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Depression not responsible for teen weight gain, but SSRIs may be
Adolescents with major depressive disorder (MDD) were more likely to lose weight, but treatment with some SSRIs was associated with weight gain, based on data from a longitudinal study of 264 participants published online June 16 in Pediatrics.
MDD was associated with decrease in body mass index (BMI), fat mass index (FMI), and lean BMI (LBMI) z scores after controlling for factors including age, sex, physical activity, dietary intake, and length of study participation. However, dosage and duration of treatment with SSRIs were associated with increases in BMI, FMI, and LBMI z scores (Pediatrics. 2017. doi: 10.1542/peds.2016-3943).
The participants were part of a 2-year prospective study on the skeletal impact of SSRI use in older adolescents, and the average length of study participation was 1.5 years. After a baseline visit, they had follow-up visits, at which they completed the Inventory of Depressive Symptomatology (IDS), the Beck Depression Inventory (BDI-II), the Beck Anxiety Inventory (BAI), and the modified version of the Physical Activity Questionnaire for Adolescents, every four months. In addition, height, weight, and grip strength were measured. Body composition was measured using the BMI z score, FMI z score, LBMI z score, and visceral fat (Vfat) score.
Depression and anxiety, based on IDS and BAI scores, were inversely associated with changes in BMI z scores, and longer SSRI use was associated with increased BMI z scores. These changes remained significant when IDS scores and cumulative SSRI doses were included in the analysis.
In addition, use and duration of SSRIs each were significantly associated with increased FMI and LBMI scores after adjusting for standard confounding variables. SSRI use was associated with increased visceral fat mass, but the change was not significant.
When the researchers examined differences among individual drugs, they found that citalopram and escitalopram, but not sertraline, were associated with significant increases in both adiposity and lean mass. Fluoxetine showed a smaller, but still significant, effect.
SSRI use also impacted height over the study period (P less than .05), and fluoxetine had the greatest effect. Depression (IDS score) had no significant impact on height.
No significant differences appeared in the impact of SSRI use according to gender for LBMI, height z scores, or VFat. However, males had a significantly greater increase in BMI and FMI z scores, compared with females, over a longer period of SSRI use, a finding that deserves additional study, Dr. Calarge and associates noted.
The results were limited by several factors including the relatively small sample size, the use of self-reports, and the challenges of accurately documenting medication use, the researchers said.
Fat and lean mass were measured separately in this study, and, “to our surprise, SSRI use was positively associated with both outcome variables in a similar manner,” Dr. Calarge and associates noted. “When we specifically focused on VFat, the association with SSRI use remained positive, albeit weaker. This suggests that, over extended periods of use, SSRIs will cause an overall increase in BMI, comprising an increase in both fat and lean mass. Importantly, this is also associated with an increase in VFat, which is particularly detrimental to health,” and may contribute to the higher incidence of cardiovascular disease in MDD patients, they added. Future research should explore mechanisms of action and interventions to address treatment effects.
The researchers had no relevant financial disclosures. The study was funded by the National Institutes of Health, the National Institute of Mental Health, and the National Center for Research Resources.
Adolescents with major depressive disorder (MDD) were more likely to lose weight, but treatment with some SSRIs was associated with weight gain, based on data from a longitudinal study of 264 participants published online June 16 in Pediatrics.
MDD was associated with decrease in body mass index (BMI), fat mass index (FMI), and lean BMI (LBMI) z scores after controlling for factors including age, sex, physical activity, dietary intake, and length of study participation. However, dosage and duration of treatment with SSRIs were associated with increases in BMI, FMI, and LBMI z scores (Pediatrics. 2017. doi: 10.1542/peds.2016-3943).
The participants were part of a 2-year prospective study on the skeletal impact of SSRI use in older adolescents, and the average length of study participation was 1.5 years. After a baseline visit, they had follow-up visits, at which they completed the Inventory of Depressive Symptomatology (IDS), the Beck Depression Inventory (BDI-II), the Beck Anxiety Inventory (BAI), and the modified version of the Physical Activity Questionnaire for Adolescents, every four months. In addition, height, weight, and grip strength were measured. Body composition was measured using the BMI z score, FMI z score, LBMI z score, and visceral fat (Vfat) score.
Depression and anxiety, based on IDS and BAI scores, were inversely associated with changes in BMI z scores, and longer SSRI use was associated with increased BMI z scores. These changes remained significant when IDS scores and cumulative SSRI doses were included in the analysis.
In addition, use and duration of SSRIs each were significantly associated with increased FMI and LBMI scores after adjusting for standard confounding variables. SSRI use was associated with increased visceral fat mass, but the change was not significant.
When the researchers examined differences among individual drugs, they found that citalopram and escitalopram, but not sertraline, were associated with significant increases in both adiposity and lean mass. Fluoxetine showed a smaller, but still significant, effect.
SSRI use also impacted height over the study period (P less than .05), and fluoxetine had the greatest effect. Depression (IDS score) had no significant impact on height.
No significant differences appeared in the impact of SSRI use according to gender for LBMI, height z scores, or VFat. However, males had a significantly greater increase in BMI and FMI z scores, compared with females, over a longer period of SSRI use, a finding that deserves additional study, Dr. Calarge and associates noted.
The results were limited by several factors including the relatively small sample size, the use of self-reports, and the challenges of accurately documenting medication use, the researchers said.
Fat and lean mass were measured separately in this study, and, “to our surprise, SSRI use was positively associated with both outcome variables in a similar manner,” Dr. Calarge and associates noted. “When we specifically focused on VFat, the association with SSRI use remained positive, albeit weaker. This suggests that, over extended periods of use, SSRIs will cause an overall increase in BMI, comprising an increase in both fat and lean mass. Importantly, this is also associated with an increase in VFat, which is particularly detrimental to health,” and may contribute to the higher incidence of cardiovascular disease in MDD patients, they added. Future research should explore mechanisms of action and interventions to address treatment effects.
The researchers had no relevant financial disclosures. The study was funded by the National Institutes of Health, the National Institute of Mental Health, and the National Center for Research Resources.
Adolescents with major depressive disorder (MDD) were more likely to lose weight, but treatment with some SSRIs was associated with weight gain, based on data from a longitudinal study of 264 participants published online June 16 in Pediatrics.
MDD was associated with decrease in body mass index (BMI), fat mass index (FMI), and lean BMI (LBMI) z scores after controlling for factors including age, sex, physical activity, dietary intake, and length of study participation. However, dosage and duration of treatment with SSRIs were associated with increases in BMI, FMI, and LBMI z scores (Pediatrics. 2017. doi: 10.1542/peds.2016-3943).
The participants were part of a 2-year prospective study on the skeletal impact of SSRI use in older adolescents, and the average length of study participation was 1.5 years. After a baseline visit, they had follow-up visits, at which they completed the Inventory of Depressive Symptomatology (IDS), the Beck Depression Inventory (BDI-II), the Beck Anxiety Inventory (BAI), and the modified version of the Physical Activity Questionnaire for Adolescents, every four months. In addition, height, weight, and grip strength were measured. Body composition was measured using the BMI z score, FMI z score, LBMI z score, and visceral fat (Vfat) score.
Depression and anxiety, based on IDS and BAI scores, were inversely associated with changes in BMI z scores, and longer SSRI use was associated with increased BMI z scores. These changes remained significant when IDS scores and cumulative SSRI doses were included in the analysis.
In addition, use and duration of SSRIs each were significantly associated with increased FMI and LBMI scores after adjusting for standard confounding variables. SSRI use was associated with increased visceral fat mass, but the change was not significant.
When the researchers examined differences among individual drugs, they found that citalopram and escitalopram, but not sertraline, were associated with significant increases in both adiposity and lean mass. Fluoxetine showed a smaller, but still significant, effect.
SSRI use also impacted height over the study period (P less than .05), and fluoxetine had the greatest effect. Depression (IDS score) had no significant impact on height.
No significant differences appeared in the impact of SSRI use according to gender for LBMI, height z scores, or VFat. However, males had a significantly greater increase in BMI and FMI z scores, compared with females, over a longer period of SSRI use, a finding that deserves additional study, Dr. Calarge and associates noted.
The results were limited by several factors including the relatively small sample size, the use of self-reports, and the challenges of accurately documenting medication use, the researchers said.
Fat and lean mass were measured separately in this study, and, “to our surprise, SSRI use was positively associated with both outcome variables in a similar manner,” Dr. Calarge and associates noted. “When we specifically focused on VFat, the association with SSRI use remained positive, albeit weaker. This suggests that, over extended periods of use, SSRIs will cause an overall increase in BMI, comprising an increase in both fat and lean mass. Importantly, this is also associated with an increase in VFat, which is particularly detrimental to health,” and may contribute to the higher incidence of cardiovascular disease in MDD patients, they added. Future research should explore mechanisms of action and interventions to address treatment effects.
The researchers had no relevant financial disclosures. The study was funded by the National Institutes of Health, the National Institute of Mental Health, and the National Center for Research Resources.
FROM PEDIATRICS
Key clinical point: Major depressive disorder failed to promote changes in BMI in older adolescents.
Major finding: (P less than .003).
Data source: The data came from a longitudinal study of 264 adolescents aged 15-20 years.
Disclosures: The researchers had no relevant financial disclosures. The study was funded by the National Institutes of Health, the National Institute of Mental Health, and the National Center for Research Resources.
Experts endorse routine screening for pediatric psoriasis comorbidities
Pediatric psoriasis patients should be screened regularly to identify risk factors for comorbidities including depression, gastrointestinal problems, diabetes, and dyslipidemia, according to the debut guidelines issued by an expert panel.
The National Psoriasis Foundation and the Pediatric Dermatology Research Alliance joined forces to assess the literature and develop recommendations for screening comorbidities for children with psoriasis. The National Psoriasis Foundation has guidelines for comorbidity screening in adults with psoriasis, but no guidelines previously existed for children, wrote Emily Osier, MD, of Eastern Virginia Medical School, Norfolk, and her colleagues (JAMA Dermatol 2017 May 17. doi: 10.1001/jamadermatol.2017.0499).
The panelists reviewed the literature on psoriasis and comorbidities published between 1999 and 2015 and identified 153 studies, 26 of which involved children.
“The screening recommendations derived are largely consistent with those endorsed by the AAP for the general pediatric patient,” the researchers noted.
Although many young children are screened for a range of comorbid conditions at annual checkups, preteens and teenagers may be less likely to receive preventive services in primary care, they said. “Thus, all health care providers caring for patients with pediatric psoriasis should help assess and ensure that appropriate screening has been performed,” they emphasized.
Some notable recommendations include the following:
• Screen children with psoriasis for overweight and obesity annually using body mass index percentiles.
• Screen for diabetes every 3 years starting at age 10 years.
• Perform universal lipid screening at ages 9-11 years and 17-21 years.
• Screen for nonalcoholic fatty liver disease every 2-3 years starting at age 9-11 years.
• Screen for hypertension annually starting at age 3 years.
• Screen for arthritis at the time of psoriasis diagnosis and periodically.
• Screen yearly for depression and anxiety at all ages, with yearly screening for substance abuse starting at age 11 years.
Uveitis screening is recommended only for children with psoriatic arthritis, the researchers said.
In addition, clinicians “should recognize the profound psychosocial ramifications of psoriasis and the potential significant impact on quality of life of patients and caregivers,” the researchers wrote. Clinicians may consider a formal quality of life measurement, such as the Children’s Dermatology Life Quality Index, or at least asking questions about the impact of psoriasis on the child’s life at home, at school, and during other activities.
Awareness of comorbidities also impacts potential psoriasis treatment, the researchers said. “Direct baseline screening and monitoring tests should be performed as indicated by each individual’s therapeutic plan,” they said.
The consensus statement is a starting point for screening that will be refined over time, and may include stratifying patients by age, disease subtype, or disease severity, the researchers noted.
“Communication and collaboration between dermatologists, primary care providers, and other pediatric specialists will be critical to accomplish the recommended screenings and to limit the sequelae of this disorder,” they wrote.
The National Psoriasis Foundation and the University of California, San Diego, Eczema and Inflammatory Skin Disease Center supported the study. Dr. Osier was supported in part by a Medical Dermatology Research Fellowship grant from the National Psoriasis Foundation in 2014-2016, but she had no financial conflicts to disclose.
Pediatric psoriasis patients should be screened regularly to identify risk factors for comorbidities including depression, gastrointestinal problems, diabetes, and dyslipidemia, according to the debut guidelines issued by an expert panel.
The National Psoriasis Foundation and the Pediatric Dermatology Research Alliance joined forces to assess the literature and develop recommendations for screening comorbidities for children with psoriasis. The National Psoriasis Foundation has guidelines for comorbidity screening in adults with psoriasis, but no guidelines previously existed for children, wrote Emily Osier, MD, of Eastern Virginia Medical School, Norfolk, and her colleagues (JAMA Dermatol 2017 May 17. doi: 10.1001/jamadermatol.2017.0499).
The panelists reviewed the literature on psoriasis and comorbidities published between 1999 and 2015 and identified 153 studies, 26 of which involved children.
“The screening recommendations derived are largely consistent with those endorsed by the AAP for the general pediatric patient,” the researchers noted.
Although many young children are screened for a range of comorbid conditions at annual checkups, preteens and teenagers may be less likely to receive preventive services in primary care, they said. “Thus, all health care providers caring for patients with pediatric psoriasis should help assess and ensure that appropriate screening has been performed,” they emphasized.
Some notable recommendations include the following:
• Screen children with psoriasis for overweight and obesity annually using body mass index percentiles.
• Screen for diabetes every 3 years starting at age 10 years.
• Perform universal lipid screening at ages 9-11 years and 17-21 years.
• Screen for nonalcoholic fatty liver disease every 2-3 years starting at age 9-11 years.
• Screen for hypertension annually starting at age 3 years.
• Screen for arthritis at the time of psoriasis diagnosis and periodically.
• Screen yearly for depression and anxiety at all ages, with yearly screening for substance abuse starting at age 11 years.
Uveitis screening is recommended only for children with psoriatic arthritis, the researchers said.
In addition, clinicians “should recognize the profound psychosocial ramifications of psoriasis and the potential significant impact on quality of life of patients and caregivers,” the researchers wrote. Clinicians may consider a formal quality of life measurement, such as the Children’s Dermatology Life Quality Index, or at least asking questions about the impact of psoriasis on the child’s life at home, at school, and during other activities.
Awareness of comorbidities also impacts potential psoriasis treatment, the researchers said. “Direct baseline screening and monitoring tests should be performed as indicated by each individual’s therapeutic plan,” they said.
The consensus statement is a starting point for screening that will be refined over time, and may include stratifying patients by age, disease subtype, or disease severity, the researchers noted.
“Communication and collaboration between dermatologists, primary care providers, and other pediatric specialists will be critical to accomplish the recommended screenings and to limit the sequelae of this disorder,” they wrote.
The National Psoriasis Foundation and the University of California, San Diego, Eczema and Inflammatory Skin Disease Center supported the study. Dr. Osier was supported in part by a Medical Dermatology Research Fellowship grant from the National Psoriasis Foundation in 2014-2016, but she had no financial conflicts to disclose.
Pediatric psoriasis patients should be screened regularly to identify risk factors for comorbidities including depression, gastrointestinal problems, diabetes, and dyslipidemia, according to the debut guidelines issued by an expert panel.
The National Psoriasis Foundation and the Pediatric Dermatology Research Alliance joined forces to assess the literature and develop recommendations for screening comorbidities for children with psoriasis. The National Psoriasis Foundation has guidelines for comorbidity screening in adults with psoriasis, but no guidelines previously existed for children, wrote Emily Osier, MD, of Eastern Virginia Medical School, Norfolk, and her colleagues (JAMA Dermatol 2017 May 17. doi: 10.1001/jamadermatol.2017.0499).
The panelists reviewed the literature on psoriasis and comorbidities published between 1999 and 2015 and identified 153 studies, 26 of which involved children.
“The screening recommendations derived are largely consistent with those endorsed by the AAP for the general pediatric patient,” the researchers noted.
Although many young children are screened for a range of comorbid conditions at annual checkups, preteens and teenagers may be less likely to receive preventive services in primary care, they said. “Thus, all health care providers caring for patients with pediatric psoriasis should help assess and ensure that appropriate screening has been performed,” they emphasized.
Some notable recommendations include the following:
• Screen children with psoriasis for overweight and obesity annually using body mass index percentiles.
• Screen for diabetes every 3 years starting at age 10 years.
• Perform universal lipid screening at ages 9-11 years and 17-21 years.
• Screen for nonalcoholic fatty liver disease every 2-3 years starting at age 9-11 years.
• Screen for hypertension annually starting at age 3 years.
• Screen for arthritis at the time of psoriasis diagnosis and periodically.
• Screen yearly for depression and anxiety at all ages, with yearly screening for substance abuse starting at age 11 years.
Uveitis screening is recommended only for children with psoriatic arthritis, the researchers said.
In addition, clinicians “should recognize the profound psychosocial ramifications of psoriasis and the potential significant impact on quality of life of patients and caregivers,” the researchers wrote. Clinicians may consider a formal quality of life measurement, such as the Children’s Dermatology Life Quality Index, or at least asking questions about the impact of psoriasis on the child’s life at home, at school, and during other activities.
Awareness of comorbidities also impacts potential psoriasis treatment, the researchers said. “Direct baseline screening and monitoring tests should be performed as indicated by each individual’s therapeutic plan,” they said.
The consensus statement is a starting point for screening that will be refined over time, and may include stratifying patients by age, disease subtype, or disease severity, the researchers noted.
“Communication and collaboration between dermatologists, primary care providers, and other pediatric specialists will be critical to accomplish the recommended screenings and to limit the sequelae of this disorder,” they wrote.
The National Psoriasis Foundation and the University of California, San Diego, Eczema and Inflammatory Skin Disease Center supported the study. Dr. Osier was supported in part by a Medical Dermatology Research Fellowship grant from the National Psoriasis Foundation in 2014-2016, but she had no financial conflicts to disclose.
FROM JAMA DERMATOLOGY
Osteoarthritis contributes more to difficulty walking than do diabetes, CVD
Hip and knee osteoarthritis on their own predict difficulty walking in adults aged 55 years and older to a greater extent than do diabetes or cardiovascular disease individually, according to findings from a Canadian population-based study.
The ability of hip and knee osteoarthritis (OA) to predict difficulty walking also increased with the number of joints affected and acted additively with either diabetes or cardiovascular disease (CVD) or both to raise the odds for walking problems, reported Lauren K. King, MBBS, of the University of Toronto, and colleagues.
To determine the impact of hip and knee OA on difficulty walking, the researchers reviewed data from 18,490 adults recruited between 1996 and 1998. The average age of the participants was 68 years, 60% were women, and 25% reported difficulty with walking during the past 3 months (Arthritis Care Res. 2017 May 17 doi: 10.1002/acr.23250). They completed questionnaires about their health conditions, and the researchers developed a clinical nomogram using their final multivariate logistic model.
The researchers calculated that the predicted probability of difficulty walking for a 60-year-old, middle-income, normal-weight woman with no health conditions was 5%-10%. However, the probability of walking problems was 10%-20% for the same woman with diabetes and CVD; 40% with osteoarthritis in two hips/knees; 60%-70% with diabetes, CVD, and osteoarthritis in two hips/knees; and 80% with diabetes, CVD, and osteoarthritis in all hips/knees.
Overall, 10% of the participants met criteria for hip OA and 15% met criteria for knee OA. The most common chronic conditions were hypertension (43%), diabetes (11%), and CVD (11%).
In a multivariate analysis, individuals with knee or hip OA had the highest odds of reporting walking difficulty, and the odds increased with the number of joints affected.
The results were limited by the cross-sectional nature of the study and the use of self-reports, the researchers noted.
However, “Given the high prevalence of OA and the substantial physical, social, and psychological consequences of walking difficulty, we believe our findings have high clinical relevance to primary care physicians and internal medicine specialists beyond rheumatology,” they said.
“Further research is warranted to understand the mechanisms by which chronic conditions affect mobility, physical activity, and sedentary behavior, and to elucidate safe and effective management approaches to reduce OA-related walking difficulty,” they added.
None of the investigators had relevant financial disclosures to report.
Hip and knee osteoarthritis on their own predict difficulty walking in adults aged 55 years and older to a greater extent than do diabetes or cardiovascular disease individually, according to findings from a Canadian population-based study.
The ability of hip and knee osteoarthritis (OA) to predict difficulty walking also increased with the number of joints affected and acted additively with either diabetes or cardiovascular disease (CVD) or both to raise the odds for walking problems, reported Lauren K. King, MBBS, of the University of Toronto, and colleagues.
To determine the impact of hip and knee OA on difficulty walking, the researchers reviewed data from 18,490 adults recruited between 1996 and 1998. The average age of the participants was 68 years, 60% were women, and 25% reported difficulty with walking during the past 3 months (Arthritis Care Res. 2017 May 17 doi: 10.1002/acr.23250). They completed questionnaires about their health conditions, and the researchers developed a clinical nomogram using their final multivariate logistic model.
The researchers calculated that the predicted probability of difficulty walking for a 60-year-old, middle-income, normal-weight woman with no health conditions was 5%-10%. However, the probability of walking problems was 10%-20% for the same woman with diabetes and CVD; 40% with osteoarthritis in two hips/knees; 60%-70% with diabetes, CVD, and osteoarthritis in two hips/knees; and 80% with diabetes, CVD, and osteoarthritis in all hips/knees.
Overall, 10% of the participants met criteria for hip OA and 15% met criteria for knee OA. The most common chronic conditions were hypertension (43%), diabetes (11%), and CVD (11%).
In a multivariate analysis, individuals with knee or hip OA had the highest odds of reporting walking difficulty, and the odds increased with the number of joints affected.
The results were limited by the cross-sectional nature of the study and the use of self-reports, the researchers noted.
However, “Given the high prevalence of OA and the substantial physical, social, and psychological consequences of walking difficulty, we believe our findings have high clinical relevance to primary care physicians and internal medicine specialists beyond rheumatology,” they said.
“Further research is warranted to understand the mechanisms by which chronic conditions affect mobility, physical activity, and sedentary behavior, and to elucidate safe and effective management approaches to reduce OA-related walking difficulty,” they added.
None of the investigators had relevant financial disclosures to report.
Hip and knee osteoarthritis on their own predict difficulty walking in adults aged 55 years and older to a greater extent than do diabetes or cardiovascular disease individually, according to findings from a Canadian population-based study.
The ability of hip and knee osteoarthritis (OA) to predict difficulty walking also increased with the number of joints affected and acted additively with either diabetes or cardiovascular disease (CVD) or both to raise the odds for walking problems, reported Lauren K. King, MBBS, of the University of Toronto, and colleagues.
To determine the impact of hip and knee OA on difficulty walking, the researchers reviewed data from 18,490 adults recruited between 1996 and 1998. The average age of the participants was 68 years, 60% were women, and 25% reported difficulty with walking during the past 3 months (Arthritis Care Res. 2017 May 17 doi: 10.1002/acr.23250). They completed questionnaires about their health conditions, and the researchers developed a clinical nomogram using their final multivariate logistic model.
The researchers calculated that the predicted probability of difficulty walking for a 60-year-old, middle-income, normal-weight woman with no health conditions was 5%-10%. However, the probability of walking problems was 10%-20% for the same woman with diabetes and CVD; 40% with osteoarthritis in two hips/knees; 60%-70% with diabetes, CVD, and osteoarthritis in two hips/knees; and 80% with diabetes, CVD, and osteoarthritis in all hips/knees.
Overall, 10% of the participants met criteria for hip OA and 15% met criteria for knee OA. The most common chronic conditions were hypertension (43%), diabetes (11%), and CVD (11%).
In a multivariate analysis, individuals with knee or hip OA had the highest odds of reporting walking difficulty, and the odds increased with the number of joints affected.
The results were limited by the cross-sectional nature of the study and the use of self-reports, the researchers noted.
However, “Given the high prevalence of OA and the substantial physical, social, and psychological consequences of walking difficulty, we believe our findings have high clinical relevance to primary care physicians and internal medicine specialists beyond rheumatology,” they said.
“Further research is warranted to understand the mechanisms by which chronic conditions affect mobility, physical activity, and sedentary behavior, and to elucidate safe and effective management approaches to reduce OA-related walking difficulty,” they added.
None of the investigators had relevant financial disclosures to report.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point:
Major finding: The probability of difficulty walking was 40% for a 60-year-old, middle-income, normal-weight woman with OA in two hips or knees vs. 5% in the same woman with no health conditions.
Data source: A population-based cohort study of 18,490 adults aged 55 years and older.
Disclosures: None of the investigators had relevant financial disclosures to report.
Benefits, safety of dupilumab-steroid combination in adults with AD sustained
Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.
The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).
Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.
In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.
At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).
“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.
Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.
The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.
The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.
Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.
The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).
Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.
In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.
At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).
“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.
Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.
The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.
The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.
Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.
The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).
Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.
In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.
At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).
“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.
Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.
The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.
The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.
FROM THE LANCET
Key clinical point: One year data on the efficacy and safety of dupilumab, combined with topical steroids, in adults with atopic dermatitis reflected the positive 16-week results, with encouraging safety data.
Major finding: After 16 weeks, 39% of atopic dermatitis patients who received dupilumab in addition to topical steroids met endpoints for improved symptoms, vs. 12% of patients who received topical steroids plus placebo. These benefits were sustained through one year.
Data source: An international phase III randomized trial of adults with moderate to severe atopic dermatitis.
Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals. The lead author and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.
Speedy sepsis care slows in-hospital mortality
WASHINGTON – Sepsis and septic shock patients treated within 3 hours had lower in-hospital mortality rates than those treated between hours 3 and 12, based on data from nearly 50,000 adult patients. The findings were presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Considerable controversy exists about how rapidly sepsis must be treated,” wrote Christopher Seymour, MD, of the University of Pittsburgh, Pennsylvania, and his colleagues. The researchers reviewed data from New York State, where hospitals have mandated protocols for sepsis treatment, to assess the impact of treatment timing on risk-adjusted mortality (NEJM. 2017. doi: 10.1056/NEJMoa1703058).
The primary outcome was in-hospital mortality, and each hour taken to complete the 3-hour treatment bundle was associated with increased mortality (odds ratio, 1.04 per hour). Overall, patients whose 3-hour treatment bundle was completed between 3 and 12 hours after hospital admission were 14% more likely to die than those who received the treatment bundle within 3 hours.
“These associations appeared to be stronger among patients receiving vasopressors than among those who were not receiving vasopressors,” the researchers noted.
On average, patients received the complete 3-hour treatment bundle in 1.30 hours, antibiotics in 0.95 hours, and a fluid bolus in 2.56 hours.
Odds of risk-adjusted in-hospital mortality were significantly higher for those with a longer time to completion of the 3-hour bundle within 12 hours (OR, 1.04) and for those with a longer time to administration of antibiotics (OR, 1.04); however, the time to bolus of IV fluids did not significantly impact in-hospital mortality.
The study was limited as a review and not a randomized trial and by a lack of data on the appropriateness of broad-spectrum antibiotics, the researchers said. However, the data suggest that, if there is a causal relationship between treatment timing and mortality, “prompt recognition and faster treatment of sepsis and septic shock in the context of emergency care may reduce the incidence of avoidable deaths,” they said.
Lead author Dr. Seymour reported grants from the National Institutes of Health and financial relationships with Beckman Coulter and Edwards Lifesciences.
“To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care,” wrote Tina B. Hershey, JD, MPH, and Jeremy M. Kahn, MD, in an accompanying editorial. The regulations implemented in New York State in 2013 “mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and treatment outcomes,” they said. Although the regulations in New York are fairly new, the data show an increased used of protocols and reduced mortality, they noted. “However, several crucial questions remain, concerning not only the regulations’ specific impact but also the broader question of the value of statewide mandates for protocolized sepsis care,” they said.
Ms. Hershey and Dr. Kahn are affiliated with the University of Pittsburgh, Pennsylvania, in the department of health policy and management and the department of critical care medicine, respectively. Both Ms. Hershey and Dr. Kahn disclosed that their institutions have applied for federal grants to study sepsis policymaking and its impact on health care costs and outcomes.
“To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care,” wrote Tina B. Hershey, JD, MPH, and Jeremy M. Kahn, MD, in an accompanying editorial. The regulations implemented in New York State in 2013 “mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and treatment outcomes,” they said. Although the regulations in New York are fairly new, the data show an increased used of protocols and reduced mortality, they noted. “However, several crucial questions remain, concerning not only the regulations’ specific impact but also the broader question of the value of statewide mandates for protocolized sepsis care,” they said.
Ms. Hershey and Dr. Kahn are affiliated with the University of Pittsburgh, Pennsylvania, in the department of health policy and management and the department of critical care medicine, respectively. Both Ms. Hershey and Dr. Kahn disclosed that their institutions have applied for federal grants to study sepsis policymaking and its impact on health care costs and outcomes.
“To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care,” wrote Tina B. Hershey, JD, MPH, and Jeremy M. Kahn, MD, in an accompanying editorial. The regulations implemented in New York State in 2013 “mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and treatment outcomes,” they said. Although the regulations in New York are fairly new, the data show an increased used of protocols and reduced mortality, they noted. “However, several crucial questions remain, concerning not only the regulations’ specific impact but also the broader question of the value of statewide mandates for protocolized sepsis care,” they said.
Ms. Hershey and Dr. Kahn are affiliated with the University of Pittsburgh, Pennsylvania, in the department of health policy and management and the department of critical care medicine, respectively. Both Ms. Hershey and Dr. Kahn disclosed that their institutions have applied for federal grants to study sepsis policymaking and its impact on health care costs and outcomes.
WASHINGTON – Sepsis and septic shock patients treated within 3 hours had lower in-hospital mortality rates than those treated between hours 3 and 12, based on data from nearly 50,000 adult patients. The findings were presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Considerable controversy exists about how rapidly sepsis must be treated,” wrote Christopher Seymour, MD, of the University of Pittsburgh, Pennsylvania, and his colleagues. The researchers reviewed data from New York State, where hospitals have mandated protocols for sepsis treatment, to assess the impact of treatment timing on risk-adjusted mortality (NEJM. 2017. doi: 10.1056/NEJMoa1703058).
The primary outcome was in-hospital mortality, and each hour taken to complete the 3-hour treatment bundle was associated with increased mortality (odds ratio, 1.04 per hour). Overall, patients whose 3-hour treatment bundle was completed between 3 and 12 hours after hospital admission were 14% more likely to die than those who received the treatment bundle within 3 hours.
“These associations appeared to be stronger among patients receiving vasopressors than among those who were not receiving vasopressors,” the researchers noted.
On average, patients received the complete 3-hour treatment bundle in 1.30 hours, antibiotics in 0.95 hours, and a fluid bolus in 2.56 hours.
Odds of risk-adjusted in-hospital mortality were significantly higher for those with a longer time to completion of the 3-hour bundle within 12 hours (OR, 1.04) and for those with a longer time to administration of antibiotics (OR, 1.04); however, the time to bolus of IV fluids did not significantly impact in-hospital mortality.
The study was limited as a review and not a randomized trial and by a lack of data on the appropriateness of broad-spectrum antibiotics, the researchers said. However, the data suggest that, if there is a causal relationship between treatment timing and mortality, “prompt recognition and faster treatment of sepsis and septic shock in the context of emergency care may reduce the incidence of avoidable deaths,” they said.
Lead author Dr. Seymour reported grants from the National Institutes of Health and financial relationships with Beckman Coulter and Edwards Lifesciences.
WASHINGTON – Sepsis and septic shock patients treated within 3 hours had lower in-hospital mortality rates than those treated between hours 3 and 12, based on data from nearly 50,000 adult patients. The findings were presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Considerable controversy exists about how rapidly sepsis must be treated,” wrote Christopher Seymour, MD, of the University of Pittsburgh, Pennsylvania, and his colleagues. The researchers reviewed data from New York State, where hospitals have mandated protocols for sepsis treatment, to assess the impact of treatment timing on risk-adjusted mortality (NEJM. 2017. doi: 10.1056/NEJMoa1703058).
The primary outcome was in-hospital mortality, and each hour taken to complete the 3-hour treatment bundle was associated with increased mortality (odds ratio, 1.04 per hour). Overall, patients whose 3-hour treatment bundle was completed between 3 and 12 hours after hospital admission were 14% more likely to die than those who received the treatment bundle within 3 hours.
“These associations appeared to be stronger among patients receiving vasopressors than among those who were not receiving vasopressors,” the researchers noted.
On average, patients received the complete 3-hour treatment bundle in 1.30 hours, antibiotics in 0.95 hours, and a fluid bolus in 2.56 hours.
Odds of risk-adjusted in-hospital mortality were significantly higher for those with a longer time to completion of the 3-hour bundle within 12 hours (OR, 1.04) and for those with a longer time to administration of antibiotics (OR, 1.04); however, the time to bolus of IV fluids did not significantly impact in-hospital mortality.
The study was limited as a review and not a randomized trial and by a lack of data on the appropriateness of broad-spectrum antibiotics, the researchers said. However, the data suggest that, if there is a causal relationship between treatment timing and mortality, “prompt recognition and faster treatment of sepsis and septic shock in the context of emergency care may reduce the incidence of avoidable deaths,” they said.
Lead author Dr. Seymour reported grants from the National Institutes of Health and financial relationships with Beckman Coulter and Edwards Lifesciences.
Key clinical point: In-hospital mortality rates were lower for sepsis patients who were treated more rapidly (within 3 hours) with a 3-hour bundle of sepsis care and antibiotics.
Major finding: Sepsis patients whose 3-hour treatment bundle was completed between hour 3 and 12 were 14% more likely to die than those who received the treatment within 3 hours.
Data source: A review of data from 49,331 sepsis and septic shock patients at 149 hospitals.
Disclosures: Lead author Dr. Seymour reported grants from the National Institutes of Health and financial relationships with Beckman Coulter and Edwards Lifesciences.
Strength plus aerobics equals fitness for obese older adults
Physical performance measures increased by 21% in obese older adults who followed a combination aerobic and resistance exercise routine for weight management, based on data form 141 participants. The findings were published May 17 in the New England Journal of Medicine.
The combination plan scores improved significantly more than either an aerobic exercise or resistance exercise plan (14%), wrote Dennis T. Villareal, MD, professor in the division of diabetes, endocrinology and metabolism at Baylor College of Medicine, Houston, and his colleagues (N Engl J Med. 2017 May 18;376[20]:1943-55).
The researchers randomized 40 adults to each of four interventions: aerobic exercise, resistance exercise, combination aerobic/resistance, and control. A total of 141 participants completed the study, and baseline demographic characteristics were similar among the groups.
Overall, among members of the combination group, scores on the Physical Performance Test showed the greatest increase from baseline to 6 months (from 28 to 33 points), compared with the aerobic group (29 to 33 points) and the resistance group (29 to 33 points).
Peak oxygen consumption was significantly higher at the end of the training period than at baseline in the combination and aerobic groups, compared with the resistance group (with increases of 17%, 18%, and 8% increase, respectively). Strength was significantly higher in the combination and resistance groups than in the aerobic group (18%, 19%, and 4% increase, respectively). Both decreases in both lean body mass and bone mineral density were significantly less in the combination and resistance groups, compared with the aerobic group.
Body weight decreased by approximately 9% from baseline in all three exercise groups, but no significant change was noted in the control group.
Adverse events “were relatively few and consistent with coexisting medical conditions,” the researchers said. Exercise-related adverse events included knee, back, and hip pain in the combination group; falling, shoulder pain, and back pain in the aerobic group; and shoulder pain, knee pain, and atrial fibrillation in the resistance group.
The study was limited in part by factors including the physical ability of the study population, which may not represent obese older adults in general, the researchers said. However, “our findings support that the recommendation by the American Heart Association and American College of Sports Medicine to combine aerobic exercise with resistance exercise for overall health extends to obese older adults undertaking weight loss,” they noted.
The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
Physical performance measures increased by 21% in obese older adults who followed a combination aerobic and resistance exercise routine for weight management, based on data form 141 participants. The findings were published May 17 in the New England Journal of Medicine.
The combination plan scores improved significantly more than either an aerobic exercise or resistance exercise plan (14%), wrote Dennis T. Villareal, MD, professor in the division of diabetes, endocrinology and metabolism at Baylor College of Medicine, Houston, and his colleagues (N Engl J Med. 2017 May 18;376[20]:1943-55).
The researchers randomized 40 adults to each of four interventions: aerobic exercise, resistance exercise, combination aerobic/resistance, and control. A total of 141 participants completed the study, and baseline demographic characteristics were similar among the groups.
Overall, among members of the combination group, scores on the Physical Performance Test showed the greatest increase from baseline to 6 months (from 28 to 33 points), compared with the aerobic group (29 to 33 points) and the resistance group (29 to 33 points).
Peak oxygen consumption was significantly higher at the end of the training period than at baseline in the combination and aerobic groups, compared with the resistance group (with increases of 17%, 18%, and 8% increase, respectively). Strength was significantly higher in the combination and resistance groups than in the aerobic group (18%, 19%, and 4% increase, respectively). Both decreases in both lean body mass and bone mineral density were significantly less in the combination and resistance groups, compared with the aerobic group.
Body weight decreased by approximately 9% from baseline in all three exercise groups, but no significant change was noted in the control group.
Adverse events “were relatively few and consistent with coexisting medical conditions,” the researchers said. Exercise-related adverse events included knee, back, and hip pain in the combination group; falling, shoulder pain, and back pain in the aerobic group; and shoulder pain, knee pain, and atrial fibrillation in the resistance group.
The study was limited in part by factors including the physical ability of the study population, which may not represent obese older adults in general, the researchers said. However, “our findings support that the recommendation by the American Heart Association and American College of Sports Medicine to combine aerobic exercise with resistance exercise for overall health extends to obese older adults undertaking weight loss,” they noted.
The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
Physical performance measures increased by 21% in obese older adults who followed a combination aerobic and resistance exercise routine for weight management, based on data form 141 participants. The findings were published May 17 in the New England Journal of Medicine.
The combination plan scores improved significantly more than either an aerobic exercise or resistance exercise plan (14%), wrote Dennis T. Villareal, MD, professor in the division of diabetes, endocrinology and metabolism at Baylor College of Medicine, Houston, and his colleagues (N Engl J Med. 2017 May 18;376[20]:1943-55).
The researchers randomized 40 adults to each of four interventions: aerobic exercise, resistance exercise, combination aerobic/resistance, and control. A total of 141 participants completed the study, and baseline demographic characteristics were similar among the groups.
Overall, among members of the combination group, scores on the Physical Performance Test showed the greatest increase from baseline to 6 months (from 28 to 33 points), compared with the aerobic group (29 to 33 points) and the resistance group (29 to 33 points).
Peak oxygen consumption was significantly higher at the end of the training period than at baseline in the combination and aerobic groups, compared with the resistance group (with increases of 17%, 18%, and 8% increase, respectively). Strength was significantly higher in the combination and resistance groups than in the aerobic group (18%, 19%, and 4% increase, respectively). Both decreases in both lean body mass and bone mineral density were significantly less in the combination and resistance groups, compared with the aerobic group.
Body weight decreased by approximately 9% from baseline in all three exercise groups, but no significant change was noted in the control group.
Adverse events “were relatively few and consistent with coexisting medical conditions,” the researchers said. Exercise-related adverse events included knee, back, and hip pain in the combination group; falling, shoulder pain, and back pain in the aerobic group; and shoulder pain, knee pain, and atrial fibrillation in the resistance group.
The study was limited in part by factors including the physical ability of the study population, which may not represent obese older adults in general, the researchers said. However, “our findings support that the recommendation by the American Heart Association and American College of Sports Medicine to combine aerobic exercise with resistance exercise for overall health extends to obese older adults undertaking weight loss,” they noted.
The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Combining aerobic and resistance exercise was significantly more effective for improving physical function in obese older adults.
Major finding: Physical performance test scores improved by 21% from baseline for obese adults in a combination exercise program vs. 14% for those in either an aerobic-only or resistance-only exercise program.
Data source: The data came from a randomized trial of 141 obese adults aged 65 years and older.
Disclosures: The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
USPSTF discourages postmenopausal hormone therapy for prevention
Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.
The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.
After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.
The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.
Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.
However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).
Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.
The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.
Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.
View the recommendations online at uspreventiveservicestaskforce.org.
Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.
The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.
After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.
The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.
Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.
However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).
Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.
The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.
Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.
View the recommendations online at uspreventiveservicestaskforce.org.
Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.
The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.
After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.
The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.
Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.
However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).
Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.
The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.
Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.
View the recommendations online at uspreventiveservicestaskforce.org.
Mycobacteria subset plagues pulmonary patients
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
FROM CHEST
Key clinical point: An optimal multidrug treatment has not yet been found for patients with nontuberculosis mycobacteria (NTM)–related pulmonary disease.
Major finding: The average proportion of sputum culture conversion (SCC) for patients with M. abscessus was 42% after subtraction for posttreatment relapses, but reached 79% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with M. xenopi, and 54% for those with M. malmoense.
Data source: A meta-analysis of 24 studies and 1,224 patients.
Disclosures: Dr. Roland Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
In pyoderma gangrenosum, cyclosporine is cost effective for large lesions
, based on data from a multicenter, randomized trial published online in the British Journal of Dermatology.
In the STOP-GAP trial, researchers recruited 112 adults with pyoderma gangrenosum and similar baseline demographics. The patients were randomized to receive cyclosporine or prednisolone and were assessed at 6 weeks and 6 months. The researchers also collected quality of life data and cost and resource information.
Healing rates within 6 months were approximately 47% for the cyclosporine and prednisolone groups. Adverse reactions were similar between the two groups at 68% and 66%, respectively.
“Having found no difference for a range of objective and patient-reported outcomes, the trialists concluded that treatment decisions for individual patients should be guided by the different side effect profiles of the two drugs and patient preference,” wrote James M. Mason, MD, of the University of Warwick (England), and his colleagues. Compared with prednisolone, cyclosporine reduced the costs of treatment by 1,100 British pounds, the researchers noted. However, most of that cost savings was seen in patients with lesions of 20 cm2 or greater; the decreased cost for these patients averaged 5,310 British pounds. The cost savings were 1,007 British pounds for patients with lesions less than 20 cm2 (Br J Dermatol. 2017. doi: 10.1111/bjd.15561). “These differences were driven by the pattern of hospitalization, which predominantly occurred in patients receiving prednisolone and may be linked to the occurrence of serious adverse events,” the researchers wrote.
Quality of life was assessed using the EuroQol questionnaire and the Dermatology Life Quality Index.
No significant differences were noted between the two treatments in terms of quality of life scores, although there was a slight increase in quality of life scores among cyclosporine-treated patients over the 24-week follow-up period.
The findings were limited by incomplete data and the use of a base case analysis to complete the gaps, the researchers said. However, the results suggest that cyclosporine may be a cost-effective strategy for patients with larger lesions; no clear advantage was seen for cyclosporine vs. prednisolone treatment in patients with smaller lesions.
The study was supported in part by a grant from the National Institute for Health Research. The researchers had no financial conflicts to disclose.
, based on data from a multicenter, randomized trial published online in the British Journal of Dermatology.
In the STOP-GAP trial, researchers recruited 112 adults with pyoderma gangrenosum and similar baseline demographics. The patients were randomized to receive cyclosporine or prednisolone and were assessed at 6 weeks and 6 months. The researchers also collected quality of life data and cost and resource information.
Healing rates within 6 months were approximately 47% for the cyclosporine and prednisolone groups. Adverse reactions were similar between the two groups at 68% and 66%, respectively.
“Having found no difference for a range of objective and patient-reported outcomes, the trialists concluded that treatment decisions for individual patients should be guided by the different side effect profiles of the two drugs and patient preference,” wrote James M. Mason, MD, of the University of Warwick (England), and his colleagues. Compared with prednisolone, cyclosporine reduced the costs of treatment by 1,100 British pounds, the researchers noted. However, most of that cost savings was seen in patients with lesions of 20 cm2 or greater; the decreased cost for these patients averaged 5,310 British pounds. The cost savings were 1,007 British pounds for patients with lesions less than 20 cm2 (Br J Dermatol. 2017. doi: 10.1111/bjd.15561). “These differences were driven by the pattern of hospitalization, which predominantly occurred in patients receiving prednisolone and may be linked to the occurrence of serious adverse events,” the researchers wrote.
Quality of life was assessed using the EuroQol questionnaire and the Dermatology Life Quality Index.
No significant differences were noted between the two treatments in terms of quality of life scores, although there was a slight increase in quality of life scores among cyclosporine-treated patients over the 24-week follow-up period.
The findings were limited by incomplete data and the use of a base case analysis to complete the gaps, the researchers said. However, the results suggest that cyclosporine may be a cost-effective strategy for patients with larger lesions; no clear advantage was seen for cyclosporine vs. prednisolone treatment in patients with smaller lesions.
The study was supported in part by a grant from the National Institute for Health Research. The researchers had no financial conflicts to disclose.
, based on data from a multicenter, randomized trial published online in the British Journal of Dermatology.
In the STOP-GAP trial, researchers recruited 112 adults with pyoderma gangrenosum and similar baseline demographics. The patients were randomized to receive cyclosporine or prednisolone and were assessed at 6 weeks and 6 months. The researchers also collected quality of life data and cost and resource information.
Healing rates within 6 months were approximately 47% for the cyclosporine and prednisolone groups. Adverse reactions were similar between the two groups at 68% and 66%, respectively.
“Having found no difference for a range of objective and patient-reported outcomes, the trialists concluded that treatment decisions for individual patients should be guided by the different side effect profiles of the two drugs and patient preference,” wrote James M. Mason, MD, of the University of Warwick (England), and his colleagues. Compared with prednisolone, cyclosporine reduced the costs of treatment by 1,100 British pounds, the researchers noted. However, most of that cost savings was seen in patients with lesions of 20 cm2 or greater; the decreased cost for these patients averaged 5,310 British pounds. The cost savings were 1,007 British pounds for patients with lesions less than 20 cm2 (Br J Dermatol. 2017. doi: 10.1111/bjd.15561). “These differences were driven by the pattern of hospitalization, which predominantly occurred in patients receiving prednisolone and may be linked to the occurrence of serious adverse events,” the researchers wrote.
Quality of life was assessed using the EuroQol questionnaire and the Dermatology Life Quality Index.
No significant differences were noted between the two treatments in terms of quality of life scores, although there was a slight increase in quality of life scores among cyclosporine-treated patients over the 24-week follow-up period.
The findings were limited by incomplete data and the use of a base case analysis to complete the gaps, the researchers said. However, the results suggest that cyclosporine may be a cost-effective strategy for patients with larger lesions; no clear advantage was seen for cyclosporine vs. prednisolone treatment in patients with smaller lesions.
The study was supported in part by a grant from the National Institute for Health Research. The researchers had no financial conflicts to disclose.
Key clinical point: Approximately 50% of ulcers in pyoderma gangrenosum patients healed by 6 months on either cyclosporine or prednisolone, but cyclosporine cost less for patients with larger lesions.
Major finding: Cyclosporine was associated with an average cost reduction of 5,310 British pounds for pyoderma gangrenosum patients with lesions 20 cm2 or larger.
Data source: A cost-effectiveness analysis of the STOP-GAP randomized trial of adults with pyoderma gangrenosum.
Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by a grant from the National Institute for Health Research.
Novel robotic camera photographs colon
A novel robotically driven capsule successfully navigated a colon in a pig model in 100% of 30 retroflexion maneuvers, setting the stage for further study of robotics in colonoscopy. The data were presented at the annual Digestive Disease Week.
Although capsule technology has expanded exploration of the GI tract, current capsules are limited by passive movement and lack therapeutic capability, said Keith L. Obstein, MD, of Vanderbilt University in Nashville, Tenn.
The researchers developed a capsule with an 18-mm head and interior permanent magnets designed to be automatically controlled by an external robotic arm in difficult areas.
“Retroflexion is a common but mechanically complex maneuver during colonoscopy, and therefore serves as an excellent subject for autonomous control,” the researchers noted.
Logistically, the capsule is soft-tethered after it is introduced through the rectum, which allows the potential for therapeutic procedures such as biopsies and polyp removal. In addition, the use of an external magnet to pull the robot with the tether may reduce the pressure on the colon that typically created when a physician pushes the colonoscope from behind. Therefore, use of a robotic capsule may help reduce patients’ discomfort and make them more amenable to the procedure, Dr. Obstein said.
In the study, an endoscopist performed the first retroflexion with a standard colonoscope at 15 cm from the anal sphincter, and these parameters were used to set the robotic system for autonomous retroflexion at 15 cm from the anal sphincter.
The success rate was 100% for both the standard endoscope and the automatically controlled robot for each of 30 maneuvers. The average time for a robotic maneuver was 12 seconds, and no leaks or histologic abnormalities were noted.
Studies to evaluate additional control algorithms are in progress, and the robot capsule may be ready for human trials in 2018, Dr. Obstein said.
This study was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992. Dr. Obstein had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
A novel robotically driven capsule successfully navigated a colon in a pig model in 100% of 30 retroflexion maneuvers, setting the stage for further study of robotics in colonoscopy. The data were presented at the annual Digestive Disease Week.
Although capsule technology has expanded exploration of the GI tract, current capsules are limited by passive movement and lack therapeutic capability, said Keith L. Obstein, MD, of Vanderbilt University in Nashville, Tenn.
The researchers developed a capsule with an 18-mm head and interior permanent magnets designed to be automatically controlled by an external robotic arm in difficult areas.
“Retroflexion is a common but mechanically complex maneuver during colonoscopy, and therefore serves as an excellent subject for autonomous control,” the researchers noted.
Logistically, the capsule is soft-tethered after it is introduced through the rectum, which allows the potential for therapeutic procedures such as biopsies and polyp removal. In addition, the use of an external magnet to pull the robot with the tether may reduce the pressure on the colon that typically created when a physician pushes the colonoscope from behind. Therefore, use of a robotic capsule may help reduce patients’ discomfort and make them more amenable to the procedure, Dr. Obstein said.
In the study, an endoscopist performed the first retroflexion with a standard colonoscope at 15 cm from the anal sphincter, and these parameters were used to set the robotic system for autonomous retroflexion at 15 cm from the anal sphincter.
The success rate was 100% for both the standard endoscope and the automatically controlled robot for each of 30 maneuvers. The average time for a robotic maneuver was 12 seconds, and no leaks or histologic abnormalities were noted.
Studies to evaluate additional control algorithms are in progress, and the robot capsule may be ready for human trials in 2018, Dr. Obstein said.
This study was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992. Dr. Obstein had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
A novel robotically driven capsule successfully navigated a colon in a pig model in 100% of 30 retroflexion maneuvers, setting the stage for further study of robotics in colonoscopy. The data were presented at the annual Digestive Disease Week.
Although capsule technology has expanded exploration of the GI tract, current capsules are limited by passive movement and lack therapeutic capability, said Keith L. Obstein, MD, of Vanderbilt University in Nashville, Tenn.
The researchers developed a capsule with an 18-mm head and interior permanent magnets designed to be automatically controlled by an external robotic arm in difficult areas.
“Retroflexion is a common but mechanically complex maneuver during colonoscopy, and therefore serves as an excellent subject for autonomous control,” the researchers noted.
Logistically, the capsule is soft-tethered after it is introduced through the rectum, which allows the potential for therapeutic procedures such as biopsies and polyp removal. In addition, the use of an external magnet to pull the robot with the tether may reduce the pressure on the colon that typically created when a physician pushes the colonoscope from behind. Therefore, use of a robotic capsule may help reduce patients’ discomfort and make them more amenable to the procedure, Dr. Obstein said.
In the study, an endoscopist performed the first retroflexion with a standard colonoscope at 15 cm from the anal sphincter, and these parameters were used to set the robotic system for autonomous retroflexion at 15 cm from the anal sphincter.
The success rate was 100% for both the standard endoscope and the automatically controlled robot for each of 30 maneuvers. The average time for a robotic maneuver was 12 seconds, and no leaks or histologic abnormalities were noted.
Studies to evaluate additional control algorithms are in progress, and the robot capsule may be ready for human trials in 2018, Dr. Obstein said.
This study was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992. Dr. Obstein had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
FROM DDW
Key clinical point: An 18-mm magnetized capsule colonoscope successfully navigated a pig colon, and researchers are planning human trials for 2018.
Major finding: An automated robot capsule successfully completed 30 retroflexion maneuvers in a pig colon with an average time of 12 seconds.
Data source: The data come from a test of 30 maneuvers.
Disclosures: This study was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992. Dr. Obstein had no relevant financial conflicts to disclose.