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Vaginal cleansing protocol curbs deep SSIs after cesarean
reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.
“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists..
Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.
“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.
The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.
A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
Cleansing protocol reduces SSIs
Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).
The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
Data sharing boosts compliance
In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.
When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.
The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.
Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”
The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.
The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.
reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.
“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists..
Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.
“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.
The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.
A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
Cleansing protocol reduces SSIs
Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).
The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
Data sharing boosts compliance
In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.
When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.
The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.
Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”
The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.
The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.
reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.
“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists..
Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.
“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.
The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.
A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
Cleansing protocol reduces SSIs
Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).
The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
Data sharing boosts compliance
In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.
When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.
The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.
Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”
The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.
The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.
FROM ACOG 2020
Mortality higher in older adults hospitalized for IBD
Adults older than 65 years with inflammatory bowel diseases (IBD) had significantly higher rates of inpatient mortality, compared with those younger than 65 years, independent of factors including disease severity, based on data from more than 200,000 hospital admissions.
Older adults use a disproportionate share of health care resources, but data on outcomes among hospitalized older adults with gastrointestinal illness are limited, Jeffrey Schwartz, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, and colleagues wrote in the Journal of Clinical Gastroenterology.
“In particular, there remains a significant concern that elderly patients are more susceptible to the development of opportunistic infections and malignancy in the setting of biological therapy, which has evolved into the standard of care for IBD over the past 10 years,” they wrote.
In their study, the researchers identified 162,800 hospital admissions for Crohn’s disease and 96,450 admissions for ulcerative colitis. Of these, 20% and 30%, respectively, were older than 65 years, which the researchers designated as the geriatric group.
In a multivariate analysis, age older than 65 years was significantly associated with increased mortality in both Crohn’s disease (odds ratio, 3.47; 95% confidence interval, 2.72-4.44; P < .001) and ulcerative colitis (OR, 2.75; 95% CI, 2.16-3.49; P < .001). The association was independent of factors included comorbidities, admission type, hospital type, inpatient surgery, and IBD subtype.
The most frequent cause of death in both groups across all ages and disease subtypes was infections (approximately 80% for all groups). The total hospital length of stay was significantly longer for geriatric patients, compared with younger patients with Crohn’s disease, in multivariate analysis (average increase, 0.19 days; P = .009). The total charges also were significantly higher among geriatric Crohn’s disease patients, compared with younger patients (average increase, $2,467; P = .012). No significant differences in hospital stay or total charges appeared between geriatric and younger patients with ulcerative colitis.
The study findings were limited by several factors such as the inclusion of older patients with IBD who were hospitalized for other reasons and by the potential for increased mortality because of comorbidities among elderly patients, the researchers noted. However, the findings support the limited data from similar previous studies and showed greater inpatient mortality for older adults with IBD, compared with hospital inpatients overall.
“Given the high prevalence of IBD patients that require inpatient admission, as well as the rapidly aging nature of the U.S. population, further studies are needed targeting geriatric patients with UC [ulcerative colitis] and CD [Crohn’s disease] to improve their overall management and quality of care to determine if this mortality risk can be reduced,” they concluded.
Tune in to risks in older adults
The study is important because the percentage of the population older than 65 years has been increasing; “at the same time, we are seeing more elderly patients being newly diagnosed with Crohn’s disease and ulcerative colitis,” said Russell D. Cohen, MD, of the University of Chicago, in an interview. “These patients are more vulnerable to complications of the diseases, such as infections, as well as complications from the medications used to treat these diseases.” However, older adults are often excluded from clinical trials and even from many observational studies in IBD, he noted.
“We have known from past studies that infections such as sepsis are a leading cause of death in our IBD patients,” said Dr. Cohen. “It is also understandable that those patients who have had complicated courses and those with other comorbidities have a higher mortality rate. However, what was surprising in the current study is that, even when the authors controlled for these factors, the geriatric patients still had two and three-quarters to three and a half times the mortality than those who were younger.”
The take-home message for clinicians is that “the geriatric patient with IBD is at a much higher rate for inpatient mortality, most commonly from infectious complications, than younger patients,” Dr. Cohen emphasized. “Quicker attention to what may seem minor but could become a potentially life-threatening infection is imperative. Caution with the use of multiple immune suppressing medications in older patients is paramount, as is timely surgical intervention in IBD patients in whom medications simply are not working.”
Focus research on infection prevention, cost burden
“More research should be directed at finding out whether these deadly infections could be prevented, perhaps by preventative ‘prophylactic’ antibiotics in the elderly patients, especially those on multiple immunosuppressive agents,” said Dr. Cohen. “In addition, research into the undue cost burden that these patients place on our health care system and counter that with better access to the newer, safer biological therapies [most of which Medicare does not cover] rather than corticosteroids.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Cohen disclosed relationships with multiple companies including AbbVie, Bristol-Myers Squibb/Celgene, Eli Lilly, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB Pharma.
SOURCE: Schwartz J et al. J Clin Gastroenterol. 2020 Nov 23. doi: 10.1097/MCG.0000000000001458.
Adults older than 65 years with inflammatory bowel diseases (IBD) had significantly higher rates of inpatient mortality, compared with those younger than 65 years, independent of factors including disease severity, based on data from more than 200,000 hospital admissions.
Older adults use a disproportionate share of health care resources, but data on outcomes among hospitalized older adults with gastrointestinal illness are limited, Jeffrey Schwartz, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, and colleagues wrote in the Journal of Clinical Gastroenterology.
“In particular, there remains a significant concern that elderly patients are more susceptible to the development of opportunistic infections and malignancy in the setting of biological therapy, which has evolved into the standard of care for IBD over the past 10 years,” they wrote.
In their study, the researchers identified 162,800 hospital admissions for Crohn’s disease and 96,450 admissions for ulcerative colitis. Of these, 20% and 30%, respectively, were older than 65 years, which the researchers designated as the geriatric group.
In a multivariate analysis, age older than 65 years was significantly associated with increased mortality in both Crohn’s disease (odds ratio, 3.47; 95% confidence interval, 2.72-4.44; P < .001) and ulcerative colitis (OR, 2.75; 95% CI, 2.16-3.49; P < .001). The association was independent of factors included comorbidities, admission type, hospital type, inpatient surgery, and IBD subtype.
The most frequent cause of death in both groups across all ages and disease subtypes was infections (approximately 80% for all groups). The total hospital length of stay was significantly longer for geriatric patients, compared with younger patients with Crohn’s disease, in multivariate analysis (average increase, 0.19 days; P = .009). The total charges also were significantly higher among geriatric Crohn’s disease patients, compared with younger patients (average increase, $2,467; P = .012). No significant differences in hospital stay or total charges appeared between geriatric and younger patients with ulcerative colitis.
The study findings were limited by several factors such as the inclusion of older patients with IBD who were hospitalized for other reasons and by the potential for increased mortality because of comorbidities among elderly patients, the researchers noted. However, the findings support the limited data from similar previous studies and showed greater inpatient mortality for older adults with IBD, compared with hospital inpatients overall.
“Given the high prevalence of IBD patients that require inpatient admission, as well as the rapidly aging nature of the U.S. population, further studies are needed targeting geriatric patients with UC [ulcerative colitis] and CD [Crohn’s disease] to improve their overall management and quality of care to determine if this mortality risk can be reduced,” they concluded.
Tune in to risks in older adults
The study is important because the percentage of the population older than 65 years has been increasing; “at the same time, we are seeing more elderly patients being newly diagnosed with Crohn’s disease and ulcerative colitis,” said Russell D. Cohen, MD, of the University of Chicago, in an interview. “These patients are more vulnerable to complications of the diseases, such as infections, as well as complications from the medications used to treat these diseases.” However, older adults are often excluded from clinical trials and even from many observational studies in IBD, he noted.
“We have known from past studies that infections such as sepsis are a leading cause of death in our IBD patients,” said Dr. Cohen. “It is also understandable that those patients who have had complicated courses and those with other comorbidities have a higher mortality rate. However, what was surprising in the current study is that, even when the authors controlled for these factors, the geriatric patients still had two and three-quarters to three and a half times the mortality than those who were younger.”
The take-home message for clinicians is that “the geriatric patient with IBD is at a much higher rate for inpatient mortality, most commonly from infectious complications, than younger patients,” Dr. Cohen emphasized. “Quicker attention to what may seem minor but could become a potentially life-threatening infection is imperative. Caution with the use of multiple immune suppressing medications in older patients is paramount, as is timely surgical intervention in IBD patients in whom medications simply are not working.”
Focus research on infection prevention, cost burden
“More research should be directed at finding out whether these deadly infections could be prevented, perhaps by preventative ‘prophylactic’ antibiotics in the elderly patients, especially those on multiple immunosuppressive agents,” said Dr. Cohen. “In addition, research into the undue cost burden that these patients place on our health care system and counter that with better access to the newer, safer biological therapies [most of which Medicare does not cover] rather than corticosteroids.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Cohen disclosed relationships with multiple companies including AbbVie, Bristol-Myers Squibb/Celgene, Eli Lilly, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB Pharma.
SOURCE: Schwartz J et al. J Clin Gastroenterol. 2020 Nov 23. doi: 10.1097/MCG.0000000000001458.
Adults older than 65 years with inflammatory bowel diseases (IBD) had significantly higher rates of inpatient mortality, compared with those younger than 65 years, independent of factors including disease severity, based on data from more than 200,000 hospital admissions.
Older adults use a disproportionate share of health care resources, but data on outcomes among hospitalized older adults with gastrointestinal illness are limited, Jeffrey Schwartz, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, and colleagues wrote in the Journal of Clinical Gastroenterology.
“In particular, there remains a significant concern that elderly patients are more susceptible to the development of opportunistic infections and malignancy in the setting of biological therapy, which has evolved into the standard of care for IBD over the past 10 years,” they wrote.
In their study, the researchers identified 162,800 hospital admissions for Crohn’s disease and 96,450 admissions for ulcerative colitis. Of these, 20% and 30%, respectively, were older than 65 years, which the researchers designated as the geriatric group.
In a multivariate analysis, age older than 65 years was significantly associated with increased mortality in both Crohn’s disease (odds ratio, 3.47; 95% confidence interval, 2.72-4.44; P < .001) and ulcerative colitis (OR, 2.75; 95% CI, 2.16-3.49; P < .001). The association was independent of factors included comorbidities, admission type, hospital type, inpatient surgery, and IBD subtype.
The most frequent cause of death in both groups across all ages and disease subtypes was infections (approximately 80% for all groups). The total hospital length of stay was significantly longer for geriatric patients, compared with younger patients with Crohn’s disease, in multivariate analysis (average increase, 0.19 days; P = .009). The total charges also were significantly higher among geriatric Crohn’s disease patients, compared with younger patients (average increase, $2,467; P = .012). No significant differences in hospital stay or total charges appeared between geriatric and younger patients with ulcerative colitis.
The study findings were limited by several factors such as the inclusion of older patients with IBD who were hospitalized for other reasons and by the potential for increased mortality because of comorbidities among elderly patients, the researchers noted. However, the findings support the limited data from similar previous studies and showed greater inpatient mortality for older adults with IBD, compared with hospital inpatients overall.
“Given the high prevalence of IBD patients that require inpatient admission, as well as the rapidly aging nature of the U.S. population, further studies are needed targeting geriatric patients with UC [ulcerative colitis] and CD [Crohn’s disease] to improve their overall management and quality of care to determine if this mortality risk can be reduced,” they concluded.
Tune in to risks in older adults
The study is important because the percentage of the population older than 65 years has been increasing; “at the same time, we are seeing more elderly patients being newly diagnosed with Crohn’s disease and ulcerative colitis,” said Russell D. Cohen, MD, of the University of Chicago, in an interview. “These patients are more vulnerable to complications of the diseases, such as infections, as well as complications from the medications used to treat these diseases.” However, older adults are often excluded from clinical trials and even from many observational studies in IBD, he noted.
“We have known from past studies that infections such as sepsis are a leading cause of death in our IBD patients,” said Dr. Cohen. “It is also understandable that those patients who have had complicated courses and those with other comorbidities have a higher mortality rate. However, what was surprising in the current study is that, even when the authors controlled for these factors, the geriatric patients still had two and three-quarters to three and a half times the mortality than those who were younger.”
The take-home message for clinicians is that “the geriatric patient with IBD is at a much higher rate for inpatient mortality, most commonly from infectious complications, than younger patients,” Dr. Cohen emphasized. “Quicker attention to what may seem minor but could become a potentially life-threatening infection is imperative. Caution with the use of multiple immune suppressing medications in older patients is paramount, as is timely surgical intervention in IBD patients in whom medications simply are not working.”
Focus research on infection prevention, cost burden
“More research should be directed at finding out whether these deadly infections could be prevented, perhaps by preventative ‘prophylactic’ antibiotics in the elderly patients, especially those on multiple immunosuppressive agents,” said Dr. Cohen. “In addition, research into the undue cost burden that these patients place on our health care system and counter that with better access to the newer, safer biological therapies [most of which Medicare does not cover] rather than corticosteroids.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Cohen disclosed relationships with multiple companies including AbbVie, Bristol-Myers Squibb/Celgene, Eli Lilly, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB Pharma.
SOURCE: Schwartz J et al. J Clin Gastroenterol. 2020 Nov 23. doi: 10.1097/MCG.0000000000001458.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Obesity, hypoxia predict severity in children with COVID-19
based on data from 281 patients at 8 locations.
Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.
In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
Independent predictors of disease severity in children found
After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).
“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.
Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.
During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.
“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.
“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.
The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.
“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
Findings confirm other clinical experience
The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.
Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”
Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.
The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.
SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.
based on data from 281 patients at 8 locations.
Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.
In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
Independent predictors of disease severity in children found
After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).
“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.
Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.
During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.
“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.
“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.
The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.
“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
Findings confirm other clinical experience
The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.
Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”
Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.
The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.
SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.
based on data from 281 patients at 8 locations.
Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.
In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
Independent predictors of disease severity in children found
After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).
“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.
Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.
During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.
“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.
“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.
The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.
“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
Findings confirm other clinical experience
The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.
Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”
Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.
The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.
SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.
FROM THE JOURNAL OF PEDIATRICS
COVID-19 impacts women’s contraception choices
The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.
“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.
“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
Help patients feel empowered
Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.
The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.
A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.
ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.
ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.
“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
Consider MEC categories for contraception
When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.
Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.
“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”
For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.
Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.
Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
Annovera offers more options
The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.
During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.
Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”
As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
IUDs appropriate for younger women
When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.
Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”
“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.
Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.
The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.
“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.
“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
Help patients feel empowered
Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.
The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.
A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.
ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.
ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.
“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
Consider MEC categories for contraception
When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.
Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.
“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”
For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.
Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.
Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
Annovera offers more options
The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.
During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.
Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”
As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
IUDs appropriate for younger women
When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.
Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”
“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.
Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.
The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.
“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.
“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
Help patients feel empowered
Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.
The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.
A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.
ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.
ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.
“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
Consider MEC categories for contraception
When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.
Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.
“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”
For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.
Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.
Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
Annovera offers more options
The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.
During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.
Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”
As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
IUDs appropriate for younger women
When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.
Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”
“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.
Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.
EXPERT ANALYSIS FROM ACOG 2020
Menstrual cup use increases risk of IUD expulsion
Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.
Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.
“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.
The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.
At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
Patient behavior persists despite advisory
Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).
The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).
In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).
Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.
Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
More data to come from further analysis
During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.
“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”
When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.
Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.
The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.
The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.
Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.
Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.
“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.
The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.
At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
Patient behavior persists despite advisory
Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).
The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).
In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).
Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.
Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
More data to come from further analysis
During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.
“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”
When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.
Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.
The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.
The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.
Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.
Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.
Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.
“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.
The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.
At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
Patient behavior persists despite advisory
Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).
The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).
In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).
Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.
Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
More data to come from further analysis
During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.
“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”
When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.
Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.
The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.
The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.
FROM ACOG 2020
Real acupuncture beat sham for osteoarthritis knee pain
Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.
The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.
In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.
The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.
Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.
Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.
Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.
The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.
However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”
Optimal dosing questions remain
Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.
The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.
“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”
The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.
SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.
Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.
The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.
In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.
The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.
Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.
Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.
Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.
The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.
However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”
Optimal dosing questions remain
Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.
The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.
“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”
The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.
SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.
Electro-acupuncture resulted in significant improvement in pain and function, compared with sham acupuncture, in a randomized trial of more than 400 adults with knee OA.
The socioeconomic burden of knee OA (KOA) remains high, and will likely increase with the aging population and rising rates of obesity, wrote first author Jian-Feng Tu, MD, PhD, of Beijing University of Chinese Medicine and colleagues. “Since no disease-modifying pharmaceutical agents have been approved, current KOA treatments are mainly symptomatic,” and identifying new therapies in addition to pharmacological agents or surgery is a research priority, they added. The research on acupuncture as a treatment for KOA has increased, but remains controversial as researchers attempt to determine the number of sessions needed for effectiveness.
In a study published in Arthritis & Rheumatology, the researchers recruited 480 adults aged 45-75 years with confirmed KOA who reported knee pain for longer than 6 months. Participants were randomized to three groups: electroacupuncture (EA), manual acupuncture (MA), or sham acupuncture (SA). Each group received three treatment sessions per week. In all groups, electrodes were attached to selected acupuncture needles, but the current was turned on only in the EA treatment group.
The primary outcome was the response rate after 8 weeks of treatment, defined as patients who achieved the minimal clinically important improvement (MCII) on both the Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index function subscale.
Overall, response rates at 8 weeks were 60.3%, 58.6%, and 47.3% for the EA, MA, and SA groups, respectively.
Between-group differences were statistically significant for EA versus SA (13%, P = .0234) but not for MA versus SA (11.3%, P = .0507) at 8 weeks; however, both EA and MA groups showed significantly higher response rates, compared with the SA group at 16 and 26 weeks. “Although a clinically meaningful response rate for KOA is not available in the literature, the difference of 11.3%, which indicates the number needed to treat of 9, is acceptable in clinical practices,” the researchers noted.
Adverse events occurred in 11.5% of the EA group, 14.2% of the MA group, and 10.8% of the SA group, and included subcutaneous hematoma, post-needling pain, and pantalgia. All adverse events related to acupuncture resolved within a week and none were serious, the researchers wrote.
The study findings were limited by several factors, including the potential burden on patients of three sessions per week, the limited study population of patients with radiologic grades of II or III only, the use of self-reports, and the lack of blinding for outcome assessors, the researchers noted.
However, the results show persistent effects in reducing pain and improving function with EA or MA, compared with SA, the researchers wrote. The findings were strengthened by “adequate dosage of acupuncture, the use of the primary outcome at an individual level, and the rigorous methodology.” The use of the MCII in the primary outcome “can provide patients and policy makers with more straightforward information to decide whether a treatment should be used.”
Optimal dosing questions remain
Current options for managing KOA are limited by factors that include low efficacy and unwanted side effects, while joint replacements increase the burden on health care systems, wrote David J. Hunter, MBBS, PhD, of the University of Sydney, and Richard E. Harris, PhD, of the University of Michigan, Ann Arbor, in an accompanying editorial. “In this context, development of new treatments or identification of efficacy of existing therapies to address the huge unmet need of pain are strongly desired.” Acupuncture continues to gain popularity in North and South America, but its efficacy for pain and KOA remain controversial.
The question of dose is challenging when assessing acupuncture because the optimal dose and how to classify it remains unknown. “In this study, the authors used three treatments a week, which is more frequent than typical studies done in the West and potentially may not be feasible in some health care settings. A recent systematic review suggests that treatment frequency matters and a dose of three sessions per week may be superior to less frequent treatment,” they emphasized. Acupuncture is generally considered to be safe, but many health systems do not reimburse for it. Patients may have large out-of-pocket expenses because of the number of visits required, which may be a barrier to further implementation in practice.
“Acupuncture is already widely practiced and readily available in many countries and health care systems,” the editorialists said. However, “more research is needed in the areas of dose-response relationships, effects of blinding the acupuncturist, feasibility of three times weekly regimens, and clarifying the mechanism of effect, particularly given the persistence of benefit.”
The study was funded by Beijing Municipal Science & Technology Commission and Beijing Municipal Administration of Hospitals. The researchers had no financial conflicts to disclose. Dr. Hunter disclosed support from a National Health and Medical Research Council Investigator Grant and providing consulting advice for Merck Serono, TLC Bio, Tissuegene, Lilly, and Pfizer.
SOURCE: Tu J-F et al. Arthritis Rheumatol. 2020 Nov 10. doi: 10.1002/art.41584.
FROM ARTHRITIS & RHEUMATOLOGY
Histologic remission fails to be related to UC relapse
Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.
Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.
“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.
In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.
Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).
No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.
The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.
“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
More research may support clinical applications
“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.
“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized.
Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.
The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.
SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.
Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.
Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.
“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.
In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.
Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).
No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.
The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.
“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
More research may support clinical applications
“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.
“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized.
Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.
The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.
SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.
Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.
Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.
“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.
In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.
Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).
No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.
The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.
“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
More research may support clinical applications
“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.
“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized.
Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.
The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.
SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.
FROM ALIMENTARY PHARMACOLOGY AND THERAPEUTICS
Several approaches recommended to reduce filler, neuromodulator complications
Katie Beleznay, MD, of the University of British Columbia, Vancouver, said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.
The number of reported cases of vascular complications in patients receiving fillers has increased in recent years, said Dr. Beleznay, who also treats patients in private practice in Vancouver. However, knowing the facial anatomy and recognizing that there is no “one-size-fits-all” approach goes a long way in preventing and managing complications.
In terms of neuromodulators such as Botox, the upper face is the most common area for treatment, and potential complications include eyelid ptosis, brow ptosis, and the “Spock brow,” Dr. Beleznay noted. For example, patients won’t be able to engage elevator muscles, such as the frontalis, if too much neuromodulator is injected. But, a couple of units in the upper forehead can help make the effect look natural, soften the lines, without being too frozen.
To help avoid eyelid ptosis with neuromodulators, inject at least one centimeter above the supraorbital rim at the midpupillary line, Dr. Beleznay advised. “I will feel the muscle,” because some brows are drawn or microbladed on, she noted. Patients who develop eyelid ptosis can be treated with apraclonidine drops.
To avoid brow ptosis with neuromodulators, it is important to assess the anatomy at baseline, Dr. Beleznay said. Some patients like to be able to lift their brows, and too much Botox will prevent their doing so. In order to mitigate this, it is important to treat brow depressors to balance and provide lift, and staying above the first horizontal forehead rhytid when injecting can help reduce brow ptosis risk.
Remember when injecting the upper face there are several glabellar contraction patterns, so “be sure you are targeting the treatment for the muscle pulling pattern that you see,” she said.
Complications associated with fillers
When injecting fillers, there are rare complications, including blindness, that are worth acknowledging, said Dr. Beleznay, lead author of a study on global cases of blindness caused by fillers published in 2015, including 98 cases up to 2015, and another 48 cases in a study published in 2019.
The highest-risk areas for causing blindness with fillers are the glabella and the nose, but “anywhere you are injecting is at risk for this complication,” she commented.
Explaining the mechanism of action for blindness resulting from filler injections, she said: “When the tip of the needle gets into the vessel, if you put enough pressure on the plunger, the filler can travel retrograde in the vessel back into the ophthalmic artery system, and then travels distally and blocks blood supply to the retina,” causing vision complications.
Understanding the potential mechanism for these complications informs preventive strategies, Dr. Beleznay emphasized.
If vision complications from fillers occur, they are likely to happen immediately, she said. There could be skin involvement or stroke-like features in addition to vision complications, so it is important to screen for these conditions as well if patients complain of vision loss.
Tips for prevention
Knowing the anatomy is the first step to maximize safe placement of fillers, Dr. Beleznay said. For example, the glabella is a high-risk location and includes the supraorbital and supratrochlear arteries, which start deep and become more superficial as they travel up the forehead.
When Dr. Beleznay injects in the glabella area, “I will do a true intradermal injection using tiny microdroplets, because that feels safest to me.” A video with additional details on surface anatomy and safer planes for injecting is available online to members of the American Society of Dermatologic Surgery.
Other tips to reduce the risk of vascular complications include injecting slowly and with a minimal amount of pressure, Dr. Beleznay emphasized. Injecting in small increments, moving the needle tip between injections, and using a cannula also may help reduce risk.
Always ask and use caution if patients have had other recent surgical procedures, she added.
Vascular complications such as blindness can be devastating, but the overall risks remain low. It’s important that clinicians know their anatomy, educate patients, and have prepared treatment protocols in place in the event of serious complications, Dr. Beleznay noted.
Dr. Beleznay disclosed relationships as an investigator, speaker, and/or consultant with AbbVie, Actelion, Allergan, Almirall, Amgen, Bausch Health, Celgene, Cipher, Evolus, Galderma, Johnson & Johnson, L’Oreal, Leo, Merz, Novartis, Procter & Gamble, Prollenium, Revance, Sandoz, Sanofi, Valeant, Vichy, and Zeltiq.
MedscapeLive and this news organization are owned by the same parent company.
Katie Beleznay, MD, of the University of British Columbia, Vancouver, said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.
The number of reported cases of vascular complications in patients receiving fillers has increased in recent years, said Dr. Beleznay, who also treats patients in private practice in Vancouver. However, knowing the facial anatomy and recognizing that there is no “one-size-fits-all” approach goes a long way in preventing and managing complications.
In terms of neuromodulators such as Botox, the upper face is the most common area for treatment, and potential complications include eyelid ptosis, brow ptosis, and the “Spock brow,” Dr. Beleznay noted. For example, patients won’t be able to engage elevator muscles, such as the frontalis, if too much neuromodulator is injected. But, a couple of units in the upper forehead can help make the effect look natural, soften the lines, without being too frozen.
To help avoid eyelid ptosis with neuromodulators, inject at least one centimeter above the supraorbital rim at the midpupillary line, Dr. Beleznay advised. “I will feel the muscle,” because some brows are drawn or microbladed on, she noted. Patients who develop eyelid ptosis can be treated with apraclonidine drops.
To avoid brow ptosis with neuromodulators, it is important to assess the anatomy at baseline, Dr. Beleznay said. Some patients like to be able to lift their brows, and too much Botox will prevent their doing so. In order to mitigate this, it is important to treat brow depressors to balance and provide lift, and staying above the first horizontal forehead rhytid when injecting can help reduce brow ptosis risk.
Remember when injecting the upper face there are several glabellar contraction patterns, so “be sure you are targeting the treatment for the muscle pulling pattern that you see,” she said.
Complications associated with fillers
When injecting fillers, there are rare complications, including blindness, that are worth acknowledging, said Dr. Beleznay, lead author of a study on global cases of blindness caused by fillers published in 2015, including 98 cases up to 2015, and another 48 cases in a study published in 2019.
The highest-risk areas for causing blindness with fillers are the glabella and the nose, but “anywhere you are injecting is at risk for this complication,” she commented.
Explaining the mechanism of action for blindness resulting from filler injections, she said: “When the tip of the needle gets into the vessel, if you put enough pressure on the plunger, the filler can travel retrograde in the vessel back into the ophthalmic artery system, and then travels distally and blocks blood supply to the retina,” causing vision complications.
Understanding the potential mechanism for these complications informs preventive strategies, Dr. Beleznay emphasized.
If vision complications from fillers occur, they are likely to happen immediately, she said. There could be skin involvement or stroke-like features in addition to vision complications, so it is important to screen for these conditions as well if patients complain of vision loss.
Tips for prevention
Knowing the anatomy is the first step to maximize safe placement of fillers, Dr. Beleznay said. For example, the glabella is a high-risk location and includes the supraorbital and supratrochlear arteries, which start deep and become more superficial as they travel up the forehead.
When Dr. Beleznay injects in the glabella area, “I will do a true intradermal injection using tiny microdroplets, because that feels safest to me.” A video with additional details on surface anatomy and safer planes for injecting is available online to members of the American Society of Dermatologic Surgery.
Other tips to reduce the risk of vascular complications include injecting slowly and with a minimal amount of pressure, Dr. Beleznay emphasized. Injecting in small increments, moving the needle tip between injections, and using a cannula also may help reduce risk.
Always ask and use caution if patients have had other recent surgical procedures, she added.
Vascular complications such as blindness can be devastating, but the overall risks remain low. It’s important that clinicians know their anatomy, educate patients, and have prepared treatment protocols in place in the event of serious complications, Dr. Beleznay noted.
Dr. Beleznay disclosed relationships as an investigator, speaker, and/or consultant with AbbVie, Actelion, Allergan, Almirall, Amgen, Bausch Health, Celgene, Cipher, Evolus, Galderma, Johnson & Johnson, L’Oreal, Leo, Merz, Novartis, Procter & Gamble, Prollenium, Revance, Sandoz, Sanofi, Valeant, Vichy, and Zeltiq.
MedscapeLive and this news organization are owned by the same parent company.
Katie Beleznay, MD, of the University of British Columbia, Vancouver, said in a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.
The number of reported cases of vascular complications in patients receiving fillers has increased in recent years, said Dr. Beleznay, who also treats patients in private practice in Vancouver. However, knowing the facial anatomy and recognizing that there is no “one-size-fits-all” approach goes a long way in preventing and managing complications.
In terms of neuromodulators such as Botox, the upper face is the most common area for treatment, and potential complications include eyelid ptosis, brow ptosis, and the “Spock brow,” Dr. Beleznay noted. For example, patients won’t be able to engage elevator muscles, such as the frontalis, if too much neuromodulator is injected. But, a couple of units in the upper forehead can help make the effect look natural, soften the lines, without being too frozen.
To help avoid eyelid ptosis with neuromodulators, inject at least one centimeter above the supraorbital rim at the midpupillary line, Dr. Beleznay advised. “I will feel the muscle,” because some brows are drawn or microbladed on, she noted. Patients who develop eyelid ptosis can be treated with apraclonidine drops.
To avoid brow ptosis with neuromodulators, it is important to assess the anatomy at baseline, Dr. Beleznay said. Some patients like to be able to lift their brows, and too much Botox will prevent their doing so. In order to mitigate this, it is important to treat brow depressors to balance and provide lift, and staying above the first horizontal forehead rhytid when injecting can help reduce brow ptosis risk.
Remember when injecting the upper face there are several glabellar contraction patterns, so “be sure you are targeting the treatment for the muscle pulling pattern that you see,” she said.
Complications associated with fillers
When injecting fillers, there are rare complications, including blindness, that are worth acknowledging, said Dr. Beleznay, lead author of a study on global cases of blindness caused by fillers published in 2015, including 98 cases up to 2015, and another 48 cases in a study published in 2019.
The highest-risk areas for causing blindness with fillers are the glabella and the nose, but “anywhere you are injecting is at risk for this complication,” she commented.
Explaining the mechanism of action for blindness resulting from filler injections, she said: “When the tip of the needle gets into the vessel, if you put enough pressure on the plunger, the filler can travel retrograde in the vessel back into the ophthalmic artery system, and then travels distally and blocks blood supply to the retina,” causing vision complications.
Understanding the potential mechanism for these complications informs preventive strategies, Dr. Beleznay emphasized.
If vision complications from fillers occur, they are likely to happen immediately, she said. There could be skin involvement or stroke-like features in addition to vision complications, so it is important to screen for these conditions as well if patients complain of vision loss.
Tips for prevention
Knowing the anatomy is the first step to maximize safe placement of fillers, Dr. Beleznay said. For example, the glabella is a high-risk location and includes the supraorbital and supratrochlear arteries, which start deep and become more superficial as they travel up the forehead.
When Dr. Beleznay injects in the glabella area, “I will do a true intradermal injection using tiny microdroplets, because that feels safest to me.” A video with additional details on surface anatomy and safer planes for injecting is available online to members of the American Society of Dermatologic Surgery.
Other tips to reduce the risk of vascular complications include injecting slowly and with a minimal amount of pressure, Dr. Beleznay emphasized. Injecting in small increments, moving the needle tip between injections, and using a cannula also may help reduce risk.
Always ask and use caution if patients have had other recent surgical procedures, she added.
Vascular complications such as blindness can be devastating, but the overall risks remain low. It’s important that clinicians know their anatomy, educate patients, and have prepared treatment protocols in place in the event of serious complications, Dr. Beleznay noted.
Dr. Beleznay disclosed relationships as an investigator, speaker, and/or consultant with AbbVie, Actelion, Allergan, Almirall, Amgen, Bausch Health, Celgene, Cipher, Evolus, Galderma, Johnson & Johnson, L’Oreal, Leo, Merz, Novartis, Procter & Gamble, Prollenium, Revance, Sandoz, Sanofi, Valeant, Vichy, and Zeltiq.
MedscapeLive and this news organization are owned by the same parent company.
FROM MEDSCAPELIVE LAS VEGAS DERMATOLOGY SEMINAR
Sedentary postmenopausal women have higher heart failure risk
The more time older women spent sitting or lying down, the more likely their risk of hospitalization for heart failure, based on data from more than 80,000 postmenopausal women.
The 2018 Physical Activity Guidelines show evidence of the impact of physical activity on reducing heart failure risk, but the association between activity, sedentary behavior (SB) and heart failure (HF) in older women in particular has not been well studied, wrote Michael J. LaMonte, PhD, MPH, of the State University of New York at Buffalo, and colleagues in a study published in Circulation: Heart Failure. “Given the high prevalence of prolonged sedentary time among U.S. adults aged 65 and older, among whom HF burden is substantial, understanding the role SB has in HF development is relevant to future HF prevention strategies,” the researchers wrote.
The researchers identified 80,982 women aged 50-79 years who were enrolled in the Women’s Health Initiative Observational Study, had no known HF, and could walk at least one block unassisted. The average follow-up period was 9 years, and a total of 1,402 women were hospitalized for heart failure during the period of time they were observed.
The time spent sedentary (combined sitting or lying down) was divided into tertiles of 6.5 hours or less, 6.6-9.5 hours, and more than 9.5 hours. Time spent sitting was divided into tertiles of 4.5 hours or less; 4.6-8.5 hours; and more than 8.5 hours.
Heart failure risk goes up with more down time
After controlling for multiple variables including age, race, education, income, smoking status alcohol use, menopausal hormone therapy, and hysterectomy status, the researchers found that patients in the second tertile for sedentary behavior had a significantly increased heart failure risk than patients in the first tertile for sedentary behavior. This risk was even greater for patients falling in the third tertile for sedentary behavior. Odds ratios were 1.00 (referent), 1.15, and 1.42 for the lowest to highest tertiles for total sedentary behavior, respectively, and 1.00 (referent), 1.14, and 1.54 for sitting (P < .001 for both total sedentary behavior and sitting only).
The trends remained significant after controlling for comorbidities including MI and coronary revascularization, and the associations were similar among categories of women with additional HF risk factors, including body mass index, diabetes, hypertension, and coronary heart disease.
Notably, the association between hours spent sitting or lying down and HF risk persisted even in women who met recommended activity levels, the researchers wrote.
The study findings were limited by the use of self-reports and by the inability to evaluate SB patterns or SB and HF subtypes, the researchers noted. However, the results were strengthened by the large sample size, use of time-varying SB exposure, and extensive controlling, and the data support the risk of increased SB on adverse cardiovascular outcomes.
“Results of this study underscore the need for effective strategies to reduce daily SB time, in addition to increasing recreational physical activity, as part of population efforts for HF prevention,” they concluded.
Clinicians know the value of a physically active lifestyle for heart health, said lead author Dr. LaMonte in a statement accompanying the study’s release. “However, our study clearly shows that we also need to increase efforts to reduce daily sedentary time and encourage adults to frequently interrupt their sedentary time. This does not necessarily require an extended bout of physical activity; it might simply be standing up for 5 minutes or standing and moving one’s feet in place.
“We do not have sufficient evidence on the best approach to recommend for interrupting sedentary time. However, accumulating data suggest that habitual activities such as steps taken during household and other activities of daily living are an important aspect of cardiovascular disease prevention and healthy aging,” Dr. LaMonte added.
Promote more movement and less sitting
“This is the first study to assess sedentary time and the risk for incident heart failure hospitalization in postmenopausal women,” said Robert H. Hopkins Jr., MD, of the University of Arkansas for Medical Sciences, Little Rock, in an interview.
“Heart failure is the cause of approximately 35% of cardiovascular mortalities in women, and sedentary behaviors are common in older adults,” he noted.
Kashif J. Piracha, MD, of Houston Methodist Willowbrook Hospital, agreed that there is a lack of existing data looking at the relationship between sedentary behavior and the risk of the development of heart failure in postmenopausal women. In an interview, he cited this as a reason “it was important to conduct this study.”
Dr. Hopkins added that he was not surprised by the study results “There are a number of studies which have demonstrated reduction in risk for heart failure in men and in combined populations of men and women with increased physical activity.” There are fewer data (but similar outcomes) in studies of men with increased levels of sedentary behaviors, he said.
“This study adds one more reason that other clinicians in primary care and me need to encourage our older patients to get up and move,” said Dr. Hopkins, who also serves on the editorial advisory board of Internal Medicine News. “Many of us have focused our efforts in the past on achieving exercise goals and this study provides a foundation for a recommendation that ‘it is not just about exercise;’ we need to also encourage our patients to minimize their time in sedentary pursuits in addition to exercise if we are to optimize their health into older age.”
Dr. Hopkins noted that the large size of the study was a strength, but the observational design and use of patient surveys were limitations.
“We need further studies to better tease out whether there are risk differences in different sedentary behavior patterns, whether this applies across heart failure with reduced ejection fraction versus heart failure with preserved ejection fraction, and whether there are additional ways we can mitigate these risks as our society ages,” he said.
Findings differ from California Men’s Health Study’s
“The results corroborate the fact that there is less risk of heart failure in physically active patients,” Dr. Piracha noted.
The message for clinicians is to encourage postmenopausal female patients to engage in physical activity as much as possible, said Dr. Piracha. “Also, it appears that in this population, even with good physical activity, prolonged sedentary behavior of more than 8.5 hours a day was still associated with a higher risk of incident HF hospitalization. Therefore, a case can be made to focus on carrying out physical activity with an intensity that can be sustained for longer, rather than shorter periods of time.”
Notably, the finding of increased HF hospitalization in women who reported high amounts of physical activity but were still sedentary for more than 8.5 hours a day “is contrary to what was seen in the California Men’s Health Study.” In that study, “men with high physical activity levels who also had prolonged sitting time did not have increased risk of HF hospitalization,” Dr. Piracha noted. “Further research is needed to elucidate what hormonal or other factors contribute to this difference.”
The new study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Hopkins and Dr. Piracha had no financial conflicts to disclose.
SOURCE: LaMonte MJ et al. Circ Heart Fail. 2020 Nov 24. doi: 10.1161/CIRCHEARTFAILURE.120.007508.
The more time older women spent sitting or lying down, the more likely their risk of hospitalization for heart failure, based on data from more than 80,000 postmenopausal women.
The 2018 Physical Activity Guidelines show evidence of the impact of physical activity on reducing heart failure risk, but the association between activity, sedentary behavior (SB) and heart failure (HF) in older women in particular has not been well studied, wrote Michael J. LaMonte, PhD, MPH, of the State University of New York at Buffalo, and colleagues in a study published in Circulation: Heart Failure. “Given the high prevalence of prolonged sedentary time among U.S. adults aged 65 and older, among whom HF burden is substantial, understanding the role SB has in HF development is relevant to future HF prevention strategies,” the researchers wrote.
The researchers identified 80,982 women aged 50-79 years who were enrolled in the Women’s Health Initiative Observational Study, had no known HF, and could walk at least one block unassisted. The average follow-up period was 9 years, and a total of 1,402 women were hospitalized for heart failure during the period of time they were observed.
The time spent sedentary (combined sitting or lying down) was divided into tertiles of 6.5 hours or less, 6.6-9.5 hours, and more than 9.5 hours. Time spent sitting was divided into tertiles of 4.5 hours or less; 4.6-8.5 hours; and more than 8.5 hours.
Heart failure risk goes up with more down time
After controlling for multiple variables including age, race, education, income, smoking status alcohol use, menopausal hormone therapy, and hysterectomy status, the researchers found that patients in the second tertile for sedentary behavior had a significantly increased heart failure risk than patients in the first tertile for sedentary behavior. This risk was even greater for patients falling in the third tertile for sedentary behavior. Odds ratios were 1.00 (referent), 1.15, and 1.42 for the lowest to highest tertiles for total sedentary behavior, respectively, and 1.00 (referent), 1.14, and 1.54 for sitting (P < .001 for both total sedentary behavior and sitting only).
The trends remained significant after controlling for comorbidities including MI and coronary revascularization, and the associations were similar among categories of women with additional HF risk factors, including body mass index, diabetes, hypertension, and coronary heart disease.
Notably, the association between hours spent sitting or lying down and HF risk persisted even in women who met recommended activity levels, the researchers wrote.
The study findings were limited by the use of self-reports and by the inability to evaluate SB patterns or SB and HF subtypes, the researchers noted. However, the results were strengthened by the large sample size, use of time-varying SB exposure, and extensive controlling, and the data support the risk of increased SB on adverse cardiovascular outcomes.
“Results of this study underscore the need for effective strategies to reduce daily SB time, in addition to increasing recreational physical activity, as part of population efforts for HF prevention,” they concluded.
Clinicians know the value of a physically active lifestyle for heart health, said lead author Dr. LaMonte in a statement accompanying the study’s release. “However, our study clearly shows that we also need to increase efforts to reduce daily sedentary time and encourage adults to frequently interrupt their sedentary time. This does not necessarily require an extended bout of physical activity; it might simply be standing up for 5 minutes or standing and moving one’s feet in place.
“We do not have sufficient evidence on the best approach to recommend for interrupting sedentary time. However, accumulating data suggest that habitual activities such as steps taken during household and other activities of daily living are an important aspect of cardiovascular disease prevention and healthy aging,” Dr. LaMonte added.
Promote more movement and less sitting
“This is the first study to assess sedentary time and the risk for incident heart failure hospitalization in postmenopausal women,” said Robert H. Hopkins Jr., MD, of the University of Arkansas for Medical Sciences, Little Rock, in an interview.
“Heart failure is the cause of approximately 35% of cardiovascular mortalities in women, and sedentary behaviors are common in older adults,” he noted.
Kashif J. Piracha, MD, of Houston Methodist Willowbrook Hospital, agreed that there is a lack of existing data looking at the relationship between sedentary behavior and the risk of the development of heart failure in postmenopausal women. In an interview, he cited this as a reason “it was important to conduct this study.”
Dr. Hopkins added that he was not surprised by the study results “There are a number of studies which have demonstrated reduction in risk for heart failure in men and in combined populations of men and women with increased physical activity.” There are fewer data (but similar outcomes) in studies of men with increased levels of sedentary behaviors, he said.
“This study adds one more reason that other clinicians in primary care and me need to encourage our older patients to get up and move,” said Dr. Hopkins, who also serves on the editorial advisory board of Internal Medicine News. “Many of us have focused our efforts in the past on achieving exercise goals and this study provides a foundation for a recommendation that ‘it is not just about exercise;’ we need to also encourage our patients to minimize their time in sedentary pursuits in addition to exercise if we are to optimize their health into older age.”
Dr. Hopkins noted that the large size of the study was a strength, but the observational design and use of patient surveys were limitations.
“We need further studies to better tease out whether there are risk differences in different sedentary behavior patterns, whether this applies across heart failure with reduced ejection fraction versus heart failure with preserved ejection fraction, and whether there are additional ways we can mitigate these risks as our society ages,” he said.
Findings differ from California Men’s Health Study’s
“The results corroborate the fact that there is less risk of heart failure in physically active patients,” Dr. Piracha noted.
The message for clinicians is to encourage postmenopausal female patients to engage in physical activity as much as possible, said Dr. Piracha. “Also, it appears that in this population, even with good physical activity, prolonged sedentary behavior of more than 8.5 hours a day was still associated with a higher risk of incident HF hospitalization. Therefore, a case can be made to focus on carrying out physical activity with an intensity that can be sustained for longer, rather than shorter periods of time.”
Notably, the finding of increased HF hospitalization in women who reported high amounts of physical activity but were still sedentary for more than 8.5 hours a day “is contrary to what was seen in the California Men’s Health Study.” In that study, “men with high physical activity levels who also had prolonged sitting time did not have increased risk of HF hospitalization,” Dr. Piracha noted. “Further research is needed to elucidate what hormonal or other factors contribute to this difference.”
The new study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Hopkins and Dr. Piracha had no financial conflicts to disclose.
SOURCE: LaMonte MJ et al. Circ Heart Fail. 2020 Nov 24. doi: 10.1161/CIRCHEARTFAILURE.120.007508.
The more time older women spent sitting or lying down, the more likely their risk of hospitalization for heart failure, based on data from more than 80,000 postmenopausal women.
The 2018 Physical Activity Guidelines show evidence of the impact of physical activity on reducing heart failure risk, but the association between activity, sedentary behavior (SB) and heart failure (HF) in older women in particular has not been well studied, wrote Michael J. LaMonte, PhD, MPH, of the State University of New York at Buffalo, and colleagues in a study published in Circulation: Heart Failure. “Given the high prevalence of prolonged sedentary time among U.S. adults aged 65 and older, among whom HF burden is substantial, understanding the role SB has in HF development is relevant to future HF prevention strategies,” the researchers wrote.
The researchers identified 80,982 women aged 50-79 years who were enrolled in the Women’s Health Initiative Observational Study, had no known HF, and could walk at least one block unassisted. The average follow-up period was 9 years, and a total of 1,402 women were hospitalized for heart failure during the period of time they were observed.
The time spent sedentary (combined sitting or lying down) was divided into tertiles of 6.5 hours or less, 6.6-9.5 hours, and more than 9.5 hours. Time spent sitting was divided into tertiles of 4.5 hours or less; 4.6-8.5 hours; and more than 8.5 hours.
Heart failure risk goes up with more down time
After controlling for multiple variables including age, race, education, income, smoking status alcohol use, menopausal hormone therapy, and hysterectomy status, the researchers found that patients in the second tertile for sedentary behavior had a significantly increased heart failure risk than patients in the first tertile for sedentary behavior. This risk was even greater for patients falling in the third tertile for sedentary behavior. Odds ratios were 1.00 (referent), 1.15, and 1.42 for the lowest to highest tertiles for total sedentary behavior, respectively, and 1.00 (referent), 1.14, and 1.54 for sitting (P < .001 for both total sedentary behavior and sitting only).
The trends remained significant after controlling for comorbidities including MI and coronary revascularization, and the associations were similar among categories of women with additional HF risk factors, including body mass index, diabetes, hypertension, and coronary heart disease.
Notably, the association between hours spent sitting or lying down and HF risk persisted even in women who met recommended activity levels, the researchers wrote.
The study findings were limited by the use of self-reports and by the inability to evaluate SB patterns or SB and HF subtypes, the researchers noted. However, the results were strengthened by the large sample size, use of time-varying SB exposure, and extensive controlling, and the data support the risk of increased SB on adverse cardiovascular outcomes.
“Results of this study underscore the need for effective strategies to reduce daily SB time, in addition to increasing recreational physical activity, as part of population efforts for HF prevention,” they concluded.
Clinicians know the value of a physically active lifestyle for heart health, said lead author Dr. LaMonte in a statement accompanying the study’s release. “However, our study clearly shows that we also need to increase efforts to reduce daily sedentary time and encourage adults to frequently interrupt their sedentary time. This does not necessarily require an extended bout of physical activity; it might simply be standing up for 5 minutes or standing and moving one’s feet in place.
“We do not have sufficient evidence on the best approach to recommend for interrupting sedentary time. However, accumulating data suggest that habitual activities such as steps taken during household and other activities of daily living are an important aspect of cardiovascular disease prevention and healthy aging,” Dr. LaMonte added.
Promote more movement and less sitting
“This is the first study to assess sedentary time and the risk for incident heart failure hospitalization in postmenopausal women,” said Robert H. Hopkins Jr., MD, of the University of Arkansas for Medical Sciences, Little Rock, in an interview.
“Heart failure is the cause of approximately 35% of cardiovascular mortalities in women, and sedentary behaviors are common in older adults,” he noted.
Kashif J. Piracha, MD, of Houston Methodist Willowbrook Hospital, agreed that there is a lack of existing data looking at the relationship between sedentary behavior and the risk of the development of heart failure in postmenopausal women. In an interview, he cited this as a reason “it was important to conduct this study.”
Dr. Hopkins added that he was not surprised by the study results “There are a number of studies which have demonstrated reduction in risk for heart failure in men and in combined populations of men and women with increased physical activity.” There are fewer data (but similar outcomes) in studies of men with increased levels of sedentary behaviors, he said.
“This study adds one more reason that other clinicians in primary care and me need to encourage our older patients to get up and move,” said Dr. Hopkins, who also serves on the editorial advisory board of Internal Medicine News. “Many of us have focused our efforts in the past on achieving exercise goals and this study provides a foundation for a recommendation that ‘it is not just about exercise;’ we need to also encourage our patients to minimize their time in sedentary pursuits in addition to exercise if we are to optimize their health into older age.”
Dr. Hopkins noted that the large size of the study was a strength, but the observational design and use of patient surveys were limitations.
“We need further studies to better tease out whether there are risk differences in different sedentary behavior patterns, whether this applies across heart failure with reduced ejection fraction versus heart failure with preserved ejection fraction, and whether there are additional ways we can mitigate these risks as our society ages,” he said.
Findings differ from California Men’s Health Study’s
“The results corroborate the fact that there is less risk of heart failure in physically active patients,” Dr. Piracha noted.
The message for clinicians is to encourage postmenopausal female patients to engage in physical activity as much as possible, said Dr. Piracha. “Also, it appears that in this population, even with good physical activity, prolonged sedentary behavior of more than 8.5 hours a day was still associated with a higher risk of incident HF hospitalization. Therefore, a case can be made to focus on carrying out physical activity with an intensity that can be sustained for longer, rather than shorter periods of time.”
Notably, the finding of increased HF hospitalization in women who reported high amounts of physical activity but were still sedentary for more than 8.5 hours a day “is contrary to what was seen in the California Men’s Health Study.” In that study, “men with high physical activity levels who also had prolonged sitting time did not have increased risk of HF hospitalization,” Dr. Piracha noted. “Further research is needed to elucidate what hormonal or other factors contribute to this difference.”
The new study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Hopkins and Dr. Piracha had no financial conflicts to disclose.
SOURCE: LaMonte MJ et al. Circ Heart Fail. 2020 Nov 24. doi: 10.1161/CIRCHEARTFAILURE.120.007508.
FROM CIRCULATION: HEART FAILURE
Embrace new and classic acne treatments
Recognizing the ongoing value of benzoyl peroxide, educating patients about the role of antibiotics, and embracing spironolactone are among the acne treatment pearls provided by Hilary Baldwin, MD, during a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
Benzoyl peroxide celebrates its 60th birthday and is still going strong as an acne treatment, said Dr. Baldwin, of the department of dermatology, Rutgers Robert Wood Johnston Medical Center, New Brunswick, N.J. Benzoyl peroxide can be used as a stand-alone and has the added benefit of not being associated with antimicrobial resistance. In addition, “benzoyl peroxide is the heavy lifter in combinations,” she said. In fact, benzoyl peroxide can prevent the development of resistance to topical and oral antibiotics such as clindamycin, and can reverse resistance that has occurred, she noted.
However, patient compliance can be an issue. Benzoyl peroxide often is underused because of its tendency to bleach fabric, noted Dr. Baldwin, who is also medical director of The Acne Treatment and Research Center in New York. To help combat this problem and improve compliance, she advises patients to establish a dosing schedule for benzoyl peroxide, such as using it first thing in the morning, or applying in the afternoon and using a paper towel first, or a white towel, to wash their faces at bedtime, she said. When dealing with teenagers, “it sounds like a lot of work, but it makes the mothers much happier not to have their towels bleached.”
Although clinicians want to reduce unnecessary antibiotic use in acne, there is a place for antibiotics, but not as monotherapy, Dr. Baldwin said. Instead, initiate topical therapy, such as a retinoid or benzoyl peroxide, simultaneously with antibiotics and evaluate the response in 6-8 weeks, she advised. At that point, the antibiotics can be stopped, even if 100% clearing has not been achieved, and “the topicals can carry you on for months and months,” she noted.
Also, in female patients, consider oral contraceptive pills or spironolactone at the same time as oral antibiotics, then discontinue the antibiotics and continue with the hormonal therapy, she added. “Plan your exit strategy early,” she said. Explain to patients that you will stop the oral antibiotics after 2 months, so they must continue with the topicals.
“Embrace spironolactone if you haven’t already,” said Dr. Baldwin, who noted that spironolactone has been underused in recent years. Spironolactone use for acne has not been well studied, “but consensus groups and expert opinions certainly favor its use,” she added.
Spironolactone takes 3-6 months to reach its full effect, so Dr. Baldwin recommends beginning the therapy in combination with other strategies. “I begin in combination with oral antibiotics,” she said. Also, be sure to check hormone levels before initiating therapy if appropriate. Potential side effects include menstrual irregularities and breast tenderness, but they tend to decrease over time, Dr. Baldwin noted. Other side effects such as CNS symptoms (fatigue, dizziness, and headache) can be eased by paying attention to proper hydration and starting with a lower dose, she added. Studies in younger adults show no reason for concern about potassium levels, but potassium should be checked at baseline in older patients, after the first month, and after a dose increase, she said.
Dr. Baldwin was enthusiastic about the recent introduction of several new treatments for acne: Sarecycline, now approved by the Food and Drug Administration for use in patients as young as 9 years; trifarotene 0.005% cream, the first 4th generation retinoid, with truncal acne data; tazarotene 0.045% lotion, with improved tolerability; minocycline 4% foam, with high cutaneous levels and minimal systemic absorption; and clascoterone 1% cream, “the first topical antiandrogen and safe for use in males,” she said.
Relevant to her presentation, Dr. Baldwin disclosed relationships as an adviser, speaker, and/or investigator for Almirall, EPI Health, Foamix, Galderma, Johnson & Johnson, LaRoche-Posay, Menlo Therapeutics, Ortho Dermatologics, Sol-Gel, and Sun.
MedscapeLive and this news organization are owned by the same parent company.
Recognizing the ongoing value of benzoyl peroxide, educating patients about the role of antibiotics, and embracing spironolactone are among the acne treatment pearls provided by Hilary Baldwin, MD, during a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
Benzoyl peroxide celebrates its 60th birthday and is still going strong as an acne treatment, said Dr. Baldwin, of the department of dermatology, Rutgers Robert Wood Johnston Medical Center, New Brunswick, N.J. Benzoyl peroxide can be used as a stand-alone and has the added benefit of not being associated with antimicrobial resistance. In addition, “benzoyl peroxide is the heavy lifter in combinations,” she said. In fact, benzoyl peroxide can prevent the development of resistance to topical and oral antibiotics such as clindamycin, and can reverse resistance that has occurred, she noted.
However, patient compliance can be an issue. Benzoyl peroxide often is underused because of its tendency to bleach fabric, noted Dr. Baldwin, who is also medical director of The Acne Treatment and Research Center in New York. To help combat this problem and improve compliance, she advises patients to establish a dosing schedule for benzoyl peroxide, such as using it first thing in the morning, or applying in the afternoon and using a paper towel first, or a white towel, to wash their faces at bedtime, she said. When dealing with teenagers, “it sounds like a lot of work, but it makes the mothers much happier not to have their towels bleached.”
Although clinicians want to reduce unnecessary antibiotic use in acne, there is a place for antibiotics, but not as monotherapy, Dr. Baldwin said. Instead, initiate topical therapy, such as a retinoid or benzoyl peroxide, simultaneously with antibiotics and evaluate the response in 6-8 weeks, she advised. At that point, the antibiotics can be stopped, even if 100% clearing has not been achieved, and “the topicals can carry you on for months and months,” she noted.
Also, in female patients, consider oral contraceptive pills or spironolactone at the same time as oral antibiotics, then discontinue the antibiotics and continue with the hormonal therapy, she added. “Plan your exit strategy early,” she said. Explain to patients that you will stop the oral antibiotics after 2 months, so they must continue with the topicals.
“Embrace spironolactone if you haven’t already,” said Dr. Baldwin, who noted that spironolactone has been underused in recent years. Spironolactone use for acne has not been well studied, “but consensus groups and expert opinions certainly favor its use,” she added.
Spironolactone takes 3-6 months to reach its full effect, so Dr. Baldwin recommends beginning the therapy in combination with other strategies. “I begin in combination with oral antibiotics,” she said. Also, be sure to check hormone levels before initiating therapy if appropriate. Potential side effects include menstrual irregularities and breast tenderness, but they tend to decrease over time, Dr. Baldwin noted. Other side effects such as CNS symptoms (fatigue, dizziness, and headache) can be eased by paying attention to proper hydration and starting with a lower dose, she added. Studies in younger adults show no reason for concern about potassium levels, but potassium should be checked at baseline in older patients, after the first month, and after a dose increase, she said.
Dr. Baldwin was enthusiastic about the recent introduction of several new treatments for acne: Sarecycline, now approved by the Food and Drug Administration for use in patients as young as 9 years; trifarotene 0.005% cream, the first 4th generation retinoid, with truncal acne data; tazarotene 0.045% lotion, with improved tolerability; minocycline 4% foam, with high cutaneous levels and minimal systemic absorption; and clascoterone 1% cream, “the first topical antiandrogen and safe for use in males,” she said.
Relevant to her presentation, Dr. Baldwin disclosed relationships as an adviser, speaker, and/or investigator for Almirall, EPI Health, Foamix, Galderma, Johnson & Johnson, LaRoche-Posay, Menlo Therapeutics, Ortho Dermatologics, Sol-Gel, and Sun.
MedscapeLive and this news organization are owned by the same parent company.
Recognizing the ongoing value of benzoyl peroxide, educating patients about the role of antibiotics, and embracing spironolactone are among the acne treatment pearls provided by Hilary Baldwin, MD, during a virtual presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
Benzoyl peroxide celebrates its 60th birthday and is still going strong as an acne treatment, said Dr. Baldwin, of the department of dermatology, Rutgers Robert Wood Johnston Medical Center, New Brunswick, N.J. Benzoyl peroxide can be used as a stand-alone and has the added benefit of not being associated with antimicrobial resistance. In addition, “benzoyl peroxide is the heavy lifter in combinations,” she said. In fact, benzoyl peroxide can prevent the development of resistance to topical and oral antibiotics such as clindamycin, and can reverse resistance that has occurred, she noted.
However, patient compliance can be an issue. Benzoyl peroxide often is underused because of its tendency to bleach fabric, noted Dr. Baldwin, who is also medical director of The Acne Treatment and Research Center in New York. To help combat this problem and improve compliance, she advises patients to establish a dosing schedule for benzoyl peroxide, such as using it first thing in the morning, or applying in the afternoon and using a paper towel first, or a white towel, to wash their faces at bedtime, she said. When dealing with teenagers, “it sounds like a lot of work, but it makes the mothers much happier not to have their towels bleached.”
Although clinicians want to reduce unnecessary antibiotic use in acne, there is a place for antibiotics, but not as monotherapy, Dr. Baldwin said. Instead, initiate topical therapy, such as a retinoid or benzoyl peroxide, simultaneously with antibiotics and evaluate the response in 6-8 weeks, she advised. At that point, the antibiotics can be stopped, even if 100% clearing has not been achieved, and “the topicals can carry you on for months and months,” she noted.
Also, in female patients, consider oral contraceptive pills or spironolactone at the same time as oral antibiotics, then discontinue the antibiotics and continue with the hormonal therapy, she added. “Plan your exit strategy early,” she said. Explain to patients that you will stop the oral antibiotics after 2 months, so they must continue with the topicals.
“Embrace spironolactone if you haven’t already,” said Dr. Baldwin, who noted that spironolactone has been underused in recent years. Spironolactone use for acne has not been well studied, “but consensus groups and expert opinions certainly favor its use,” she added.
Spironolactone takes 3-6 months to reach its full effect, so Dr. Baldwin recommends beginning the therapy in combination with other strategies. “I begin in combination with oral antibiotics,” she said. Also, be sure to check hormone levels before initiating therapy if appropriate. Potential side effects include menstrual irregularities and breast tenderness, but they tend to decrease over time, Dr. Baldwin noted. Other side effects such as CNS symptoms (fatigue, dizziness, and headache) can be eased by paying attention to proper hydration and starting with a lower dose, she added. Studies in younger adults show no reason for concern about potassium levels, but potassium should be checked at baseline in older patients, after the first month, and after a dose increase, she said.
Dr. Baldwin was enthusiastic about the recent introduction of several new treatments for acne: Sarecycline, now approved by the Food and Drug Administration for use in patients as young as 9 years; trifarotene 0.005% cream, the first 4th generation retinoid, with truncal acne data; tazarotene 0.045% lotion, with improved tolerability; minocycline 4% foam, with high cutaneous levels and minimal systemic absorption; and clascoterone 1% cream, “the first topical antiandrogen and safe for use in males,” she said.
Relevant to her presentation, Dr. Baldwin disclosed relationships as an adviser, speaker, and/or investigator for Almirall, EPI Health, Foamix, Galderma, Johnson & Johnson, LaRoche-Posay, Menlo Therapeutics, Ortho Dermatologics, Sol-Gel, and Sun.
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FROM THE MEDSCAPELIVE LAS VEGAS DERMATOLOGY SEMINAR
