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Extreme caffeine use in early pregnancy risks offspring behavioral disorders
, Susanne Hvolgaard Mikkelsen, PhD, of Aarhus (Denmark) University and her associates said.
“Caffeine metabolism is delayed during pregnancy, allowing longer opportunities for absorption. Caffeine increases dopamine levels by slowing down the rate of dopamine reabsorption, and this dysfunction of the dopaminergic system is thought to explain part of the association between caffeine consumption and offspring behavioral disorders,” the investigators said.
From 1996 to 2002, Danish physicians recruited women during their first pregnancy visit to participate in a study evaluating daily coffee and tea consumption during pregnancy, with follow-up of the children at age 11 years using the Danish National Birth Cohort. A follow-up questionnaire, including the Strength and Difficulties Questionnaire, was completed by the children, their parents, and their teachers; the results were paired with data on coffee and tea consumption by the mothers of 47,491 children. At 15 weeks’ gestation, 12% of the women had consumed more than three cups/day of coffee, and 3% ingested eight or more cups/day of coffee; 19% of the women drank more than three cups/day of tea, and 4% drank eight or more cups/day of tea. The amount of coffee and tea consumed at 30 weeks’ gestation was only slightly less.
The percentage of children predicted to have “possible/probable” ADHD was 5%, conduct-oppositional disorders was 7%, anxiety-depressive disorders was 7%, and any psychiatric disorder was 14%.
A statistically significant association was found between maternal consumption of eight or more cups of coffee at 15 weeks’ gestation and greater risk of ADHD (a risk ratio [RR] of 1.47), conduct-oppositional disorder (RR, 1.22), and any psychiatric disorder (RR, 1.23). A statistically significant link was found between maternal consumption of eight or more cups of tea at 15 weeks’ gestation and greater risk of conduct-oppositional disorder (RR, 1.21). There was a statistically significant association between maternal consumption of eight or more cups of tea at 15 weeks’ gestation and a higher risk of anxiety-depressive disorder (RR, 1.28), but not for coffee. These significant relationships were not found again at 30 weeks’ gestation.
“The period of greatest prenatal brain development is 10-26 weeks after conception,which may explain our results suggesting the fetus to be more vulnerable to caffeine in first and second trimester, compared with the third trimester,” the researchers said.
There was no information available about caffeine consumption by chocolate, energy drinks, or medication; the measure of cola consumption also was not taken into account. Confounding by genetics or socioeconomic factors may affect these findings, Dr. Mikkelsen and her associates said.
Read more at (J Pediatr. 2017 Jul 18. doi: 10.1016/j.jpeds.2017.06.051).
, Susanne Hvolgaard Mikkelsen, PhD, of Aarhus (Denmark) University and her associates said.
“Caffeine metabolism is delayed during pregnancy, allowing longer opportunities for absorption. Caffeine increases dopamine levels by slowing down the rate of dopamine reabsorption, and this dysfunction of the dopaminergic system is thought to explain part of the association between caffeine consumption and offspring behavioral disorders,” the investigators said.
From 1996 to 2002, Danish physicians recruited women during their first pregnancy visit to participate in a study evaluating daily coffee and tea consumption during pregnancy, with follow-up of the children at age 11 years using the Danish National Birth Cohort. A follow-up questionnaire, including the Strength and Difficulties Questionnaire, was completed by the children, their parents, and their teachers; the results were paired with data on coffee and tea consumption by the mothers of 47,491 children. At 15 weeks’ gestation, 12% of the women had consumed more than three cups/day of coffee, and 3% ingested eight or more cups/day of coffee; 19% of the women drank more than three cups/day of tea, and 4% drank eight or more cups/day of tea. The amount of coffee and tea consumed at 30 weeks’ gestation was only slightly less.
The percentage of children predicted to have “possible/probable” ADHD was 5%, conduct-oppositional disorders was 7%, anxiety-depressive disorders was 7%, and any psychiatric disorder was 14%.
A statistically significant association was found between maternal consumption of eight or more cups of coffee at 15 weeks’ gestation and greater risk of ADHD (a risk ratio [RR] of 1.47), conduct-oppositional disorder (RR, 1.22), and any psychiatric disorder (RR, 1.23). A statistically significant link was found between maternal consumption of eight or more cups of tea at 15 weeks’ gestation and greater risk of conduct-oppositional disorder (RR, 1.21). There was a statistically significant association between maternal consumption of eight or more cups of tea at 15 weeks’ gestation and a higher risk of anxiety-depressive disorder (RR, 1.28), but not for coffee. These significant relationships were not found again at 30 weeks’ gestation.
“The period of greatest prenatal brain development is 10-26 weeks after conception,which may explain our results suggesting the fetus to be more vulnerable to caffeine in first and second trimester, compared with the third trimester,” the researchers said.
There was no information available about caffeine consumption by chocolate, energy drinks, or medication; the measure of cola consumption also was not taken into account. Confounding by genetics or socioeconomic factors may affect these findings, Dr. Mikkelsen and her associates said.
Read more at (J Pediatr. 2017 Jul 18. doi: 10.1016/j.jpeds.2017.06.051).
, Susanne Hvolgaard Mikkelsen, PhD, of Aarhus (Denmark) University and her associates said.
“Caffeine metabolism is delayed during pregnancy, allowing longer opportunities for absorption. Caffeine increases dopamine levels by slowing down the rate of dopamine reabsorption, and this dysfunction of the dopaminergic system is thought to explain part of the association between caffeine consumption and offspring behavioral disorders,” the investigators said.
From 1996 to 2002, Danish physicians recruited women during their first pregnancy visit to participate in a study evaluating daily coffee and tea consumption during pregnancy, with follow-up of the children at age 11 years using the Danish National Birth Cohort. A follow-up questionnaire, including the Strength and Difficulties Questionnaire, was completed by the children, their parents, and their teachers; the results were paired with data on coffee and tea consumption by the mothers of 47,491 children. At 15 weeks’ gestation, 12% of the women had consumed more than three cups/day of coffee, and 3% ingested eight or more cups/day of coffee; 19% of the women drank more than three cups/day of tea, and 4% drank eight or more cups/day of tea. The amount of coffee and tea consumed at 30 weeks’ gestation was only slightly less.
The percentage of children predicted to have “possible/probable” ADHD was 5%, conduct-oppositional disorders was 7%, anxiety-depressive disorders was 7%, and any psychiatric disorder was 14%.
A statistically significant association was found between maternal consumption of eight or more cups of coffee at 15 weeks’ gestation and greater risk of ADHD (a risk ratio [RR] of 1.47), conduct-oppositional disorder (RR, 1.22), and any psychiatric disorder (RR, 1.23). A statistically significant link was found between maternal consumption of eight or more cups of tea at 15 weeks’ gestation and greater risk of conduct-oppositional disorder (RR, 1.21). There was a statistically significant association between maternal consumption of eight or more cups of tea at 15 weeks’ gestation and a higher risk of anxiety-depressive disorder (RR, 1.28), but not for coffee. These significant relationships were not found again at 30 weeks’ gestation.
“The period of greatest prenatal brain development is 10-26 weeks after conception,which may explain our results suggesting the fetus to be more vulnerable to caffeine in first and second trimester, compared with the third trimester,” the researchers said.
There was no information available about caffeine consumption by chocolate, energy drinks, or medication; the measure of cola consumption also was not taken into account. Confounding by genetics or socioeconomic factors may affect these findings, Dr. Mikkelsen and her associates said.
Read more at (J Pediatr. 2017 Jul 18. doi: 10.1016/j.jpeds.2017.06.051).
FROM THE JOURNAL OF PEDIATRICS
Long-acting injectable antiretroviral combo as good as HIV oral therapy
A long-acting injectable formulation combining two antiretroviral drugs – cabotegravir and rilpivirine – is as effective as a daily oral regimen of cabotegravir plus abacavir and lamivudine, according to interim results from the LATTE-2 trial.
Writing in the July 24 online edition of The Lancet, researchers have reported the 96-week results of the ongoing open-label phase 2b trial involving 286 treatment-naive adults infected with HIV-1.
At 32 weeks, 95% of patients in 8-week group, 94% of patients in the 4-week group, and 91% of patients in the oral therapy group had maintained viral suppression, defined as plasma HIV-1 RNA less than 50 copies per mL (Lancet. 2017 Jul 24. doi: 10.1016/S0140-6736[17]31917-7).
By week 96, viral suppression was seen in 94% of patients in the 8-week group, 87% of patients in the 4-week group and 84% of patients on oral treatment.
A nonresponse at 96 weeks was seen in five patients in the 8-week group and one patient in the oral therapy group. There were also two patients in the 8-week group and one in the oral treatment group who met the criteria for virologic failure.
“Viral genotyping analysis for the patient in the oral treatment group had no treatment-emergent resistance mutations in the genes encoding viral reverse transcriptase, protease, or integrase,” wrote David A. Margolis, MD, from ViiV Healthcare, and his coauthors.
Injection-site pain was the most common adverse event in the injectable groups, experienced by 96%-97% of patients, but most reactions were mild or moderate and lasted a median of 3 days.
There was only one drug-related serious adverse event, which was a migraine that occurred in one patient during the oral induction period. None of the other serious adverse events were deemed to be drug-related.
Patients reported high levels of treatment satisfaction across all study groups, and more than 99% of patients in the injectable treatment arms said they would be highly satisfied to continue with the regimen, compared with 78% of patients in the oral treatment arm.
“The acceptability and tolerability of injectable dosing options will be an important component of long-term treatment success, and a high degree of treatment satisfaction will avail this option for patients burdened by life-long daily oral medication compliance,” the authors wrote.
However they did note that the study population was mostly white men with a CD4+ cell count at entry of at least 200 cells per mm.
“Therefore, the efficacy, safety, and pharmacokinetic outcomes of long-acting cabotegravir plus rilpivirine in different subpopulations infected with HIV-1 needs further evaluation,” the investigators concluded.
The study was funded by ViiV Healthcare and Janssen R&D. Nine authors are employees of ViiV Healthcare and shareholders in GlaxoSmithKline. Nine authors declared funding, grants, and honoraria from a range of pharmaceutical companies including ViiV Healthcare. Two authors are employees and shareholders of GlaxoSmithKline. Two authors are employees of Janssen, and stockholders of Johnson & Johnson, AstraZeneca, or GlaxoSmithKline. One author had no conflicts to disclose.
A long-acting injectable formulation combining two antiretroviral drugs – cabotegravir and rilpivirine – is as effective as a daily oral regimen of cabotegravir plus abacavir and lamivudine, according to interim results from the LATTE-2 trial.
Writing in the July 24 online edition of The Lancet, researchers have reported the 96-week results of the ongoing open-label phase 2b trial involving 286 treatment-naive adults infected with HIV-1.
At 32 weeks, 95% of patients in 8-week group, 94% of patients in the 4-week group, and 91% of patients in the oral therapy group had maintained viral suppression, defined as plasma HIV-1 RNA less than 50 copies per mL (Lancet. 2017 Jul 24. doi: 10.1016/S0140-6736[17]31917-7).
By week 96, viral suppression was seen in 94% of patients in the 8-week group, 87% of patients in the 4-week group and 84% of patients on oral treatment.
A nonresponse at 96 weeks was seen in five patients in the 8-week group and one patient in the oral therapy group. There were also two patients in the 8-week group and one in the oral treatment group who met the criteria for virologic failure.
“Viral genotyping analysis for the patient in the oral treatment group had no treatment-emergent resistance mutations in the genes encoding viral reverse transcriptase, protease, or integrase,” wrote David A. Margolis, MD, from ViiV Healthcare, and his coauthors.
Injection-site pain was the most common adverse event in the injectable groups, experienced by 96%-97% of patients, but most reactions were mild or moderate and lasted a median of 3 days.
There was only one drug-related serious adverse event, which was a migraine that occurred in one patient during the oral induction period. None of the other serious adverse events were deemed to be drug-related.
Patients reported high levels of treatment satisfaction across all study groups, and more than 99% of patients in the injectable treatment arms said they would be highly satisfied to continue with the regimen, compared with 78% of patients in the oral treatment arm.
“The acceptability and tolerability of injectable dosing options will be an important component of long-term treatment success, and a high degree of treatment satisfaction will avail this option for patients burdened by life-long daily oral medication compliance,” the authors wrote.
However they did note that the study population was mostly white men with a CD4+ cell count at entry of at least 200 cells per mm.
“Therefore, the efficacy, safety, and pharmacokinetic outcomes of long-acting cabotegravir plus rilpivirine in different subpopulations infected with HIV-1 needs further evaluation,” the investigators concluded.
The study was funded by ViiV Healthcare and Janssen R&D. Nine authors are employees of ViiV Healthcare and shareholders in GlaxoSmithKline. Nine authors declared funding, grants, and honoraria from a range of pharmaceutical companies including ViiV Healthcare. Two authors are employees and shareholders of GlaxoSmithKline. Two authors are employees of Janssen, and stockholders of Johnson & Johnson, AstraZeneca, or GlaxoSmithKline. One author had no conflicts to disclose.
A long-acting injectable formulation combining two antiretroviral drugs – cabotegravir and rilpivirine – is as effective as a daily oral regimen of cabotegravir plus abacavir and lamivudine, according to interim results from the LATTE-2 trial.
Writing in the July 24 online edition of The Lancet, researchers have reported the 96-week results of the ongoing open-label phase 2b trial involving 286 treatment-naive adults infected with HIV-1.
At 32 weeks, 95% of patients in 8-week group, 94% of patients in the 4-week group, and 91% of patients in the oral therapy group had maintained viral suppression, defined as plasma HIV-1 RNA less than 50 copies per mL (Lancet. 2017 Jul 24. doi: 10.1016/S0140-6736[17]31917-7).
By week 96, viral suppression was seen in 94% of patients in the 8-week group, 87% of patients in the 4-week group and 84% of patients on oral treatment.
A nonresponse at 96 weeks was seen in five patients in the 8-week group and one patient in the oral therapy group. There were also two patients in the 8-week group and one in the oral treatment group who met the criteria for virologic failure.
“Viral genotyping analysis for the patient in the oral treatment group had no treatment-emergent resistance mutations in the genes encoding viral reverse transcriptase, protease, or integrase,” wrote David A. Margolis, MD, from ViiV Healthcare, and his coauthors.
Injection-site pain was the most common adverse event in the injectable groups, experienced by 96%-97% of patients, but most reactions were mild or moderate and lasted a median of 3 days.
There was only one drug-related serious adverse event, which was a migraine that occurred in one patient during the oral induction period. None of the other serious adverse events were deemed to be drug-related.
Patients reported high levels of treatment satisfaction across all study groups, and more than 99% of patients in the injectable treatment arms said they would be highly satisfied to continue with the regimen, compared with 78% of patients in the oral treatment arm.
“The acceptability and tolerability of injectable dosing options will be an important component of long-term treatment success, and a high degree of treatment satisfaction will avail this option for patients burdened by life-long daily oral medication compliance,” the authors wrote.
However they did note that the study population was mostly white men with a CD4+ cell count at entry of at least 200 cells per mm.
“Therefore, the efficacy, safety, and pharmacokinetic outcomes of long-acting cabotegravir plus rilpivirine in different subpopulations infected with HIV-1 needs further evaluation,” the investigators concluded.
The study was funded by ViiV Healthcare and Janssen R&D. Nine authors are employees of ViiV Healthcare and shareholders in GlaxoSmithKline. Nine authors declared funding, grants, and honoraria from a range of pharmaceutical companies including ViiV Healthcare. Two authors are employees and shareholders of GlaxoSmithKline. Two authors are employees of Janssen, and stockholders of Johnson & Johnson, AstraZeneca, or GlaxoSmithKline. One author had no conflicts to disclose.
FROM THE LANCET
Key clinical point: The long-acting injectable formulation of cabotegravir and rilpivirine is as effective as a daily oral regimen of cabotegravir plus abacavir and lamivudine.
Major finding: A long-acting injectable formulation of cabotegravir and rilpivirine, given either every 4 or 8 weeks, achieved similar levels of viral suppression to daily oral therapy with cabotegravir plus abacavir and lamivudine.
Data source: Randomized, open-label phase 2b study in 286 adults with HIV-1 infection.
Disclosures: This study was funded by ViiV Healthcare and Janssen R&D. Nine authors are employees of ViiV Healthcare and shareholders in GlaxoSmithKline. Nine authors declared funding, grants, and honoraria from a range of pharmaceutical companies including ViiV Healthcare. Two authors are employees and shareholders of GlaxoSmithKline. Two authors are employees of Janssen, and stockholders of Johnson & Johnson, AstraZeneca, or GlaxoSmithKline. One author had no conflicts to disclose.
Procalcitonin-guided decision making found best in neonatal suspected sepsis
, according to an investigator-initiated, superiority and noninferiority, multicenter, randomized controlled intervention study.
In the Neonatal Procalcitonin Intervention Study (NeoPInS) study aimed to reduce the duration of antibiotic treatment, 1,710 neonates who were already receiving antibiotic therapy were enrolled in 18 hospitals in Canada, the Czech Republic, the Netherlands, and Switzerland, and randomized to procalcitonin-guided decision making or standard care. Some patients were excluded from the larger initial population because of congenital malformation, surgery in the first week of life, or a lack of parental consent, among other reasons.
The intention-to-treat population included 866 neonates in the procalcitonin group whose median treatment duration was 55 hours (95% confidence interval [CI], 50.5-60.0) and 844 in the standard group whose median treatment duration was 65 hours (95% CI, 63.0-69.0; P less than .0001), with a median difference of –9.9. The per-protocol population saw an even greater median difference of –12.2, with a treatment duration of 52 hours in 745 neonates assigned to procalcitonin-guided decision making (95% CI, 48.2-56.0) and a duration of 64 hours in 663 neonates assigned to standard care (95% CI, 61.0-68.1; P less than .0001).
Length of hospital stay also was significantly shorter in both procalcitonin groups, according to the researchers.
One neonate in the standard group died from the consequences of severe perinatal asphyxia. In each procalcitonin group, five (0.6% and 0.7%, respectively) had a suspected reinfection, compared with three in each of the standard groups (0.5% and 0.6%, respectively). None of the neonates suspected of reinfection had a culture-proven bacteria infection.
“In this era of globally increasing antibiotic resistance rates ... every dose of antimicrobial therapy counts in the emergence of antimicrobial resistance and in changing the human microbiome,” the investigators wrote, “and other evidence suggests that changes in the microbiome in early life are particularly important in shaping the individual’s immune system and future health.”
The primary outcomes of the study were duration of treatment and reinfection or death in the first month of life, with a secondary outcome of length of hospital stay. Noninferiority for reinfection and death could not be shown because there were too few of these events.
“Procalcitonin-guided decision making led to a significant reduction in duration of empirical antibiotic therapy and hospital stay in term and near-term neonates with suspected early-onset sepsis, with a low rate of reinfections and with no study-related mortality. Combining serial procalcitonin measurements with initial assessment based on perinatal risk factors, the neonate’s clinical signs and symptoms, and conventional laboratory variables support antimicrobial stewardship and help physicians to decide to discontinue antibiotic treatment sooner in neonates classified as having low or moderate risk of infection,” Dr. Stocker, Dr. van Herk, and their associates said.
A limitation was that results cannot be extrapolated to other populations. The neonates in this study all had easy and low-threshold access to care, so the results may not apply to low-income or low-access areas, they said.
Length of hospital stay results may be affected by other conditions developed by the neonates. “It would be interesting to analyze duration of hospital stay separately for neonates with or without other reasons for hospital admission, but this was not possible in our study design,” the investigators said.
The authors reported no relevant financial disclosures. The Thrasher Foundation, the NutsOhra Foundation, and the Sophia Foundation for Scientific Research funded the study.
Dr. Stocker, Dr. Herk, and their coauthors “are to be commended for conducting this pragmatic and international, multicenter trial.” When withholding antibiotics, especially from neonates who are susceptible to infection, safety is key. In this “landmark study done in neonates,” the authors determined that procalcitonin can be safely used to guide decision making in neonates at low risk of sepsis. Using procalcitonin in a clinical algorithm also was effective, reducing the duration of antibiotic therapy by around 20% and the length of hospital stay by around 5%.
Although the biomarker is the most accurate diagnostic tool currently available, it should be used with caution. On its own, it is not enough to determine if a neonate is in need of continued antibiotic therapy. It should be used in conjunction with clinical examination and reasoning on the part of the physician. In addition, the cutoffs that have been determined for adults are too low for neonates. “Nevertheless, if the cutoff is adapted accordingly and embedded in a reasonable clinical algorithm – as done in the NeoPInS study – procalcitonin can and should be used to improve antibiotic stewardship.
“Procalcitonin-guided antibiotic de-escalation therapy is evidence based and state of the art for antibiotic therapy for suspected and proven bacterial infection in different clinical settings and different acuity of infections.”
Philipp Schuetz, MD, and Beat Mueller, MD, are of the University of Basel, Aarau, Switzerland. Dr. Schuetz received support from BRAHMS/Thermofisher and bioMérieux to attend meetings, fulfill speaking engagements, and for unrestricted research grants related to procalcitonin. Dr. Mueller has received research support, as well as consulting fees and speakers’ honoraria, from BRAHMS/Thermofisher and bioMérieux, related to procalcitonin. They made these remarks in a commentary accompanying Dr. Stocker’s and Dr. van Herk’s report (Lancet. 2017 Jul 12. doi: 10.1016/S0140-6736[17]31628-8).
Dr. Stocker, Dr. Herk, and their coauthors “are to be commended for conducting this pragmatic and international, multicenter trial.” When withholding antibiotics, especially from neonates who are susceptible to infection, safety is key. In this “landmark study done in neonates,” the authors determined that procalcitonin can be safely used to guide decision making in neonates at low risk of sepsis. Using procalcitonin in a clinical algorithm also was effective, reducing the duration of antibiotic therapy by around 20% and the length of hospital stay by around 5%.
Although the biomarker is the most accurate diagnostic tool currently available, it should be used with caution. On its own, it is not enough to determine if a neonate is in need of continued antibiotic therapy. It should be used in conjunction with clinical examination and reasoning on the part of the physician. In addition, the cutoffs that have been determined for adults are too low for neonates. “Nevertheless, if the cutoff is adapted accordingly and embedded in a reasonable clinical algorithm – as done in the NeoPInS study – procalcitonin can and should be used to improve antibiotic stewardship.
“Procalcitonin-guided antibiotic de-escalation therapy is evidence based and state of the art for antibiotic therapy for suspected and proven bacterial infection in different clinical settings and different acuity of infections.”
Philipp Schuetz, MD, and Beat Mueller, MD, are of the University of Basel, Aarau, Switzerland. Dr. Schuetz received support from BRAHMS/Thermofisher and bioMérieux to attend meetings, fulfill speaking engagements, and for unrestricted research grants related to procalcitonin. Dr. Mueller has received research support, as well as consulting fees and speakers’ honoraria, from BRAHMS/Thermofisher and bioMérieux, related to procalcitonin. They made these remarks in a commentary accompanying Dr. Stocker’s and Dr. van Herk’s report (Lancet. 2017 Jul 12. doi: 10.1016/S0140-6736[17]31628-8).
Dr. Stocker, Dr. Herk, and their coauthors “are to be commended for conducting this pragmatic and international, multicenter trial.” When withholding antibiotics, especially from neonates who are susceptible to infection, safety is key. In this “landmark study done in neonates,” the authors determined that procalcitonin can be safely used to guide decision making in neonates at low risk of sepsis. Using procalcitonin in a clinical algorithm also was effective, reducing the duration of antibiotic therapy by around 20% and the length of hospital stay by around 5%.
Although the biomarker is the most accurate diagnostic tool currently available, it should be used with caution. On its own, it is not enough to determine if a neonate is in need of continued antibiotic therapy. It should be used in conjunction with clinical examination and reasoning on the part of the physician. In addition, the cutoffs that have been determined for adults are too low for neonates. “Nevertheless, if the cutoff is adapted accordingly and embedded in a reasonable clinical algorithm – as done in the NeoPInS study – procalcitonin can and should be used to improve antibiotic stewardship.
“Procalcitonin-guided antibiotic de-escalation therapy is evidence based and state of the art for antibiotic therapy for suspected and proven bacterial infection in different clinical settings and different acuity of infections.”
Philipp Schuetz, MD, and Beat Mueller, MD, are of the University of Basel, Aarau, Switzerland. Dr. Schuetz received support from BRAHMS/Thermofisher and bioMérieux to attend meetings, fulfill speaking engagements, and for unrestricted research grants related to procalcitonin. Dr. Mueller has received research support, as well as consulting fees and speakers’ honoraria, from BRAHMS/Thermofisher and bioMérieux, related to procalcitonin. They made these remarks in a commentary accompanying Dr. Stocker’s and Dr. van Herk’s report (Lancet. 2017 Jul 12. doi: 10.1016/S0140-6736[17]31628-8).
, according to an investigator-initiated, superiority and noninferiority, multicenter, randomized controlled intervention study.
In the Neonatal Procalcitonin Intervention Study (NeoPInS) study aimed to reduce the duration of antibiotic treatment, 1,710 neonates who were already receiving antibiotic therapy were enrolled in 18 hospitals in Canada, the Czech Republic, the Netherlands, and Switzerland, and randomized to procalcitonin-guided decision making or standard care. Some patients were excluded from the larger initial population because of congenital malformation, surgery in the first week of life, or a lack of parental consent, among other reasons.
The intention-to-treat population included 866 neonates in the procalcitonin group whose median treatment duration was 55 hours (95% confidence interval [CI], 50.5-60.0) and 844 in the standard group whose median treatment duration was 65 hours (95% CI, 63.0-69.0; P less than .0001), with a median difference of –9.9. The per-protocol population saw an even greater median difference of –12.2, with a treatment duration of 52 hours in 745 neonates assigned to procalcitonin-guided decision making (95% CI, 48.2-56.0) and a duration of 64 hours in 663 neonates assigned to standard care (95% CI, 61.0-68.1; P less than .0001).
Length of hospital stay also was significantly shorter in both procalcitonin groups, according to the researchers.
One neonate in the standard group died from the consequences of severe perinatal asphyxia. In each procalcitonin group, five (0.6% and 0.7%, respectively) had a suspected reinfection, compared with three in each of the standard groups (0.5% and 0.6%, respectively). None of the neonates suspected of reinfection had a culture-proven bacteria infection.
“In this era of globally increasing antibiotic resistance rates ... every dose of antimicrobial therapy counts in the emergence of antimicrobial resistance and in changing the human microbiome,” the investigators wrote, “and other evidence suggests that changes in the microbiome in early life are particularly important in shaping the individual’s immune system and future health.”
The primary outcomes of the study were duration of treatment and reinfection or death in the first month of life, with a secondary outcome of length of hospital stay. Noninferiority for reinfection and death could not be shown because there were too few of these events.
“Procalcitonin-guided decision making led to a significant reduction in duration of empirical antibiotic therapy and hospital stay in term and near-term neonates with suspected early-onset sepsis, with a low rate of reinfections and with no study-related mortality. Combining serial procalcitonin measurements with initial assessment based on perinatal risk factors, the neonate’s clinical signs and symptoms, and conventional laboratory variables support antimicrobial stewardship and help physicians to decide to discontinue antibiotic treatment sooner in neonates classified as having low or moderate risk of infection,” Dr. Stocker, Dr. van Herk, and their associates said.
A limitation was that results cannot be extrapolated to other populations. The neonates in this study all had easy and low-threshold access to care, so the results may not apply to low-income or low-access areas, they said.
Length of hospital stay results may be affected by other conditions developed by the neonates. “It would be interesting to analyze duration of hospital stay separately for neonates with or without other reasons for hospital admission, but this was not possible in our study design,” the investigators said.
The authors reported no relevant financial disclosures. The Thrasher Foundation, the NutsOhra Foundation, and the Sophia Foundation for Scientific Research funded the study.
, according to an investigator-initiated, superiority and noninferiority, multicenter, randomized controlled intervention study.
In the Neonatal Procalcitonin Intervention Study (NeoPInS) study aimed to reduce the duration of antibiotic treatment, 1,710 neonates who were already receiving antibiotic therapy were enrolled in 18 hospitals in Canada, the Czech Republic, the Netherlands, and Switzerland, and randomized to procalcitonin-guided decision making or standard care. Some patients were excluded from the larger initial population because of congenital malformation, surgery in the first week of life, or a lack of parental consent, among other reasons.
The intention-to-treat population included 866 neonates in the procalcitonin group whose median treatment duration was 55 hours (95% confidence interval [CI], 50.5-60.0) and 844 in the standard group whose median treatment duration was 65 hours (95% CI, 63.0-69.0; P less than .0001), with a median difference of –9.9. The per-protocol population saw an even greater median difference of –12.2, with a treatment duration of 52 hours in 745 neonates assigned to procalcitonin-guided decision making (95% CI, 48.2-56.0) and a duration of 64 hours in 663 neonates assigned to standard care (95% CI, 61.0-68.1; P less than .0001).
Length of hospital stay also was significantly shorter in both procalcitonin groups, according to the researchers.
One neonate in the standard group died from the consequences of severe perinatal asphyxia. In each procalcitonin group, five (0.6% and 0.7%, respectively) had a suspected reinfection, compared with three in each of the standard groups (0.5% and 0.6%, respectively). None of the neonates suspected of reinfection had a culture-proven bacteria infection.
“In this era of globally increasing antibiotic resistance rates ... every dose of antimicrobial therapy counts in the emergence of antimicrobial resistance and in changing the human microbiome,” the investigators wrote, “and other evidence suggests that changes in the microbiome in early life are particularly important in shaping the individual’s immune system and future health.”
The primary outcomes of the study were duration of treatment and reinfection or death in the first month of life, with a secondary outcome of length of hospital stay. Noninferiority for reinfection and death could not be shown because there were too few of these events.
“Procalcitonin-guided decision making led to a significant reduction in duration of empirical antibiotic therapy and hospital stay in term and near-term neonates with suspected early-onset sepsis, with a low rate of reinfections and with no study-related mortality. Combining serial procalcitonin measurements with initial assessment based on perinatal risk factors, the neonate’s clinical signs and symptoms, and conventional laboratory variables support antimicrobial stewardship and help physicians to decide to discontinue antibiotic treatment sooner in neonates classified as having low or moderate risk of infection,” Dr. Stocker, Dr. van Herk, and their associates said.
A limitation was that results cannot be extrapolated to other populations. The neonates in this study all had easy and low-threshold access to care, so the results may not apply to low-income or low-access areas, they said.
Length of hospital stay results may be affected by other conditions developed by the neonates. “It would be interesting to analyze duration of hospital stay separately for neonates with or without other reasons for hospital admission, but this was not possible in our study design,” the investigators said.
The authors reported no relevant financial disclosures. The Thrasher Foundation, the NutsOhra Foundation, and the Sophia Foundation for Scientific Research funded the study.
FROM THE LANCET
Key clinical point: Procalcitonin-guided decision making had a significant impact on duration of antibiotic treatment and hospital stay in pediatric patients with suspected early-onset sepsis.
Major finding: The median differences in antibiotic treatment duration between procalcitonin groups and standard care groups were –9.9 and –12.1 hours in intention-to-treat and per protocol study populations.
Data source: An investigator-initiated, superiority and noninferiority, multicenter, randomized controlled intervention study (NeoPInS) of 1,710 neonates with suspected early-stage sepsis.
Disclosures: The authors reported no relevant financial disclosures. The Thrasher Foundation, the NutsOhra Foundation, and the Sophia Foundation for Scientific Research funded the study.
CCDSSs to prevent VTE
Title: Use of computerized clinical decision support systems decreases venous thromboembolic events in surgical patients
Clinical Question: Do computerized clinical decision support systems (CCDSSs) decrease the risk of venous thromboembolism (VTE) in surgical patients?
Background: VTE remains the leading preventable cause of death in the hospital. Despite multiple tools that are available to stratify risk of VTE, they are not used uniformly or are used incorrectly. It is unclear whether CCDSSs help prevent VTE compared to standard care.
Study Design: Retrospective systematic review and meta-analysis.
Setting: 188 studies initially screened, 11 studies were included.
Synopsis: Multiple studies relevant to the topic were reviewed; only studies that used an electronic medical record (EMR)–based tool to augment the rate of appropriate prophylaxis of VTE were included. Primary outcomes assessed were rate of appropriate prophylaxis for VTE and rate of VTE events. A total of 156,366 patients were analyzed, of which 104,241 (66%) received intervention with CCDSSs and 52,125 (33%) received standard care (physician judgment and discretion). The use of CCDSSs was associated with a significant increase in the rate of appropriate ordering of prophylaxis for VTE (odds ratio, 2.35; 95% confidence interval, 1.78-3.10; P less than .001) and a significant decrease in the risk of VTE events (risk ratio, 0.78; 95% CI, 0.72-0.85; P less than .001). The major limitation of this study is that it did not evaluate the number of adverse events as a result of VTE prophylaxis, such as bleeding, which may have been significantly increased in the CCDSS group.
Bottom Line: The use of CCDSSs increases the proportion of surgical patients who are prescribed adequate prophylaxis for VTE and correlates with a reduction in VTE events.
Citation: Borab ZM, Lanni MA, Tecce MG, Pannucci CJ, Fischer JP. Use of computerized clinical decision support systems to prevent venous thromboembolism in surgical patients: A systematic review and meta-analysis. JAMA Surg. 2017; doi: 10.1001/jamasurg.2017.0131.
Dr. Mayasy is assistant professor in the department of hospital medicine at the University of New Mexico.
Title: Use of computerized clinical decision support systems decreases venous thromboembolic events in surgical patients
Clinical Question: Do computerized clinical decision support systems (CCDSSs) decrease the risk of venous thromboembolism (VTE) in surgical patients?
Background: VTE remains the leading preventable cause of death in the hospital. Despite multiple tools that are available to stratify risk of VTE, they are not used uniformly or are used incorrectly. It is unclear whether CCDSSs help prevent VTE compared to standard care.
Study Design: Retrospective systematic review and meta-analysis.
Setting: 188 studies initially screened, 11 studies were included.
Synopsis: Multiple studies relevant to the topic were reviewed; only studies that used an electronic medical record (EMR)–based tool to augment the rate of appropriate prophylaxis of VTE were included. Primary outcomes assessed were rate of appropriate prophylaxis for VTE and rate of VTE events. A total of 156,366 patients were analyzed, of which 104,241 (66%) received intervention with CCDSSs and 52,125 (33%) received standard care (physician judgment and discretion). The use of CCDSSs was associated with a significant increase in the rate of appropriate ordering of prophylaxis for VTE (odds ratio, 2.35; 95% confidence interval, 1.78-3.10; P less than .001) and a significant decrease in the risk of VTE events (risk ratio, 0.78; 95% CI, 0.72-0.85; P less than .001). The major limitation of this study is that it did not evaluate the number of adverse events as a result of VTE prophylaxis, such as bleeding, which may have been significantly increased in the CCDSS group.
Bottom Line: The use of CCDSSs increases the proportion of surgical patients who are prescribed adequate prophylaxis for VTE and correlates with a reduction in VTE events.
Citation: Borab ZM, Lanni MA, Tecce MG, Pannucci CJ, Fischer JP. Use of computerized clinical decision support systems to prevent venous thromboembolism in surgical patients: A systematic review and meta-analysis. JAMA Surg. 2017; doi: 10.1001/jamasurg.2017.0131.
Dr. Mayasy is assistant professor in the department of hospital medicine at the University of New Mexico.
Title: Use of computerized clinical decision support systems decreases venous thromboembolic events in surgical patients
Clinical Question: Do computerized clinical decision support systems (CCDSSs) decrease the risk of venous thromboembolism (VTE) in surgical patients?
Background: VTE remains the leading preventable cause of death in the hospital. Despite multiple tools that are available to stratify risk of VTE, they are not used uniformly or are used incorrectly. It is unclear whether CCDSSs help prevent VTE compared to standard care.
Study Design: Retrospective systematic review and meta-analysis.
Setting: 188 studies initially screened, 11 studies were included.
Synopsis: Multiple studies relevant to the topic were reviewed; only studies that used an electronic medical record (EMR)–based tool to augment the rate of appropriate prophylaxis of VTE were included. Primary outcomes assessed were rate of appropriate prophylaxis for VTE and rate of VTE events. A total of 156,366 patients were analyzed, of which 104,241 (66%) received intervention with CCDSSs and 52,125 (33%) received standard care (physician judgment and discretion). The use of CCDSSs was associated with a significant increase in the rate of appropriate ordering of prophylaxis for VTE (odds ratio, 2.35; 95% confidence interval, 1.78-3.10; P less than .001) and a significant decrease in the risk of VTE events (risk ratio, 0.78; 95% CI, 0.72-0.85; P less than .001). The major limitation of this study is that it did not evaluate the number of adverse events as a result of VTE prophylaxis, such as bleeding, which may have been significantly increased in the CCDSS group.
Bottom Line: The use of CCDSSs increases the proportion of surgical patients who are prescribed adequate prophylaxis for VTE and correlates with a reduction in VTE events.
Citation: Borab ZM, Lanni MA, Tecce MG, Pannucci CJ, Fischer JP. Use of computerized clinical decision support systems to prevent venous thromboembolism in surgical patients: A systematic review and meta-analysis. JAMA Surg. 2017; doi: 10.1001/jamasurg.2017.0131.
Dr. Mayasy is assistant professor in the department of hospital medicine at the University of New Mexico.
Ask PAs to Complete Survey on Joining 1st SVS ‘Section’
SVS President Dr. Clem Darling is asking all members to pass an email message – and survey – along to PAs and Nurse Practitioners with whom members work.
During the recent Vascular Annual Meeting, SVS leaders met with six physician assistants, all of whom work in vascular settings, and asked if they wish to work on establishing a home within the SVS. “Their response was a resounding and enthusiastic …YES!,” said Dr. Darling.
The group has now become the Steering Committee organizing the effort to create the historic first "Section" of the SVS.
SVS President Dr. Clem Darling is asking all members to pass an email message – and survey – along to PAs and Nurse Practitioners with whom members work.
During the recent Vascular Annual Meeting, SVS leaders met with six physician assistants, all of whom work in vascular settings, and asked if they wish to work on establishing a home within the SVS. “Their response was a resounding and enthusiastic …YES!,” said Dr. Darling.
The group has now become the Steering Committee organizing the effort to create the historic first "Section" of the SVS.
SVS President Dr. Clem Darling is asking all members to pass an email message – and survey – along to PAs and Nurse Practitioners with whom members work.
During the recent Vascular Annual Meeting, SVS leaders met with six physician assistants, all of whom work in vascular settings, and asked if they wish to work on establishing a home within the SVS. “Their response was a resounding and enthusiastic …YES!,” said Dr. Darling.
The group has now become the Steering Committee organizing the effort to create the historic first "Section" of the SVS.
Senate parliamentarian upends GOP hopes for health bill
The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.
Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.
The list was released by Democrats on the Senate Budget Committee and later confirmed by a spokesman for the committee Republicans. It is the result of what is called the “Byrd Bath,” a process in which the parliamentarian hears arguments from Democrats and Republicans and then advises on which provisions comply with the Byrd Rule. That rule requires that only matters directly pertaining to the federal budget are included. The rule is named for former Senate Majority Leader Robert Byrd (D-W.Va.), who first wrote it.
Senate Republicans were quick to point out that the document is “guidance” that they can use to try to rewrite impermissible language. The guidance “will help inform action on the legislation going forward,” said a spokesman for Senate Budget Committee Chairman Mike Enzi (R-Wyo.).
Among the other provisions that the parliamentarian has advised should require 60 votes are ones that would eliminate Medicaid requirements to provide 10 “essential health benefits.” Also on the list is a provision to repeal a requirement that insurers spend a minimum amount of each premium dollar on direct medical services, rather than administration or profits.
The determination also pertains to a part of the bill that would continue payments for “cost-sharing subsidies” to insurers for 2 more years. Those subsidies help lower-income people afford out-of-pocket costs such as deductibles. The parliamentarian said that duplicated existing law.
Ms. MacDonough also said that a provision in the House version of the bill that pertains directly to New York violates the Byrd Rule. That measure would change the way the state collects money for Medicaid. That could suggest efforts by Senate Majority Leader Mitch McConnell (R-Ky.) to offer state-specific changes to gain support for the bill might meet the same fate.
Minority Leader Chuck Schumer (D-N.Y.) said that decision could have “the greatest effect on Republicans’ ability to pass this bill.” He predicted it would “tie the majority leader’s hands as he tries to win over reluctant Republicans.”
Some of the provisions that didn’t pass muster with Ms. MacDonough were key to getting the bill through the House. And if they are dropped, it might make it difficult for the House to approve a final version of the bill.
Not all the decisions went the Democrats’ way. Ms. MacDonough found that only a simple majority is needed for language allowing states to impose work requirements for Medicaid recipients. She also said that a provision that will ban abortions if the services are paid through a new fund provided to states would be allowed. That’s because that fund will be governed by existing rules that already ban abortion in most cases.
A few provisions remain under review, according to the list. Those include allowing states to waive a long list of insurance protections, including the ACA’s essential health benefits and preexisting coverage guarantees. Also still under review is language allowing small businesses to pool together to purchase insurance as well as a provision changing requirements related to how much more insurers can charge older adults.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.
Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.
The list was released by Democrats on the Senate Budget Committee and later confirmed by a spokesman for the committee Republicans. It is the result of what is called the “Byrd Bath,” a process in which the parliamentarian hears arguments from Democrats and Republicans and then advises on which provisions comply with the Byrd Rule. That rule requires that only matters directly pertaining to the federal budget are included. The rule is named for former Senate Majority Leader Robert Byrd (D-W.Va.), who first wrote it.
Senate Republicans were quick to point out that the document is “guidance” that they can use to try to rewrite impermissible language. The guidance “will help inform action on the legislation going forward,” said a spokesman for Senate Budget Committee Chairman Mike Enzi (R-Wyo.).
Among the other provisions that the parliamentarian has advised should require 60 votes are ones that would eliminate Medicaid requirements to provide 10 “essential health benefits.” Also on the list is a provision to repeal a requirement that insurers spend a minimum amount of each premium dollar on direct medical services, rather than administration or profits.
The determination also pertains to a part of the bill that would continue payments for “cost-sharing subsidies” to insurers for 2 more years. Those subsidies help lower-income people afford out-of-pocket costs such as deductibles. The parliamentarian said that duplicated existing law.
Ms. MacDonough also said that a provision in the House version of the bill that pertains directly to New York violates the Byrd Rule. That measure would change the way the state collects money for Medicaid. That could suggest efforts by Senate Majority Leader Mitch McConnell (R-Ky.) to offer state-specific changes to gain support for the bill might meet the same fate.
Minority Leader Chuck Schumer (D-N.Y.) said that decision could have “the greatest effect on Republicans’ ability to pass this bill.” He predicted it would “tie the majority leader’s hands as he tries to win over reluctant Republicans.”
Some of the provisions that didn’t pass muster with Ms. MacDonough were key to getting the bill through the House. And if they are dropped, it might make it difficult for the House to approve a final version of the bill.
Not all the decisions went the Democrats’ way. Ms. MacDonough found that only a simple majority is needed for language allowing states to impose work requirements for Medicaid recipients. She also said that a provision that will ban abortions if the services are paid through a new fund provided to states would be allowed. That’s because that fund will be governed by existing rules that already ban abortion in most cases.
A few provisions remain under review, according to the list. Those include allowing states to waive a long list of insurance protections, including the ACA’s essential health benefits and preexisting coverage guarantees. Also still under review is language allowing small businesses to pool together to purchase insurance as well as a provision changing requirements related to how much more insurers can charge older adults.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.
Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.
The list was released by Democrats on the Senate Budget Committee and later confirmed by a spokesman for the committee Republicans. It is the result of what is called the “Byrd Bath,” a process in which the parliamentarian hears arguments from Democrats and Republicans and then advises on which provisions comply with the Byrd Rule. That rule requires that only matters directly pertaining to the federal budget are included. The rule is named for former Senate Majority Leader Robert Byrd (D-W.Va.), who first wrote it.
Senate Republicans were quick to point out that the document is “guidance” that they can use to try to rewrite impermissible language. The guidance “will help inform action on the legislation going forward,” said a spokesman for Senate Budget Committee Chairman Mike Enzi (R-Wyo.).
Among the other provisions that the parliamentarian has advised should require 60 votes are ones that would eliminate Medicaid requirements to provide 10 “essential health benefits.” Also on the list is a provision to repeal a requirement that insurers spend a minimum amount of each premium dollar on direct medical services, rather than administration or profits.
The determination also pertains to a part of the bill that would continue payments for “cost-sharing subsidies” to insurers for 2 more years. Those subsidies help lower-income people afford out-of-pocket costs such as deductibles. The parliamentarian said that duplicated existing law.
Ms. MacDonough also said that a provision in the House version of the bill that pertains directly to New York violates the Byrd Rule. That measure would change the way the state collects money for Medicaid. That could suggest efforts by Senate Majority Leader Mitch McConnell (R-Ky.) to offer state-specific changes to gain support for the bill might meet the same fate.
Minority Leader Chuck Schumer (D-N.Y.) said that decision could have “the greatest effect on Republicans’ ability to pass this bill.” He predicted it would “tie the majority leader’s hands as he tries to win over reluctant Republicans.”
Some of the provisions that didn’t pass muster with Ms. MacDonough were key to getting the bill through the House. And if they are dropped, it might make it difficult for the House to approve a final version of the bill.
Not all the decisions went the Democrats’ way. Ms. MacDonough found that only a simple majority is needed for language allowing states to impose work requirements for Medicaid recipients. She also said that a provision that will ban abortions if the services are paid through a new fund provided to states would be allowed. That’s because that fund will be governed by existing rules that already ban abortion in most cases.
A few provisions remain under review, according to the list. Those include allowing states to waive a long list of insurance protections, including the ACA’s essential health benefits and preexisting coverage guarantees. Also still under review is language allowing small businesses to pool together to purchase insurance as well as a provision changing requirements related to how much more insurers can charge older adults.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Novel knee osteoarthritis drugs target pain, joint space narrowing
MADRID – Two independently conducted, randomized, phase 2 trials of novel agents for moderate to severe knee osteoarthritis have produced promising results, as reported at the European Congress of Rheumatology.
In the 24-week, dose-ranging TRIUMPH trial involving 175 patients, treatment with the synthetic trans-capsaicin CNTX-4975 was associated with improvements in several clinical parameters, such as pain when walking, knee stiffness, and physical function, as well as being generally well tolerated.
These findings suggest that both could be future alternatives to using nonsteroidal anti-inflammatory drugs (NSAIDs), injected corticosteroids, and opioid analgesics, which are currently used to help manage knee OA.
Synthetic trans-capsaicin CNTX-4975
“Few effective pharmacologic therapies are available to manage the chronic pain of OA,” said Randall Stevens, MD, chief medical officer for Centrexion Therapeutics (Boston), the company developing CNTX-4975. Both NSAIDs and corticosteroids are associated with substantial toxicities, he argued, and opioid analgesics are not ideal to use long term because of the risk of side effects and addiction.
CNTX-4975 is a nonopioid analgesic that acts directly on the pain fibers in the knee, Dr. Stevens explained. Specifically, after a single injection, it targets the capsaicin receptor (transient receptor potential vanilloid 1, TRPV1) to inactivate only the local fibers transmitting pain signals to the brain. It does not affect other sensory fibers involved in sensation to touch or pressure, he said.
The aim of the phase 2b TRIUMPH trial was to examine the efficacy and safety of two doses (0.5 mg and 1.0 mg) of the synthetic trans-capsaicin versus placebo in patients with chronic, stable, moderate to severe knee OA who had been experiencing knee pain for at least 2 months or more. For inclusion, patients could be aged between 45 and 80 years, have a body mass index of up to 45 kg/m2, and had to have failed treatment or not be able to tolerate oral or intra-articular analgesics. Patients who had undergone recent knee surgery were excluded.
The primary endpoint was the change in pain with walking from baseline to week 12 measured as the area under the curve (AUC) for daily Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 score. Significant improvements were seen, with a least squares mean difference (LSMD) of –0.8 (P = .07) and –1.6 (P less than .0001) with the 0.5 mg and 1.0 mg doses of CNTX-4975, respectively, versus placebo.
The effects of CNTX-4975 were maintained to 24 weeks, Dr. Stevens reported, with significant improvements in pain with walking, comparing the 1.0-mg dose with placebo (LSMD, –1.35; P = .0002).
“These are the largest effect sizes I’ve seen with osteoarthritis knee pain,” Dr. Stevens said.
The investigators saw improvements in other efficacy endpoints, such as the weekly pain with walking (WOMAC A1) score and the change in weekly average joint stiffness (WOMAC B subscale, LSMD: −2.5; P = .0013) and physical function (WOMAC C subscale, LSMD: −18.3; P = .004) versus placebo at week 12. Numerically greater improvements occurred at week 24.
A similar percentage of patients experienced any treatment-emergent adverse events in the 1.0-mg (29.6%) CNTX-4975 treated and placebo groups (30%). Although a higher percentage of patients given the lower CNTX-4975 dose reported side effects (47.1%), most were mild to moderate and were considered unrelated to study treatment. Arthralgia was the most common side effect with CNTX-4975 1.0 mg versus placebo (7% vs. 5.7%).
“With these findings, we are moving in to phase 3 with the 1.0-mg dose,” Dr. Stevens said.
Wnt inhibitor SM04690
Promising data from the phase 2 trial of the Wnt inhibitor SM04690 also suggest that it, too, could soon be heading into phase 3 trials.
Several early clinical studies have been completed already, noted Yusuf Yazici, MD, chief medical officer of Samumed (San Diego), the California-based company that is developing SMO4690.
SM04690 is a small molecule inhibitor of the Wnt pathway, which is involved in increased bone formation and turnover, he explained. The hypothesis is that by blocking this pathway, the joint can be protected and cartilage could perhaps be regenerated.
Dr. Yazici presented radiographic outcomes at 26 weeks from a 52-week trial that “demonstrated SM04690 treatment maintained or increased medial joint space width compared to placebo.” This is important, as “joint space narrowing is indicative of OA progression and is predictive of knee surgery,” and radiographic progression remains a “gold standard” for assessing potential disease modification in OA, said Dr. Yazici, who is also clinical associate professor and director of the Seligman Center for Advanced Therapeutics at New York University.
In the phase 2 trial he presented, three doses of SM04690 (0.03 mg, 0.07 mg, and 0.23 mg), given as one 2-mL intra-articular injection into a single target knee, were tested and compared against placebo. The target knee was the knee designated as causing the patient the most pain, according to the study investigator.
Radiographs of both knees were taken at the start of treatment, at week 26, and again at week 52, with the change in medial joint space width analyzed. Clinical assessments included changes in WOMAC total, function, and pain subscale scores, and patients’ and physicians’ global assessments.
A total of 455 subjects, mean age 60 years, were randomized into the trial.
Considering all patients, the mean increase in medial joint space width from baseline to 26-week assessment versus placebo was –0.07 mm in the SM04690 0.03-mg group, –0.16 mm in the SM04690 0.07-mg group, and –0.03 mm in the SM04690 0.23-mg group.
An improvement in mean medial joint space narrowing was observed in 47.6% with SM04690 0.03 mg, 40.5% with 0.07 mg, 39.6% with 0.23 mg, and 30.5% with placebo. There was no change in a respective 7.6%, 9%, 17.8%, and 11.4%, and narrowing in the remainder (44.8%, 50.5%, 42,6%, and 58.1%) in this intent-to-treat population.
The investigators conducted prespecified subanalyses in a “unilateral symptomatic” population of 164 patients, and this showed slightly better results, with a higher probability of improved medial joint space width with SM04690 than with placebo (odds ratio, 5.2; 95% confidence interval, 2.1-12.8; P less than .001).
However, an important limitation of the study is that it was not formerly powered to look at radiographic progression, Dr. Yazici said. Nevertheless, radiographs were centrally read and high intra- and inter-observer reproducibility was observed.
Safety and clinical outcomes from the trial, which were reported separately in a poster at the meeting, showed no undue concerns and clinically meaningful improvements in both patients’ and physicians’ global assessments of pain with SM04690 versus placebo.
“Radiographic and clinical outcomes from this 26-week interim analysis of a 52-week trial suggest that SM04690 has potential as a disease-modifying osteoarthritis drug (DMOAD) for knee OA,” Dr. Yazici concluded.
The studies were supported by Samumed and by Centrexion Therapeutics. Dr. Yazici is an employee and shareholder of Samumed. Dr. Stevens is an employee and shareholder of Centrexion Therapeutics.
MADRID – Two independently conducted, randomized, phase 2 trials of novel agents for moderate to severe knee osteoarthritis have produced promising results, as reported at the European Congress of Rheumatology.
In the 24-week, dose-ranging TRIUMPH trial involving 175 patients, treatment with the synthetic trans-capsaicin CNTX-4975 was associated with improvements in several clinical parameters, such as pain when walking, knee stiffness, and physical function, as well as being generally well tolerated.
These findings suggest that both could be future alternatives to using nonsteroidal anti-inflammatory drugs (NSAIDs), injected corticosteroids, and opioid analgesics, which are currently used to help manage knee OA.
Synthetic trans-capsaicin CNTX-4975
“Few effective pharmacologic therapies are available to manage the chronic pain of OA,” said Randall Stevens, MD, chief medical officer for Centrexion Therapeutics (Boston), the company developing CNTX-4975. Both NSAIDs and corticosteroids are associated with substantial toxicities, he argued, and opioid analgesics are not ideal to use long term because of the risk of side effects and addiction.
CNTX-4975 is a nonopioid analgesic that acts directly on the pain fibers in the knee, Dr. Stevens explained. Specifically, after a single injection, it targets the capsaicin receptor (transient receptor potential vanilloid 1, TRPV1) to inactivate only the local fibers transmitting pain signals to the brain. It does not affect other sensory fibers involved in sensation to touch or pressure, he said.
The aim of the phase 2b TRIUMPH trial was to examine the efficacy and safety of two doses (0.5 mg and 1.0 mg) of the synthetic trans-capsaicin versus placebo in patients with chronic, stable, moderate to severe knee OA who had been experiencing knee pain for at least 2 months or more. For inclusion, patients could be aged between 45 and 80 years, have a body mass index of up to 45 kg/m2, and had to have failed treatment or not be able to tolerate oral or intra-articular analgesics. Patients who had undergone recent knee surgery were excluded.
The primary endpoint was the change in pain with walking from baseline to week 12 measured as the area under the curve (AUC) for daily Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 score. Significant improvements were seen, with a least squares mean difference (LSMD) of –0.8 (P = .07) and –1.6 (P less than .0001) with the 0.5 mg and 1.0 mg doses of CNTX-4975, respectively, versus placebo.
The effects of CNTX-4975 were maintained to 24 weeks, Dr. Stevens reported, with significant improvements in pain with walking, comparing the 1.0-mg dose with placebo (LSMD, –1.35; P = .0002).
“These are the largest effect sizes I’ve seen with osteoarthritis knee pain,” Dr. Stevens said.
The investigators saw improvements in other efficacy endpoints, such as the weekly pain with walking (WOMAC A1) score and the change in weekly average joint stiffness (WOMAC B subscale, LSMD: −2.5; P = .0013) and physical function (WOMAC C subscale, LSMD: −18.3; P = .004) versus placebo at week 12. Numerically greater improvements occurred at week 24.
A similar percentage of patients experienced any treatment-emergent adverse events in the 1.0-mg (29.6%) CNTX-4975 treated and placebo groups (30%). Although a higher percentage of patients given the lower CNTX-4975 dose reported side effects (47.1%), most were mild to moderate and were considered unrelated to study treatment. Arthralgia was the most common side effect with CNTX-4975 1.0 mg versus placebo (7% vs. 5.7%).
“With these findings, we are moving in to phase 3 with the 1.0-mg dose,” Dr. Stevens said.
Wnt inhibitor SM04690
Promising data from the phase 2 trial of the Wnt inhibitor SM04690 also suggest that it, too, could soon be heading into phase 3 trials.
Several early clinical studies have been completed already, noted Yusuf Yazici, MD, chief medical officer of Samumed (San Diego), the California-based company that is developing SMO4690.
SM04690 is a small molecule inhibitor of the Wnt pathway, which is involved in increased bone formation and turnover, he explained. The hypothesis is that by blocking this pathway, the joint can be protected and cartilage could perhaps be regenerated.
Dr. Yazici presented radiographic outcomes at 26 weeks from a 52-week trial that “demonstrated SM04690 treatment maintained or increased medial joint space width compared to placebo.” This is important, as “joint space narrowing is indicative of OA progression and is predictive of knee surgery,” and radiographic progression remains a “gold standard” for assessing potential disease modification in OA, said Dr. Yazici, who is also clinical associate professor and director of the Seligman Center for Advanced Therapeutics at New York University.
In the phase 2 trial he presented, three doses of SM04690 (0.03 mg, 0.07 mg, and 0.23 mg), given as one 2-mL intra-articular injection into a single target knee, were tested and compared against placebo. The target knee was the knee designated as causing the patient the most pain, according to the study investigator.
Radiographs of both knees were taken at the start of treatment, at week 26, and again at week 52, with the change in medial joint space width analyzed. Clinical assessments included changes in WOMAC total, function, and pain subscale scores, and patients’ and physicians’ global assessments.
A total of 455 subjects, mean age 60 years, were randomized into the trial.
Considering all patients, the mean increase in medial joint space width from baseline to 26-week assessment versus placebo was –0.07 mm in the SM04690 0.03-mg group, –0.16 mm in the SM04690 0.07-mg group, and –0.03 mm in the SM04690 0.23-mg group.
An improvement in mean medial joint space narrowing was observed in 47.6% with SM04690 0.03 mg, 40.5% with 0.07 mg, 39.6% with 0.23 mg, and 30.5% with placebo. There was no change in a respective 7.6%, 9%, 17.8%, and 11.4%, and narrowing in the remainder (44.8%, 50.5%, 42,6%, and 58.1%) in this intent-to-treat population.
The investigators conducted prespecified subanalyses in a “unilateral symptomatic” population of 164 patients, and this showed slightly better results, with a higher probability of improved medial joint space width with SM04690 than with placebo (odds ratio, 5.2; 95% confidence interval, 2.1-12.8; P less than .001).
However, an important limitation of the study is that it was not formerly powered to look at radiographic progression, Dr. Yazici said. Nevertheless, radiographs were centrally read and high intra- and inter-observer reproducibility was observed.
Safety and clinical outcomes from the trial, which were reported separately in a poster at the meeting, showed no undue concerns and clinically meaningful improvements in both patients’ and physicians’ global assessments of pain with SM04690 versus placebo.
“Radiographic and clinical outcomes from this 26-week interim analysis of a 52-week trial suggest that SM04690 has potential as a disease-modifying osteoarthritis drug (DMOAD) for knee OA,” Dr. Yazici concluded.
The studies were supported by Samumed and by Centrexion Therapeutics. Dr. Yazici is an employee and shareholder of Samumed. Dr. Stevens is an employee and shareholder of Centrexion Therapeutics.
MADRID – Two independently conducted, randomized, phase 2 trials of novel agents for moderate to severe knee osteoarthritis have produced promising results, as reported at the European Congress of Rheumatology.
In the 24-week, dose-ranging TRIUMPH trial involving 175 patients, treatment with the synthetic trans-capsaicin CNTX-4975 was associated with improvements in several clinical parameters, such as pain when walking, knee stiffness, and physical function, as well as being generally well tolerated.
These findings suggest that both could be future alternatives to using nonsteroidal anti-inflammatory drugs (NSAIDs), injected corticosteroids, and opioid analgesics, which are currently used to help manage knee OA.
Synthetic trans-capsaicin CNTX-4975
“Few effective pharmacologic therapies are available to manage the chronic pain of OA,” said Randall Stevens, MD, chief medical officer for Centrexion Therapeutics (Boston), the company developing CNTX-4975. Both NSAIDs and corticosteroids are associated with substantial toxicities, he argued, and opioid analgesics are not ideal to use long term because of the risk of side effects and addiction.
CNTX-4975 is a nonopioid analgesic that acts directly on the pain fibers in the knee, Dr. Stevens explained. Specifically, after a single injection, it targets the capsaicin receptor (transient receptor potential vanilloid 1, TRPV1) to inactivate only the local fibers transmitting pain signals to the brain. It does not affect other sensory fibers involved in sensation to touch or pressure, he said.
The aim of the phase 2b TRIUMPH trial was to examine the efficacy and safety of two doses (0.5 mg and 1.0 mg) of the synthetic trans-capsaicin versus placebo in patients with chronic, stable, moderate to severe knee OA who had been experiencing knee pain for at least 2 months or more. For inclusion, patients could be aged between 45 and 80 years, have a body mass index of up to 45 kg/m2, and had to have failed treatment or not be able to tolerate oral or intra-articular analgesics. Patients who had undergone recent knee surgery were excluded.
The primary endpoint was the change in pain with walking from baseline to week 12 measured as the area under the curve (AUC) for daily Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 score. Significant improvements were seen, with a least squares mean difference (LSMD) of –0.8 (P = .07) and –1.6 (P less than .0001) with the 0.5 mg and 1.0 mg doses of CNTX-4975, respectively, versus placebo.
The effects of CNTX-4975 were maintained to 24 weeks, Dr. Stevens reported, with significant improvements in pain with walking, comparing the 1.0-mg dose with placebo (LSMD, –1.35; P = .0002).
“These are the largest effect sizes I’ve seen with osteoarthritis knee pain,” Dr. Stevens said.
The investigators saw improvements in other efficacy endpoints, such as the weekly pain with walking (WOMAC A1) score and the change in weekly average joint stiffness (WOMAC B subscale, LSMD: −2.5; P = .0013) and physical function (WOMAC C subscale, LSMD: −18.3; P = .004) versus placebo at week 12. Numerically greater improvements occurred at week 24.
A similar percentage of patients experienced any treatment-emergent adverse events in the 1.0-mg (29.6%) CNTX-4975 treated and placebo groups (30%). Although a higher percentage of patients given the lower CNTX-4975 dose reported side effects (47.1%), most were mild to moderate and were considered unrelated to study treatment. Arthralgia was the most common side effect with CNTX-4975 1.0 mg versus placebo (7% vs. 5.7%).
“With these findings, we are moving in to phase 3 with the 1.0-mg dose,” Dr. Stevens said.
Wnt inhibitor SM04690
Promising data from the phase 2 trial of the Wnt inhibitor SM04690 also suggest that it, too, could soon be heading into phase 3 trials.
Several early clinical studies have been completed already, noted Yusuf Yazici, MD, chief medical officer of Samumed (San Diego), the California-based company that is developing SMO4690.
SM04690 is a small molecule inhibitor of the Wnt pathway, which is involved in increased bone formation and turnover, he explained. The hypothesis is that by blocking this pathway, the joint can be protected and cartilage could perhaps be regenerated.
Dr. Yazici presented radiographic outcomes at 26 weeks from a 52-week trial that “demonstrated SM04690 treatment maintained or increased medial joint space width compared to placebo.” This is important, as “joint space narrowing is indicative of OA progression and is predictive of knee surgery,” and radiographic progression remains a “gold standard” for assessing potential disease modification in OA, said Dr. Yazici, who is also clinical associate professor and director of the Seligman Center for Advanced Therapeutics at New York University.
In the phase 2 trial he presented, three doses of SM04690 (0.03 mg, 0.07 mg, and 0.23 mg), given as one 2-mL intra-articular injection into a single target knee, were tested and compared against placebo. The target knee was the knee designated as causing the patient the most pain, according to the study investigator.
Radiographs of both knees were taken at the start of treatment, at week 26, and again at week 52, with the change in medial joint space width analyzed. Clinical assessments included changes in WOMAC total, function, and pain subscale scores, and patients’ and physicians’ global assessments.
A total of 455 subjects, mean age 60 years, were randomized into the trial.
Considering all patients, the mean increase in medial joint space width from baseline to 26-week assessment versus placebo was –0.07 mm in the SM04690 0.03-mg group, –0.16 mm in the SM04690 0.07-mg group, and –0.03 mm in the SM04690 0.23-mg group.
An improvement in mean medial joint space narrowing was observed in 47.6% with SM04690 0.03 mg, 40.5% with 0.07 mg, 39.6% with 0.23 mg, and 30.5% with placebo. There was no change in a respective 7.6%, 9%, 17.8%, and 11.4%, and narrowing in the remainder (44.8%, 50.5%, 42,6%, and 58.1%) in this intent-to-treat population.
The investigators conducted prespecified subanalyses in a “unilateral symptomatic” population of 164 patients, and this showed slightly better results, with a higher probability of improved medial joint space width with SM04690 than with placebo (odds ratio, 5.2; 95% confidence interval, 2.1-12.8; P less than .001).
However, an important limitation of the study is that it was not formerly powered to look at radiographic progression, Dr. Yazici said. Nevertheless, radiographs were centrally read and high intra- and inter-observer reproducibility was observed.
Safety and clinical outcomes from the trial, which were reported separately in a poster at the meeting, showed no undue concerns and clinically meaningful improvements in both patients’ and physicians’ global assessments of pain with SM04690 versus placebo.
“Radiographic and clinical outcomes from this 26-week interim analysis of a 52-week trial suggest that SM04690 has potential as a disease-modifying osteoarthritis drug (DMOAD) for knee OA,” Dr. Yazici concluded.
The studies were supported by Samumed and by Centrexion Therapeutics. Dr. Yazici is an employee and shareholder of Samumed. Dr. Stevens is an employee and shareholder of Centrexion Therapeutics.
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Radiographic joint space narrowing was no worse or improved after treatment with the Wnt pathway inhibitor SM04690. Treatment with the synthetic trans-capsaicin CNTX-4975 improved pain when walking, knee stiffness, and physical function.
Data source: Two independently conducted randomized, phase 2 trials of patients with moderate to severe knee OA: a 52-week trial with SM04690 in 455 patients and a 24-week trial of CNTX-4975 in 175 patients.
Disclosures: Samumed and Centrexion Therapeutics sponsored the two separate studies. The presenting authors were employees and shareholders of their respective companies.
Meta-analysis shows correlation between diabetes and erectile dysfunction
WASHINGTON – More than half of men with type 1 or type 2 diabetes develop erectile dysfunction, making them more than three times as likely to develop ED, compared with healthy men, according to a systematic review of diabetes studies.
Data on the exact prevalence of erectile dysfunction in this population has been lacking until now. More precise figures are available from a meta-analysis of 145 studies taken from international diabetes databases.
In terms of risk, men with diabetes were 3.62 (95% CI, 2.53-5.16; P less than .0001) times more likely to develop ED, compared with healthy controls, according to investigators (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403).
“Regarding sexual activity and the psychological impact of erectile dysfunction in men with diabetes mellitus, significant and positive associations have been found between depressive symptoms and erectile dysfunction,” said Youssef Kouidrat, MD, PhD, of the department of psychosis studies, Institute of Psychiatry, King’s College London, and his fellow researchers. “Therefore, early detection of erectile dysfunction is essential to improve the psychological health and men’s quality of life.”
Given ED’s serious effects on patients’ physical and emotional well being, it is essential for physicians to have a better understanding of the root causes of the condition in order to help patients as soon as possible, wrote the investigators.
The studies included in the meta-analysis represented a population of 88.755 men with an average age of 56 years, with dates of the studies ranging from the inception of the databases they were taken from up until November 2016.
A majority of the studies included were conducted in Asia (61), followed by Europe (48), North America (17), Africa (15), and Oceania, South America, and multiple continents (4 in total).
South America reported the highest prevalence of ED (74.6%), while the lowest prevalence reported was among studies in North America (34.5%).
Patients who were assessed using the Sexual Health Inventory for Men (SHIM) score reported a higher ED prevalence (82.2%), as did men above the age of 60 years old (62.2%).
With ED correlated to cardiovascular health and mortality, investigators advise physicians to keep testing in mind when assessing patients’ cardiovascular risk.
This study was limited by incomplete data from studies included, which made it difficult to determine prevalence by certain categories.
Other limitations included the lack of separation between type 1 and type 2 diabetes among many of the studies analyzed, as well as a lack of information from the studies analyzed on other risk factors concerning diabetes-related erectile dysfunction.
Investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
WASHINGTON – More than half of men with type 1 or type 2 diabetes develop erectile dysfunction, making them more than three times as likely to develop ED, compared with healthy men, according to a systematic review of diabetes studies.
Data on the exact prevalence of erectile dysfunction in this population has been lacking until now. More precise figures are available from a meta-analysis of 145 studies taken from international diabetes databases.
In terms of risk, men with diabetes were 3.62 (95% CI, 2.53-5.16; P less than .0001) times more likely to develop ED, compared with healthy controls, according to investigators (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403).
“Regarding sexual activity and the psychological impact of erectile dysfunction in men with diabetes mellitus, significant and positive associations have been found between depressive symptoms and erectile dysfunction,” said Youssef Kouidrat, MD, PhD, of the department of psychosis studies, Institute of Psychiatry, King’s College London, and his fellow researchers. “Therefore, early detection of erectile dysfunction is essential to improve the psychological health and men’s quality of life.”
Given ED’s serious effects on patients’ physical and emotional well being, it is essential for physicians to have a better understanding of the root causes of the condition in order to help patients as soon as possible, wrote the investigators.
The studies included in the meta-analysis represented a population of 88.755 men with an average age of 56 years, with dates of the studies ranging from the inception of the databases they were taken from up until November 2016.
A majority of the studies included were conducted in Asia (61), followed by Europe (48), North America (17), Africa (15), and Oceania, South America, and multiple continents (4 in total).
South America reported the highest prevalence of ED (74.6%), while the lowest prevalence reported was among studies in North America (34.5%).
Patients who were assessed using the Sexual Health Inventory for Men (SHIM) score reported a higher ED prevalence (82.2%), as did men above the age of 60 years old (62.2%).
With ED correlated to cardiovascular health and mortality, investigators advise physicians to keep testing in mind when assessing patients’ cardiovascular risk.
This study was limited by incomplete data from studies included, which made it difficult to determine prevalence by certain categories.
Other limitations included the lack of separation between type 1 and type 2 diabetes among many of the studies analyzed, as well as a lack of information from the studies analyzed on other risk factors concerning diabetes-related erectile dysfunction.
Investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
WASHINGTON – More than half of men with type 1 or type 2 diabetes develop erectile dysfunction, making them more than three times as likely to develop ED, compared with healthy men, according to a systematic review of diabetes studies.
Data on the exact prevalence of erectile dysfunction in this population has been lacking until now. More precise figures are available from a meta-analysis of 145 studies taken from international diabetes databases.
In terms of risk, men with diabetes were 3.62 (95% CI, 2.53-5.16; P less than .0001) times more likely to develop ED, compared with healthy controls, according to investigators (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403).
“Regarding sexual activity and the psychological impact of erectile dysfunction in men with diabetes mellitus, significant and positive associations have been found between depressive symptoms and erectile dysfunction,” said Youssef Kouidrat, MD, PhD, of the department of psychosis studies, Institute of Psychiatry, King’s College London, and his fellow researchers. “Therefore, early detection of erectile dysfunction is essential to improve the psychological health and men’s quality of life.”
Given ED’s serious effects on patients’ physical and emotional well being, it is essential for physicians to have a better understanding of the root causes of the condition in order to help patients as soon as possible, wrote the investigators.
The studies included in the meta-analysis represented a population of 88.755 men with an average age of 56 years, with dates of the studies ranging from the inception of the databases they were taken from up until November 2016.
A majority of the studies included were conducted in Asia (61), followed by Europe (48), North America (17), Africa (15), and Oceania, South America, and multiple continents (4 in total).
South America reported the highest prevalence of ED (74.6%), while the lowest prevalence reported was among studies in North America (34.5%).
Patients who were assessed using the Sexual Health Inventory for Men (SHIM) score reported a higher ED prevalence (82.2%), as did men above the age of 60 years old (62.2%).
With ED correlated to cardiovascular health and mortality, investigators advise physicians to keep testing in mind when assessing patients’ cardiovascular risk.
This study was limited by incomplete data from studies included, which made it difficult to determine prevalence by certain categories.
Other limitations included the lack of separation between type 1 and type 2 diabetes among many of the studies analyzed, as well as a lack of information from the studies analyzed on other risk factors concerning diabetes-related erectile dysfunction.
Investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
FROM DIABETIC MEDICINE
Key clinical point:
Major finding: Men with diabetes showed an odds ratio of 3.62 (95% CI, 2.53-5.16; P less than .0001) of developing erectile dysfunction, compared with healthy controls.
Data source: An analysis of 145 studies representing 88,577 men from international databases spanning from creation of the database to November 2016.
Disclosures: Investigators report no relevant financial disclosures.
Painful autoimmune neuropathy may mimic Guillain-Barré syndrome
Patients with an acute transient immune response that is directed against small nerve fibers can display features similar to those of Guillain-Barré syndrome, according to Nobuhiro Yuki, PhD, and associates.
The investigators described three Chinese patients with severe pain in their extremities weeks after infectious illness. Pain greatly improved in two of the patients within days (up to 1 week) of treatment with intravenous immunoglobulin. One patient who refused intravenous immunoglobulin gradually improved with 3 weeks of prednisolone treatment but did not improve as much as the other two.
The investigators found that intrathecal injections of the sera from the acute phase of these patients’ illnesses into nociceptive thermal mouse models induced a transient thermal hypersensitivity, whereas sera from 25 patients with Charcot-Marie-Tooth disease and 25 patients with chronic inflammatory demyelinating polyneuropathy who served as disease controls did not. The intrathecal injections of sera from a healthy donor or from the first two of the three described patients after recovery did not affect thermal sensitivity.
Also, patients’ sera in the acute phase strongly and widely stained small nerve fibers in the dermis of the foot pads of the mice and colocalized with a nerve marker. The sera did not react against myelinated fibers from mouse sciatic nerves. Serum IgG antibodies immunostained the dorsal horn of the lumber spinal cord during the acute phase in all patients, but none of the patients showed reactivity in the convalescent phase.
Patients’ IgG antibodies reacted against surface antigens from the neuron cell body and axon from patients’ sera, but none of the patients with Charcot-Marie-Tooth or chronic inflammatory demyelinating polyneuropathy presented a similar reaction against dorsal root ganglion neurons.
“Our case series and the cases identified in the literature suggest that an acute immune response can be directed against small fibers and exhibit similarities to Guillain-Barré syndrome, including acute preceding infectious illness, a monophasic course, and albuminocytologic dissociation,” the researchers concluded. “It is also worth pointing out that patients with ‘acute small fiber sensory neuropathy’ subsequent to infection or vaccination do not always complain of pain, suggesting a different disease entity.”
Read the full study in Muscle & Nerve (2017. doi: 10.1002/mus.25738).
Patients with an acute transient immune response that is directed against small nerve fibers can display features similar to those of Guillain-Barré syndrome, according to Nobuhiro Yuki, PhD, and associates.
The investigators described three Chinese patients with severe pain in their extremities weeks after infectious illness. Pain greatly improved in two of the patients within days (up to 1 week) of treatment with intravenous immunoglobulin. One patient who refused intravenous immunoglobulin gradually improved with 3 weeks of prednisolone treatment but did not improve as much as the other two.
The investigators found that intrathecal injections of the sera from the acute phase of these patients’ illnesses into nociceptive thermal mouse models induced a transient thermal hypersensitivity, whereas sera from 25 patients with Charcot-Marie-Tooth disease and 25 patients with chronic inflammatory demyelinating polyneuropathy who served as disease controls did not. The intrathecal injections of sera from a healthy donor or from the first two of the three described patients after recovery did not affect thermal sensitivity.
Also, patients’ sera in the acute phase strongly and widely stained small nerve fibers in the dermis of the foot pads of the mice and colocalized with a nerve marker. The sera did not react against myelinated fibers from mouse sciatic nerves. Serum IgG antibodies immunostained the dorsal horn of the lumber spinal cord during the acute phase in all patients, but none of the patients showed reactivity in the convalescent phase.
Patients’ IgG antibodies reacted against surface antigens from the neuron cell body and axon from patients’ sera, but none of the patients with Charcot-Marie-Tooth or chronic inflammatory demyelinating polyneuropathy presented a similar reaction against dorsal root ganglion neurons.
“Our case series and the cases identified in the literature suggest that an acute immune response can be directed against small fibers and exhibit similarities to Guillain-Barré syndrome, including acute preceding infectious illness, a monophasic course, and albuminocytologic dissociation,” the researchers concluded. “It is also worth pointing out that patients with ‘acute small fiber sensory neuropathy’ subsequent to infection or vaccination do not always complain of pain, suggesting a different disease entity.”
Read the full study in Muscle & Nerve (2017. doi: 10.1002/mus.25738).
Patients with an acute transient immune response that is directed against small nerve fibers can display features similar to those of Guillain-Barré syndrome, according to Nobuhiro Yuki, PhD, and associates.
The investigators described three Chinese patients with severe pain in their extremities weeks after infectious illness. Pain greatly improved in two of the patients within days (up to 1 week) of treatment with intravenous immunoglobulin. One patient who refused intravenous immunoglobulin gradually improved with 3 weeks of prednisolone treatment but did not improve as much as the other two.
The investigators found that intrathecal injections of the sera from the acute phase of these patients’ illnesses into nociceptive thermal mouse models induced a transient thermal hypersensitivity, whereas sera from 25 patients with Charcot-Marie-Tooth disease and 25 patients with chronic inflammatory demyelinating polyneuropathy who served as disease controls did not. The intrathecal injections of sera from a healthy donor or from the first two of the three described patients after recovery did not affect thermal sensitivity.
Also, patients’ sera in the acute phase strongly and widely stained small nerve fibers in the dermis of the foot pads of the mice and colocalized with a nerve marker. The sera did not react against myelinated fibers from mouse sciatic nerves. Serum IgG antibodies immunostained the dorsal horn of the lumber spinal cord during the acute phase in all patients, but none of the patients showed reactivity in the convalescent phase.
Patients’ IgG antibodies reacted against surface antigens from the neuron cell body and axon from patients’ sera, but none of the patients with Charcot-Marie-Tooth or chronic inflammatory demyelinating polyneuropathy presented a similar reaction against dorsal root ganglion neurons.
“Our case series and the cases identified in the literature suggest that an acute immune response can be directed against small fibers and exhibit similarities to Guillain-Barré syndrome, including acute preceding infectious illness, a monophasic course, and albuminocytologic dissociation,” the researchers concluded. “It is also worth pointing out that patients with ‘acute small fiber sensory neuropathy’ subsequent to infection or vaccination do not always complain of pain, suggesting a different disease entity.”
Read the full study in Muscle & Nerve (2017. doi: 10.1002/mus.25738).
FROM MUSCLE & NERVE
5 ways White House can use its muscle to undercut Obamacare
President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.
He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.
In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.
Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)
“The administration has a lot of power to undermine the markets and make them dysfunctional,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms, who specializes in private insurance markets.
Here’s a look at five ways the White House is already working to weaken the health law, and what that means for consumers.
‘Cost-sharing reductions’
Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.
Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.
The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.
Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.
The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.
Weaken the mandate
The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.
Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.
For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.
But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.
If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.
Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.
But even with the mandate in effect, the efforts to defang it bring confusion.
“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.
As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.
“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”
Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.
A bare market
Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.
Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”
And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.
“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.
All quiet on the enrollment front
The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.
That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.
Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.
The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.
Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.
Again, Mr. Jost said, that affects insurer participation.
“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.
Word of (bad) mouth
HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.
If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.
Perceived hostility also has an effect on insurers, steering them away from marketplace participation.
“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.
He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.
In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.
Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)
“The administration has a lot of power to undermine the markets and make them dysfunctional,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms, who specializes in private insurance markets.
Here’s a look at five ways the White House is already working to weaken the health law, and what that means for consumers.
‘Cost-sharing reductions’
Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.
Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.
The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.
Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.
The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.
Weaken the mandate
The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.
Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.
For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.
But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.
If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.
Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.
But even with the mandate in effect, the efforts to defang it bring confusion.
“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.
As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.
“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”
Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.
A bare market
Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.
Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”
And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.
“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.
All quiet on the enrollment front
The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.
That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.
Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.
The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.
Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.
Again, Mr. Jost said, that affects insurer participation.
“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.
Word of (bad) mouth
HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.
If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.
Perceived hostility also has an effect on insurers, steering them away from marketplace participation.
“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
President Donald Trump has vowed to “let Obamacare fail,” after legislative efforts to undo the Affordable Care Act have stalled.
He and congressional Republicans have repeatedly portrayed the Affordable Care Act insurance marketplaces, also known as exchanges, as being in a “death spiral.” But independent analyses have concluded that such spontaneous disintegration isn’t happening.
In a number of ways, the Trump administration’s policies are pushing Obamacare into the vortex.
Reports from Standard & Poor’s, the Congressional Budget Office and the Kaiser Family Foundation all suggest that the exchanges – where people can shop for coverage, often with the help of a government subsidy – are stabilizing. (Kaiser Health News is an editorially independent program of the foundation.)
“The administration has a lot of power to undermine the markets and make them dysfunctional,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms, who specializes in private insurance markets.
Here’s a look at five ways the White House is already working to weaken the health law, and what that means for consumers.
‘Cost-sharing reductions’
Under the ACA, when someone’s income falls between 100% and 250% of the federal poverty level – up to about $29,000 for an individual or around $61,000 for a family of four – marketplace carriers must offer a plan with “cost-sharing reductions” (CSRs) that reduce consumers’ out-of-pocket expenses.
Reducing cost-sharing – generally copayments and deductibles – makes plans more expensive for the insurers. The Obama administration used its rule-making power to set up direct payments to carriers to help offset this burden. The Trump White House has inherited that responsibility but also has the power to end the payment program.
The nonpartisan Congressional Budget Office estimated CSR subsidies in 2017 would total about $7 billion. Without that money, analysts say, more insurers might choose to exit, limiting options for consumers, and letting the insurers who remain charge higher prices.
Trump has been committedly noncommittal, publicly indicating he would like to halt the subsidies, but so far – on a month-to-month basis – letting them continue.
The uncertainty makes insurance companies skittish about participating, analysts noted. It’s also one reason some plans say they have had to increase their rates, noted Charles Gaba, a Michigan-based blogger who tracks ACA sign-ups. For instance: When filing plans for the 2018 marketplace, carriers on average raised premiums by about 34% – with about 20 points stemming from CSR uncertainty, Mr. Gaba said, based on an analysis of 21 states’ initial rate filings. Dropping the subsidies altogether would be even more damaging.
Weaken the mandate
The White House has already signaled it does not want to enforce the individual mandate – the health law’s requirement that all people have coverage. And administration officials have repeated that position.
Meanwhile, in January, it issued an executive order that encouraged U.S. agencies to grant exemptions and waive or defer health law provisions that could put financial strain on companies or individuals – which could also be applied to the individual mandate.
For 2016 tax returns, though, the Internal Revenue Service continued to impose a financial penalty on people who didn’t have health insurance and who didn’t qualify for an exemption.
But enforcement may be waning. This year, the IRS was supposed to reject tax returns if people didn’t indicate whether they had coverage, flagging them for a potential penalty. Instead, it continued processing them, citing Trump’s executive order.
If the IRS has already processed any tax refunds for consumers, then they “don’t have much leverage” when attempting to collect the mandate fee, said Timothy Jost, emeritus law professor at Washington and Lee University in Virginia and an expert on health reform.
Enforcement of the mandate, economists note, is crucial to ensuring that enough healthy people buy coverage to balance the costs of sicker beneficiaries.
But even with the mandate in effect, the efforts to defang it bring confusion.
“A lot of people believe the Trump administration is not enforcing it,” Mr. Jost said.
As a result, healthy people may become less likely to buy insurance, even as sick ones continue seeking it. That means higher prices, and a shakier pool.
“If they don’t think they’re going to get healthy people in the risk pool, they’re going to increase their rates further to protect themselves,” Mr. Jost said. “And as they raise their rates further to protect themselves, people … start to drop out.”
Thus, the president’s position on the mandate is leaving insurance carriers and commissioners “apprehensive,” noted Mike Kreidler, Washington state’s insurance commissioner.
A bare market
Skittishness on the part of insurers could lead them to drop out of some marketplaces, leaving consumers in some areas with few or no choices. Those “bare markets” are possible under even stable circumstances – and preventing them requires active federal involvement.
Under the Obama administration, high-level officials were “on the phone daily with insurance company executives … trying to get them to participate,” Ms. Corlette said. “It was very much an all-hands-on-deck, ‘we’re going to make it work for you guys’ kind of communication.”
And so far Trump’s Department of Health and Human Services doesn’t appear to be emphasizing this kind of essential outreach, both Ms. Corlette and Mr. Jost suggested. A few months ago, Mr. Kreidler agreed, HHS staffers appeared interested in helping states fill their bare counties – but that support has since dwindled.
“This may be sort of under the radar, but it can have real, lasting effects” for consumer choice, Ms. Corlette said.
All quiet on the enrollment front
The administration could further undermine the marketplace by dropping outreach to consumers. It’s already a shorter enrollment period this year – spanning 6 weeks instead of 3 months, from Nov. 1 to Dec. 15 – though that change was already slated to eventually take effect.
That shorter period means people may miss the memo on signing up – or at least need an extra push, Ms. Corlette said. And that’s another way the administration could undermine the marketplaces: simply choosing not to advertise them.
Last sign-up season, HHS stopped open enrollment advertising in January, pulling ads a few days before the period ended. Enrollment dropped compared with previous years, Mr. Jost and Mr. Gaba noted, with young, healthy people being more likely not to buy coverage.
The administration also just stopped funding federal contractors that supported efforts by community groups and other organizations in some of the nation’s largest cities to sign up people.
Dropping advertising, shortening open enrollment, or simply scaling back on technical maintenance for the marketplace website could all have significant impact, Ms. Corlette said. People who are sick and need insurance will likely seek it out, but those who are healthier – for whom health insurance is a less pressing priority – could miss the boat.
Again, Mr. Jost said, that affects insurer participation.
“Insurance is a product that needs to be sold,” he said. “If the insurers believe they’re not going to get any help at all in marketing their product,” he added, fewer will want to enter the marketplace.
Word of (bad) mouth
HHS has taken an active role in criticizing the health law – pushing press releases and videos that argue it has helped more than hurt. That strategy could do a lot of harm, experts said.
If consumers keep hearing the law is failing, Mr. Jost noted, some will ultimately believe it, buying coverage only if they need it and thereby skewing the insurance risk pool.
Perceived hostility also has an effect on insurers, steering them away from marketplace participation.
“When you undermine confidence in the marketplace, you don’t need a Ph.D. in economics to know it’s not good long term,” Ms. Corlette said.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.