptoms with drugs that suppress the immune system.
What this means, he said, is that COVID will be with us for a long, long time.
“We have to realize that there’s going to be long-term damage from this virus for the survivors. Not just the long haulers, but all the people who have lung damage and heart damage and everything else. We’re going to be studying this virus and it’s badness for decades,” Dr. Utz said.
A version of this article first appeared on WebMD.com.
An international team of researchers studying COVID-19 has made a startling and pivotal discovery: The virus appears to cause the body to make weapons to attack its own tissues.
The finding could unlock a number of COVID-19’s clinical mysteries. They include the puzzling collection of symptoms that can come with the infection; the persistence of symptoms in some people for months after they clear the virus, a phenomenon dubbed long COVID-19; and why some children and adults have a serious inflammatory syndrome, called multisystem inflammatory syndrome in children (MIS-C) or MIS in adults (MIS-A), after their infections.
“It suggests that the virus might be directly causing autoimmunity, which would be fascinating,” says lead study author Paul Utz, MD, who studies immunology and autoimmunity at Stanford (Calif.) University.
The study also deepens the question of whether other respiratory viruses might also break the body’s tolerance to itself, setting people up for autoimmune diseases like multiple sclerosis, rheumatoid arthritis, and lupus later in life.
Dr. Utz said he and his team are next going to study flu patients to see if that virus might also cause this phenomenon.
“My prediction is that it isn’t going to be specific just to SARS-CoV-2. I’m willing to bet that we will find this with other respiratory viruses,” he said.
The study comes on the heels of a handful of smaller, detailed investigations that have come to similar conclusions.
The study included data from more than 300 patients from four hospitals: two in California, one in Pennsylvania, and another in Germany.
Researchers used blood tests to study their immune responses as their infections progressed. Researchers looked for autoantibodies – weapons of the immune system that go rogue and launch an attack against the body’s own tissues. They compared these autoantibodies with those found in people who were not infected with the virus that causes COVID.
As previous studies have found, autoantibodies were more common after COVID – 50% of people hospitalized for their infections had autoantibodies, compared with less than 15% of those who were healthy and uninfected.
Some people with autoantibodies had little change in them as their infections progressed. That suggests the autoantibodies were there to begin with, possibly allowing the infection to burn out of control in the body.
“Their body is set up to get bad COVID, and it’s probably caused by the autoantibodies,” Dr. Utz said.
But in others, about 20% of people who had them, the autoantibodies became more common as the infection progressed, suggesting they were directly related to the viral infection, instead of being a preexisting condition.
Some of these were antibodies that attack key components of the immune system’s weapons against the virus, like interferon. Interferons are proteins that help infected cells call for reinforcements and can also interfere with a virus’s ability to copy itself. Taking them out is a powerful evasive tactic, and previous studies have shown that people who are born with genes that cause them to have lower interferon function, or who make autoantibodies against these proteins, appear to be at higher risk for life-threatening COVID infections.
“It seems to give the virus a powerful advantage,” said study author, John Wherry, PhD, who directs the Institute for Immunology at the University of Pennsylvania, Philadelphia. “Now your immune system, instead of having a tiny little hill to climb, is staring at Mount Everest. That really is devious.”
In addition to those that sabotage the immune system, some people in the study had autoantibodies against muscles and connective tissues that are seen in some rare disorders.
Dr. Utz said they started the study after seeing COVID patients with strange collections of symptoms that looked more like autoimmune diseases than viral infections – skin rashes, joint pain, fatigue, aching muscles, brain swelling, dry eyes, blood that clots easily, and inflamed blood vessels.
“One thing that’s very important to note is that we don’t know if these patients are going to go on to develop autoimmune disease,” Dr. Utz said. “I think we’ll be able to answer that question in the next 6-12 months as we follow the long haulers and study their samples.”
Dr. Utz said it will be important to study autoantibodies in long haulers to see if they can identify exactly which ones seem to be at work in the condition. If you can catch them early, it might be possible to treat those at risk for enduring symptoms with drugs that suppress the immune system.
What this means, he said, is that COVID will be with us for a long, long time.
“We have to realize that there’s going to be long-term damage from this virus for the survivors. Not just the long haulers, but all the people who have lung damage and heart damage and everything else. We’re going to be studying this virus and it’s badness for decades,” Dr. Utz said.
A version of this article first appeared on WebMD.com.