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Sex assault by intimate partners as distressing as stranger attack
Sexual assault by an intimate partner was associated with a similar level of psychological distress and a greater likelihood of extragenital traumatic injuries, compared with sexual assaults by a stranger or an acquaintance.
Dr. Patrick Chariot of the department of forensic medicine at Hôpital Jean-Verdier in Bondy, France, and his colleagues conducted an observational and prospective study to compare the psychological and physical symptoms of women assaulted by intimate partners with the symptoms of women who were assaulted by an acquaintance or unknown person.
Participants included girls and women aged 15 years or older who were referred to a sexual assault center and received examination. Data was grouped according to the woman’s reported relationship to their assailant as a current or former intimate partner, stranger, or acquaintance (Obstet Gynecol. 2016 Feb;127:516–26).
A total of 767 patients were included in the study. Assault by an intimate partner was reported by 263 women, assault by an acquaintance by 229 women, and assault by a stranger by 275 women. A 1-month follow-up examination was performed in 38% of participants.
Nearly half of the study participants reported a previous physical or sexual assault. A history of previous assault was more often reported by women in the intimate partner group (71%), compared with those in the acquaintance group (49%) and those in the stranger group (28%).
Extragenital trauma was more common in women assaulted by intimate partners (52% versus 33% and 43%, in acquaintance and strangers, respectively).
The most common psychological symptoms reported at the time of examination included anxiety, fear, shame, and sadness with reports of fear being more common in those with an intimate partner assault (46% versus 30% and 25%). The most common symptoms reported at follow-up included sleep disorders, depression, fear, intrusive thoughts, social withdrawal, shame, and anxiety.
Most of the study participants had scores suggestive of a minor psychiatric disorder (89%) or post-traumatic stress disorder (79%), with similar results in all groups, according to the researchers.
“This study demonstrates that extragenital physical assaults coincident with the sexual assault are more commonly perpetrated by intimate assailants than either strangers or acquaintances,” the researchers wrote. “Additionally, there is no difference in the victim’s psychologic symptoms nor in the reaction to reports of the assault to family and friends.”
The researchers reported having no financial disclosures.
Sexual assault by an intimate partner was associated with a similar level of psychological distress and a greater likelihood of extragenital traumatic injuries, compared with sexual assaults by a stranger or an acquaintance.
Dr. Patrick Chariot of the department of forensic medicine at Hôpital Jean-Verdier in Bondy, France, and his colleagues conducted an observational and prospective study to compare the psychological and physical symptoms of women assaulted by intimate partners with the symptoms of women who were assaulted by an acquaintance or unknown person.
Participants included girls and women aged 15 years or older who were referred to a sexual assault center and received examination. Data was grouped according to the woman’s reported relationship to their assailant as a current or former intimate partner, stranger, or acquaintance (Obstet Gynecol. 2016 Feb;127:516–26).
A total of 767 patients were included in the study. Assault by an intimate partner was reported by 263 women, assault by an acquaintance by 229 women, and assault by a stranger by 275 women. A 1-month follow-up examination was performed in 38% of participants.
Nearly half of the study participants reported a previous physical or sexual assault. A history of previous assault was more often reported by women in the intimate partner group (71%), compared with those in the acquaintance group (49%) and those in the stranger group (28%).
Extragenital trauma was more common in women assaulted by intimate partners (52% versus 33% and 43%, in acquaintance and strangers, respectively).
The most common psychological symptoms reported at the time of examination included anxiety, fear, shame, and sadness with reports of fear being more common in those with an intimate partner assault (46% versus 30% and 25%). The most common symptoms reported at follow-up included sleep disorders, depression, fear, intrusive thoughts, social withdrawal, shame, and anxiety.
Most of the study participants had scores suggestive of a minor psychiatric disorder (89%) or post-traumatic stress disorder (79%), with similar results in all groups, according to the researchers.
“This study demonstrates that extragenital physical assaults coincident with the sexual assault are more commonly perpetrated by intimate assailants than either strangers or acquaintances,” the researchers wrote. “Additionally, there is no difference in the victim’s psychologic symptoms nor in the reaction to reports of the assault to family and friends.”
The researchers reported having no financial disclosures.
Sexual assault by an intimate partner was associated with a similar level of psychological distress and a greater likelihood of extragenital traumatic injuries, compared with sexual assaults by a stranger or an acquaintance.
Dr. Patrick Chariot of the department of forensic medicine at Hôpital Jean-Verdier in Bondy, France, and his colleagues conducted an observational and prospective study to compare the psychological and physical symptoms of women assaulted by intimate partners with the symptoms of women who were assaulted by an acquaintance or unknown person.
Participants included girls and women aged 15 years or older who were referred to a sexual assault center and received examination. Data was grouped according to the woman’s reported relationship to their assailant as a current or former intimate partner, stranger, or acquaintance (Obstet Gynecol. 2016 Feb;127:516–26).
A total of 767 patients were included in the study. Assault by an intimate partner was reported by 263 women, assault by an acquaintance by 229 women, and assault by a stranger by 275 women. A 1-month follow-up examination was performed in 38% of participants.
Nearly half of the study participants reported a previous physical or sexual assault. A history of previous assault was more often reported by women in the intimate partner group (71%), compared with those in the acquaintance group (49%) and those in the stranger group (28%).
Extragenital trauma was more common in women assaulted by intimate partners (52% versus 33% and 43%, in acquaintance and strangers, respectively).
The most common psychological symptoms reported at the time of examination included anxiety, fear, shame, and sadness with reports of fear being more common in those with an intimate partner assault (46% versus 30% and 25%). The most common symptoms reported at follow-up included sleep disorders, depression, fear, intrusive thoughts, social withdrawal, shame, and anxiety.
Most of the study participants had scores suggestive of a minor psychiatric disorder (89%) or post-traumatic stress disorder (79%), with similar results in all groups, according to the researchers.
“This study demonstrates that extragenital physical assaults coincident with the sexual assault are more commonly perpetrated by intimate assailants than either strangers or acquaintances,” the researchers wrote. “Additionally, there is no difference in the victim’s psychologic symptoms nor in the reaction to reports of the assault to family and friends.”
The researchers reported having no financial disclosures.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Intimate partner sexual assault had similar psychological distress and lack of support as those assaulted by a stranger or acquaintance.
Major finding: Extragenital trauma was more common in women assaulted by an intimate partner (52% vs. 33% and 43%, in acquaintance and strangers, respectively).
Data source: An observational and prospective study of 767 women aged 15 years or older who were referred to a sexual assault center.
Disclosures: The researchers reported having no financial disclosures.
Accumulated victimization tied to depression, PTSD in LGBT youth
Lesbian, gay, bisexual, and transgender youth who report a history of increasing or high levels of victimization are at increased risk for major depressive disorder and posttraumatic stress disorder, a longitudinal study shows.
Results from the study, which is ongoing, show that people who identify as lesbian, gay, bisexual, and transgender (LGBT) are at higher risk for other mental disorders also, such as anxiety and suicide, than are their heterosexual or cisgender counterparts. Further, a history of harassment, victimization, or discrimination proved a predictor of mental health disorders.
The researchers, led by Brian Mustanski, Ph.D., sought to understand the trajectories of victimization and how they affect the development of depression and PTSD in LGBT youth. Initial recruitment included 248 youth. The mean age of the participants was 18.7 years old, and 54.7% were black. Eligibility was met in 234 participants (53% female), and after the seventh wave of data collection, 206 participants (83.1%) remained in the study (Am J Public Health. 2016 Jan 21. doi: 10.2105/AJPH.2015.302976), reported Dr. Mustanski and his colleagues, of the department of medical social sciences at Northwestern University, Chicago.
LGBT victimization was measured using a 10-item questionnaire, and depression and PTSD were assessed with psychiatric interviews at baseline and at the seventh wave of data collection. At the 48-month follow-up, female participants were more likely to complete the interview than were male participants (odds ratio, 2.01; 95% confidence interval, 1.12-4.51; P less than .05).
The researchers were able to identify 4 classes of victimization. Class 1 accounted for 65.4% of the sample and reported low levels of victimization that declined over time (P less than .01). Class 2 accounted for 10.3% of the sample and reported moderate victimization that increased over time (P less than .01). Class 3 included 5.1% of the sample and reported high levels of victimization that remained steady (P = .87). Class 4 included 19.2% of the sample and reported high levels of victimization that declined over time (P less than .01).
Between the classes, significant differences were not found by race or age, and participants in the class 1 group included a higher proportion of females.
Participants in class 2 (OR, 5.54; 95% CI, 1.94-15.82; P less than .001) and class 3 (OR, 4.23; 95% CI, 1.15-15.48; P less than .05) were found to be at higher risk for depression at follow-up than participants in class 1. Likewise, a higher risk for PTSD was found in participants in class 2 (OR, 9.37; 95% CI, 2.76-31.88; P less than .001) and class 3 (OR, 8.66; 95% CI, 1.93-39; P less than .01), compared with class 1. Class 4, however, was associated with a higher risk of PTSD (OR, 4.19; 95% CI, 1.39-12.63; P less than .01) but not depression.
“Our results highlight that it is not only isolated experiences of victimization that affect mental health (which has been the focus of much previous research),” the authors wrote, “but instead, the accumulation of these stressors that exacerbates mental health problems.”
The National Institutes of Mental Health, the American Foundation for Suicide Prevention, the William T. Grant Foundation, and the David Bohnett Foundation funded the study.
Lesbian, gay, bisexual, and transgender youth who report a history of increasing or high levels of victimization are at increased risk for major depressive disorder and posttraumatic stress disorder, a longitudinal study shows.
Results from the study, which is ongoing, show that people who identify as lesbian, gay, bisexual, and transgender (LGBT) are at higher risk for other mental disorders also, such as anxiety and suicide, than are their heterosexual or cisgender counterparts. Further, a history of harassment, victimization, or discrimination proved a predictor of mental health disorders.
The researchers, led by Brian Mustanski, Ph.D., sought to understand the trajectories of victimization and how they affect the development of depression and PTSD in LGBT youth. Initial recruitment included 248 youth. The mean age of the participants was 18.7 years old, and 54.7% were black. Eligibility was met in 234 participants (53% female), and after the seventh wave of data collection, 206 participants (83.1%) remained in the study (Am J Public Health. 2016 Jan 21. doi: 10.2105/AJPH.2015.302976), reported Dr. Mustanski and his colleagues, of the department of medical social sciences at Northwestern University, Chicago.
LGBT victimization was measured using a 10-item questionnaire, and depression and PTSD were assessed with psychiatric interviews at baseline and at the seventh wave of data collection. At the 48-month follow-up, female participants were more likely to complete the interview than were male participants (odds ratio, 2.01; 95% confidence interval, 1.12-4.51; P less than .05).
The researchers were able to identify 4 classes of victimization. Class 1 accounted for 65.4% of the sample and reported low levels of victimization that declined over time (P less than .01). Class 2 accounted for 10.3% of the sample and reported moderate victimization that increased over time (P less than .01). Class 3 included 5.1% of the sample and reported high levels of victimization that remained steady (P = .87). Class 4 included 19.2% of the sample and reported high levels of victimization that declined over time (P less than .01).
Between the classes, significant differences were not found by race or age, and participants in the class 1 group included a higher proportion of females.
Participants in class 2 (OR, 5.54; 95% CI, 1.94-15.82; P less than .001) and class 3 (OR, 4.23; 95% CI, 1.15-15.48; P less than .05) were found to be at higher risk for depression at follow-up than participants in class 1. Likewise, a higher risk for PTSD was found in participants in class 2 (OR, 9.37; 95% CI, 2.76-31.88; P less than .001) and class 3 (OR, 8.66; 95% CI, 1.93-39; P less than .01), compared with class 1. Class 4, however, was associated with a higher risk of PTSD (OR, 4.19; 95% CI, 1.39-12.63; P less than .01) but not depression.
“Our results highlight that it is not only isolated experiences of victimization that affect mental health (which has been the focus of much previous research),” the authors wrote, “but instead, the accumulation of these stressors that exacerbates mental health problems.”
The National Institutes of Mental Health, the American Foundation for Suicide Prevention, the William T. Grant Foundation, and the David Bohnett Foundation funded the study.
Lesbian, gay, bisexual, and transgender youth who report a history of increasing or high levels of victimization are at increased risk for major depressive disorder and posttraumatic stress disorder, a longitudinal study shows.
Results from the study, which is ongoing, show that people who identify as lesbian, gay, bisexual, and transgender (LGBT) are at higher risk for other mental disorders also, such as anxiety and suicide, than are their heterosexual or cisgender counterparts. Further, a history of harassment, victimization, or discrimination proved a predictor of mental health disorders.
The researchers, led by Brian Mustanski, Ph.D., sought to understand the trajectories of victimization and how they affect the development of depression and PTSD in LGBT youth. Initial recruitment included 248 youth. The mean age of the participants was 18.7 years old, and 54.7% were black. Eligibility was met in 234 participants (53% female), and after the seventh wave of data collection, 206 participants (83.1%) remained in the study (Am J Public Health. 2016 Jan 21. doi: 10.2105/AJPH.2015.302976), reported Dr. Mustanski and his colleagues, of the department of medical social sciences at Northwestern University, Chicago.
LGBT victimization was measured using a 10-item questionnaire, and depression and PTSD were assessed with psychiatric interviews at baseline and at the seventh wave of data collection. At the 48-month follow-up, female participants were more likely to complete the interview than were male participants (odds ratio, 2.01; 95% confidence interval, 1.12-4.51; P less than .05).
The researchers were able to identify 4 classes of victimization. Class 1 accounted for 65.4% of the sample and reported low levels of victimization that declined over time (P less than .01). Class 2 accounted for 10.3% of the sample and reported moderate victimization that increased over time (P less than .01). Class 3 included 5.1% of the sample and reported high levels of victimization that remained steady (P = .87). Class 4 included 19.2% of the sample and reported high levels of victimization that declined over time (P less than .01).
Between the classes, significant differences were not found by race or age, and participants in the class 1 group included a higher proportion of females.
Participants in class 2 (OR, 5.54; 95% CI, 1.94-15.82; P less than .001) and class 3 (OR, 4.23; 95% CI, 1.15-15.48; P less than .05) were found to be at higher risk for depression at follow-up than participants in class 1. Likewise, a higher risk for PTSD was found in participants in class 2 (OR, 9.37; 95% CI, 2.76-31.88; P less than .001) and class 3 (OR, 8.66; 95% CI, 1.93-39; P less than .01), compared with class 1. Class 4, however, was associated with a higher risk of PTSD (OR, 4.19; 95% CI, 1.39-12.63; P less than .01) but not depression.
“Our results highlight that it is not only isolated experiences of victimization that affect mental health (which has been the focus of much previous research),” the authors wrote, “but instead, the accumulation of these stressors that exacerbates mental health problems.”
The National Institutes of Mental Health, the American Foundation for Suicide Prevention, the William T. Grant Foundation, and the David Bohnett Foundation funded the study.
FROM THE AMERICAN JOURNAL OF PUBLIC HEALTH
Key clinical point: Understanding the experiences of LGBT youth and trajectories of victimization can lead to interventions that might decrease their risk of developing mental health problems such as major depressive disorder and posttraumatic stress disorder.
Major finding: Participants who experience moderate, increasing victimization and those in the high, steady victimization categories were found to be at higher risk for depression and PTSD, compared with those who had low, decreasing victimization.
Data source: LGBT victimization was measured using a 10-item questionnaire. Depression and PTSD were assessed with psychiatric interviews at baseline and at the seventh wave of data collection.
Disclosures: The National Institutes of Mental Health, the American Foundation for Suicide Prevention, the William T. Grant Foundation, and the David Bohnett Foundation funded the study.
Tenofovir resistance far higher than expected
A higher prevalence of tenofovir resistance was identified in patients with HIV infection living in low- and middle-income settings and with lower baseline CD4 cell counts, according to a retrospective cohort study.
Dr. Ravindra Gupta of the department of infection at University College London and colleagues in the TenoRes collaboration conducted a multicenter retrospective cohort study to analyze resistance rates in adult patients with HIV undergoing resistance testing secondary to failure of a first-line regimen containing tenofovir, a non-nucleotide reverse-transcriptase inhibitor (nevirapine or efavirenz), and a cytosine analogue (emtricitabine or lamivudine). The TenoRes cohort includes patients from Asia, sub-Saharan Africa, Latin and North America, and Europe (Lancet Infect Dis. 2016 Jan 28. doi: 10.1016/S1473-3099[15]00536-8).
Combination antiretroviral therapy (cART) recommendations by the World Health Organization include tenofovir with the non-nucleotide reverse-transcriptase inhibitor (NNRTI) efavirenz, and emtricitabine or lamivudine for adult HIV-1 infection.
From 1998 until 2015, data were analyzed on a cohort of 1,926 participants with treatment failure from 36 countries. Prior to ART initiation, the median CD4 count was 190 cells per mcL and 144 cells per mcL in Europe and North America, respectively, compared to a median CD4 count of 44-104 cells per mcL in Latin America, Asia, and sub-Saharan Africa. Further, the pretreatment viral load was higher in participants from Latin America and central, western, and eastern Africa.
Tenofovir resistance was highest in low- and middle-income settings and in sub-Saharan Africa (370/654, 57%). Factors associated with tenofovir resistance included the pre-ART CD4 cell count (OR 1.50, 95% CI: 1.27-1.77 for CD4 count less than 100 cells per mcL), use of lamivudine over emtricitabine (OR 1.48, 95% CI: 1.20-1.82), and use of the NNRTI nevirapine over efavirenz (OR 1.46, 95% CI: 1.28-1.67).
Tenofovir resistance was observed in 700 participants; 78% (n = 543) had major NNRTI resistance, 83% (n = 578) had the M184V/I mutation with cytosine resistance, and 65% (n = 457) were resistant to both.
Finally, participants with tenofovir resistance and those without had similar plasma viral loads at the time of treatment failure and a high baseline viral load was nonsignificantly associated with tenofovir resistance (OR 1.17, 95% CI: 0.91-1.44, for 100,000 or more copies per mL versus less than 100,000 copies per mL).
“CD4 cell count of less than 100 cells per mcL, treatment with nevirapine rather than efavirenz, and treatment with lamivudine rather than emtricitabine, were consistently associated with a 50% higher odds of tenofovir resistance in those with viral failure,” the researchers noted.
They hypothesized that differences in tenofovir resistance by region and income may be due to the frequency of patient follow-up and viral load monitoring with high-income patients receiving more frequent viral load testing and thus earlier detection of failure before resistance develops. They also said the association between tenofovir resistance and baseline CD4 counts highlights the benefit of CD4 testing at HIV diagnosis along with identifying opportunistic infection prophylaxis needs.
“Patient numbers were somewhat limited by the slow uptake of tenofovir-based regimens in west and central Africa, eastern Europe, and Asia ... and information about baseline viral load in these settings was uncommon. As a result, European countries, Thailand, and South Africa contributed substantially to the analysis,” the researchers wrote.
The Wellcome Trust funded the study. The authors reported multiple disclosures including stipends from various pharmaceutical companies.
The finding of higher-than-expected levels of tenofovir resistance highlights the need to develop HIV therapies that are less susceptible to resistance.
The pro-drug tenofovir alafenamide fumarate might be less prone to development of drug resistance because of lower toxic effects than tenofovir itself. However, this might not necessarily translate into lower levels of drug resistance because the same mutation at position K65R in reverse transcriptase causes resistance to both drugs and might be more prone to develop in subtype C viruses that were assessed in this and other studies.
Another important finding of this study, the higher likelihood of drug resistance with low CD4 counts, illustrates the importance of early initiation of treatment after HIV diagnosis.
Dr. Mark A. Wainberg is associated with McGill University AIDS Centre and Jewish General Hospital in Montreal. This was adapted from an editorial accompanying the original study (Lancet Infect Dis. 2016 Jan 28. doi: 10.1016/S1473-3099[16]00013-X).
The finding of higher-than-expected levels of tenofovir resistance highlights the need to develop HIV therapies that are less susceptible to resistance.
The pro-drug tenofovir alafenamide fumarate might be less prone to development of drug resistance because of lower toxic effects than tenofovir itself. However, this might not necessarily translate into lower levels of drug resistance because the same mutation at position K65R in reverse transcriptase causes resistance to both drugs and might be more prone to develop in subtype C viruses that were assessed in this and other studies.
Another important finding of this study, the higher likelihood of drug resistance with low CD4 counts, illustrates the importance of early initiation of treatment after HIV diagnosis.
Dr. Mark A. Wainberg is associated with McGill University AIDS Centre and Jewish General Hospital in Montreal. This was adapted from an editorial accompanying the original study (Lancet Infect Dis. 2016 Jan 28. doi: 10.1016/S1473-3099[16]00013-X).
The finding of higher-than-expected levels of tenofovir resistance highlights the need to develop HIV therapies that are less susceptible to resistance.
The pro-drug tenofovir alafenamide fumarate might be less prone to development of drug resistance because of lower toxic effects than tenofovir itself. However, this might not necessarily translate into lower levels of drug resistance because the same mutation at position K65R in reverse transcriptase causes resistance to both drugs and might be more prone to develop in subtype C viruses that were assessed in this and other studies.
Another important finding of this study, the higher likelihood of drug resistance with low CD4 counts, illustrates the importance of early initiation of treatment after HIV diagnosis.
Dr. Mark A. Wainberg is associated with McGill University AIDS Centre and Jewish General Hospital in Montreal. This was adapted from an editorial accompanying the original study (Lancet Infect Dis. 2016 Jan 28. doi: 10.1016/S1473-3099[16]00013-X).
A higher prevalence of tenofovir resistance was identified in patients with HIV infection living in low- and middle-income settings and with lower baseline CD4 cell counts, according to a retrospective cohort study.
Dr. Ravindra Gupta of the department of infection at University College London and colleagues in the TenoRes collaboration conducted a multicenter retrospective cohort study to analyze resistance rates in adult patients with HIV undergoing resistance testing secondary to failure of a first-line regimen containing tenofovir, a non-nucleotide reverse-transcriptase inhibitor (nevirapine or efavirenz), and a cytosine analogue (emtricitabine or lamivudine). The TenoRes cohort includes patients from Asia, sub-Saharan Africa, Latin and North America, and Europe (Lancet Infect Dis. 2016 Jan 28. doi: 10.1016/S1473-3099[15]00536-8).
Combination antiretroviral therapy (cART) recommendations by the World Health Organization include tenofovir with the non-nucleotide reverse-transcriptase inhibitor (NNRTI) efavirenz, and emtricitabine or lamivudine for adult HIV-1 infection.
From 1998 until 2015, data were analyzed on a cohort of 1,926 participants with treatment failure from 36 countries. Prior to ART initiation, the median CD4 count was 190 cells per mcL and 144 cells per mcL in Europe and North America, respectively, compared to a median CD4 count of 44-104 cells per mcL in Latin America, Asia, and sub-Saharan Africa. Further, the pretreatment viral load was higher in participants from Latin America and central, western, and eastern Africa.
Tenofovir resistance was highest in low- and middle-income settings and in sub-Saharan Africa (370/654, 57%). Factors associated with tenofovir resistance included the pre-ART CD4 cell count (OR 1.50, 95% CI: 1.27-1.77 for CD4 count less than 100 cells per mcL), use of lamivudine over emtricitabine (OR 1.48, 95% CI: 1.20-1.82), and use of the NNRTI nevirapine over efavirenz (OR 1.46, 95% CI: 1.28-1.67).
Tenofovir resistance was observed in 700 participants; 78% (n = 543) had major NNRTI resistance, 83% (n = 578) had the M184V/I mutation with cytosine resistance, and 65% (n = 457) were resistant to both.
Finally, participants with tenofovir resistance and those without had similar plasma viral loads at the time of treatment failure and a high baseline viral load was nonsignificantly associated with tenofovir resistance (OR 1.17, 95% CI: 0.91-1.44, for 100,000 or more copies per mL versus less than 100,000 copies per mL).
“CD4 cell count of less than 100 cells per mcL, treatment with nevirapine rather than efavirenz, and treatment with lamivudine rather than emtricitabine, were consistently associated with a 50% higher odds of tenofovir resistance in those with viral failure,” the researchers noted.
They hypothesized that differences in tenofovir resistance by region and income may be due to the frequency of patient follow-up and viral load monitoring with high-income patients receiving more frequent viral load testing and thus earlier detection of failure before resistance develops. They also said the association between tenofovir resistance and baseline CD4 counts highlights the benefit of CD4 testing at HIV diagnosis along with identifying opportunistic infection prophylaxis needs.
“Patient numbers were somewhat limited by the slow uptake of tenofovir-based regimens in west and central Africa, eastern Europe, and Asia ... and information about baseline viral load in these settings was uncommon. As a result, European countries, Thailand, and South Africa contributed substantially to the analysis,” the researchers wrote.
The Wellcome Trust funded the study. The authors reported multiple disclosures including stipends from various pharmaceutical companies.
A higher prevalence of tenofovir resistance was identified in patients with HIV infection living in low- and middle-income settings and with lower baseline CD4 cell counts, according to a retrospective cohort study.
Dr. Ravindra Gupta of the department of infection at University College London and colleagues in the TenoRes collaboration conducted a multicenter retrospective cohort study to analyze resistance rates in adult patients with HIV undergoing resistance testing secondary to failure of a first-line regimen containing tenofovir, a non-nucleotide reverse-transcriptase inhibitor (nevirapine or efavirenz), and a cytosine analogue (emtricitabine or lamivudine). The TenoRes cohort includes patients from Asia, sub-Saharan Africa, Latin and North America, and Europe (Lancet Infect Dis. 2016 Jan 28. doi: 10.1016/S1473-3099[15]00536-8).
Combination antiretroviral therapy (cART) recommendations by the World Health Organization include tenofovir with the non-nucleotide reverse-transcriptase inhibitor (NNRTI) efavirenz, and emtricitabine or lamivudine for adult HIV-1 infection.
From 1998 until 2015, data were analyzed on a cohort of 1,926 participants with treatment failure from 36 countries. Prior to ART initiation, the median CD4 count was 190 cells per mcL and 144 cells per mcL in Europe and North America, respectively, compared to a median CD4 count of 44-104 cells per mcL in Latin America, Asia, and sub-Saharan Africa. Further, the pretreatment viral load was higher in participants from Latin America and central, western, and eastern Africa.
Tenofovir resistance was highest in low- and middle-income settings and in sub-Saharan Africa (370/654, 57%). Factors associated with tenofovir resistance included the pre-ART CD4 cell count (OR 1.50, 95% CI: 1.27-1.77 for CD4 count less than 100 cells per mcL), use of lamivudine over emtricitabine (OR 1.48, 95% CI: 1.20-1.82), and use of the NNRTI nevirapine over efavirenz (OR 1.46, 95% CI: 1.28-1.67).
Tenofovir resistance was observed in 700 participants; 78% (n = 543) had major NNRTI resistance, 83% (n = 578) had the M184V/I mutation with cytosine resistance, and 65% (n = 457) were resistant to both.
Finally, participants with tenofovir resistance and those without had similar plasma viral loads at the time of treatment failure and a high baseline viral load was nonsignificantly associated with tenofovir resistance (OR 1.17, 95% CI: 0.91-1.44, for 100,000 or more copies per mL versus less than 100,000 copies per mL).
“CD4 cell count of less than 100 cells per mcL, treatment with nevirapine rather than efavirenz, and treatment with lamivudine rather than emtricitabine, were consistently associated with a 50% higher odds of tenofovir resistance in those with viral failure,” the researchers noted.
They hypothesized that differences in tenofovir resistance by region and income may be due to the frequency of patient follow-up and viral load monitoring with high-income patients receiving more frequent viral load testing and thus earlier detection of failure before resistance develops. They also said the association between tenofovir resistance and baseline CD4 counts highlights the benefit of CD4 testing at HIV diagnosis along with identifying opportunistic infection prophylaxis needs.
“Patient numbers were somewhat limited by the slow uptake of tenofovir-based regimens in west and central Africa, eastern Europe, and Asia ... and information about baseline viral load in these settings was uncommon. As a result, European countries, Thailand, and South Africa contributed substantially to the analysis,” the researchers wrote.
The Wellcome Trust funded the study. The authors reported multiple disclosures including stipends from various pharmaceutical companies.
FROM LANCET INFECTIOUS DISEASES
Key clinical point: A higher prevalence of tenofovir resistance was associated with low- and middle-income settings, sub-Saharan Africa, and a low CD4 count.
Major finding: Tenofovir resistance was associated with low- and middle-income settings, sub-Saharan Africa (370/654, 57%), and pre-ART CD4 cell count (OR 1.50, 95% CI: 1.27-1.77 for CD4 count less than 100 cells per mcL).
Data source: A multicenter retrospective cohort study to analyze resistance rates in adult patients with HIV undergoing resistance testing secondary to failure of a first-line regimen containing tenofovir.
Disclosures: Wellcome Trust funded the study. The authors reported multiple disclosures including stipends from various pharmaceutical companies.
Antidepressant use in children, adolescents may double aggression, suicidality risk
Children and adolescents who take certain SSRIs and SNRIs appear to be at double the risk of aggression and suicidality, however, no such associations are found in adults, according to results of a systematic review and meta-analysis published online Jan. 27.
Those are some of the results of the review and meta-analysis involving more than 18,500 patients conducted by Tarang Sharma of the Nordic Cochrane Centre in Copenhagen, and her colleagues of five antidepressants. The researchers sought to assess the associations between selective serotonin reuptake inhibitors and four outcomes: mortality, suicidality, aggression, and akathisia. Their report was published online in BMJ (2016 Jan 27. doi: 10.1136/bmj.i65).
Ms. Sharma and her colleagues analyzed 68 clinical study reports involving 70 trials investigating duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine. Of the included trials, 11 involved children and adolescents, and 63% (n = 44) excluded patients at risk for suicide.
Overall, the researchers found no significant differences in akathisia (odds ratio, 2.04; 95% confidence interval, 0.93-4.48), suicidality (OR, 1.21; 95% CI, 0.81-1.74), or mortality (OR, 1.28; 95% CI, 0.40-4.06). However, they did find an association with aggressive behavior (OR, 1.93; 95% CI, 1.26-2.95).
When they separated the adult data from those of younger patients, however, they found that children and adolescents had double the risk of aggression (OR 2.79, 95% CI: 1.62-4.81) and suicidality (OR, 2.39; 95% CI, 1.31-4.33). The risk of akathisia was lower (OR, 2.19; 95% CI, 0.48-9.65). Data for adults did not demonstrate a significant increase in aggression (OR, 1.09; 95% CI, 0.55-2.14), suicidality (OR, 0.81; 95% 0.51-1.28), or akathisia (OR, 2.00; 95% CI, 0.79-5.04).
The authors noted several limitations in the trials, such as insufficient lead-in periods. In addition, there were inconsistencies between the trials in how the events were coded. Further, 46% of the trials included in the analysis did not note which coding dictionary was used. The authors point out that the limitations of the trials in terms of clinical study reports “may have led to serious underestimation of the harms” and that there is still uncertainty of the true risks.
The Laura and John Arnold Foundation funded the study. The authors report no disclosures.
The analysis by Tarang Sharma and her colleagues suggests that clinical study reports probably underestimate the possible negative effects of antidepressants, Dr. Joanna Moncrieff wrote in an accompanying editorial.
“To reevaluate antidepressants properly, we need access to original data from trials, but we also need research that clarifies the whole range of antidepressant-induced … alterations” after acute treatment, use, and withdrawal, she wrote.
Dr. Moncrieff, a senior lecturer in the division of psychiatry at the University College London, is a cochair of the Critical Psychiatry Network. Her editorial also was published in BMJ online (2016 Jan 27. doi: 10.1136/bmj.i217.
The analysis by Tarang Sharma and her colleagues suggests that clinical study reports probably underestimate the possible negative effects of antidepressants, Dr. Joanna Moncrieff wrote in an accompanying editorial.
“To reevaluate antidepressants properly, we need access to original data from trials, but we also need research that clarifies the whole range of antidepressant-induced … alterations” after acute treatment, use, and withdrawal, she wrote.
Dr. Moncrieff, a senior lecturer in the division of psychiatry at the University College London, is a cochair of the Critical Psychiatry Network. Her editorial also was published in BMJ online (2016 Jan 27. doi: 10.1136/bmj.i217.
The analysis by Tarang Sharma and her colleagues suggests that clinical study reports probably underestimate the possible negative effects of antidepressants, Dr. Joanna Moncrieff wrote in an accompanying editorial.
“To reevaluate antidepressants properly, we need access to original data from trials, but we also need research that clarifies the whole range of antidepressant-induced … alterations” after acute treatment, use, and withdrawal, she wrote.
Dr. Moncrieff, a senior lecturer in the division of psychiatry at the University College London, is a cochair of the Critical Psychiatry Network. Her editorial also was published in BMJ online (2016 Jan 27. doi: 10.1136/bmj.i217.
Children and adolescents who take certain SSRIs and SNRIs appear to be at double the risk of aggression and suicidality, however, no such associations are found in adults, according to results of a systematic review and meta-analysis published online Jan. 27.
Those are some of the results of the review and meta-analysis involving more than 18,500 patients conducted by Tarang Sharma of the Nordic Cochrane Centre in Copenhagen, and her colleagues of five antidepressants. The researchers sought to assess the associations between selective serotonin reuptake inhibitors and four outcomes: mortality, suicidality, aggression, and akathisia. Their report was published online in BMJ (2016 Jan 27. doi: 10.1136/bmj.i65).
Ms. Sharma and her colleagues analyzed 68 clinical study reports involving 70 trials investigating duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine. Of the included trials, 11 involved children and adolescents, and 63% (n = 44) excluded patients at risk for suicide.
Overall, the researchers found no significant differences in akathisia (odds ratio, 2.04; 95% confidence interval, 0.93-4.48), suicidality (OR, 1.21; 95% CI, 0.81-1.74), or mortality (OR, 1.28; 95% CI, 0.40-4.06). However, they did find an association with aggressive behavior (OR, 1.93; 95% CI, 1.26-2.95).
When they separated the adult data from those of younger patients, however, they found that children and adolescents had double the risk of aggression (OR 2.79, 95% CI: 1.62-4.81) and suicidality (OR, 2.39; 95% CI, 1.31-4.33). The risk of akathisia was lower (OR, 2.19; 95% CI, 0.48-9.65). Data for adults did not demonstrate a significant increase in aggression (OR, 1.09; 95% CI, 0.55-2.14), suicidality (OR, 0.81; 95% 0.51-1.28), or akathisia (OR, 2.00; 95% CI, 0.79-5.04).
The authors noted several limitations in the trials, such as insufficient lead-in periods. In addition, there were inconsistencies between the trials in how the events were coded. Further, 46% of the trials included in the analysis did not note which coding dictionary was used. The authors point out that the limitations of the trials in terms of clinical study reports “may have led to serious underestimation of the harms” and that there is still uncertainty of the true risks.
The Laura and John Arnold Foundation funded the study. The authors report no disclosures.
Children and adolescents who take certain SSRIs and SNRIs appear to be at double the risk of aggression and suicidality, however, no such associations are found in adults, according to results of a systematic review and meta-analysis published online Jan. 27.
Those are some of the results of the review and meta-analysis involving more than 18,500 patients conducted by Tarang Sharma of the Nordic Cochrane Centre in Copenhagen, and her colleagues of five antidepressants. The researchers sought to assess the associations between selective serotonin reuptake inhibitors and four outcomes: mortality, suicidality, aggression, and akathisia. Their report was published online in BMJ (2016 Jan 27. doi: 10.1136/bmj.i65).
Ms. Sharma and her colleagues analyzed 68 clinical study reports involving 70 trials investigating duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine. Of the included trials, 11 involved children and adolescents, and 63% (n = 44) excluded patients at risk for suicide.
Overall, the researchers found no significant differences in akathisia (odds ratio, 2.04; 95% confidence interval, 0.93-4.48), suicidality (OR, 1.21; 95% CI, 0.81-1.74), or mortality (OR, 1.28; 95% CI, 0.40-4.06). However, they did find an association with aggressive behavior (OR, 1.93; 95% CI, 1.26-2.95).
When they separated the adult data from those of younger patients, however, they found that children and adolescents had double the risk of aggression (OR 2.79, 95% CI: 1.62-4.81) and suicidality (OR, 2.39; 95% CI, 1.31-4.33). The risk of akathisia was lower (OR, 2.19; 95% CI, 0.48-9.65). Data for adults did not demonstrate a significant increase in aggression (OR, 1.09; 95% CI, 0.55-2.14), suicidality (OR, 0.81; 95% 0.51-1.28), or akathisia (OR, 2.00; 95% CI, 0.79-5.04).
The authors noted several limitations in the trials, such as insufficient lead-in periods. In addition, there were inconsistencies between the trials in how the events were coded. Further, 46% of the trials included in the analysis did not note which coding dictionary was used. The authors point out that the limitations of the trials in terms of clinical study reports “may have led to serious underestimation of the harms” and that there is still uncertainty of the true risks.
The Laura and John Arnold Foundation funded the study. The authors report no disclosures.
FROM BMJ
Key clinical point: Meta-analysis finds increased risk of suicidality and aggression in children and adolescents taking certain antidepressants.
Major finding: Children and adolescents had double the risk of aggression (OR, 2.79; 95% CI, 1.62-4.81) and suicidality (OR, 2.39; 95% CI, 1.31-4.33).
Data source: A systematic review and meta-analysis of clinical study reports for five antidepressants to assess potential harms associated with SSRIs and SNRIs.
Disclosures: The Laura and John Arnold Foundation funded the study. The authors report no disclosures.
Disclosing both heart, Alzheimer’s risks during APOE testing found safe
Anxiety and depression were not increased with disclosure of pleiotropic genetic information during genetic testing for Alzheimer’s disease, according to results from the randomized REVEAL trial.
Disclosure of risk for both Alzheimer’s disease (AD) and coronary artery disease (CAD) in people who carried the pleiotropic epsilon-4 allele of the apolipoprotein E gene (APOE4) was associated with less distress and anxiety than was disclosure of AD risk alone and led to more reported change in health behaviors.
Kurt D. Christensen, Ph.D., of Brigham and Women’s Hospital, Boston, and his colleagues conducted the REVEAL (Risk Evaluation and Education for Alzheimer’s Disease) trial to assess participant’s anxiety and depression levels and behavioral change after disclosure of the association of CAD with APOE genotype during genetic testing for AD because of the dearth of research into the harms and benefits of revealing incidental genomic findings to the patient (Ann Intern Med. 2016 Jan 26. doi: 10.7326/M15-0187).
Participants were randomly assigned to receive AD disclosure or AD and CAD disclosure by telephone or in person. Of the 257 adult participants, 69% had a first-degree relative with AD. Participant dropout prior to disclosure occurred at 15% and 8% in the AD/CAD group and AD group, respectively. Participants who were younger (P = .003), unmarried (P = .028), less educated (P less than .001), and female (P = .009) were more likely to drop out.
After 12 months of follow-up, both the AD and the AD/CAD group had a mean Beck Anxiety Inventory of 3.5 (difference, 0.0; 95% confidence interval, –1.0 to 1.0), and the mean Center for Epidemiologic Studies Depression Scale was 6.4 in the AD group and 7.1 in the AD/CAD group (difference, 0.7; 95% CI, –1.0 to 2.4).
Among APOE4 carriers, people who received CAD disclosure had less distress than did noncarriers (difference, –4.8; 95% CI, –8.6 to –1.0; P = .031 for interaction), but those who received only AD disclosure had higher anxiety scores (12-month mean difference, 1.9; 95% CI, 0.1 to 3.7).
Both APOE4 carriers and those who received AD and CAD disclosure were more likely to report changes in health behaviors.
“Responses on the primary outcomes of anxiety and depression were equivalent between participants receiving information on AD risk plus secondary information on CAD risk and those receiving information on AD risk only ... However, participants at increased risk for disease (APOE4 carriers) seemed to experience less test-related distress at 12 months, if they also received CAD information,” the authors wrote.
The study was supported by grants from the National Institutes of Health. The authors reported multiple disclosures.
Dr. Christensen and his colleagues’ work highlights that disclosure of incidental genetic findings with known prevention strategies can be tolerated well by participants.
However, specifically for APOE, the risk for AD is likely in the category of high predictive value but low preventive value. Whereas, using APOE for CAD risk is likely in the category of high preventive value but low predictive value. Therefore, these together may not be a high priority for testing at this point.
Dr. Michael F. Murray is with the Genomic Medicine Institute in the Geisinger Health System in Forty Fort, Pa. These comments are taken from his editorial that accompanied Dr. Christensen’s report (Ann Intern Med. 2016 Jan 26. doi: 10.7326/M15-2993). He had no disclosures to report.
Dr. Christensen and his colleagues’ work highlights that disclosure of incidental genetic findings with known prevention strategies can be tolerated well by participants.
However, specifically for APOE, the risk for AD is likely in the category of high predictive value but low preventive value. Whereas, using APOE for CAD risk is likely in the category of high preventive value but low predictive value. Therefore, these together may not be a high priority for testing at this point.
Dr. Michael F. Murray is with the Genomic Medicine Institute in the Geisinger Health System in Forty Fort, Pa. These comments are taken from his editorial that accompanied Dr. Christensen’s report (Ann Intern Med. 2016 Jan 26. doi: 10.7326/M15-2993). He had no disclosures to report.
Dr. Christensen and his colleagues’ work highlights that disclosure of incidental genetic findings with known prevention strategies can be tolerated well by participants.
However, specifically for APOE, the risk for AD is likely in the category of high predictive value but low preventive value. Whereas, using APOE for CAD risk is likely in the category of high preventive value but low predictive value. Therefore, these together may not be a high priority for testing at this point.
Dr. Michael F. Murray is with the Genomic Medicine Institute in the Geisinger Health System in Forty Fort, Pa. These comments are taken from his editorial that accompanied Dr. Christensen’s report (Ann Intern Med. 2016 Jan 26. doi: 10.7326/M15-2993). He had no disclosures to report.
Anxiety and depression were not increased with disclosure of pleiotropic genetic information during genetic testing for Alzheimer’s disease, according to results from the randomized REVEAL trial.
Disclosure of risk for both Alzheimer’s disease (AD) and coronary artery disease (CAD) in people who carried the pleiotropic epsilon-4 allele of the apolipoprotein E gene (APOE4) was associated with less distress and anxiety than was disclosure of AD risk alone and led to more reported change in health behaviors.
Kurt D. Christensen, Ph.D., of Brigham and Women’s Hospital, Boston, and his colleagues conducted the REVEAL (Risk Evaluation and Education for Alzheimer’s Disease) trial to assess participant’s anxiety and depression levels and behavioral change after disclosure of the association of CAD with APOE genotype during genetic testing for AD because of the dearth of research into the harms and benefits of revealing incidental genomic findings to the patient (Ann Intern Med. 2016 Jan 26. doi: 10.7326/M15-0187).
Participants were randomly assigned to receive AD disclosure or AD and CAD disclosure by telephone or in person. Of the 257 adult participants, 69% had a first-degree relative with AD. Participant dropout prior to disclosure occurred at 15% and 8% in the AD/CAD group and AD group, respectively. Participants who were younger (P = .003), unmarried (P = .028), less educated (P less than .001), and female (P = .009) were more likely to drop out.
After 12 months of follow-up, both the AD and the AD/CAD group had a mean Beck Anxiety Inventory of 3.5 (difference, 0.0; 95% confidence interval, –1.0 to 1.0), and the mean Center for Epidemiologic Studies Depression Scale was 6.4 in the AD group and 7.1 in the AD/CAD group (difference, 0.7; 95% CI, –1.0 to 2.4).
Among APOE4 carriers, people who received CAD disclosure had less distress than did noncarriers (difference, –4.8; 95% CI, –8.6 to –1.0; P = .031 for interaction), but those who received only AD disclosure had higher anxiety scores (12-month mean difference, 1.9; 95% CI, 0.1 to 3.7).
Both APOE4 carriers and those who received AD and CAD disclosure were more likely to report changes in health behaviors.
“Responses on the primary outcomes of anxiety and depression were equivalent between participants receiving information on AD risk plus secondary information on CAD risk and those receiving information on AD risk only ... However, participants at increased risk for disease (APOE4 carriers) seemed to experience less test-related distress at 12 months, if they also received CAD information,” the authors wrote.
The study was supported by grants from the National Institutes of Health. The authors reported multiple disclosures.
Anxiety and depression were not increased with disclosure of pleiotropic genetic information during genetic testing for Alzheimer’s disease, according to results from the randomized REVEAL trial.
Disclosure of risk for both Alzheimer’s disease (AD) and coronary artery disease (CAD) in people who carried the pleiotropic epsilon-4 allele of the apolipoprotein E gene (APOE4) was associated with less distress and anxiety than was disclosure of AD risk alone and led to more reported change in health behaviors.
Kurt D. Christensen, Ph.D., of Brigham and Women’s Hospital, Boston, and his colleagues conducted the REVEAL (Risk Evaluation and Education for Alzheimer’s Disease) trial to assess participant’s anxiety and depression levels and behavioral change after disclosure of the association of CAD with APOE genotype during genetic testing for AD because of the dearth of research into the harms and benefits of revealing incidental genomic findings to the patient (Ann Intern Med. 2016 Jan 26. doi: 10.7326/M15-0187).
Participants were randomly assigned to receive AD disclosure or AD and CAD disclosure by telephone or in person. Of the 257 adult participants, 69% had a first-degree relative with AD. Participant dropout prior to disclosure occurred at 15% and 8% in the AD/CAD group and AD group, respectively. Participants who were younger (P = .003), unmarried (P = .028), less educated (P less than .001), and female (P = .009) were more likely to drop out.
After 12 months of follow-up, both the AD and the AD/CAD group had a mean Beck Anxiety Inventory of 3.5 (difference, 0.0; 95% confidence interval, –1.0 to 1.0), and the mean Center for Epidemiologic Studies Depression Scale was 6.4 in the AD group and 7.1 in the AD/CAD group (difference, 0.7; 95% CI, –1.0 to 2.4).
Among APOE4 carriers, people who received CAD disclosure had less distress than did noncarriers (difference, –4.8; 95% CI, –8.6 to –1.0; P = .031 for interaction), but those who received only AD disclosure had higher anxiety scores (12-month mean difference, 1.9; 95% CI, 0.1 to 3.7).
Both APOE4 carriers and those who received AD and CAD disclosure were more likely to report changes in health behaviors.
“Responses on the primary outcomes of anxiety and depression were equivalent between participants receiving information on AD risk plus secondary information on CAD risk and those receiving information on AD risk only ... However, participants at increased risk for disease (APOE4 carriers) seemed to experience less test-related distress at 12 months, if they also received CAD information,” the authors wrote.
The study was supported by grants from the National Institutes of Health. The authors reported multiple disclosures.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Anxiety and depression did not increase with disclosure of pleiotropic genetic information during genetic testing for Alzheimer’s disease.
Major finding: Disclosure of CAD risk with AD risk was not associated with increased anxiety or depression and may have decreased distress and increased changes in health behaviors.
Data source: A randomized trial of 257 participants who underwent APOE genotyping and received Alzheimer’s disease risk information with or without CAD risk disclosure.
Disclosures: The study was supported by grants from the NIH. The authors report multiple disclosures.
High participation, steady sensitivity for CRC with annual FIT screening
Annual fecal immunochemical testing (FIT) for colorectal cancer screening demonstrated slightly decreased but steady sensitivity and predictive values over several rounds with a high participation rate.
According to the report, noninvasive fecal blood testing has been shown to decrease colorectal cancer (CRC) incidence and mortality. Further, screening with fecal immunochemical testing (FIT) doesn’t require consideration of medications or dietary factors as guaiac stool testing does.
Dr. Christopher Jensen of the Kaiser Permanente Division of Research in Oakland, Calif., and colleagues conducted a retrospective cohort study of 50- to 70-year-olds to assess the performance of FIT for 4 years of annual screening. Their results were published in Annals of Internal Medicine.
In total, 670,841 participants received FIT kits and 48.2% returned completed kits. Among the participants in round 1, 55.4% were white, 46.4% were men, and the mean age was 58.5 years. In subsequent rounds, eligible participants returned the kits at a rate of 75.3% for round 2, 83.4% for round 3, 86.1% for round 4, and 63.8% overall.
Tests were 5% positive in the first round and ranged from 3.7% to 4.3% positive in subsequent rounds. Further, men compared with women (5.1% versus 3.7%) and older participants compared to younger (5.2% versus 4.1%) had higher rates of FIT positivity. Follow-up colonoscopy was obtained within 1 year (median 45 days) of a positive FIT in 78.4% of participants.
The positive predictive value for adenoma was highest in the first round at 51.5% and ranged from 47.4% to 48.5% in subsequent rounds. Similarly, the positive predictive value for colorectal cancer was 3.4% in the first round and ranged from 2.1% to 2.3% in subsequent rounds.
Finally, the sensitivity of FIT for CRC was 84.5% in the first round and between 73.4% and 78% in subsequent rounds. Across all screening rounds, participants with a diagnosis with CRC had a positive FIT between 79.7% in round 1 to 75.3% in round 4 beforehand. The authors point out that sensitivity was slightly lower for proximal compared with distal cancer. Further, those with a positive FIT the year prior were less likely to have advanced-stage CRC (26.9%) than those with a negative FIT (33.1%) or not screened (37.1%).
Dr. Corley and Dr. Levin reported grants from the National Cancer Institute, which supported the study. Dr. Jensen reported grants from the National Institutes of Health, and Dr. Doubeni reported consulting for Exact Sciences.
Annual fecal immunochemical testing (FIT) for colorectal cancer screening demonstrated slightly decreased but steady sensitivity and predictive values over several rounds with a high participation rate.
According to the report, noninvasive fecal blood testing has been shown to decrease colorectal cancer (CRC) incidence and mortality. Further, screening with fecal immunochemical testing (FIT) doesn’t require consideration of medications or dietary factors as guaiac stool testing does.
Dr. Christopher Jensen of the Kaiser Permanente Division of Research in Oakland, Calif., and colleagues conducted a retrospective cohort study of 50- to 70-year-olds to assess the performance of FIT for 4 years of annual screening. Their results were published in Annals of Internal Medicine.
In total, 670,841 participants received FIT kits and 48.2% returned completed kits. Among the participants in round 1, 55.4% were white, 46.4% were men, and the mean age was 58.5 years. In subsequent rounds, eligible participants returned the kits at a rate of 75.3% for round 2, 83.4% for round 3, 86.1% for round 4, and 63.8% overall.
Tests were 5% positive in the first round and ranged from 3.7% to 4.3% positive in subsequent rounds. Further, men compared with women (5.1% versus 3.7%) and older participants compared to younger (5.2% versus 4.1%) had higher rates of FIT positivity. Follow-up colonoscopy was obtained within 1 year (median 45 days) of a positive FIT in 78.4% of participants.
The positive predictive value for adenoma was highest in the first round at 51.5% and ranged from 47.4% to 48.5% in subsequent rounds. Similarly, the positive predictive value for colorectal cancer was 3.4% in the first round and ranged from 2.1% to 2.3% in subsequent rounds.
Finally, the sensitivity of FIT for CRC was 84.5% in the first round and between 73.4% and 78% in subsequent rounds. Across all screening rounds, participants with a diagnosis with CRC had a positive FIT between 79.7% in round 1 to 75.3% in round 4 beforehand. The authors point out that sensitivity was slightly lower for proximal compared with distal cancer. Further, those with a positive FIT the year prior were less likely to have advanced-stage CRC (26.9%) than those with a negative FIT (33.1%) or not screened (37.1%).
Dr. Corley and Dr. Levin reported grants from the National Cancer Institute, which supported the study. Dr. Jensen reported grants from the National Institutes of Health, and Dr. Doubeni reported consulting for Exact Sciences.
Annual fecal immunochemical testing (FIT) for colorectal cancer screening demonstrated slightly decreased but steady sensitivity and predictive values over several rounds with a high participation rate.
According to the report, noninvasive fecal blood testing has been shown to decrease colorectal cancer (CRC) incidence and mortality. Further, screening with fecal immunochemical testing (FIT) doesn’t require consideration of medications or dietary factors as guaiac stool testing does.
Dr. Christopher Jensen of the Kaiser Permanente Division of Research in Oakland, Calif., and colleagues conducted a retrospective cohort study of 50- to 70-year-olds to assess the performance of FIT for 4 years of annual screening. Their results were published in Annals of Internal Medicine.
In total, 670,841 participants received FIT kits and 48.2% returned completed kits. Among the participants in round 1, 55.4% were white, 46.4% were men, and the mean age was 58.5 years. In subsequent rounds, eligible participants returned the kits at a rate of 75.3% for round 2, 83.4% for round 3, 86.1% for round 4, and 63.8% overall.
Tests were 5% positive in the first round and ranged from 3.7% to 4.3% positive in subsequent rounds. Further, men compared with women (5.1% versus 3.7%) and older participants compared to younger (5.2% versus 4.1%) had higher rates of FIT positivity. Follow-up colonoscopy was obtained within 1 year (median 45 days) of a positive FIT in 78.4% of participants.
The positive predictive value for adenoma was highest in the first round at 51.5% and ranged from 47.4% to 48.5% in subsequent rounds. Similarly, the positive predictive value for colorectal cancer was 3.4% in the first round and ranged from 2.1% to 2.3% in subsequent rounds.
Finally, the sensitivity of FIT for CRC was 84.5% in the first round and between 73.4% and 78% in subsequent rounds. Across all screening rounds, participants with a diagnosis with CRC had a positive FIT between 79.7% in round 1 to 75.3% in round 4 beforehand. The authors point out that sensitivity was slightly lower for proximal compared with distal cancer. Further, those with a positive FIT the year prior were less likely to have advanced-stage CRC (26.9%) than those with a negative FIT (33.1%) or not screened (37.1%).
Dr. Corley and Dr. Levin reported grants from the National Cancer Institute, which supported the study. Dr. Jensen reported grants from the National Institutes of Health, and Dr. Doubeni reported consulting for Exact Sciences.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Annual FIT screening had high participation and steady sensitivity for CRC.
Major finding: The positive predictive value for adenoma was 51.5% in round 1 (47.4%-48.5% in subsequent rounds), the PPV for CRC was 3.4% in round 1 (2.1%-2.3% in subsequent rounds), and the sensitivity for CRC was 84.5% in round 1 (73.4%-78% in subsequent rounds).
Data source: Retrospective cohort study of 50- to 70-year-olds to assess the performance of FIT for 4 years of annual screening.
Disclosures: Dr. Corley and Dr. Levin reported grants from the National Cancer Institute, which supported the study. Dr. Jensen reported grants from the National Institutes of Health, and Dr. Doubeni reported consulting for Exact Sciences.
Sugary beverages tied to increased visceral fat
Daily consumption of sugar-sweetened beverages was associated with a 27% increase in visceral adipose tissue over time, according to an analysis of the Framingham Heart Study published online on Jan. 11 in Circulation.
“There is evidence linking sugar-sweetened beverages with cardiovascular disease and type 2 diabetes. Our message to consumers is to follow the current dietary guidelines and to be mindful of how much sugar-sweetened beverages they drink. To policy makers, this study adds another piece of evidence to the growing body of research suggesting sugar-sweetened beverages may be harmful to our health,” Dr. Caroline Fox of the National Heart, Lung, and Blood Institute’s Framingham Heart Study and Population Sciences Branch said in a press release.
These results coincide with the recent release of the updated dietary guidelines by the U.S. Department of Health and Human Services which note to limit added sugars to less than 10% of daily caloric intake.
Furthermore, sugar-sweetened beverages are a major contributor of additional sugar in the American diet. According to the study, cardiometabolic risk can potentially be associated with an increase in abdominal adipose tissue. Likewise, type 2 diabetes and cardiovascular disease have been linked to larger amounts of visceral adipose tissue (VAT).
Dr. Fox and her colleagues conducted a prospective study of participants in the third generation cohort of the Framingham Heart Study to explore the relationship between sugar-sweetened beverage intake vs. diet soda and differences over time in VAT and subcutaneous adipose tissue (SAT) on CT scans. Measurements of the quantity and quality of abdominal adipose tissue were obtained from two CT scans taken roughly 6 years apart. Participants were assessed for frequency of sugar-sweetened beverage vs. diet soda intake, and body measurements were obtained.
The mean age of the 1,003 participants was 45.3 years, and women made up 45%. Of them, 85% (852) reported drinking a combination of diet soda and sugar-sweetened beverages and 14% (138) reported not drinking either. Sugar-sweetened beverage intake was reported as daily, frequent, occasional, or not at all, in 13%, 35%, 20%, and 32% of the participants, respectively. Those consuming sugar-sweetened beverages were less likely to have diabetes but more likely to be young, male, report more physical activity, and smoke.
Interestingly, those reporting diet soda intake had a higher prevalence of diabetes, had an increased body mass index, and reported less activity (Circulation. 2016 Jan 11).
Over the 6 years, they found more sugar-sweetened beverage consumption was associated with greater change in VAT volume, which was significant after accounting for the change in body weight (P less than .001). As the consumption of sugar-sweetened beverages increased from no consumption to daily consumption, the VAT volume increased by 658 cm3, 649 cm3, 707 cm3, and 852 cm3, respectively.
Finally, they found no association with diet soda intake and change in weight or change in VAT volume.
“In this prospective observational study of middle-aged adults, we observed that individuals who consumed at least one serving of sugar-sweetened beverages per day ... had a 27% greater increase in VAT volume over 6 years compared to non-consumers,” the investigators wrote.
The authors reported having no disclosures. The study was funded by the National Heart, Lung, and Blood Institute.
Daily consumption of sugar-sweetened beverages was associated with a 27% increase in visceral adipose tissue over time, according to an analysis of the Framingham Heart Study published online on Jan. 11 in Circulation.
“There is evidence linking sugar-sweetened beverages with cardiovascular disease and type 2 diabetes. Our message to consumers is to follow the current dietary guidelines and to be mindful of how much sugar-sweetened beverages they drink. To policy makers, this study adds another piece of evidence to the growing body of research suggesting sugar-sweetened beverages may be harmful to our health,” Dr. Caroline Fox of the National Heart, Lung, and Blood Institute’s Framingham Heart Study and Population Sciences Branch said in a press release.
These results coincide with the recent release of the updated dietary guidelines by the U.S. Department of Health and Human Services which note to limit added sugars to less than 10% of daily caloric intake.
Furthermore, sugar-sweetened beverages are a major contributor of additional sugar in the American diet. According to the study, cardiometabolic risk can potentially be associated with an increase in abdominal adipose tissue. Likewise, type 2 diabetes and cardiovascular disease have been linked to larger amounts of visceral adipose tissue (VAT).
Dr. Fox and her colleagues conducted a prospective study of participants in the third generation cohort of the Framingham Heart Study to explore the relationship between sugar-sweetened beverage intake vs. diet soda and differences over time in VAT and subcutaneous adipose tissue (SAT) on CT scans. Measurements of the quantity and quality of abdominal adipose tissue were obtained from two CT scans taken roughly 6 years apart. Participants were assessed for frequency of sugar-sweetened beverage vs. diet soda intake, and body measurements were obtained.
The mean age of the 1,003 participants was 45.3 years, and women made up 45%. Of them, 85% (852) reported drinking a combination of diet soda and sugar-sweetened beverages and 14% (138) reported not drinking either. Sugar-sweetened beverage intake was reported as daily, frequent, occasional, or not at all, in 13%, 35%, 20%, and 32% of the participants, respectively. Those consuming sugar-sweetened beverages were less likely to have diabetes but more likely to be young, male, report more physical activity, and smoke.
Interestingly, those reporting diet soda intake had a higher prevalence of diabetes, had an increased body mass index, and reported less activity (Circulation. 2016 Jan 11).
Over the 6 years, they found more sugar-sweetened beverage consumption was associated with greater change in VAT volume, which was significant after accounting for the change in body weight (P less than .001). As the consumption of sugar-sweetened beverages increased from no consumption to daily consumption, the VAT volume increased by 658 cm3, 649 cm3, 707 cm3, and 852 cm3, respectively.
Finally, they found no association with diet soda intake and change in weight or change in VAT volume.
“In this prospective observational study of middle-aged adults, we observed that individuals who consumed at least one serving of sugar-sweetened beverages per day ... had a 27% greater increase in VAT volume over 6 years compared to non-consumers,” the investigators wrote.
The authors reported having no disclosures. The study was funded by the National Heart, Lung, and Blood Institute.
Daily consumption of sugar-sweetened beverages was associated with a 27% increase in visceral adipose tissue over time, according to an analysis of the Framingham Heart Study published online on Jan. 11 in Circulation.
“There is evidence linking sugar-sweetened beverages with cardiovascular disease and type 2 diabetes. Our message to consumers is to follow the current dietary guidelines and to be mindful of how much sugar-sweetened beverages they drink. To policy makers, this study adds another piece of evidence to the growing body of research suggesting sugar-sweetened beverages may be harmful to our health,” Dr. Caroline Fox of the National Heart, Lung, and Blood Institute’s Framingham Heart Study and Population Sciences Branch said in a press release.
These results coincide with the recent release of the updated dietary guidelines by the U.S. Department of Health and Human Services which note to limit added sugars to less than 10% of daily caloric intake.
Furthermore, sugar-sweetened beverages are a major contributor of additional sugar in the American diet. According to the study, cardiometabolic risk can potentially be associated with an increase in abdominal adipose tissue. Likewise, type 2 diabetes and cardiovascular disease have been linked to larger amounts of visceral adipose tissue (VAT).
Dr. Fox and her colleagues conducted a prospective study of participants in the third generation cohort of the Framingham Heart Study to explore the relationship between sugar-sweetened beverage intake vs. diet soda and differences over time in VAT and subcutaneous adipose tissue (SAT) on CT scans. Measurements of the quantity and quality of abdominal adipose tissue were obtained from two CT scans taken roughly 6 years apart. Participants were assessed for frequency of sugar-sweetened beverage vs. diet soda intake, and body measurements were obtained.
The mean age of the 1,003 participants was 45.3 years, and women made up 45%. Of them, 85% (852) reported drinking a combination of diet soda and sugar-sweetened beverages and 14% (138) reported not drinking either. Sugar-sweetened beverage intake was reported as daily, frequent, occasional, or not at all, in 13%, 35%, 20%, and 32% of the participants, respectively. Those consuming sugar-sweetened beverages were less likely to have diabetes but more likely to be young, male, report more physical activity, and smoke.
Interestingly, those reporting diet soda intake had a higher prevalence of diabetes, had an increased body mass index, and reported less activity (Circulation. 2016 Jan 11).
Over the 6 years, they found more sugar-sweetened beverage consumption was associated with greater change in VAT volume, which was significant after accounting for the change in body weight (P less than .001). As the consumption of sugar-sweetened beverages increased from no consumption to daily consumption, the VAT volume increased by 658 cm3, 649 cm3, 707 cm3, and 852 cm3, respectively.
Finally, they found no association with diet soda intake and change in weight or change in VAT volume.
“In this prospective observational study of middle-aged adults, we observed that individuals who consumed at least one serving of sugar-sweetened beverages per day ... had a 27% greater increase in VAT volume over 6 years compared to non-consumers,” the investigators wrote.
The authors reported having no disclosures. The study was funded by the National Heart, Lung, and Blood Institute.
FROM CIRCULATION
Key clinical point: Daily consumption of sugar-sweetened beverages was associated with a 27% increase in visceral adipose tissue.
Major finding: More sugar-sweetened beverage consumption was associated with greater change in VAT volume which was significant after accounting for the change in body weight (P less than .001).
Data source: A prospective study of participants in the third-generation cohort of the Framingham Heart Study.
Disclosures: The authors report having no disclosures. The study was funded by the National Heart, Lung, and Blood Institute.
Study: PDT with methyl aminolevulinate promising for severe acne
Methyl aminolevulinate plus photodynamic therapy shows promise as a treatment for severe acne vulgaris, according to a U.S. study published in the British Journal of Dermatology.
Dr. David M. Pariser of Eastern Virginia Medical School, Norfolk, and his associates conducted the randomized double-blind, vehicle-controlled trial of photodynamic therapy (PDT) with methyl aminolevulinate (MAL) as a photosensitizer in 153 males and females aged 12-35 years with severe facial acne. Inclusion criteria comprised an Investigator Global Assessment (IGA) rating score of 4, 20-100 noninflammatory lesions, and 25-75 inflammatory lesions with no more than three nodules (Br J Dermatol. 2015 December. doi: 10.1111/bjd.14345).
Participants received topical MAL 80 mg/g (100) or vehicle cream (53) and PDT every 2 weeks for four treatments, and were evaluated at each treatment and at 12 weeks. The MAL or vehicle cream was applied and covered for 1.5 hours, followed by PDT (635 nm of red light for a total dose of 37 J/cm2). Most completed the study (85% in MAL group and 91% in vehicle group).
Those in the MAL PDT group demonstrated a significant reduction in inflammatory lesions based on the percentage change at 12 weeks (a mean reduction of 37.3% vs. 16.2%; P = .003), and absolute change (a mean reduction of 15.6 lesions vs. 7.8; P = .006). However, the reduction in noninflammatory lesions was not significantly different between the two groups (a mean reduction of 11.8 lesions among those on MAL PDT vs. 10.7 with vehicle PDT) .
The rates of treatment success, defined as improvement of 2 or more IGA grades at 12 weeks, were higher among those in the MAL PDT group (44% vs. 26.4%; OR, 3.24; P = .013).
Pain scores were higher during PDT for the MAL group and remained similar with subsequent treatments. The MAL treatment was discontinued in six participants because of pain and PDT was paused briefly in 15 participants. More participants in the MAL group reported moderate erythema after the first PDT session (46% versus 15%) and three reported severe erythema.
The most commonly reported adverse events in the MAL treatment group were a sensation of skin burning and pain, mostly mild to moderate, lasting a median of 3 days. Further, 12% of those in the MAL group withdrew secondary to adverse events.
“This large, controlled randomized clinical study shows the potential of PDT using 80 mg/g MAL cream for treatment of severe acne” in patients aged 12 years and older, with all skin types, the authors concluded, noting that more follow-up data are needed on the duration of treatment response and long-term effect on scarring. “Severe acne has limited therapeutic options with problematic side effects and bacterial resistance and 80 mg/g MAL PDT could be an alternative approach with improved tolerability for these patients,” they added.
The authors noted that for severe cases of acne, treatment is limited, and while oral isotretinoin is often used, it is teratogenic, has side effects, and is associated with reimbursement difficulties.
Dr. Pariser and two colleagues disclosed receiving honoraria from Photocure ASA, which markets MAL as Visonac. The company funded the study.
Methyl aminolevulinate plus photodynamic therapy shows promise as a treatment for severe acne vulgaris, according to a U.S. study published in the British Journal of Dermatology.
Dr. David M. Pariser of Eastern Virginia Medical School, Norfolk, and his associates conducted the randomized double-blind, vehicle-controlled trial of photodynamic therapy (PDT) with methyl aminolevulinate (MAL) as a photosensitizer in 153 males and females aged 12-35 years with severe facial acne. Inclusion criteria comprised an Investigator Global Assessment (IGA) rating score of 4, 20-100 noninflammatory lesions, and 25-75 inflammatory lesions with no more than three nodules (Br J Dermatol. 2015 December. doi: 10.1111/bjd.14345).
Participants received topical MAL 80 mg/g (100) or vehicle cream (53) and PDT every 2 weeks for four treatments, and were evaluated at each treatment and at 12 weeks. The MAL or vehicle cream was applied and covered for 1.5 hours, followed by PDT (635 nm of red light for a total dose of 37 J/cm2). Most completed the study (85% in MAL group and 91% in vehicle group).
Those in the MAL PDT group demonstrated a significant reduction in inflammatory lesions based on the percentage change at 12 weeks (a mean reduction of 37.3% vs. 16.2%; P = .003), and absolute change (a mean reduction of 15.6 lesions vs. 7.8; P = .006). However, the reduction in noninflammatory lesions was not significantly different between the two groups (a mean reduction of 11.8 lesions among those on MAL PDT vs. 10.7 with vehicle PDT) .
The rates of treatment success, defined as improvement of 2 or more IGA grades at 12 weeks, were higher among those in the MAL PDT group (44% vs. 26.4%; OR, 3.24; P = .013).
Pain scores were higher during PDT for the MAL group and remained similar with subsequent treatments. The MAL treatment was discontinued in six participants because of pain and PDT was paused briefly in 15 participants. More participants in the MAL group reported moderate erythema after the first PDT session (46% versus 15%) and three reported severe erythema.
The most commonly reported adverse events in the MAL treatment group were a sensation of skin burning and pain, mostly mild to moderate, lasting a median of 3 days. Further, 12% of those in the MAL group withdrew secondary to adverse events.
“This large, controlled randomized clinical study shows the potential of PDT using 80 mg/g MAL cream for treatment of severe acne” in patients aged 12 years and older, with all skin types, the authors concluded, noting that more follow-up data are needed on the duration of treatment response and long-term effect on scarring. “Severe acne has limited therapeutic options with problematic side effects and bacterial resistance and 80 mg/g MAL PDT could be an alternative approach with improved tolerability for these patients,” they added.
The authors noted that for severe cases of acne, treatment is limited, and while oral isotretinoin is often used, it is teratogenic, has side effects, and is associated with reimbursement difficulties.
Dr. Pariser and two colleagues disclosed receiving honoraria from Photocure ASA, which markets MAL as Visonac. The company funded the study.
Methyl aminolevulinate plus photodynamic therapy shows promise as a treatment for severe acne vulgaris, according to a U.S. study published in the British Journal of Dermatology.
Dr. David M. Pariser of Eastern Virginia Medical School, Norfolk, and his associates conducted the randomized double-blind, vehicle-controlled trial of photodynamic therapy (PDT) with methyl aminolevulinate (MAL) as a photosensitizer in 153 males and females aged 12-35 years with severe facial acne. Inclusion criteria comprised an Investigator Global Assessment (IGA) rating score of 4, 20-100 noninflammatory lesions, and 25-75 inflammatory lesions with no more than three nodules (Br J Dermatol. 2015 December. doi: 10.1111/bjd.14345).
Participants received topical MAL 80 mg/g (100) or vehicle cream (53) and PDT every 2 weeks for four treatments, and were evaluated at each treatment and at 12 weeks. The MAL or vehicle cream was applied and covered for 1.5 hours, followed by PDT (635 nm of red light for a total dose of 37 J/cm2). Most completed the study (85% in MAL group and 91% in vehicle group).
Those in the MAL PDT group demonstrated a significant reduction in inflammatory lesions based on the percentage change at 12 weeks (a mean reduction of 37.3% vs. 16.2%; P = .003), and absolute change (a mean reduction of 15.6 lesions vs. 7.8; P = .006). However, the reduction in noninflammatory lesions was not significantly different between the two groups (a mean reduction of 11.8 lesions among those on MAL PDT vs. 10.7 with vehicle PDT) .
The rates of treatment success, defined as improvement of 2 or more IGA grades at 12 weeks, were higher among those in the MAL PDT group (44% vs. 26.4%; OR, 3.24; P = .013).
Pain scores were higher during PDT for the MAL group and remained similar with subsequent treatments. The MAL treatment was discontinued in six participants because of pain and PDT was paused briefly in 15 participants. More participants in the MAL group reported moderate erythema after the first PDT session (46% versus 15%) and three reported severe erythema.
The most commonly reported adverse events in the MAL treatment group were a sensation of skin burning and pain, mostly mild to moderate, lasting a median of 3 days. Further, 12% of those in the MAL group withdrew secondary to adverse events.
“This large, controlled randomized clinical study shows the potential of PDT using 80 mg/g MAL cream for treatment of severe acne” in patients aged 12 years and older, with all skin types, the authors concluded, noting that more follow-up data are needed on the duration of treatment response and long-term effect on scarring. “Severe acne has limited therapeutic options with problematic side effects and bacterial resistance and 80 mg/g MAL PDT could be an alternative approach with improved tolerability for these patients,” they added.
The authors noted that for severe cases of acne, treatment is limited, and while oral isotretinoin is often used, it is teratogenic, has side effects, and is associated with reimbursement difficulties.
Dr. Pariser and two colleagues disclosed receiving honoraria from Photocure ASA, which markets MAL as Visonac. The company funded the study.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: Methyl aminolevulinate (MAL) with photodynamic therapy (PDT) shows promise as an alternative treatment for severe acne vulgaris.
Major finding: The MAL/PDT group had a significantly higher rate of treatment success compared with the vehicle/PDT group at 12 weeks (44% vs. 26.4%; P = .013).
Data source: A randomized, double-blind, vehicle-controlled study evaluating the safety and efficacy of PDT with MAL in 153 people aged 12-35 years, with severe facial acne, at 15 outpatient dermatology centers in the United States.
Disclosures: Dr. Pariser and two colleagues disclosed receiving honoraria from MAL manufacturer Photocure ASA, which funded the study.
ACOG, SMFM support short-term use of magnesium sulfate in pregnancy
The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to support the use of magnesium sulfate injection during pregnancy in limited circumstances and for short periods of time, despite a warning from the Food and Drug Administration that the drug has the potential to harm a developing fetus.
In 2013, the Food and Drug Administration issued a safety announcement warning against the prolonged use of intravenous magnesium sulfate (beyond 5-7 days) to treat preterm labor, citing risks of bone changes and low calcium levels in the developing fetus. Agency officials also changed the Pregnancy category classification for magnesium sulfate from a category A to a category D.
The FDA announcement highlighted that although use of magnesium sulfate for preterm labor longer than 5-7 days was considered “off label,” it is approved for the treatment of preeclampsia.
But in a committee opinion issued on Dec. 22, ACOG and the Society for Maternal-Fetal Medicine (SMFM) pointed out that the FDA changes were prompted by reports of fractures and bone demineralization after magnesium sulfate treatment for “a much longer duration and much higher dose than is currently recommended for obstetric use.” In the cases cited by the FDA, average exposure was 9.6 weeks with an average total maternal dose of 3,700 g, according to the committee opinion (Obstet Gynecol. 2016;127:e52-3.).
Magnesium sulfate has been used and studied in obstetrics for many years without concerns for fractures or bone demineralization being raised, including in recent trials of magnesium for neuroprotection, ACOG and SMFM officials wrote.
The updated committee opinion outlines the continued short-term (less than 48 hours) use of magnesium sulfate for certain conditions:
• Prevention and treatment of seizures in women with preeclampsia or eclampsia.
• Preterm labor at less than 32 weeks’ gestation for fetal neuroprotection.
• Prolonging pregnancy for up to 48 hours to allow for administration of antenatal corticosteroids in women at risk for preterm delivery within 7 days.
“Practitioners should not stop using magnesium sulfate for these indications based on the FDA reclassification,” ACOG and SMFM committee members wrote. “In all of these conditions, prolonged use of magnesium sulfate is never indicated. Therefore, the FDA’s change in the pregnancy classification of magnesium sulfate addresses an unindicated and nonstandard use of this medication.”
The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to support the use of magnesium sulfate injection during pregnancy in limited circumstances and for short periods of time, despite a warning from the Food and Drug Administration that the drug has the potential to harm a developing fetus.
In 2013, the Food and Drug Administration issued a safety announcement warning against the prolonged use of intravenous magnesium sulfate (beyond 5-7 days) to treat preterm labor, citing risks of bone changes and low calcium levels in the developing fetus. Agency officials also changed the Pregnancy category classification for magnesium sulfate from a category A to a category D.
The FDA announcement highlighted that although use of magnesium sulfate for preterm labor longer than 5-7 days was considered “off label,” it is approved for the treatment of preeclampsia.
But in a committee opinion issued on Dec. 22, ACOG and the Society for Maternal-Fetal Medicine (SMFM) pointed out that the FDA changes were prompted by reports of fractures and bone demineralization after magnesium sulfate treatment for “a much longer duration and much higher dose than is currently recommended for obstetric use.” In the cases cited by the FDA, average exposure was 9.6 weeks with an average total maternal dose of 3,700 g, according to the committee opinion (Obstet Gynecol. 2016;127:e52-3.).
Magnesium sulfate has been used and studied in obstetrics for many years without concerns for fractures or bone demineralization being raised, including in recent trials of magnesium for neuroprotection, ACOG and SMFM officials wrote.
The updated committee opinion outlines the continued short-term (less than 48 hours) use of magnesium sulfate for certain conditions:
• Prevention and treatment of seizures in women with preeclampsia or eclampsia.
• Preterm labor at less than 32 weeks’ gestation for fetal neuroprotection.
• Prolonging pregnancy for up to 48 hours to allow for administration of antenatal corticosteroids in women at risk for preterm delivery within 7 days.
“Practitioners should not stop using magnesium sulfate for these indications based on the FDA reclassification,” ACOG and SMFM committee members wrote. “In all of these conditions, prolonged use of magnesium sulfate is never indicated. Therefore, the FDA’s change in the pregnancy classification of magnesium sulfate addresses an unindicated and nonstandard use of this medication.”
The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to support the use of magnesium sulfate injection during pregnancy in limited circumstances and for short periods of time, despite a warning from the Food and Drug Administration that the drug has the potential to harm a developing fetus.
In 2013, the Food and Drug Administration issued a safety announcement warning against the prolonged use of intravenous magnesium sulfate (beyond 5-7 days) to treat preterm labor, citing risks of bone changes and low calcium levels in the developing fetus. Agency officials also changed the Pregnancy category classification for magnesium sulfate from a category A to a category D.
The FDA announcement highlighted that although use of magnesium sulfate for preterm labor longer than 5-7 days was considered “off label,” it is approved for the treatment of preeclampsia.
But in a committee opinion issued on Dec. 22, ACOG and the Society for Maternal-Fetal Medicine (SMFM) pointed out that the FDA changes were prompted by reports of fractures and bone demineralization after magnesium sulfate treatment for “a much longer duration and much higher dose than is currently recommended for obstetric use.” In the cases cited by the FDA, average exposure was 9.6 weeks with an average total maternal dose of 3,700 g, according to the committee opinion (Obstet Gynecol. 2016;127:e52-3.).
Magnesium sulfate has been used and studied in obstetrics for many years without concerns for fractures or bone demineralization being raised, including in recent trials of magnesium for neuroprotection, ACOG and SMFM officials wrote.
The updated committee opinion outlines the continued short-term (less than 48 hours) use of magnesium sulfate for certain conditions:
• Prevention and treatment of seizures in women with preeclampsia or eclampsia.
• Preterm labor at less than 32 weeks’ gestation for fetal neuroprotection.
• Prolonging pregnancy for up to 48 hours to allow for administration of antenatal corticosteroids in women at risk for preterm delivery within 7 days.
“Practitioners should not stop using magnesium sulfate for these indications based on the FDA reclassification,” ACOG and SMFM committee members wrote. “In all of these conditions, prolonged use of magnesium sulfate is never indicated. Therefore, the FDA’s change in the pregnancy classification of magnesium sulfate addresses an unindicated and nonstandard use of this medication.”
Antibiotic-resistant bacteria uncommon in nursing homes, but better testing needed
A low incidence of antibiotic-resistant Enterobacteriaceae bacteria was found in a study of Rhode Island nursing home residents admitted to acute care facilities, but researchers said a better understanding of risk factors associated with carriage of carbapenem-resistant gram-negative bacteria among nursing home patients is needed.
Dr. Cheston B. Cunha of the division of infectious diseases at Rhode Island Hospital in Providence and colleagues investigated the prevalence of carbapenem-resistant Enterobacteriaceae (CRE) and carbapenemase-producing Enterobacteriaceae (CPE) in fecal samples of asymptomatic nursing home residents during hospitalization. Their results were published online in the American Journal of Infection Control (2015 Nov 24. doi: 10.1016/j.ajic.2015.09.019)
The researchers conducted a point prevalence survey of 500 hospitalizations of nursing home residents admitted to two Providence, R.I., hospitals. Risk factors associated with CRE carriage were determined by a case-control study. They obtained cultures on 404 patients with 96 readmissions for a total of 500 rectal swabs. The study population consisted of 40% men with a mean age of 80 years.
In total, 23 patients with 30 isolates (4.6%) grew carbapenem resistant or carbapenemase-producing gram-negative bacteria. Of those, seven isolates (1.4%) were CPE or CRE with two isolates (0.4%) that were Citrobacter freundii that contained Klebsiella pneumoniae carbapenemase.
On univariate analysis the researchers found the use of a gastrostomy tube was associated with fecal carriage of CRE (P = .4).
“We found seven CRE-CPE [isolates] among 500 hospital admissions from local nursing homes; however, only two, both C. freundii isolates, contained potentially transmissible carbapenem-resistance genes,” the authors said, noting that the results suggest that in their region, the levels of CPE and CRE carriage are low in nursing home patients.
Furthermore, the investigators suggested that antibiotic resistance is likely promoted by overtreatment with antibiotics, with nursing home residents being at risk for transmission of multidrug-resistant bacteria. “Active infection with CRE and CPE is associated with a high mortality; therefore, efforts to control their spread is of paramount importance,” the authors wrote.
Several limitations of the study were highlighted, including its retrospective design, that it was underpowered to assess risk factors, and that the study population may have been a sicker group of patients because only hospitalized patients were included.
Coauthor Fred C. Tenover, Ph.D., reported employment by Cepheid, and coauthor Ryan Chan reported employment by Cepheid and GeneWeave Biosciences.
A low incidence of antibiotic-resistant Enterobacteriaceae bacteria was found in a study of Rhode Island nursing home residents admitted to acute care facilities, but researchers said a better understanding of risk factors associated with carriage of carbapenem-resistant gram-negative bacteria among nursing home patients is needed.
Dr. Cheston B. Cunha of the division of infectious diseases at Rhode Island Hospital in Providence and colleagues investigated the prevalence of carbapenem-resistant Enterobacteriaceae (CRE) and carbapenemase-producing Enterobacteriaceae (CPE) in fecal samples of asymptomatic nursing home residents during hospitalization. Their results were published online in the American Journal of Infection Control (2015 Nov 24. doi: 10.1016/j.ajic.2015.09.019)
The researchers conducted a point prevalence survey of 500 hospitalizations of nursing home residents admitted to two Providence, R.I., hospitals. Risk factors associated with CRE carriage were determined by a case-control study. They obtained cultures on 404 patients with 96 readmissions for a total of 500 rectal swabs. The study population consisted of 40% men with a mean age of 80 years.
In total, 23 patients with 30 isolates (4.6%) grew carbapenem resistant or carbapenemase-producing gram-negative bacteria. Of those, seven isolates (1.4%) were CPE or CRE with two isolates (0.4%) that were Citrobacter freundii that contained Klebsiella pneumoniae carbapenemase.
On univariate analysis the researchers found the use of a gastrostomy tube was associated with fecal carriage of CRE (P = .4).
“We found seven CRE-CPE [isolates] among 500 hospital admissions from local nursing homes; however, only two, both C. freundii isolates, contained potentially transmissible carbapenem-resistance genes,” the authors said, noting that the results suggest that in their region, the levels of CPE and CRE carriage are low in nursing home patients.
Furthermore, the investigators suggested that antibiotic resistance is likely promoted by overtreatment with antibiotics, with nursing home residents being at risk for transmission of multidrug-resistant bacteria. “Active infection with CRE and CPE is associated with a high mortality; therefore, efforts to control their spread is of paramount importance,” the authors wrote.
Several limitations of the study were highlighted, including its retrospective design, that it was underpowered to assess risk factors, and that the study population may have been a sicker group of patients because only hospitalized patients were included.
Coauthor Fred C. Tenover, Ph.D., reported employment by Cepheid, and coauthor Ryan Chan reported employment by Cepheid and GeneWeave Biosciences.
A low incidence of antibiotic-resistant Enterobacteriaceae bacteria was found in a study of Rhode Island nursing home residents admitted to acute care facilities, but researchers said a better understanding of risk factors associated with carriage of carbapenem-resistant gram-negative bacteria among nursing home patients is needed.
Dr. Cheston B. Cunha of the division of infectious diseases at Rhode Island Hospital in Providence and colleagues investigated the prevalence of carbapenem-resistant Enterobacteriaceae (CRE) and carbapenemase-producing Enterobacteriaceae (CPE) in fecal samples of asymptomatic nursing home residents during hospitalization. Their results were published online in the American Journal of Infection Control (2015 Nov 24. doi: 10.1016/j.ajic.2015.09.019)
The researchers conducted a point prevalence survey of 500 hospitalizations of nursing home residents admitted to two Providence, R.I., hospitals. Risk factors associated with CRE carriage were determined by a case-control study. They obtained cultures on 404 patients with 96 readmissions for a total of 500 rectal swabs. The study population consisted of 40% men with a mean age of 80 years.
In total, 23 patients with 30 isolates (4.6%) grew carbapenem resistant or carbapenemase-producing gram-negative bacteria. Of those, seven isolates (1.4%) were CPE or CRE with two isolates (0.4%) that were Citrobacter freundii that contained Klebsiella pneumoniae carbapenemase.
On univariate analysis the researchers found the use of a gastrostomy tube was associated with fecal carriage of CRE (P = .4).
“We found seven CRE-CPE [isolates] among 500 hospital admissions from local nursing homes; however, only two, both C. freundii isolates, contained potentially transmissible carbapenem-resistance genes,” the authors said, noting that the results suggest that in their region, the levels of CPE and CRE carriage are low in nursing home patients.
Furthermore, the investigators suggested that antibiotic resistance is likely promoted by overtreatment with antibiotics, with nursing home residents being at risk for transmission of multidrug-resistant bacteria. “Active infection with CRE and CPE is associated with a high mortality; therefore, efforts to control their spread is of paramount importance,” the authors wrote.
Several limitations of the study were highlighted, including its retrospective design, that it was underpowered to assess risk factors, and that the study population may have been a sicker group of patients because only hospitalized patients were included.
Coauthor Fred C. Tenover, Ph.D., reported employment by Cepheid, and coauthor Ryan Chan reported employment by Cepheid and GeneWeave Biosciences.
FROM AMERICAN JOURNAL OF INFECTION CONTROL
Key clinical point: A study of antibiotic-resistant Enterobacteriaceae in Rhode Island nursing home residents admitted to acute care facilities found a low incidence of the bacteria.
Major finding: In total, 4.6% of study subjects grew carbapenem-resistant or carbapenemase-producing gram-negative bacteria, and 1.4% of the isolates were CPE or CRE.
Data source: A point prevalence survey of 500 hospitalizations of nursing home residents and a case-control study to assess risk factors associated with CRE.
Disclosures: Coauthor Fred C. Tenover, Ph.D., reported employment by Cepheid and coauthor Ryan Chan reported employment by Cepheid and GeneWeave Biosciences.
