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Obesity affects the ability to diagnose liver fibrosis
Body mass index accounts for a 43.7% discordance in fibrosis findings between magnetic resonance elastography (MRE) and transient elastography (TE), according to a study from the University of California, San Diego.
“This study demonstrates that BMI is a significant factor of discordancy between MRE and TE for the stage of significant fibrosis (2-4 vs. 0-1),” wrote Cyrielle Caussy, MD, and her colleagues (Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037). “Furthermore, this study showed that the grade of obesity is also a significant predictor of discordancy between MRE and TE because the discordance rate between MRE and TE increases with the increase in BMI.”
Dr. Caussy of the University of California, San Diego, and her colleagues had noted that MRE and TE had discordant findings in obese patients. To ascertain under what conditions TE and MRE produce the same readings, Dr. Caussy and her associates conducted a cross-sectional study of two cohorts with nonalcoholic fatty liver disease (NAFLD) who underwent contemporaneous MRE, TE, and liver biopsy. TE utilized both M and XL probes during imaging. The training cohort involved 119 adult patients undergoing NAFLD testing from October 2011 through January 2017. The validation cohort, consisting of 75 adults with NAFLD undergoing liver imaging from March 2010 through May 2013, was formed to validate the findings of the training cohort.
The study revealed that BMI was a significant predictor of the difference between MRE and TE results and made it difficult to assess the stage of liver fibrosis (2-4 vs. 0-1). After adjustment for age and sex, BMI accounted for a 5-unit increase of 1.694 (95% confidence interval, 1.145-2.507; P = .008). This was not a static relationship, and as BMI increased, so did the discordance between MRE and TE (P = .0309). Interestingly, the discordance rate was significantly higher in participants with BMIs greater than 35 kg/m2, compared with participants with BMIs below 35 (63.0% vs. 38.0%; P = .022), the investigators reported.
While the study revealed valuable information, it had both strengths and limitations. A strength of the study was the use of two cohorts, specifically the validation cohort. The use of the liver biopsy as a reference, which is the standard for assessing fibrosis, was also a strength of the study. A limitation was that the study was conducted at specialized, tertiary care centers using advanced imaging techniques that may not be available at other clinics. Additionally, the cohorts included a small number of patients with advanced fibrosis.
“The integration of the BMI in the screening strategy for the noninvasive detection of liver fibrosis in NAFLD should be considered, and this parameter would help to determine when MRE is not needed in future guidelines” wrote Dr. Caussy and her associates. “Further cost-effectiveness studies are necessary to evaluate the clinical utility of MRE, TE, and/or liver biopsy to develop optimal screening strategies for diagnosing NAFLD-associated fibrosis.”
Jun Chen, MD, Meng Yin, MD, and Richard L. Ehman, MD, all have intellectual property rights and financial interests in elastography technology. Dr. Ehman also serves as an noncompensated CEO of Resoundant. Claude B. Sirlin, MD, has served as a consultant to Bayer and GE Healthcare. All other authors did not disclose any conflicts.
The AGA Obesity Practice Guide provides a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.
SOURCE: Caussy C et al. Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037.
Body mass index accounts for a 43.7% discordance in fibrosis findings between magnetic resonance elastography (MRE) and transient elastography (TE), according to a study from the University of California, San Diego.
“This study demonstrates that BMI is a significant factor of discordancy between MRE and TE for the stage of significant fibrosis (2-4 vs. 0-1),” wrote Cyrielle Caussy, MD, and her colleagues (Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037). “Furthermore, this study showed that the grade of obesity is also a significant predictor of discordancy between MRE and TE because the discordance rate between MRE and TE increases with the increase in BMI.”
Dr. Caussy of the University of California, San Diego, and her colleagues had noted that MRE and TE had discordant findings in obese patients. To ascertain under what conditions TE and MRE produce the same readings, Dr. Caussy and her associates conducted a cross-sectional study of two cohorts with nonalcoholic fatty liver disease (NAFLD) who underwent contemporaneous MRE, TE, and liver biopsy. TE utilized both M and XL probes during imaging. The training cohort involved 119 adult patients undergoing NAFLD testing from October 2011 through January 2017. The validation cohort, consisting of 75 adults with NAFLD undergoing liver imaging from March 2010 through May 2013, was formed to validate the findings of the training cohort.
The study revealed that BMI was a significant predictor of the difference between MRE and TE results and made it difficult to assess the stage of liver fibrosis (2-4 vs. 0-1). After adjustment for age and sex, BMI accounted for a 5-unit increase of 1.694 (95% confidence interval, 1.145-2.507; P = .008). This was not a static relationship, and as BMI increased, so did the discordance between MRE and TE (P = .0309). Interestingly, the discordance rate was significantly higher in participants with BMIs greater than 35 kg/m2, compared with participants with BMIs below 35 (63.0% vs. 38.0%; P = .022), the investigators reported.
While the study revealed valuable information, it had both strengths and limitations. A strength of the study was the use of two cohorts, specifically the validation cohort. The use of the liver biopsy as a reference, which is the standard for assessing fibrosis, was also a strength of the study. A limitation was that the study was conducted at specialized, tertiary care centers using advanced imaging techniques that may not be available at other clinics. Additionally, the cohorts included a small number of patients with advanced fibrosis.
“The integration of the BMI in the screening strategy for the noninvasive detection of liver fibrosis in NAFLD should be considered, and this parameter would help to determine when MRE is not needed in future guidelines” wrote Dr. Caussy and her associates. “Further cost-effectiveness studies are necessary to evaluate the clinical utility of MRE, TE, and/or liver biopsy to develop optimal screening strategies for diagnosing NAFLD-associated fibrosis.”
Jun Chen, MD, Meng Yin, MD, and Richard L. Ehman, MD, all have intellectual property rights and financial interests in elastography technology. Dr. Ehman also serves as an noncompensated CEO of Resoundant. Claude B. Sirlin, MD, has served as a consultant to Bayer and GE Healthcare. All other authors did not disclose any conflicts.
The AGA Obesity Practice Guide provides a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.
SOURCE: Caussy C et al. Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037.
Body mass index accounts for a 43.7% discordance in fibrosis findings between magnetic resonance elastography (MRE) and transient elastography (TE), according to a study from the University of California, San Diego.
“This study demonstrates that BMI is a significant factor of discordancy between MRE and TE for the stage of significant fibrosis (2-4 vs. 0-1),” wrote Cyrielle Caussy, MD, and her colleagues (Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037). “Furthermore, this study showed that the grade of obesity is also a significant predictor of discordancy between MRE and TE because the discordance rate between MRE and TE increases with the increase in BMI.”
Dr. Caussy of the University of California, San Diego, and her colleagues had noted that MRE and TE had discordant findings in obese patients. To ascertain under what conditions TE and MRE produce the same readings, Dr. Caussy and her associates conducted a cross-sectional study of two cohorts with nonalcoholic fatty liver disease (NAFLD) who underwent contemporaneous MRE, TE, and liver biopsy. TE utilized both M and XL probes during imaging. The training cohort involved 119 adult patients undergoing NAFLD testing from October 2011 through January 2017. The validation cohort, consisting of 75 adults with NAFLD undergoing liver imaging from March 2010 through May 2013, was formed to validate the findings of the training cohort.
The study revealed that BMI was a significant predictor of the difference between MRE and TE results and made it difficult to assess the stage of liver fibrosis (2-4 vs. 0-1). After adjustment for age and sex, BMI accounted for a 5-unit increase of 1.694 (95% confidence interval, 1.145-2.507; P = .008). This was not a static relationship, and as BMI increased, so did the discordance between MRE and TE (P = .0309). Interestingly, the discordance rate was significantly higher in participants with BMIs greater than 35 kg/m2, compared with participants with BMIs below 35 (63.0% vs. 38.0%; P = .022), the investigators reported.
While the study revealed valuable information, it had both strengths and limitations. A strength of the study was the use of two cohorts, specifically the validation cohort. The use of the liver biopsy as a reference, which is the standard for assessing fibrosis, was also a strength of the study. A limitation was that the study was conducted at specialized, tertiary care centers using advanced imaging techniques that may not be available at other clinics. Additionally, the cohorts included a small number of patients with advanced fibrosis.
“The integration of the BMI in the screening strategy for the noninvasive detection of liver fibrosis in NAFLD should be considered, and this parameter would help to determine when MRE is not needed in future guidelines” wrote Dr. Caussy and her associates. “Further cost-effectiveness studies are necessary to evaluate the clinical utility of MRE, TE, and/or liver biopsy to develop optimal screening strategies for diagnosing NAFLD-associated fibrosis.”
Jun Chen, MD, Meng Yin, MD, and Richard L. Ehman, MD, all have intellectual property rights and financial interests in elastography technology. Dr. Ehman also serves as an noncompensated CEO of Resoundant. Claude B. Sirlin, MD, has served as a consultant to Bayer and GE Healthcare. All other authors did not disclose any conflicts.
The AGA Obesity Practice Guide provides a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.
SOURCE: Caussy C et al. Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037.
Levetiracetam increased time between seizures for infants with epilepsy
, a multicenter, prospective, observational study has shown.
“Our findings suggest that levetiracetam has superior effectiveness compared with phenobarbital as initial monotherapy for nonsyndromic epilepsy in infants,” wrote Zachary Grinspan, MD, director of the pediatric epilepsy program at Cornell University, New York, and his colleagues. “We estimate that for every 100 infants with epilepsy treated with levetiracetam instead of phenobarbital, 44 infants would be free from monotherapy failure instead of 16.”
To evaluate the effectiveness of levetiracetam vs. phenobarbital, Dr. Grinspan and his colleagues developed the Early Life Epilepsy Study, a multicenter, prospective, observational investigation of 155 children with nonsyndromic epilepsy. Patient information for this study was obtained from medical records and was collected from March 1, 2012, through April 30, 2015. All of the patients in the study were observed in the first 3 years of life.
Of the 155 children included in the analysis for this study, 117 were treated with levetiracetam and 38 with phenobarbital. There were some differences between the groups. Children treated with levetiracetam were, on average, 2 months older at seizure onset than were those in the phenobarbital group (5.2 months vs. 3.0 months; P less than .001). Infants treated with levetiracetam also tended to begin treatment further from the time of their first seizure and exhibited less developmental delay at the time of epilepsy diagnosis. There were some other differences of possible clinical importance (developmental structural brain abnormalities, head circumference) that did not reach statistical significance.
Freedom from monotherapy failure was greater in the levetiracetam group (47 [40.2%] vs. 6 [15.8%]; P = .01; odds ratio, 3.6; 95% confidence interval, 1.5-10). Overall, the researchers concluded that levetiracetam was superior to phenobarbital for nonsyndromic epilepsy in pediatric patients (OR, 4.2; 95% CI, 1.1-16; number needed to treat, 3.5 [95% CI, 1.7-60]).
Outcome information was missing for more infants treated with levetiracetam than for those treated with phenobarbital, which could have skewed the analyses, Dr. Grinspan and his associates said. The nature of nonsyndromic epilepsy also makes it difficult to study because of the intricate genetic interactions that can influence the disorder.
Although this study provides information that could potentially benefit infantile epilepsy patients, the investigators said that more work must be done on the topic.
“A prospective clinical trial is needed. Levetiracetam and phenobarbital are both commonly used for infantile-onset epilepsy, indicating community equipoise regarding their relative effectiveness,” they wrote. “However, the effect size in our analysis was surprisingly large (number needed to treat, 3.5), suggesting that a change in practice could meaningfully improve outcomes.”
The investigators reported receiving grants and fees and consulting with a range of institutions, and the complete list can be found on the JAMA Pediatrics website. This study was funded by the Pediatric Epilepsy Research Foundation.
SOURCE: Grinspan Z et al. JAMA Pediatr. 2018 Feb 12. doi: 10.1001/jamapediatrics.2017.5211.
, a multicenter, prospective, observational study has shown.
“Our findings suggest that levetiracetam has superior effectiveness compared with phenobarbital as initial monotherapy for nonsyndromic epilepsy in infants,” wrote Zachary Grinspan, MD, director of the pediatric epilepsy program at Cornell University, New York, and his colleagues. “We estimate that for every 100 infants with epilepsy treated with levetiracetam instead of phenobarbital, 44 infants would be free from monotherapy failure instead of 16.”
To evaluate the effectiveness of levetiracetam vs. phenobarbital, Dr. Grinspan and his colleagues developed the Early Life Epilepsy Study, a multicenter, prospective, observational investigation of 155 children with nonsyndromic epilepsy. Patient information for this study was obtained from medical records and was collected from March 1, 2012, through April 30, 2015. All of the patients in the study were observed in the first 3 years of life.
Of the 155 children included in the analysis for this study, 117 were treated with levetiracetam and 38 with phenobarbital. There were some differences between the groups. Children treated with levetiracetam were, on average, 2 months older at seizure onset than were those in the phenobarbital group (5.2 months vs. 3.0 months; P less than .001). Infants treated with levetiracetam also tended to begin treatment further from the time of their first seizure and exhibited less developmental delay at the time of epilepsy diagnosis. There were some other differences of possible clinical importance (developmental structural brain abnormalities, head circumference) that did not reach statistical significance.
Freedom from monotherapy failure was greater in the levetiracetam group (47 [40.2%] vs. 6 [15.8%]; P = .01; odds ratio, 3.6; 95% confidence interval, 1.5-10). Overall, the researchers concluded that levetiracetam was superior to phenobarbital for nonsyndromic epilepsy in pediatric patients (OR, 4.2; 95% CI, 1.1-16; number needed to treat, 3.5 [95% CI, 1.7-60]).
Outcome information was missing for more infants treated with levetiracetam than for those treated with phenobarbital, which could have skewed the analyses, Dr. Grinspan and his associates said. The nature of nonsyndromic epilepsy also makes it difficult to study because of the intricate genetic interactions that can influence the disorder.
Although this study provides information that could potentially benefit infantile epilepsy patients, the investigators said that more work must be done on the topic.
“A prospective clinical trial is needed. Levetiracetam and phenobarbital are both commonly used for infantile-onset epilepsy, indicating community equipoise regarding their relative effectiveness,” they wrote. “However, the effect size in our analysis was surprisingly large (number needed to treat, 3.5), suggesting that a change in practice could meaningfully improve outcomes.”
The investigators reported receiving grants and fees and consulting with a range of institutions, and the complete list can be found on the JAMA Pediatrics website. This study was funded by the Pediatric Epilepsy Research Foundation.
SOURCE: Grinspan Z et al. JAMA Pediatr. 2018 Feb 12. doi: 10.1001/jamapediatrics.2017.5211.
, a multicenter, prospective, observational study has shown.
“Our findings suggest that levetiracetam has superior effectiveness compared with phenobarbital as initial monotherapy for nonsyndromic epilepsy in infants,” wrote Zachary Grinspan, MD, director of the pediatric epilepsy program at Cornell University, New York, and his colleagues. “We estimate that for every 100 infants with epilepsy treated with levetiracetam instead of phenobarbital, 44 infants would be free from monotherapy failure instead of 16.”
To evaluate the effectiveness of levetiracetam vs. phenobarbital, Dr. Grinspan and his colleagues developed the Early Life Epilepsy Study, a multicenter, prospective, observational investigation of 155 children with nonsyndromic epilepsy. Patient information for this study was obtained from medical records and was collected from March 1, 2012, through April 30, 2015. All of the patients in the study were observed in the first 3 years of life.
Of the 155 children included in the analysis for this study, 117 were treated with levetiracetam and 38 with phenobarbital. There were some differences between the groups. Children treated with levetiracetam were, on average, 2 months older at seizure onset than were those in the phenobarbital group (5.2 months vs. 3.0 months; P less than .001). Infants treated with levetiracetam also tended to begin treatment further from the time of their first seizure and exhibited less developmental delay at the time of epilepsy diagnosis. There were some other differences of possible clinical importance (developmental structural brain abnormalities, head circumference) that did not reach statistical significance.
Freedom from monotherapy failure was greater in the levetiracetam group (47 [40.2%] vs. 6 [15.8%]; P = .01; odds ratio, 3.6; 95% confidence interval, 1.5-10). Overall, the researchers concluded that levetiracetam was superior to phenobarbital for nonsyndromic epilepsy in pediatric patients (OR, 4.2; 95% CI, 1.1-16; number needed to treat, 3.5 [95% CI, 1.7-60]).
Outcome information was missing for more infants treated with levetiracetam than for those treated with phenobarbital, which could have skewed the analyses, Dr. Grinspan and his associates said. The nature of nonsyndromic epilepsy also makes it difficult to study because of the intricate genetic interactions that can influence the disorder.
Although this study provides information that could potentially benefit infantile epilepsy patients, the investigators said that more work must be done on the topic.
“A prospective clinical trial is needed. Levetiracetam and phenobarbital are both commonly used for infantile-onset epilepsy, indicating community equipoise regarding their relative effectiveness,” they wrote. “However, the effect size in our analysis was surprisingly large (number needed to treat, 3.5), suggesting that a change in practice could meaningfully improve outcomes.”
The investigators reported receiving grants and fees and consulting with a range of institutions, and the complete list can be found on the JAMA Pediatrics website. This study was funded by the Pediatric Epilepsy Research Foundation.
SOURCE: Grinspan Z et al. JAMA Pediatr. 2018 Feb 12. doi: 10.1001/jamapediatrics.2017.5211.
FROM JAMA PEDIATRICS
Key clinical point: Levetiracetam gave infants with nonsyndromic epilepsy greater freedom from seizure.
Major finding: Freedom from monotherapy failure was greater with levetiracetam than with phenobarbital (40.2% vs. 15.8%).
Study details: A multicenter, prospective, observational study of 155 children with nonsyndromic epilepsy.
Disclosures: The investigators reported receiving grants and fees and consulting with a range of institutions, and the complete list can be found on the JAMA Pediatrics website. This study was funded by the Pediatric Epilepsy Research Foundation.
Source: Grinspan Z et al. JAMA Pediatr. 2018 Feb 12. doi: 10.1001/jamapediatrics.2017.5211.
FDA approves new combination drug for HIV patients
The Food and Drug Administration has approved a combination drug intended to treat HIV-1 infections – bictegravir, emtricitabine, tenofovir alafenamide – in virologically suppressed (HIV-1 RNA less than 50 copies/mL) adults who have no history of antiretroviral treatment or as a replacement for their current antiretroviral regimen.
The approval of the new combination drug (Biktarvy) was based on four active, randomized, controlled trials comprising three double-blind studies and one open label study. After 48 weeks of treatment in all trials, CD4+ cell count was evaluated to determine the efficacy of bictegravir, emtricitabine, tenofovir alafenamide, compared with other antiretroviral therapies.
In trial 1489, patients were randomized 1:1 to receive Biktarvy (n = 314) or ABC/DTG/3TC (abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg) (n = 315). Trial 1490 was similar to trial 1489, with patients randomized 1:1 to receive either Biktarvy (n = 320) or DTG + FTC/TAF (dolutegravir + 50 mg, emtricitabine 200 mg/tenofovir alafenamide fumarate 25 mg) (n = 325). In trial 1489, the mean increase in CD4+ count after 48 weeks was 233 cells per mm3 and 229/mm3 in the Biktarvy and ABC/DTG/3TC groups, respectively. Similarly, counts in trial 1490 CD4+ after 48 weeks were 180/mm3 and 201/mm3 in the Biktarvy and DTG + FTC/TAF groups, respectively.
Trial 1844, another randomized trial, was composed of patients who switched to Biktarvy from their older treatment. Patients were randomized 1:1 to the new treatment (n = 282) or their previous antiretroviral regimen (n = 281).
Over 48 weeks, the mean change in CD4+ cell count was –31 cells per mm3 in subjects who switched to Biktarvy and 4/mm3 in subjects who stayed on ABC/DTG/3TC.
The open-label portion of the study, trial 1878, evaluated the safety and efficacy of switching from other retroviral treatments (n = 287) to Biktarvy (n = 290). The average change in CD4+ count after 48 weeks was 25 cells per mm3 who switched to Biktarvy and 0/mm3 who stayed on their previous regimens.
The new combination has received a boxed warning regarding the risk of severe acute exacerbations of hepatitis B that have been reported in patients coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of Biktarvy. Such patients should be closely monitored for hepatic function with both clinical and laboratory follow-up for at least several months in patients if they discontinue Biktarvy. If appropriate, antihepatitis B therapy may be warranted.
The approved recommended dosage for bictegravir, emtricitabine, tenofovir alafenamide combination drug is one tablet daily with or without food. More information is available on the FDA website.
The Food and Drug Administration has approved a combination drug intended to treat HIV-1 infections – bictegravir, emtricitabine, tenofovir alafenamide – in virologically suppressed (HIV-1 RNA less than 50 copies/mL) adults who have no history of antiretroviral treatment or as a replacement for their current antiretroviral regimen.
The approval of the new combination drug (Biktarvy) was based on four active, randomized, controlled trials comprising three double-blind studies and one open label study. After 48 weeks of treatment in all trials, CD4+ cell count was evaluated to determine the efficacy of bictegravir, emtricitabine, tenofovir alafenamide, compared with other antiretroviral therapies.
In trial 1489, patients were randomized 1:1 to receive Biktarvy (n = 314) or ABC/DTG/3TC (abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg) (n = 315). Trial 1490 was similar to trial 1489, with patients randomized 1:1 to receive either Biktarvy (n = 320) or DTG + FTC/TAF (dolutegravir + 50 mg, emtricitabine 200 mg/tenofovir alafenamide fumarate 25 mg) (n = 325). In trial 1489, the mean increase in CD4+ count after 48 weeks was 233 cells per mm3 and 229/mm3 in the Biktarvy and ABC/DTG/3TC groups, respectively. Similarly, counts in trial 1490 CD4+ after 48 weeks were 180/mm3 and 201/mm3 in the Biktarvy and DTG + FTC/TAF groups, respectively.
Trial 1844, another randomized trial, was composed of patients who switched to Biktarvy from their older treatment. Patients were randomized 1:1 to the new treatment (n = 282) or their previous antiretroviral regimen (n = 281).
Over 48 weeks, the mean change in CD4+ cell count was –31 cells per mm3 in subjects who switched to Biktarvy and 4/mm3 in subjects who stayed on ABC/DTG/3TC.
The open-label portion of the study, trial 1878, evaluated the safety and efficacy of switching from other retroviral treatments (n = 287) to Biktarvy (n = 290). The average change in CD4+ count after 48 weeks was 25 cells per mm3 who switched to Biktarvy and 0/mm3 who stayed on their previous regimens.
The new combination has received a boxed warning regarding the risk of severe acute exacerbations of hepatitis B that have been reported in patients coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of Biktarvy. Such patients should be closely monitored for hepatic function with both clinical and laboratory follow-up for at least several months in patients if they discontinue Biktarvy. If appropriate, antihepatitis B therapy may be warranted.
The approved recommended dosage for bictegravir, emtricitabine, tenofovir alafenamide combination drug is one tablet daily with or without food. More information is available on the FDA website.
The Food and Drug Administration has approved a combination drug intended to treat HIV-1 infections – bictegravir, emtricitabine, tenofovir alafenamide – in virologically suppressed (HIV-1 RNA less than 50 copies/mL) adults who have no history of antiretroviral treatment or as a replacement for their current antiretroviral regimen.
The approval of the new combination drug (Biktarvy) was based on four active, randomized, controlled trials comprising three double-blind studies and one open label study. After 48 weeks of treatment in all trials, CD4+ cell count was evaluated to determine the efficacy of bictegravir, emtricitabine, tenofovir alafenamide, compared with other antiretroviral therapies.
In trial 1489, patients were randomized 1:1 to receive Biktarvy (n = 314) or ABC/DTG/3TC (abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg) (n = 315). Trial 1490 was similar to trial 1489, with patients randomized 1:1 to receive either Biktarvy (n = 320) or DTG + FTC/TAF (dolutegravir + 50 mg, emtricitabine 200 mg/tenofovir alafenamide fumarate 25 mg) (n = 325). In trial 1489, the mean increase in CD4+ count after 48 weeks was 233 cells per mm3 and 229/mm3 in the Biktarvy and ABC/DTG/3TC groups, respectively. Similarly, counts in trial 1490 CD4+ after 48 weeks were 180/mm3 and 201/mm3 in the Biktarvy and DTG + FTC/TAF groups, respectively.
Trial 1844, another randomized trial, was composed of patients who switched to Biktarvy from their older treatment. Patients were randomized 1:1 to the new treatment (n = 282) or their previous antiretroviral regimen (n = 281).
Over 48 weeks, the mean change in CD4+ cell count was –31 cells per mm3 in subjects who switched to Biktarvy and 4/mm3 in subjects who stayed on ABC/DTG/3TC.
The open-label portion of the study, trial 1878, evaluated the safety and efficacy of switching from other retroviral treatments (n = 287) to Biktarvy (n = 290). The average change in CD4+ count after 48 weeks was 25 cells per mm3 who switched to Biktarvy and 0/mm3 who stayed on their previous regimens.
The new combination has received a boxed warning regarding the risk of severe acute exacerbations of hepatitis B that have been reported in patients coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of Biktarvy. Such patients should be closely monitored for hepatic function with both clinical and laboratory follow-up for at least several months in patients if they discontinue Biktarvy. If appropriate, antihepatitis B therapy may be warranted.
The approved recommended dosage for bictegravir, emtricitabine, tenofovir alafenamide combination drug is one tablet daily with or without food. More information is available on the FDA website.
Many prescriptions for older epilepsy patients have potential to interact
A substantial portion of older adults with epilepsy who are on Medicare receive prescriptions for antiepileptic drugs (AEDs) and nonepilepsy drugs (NEDs) that can interact to alter their effectiveness or induce toxicity, according to a retrospective analysis of a claims database.
Up to a quarter of all patients had potential interactions between AED and non-AED prescriptions, and these were more likely to occur for patients with comorbid conditions or those who were eligible for Part D Low Income Subsidy, reported Raymond Edward Faught Jr., MD, a professor in the department of neurology at Emory University, Atlanta, and his colleagues. The study was published in Epilepsia.
Dr. Faught and his coauthors analyzed a 5% random sample of beneficiaries from 2008-2010 Medicare claims who were 67 years or older in 2009 and identified 36,912 prevalent and 3,706 incident epilepsy cases from 2009, both of which were demographically similar. Prevalent cases were defined by the prevalence of epilepsy and seizures with medication, and incident cases had no history of epilepsy or seizure. The research team also compiled a list of interaction risk of AEDs and NED efficacy and rated high risk as potentially life threatening, medium risk as significant, and probable but unspecified risk.
For incident cases, the percentage with concern for drug interaction included 6.9% at high risk, 10.3% at medium risk, and 18.5% with probable but unspecified risk. As a whole, 75.5% had no interaction risk and 24.5% had some risk for interaction. In 18% of incident cases, drug interactions increased the effect of AEDs, while 2.4% decreased AED effect. There were several, specific NEDs that had a documented or probable interaction risk with AEDs. For those on simvastatin, 30.9% were concomitantly prescribed phenytoin, corresponding to 7.6% of all incident cases having a probable but unspecified risk with this combination. Warfarin users also received phenytoin one-third of the time, meaning that 3.6% of all incident cases had a high risk of an interaction with the combination.
A more pronounced effect occurred with drug combinations in prevalent cases. A total of 39% took a drug combination that altered the efficacy of NEDs, whereas 26.2% took combinations that increase the effect of AEDs and 3% had interactions that could decrease AED efficacy.
An increasing number of comorbidities raised the likelihood of having any risk for interaction (odds ratio of 2.14 for one to three comorbidities and 2.73 for four or more), compared with no comorbidities. Eligibility for Part D Low Income Subsidy increased the odds for a high-risk interaction (OR, 2.05) or high-medium risk interaction (OR, 1.44).
The authors cautioned that the list of drug interactions and the associated qualitative rankings reflect their judgment and that they evaluated only concomitant use of the 50 most commonly prescribed NEDs in the patient population. Considering that there are thousands of potential drugs that could interact with AEDs, this represents a limited sample.
The National Institute of Neurological Disorders and Stroke funded the study. Several authors reported financial relationships with pharmaceutical companies that market AEDs.
SOURCE: Faught E et al. Epilepsia. 2008 Feb 7. doi: 10.1111/epi.14010.
A substantial portion of older adults with epilepsy who are on Medicare receive prescriptions for antiepileptic drugs (AEDs) and nonepilepsy drugs (NEDs) that can interact to alter their effectiveness or induce toxicity, according to a retrospective analysis of a claims database.
Up to a quarter of all patients had potential interactions between AED and non-AED prescriptions, and these were more likely to occur for patients with comorbid conditions or those who were eligible for Part D Low Income Subsidy, reported Raymond Edward Faught Jr., MD, a professor in the department of neurology at Emory University, Atlanta, and his colleagues. The study was published in Epilepsia.
Dr. Faught and his coauthors analyzed a 5% random sample of beneficiaries from 2008-2010 Medicare claims who were 67 years or older in 2009 and identified 36,912 prevalent and 3,706 incident epilepsy cases from 2009, both of which were demographically similar. Prevalent cases were defined by the prevalence of epilepsy and seizures with medication, and incident cases had no history of epilepsy or seizure. The research team also compiled a list of interaction risk of AEDs and NED efficacy and rated high risk as potentially life threatening, medium risk as significant, and probable but unspecified risk.
For incident cases, the percentage with concern for drug interaction included 6.9% at high risk, 10.3% at medium risk, and 18.5% with probable but unspecified risk. As a whole, 75.5% had no interaction risk and 24.5% had some risk for interaction. In 18% of incident cases, drug interactions increased the effect of AEDs, while 2.4% decreased AED effect. There were several, specific NEDs that had a documented or probable interaction risk with AEDs. For those on simvastatin, 30.9% were concomitantly prescribed phenytoin, corresponding to 7.6% of all incident cases having a probable but unspecified risk with this combination. Warfarin users also received phenytoin one-third of the time, meaning that 3.6% of all incident cases had a high risk of an interaction with the combination.
A more pronounced effect occurred with drug combinations in prevalent cases. A total of 39% took a drug combination that altered the efficacy of NEDs, whereas 26.2% took combinations that increase the effect of AEDs and 3% had interactions that could decrease AED efficacy.
An increasing number of comorbidities raised the likelihood of having any risk for interaction (odds ratio of 2.14 for one to three comorbidities and 2.73 for four or more), compared with no comorbidities. Eligibility for Part D Low Income Subsidy increased the odds for a high-risk interaction (OR, 2.05) or high-medium risk interaction (OR, 1.44).
The authors cautioned that the list of drug interactions and the associated qualitative rankings reflect their judgment and that they evaluated only concomitant use of the 50 most commonly prescribed NEDs in the patient population. Considering that there are thousands of potential drugs that could interact with AEDs, this represents a limited sample.
The National Institute of Neurological Disorders and Stroke funded the study. Several authors reported financial relationships with pharmaceutical companies that market AEDs.
SOURCE: Faught E et al. Epilepsia. 2008 Feb 7. doi: 10.1111/epi.14010.
A substantial portion of older adults with epilepsy who are on Medicare receive prescriptions for antiepileptic drugs (AEDs) and nonepilepsy drugs (NEDs) that can interact to alter their effectiveness or induce toxicity, according to a retrospective analysis of a claims database.
Up to a quarter of all patients had potential interactions between AED and non-AED prescriptions, and these were more likely to occur for patients with comorbid conditions or those who were eligible for Part D Low Income Subsidy, reported Raymond Edward Faught Jr., MD, a professor in the department of neurology at Emory University, Atlanta, and his colleagues. The study was published in Epilepsia.
Dr. Faught and his coauthors analyzed a 5% random sample of beneficiaries from 2008-2010 Medicare claims who were 67 years or older in 2009 and identified 36,912 prevalent and 3,706 incident epilepsy cases from 2009, both of which were demographically similar. Prevalent cases were defined by the prevalence of epilepsy and seizures with medication, and incident cases had no history of epilepsy or seizure. The research team also compiled a list of interaction risk of AEDs and NED efficacy and rated high risk as potentially life threatening, medium risk as significant, and probable but unspecified risk.
For incident cases, the percentage with concern for drug interaction included 6.9% at high risk, 10.3% at medium risk, and 18.5% with probable but unspecified risk. As a whole, 75.5% had no interaction risk and 24.5% had some risk for interaction. In 18% of incident cases, drug interactions increased the effect of AEDs, while 2.4% decreased AED effect. There were several, specific NEDs that had a documented or probable interaction risk with AEDs. For those on simvastatin, 30.9% were concomitantly prescribed phenytoin, corresponding to 7.6% of all incident cases having a probable but unspecified risk with this combination. Warfarin users also received phenytoin one-third of the time, meaning that 3.6% of all incident cases had a high risk of an interaction with the combination.
A more pronounced effect occurred with drug combinations in prevalent cases. A total of 39% took a drug combination that altered the efficacy of NEDs, whereas 26.2% took combinations that increase the effect of AEDs and 3% had interactions that could decrease AED efficacy.
An increasing number of comorbidities raised the likelihood of having any risk for interaction (odds ratio of 2.14 for one to three comorbidities and 2.73 for four or more), compared with no comorbidities. Eligibility for Part D Low Income Subsidy increased the odds for a high-risk interaction (OR, 2.05) or high-medium risk interaction (OR, 1.44).
The authors cautioned that the list of drug interactions and the associated qualitative rankings reflect their judgment and that they evaluated only concomitant use of the 50 most commonly prescribed NEDs in the patient population. Considering that there are thousands of potential drugs that could interact with AEDs, this represents a limited sample.
The National Institute of Neurological Disorders and Stroke funded the study. Several authors reported financial relationships with pharmaceutical companies that market AEDs.
SOURCE: Faught E et al. Epilepsia. 2008 Feb 7. doi: 10.1111/epi.14010.
FROM EPILEPSIA
Key clinical point:
Major finding: In 18% of incident cases, drug interactions increased the effect of AEDs, while 2.4% decreased AED effect.
Study details: Retrospective analyses of 2008-2010 Medicare claims with a 5% random sample of beneficiaries who were 67 years or older in 2009.
Disclosures: The National Institute of Neurological Disorders and Stroke funded the study. Several authors reported financial relationships with pharmaceutical companies that market AEDs.
Source: Faught E et al. Epilepsia. 2008 Feb 7. doi: 10.1111/epi.14010.
Duodenoscope redesign prompts voluntary recall by Pentax
Pentax has issued a voluntary recall for Pentax ED-3490TK duodenoscopes because of infections associated with reprocessed duodenoscopes, and the Food and Drug Administration has cleared the 510(k) to improve the device. The new design will, it is hoped, improve cleaning and disinfection for these devices.
“Reducing infections associated with duodenoscopes remains a top priority for the FDA, and we believe the new design changes to the Pentax duodenoscope will make these devices easier to clean and high-level disinfect to help enhance their safety,” said Suzanne Schwartz, MD, associate director for science and strategic partnerships at the FDA’s Center for Devices and Radiological Health. “We will continue to encourage new innovations for these devices to protect public health while enabling patients to have continued access to minimally invasive, life-saving endoscopy procedures.”
. In one study, even after double high-level disinfection or standard high-level disinfection followed by ethylene oxide gas sterilization, duodenoscopes had similar rates of contamination. These contamination events were associated with outbreaks of carbapenem-resistant Enterobacteriaceae infections. One of the culprits behind residual contamination may be the presence of biofilms, which are notoriously difficult to clean with standard disinfection methods.
Prior to the clearance of the elevator channel sealing mechanism, the first duodenoscope with a disposable distal cap was introduced, the Pentax ED34-i10T. The use of a disposable tip for the duodenoscope is meant to decrease the risk of future infections associated with these devices. The use of a disposable tip also improves cleaning and reprocessing of the duodenoscopes.
The FDA continues to work with manufacturers to improve the safety of duodenscopes and other reusable medical devices to protect patients from bacterial infections.
Pentax has issued a voluntary recall for Pentax ED-3490TK duodenoscopes because of infections associated with reprocessed duodenoscopes, and the Food and Drug Administration has cleared the 510(k) to improve the device. The new design will, it is hoped, improve cleaning and disinfection for these devices.
“Reducing infections associated with duodenoscopes remains a top priority for the FDA, and we believe the new design changes to the Pentax duodenoscope will make these devices easier to clean and high-level disinfect to help enhance their safety,” said Suzanne Schwartz, MD, associate director for science and strategic partnerships at the FDA’s Center for Devices and Radiological Health. “We will continue to encourage new innovations for these devices to protect public health while enabling patients to have continued access to minimally invasive, life-saving endoscopy procedures.”
. In one study, even after double high-level disinfection or standard high-level disinfection followed by ethylene oxide gas sterilization, duodenoscopes had similar rates of contamination. These contamination events were associated with outbreaks of carbapenem-resistant Enterobacteriaceae infections. One of the culprits behind residual contamination may be the presence of biofilms, which are notoriously difficult to clean with standard disinfection methods.
Prior to the clearance of the elevator channel sealing mechanism, the first duodenoscope with a disposable distal cap was introduced, the Pentax ED34-i10T. The use of a disposable tip for the duodenoscope is meant to decrease the risk of future infections associated with these devices. The use of a disposable tip also improves cleaning and reprocessing of the duodenoscopes.
The FDA continues to work with manufacturers to improve the safety of duodenscopes and other reusable medical devices to protect patients from bacterial infections.
Pentax has issued a voluntary recall for Pentax ED-3490TK duodenoscopes because of infections associated with reprocessed duodenoscopes, and the Food and Drug Administration has cleared the 510(k) to improve the device. The new design will, it is hoped, improve cleaning and disinfection for these devices.
“Reducing infections associated with duodenoscopes remains a top priority for the FDA, and we believe the new design changes to the Pentax duodenoscope will make these devices easier to clean and high-level disinfect to help enhance their safety,” said Suzanne Schwartz, MD, associate director for science and strategic partnerships at the FDA’s Center for Devices and Radiological Health. “We will continue to encourage new innovations for these devices to protect public health while enabling patients to have continued access to minimally invasive, life-saving endoscopy procedures.”
. In one study, even after double high-level disinfection or standard high-level disinfection followed by ethylene oxide gas sterilization, duodenoscopes had similar rates of contamination. These contamination events were associated with outbreaks of carbapenem-resistant Enterobacteriaceae infections. One of the culprits behind residual contamination may be the presence of biofilms, which are notoriously difficult to clean with standard disinfection methods.
Prior to the clearance of the elevator channel sealing mechanism, the first duodenoscope with a disposable distal cap was introduced, the Pentax ED34-i10T. The use of a disposable tip for the duodenoscope is meant to decrease the risk of future infections associated with these devices. The use of a disposable tip also improves cleaning and reprocessing of the duodenoscopes.
The FDA continues to work with manufacturers to improve the safety of duodenscopes and other reusable medical devices to protect patients from bacterial infections.
Obesity affects diagnosis of liver fibrosis with imaging techniques
, according to a study from the University of California, San Diego.
“This study demonstrates that BMI is a significant factor of discordancy between MRE and TE for the stage of significant fibrosis (2-4 vs. 0-1),” wrote Cyrielle Caussy, MD, and her colleagues (Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037). “Furthermore, this study showed that the grade of obesity is also a significant predictor of discordancy between MRE and TE because the discordance rate between MRE and TE increases with the increase in BMI.”
Dr. Caussy of the University of California, San Diego, and her colleagues had noted that MRE and TE had discordant findings in obese patients. To ascertain under what conditions TE and MRE produce the same readings, Dr. Caussy and her associates conducted a cross-sectional study of two cohorts with nonalcoholic fatty liver disease (NAFLD) who underwent contemporaneous MRE, TE, and liver biopsy. TE utilized both M and XL probes during imaging. The training cohort involved 119 adult patients undergoing NAFLD testing from October 2011 through January 2017. The validation cohort, consisting of 75 adults with NAFLD undergoing liver imaging from March 2010 through May 2013, was formed to validate the findings of the training cohort.
The study revealed that BMI was a significant predictor of the difference between MRE and TE results and made it difficult to assess the stage of liver fibrosis (2-4 vs. 0-1). After adjustment for age and sex, BMI accounted for a 5-unit increase of 1.694 (95% confidence interval, 1.145-2.507; P = .008). This was not a static relationship, and as BMI increased, so did the discordance between MRE and TE (P = .0309). Interestingly, the discordance rate was significantly higher in participants with BMIs greater than 35 kg/m2, compared with participants with BMIs below 35 (63.0% vs. 38.0%; P = .022), the investigators reported. In severely obese adults with liver disease caused mainly by NAFLD, the accuracy of MRE was higher than TE for diagnosing significant fibrosis and advanced fibrosis.
While the study revealed valuable information, it had both strengths and limitations. A strength of the study was the use of two cohorts, specifically the validation cohort. The use of the liver biopsy as a reference, which is the standard for assessing fibrosis, was also a strength of the study. A limitation was that the study was conducted at specialized, tertiary care centers using advanced imaging techniques that may not be available at other clinics. Additionally, the cohorts included a small number of patients with advanced fibrosis.
“The integration of the BMI in the screening strategy for the noninvasive detection of liver fibrosis in NAFLD should be considered, and this parameter would help to determine when MRE is not needed in future guidelines” wrote Dr. Caussy and her associates. “Further cost-effectiveness studies are necessary to evaluate the clinical utility of MRE, TE, and/or liver biopsy to develop optimal screening strategies for diagnosing NAFLD-associated fibrosis.”
Jun Chen, MD, Meng Yin, MD, and Richard L. Ehman, MD, all have intellectual property rights and financial interests in elastography technology. Dr. Ehman also serves as an noncompensated CEO of Resoundant. Claude B. Sirlin, MD, has served as a consultant to Bayer and GE Healthcare. All other authors did not disclose any conflicts.
SOURCE: Caussy C et al. Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037.
, according to a study from the University of California, San Diego.
“This study demonstrates that BMI is a significant factor of discordancy between MRE and TE for the stage of significant fibrosis (2-4 vs. 0-1),” wrote Cyrielle Caussy, MD, and her colleagues (Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037). “Furthermore, this study showed that the grade of obesity is also a significant predictor of discordancy between MRE and TE because the discordance rate between MRE and TE increases with the increase in BMI.”
Dr. Caussy of the University of California, San Diego, and her colleagues had noted that MRE and TE had discordant findings in obese patients. To ascertain under what conditions TE and MRE produce the same readings, Dr. Caussy and her associates conducted a cross-sectional study of two cohorts with nonalcoholic fatty liver disease (NAFLD) who underwent contemporaneous MRE, TE, and liver biopsy. TE utilized both M and XL probes during imaging. The training cohort involved 119 adult patients undergoing NAFLD testing from October 2011 through January 2017. The validation cohort, consisting of 75 adults with NAFLD undergoing liver imaging from March 2010 through May 2013, was formed to validate the findings of the training cohort.
The study revealed that BMI was a significant predictor of the difference between MRE and TE results and made it difficult to assess the stage of liver fibrosis (2-4 vs. 0-1). After adjustment for age and sex, BMI accounted for a 5-unit increase of 1.694 (95% confidence interval, 1.145-2.507; P = .008). This was not a static relationship, and as BMI increased, so did the discordance between MRE and TE (P = .0309). Interestingly, the discordance rate was significantly higher in participants with BMIs greater than 35 kg/m2, compared with participants with BMIs below 35 (63.0% vs. 38.0%; P = .022), the investigators reported. In severely obese adults with liver disease caused mainly by NAFLD, the accuracy of MRE was higher than TE for diagnosing significant fibrosis and advanced fibrosis.
While the study revealed valuable information, it had both strengths and limitations. A strength of the study was the use of two cohorts, specifically the validation cohort. The use of the liver biopsy as a reference, which is the standard for assessing fibrosis, was also a strength of the study. A limitation was that the study was conducted at specialized, tertiary care centers using advanced imaging techniques that may not be available at other clinics. Additionally, the cohorts included a small number of patients with advanced fibrosis.
“The integration of the BMI in the screening strategy for the noninvasive detection of liver fibrosis in NAFLD should be considered, and this parameter would help to determine when MRE is not needed in future guidelines” wrote Dr. Caussy and her associates. “Further cost-effectiveness studies are necessary to evaluate the clinical utility of MRE, TE, and/or liver biopsy to develop optimal screening strategies for diagnosing NAFLD-associated fibrosis.”
Jun Chen, MD, Meng Yin, MD, and Richard L. Ehman, MD, all have intellectual property rights and financial interests in elastography technology. Dr. Ehman also serves as an noncompensated CEO of Resoundant. Claude B. Sirlin, MD, has served as a consultant to Bayer and GE Healthcare. All other authors did not disclose any conflicts.
SOURCE: Caussy C et al. Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037.
, according to a study from the University of California, San Diego.
“This study demonstrates that BMI is a significant factor of discordancy between MRE and TE for the stage of significant fibrosis (2-4 vs. 0-1),” wrote Cyrielle Caussy, MD, and her colleagues (Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037). “Furthermore, this study showed that the grade of obesity is also a significant predictor of discordancy between MRE and TE because the discordance rate between MRE and TE increases with the increase in BMI.”
Dr. Caussy of the University of California, San Diego, and her colleagues had noted that MRE and TE had discordant findings in obese patients. To ascertain under what conditions TE and MRE produce the same readings, Dr. Caussy and her associates conducted a cross-sectional study of two cohorts with nonalcoholic fatty liver disease (NAFLD) who underwent contemporaneous MRE, TE, and liver biopsy. TE utilized both M and XL probes during imaging. The training cohort involved 119 adult patients undergoing NAFLD testing from October 2011 through January 2017. The validation cohort, consisting of 75 adults with NAFLD undergoing liver imaging from March 2010 through May 2013, was formed to validate the findings of the training cohort.
The study revealed that BMI was a significant predictor of the difference between MRE and TE results and made it difficult to assess the stage of liver fibrosis (2-4 vs. 0-1). After adjustment for age and sex, BMI accounted for a 5-unit increase of 1.694 (95% confidence interval, 1.145-2.507; P = .008). This was not a static relationship, and as BMI increased, so did the discordance between MRE and TE (P = .0309). Interestingly, the discordance rate was significantly higher in participants with BMIs greater than 35 kg/m2, compared with participants with BMIs below 35 (63.0% vs. 38.0%; P = .022), the investigators reported. In severely obese adults with liver disease caused mainly by NAFLD, the accuracy of MRE was higher than TE for diagnosing significant fibrosis and advanced fibrosis.
While the study revealed valuable information, it had both strengths and limitations. A strength of the study was the use of two cohorts, specifically the validation cohort. The use of the liver biopsy as a reference, which is the standard for assessing fibrosis, was also a strength of the study. A limitation was that the study was conducted at specialized, tertiary care centers using advanced imaging techniques that may not be available at other clinics. Additionally, the cohorts included a small number of patients with advanced fibrosis.
“The integration of the BMI in the screening strategy for the noninvasive detection of liver fibrosis in NAFLD should be considered, and this parameter would help to determine when MRE is not needed in future guidelines” wrote Dr. Caussy and her associates. “Further cost-effectiveness studies are necessary to evaluate the clinical utility of MRE, TE, and/or liver biopsy to develop optimal screening strategies for diagnosing NAFLD-associated fibrosis.”
Jun Chen, MD, Meng Yin, MD, and Richard L. Ehman, MD, all have intellectual property rights and financial interests in elastography technology. Dr. Ehman also serves as an noncompensated CEO of Resoundant. Claude B. Sirlin, MD, has served as a consultant to Bayer and GE Healthcare. All other authors did not disclose any conflicts.
SOURCE: Caussy C et al. Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Higher BMIs make it difficult to diagnose liver fibrosis with imaging techniques.
Major finding: The discordance rate between magnetic resonance elastography and transient elastrography was 43.7% in this study.
Study details: A cross-sectional study of two cohorts with nonalcoholic fatty liver disease patients who underwent contemporaneous MRE, TE, and liver biopsy; one with 119 adults, the other with 75.
Disclosures: Jun Chen, MD, Meng Yin, MD, and Richard L. Ehman, MD, all have intellectual property rights and financial interests in elastography technology. Dr. Ehman also serves as an noncompensated CEO of Resoundant. Claude B. Sirlin, MD, has served as a consultant to Bayer and GE Healthcare. All other authors did not disclose any conflicts.
Source: Caussy C et al. Clin Gastrolenterol Hepatol. 2018 Jan 15. doi: 10.1016/j.cgh.2017.10.037.
PCOS may influence the diversity of the gut microbiome
according to a study from the Journal of Clinical Endocrinology and Metabolism.
“This study demonstrated that Caucasian women diagnosed with PCOS using the Rotterdam criteria had a reduction in overall species richness [alpha diversity] of the gut microbiome, compared to healthy women, and changes in the composition of the microbial community [beta diversity]” wrote Pedro J. Torres and his associates. “Interestingly, our study found that the biodiversity of the microbiome strongly correlated with hyperandrogenism.”
Dr. Torres of the University of California, San Diego, and his colleagues recruited 163 women at the University of Poznan (Poland) and conducted analysis on fecal samples to determine the effects of PCOS on the gut microbiome. Each woman underwent a battery of tests to determine whether she had PCOS or polycystic ovarian morphology (PCOM). Ovarian morphology was determined from a transvaginal ultrasound evaluation. The women were assessed for body mass index and hirsutism. Blood samples were taken to test for hormonal abnormalities common with PCOS and metabolic issues, like type 2 diabetes mellitus and glucose tolerance. Fecal samples were taken to analyze the gut microbiota of each study participant; analysis of the fecal samples generated gut microbial diversity profiles for each of the 163 women. Analysis of the samples was conducted at the University of California, San Diego.
Of the subjects, 48 were healthy, 42 had PCOM, and 73 were diagnosed with PCOS. The researches noted that, compared with healthy women and those with PCOM, women with PCOS had higher levels of serum total and free testosterone, as well as higher rates of hirsutism and fewer menses per year. These women also had higher levels of serum luteinizing hormone and increased ratios of luteinizing hormone to follicle stimulating hormone.
The DNA analysis of fecal samples yielded 481 sequence variants from the fecal swabs. Women with PCOS were found to have lower alpha diversity in their gut microbiome, as evidenced by abundance (P = .04) and Faith’s phylogenetic diveristy (P = .02). The luteinizing hormone to follicle stimulating hormone ratio also appeared to affect the alpha diversity of women with PCOS, as seen in observed sequence variants and Faith’s phylogenetic diversity (P = .08).
Beta diversity analysis, or the biodiversity between samples, revealed that hyperandrogenism could be a primary driver of changes in the gut microbiome. Using permutational multivariate analysis of variance, researchers determined that hyperandrogenism significantly affected beta diversity (P = .0009).
Androgens may help affect the gut microbiome in important ways, and changes in the gut microbiome may influence how the pathology of PCOS develops, according to Mr. Torres and his colleagues; however, more studies should be conducted to determine the effects of androgens on the gut microbiome.
“If hyperandrogenism drives the microbial composition of the gut, it would be interesting to determine if treatment of PCOS with androgen antagonists or oral contraceptives results in recovery of the gut microbiome and improvement of the PCOS metabolic phenotype” wrote Mr. Torres and his colleagues. “Moreover, it would be informative to determine whether the gut microbiome of women diagnosed with PCOS using the criteria of oligomenorrhea and polycystic ovaries is distinct from that of women diagnosed with the other subtypes of PCOS that include hyperandrogenism.”
The authors had no relevant financial disclosures to report.
SOURCE: Torres PJ et al. J Clin Endocrinol Metab. 2018 Jan 23. doi: 10.1210/jc.2017-02153.
Polycystic ovarian syndrome (PCOS) can manifest itself in many ways, but this study reveals that it can directly affect the metabolism of those who have the disorder.
“We’re still early days in studying this, but this study suggests that one of the clinical characteristics of these women with this disorder – their elevated testosterone – is correlated with changes in the gut microbiome,” Varykina G. Thackray, PhD, of the department of reproductive medicine and the center for reproductive science and medicine at the University of California, San Diego, said in an interview. “That means that these women are in a different group than other people with metabolic disorders, and it potentially gives us a way to think of new therapies that might be helpful for this specific group of women.”
When asked whether fecal transplants may be a potential therapy to help treat the metabolic issues associated with PCOS, Dr. Thackray stated that she did not believe a lot of women would use that as a therapy because of the “ick” factor. She stated the goal is to identify some beneficial bacteria that could be taken as a probiotic to help restore the gut microbiome.
Unfortunately, researchers still do not understand what causes PCOS. Some studies suggest that there are environmental and genetic factors, but there is nothing definitive. Dr. Thackray stated that getting more funding and conducting more research are the best ways to understand and combat this disorder.
Dr. Thackray is an associate professor of reproductive medicine at the University of California, San Diego.
Polycystic ovarian syndrome (PCOS) can manifest itself in many ways, but this study reveals that it can directly affect the metabolism of those who have the disorder.
“We’re still early days in studying this, but this study suggests that one of the clinical characteristics of these women with this disorder – their elevated testosterone – is correlated with changes in the gut microbiome,” Varykina G. Thackray, PhD, of the department of reproductive medicine and the center for reproductive science and medicine at the University of California, San Diego, said in an interview. “That means that these women are in a different group than other people with metabolic disorders, and it potentially gives us a way to think of new therapies that might be helpful for this specific group of women.”
When asked whether fecal transplants may be a potential therapy to help treat the metabolic issues associated with PCOS, Dr. Thackray stated that she did not believe a lot of women would use that as a therapy because of the “ick” factor. She stated the goal is to identify some beneficial bacteria that could be taken as a probiotic to help restore the gut microbiome.
Unfortunately, researchers still do not understand what causes PCOS. Some studies suggest that there are environmental and genetic factors, but there is nothing definitive. Dr. Thackray stated that getting more funding and conducting more research are the best ways to understand and combat this disorder.
Dr. Thackray is an associate professor of reproductive medicine at the University of California, San Diego.
Polycystic ovarian syndrome (PCOS) can manifest itself in many ways, but this study reveals that it can directly affect the metabolism of those who have the disorder.
“We’re still early days in studying this, but this study suggests that one of the clinical characteristics of these women with this disorder – their elevated testosterone – is correlated with changes in the gut microbiome,” Varykina G. Thackray, PhD, of the department of reproductive medicine and the center for reproductive science and medicine at the University of California, San Diego, said in an interview. “That means that these women are in a different group than other people with metabolic disorders, and it potentially gives us a way to think of new therapies that might be helpful for this specific group of women.”
When asked whether fecal transplants may be a potential therapy to help treat the metabolic issues associated with PCOS, Dr. Thackray stated that she did not believe a lot of women would use that as a therapy because of the “ick” factor. She stated the goal is to identify some beneficial bacteria that could be taken as a probiotic to help restore the gut microbiome.
Unfortunately, researchers still do not understand what causes PCOS. Some studies suggest that there are environmental and genetic factors, but there is nothing definitive. Dr. Thackray stated that getting more funding and conducting more research are the best ways to understand and combat this disorder.
Dr. Thackray is an associate professor of reproductive medicine at the University of California, San Diego.
according to a study from the Journal of Clinical Endocrinology and Metabolism.
“This study demonstrated that Caucasian women diagnosed with PCOS using the Rotterdam criteria had a reduction in overall species richness [alpha diversity] of the gut microbiome, compared to healthy women, and changes in the composition of the microbial community [beta diversity]” wrote Pedro J. Torres and his associates. “Interestingly, our study found that the biodiversity of the microbiome strongly correlated with hyperandrogenism.”
Dr. Torres of the University of California, San Diego, and his colleagues recruited 163 women at the University of Poznan (Poland) and conducted analysis on fecal samples to determine the effects of PCOS on the gut microbiome. Each woman underwent a battery of tests to determine whether she had PCOS or polycystic ovarian morphology (PCOM). Ovarian morphology was determined from a transvaginal ultrasound evaluation. The women were assessed for body mass index and hirsutism. Blood samples were taken to test for hormonal abnormalities common with PCOS and metabolic issues, like type 2 diabetes mellitus and glucose tolerance. Fecal samples were taken to analyze the gut microbiota of each study participant; analysis of the fecal samples generated gut microbial diversity profiles for each of the 163 women. Analysis of the samples was conducted at the University of California, San Diego.
Of the subjects, 48 were healthy, 42 had PCOM, and 73 were diagnosed with PCOS. The researches noted that, compared with healthy women and those with PCOM, women with PCOS had higher levels of serum total and free testosterone, as well as higher rates of hirsutism and fewer menses per year. These women also had higher levels of serum luteinizing hormone and increased ratios of luteinizing hormone to follicle stimulating hormone.
The DNA analysis of fecal samples yielded 481 sequence variants from the fecal swabs. Women with PCOS were found to have lower alpha diversity in their gut microbiome, as evidenced by abundance (P = .04) and Faith’s phylogenetic diveristy (P = .02). The luteinizing hormone to follicle stimulating hormone ratio also appeared to affect the alpha diversity of women with PCOS, as seen in observed sequence variants and Faith’s phylogenetic diversity (P = .08).
Beta diversity analysis, or the biodiversity between samples, revealed that hyperandrogenism could be a primary driver of changes in the gut microbiome. Using permutational multivariate analysis of variance, researchers determined that hyperandrogenism significantly affected beta diversity (P = .0009).
Androgens may help affect the gut microbiome in important ways, and changes in the gut microbiome may influence how the pathology of PCOS develops, according to Mr. Torres and his colleagues; however, more studies should be conducted to determine the effects of androgens on the gut microbiome.
“If hyperandrogenism drives the microbial composition of the gut, it would be interesting to determine if treatment of PCOS with androgen antagonists or oral contraceptives results in recovery of the gut microbiome and improvement of the PCOS metabolic phenotype” wrote Mr. Torres and his colleagues. “Moreover, it would be informative to determine whether the gut microbiome of women diagnosed with PCOS using the criteria of oligomenorrhea and polycystic ovaries is distinct from that of women diagnosed with the other subtypes of PCOS that include hyperandrogenism.”
The authors had no relevant financial disclosures to report.
SOURCE: Torres PJ et al. J Clin Endocrinol Metab. 2018 Jan 23. doi: 10.1210/jc.2017-02153.
according to a study from the Journal of Clinical Endocrinology and Metabolism.
“This study demonstrated that Caucasian women diagnosed with PCOS using the Rotterdam criteria had a reduction in overall species richness [alpha diversity] of the gut microbiome, compared to healthy women, and changes in the composition of the microbial community [beta diversity]” wrote Pedro J. Torres and his associates. “Interestingly, our study found that the biodiversity of the microbiome strongly correlated with hyperandrogenism.”
Dr. Torres of the University of California, San Diego, and his colleagues recruited 163 women at the University of Poznan (Poland) and conducted analysis on fecal samples to determine the effects of PCOS on the gut microbiome. Each woman underwent a battery of tests to determine whether she had PCOS or polycystic ovarian morphology (PCOM). Ovarian morphology was determined from a transvaginal ultrasound evaluation. The women were assessed for body mass index and hirsutism. Blood samples were taken to test for hormonal abnormalities common with PCOS and metabolic issues, like type 2 diabetes mellitus and glucose tolerance. Fecal samples were taken to analyze the gut microbiota of each study participant; analysis of the fecal samples generated gut microbial diversity profiles for each of the 163 women. Analysis of the samples was conducted at the University of California, San Diego.
Of the subjects, 48 were healthy, 42 had PCOM, and 73 were diagnosed with PCOS. The researches noted that, compared with healthy women and those with PCOM, women with PCOS had higher levels of serum total and free testosterone, as well as higher rates of hirsutism and fewer menses per year. These women also had higher levels of serum luteinizing hormone and increased ratios of luteinizing hormone to follicle stimulating hormone.
The DNA analysis of fecal samples yielded 481 sequence variants from the fecal swabs. Women with PCOS were found to have lower alpha diversity in their gut microbiome, as evidenced by abundance (P = .04) and Faith’s phylogenetic diveristy (P = .02). The luteinizing hormone to follicle stimulating hormone ratio also appeared to affect the alpha diversity of women with PCOS, as seen in observed sequence variants and Faith’s phylogenetic diversity (P = .08).
Beta diversity analysis, or the biodiversity between samples, revealed that hyperandrogenism could be a primary driver of changes in the gut microbiome. Using permutational multivariate analysis of variance, researchers determined that hyperandrogenism significantly affected beta diversity (P = .0009).
Androgens may help affect the gut microbiome in important ways, and changes in the gut microbiome may influence how the pathology of PCOS develops, according to Mr. Torres and his colleagues; however, more studies should be conducted to determine the effects of androgens on the gut microbiome.
“If hyperandrogenism drives the microbial composition of the gut, it would be interesting to determine if treatment of PCOS with androgen antagonists or oral contraceptives results in recovery of the gut microbiome and improvement of the PCOS metabolic phenotype” wrote Mr. Torres and his colleagues. “Moreover, it would be informative to determine whether the gut microbiome of women diagnosed with PCOS using the criteria of oligomenorrhea and polycystic ovaries is distinct from that of women diagnosed with the other subtypes of PCOS that include hyperandrogenism.”
The authors had no relevant financial disclosures to report.
SOURCE: Torres PJ et al. J Clin Endocrinol Metab. 2018 Jan 23. doi: 10.1210/jc.2017-02153.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
Key clinical point: Hyperandrogenism may have an effect on the gut microbiome of women with PCOS.
Major finding: Lower bacterial diversity was observed in women with PCOS, compared with healthy women
Study details: Researchers recruited 163 women diagnosed with PCOS. Blood and fecal samples were collected, and ovaries were imaged using ultrasound.
Disclosures: The authors had no relevant financial disclosures to report.
Source: Torres PJ et al. J Clin Endocrinol Metab. 2018 Jan 23. doi: 10.1210/jc.2017-02153.
FDA approves irritable bowel syndrome treatment
(IBS-C).
Plecanatide had previously been approved to treat adults with chronic idiopathic constipation (CIC).
Plecanatide was approved on the findings of two randomized, double-blind, 12-week, placebo-controlled clinical trials. More than 2,100 adult patients across both trials received either a 3-mg or 6-mg once-daily tablet of plecanatide, or a placebo. The primary endpoints of both studies were greater than 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) for at least half of the 12 treatment weeks.
Plecanatide met both of its primary endpoints, with reductions in abdominal pain in both studies, compared with placebo (30.2% vs. 17.8% in study 1, P < .001; 21.5% vs. 14.2% in study 2, P = .009).
Plecanatide is the only prescription, once-daily medication that treats both CIC and IBS-C in adults. The drug should be available in the first quarter of 2018.
AGA offers free patient education materials to help your patients better understand how to live with and manage their IBS. Visit www.gastro.org/ibs.
(IBS-C).
Plecanatide had previously been approved to treat adults with chronic idiopathic constipation (CIC).
Plecanatide was approved on the findings of two randomized, double-blind, 12-week, placebo-controlled clinical trials. More than 2,100 adult patients across both trials received either a 3-mg or 6-mg once-daily tablet of plecanatide, or a placebo. The primary endpoints of both studies were greater than 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) for at least half of the 12 treatment weeks.
Plecanatide met both of its primary endpoints, with reductions in abdominal pain in both studies, compared with placebo (30.2% vs. 17.8% in study 1, P < .001; 21.5% vs. 14.2% in study 2, P = .009).
Plecanatide is the only prescription, once-daily medication that treats both CIC and IBS-C in adults. The drug should be available in the first quarter of 2018.
AGA offers free patient education materials to help your patients better understand how to live with and manage their IBS. Visit www.gastro.org/ibs.
(IBS-C).
Plecanatide had previously been approved to treat adults with chronic idiopathic constipation (CIC).
Plecanatide was approved on the findings of two randomized, double-blind, 12-week, placebo-controlled clinical trials. More than 2,100 adult patients across both trials received either a 3-mg or 6-mg once-daily tablet of plecanatide, or a placebo. The primary endpoints of both studies were greater than 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) for at least half of the 12 treatment weeks.
Plecanatide met both of its primary endpoints, with reductions in abdominal pain in both studies, compared with placebo (30.2% vs. 17.8% in study 1, P < .001; 21.5% vs. 14.2% in study 2, P = .009).
Plecanatide is the only prescription, once-daily medication that treats both CIC and IBS-C in adults. The drug should be available in the first quarter of 2018.
AGA offers free patient education materials to help your patients better understand how to live with and manage their IBS. Visit www.gastro.org/ibs.
FDA approves irritable bowel syndrome treatment
(IBS-C).
Plecanatide had previously been approved to treat adults with chronic idiopathic constipation (CIC).
Plecanatide met both of its primary endpoints, with reductions in abdominal pain in both studies, compared with placebo (30.2% vs. 17.8% in study 1, P < .001; 21.5% vs. 14.2% in study 2, P = .009).
Plecanatide is the only prescription, once-daily medication that treats both CIC and IBS-C in adults. The drug should be available in the first quarter of 2018.
(IBS-C).
Plecanatide had previously been approved to treat adults with chronic idiopathic constipation (CIC).
Plecanatide met both of its primary endpoints, with reductions in abdominal pain in both studies, compared with placebo (30.2% vs. 17.8% in study 1, P < .001; 21.5% vs. 14.2% in study 2, P = .009).
Plecanatide is the only prescription, once-daily medication that treats both CIC and IBS-C in adults. The drug should be available in the first quarter of 2018.
(IBS-C).
Plecanatide had previously been approved to treat adults with chronic idiopathic constipation (CIC).
Plecanatide met both of its primary endpoints, with reductions in abdominal pain in both studies, compared with placebo (30.2% vs. 17.8% in study 1, P < .001; 21.5% vs. 14.2% in study 2, P = .009).
Plecanatide is the only prescription, once-daily medication that treats both CIC and IBS-C in adults. The drug should be available in the first quarter of 2018.
Nutrition early in life has long-term effects on neurodevelopment
Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.
“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).
The importance of macronutrients was highlighted in a study of rural Guatemalan children during 1969-1989 who received high-calorie or low-calorie protein supplements. Children who received the high-calorie/high protein supplements before age 2 years had higher test scores, better reading and vocabulary skills, and faster information processing abilities, compared with their low-calorie/low-protein counterparts.
Like the low-calorie/low-protein Guatemalans, there are many populations that lack access to high-quality macronutrient sources or have access to only low-quality macronutrients. In the United States in 2015, 16.6% of households (6.4 million) were food insecure. This was even more pronounced in households with incomes below the poverty line, with 36.8% being food insecure, according to studies from the Department of Agriculture.
Food insecurity is not limited to macronutrients but extends to micronutrients such as vitamins and minerals like zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and long-chain polyunsaturated fatty acids. A lack of any of these micronutrients in early childhood can lead to neurodevelopmental issues later in life, Dr. Schwarzenberg, Dr. Georgieff, and the committee emphasized. An important source of micronutrients is human milk, provided by breastfeeding. Studies have shown that breastfeeding of preterm and term infants improves cognitive performance, compared with infants who consume formula (J Pediatr. 2016;177:133-9.e1; Curr Opin Pediatr. 2016;28[4]:559-66).
Because proper consumption of macronutrients and micronutrients is so important, a number of government-sponsored programs exist that provide nutritional support to women, infants, and young children. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is one of the most important programs, helping 53% of children under the age of 1 year. The Supplemental Nutrition Assistance Program (SNAP) also supplies economic aid to buy nutritious foods; it kept approximately 4.9 million children out of poverty in 2012, the researchers said. SNAP Nutrition Education, a partnership between SNAP and the Department of Agriculture, gives SNAP participants and eligible nonparticipants skills and information to help them to make healthy food choices with limited money.
The article highlights some important information, but is not an exhaustive discussion of the AAP policy statement. To make the information from the policy statement more applicable, Dr. Schwarzenberg, Dr. Georgieff, and the committee provided 10 takeaway recommendations for pediatricians.
1. Be knowledgeable about breastfeeding and help breastfeeding mothers. The AAP recommends exclusive breastfeeding for the first 6 months of a child’s life and to continue breastfeeding with the addition of food for at least the first year of life, and even after that if the mother and child so desire.
2. Advocate at the local, state, and federal levels to preserve and strengthen nutritional and assistance programs focusing on prenatal and neonatal nutrition. This can help support proper neurodevelopment and minimize negative environmental factors.
3. Openly discuss proper nutritions effects on infant neurodevelopment with parents. Know which nutrients are at risk in the breastfed infant after 6 months, such as zinc, iron, and vitamin D. A good resource is “Pediatric Nutrition, 7th edition” (Itasca, Ill. American Academy of Pediatrics, 2014).
4. Convey that eating healthy is a positive choice, not just an avoidance of unhealthy foods.
5. Inform food pantries and soup kitchens that the food packages and meals they provide should have higher levels of macronutrients and micronutrients.
6. Encourage parents to make use of programs like WIC and SNAP, and advocate for removing barriers that parents face in enrolling or reenrolling in such programs.
7. Oppose changes in eligibility to assistance programs that would adversely affect children.
8. Anticipate neurodevelopmental issues with children and address the issue early. For example, educate yourself about which nutrients are at risk for deficiency and at what ages.
9. Work with obstetricians to encourage improvements in maternal diet, which will affect the micronutrients available for the developing fetus.
10. Become advocates in the “Hunger Community,” working to reduce hunger at the local level across the United States. A chart in the article lists organizations focused on hunger, such as Feeding America, 1,000 Days, Share Our Strength, and others.
There was no external funding for this research, and the authors had no relevant financial disclosures or potential conflicts of interest to report.
While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.
The AAP just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2 years). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific which is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their baby such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.
Natalie D. Muth, MD, is a pediatrician at Children’s Primary Care Medical Group in Carlsbad, Calif. She has no relevant financial disclosures.
While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.
The AAP just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2 years). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific which is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their baby such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.
Natalie D. Muth, MD, is a pediatrician at Children’s Primary Care Medical Group in Carlsbad, Calif. She has no relevant financial disclosures.
While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.
The AAP just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2 years). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific which is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their baby such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.
Natalie D. Muth, MD, is a pediatrician at Children’s Primary Care Medical Group in Carlsbad, Calif. She has no relevant financial disclosures.
Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.
“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).
The importance of macronutrients was highlighted in a study of rural Guatemalan children during 1969-1989 who received high-calorie or low-calorie protein supplements. Children who received the high-calorie/high protein supplements before age 2 years had higher test scores, better reading and vocabulary skills, and faster information processing abilities, compared with their low-calorie/low-protein counterparts.
Like the low-calorie/low-protein Guatemalans, there are many populations that lack access to high-quality macronutrient sources or have access to only low-quality macronutrients. In the United States in 2015, 16.6% of households (6.4 million) were food insecure. This was even more pronounced in households with incomes below the poverty line, with 36.8% being food insecure, according to studies from the Department of Agriculture.
Food insecurity is not limited to macronutrients but extends to micronutrients such as vitamins and minerals like zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and long-chain polyunsaturated fatty acids. A lack of any of these micronutrients in early childhood can lead to neurodevelopmental issues later in life, Dr. Schwarzenberg, Dr. Georgieff, and the committee emphasized. An important source of micronutrients is human milk, provided by breastfeeding. Studies have shown that breastfeeding of preterm and term infants improves cognitive performance, compared with infants who consume formula (J Pediatr. 2016;177:133-9.e1; Curr Opin Pediatr. 2016;28[4]:559-66).
Because proper consumption of macronutrients and micronutrients is so important, a number of government-sponsored programs exist that provide nutritional support to women, infants, and young children. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is one of the most important programs, helping 53% of children under the age of 1 year. The Supplemental Nutrition Assistance Program (SNAP) also supplies economic aid to buy nutritious foods; it kept approximately 4.9 million children out of poverty in 2012, the researchers said. SNAP Nutrition Education, a partnership between SNAP and the Department of Agriculture, gives SNAP participants and eligible nonparticipants skills and information to help them to make healthy food choices with limited money.
The article highlights some important information, but is not an exhaustive discussion of the AAP policy statement. To make the information from the policy statement more applicable, Dr. Schwarzenberg, Dr. Georgieff, and the committee provided 10 takeaway recommendations for pediatricians.
1. Be knowledgeable about breastfeeding and help breastfeeding mothers. The AAP recommends exclusive breastfeeding for the first 6 months of a child’s life and to continue breastfeeding with the addition of food for at least the first year of life, and even after that if the mother and child so desire.
2. Advocate at the local, state, and federal levels to preserve and strengthen nutritional and assistance programs focusing on prenatal and neonatal nutrition. This can help support proper neurodevelopment and minimize negative environmental factors.
3. Openly discuss proper nutritions effects on infant neurodevelopment with parents. Know which nutrients are at risk in the breastfed infant after 6 months, such as zinc, iron, and vitamin D. A good resource is “Pediatric Nutrition, 7th edition” (Itasca, Ill. American Academy of Pediatrics, 2014).
4. Convey that eating healthy is a positive choice, not just an avoidance of unhealthy foods.
5. Inform food pantries and soup kitchens that the food packages and meals they provide should have higher levels of macronutrients and micronutrients.
6. Encourage parents to make use of programs like WIC and SNAP, and advocate for removing barriers that parents face in enrolling or reenrolling in such programs.
7. Oppose changes in eligibility to assistance programs that would adversely affect children.
8. Anticipate neurodevelopmental issues with children and address the issue early. For example, educate yourself about which nutrients are at risk for deficiency and at what ages.
9. Work with obstetricians to encourage improvements in maternal diet, which will affect the micronutrients available for the developing fetus.
10. Become advocates in the “Hunger Community,” working to reduce hunger at the local level across the United States. A chart in the article lists organizations focused on hunger, such as Feeding America, 1,000 Days, Share Our Strength, and others.
There was no external funding for this research, and the authors had no relevant financial disclosures or potential conflicts of interest to report.
Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.
“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).
The importance of macronutrients was highlighted in a study of rural Guatemalan children during 1969-1989 who received high-calorie or low-calorie protein supplements. Children who received the high-calorie/high protein supplements before age 2 years had higher test scores, better reading and vocabulary skills, and faster information processing abilities, compared with their low-calorie/low-protein counterparts.
Like the low-calorie/low-protein Guatemalans, there are many populations that lack access to high-quality macronutrient sources or have access to only low-quality macronutrients. In the United States in 2015, 16.6% of households (6.4 million) were food insecure. This was even more pronounced in households with incomes below the poverty line, with 36.8% being food insecure, according to studies from the Department of Agriculture.
Food insecurity is not limited to macronutrients but extends to micronutrients such as vitamins and minerals like zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and long-chain polyunsaturated fatty acids. A lack of any of these micronutrients in early childhood can lead to neurodevelopmental issues later in life, Dr. Schwarzenberg, Dr. Georgieff, and the committee emphasized. An important source of micronutrients is human milk, provided by breastfeeding. Studies have shown that breastfeeding of preterm and term infants improves cognitive performance, compared with infants who consume formula (J Pediatr. 2016;177:133-9.e1; Curr Opin Pediatr. 2016;28[4]:559-66).
Because proper consumption of macronutrients and micronutrients is so important, a number of government-sponsored programs exist that provide nutritional support to women, infants, and young children. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is one of the most important programs, helping 53% of children under the age of 1 year. The Supplemental Nutrition Assistance Program (SNAP) also supplies economic aid to buy nutritious foods; it kept approximately 4.9 million children out of poverty in 2012, the researchers said. SNAP Nutrition Education, a partnership between SNAP and the Department of Agriculture, gives SNAP participants and eligible nonparticipants skills and information to help them to make healthy food choices with limited money.
The article highlights some important information, but is not an exhaustive discussion of the AAP policy statement. To make the information from the policy statement more applicable, Dr. Schwarzenberg, Dr. Georgieff, and the committee provided 10 takeaway recommendations for pediatricians.
1. Be knowledgeable about breastfeeding and help breastfeeding mothers. The AAP recommends exclusive breastfeeding for the first 6 months of a child’s life and to continue breastfeeding with the addition of food for at least the first year of life, and even after that if the mother and child so desire.
2. Advocate at the local, state, and federal levels to preserve and strengthen nutritional and assistance programs focusing on prenatal and neonatal nutrition. This can help support proper neurodevelopment and minimize negative environmental factors.
3. Openly discuss proper nutritions effects on infant neurodevelopment with parents. Know which nutrients are at risk in the breastfed infant after 6 months, such as zinc, iron, and vitamin D. A good resource is “Pediatric Nutrition, 7th edition” (Itasca, Ill. American Academy of Pediatrics, 2014).
4. Convey that eating healthy is a positive choice, not just an avoidance of unhealthy foods.
5. Inform food pantries and soup kitchens that the food packages and meals they provide should have higher levels of macronutrients and micronutrients.
6. Encourage parents to make use of programs like WIC and SNAP, and advocate for removing barriers that parents face in enrolling or reenrolling in such programs.
7. Oppose changes in eligibility to assistance programs that would adversely affect children.
8. Anticipate neurodevelopmental issues with children and address the issue early. For example, educate yourself about which nutrients are at risk for deficiency and at what ages.
9. Work with obstetricians to encourage improvements in maternal diet, which will affect the micronutrients available for the developing fetus.
10. Become advocates in the “Hunger Community,” working to reduce hunger at the local level across the United States. A chart in the article lists organizations focused on hunger, such as Feeding America, 1,000 Days, Share Our Strength, and others.
There was no external funding for this research, and the authors had no relevant financial disclosures or potential conflicts of interest to report.
FROM PEDIATRICS