Jennie Smith

CDC officials are “deeply concerned” that a health care worker in Dallas has tested positive for Ebola virus as a result of contact with Thomas Duncan, the index patient from Liberia who died Oct 8.

In an emergency press conference Oct. 12, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, blamed what he called a breach of protocol for the infection.

CDC/Cynthia Goldsmith

However, Dr. Frieden said that investigators had yet to identify any specific breach of protocol at Texas Presbyterian Hospital, Dallas. He pointed to two procedures performed on Mr. Duncan – respiratory intubation and kidney dialysis – as having the potential to have spread infection to the health care worker.

Additional health care workers treating Mr. Duncan are being closely monitored along with all of Mr. Duncan’s contacts both before and after admission, Dr. Frieden said.

“Unfortunately, it is possible that we will see additional cases of Ebola,” he said.

The CDC is mulling a policy in which procedures performed on Ebola patients would be limited to those deemed “essential.” Pressed to explain, Dr. Frieden said that for example, blood draws to monitor electrolytes could be limited to one per day, down from three, to reduce potential for exposure.

Dr. Frieden also cited the need to reduce the number of health care workers caring for patients with Ebola.

The news of an infected health care worker at Texas Presbyterian Hospital, Dallas, which initially failed to isolate Mr. Duncan, drew questions as to whether suspected Ebola infection cases should be transferred to special treatment centers with isolation units instead of being treated for locally.

Dr. Frieden said that it was important that all hospitals be ready to diagnose and isolate Ebola patients safely. “We can’t have any hospital let its guard down,” he said, adding that the CDC has not ruled out transferring Ebola patients to specially equipped centers for treatment.

Confirmatory results for the health care worker were expected later Oct. 12, Dr. Frieden said. The health care worker had been self-monitoring for symptoms as instructed, when she presented with a low-grade fever, and viral levels that Dr. Frieden said appeared to be low. The health care worker only reported having a single contact following the first appearance of symptoms.

Dr. Frieden said that the agency was continuing to investigate the 48 contacts of Mr. Duncan before his isolation and admission to the hospital and that it had opened another investigation into his post-admission contacts.

“It’s deeply concerning that this occurred,” Dr. Frieden said, but he added that the case “doesn’t change the bottom line, which is that we know how to break the chain of transmission” though prompt diagnosis and isolation and notification of contacts.

This new infection signifies a further need to “ramp up infection control” in the hospital setting, he said. “We know how Ebola spreads, we know how to stop it, but this reemphasizes how meticulous we have to be.”

CDC officials are “deeply concerned” that a health care worker in Dallas has tested positive for Ebola virus as a result of contact with Thomas Duncan, the index patient from Liberia who died Oct 8.

In an emergency press conference Oct. 12, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, blamed what he called a breach of protocol for the infection.

CDC/Cynthia Goldsmith

However, Dr. Frieden said that investigators had yet to identify any specific breach of protocol at Texas Presbyterian Hospital, Dallas. He pointed to two procedures performed on Mr. Duncan – respiratory intubation and kidney dialysis – as having the potential to have spread infection to the health care worker.

Additional health care workers treating Mr. Duncan are being closely monitored along with all of Mr. Duncan’s contacts both before and after admission, Dr. Frieden said.

“Unfortunately, it is possible that we will see additional cases of Ebola,” he said.

The CDC is mulling a policy in which procedures performed on Ebola patients would be limited to those deemed “essential.” Pressed to explain, Dr. Frieden said that for example, blood draws to monitor electrolytes could be limited to one per day, down from three, to reduce potential for exposure.

Dr. Frieden also cited the need to reduce the number of health care workers caring for patients with Ebola.

The news of an infected health care worker at Texas Presbyterian Hospital, Dallas, which initially failed to isolate Mr. Duncan, drew questions as to whether suspected Ebola infection cases should be transferred to special treatment centers with isolation units instead of being treated for locally.

Dr. Frieden said that it was important that all hospitals be ready to diagnose and isolate Ebola patients safely. “We can’t have any hospital let its guard down,” he said, adding that the CDC has not ruled out transferring Ebola patients to specially equipped centers for treatment.

Confirmatory results for the health care worker were expected later Oct. 12, Dr. Frieden said. The health care worker had been self-monitoring for symptoms as instructed, when she presented with a low-grade fever, and viral levels that Dr. Frieden said appeared to be low. The health care worker only reported having a single contact following the first appearance of symptoms.

Dr. Frieden said that the agency was continuing to investigate the 48 contacts of Mr. Duncan before his isolation and admission to the hospital and that it had opened another investigation into his post-admission contacts.

“It’s deeply concerning that this occurred,” Dr. Frieden said, but he added that the case “doesn’t change the bottom line, which is that we know how to break the chain of transmission” though prompt diagnosis and isolation and notification of contacts.

This new infection signifies a further need to “ramp up infection control” in the hospital setting, he said. “We know how Ebola spreads, we know how to stop it, but this reemphasizes how meticulous we have to be.”

CDC officials are “deeply concerned” that a health care worker in Dallas has tested positive for Ebola virus as a result of contact with Thomas Duncan, the index patient from Liberia who died Oct 8.

In an emergency press conference Oct. 12, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, blamed what he called a breach of protocol for the infection.

CDC/Cynthia Goldsmith

However, Dr. Frieden said that investigators had yet to identify any specific breach of protocol at Texas Presbyterian Hospital, Dallas. He pointed to two procedures performed on Mr. Duncan – respiratory intubation and kidney dialysis – as having the potential to have spread infection to the health care worker.

Additional health care workers treating Mr. Duncan are being closely monitored along with all of Mr. Duncan’s contacts both before and after admission, Dr. Frieden said.

“Unfortunately, it is possible that we will see additional cases of Ebola,” he said.

The CDC is mulling a policy in which procedures performed on Ebola patients would be limited to those deemed “essential.” Pressed to explain, Dr. Frieden said that for example, blood draws to monitor electrolytes could be limited to one per day, down from three, to reduce potential for exposure.

Dr. Frieden also cited the need to reduce the number of health care workers caring for patients with Ebola.

The news of an infected health care worker at Texas Presbyterian Hospital, Dallas, which initially failed to isolate Mr. Duncan, drew questions as to whether suspected Ebola infection cases should be transferred to special treatment centers with isolation units instead of being treated for locally.

Dr. Frieden said that it was important that all hospitals be ready to diagnose and isolate Ebola patients safely. “We can’t have any hospital let its guard down,” he said, adding that the CDC has not ruled out transferring Ebola patients to specially equipped centers for treatment.

Confirmatory results for the health care worker were expected later Oct. 12, Dr. Frieden said. The health care worker had been self-monitoring for symptoms as instructed, when she presented with a low-grade fever, and viral levels that Dr. Frieden said appeared to be low. The health care worker only reported having a single contact following the first appearance of symptoms.

Dr. Frieden said that the agency was continuing to investigate the 48 contacts of Mr. Duncan before his isolation and admission to the hospital and that it had opened another investigation into his post-admission contacts.

“It’s deeply concerning that this occurred,” Dr. Frieden said, but he added that the case “doesn’t change the bottom line, which is that we know how to break the chain of transmission” though prompt diagnosis and isolation and notification of contacts.

This new infection signifies a further need to “ramp up infection control” in the hospital setting, he said. “We know how Ebola spreads, we know how to stop it, but this reemphasizes how meticulous we have to be.”

Adding developmental surveillance and screening to a computerized clinical decision support system led to a more than threefold greater proportion of children being screened for developmental disabilities, according to results from a randomized trial.

The American Academy of Pediatrics has recommended since 2006 that all children be screened for developmental delays at 9, 18, and 30 months. This study, led by Dr. Aaron E. Carroll of the Indiana University in Indianapolis, and published in JAMA Pediatrics (2014 [doi:10.1001/jamapediatrics.2014.464]), randomized 360 children at their 9-, 18- or 30-month check-ups to screening under the Child Health Improvement through Computer Automation (CHICA) system, which prompts clinicians toward diagnostic and management strategies based on guidelines and patient records.

The study was conducted in four linked primary care clinics in Indianapolis, with the vast majority of patients covered by Medicaid. Patients in the control clinics (n = 180) were assessed using standard CHICA, while those in the intervention clinics (n = 180) were assessed with CHICA modified to include a developmental surveillance and screening component, which automatically printed a questionnaire aimed at parents. If a parent indicated any area of concern, a standardized screening tool for developmental delay was then printed for use by the physician.

The group randomized to CHICA with the developmental module saw 85% of children screened for developmental delays during the target visits, compared with 24% in the standard care group (P < .001).

Among children screened, the rate of a positive result was 19.6% for the intervention group and 18.2% for controls; this did not reach statistical significance. “This finding implies that the number of children at risk for developmental delay was similar between groups, but that more children were picked up in the intervention group because of higher screening rates,” Dr. Carroll and his colleagues wrote in their analysis.

Diagnoses of developmental delay following a target visit were shown to occur markedly earlier in the intervention group (mean age at diagnosis, 17.2 vs. 27.9 months; P < .001). “Because optimal outcomes of developmental delay depend on early detection, this finding is a critically important finding, although our study was not designed to detect changes in clinical outcomes,” the researchers wrote.

Dr. Carroll and his colleagues also looked at an additional 60 patient records in both the control and intervention clinics to determine developmental surveillance rates outside target visits. They found that the intervention led to a significant increase in the percentage of parents who were asked about concerns regarding their children’s development during those nontarget visits (71.7% vs. 41.7%, P = .04).

The researchers cited as a weakness of their study its use of the clinic as the basis of randomization, creating the potential for preexisting practice differences to affect results.

The study was funded by the Agency for Healthcare Research and Quality. None of the authors reported conflicts of interest.

Adding developmental surveillance and screening to a computerized clinical decision support system led to a more than threefold greater proportion of children being screened for developmental disabilities, according to results from a randomized trial.

The American Academy of Pediatrics has recommended since 2006 that all children be screened for developmental delays at 9, 18, and 30 months. This study, led by Dr. Aaron E. Carroll of the Indiana University in Indianapolis, and published in JAMA Pediatrics (2014 [doi:10.1001/jamapediatrics.2014.464]), randomized 360 children at their 9-, 18- or 30-month check-ups to screening under the Child Health Improvement through Computer Automation (CHICA) system, which prompts clinicians toward diagnostic and management strategies based on guidelines and patient records.

The study was conducted in four linked primary care clinics in Indianapolis, with the vast majority of patients covered by Medicaid. Patients in the control clinics (n = 180) were assessed using standard CHICA, while those in the intervention clinics (n = 180) were assessed with CHICA modified to include a developmental surveillance and screening component, which automatically printed a questionnaire aimed at parents. If a parent indicated any area of concern, a standardized screening tool for developmental delay was then printed for use by the physician.

The group randomized to CHICA with the developmental module saw 85% of children screened for developmental delays during the target visits, compared with 24% in the standard care group (P < .001).

Among children screened, the rate of a positive result was 19.6% for the intervention group and 18.2% for controls; this did not reach statistical significance. “This finding implies that the number of children at risk for developmental delay was similar between groups, but that more children were picked up in the intervention group because of higher screening rates,” Dr. Carroll and his colleagues wrote in their analysis.

Diagnoses of developmental delay following a target visit were shown to occur markedly earlier in the intervention group (mean age at diagnosis, 17.2 vs. 27.9 months; P < .001). “Because optimal outcomes of developmental delay depend on early detection, this finding is a critically important finding, although our study was not designed to detect changes in clinical outcomes,” the researchers wrote.

Dr. Carroll and his colleagues also looked at an additional 60 patient records in both the control and intervention clinics to determine developmental surveillance rates outside target visits. They found that the intervention led to a significant increase in the percentage of parents who were asked about concerns regarding their children’s development during those nontarget visits (71.7% vs. 41.7%, P = .04).

The researchers cited as a weakness of their study its use of the clinic as the basis of randomization, creating the potential for preexisting practice differences to affect results.

The study was funded by the Agency for Healthcare Research and Quality. None of the authors reported conflicts of interest.

Adding developmental surveillance and screening to a computerized clinical decision support system led to a more than threefold greater proportion of children being screened for developmental disabilities, according to results from a randomized trial.

The American Academy of Pediatrics has recommended since 2006 that all children be screened for developmental delays at 9, 18, and 30 months. This study, led by Dr. Aaron E. Carroll of the Indiana University in Indianapolis, and published in JAMA Pediatrics (2014 [doi:10.1001/jamapediatrics.2014.464]), randomized 360 children at their 9-, 18- or 30-month check-ups to screening under the Child Health Improvement through Computer Automation (CHICA) system, which prompts clinicians toward diagnostic and management strategies based on guidelines and patient records.

The study was conducted in four linked primary care clinics in Indianapolis, with the vast majority of patients covered by Medicaid. Patients in the control clinics (n = 180) were assessed using standard CHICA, while those in the intervention clinics (n = 180) were assessed with CHICA modified to include a developmental surveillance and screening component, which automatically printed a questionnaire aimed at parents. If a parent indicated any area of concern, a standardized screening tool for developmental delay was then printed for use by the physician.

The group randomized to CHICA with the developmental module saw 85% of children screened for developmental delays during the target visits, compared with 24% in the standard care group (P < .001).

Among children screened, the rate of a positive result was 19.6% for the intervention group and 18.2% for controls; this did not reach statistical significance. “This finding implies that the number of children at risk for developmental delay was similar between groups, but that more children were picked up in the intervention group because of higher screening rates,” Dr. Carroll and his colleagues wrote in their analysis.

Diagnoses of developmental delay following a target visit were shown to occur markedly earlier in the intervention group (mean age at diagnosis, 17.2 vs. 27.9 months; P < .001). “Because optimal outcomes of developmental delay depend on early detection, this finding is a critically important finding, although our study was not designed to detect changes in clinical outcomes,” the researchers wrote.

Dr. Carroll and his colleagues also looked at an additional 60 patient records in both the control and intervention clinics to determine developmental surveillance rates outside target visits. They found that the intervention led to a significant increase in the percentage of parents who were asked about concerns regarding their children’s development during those nontarget visits (71.7% vs. 41.7%, P = .04).

The researchers cited as a weakness of their study its use of the clinic as the basis of randomization, creating the potential for preexisting practice differences to affect results.

The study was funded by the Agency for Healthcare Research and Quality. None of the authors reported conflicts of interest.

Isolating patients, more than a rollout of vaccines or any change in treatment strategy, is the cornerstone of the international effort to contain the Ebola outbreak in West Africa, say officials leading the response.

Steve Monroe, Ph.D., deputy director of the National Center for Emerging and Infectious diseases at the U.S. Centers for Disease Control and Prevention, summarized the state of the outbreak and the international response in a news conference Sept. 30, hours before the agency revealed the first imported case of Ebola documented in the United States in a traveler returning from Liberia.

In the two worst-affected countries, Sierra Leone and Liberia, cases are doubling approximately every 3 weeks. “One of the things CDC modeling data show is that we must get cases into isolation and treatment,” Dr. Monroe said. “We know how to control these outbreaks: Get patients into isolation so they don’t infect other people, and then follow their contacts.”

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

To stem the outbreak “we need to get, at a minimum, 70% of cases into effective isolation,” he said, and though increasing the number and location of Ebola treatment units was key to this effort, “all strategies should be considered,” including community centers, he said. “We can’t let the perfect be the enemy of the good. Every delay results in an increasing number of people impacted by this disease.”

In Senegal and Nigeria, Dr. Monroe noted, no new cases have been reported in the past 21 days, suggesting that containment efforts have proven effective in these countries and demonstrating that outbreaks “can be brought under control” through rigorous isolation, notification of contacts, and breaking the chain of transmission. Both countries would “recognize if there is another importation and respond quickly,” he said.

Sophie Delaunay, executive director of Doctors Without Borders/Médecins Sans Frontières (MSF), also speaking at the news conference, characterized her organization as feeling “desperate and powerless” in the most affected countries but ready to respond to any sign of outbreak in neighboring countries thanks to extensive preparation work.

Ms. Delaunay added that MSF is also prioritizing isolation and safe burial of patients who have died from Ebola. “In an ideal situation, a safe and effective vaccine would be the best potential game changer … but this is not likely to be available until several months from now. In the meantime, we absolutely need to increase the [capacity for] isolation.”

Dr. Monroe noted that data indicate there has been very little evidence of community transmission related to public transportation or other settings of casual contact, with most cases attributable to direct patient care or funeral practices. “Those are the main drivers of transmission,” he said during the conference, sponsored by the Kaiser Family Foundation.

The U.S. government has, to date, pledged $175 million for the Ebola response, with a little more than half the total already committed, with some $58 million marked for vaccine and antiviral drug development. Two vaccines are sponsored for clinical trials and likely to go into phase 2 testing during the course of the current outbreak, Dr. Monroe said. The U.S. Department of Defense has an additional $500 million to $1 billion in supplemental war funding that can be used to fight Ebola in West Africa, though it is unknown how much of this will be committed to Ebola.

Ms. Delaunay said that MSF has received pledges of $120 million, much of it from private donors, of which about half has been received.

The organization is preparing medical staff weekly in Belgium before they deploy to West Africa, she said, adding that, while getting more treatment units on the ground is a key priority, the quality of the response is dependent on how rigorous and disciplined the treatment of patients is. “You need to have strong discipline and chain of command,” she said.

Isolating patients, more than a rollout of vaccines or any change in treatment strategy, is the cornerstone of the international effort to contain the Ebola outbreak in West Africa, say officials leading the response.

Steve Monroe, Ph.D., deputy director of the National Center for Emerging and Infectious diseases at the U.S. Centers for Disease Control and Prevention, summarized the state of the outbreak and the international response in a news conference Sept. 30, hours before the agency revealed the first imported case of Ebola documented in the United States in a traveler returning from Liberia.

In the two worst-affected countries, Sierra Leone and Liberia, cases are doubling approximately every 3 weeks. “One of the things CDC modeling data show is that we must get cases into isolation and treatment,” Dr. Monroe said. “We know how to control these outbreaks: Get patients into isolation so they don’t infect other people, and then follow their contacts.”

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

To stem the outbreak “we need to get, at a minimum, 70% of cases into effective isolation,” he said, and though increasing the number and location of Ebola treatment units was key to this effort, “all strategies should be considered,” including community centers, he said. “We can’t let the perfect be the enemy of the good. Every delay results in an increasing number of people impacted by this disease.”

In Senegal and Nigeria, Dr. Monroe noted, no new cases have been reported in the past 21 days, suggesting that containment efforts have proven effective in these countries and demonstrating that outbreaks “can be brought under control” through rigorous isolation, notification of contacts, and breaking the chain of transmission. Both countries would “recognize if there is another importation and respond quickly,” he said.

Sophie Delaunay, executive director of Doctors Without Borders/Médecins Sans Frontières (MSF), also speaking at the news conference, characterized her organization as feeling “desperate and powerless” in the most affected countries but ready to respond to any sign of outbreak in neighboring countries thanks to extensive preparation work.

Ms. Delaunay added that MSF is also prioritizing isolation and safe burial of patients who have died from Ebola. “In an ideal situation, a safe and effective vaccine would be the best potential game changer … but this is not likely to be available until several months from now. In the meantime, we absolutely need to increase the [capacity for] isolation.”

Dr. Monroe noted that data indicate there has been very little evidence of community transmission related to public transportation or other settings of casual contact, with most cases attributable to direct patient care or funeral practices. “Those are the main drivers of transmission,” he said during the conference, sponsored by the Kaiser Family Foundation.

The U.S. government has, to date, pledged $175 million for the Ebola response, with a little more than half the total already committed, with some $58 million marked for vaccine and antiviral drug development. Two vaccines are sponsored for clinical trials and likely to go into phase 2 testing during the course of the current outbreak, Dr. Monroe said. The U.S. Department of Defense has an additional $500 million to $1 billion in supplemental war funding that can be used to fight Ebola in West Africa, though it is unknown how much of this will be committed to Ebola.

Ms. Delaunay said that MSF has received pledges of $120 million, much of it from private donors, of which about half has been received.

The organization is preparing medical staff weekly in Belgium before they deploy to West Africa, she said, adding that, while getting more treatment units on the ground is a key priority, the quality of the response is dependent on how rigorous and disciplined the treatment of patients is. “You need to have strong discipline and chain of command,” she said.

Isolating patients, more than a rollout of vaccines or any change in treatment strategy, is the cornerstone of the international effort to contain the Ebola outbreak in West Africa, say officials leading the response.

Steve Monroe, Ph.D., deputy director of the National Center for Emerging and Infectious diseases at the U.S. Centers for Disease Control and Prevention, summarized the state of the outbreak and the international response in a news conference Sept. 30, hours before the agency revealed the first imported case of Ebola documented in the United States in a traveler returning from Liberia.

In the two worst-affected countries, Sierra Leone and Liberia, cases are doubling approximately every 3 weeks. “One of the things CDC modeling data show is that we must get cases into isolation and treatment,” Dr. Monroe said. “We know how to control these outbreaks: Get patients into isolation so they don’t infect other people, and then follow their contacts.”

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

To stem the outbreak “we need to get, at a minimum, 70% of cases into effective isolation,” he said, and though increasing the number and location of Ebola treatment units was key to this effort, “all strategies should be considered,” including community centers, he said. “We can’t let the perfect be the enemy of the good. Every delay results in an increasing number of people impacted by this disease.”

In Senegal and Nigeria, Dr. Monroe noted, no new cases have been reported in the past 21 days, suggesting that containment efforts have proven effective in these countries and demonstrating that outbreaks “can be brought under control” through rigorous isolation, notification of contacts, and breaking the chain of transmission. Both countries would “recognize if there is another importation and respond quickly,” he said.

Sophie Delaunay, executive director of Doctors Without Borders/Médecins Sans Frontières (MSF), also speaking at the news conference, characterized her organization as feeling “desperate and powerless” in the most affected countries but ready to respond to any sign of outbreak in neighboring countries thanks to extensive preparation work.

Ms. Delaunay added that MSF is also prioritizing isolation and safe burial of patients who have died from Ebola. “In an ideal situation, a safe and effective vaccine would be the best potential game changer … but this is not likely to be available until several months from now. In the meantime, we absolutely need to increase the [capacity for] isolation.”

Dr. Monroe noted that data indicate there has been very little evidence of community transmission related to public transportation or other settings of casual contact, with most cases attributable to direct patient care or funeral practices. “Those are the main drivers of transmission,” he said during the conference, sponsored by the Kaiser Family Foundation.

The U.S. government has, to date, pledged $175 million for the Ebola response, with a little more than half the total already committed, with some $58 million marked for vaccine and antiviral drug development. Two vaccines are sponsored for clinical trials and likely to go into phase 2 testing during the course of the current outbreak, Dr. Monroe said. The U.S. Department of Defense has an additional $500 million to $1 billion in supplemental war funding that can be used to fight Ebola in West Africa, though it is unknown how much of this will be committed to Ebola.

Ms. Delaunay said that MSF has received pledges of $120 million, much of it from private donors, of which about half has been received.

The organization is preparing medical staff weekly in Belgium before they deploy to West Africa, she said, adding that, while getting more treatment units on the ground is a key priority, the quality of the response is dependent on how rigorous and disciplined the treatment of patients is. “You need to have strong discipline and chain of command,” she said.

Smokers with high sodium intake were more than twice as likely to develop rheumatoid arthritis as were those with low sodium intake in a nested case-control study.

The study, which lends support to the possibility that an interaction between smoking and a diet heavy in sodium can increase RA risk, involved records from 386 individuals who had provided information on their dietary habits for a long-term, population-based study a median 7.7 years before going on to develop RA. Researchers from Umeå (Sweden) University, led by Björn Sundström, Ph.D., compared these with records for 1,886 age- and sex-matched controls who did not have RA and had taken part in the same population-based study (Rheumatology 2014 Sept. 10 [doi:10.1093/rheumatology/keu330]).

© Jupiterimages/Thinkstockphotos.com

Smokers in the highest tertile of sodium intake in the cohort (median intake was 2.15 g/day, equivalent to 5.46 g NaCl) had an odds ratio of 2.26 (95% confidence interval, 1.06-4.81; P = .036) for developing RA, compared with smokers in the lowest tertile, who had a median intake of 1.51 g/day (equivalent to 3.84 g NaCl). The significant association between high sodium intake and the development of RA was found only for smokers, not for the total study population, although smokers with low-sodium diets saw no added likelihood of developing RA, compared with nonsmokers.

Smoking is an established risk factor for RA, but in this study, “additive interaction analyses suggested that approximately half of the amount of risk from smoking in the development of RA is due to interaction with sodium intake,” Dr. Sundström and his associates wrote, with an attributable proportion of 0.54 (95% CI, 0.26-0.82). Although the researchers did not identify the possible pathways by which an interaction between smoking and high sodium intake might increase risk of RA, “these findings will provide new insights into the etiopathogenic process leading to the development of RA among smokers,” they wrote.

Their study was funded by the Swedish Research Council, the Swedish Rheumatism Association, the Swedish Controlling Chronic Inflammatory Diseases with Combined Efforts (COMBINE) program, and the Swedish royal family. None of the coauthors declared conflicts of interest.

Smokers with high sodium intake were more than twice as likely to develop rheumatoid arthritis as were those with low sodium intake in a nested case-control study.

The study, which lends support to the possibility that an interaction between smoking and a diet heavy in sodium can increase RA risk, involved records from 386 individuals who had provided information on their dietary habits for a long-term, population-based study a median 7.7 years before going on to develop RA. Researchers from Umeå (Sweden) University, led by Björn Sundström, Ph.D., compared these with records for 1,886 age- and sex-matched controls who did not have RA and had taken part in the same population-based study (Rheumatology 2014 Sept. 10 [doi:10.1093/rheumatology/keu330]).

© Jupiterimages/Thinkstockphotos.com

Smokers in the highest tertile of sodium intake in the cohort (median intake was 2.15 g/day, equivalent to 5.46 g NaCl) had an odds ratio of 2.26 (95% confidence interval, 1.06-4.81; P = .036) for developing RA, compared with smokers in the lowest tertile, who had a median intake of 1.51 g/day (equivalent to 3.84 g NaCl). The significant association between high sodium intake and the development of RA was found only for smokers, not for the total study population, although smokers with low-sodium diets saw no added likelihood of developing RA, compared with nonsmokers.

Smoking is an established risk factor for RA, but in this study, “additive interaction analyses suggested that approximately half of the amount of risk from smoking in the development of RA is due to interaction with sodium intake,” Dr. Sundström and his associates wrote, with an attributable proportion of 0.54 (95% CI, 0.26-0.82). Although the researchers did not identify the possible pathways by which an interaction between smoking and high sodium intake might increase risk of RA, “these findings will provide new insights into the etiopathogenic process leading to the development of RA among smokers,” they wrote.

Their study was funded by the Swedish Research Council, the Swedish Rheumatism Association, the Swedish Controlling Chronic Inflammatory Diseases with Combined Efforts (COMBINE) program, and the Swedish royal family. None of the coauthors declared conflicts of interest.

Smokers with high sodium intake were more than twice as likely to develop rheumatoid arthritis as were those with low sodium intake in a nested case-control study.

The study, which lends support to the possibility that an interaction between smoking and a diet heavy in sodium can increase RA risk, involved records from 386 individuals who had provided information on their dietary habits for a long-term, population-based study a median 7.7 years before going on to develop RA. Researchers from Umeå (Sweden) University, led by Björn Sundström, Ph.D., compared these with records for 1,886 age- and sex-matched controls who did not have RA and had taken part in the same population-based study (Rheumatology 2014 Sept. 10 [doi:10.1093/rheumatology/keu330]).

© Jupiterimages/Thinkstockphotos.com

Smokers in the highest tertile of sodium intake in the cohort (median intake was 2.15 g/day, equivalent to 5.46 g NaCl) had an odds ratio of 2.26 (95% confidence interval, 1.06-4.81; P = .036) for developing RA, compared with smokers in the lowest tertile, who had a median intake of 1.51 g/day (equivalent to 3.84 g NaCl). The significant association between high sodium intake and the development of RA was found only for smokers, not for the total study population, although smokers with low-sodium diets saw no added likelihood of developing RA, compared with nonsmokers.

Smoking is an established risk factor for RA, but in this study, “additive interaction analyses suggested that approximately half of the amount of risk from smoking in the development of RA is due to interaction with sodium intake,” Dr. Sundström and his associates wrote, with an attributable proportion of 0.54 (95% CI, 0.26-0.82). Although the researchers did not identify the possible pathways by which an interaction between smoking and high sodium intake might increase risk of RA, “these findings will provide new insights into the etiopathogenic process leading to the development of RA among smokers,” they wrote.

Their study was funded by the Swedish Research Council, the Swedish Rheumatism Association, the Swedish Controlling Chronic Inflammatory Diseases with Combined Efforts (COMBINE) program, and the Swedish royal family. None of the coauthors declared conflicts of interest.

Women who follow a Mediterranean-style diet – high in whole grains, nuts, fish, and legumes while low in red meats, processed meats, and saturated fats – showed no significant reduction in the risk of developing rheumatoid arthritis in a large, prospective cohort study.

However, the findings do not jibe with the results of other studies in which the diet was associated with a reduced risk of certain other inflammatory diseases or observations of clinical improvement in people with existing rheumatoid arthritis (RA).

©snyferok/thinkstockphoto.com

The study, published Sept. 23 in Arthritis Care and Research (doi:10.1002/acr.22481), evaluated data from nearly 175,000 women in two U.S. cohorts: the 1980-2008 Nurses Health Study (n = 83,245) and the 1991-2009 Nurses Health Study II (n = 91,393). Data from both cohorts were obtained through validated diet questionnaires at baseline and every 4 years during follow-up. Investigator Yang Hu of Brigham & Women’s Hospital, Boston, and his colleagues, identified 913 incident cases of RA in 3.5 million person-years of follow-up and found the pooled hazard ratio for women in the quartile most adherent to the Mediterranean diet to be 0.98 (95% confidence interval, 0.80-1.20; P for trend = .85), compared with women in the quartile representing the lowest level of adherence.

The investigators described nine measures they used to assess the Mediterranean dietary pattern, including consumption of vegetables (not potatoes), fruits, nuts, whole grains, legumes, fish ratio of monounsaturated to saturated fats, red and processed meats, and alcohol. When components of the Mediterranean diet were evaluated as separate contributors to risk, only alcohol consumption was seen significantly associated with RA risk, with moderate consumption linked to lower risk.

Two coauthors of Mr. Hu and his colleagues’ study detailed the alcohol-related findings from the same cohort in a paper earlier this year (Arthritis Rheumatol. 2014;66:1998-2005). Mr. Hu and his colleagues hypothesized that the null findings related to the Mediterranean diet could have been influenced by the fact that within the food categories used in the study (fats, vegetables, fish), certain preparations or types of food might contribute to risk while others might help lower it.

The study was supported by grants from the National Institutes of Health. None of the authors declared conflicts of interest.

Women who follow a Mediterranean-style diet – high in whole grains, nuts, fish, and legumes while low in red meats, processed meats, and saturated fats – showed no significant reduction in the risk of developing rheumatoid arthritis in a large, prospective cohort study.

However, the findings do not jibe with the results of other studies in which the diet was associated with a reduced risk of certain other inflammatory diseases or observations of clinical improvement in people with existing rheumatoid arthritis (RA).

©snyferok/thinkstockphoto.com

The study, published Sept. 23 in Arthritis Care and Research (doi:10.1002/acr.22481), evaluated data from nearly 175,000 women in two U.S. cohorts: the 1980-2008 Nurses Health Study (n = 83,245) and the 1991-2009 Nurses Health Study II (n = 91,393). Data from both cohorts were obtained through validated diet questionnaires at baseline and every 4 years during follow-up. Investigator Yang Hu of Brigham & Women’s Hospital, Boston, and his colleagues, identified 913 incident cases of RA in 3.5 million person-years of follow-up and found the pooled hazard ratio for women in the quartile most adherent to the Mediterranean diet to be 0.98 (95% confidence interval, 0.80-1.20; P for trend = .85), compared with women in the quartile representing the lowest level of adherence.

The investigators described nine measures they used to assess the Mediterranean dietary pattern, including consumption of vegetables (not potatoes), fruits, nuts, whole grains, legumes, fish ratio of monounsaturated to saturated fats, red and processed meats, and alcohol. When components of the Mediterranean diet were evaluated as separate contributors to risk, only alcohol consumption was seen significantly associated with RA risk, with moderate consumption linked to lower risk.

Two coauthors of Mr. Hu and his colleagues’ study detailed the alcohol-related findings from the same cohort in a paper earlier this year (Arthritis Rheumatol. 2014;66:1998-2005). Mr. Hu and his colleagues hypothesized that the null findings related to the Mediterranean diet could have been influenced by the fact that within the food categories used in the study (fats, vegetables, fish), certain preparations or types of food might contribute to risk while others might help lower it.

The study was supported by grants from the National Institutes of Health. None of the authors declared conflicts of interest.

Women who follow a Mediterranean-style diet – high in whole grains, nuts, fish, and legumes while low in red meats, processed meats, and saturated fats – showed no significant reduction in the risk of developing rheumatoid arthritis in a large, prospective cohort study.

However, the findings do not jibe with the results of other studies in which the diet was associated with a reduced risk of certain other inflammatory diseases or observations of clinical improvement in people with existing rheumatoid arthritis (RA).

©snyferok/thinkstockphoto.com

The study, published Sept. 23 in Arthritis Care and Research (doi:10.1002/acr.22481), evaluated data from nearly 175,000 women in two U.S. cohorts: the 1980-2008 Nurses Health Study (n = 83,245) and the 1991-2009 Nurses Health Study II (n = 91,393). Data from both cohorts were obtained through validated diet questionnaires at baseline and every 4 years during follow-up. Investigator Yang Hu of Brigham & Women’s Hospital, Boston, and his colleagues, identified 913 incident cases of RA in 3.5 million person-years of follow-up and found the pooled hazard ratio for women in the quartile most adherent to the Mediterranean diet to be 0.98 (95% confidence interval, 0.80-1.20; P for trend = .85), compared with women in the quartile representing the lowest level of adherence.

The investigators described nine measures they used to assess the Mediterranean dietary pattern, including consumption of vegetables (not potatoes), fruits, nuts, whole grains, legumes, fish ratio of monounsaturated to saturated fats, red and processed meats, and alcohol. When components of the Mediterranean diet were evaluated as separate contributors to risk, only alcohol consumption was seen significantly associated with RA risk, with moderate consumption linked to lower risk.

Two coauthors of Mr. Hu and his colleagues’ study detailed the alcohol-related findings from the same cohort in a paper earlier this year (Arthritis Rheumatol. 2014;66:1998-2005). Mr. Hu and his colleagues hypothesized that the null findings related to the Mediterranean diet could have been influenced by the fact that within the food categories used in the study (fats, vegetables, fish), certain preparations or types of food might contribute to risk while others might help lower it.

The study was supported by grants from the National Institutes of Health. None of the authors declared conflicts of interest.

Two subgroups of men with node-positive prostate cancer are more likely to benefit from adjuvant radiotherapy after surgery than others, investigators report online in the Journal of Clinical Oncology.

A retrospective observational study of 1,107 patients receiving adjuvant hormonal therapy with or without radiotherapy, found that men with one or two positive lymph nodes and intermediate- to high-grade, non–specimen-confined disease, and men with three or four positive nodes regardless of other tumor characteristics, saw significantly improved cancer-specific mortality at 8 years associated with radiotherapy (hazard ratio, 0.30; P = .002 for the former and HR, 0.21; P = .02, for the latter). Adjuvant radiotherapy did not improve survival in patients with extremely favorable (two or fewer positive lymph nodes, specimen-confined, and/or low-grade tumor) or extremely unfavorable (greater than four positive nodes) prostate cancer.

Investigators, led by Dr. Firas Abdollah of the Mayo Clinic, Rochester, Minn., looked at the records of patients treated between 1988 and 2010 at the Mayo Clinic and San Raffaele Hospital in Milan, Italy, with radical prostatectomy and anatomically extended pelvic lymph node dissection before being treated with adjuvant hormonal therapy, and adjuvant radiotherapy at the discretion of the physician (35% of the cohort received radiotherapy).

“The beneficial impact of adjuvant radiotherapy on survival in patients with prostate cancer with lymph node invasion can depend on individualized tumor characteristics,” Dr. Abdollah and his colleagues wrote (J. Clin. Onc. 2014 Sept. 22;[doi:10.1200/JCO.2014.58.1058]).

Those not expected to benefit could be spared unnecessary treatment and adverse effects associated with radiotherapy, they said. Previous studies have suggested that two positive lymph nodes might serve as a cutoff for indicating radiotherapy, the researchers noted, while this study added the additional subgroup of patients with three or four positive nodes. Dr. Abdollah and colleagues noted as limitations of their study its nonrandomized, retrospective design, and the fact that the decision to initiate radiotherapy was left to the clinical judgment of the treating physician, allowing for the possibility of selection bias. None of the researchers declared conflicts of interest.

Two subgroups of men with node-positive prostate cancer are more likely to benefit from adjuvant radiotherapy after surgery than others, investigators report online in the Journal of Clinical Oncology.

A retrospective observational study of 1,107 patients receiving adjuvant hormonal therapy with or without radiotherapy, found that men with one or two positive lymph nodes and intermediate- to high-grade, non–specimen-confined disease, and men with three or four positive nodes regardless of other tumor characteristics, saw significantly improved cancer-specific mortality at 8 years associated with radiotherapy (hazard ratio, 0.30; P = .002 for the former and HR, 0.21; P = .02, for the latter). Adjuvant radiotherapy did not improve survival in patients with extremely favorable (two or fewer positive lymph nodes, specimen-confined, and/or low-grade tumor) or extremely unfavorable (greater than four positive nodes) prostate cancer.

Investigators, led by Dr. Firas Abdollah of the Mayo Clinic, Rochester, Minn., looked at the records of patients treated between 1988 and 2010 at the Mayo Clinic and San Raffaele Hospital in Milan, Italy, with radical prostatectomy and anatomically extended pelvic lymph node dissection before being treated with adjuvant hormonal therapy, and adjuvant radiotherapy at the discretion of the physician (35% of the cohort received radiotherapy).

“The beneficial impact of adjuvant radiotherapy on survival in patients with prostate cancer with lymph node invasion can depend on individualized tumor characteristics,” Dr. Abdollah and his colleagues wrote (J. Clin. Onc. 2014 Sept. 22;[doi:10.1200/JCO.2014.58.1058]).

Those not expected to benefit could be spared unnecessary treatment and adverse effects associated with radiotherapy, they said. Previous studies have suggested that two positive lymph nodes might serve as a cutoff for indicating radiotherapy, the researchers noted, while this study added the additional subgroup of patients with three or four positive nodes. Dr. Abdollah and colleagues noted as limitations of their study its nonrandomized, retrospective design, and the fact that the decision to initiate radiotherapy was left to the clinical judgment of the treating physician, allowing for the possibility of selection bias. None of the researchers declared conflicts of interest.

Two subgroups of men with node-positive prostate cancer are more likely to benefit from adjuvant radiotherapy after surgery than others, investigators report online in the Journal of Clinical Oncology.

A retrospective observational study of 1,107 patients receiving adjuvant hormonal therapy with or without radiotherapy, found that men with one or two positive lymph nodes and intermediate- to high-grade, non–specimen-confined disease, and men with three or four positive nodes regardless of other tumor characteristics, saw significantly improved cancer-specific mortality at 8 years associated with radiotherapy (hazard ratio, 0.30; P = .002 for the former and HR, 0.21; P = .02, for the latter). Adjuvant radiotherapy did not improve survival in patients with extremely favorable (two or fewer positive lymph nodes, specimen-confined, and/or low-grade tumor) or extremely unfavorable (greater than four positive nodes) prostate cancer.

Investigators, led by Dr. Firas Abdollah of the Mayo Clinic, Rochester, Minn., looked at the records of patients treated between 1988 and 2010 at the Mayo Clinic and San Raffaele Hospital in Milan, Italy, with radical prostatectomy and anatomically extended pelvic lymph node dissection before being treated with adjuvant hormonal therapy, and adjuvant radiotherapy at the discretion of the physician (35% of the cohort received radiotherapy).

“The beneficial impact of adjuvant radiotherapy on survival in patients with prostate cancer with lymph node invasion can depend on individualized tumor characteristics,” Dr. Abdollah and his colleagues wrote (J. Clin. Onc. 2014 Sept. 22;[doi:10.1200/JCO.2014.58.1058]).

Those not expected to benefit could be spared unnecessary treatment and adverse effects associated with radiotherapy, they said. Previous studies have suggested that two positive lymph nodes might serve as a cutoff for indicating radiotherapy, the researchers noted, while this study added the additional subgroup of patients with three or four positive nodes. Dr. Abdollah and colleagues noted as limitations of their study its nonrandomized, retrospective design, and the fact that the decision to initiate radiotherapy was left to the clinical judgment of the treating physician, allowing for the possibility of selection bias. None of the researchers declared conflicts of interest.

Ultrasonography is known to be less sensitive than computed tomography for diagnosing kidney stones. But the initial use of ultrasonography, followed by CT imaging if indicated, results in less cumulative radiation exposure for patients without increasing the risk of adverse clinical outcomes or missed diagnoses, according to findings published online Sept 18 in the New England Journal of Medicine (doi:10.1056/NEJMoa1404446).

The multicenter study, led by Dr. Rebecca Smith-Bindman of the University of California, San Francisco, and colleagues, randomized 2,759 patients presenting in hospital emergency departments with symptoms of nephrolithiasis to receive initial ultrasonography performed by an emergency physician (n = 908); ultrasonography performed by a radiologist (n = 893), or abdominal CT (n = 958), with all further diagnostic and management decisions left up to the physician.

©decade3d/thinkstockphotos.com

High-risk diagnoses with complications within 30 days of initial imaging occurred infrequently across the groups (0.4% for all three, n = 11), with no significant differences seen among the groups (P = .30). Within 6 months, serious adverse advents occurred in 12.4% of patients assigned initial ED ultrasonography, 10.8% in those assigned radiology ultrasonography, and 11.2% of those assigned to CT (P = .50) with no significant differences in pain scores, return emergency department visits, or hospitalizations. Cumulative radiation exposure at 6 months, however, was significantly higher for the CT arm than for the two ultrasonography arms (P < .001).

Dr. Smith-Bindman and colleagues emphasized in their analysis that their results do not imply that patients with suspected nephrolithiasis should undergo only ultrasound imaging, “but rather that ultrasonography should be used as the initial diagnostic imaging test, with further imaging studies performed at the discretion of the physician on the basis of clinical judgment.” Patients with nephrolithiasis often undergo repeat imaging over time, the researchers observed, and “replacing initial CT with ultrasonography for this often-recurring disease reduced overall radiation exposure.”

Dr. Smith-Bindman and colleagues noted as a limitation of their study the fact that treatment assignment could not be blinded. The study was funded by the Agency for Healthcare Research and Quality; none of its authors declared financial conflicts of interest.

Ultrasonography is known to be less sensitive than computed tomography for diagnosing kidney stones. But the initial use of ultrasonography, followed by CT imaging if indicated, results in less cumulative radiation exposure for patients without increasing the risk of adverse clinical outcomes or missed diagnoses, according to findings published online Sept 18 in the New England Journal of Medicine (doi:10.1056/NEJMoa1404446).

The multicenter study, led by Dr. Rebecca Smith-Bindman of the University of California, San Francisco, and colleagues, randomized 2,759 patients presenting in hospital emergency departments with symptoms of nephrolithiasis to receive initial ultrasonography performed by an emergency physician (n = 908); ultrasonography performed by a radiologist (n = 893), or abdominal CT (n = 958), with all further diagnostic and management decisions left up to the physician.

©decade3d/thinkstockphotos.com

High-risk diagnoses with complications within 30 days of initial imaging occurred infrequently across the groups (0.4% for all three, n = 11), with no significant differences seen among the groups (P = .30). Within 6 months, serious adverse advents occurred in 12.4% of patients assigned initial ED ultrasonography, 10.8% in those assigned radiology ultrasonography, and 11.2% of those assigned to CT (P = .50) with no significant differences in pain scores, return emergency department visits, or hospitalizations. Cumulative radiation exposure at 6 months, however, was significantly higher for the CT arm than for the two ultrasonography arms (P < .001).

Dr. Smith-Bindman and colleagues emphasized in their analysis that their results do not imply that patients with suspected nephrolithiasis should undergo only ultrasound imaging, “but rather that ultrasonography should be used as the initial diagnostic imaging test, with further imaging studies performed at the discretion of the physician on the basis of clinical judgment.” Patients with nephrolithiasis often undergo repeat imaging over time, the researchers observed, and “replacing initial CT with ultrasonography for this often-recurring disease reduced overall radiation exposure.”

Dr. Smith-Bindman and colleagues noted as a limitation of their study the fact that treatment assignment could not be blinded. The study was funded by the Agency for Healthcare Research and Quality; none of its authors declared financial conflicts of interest.

Ultrasonography is known to be less sensitive than computed tomography for diagnosing kidney stones. But the initial use of ultrasonography, followed by CT imaging if indicated, results in less cumulative radiation exposure for patients without increasing the risk of adverse clinical outcomes or missed diagnoses, according to findings published online Sept 18 in the New England Journal of Medicine (doi:10.1056/NEJMoa1404446).

The multicenter study, led by Dr. Rebecca Smith-Bindman of the University of California, San Francisco, and colleagues, randomized 2,759 patients presenting in hospital emergency departments with symptoms of nephrolithiasis to receive initial ultrasonography performed by an emergency physician (n = 908); ultrasonography performed by a radiologist (n = 893), or abdominal CT (n = 958), with all further diagnostic and management decisions left up to the physician.

©decade3d/thinkstockphotos.com

High-risk diagnoses with complications within 30 days of initial imaging occurred infrequently across the groups (0.4% for all three, n = 11), with no significant differences seen among the groups (P = .30). Within 6 months, serious adverse advents occurred in 12.4% of patients assigned initial ED ultrasonography, 10.8% in those assigned radiology ultrasonography, and 11.2% of those assigned to CT (P = .50) with no significant differences in pain scores, return emergency department visits, or hospitalizations. Cumulative radiation exposure at 6 months, however, was significantly higher for the CT arm than for the two ultrasonography arms (P < .001).

Dr. Smith-Bindman and colleagues emphasized in their analysis that their results do not imply that patients with suspected nephrolithiasis should undergo only ultrasound imaging, “but rather that ultrasonography should be used as the initial diagnostic imaging test, with further imaging studies performed at the discretion of the physician on the basis of clinical judgment.” Patients with nephrolithiasis often undergo repeat imaging over time, the researchers observed, and “replacing initial CT with ultrasonography for this often-recurring disease reduced overall radiation exposure.”

Dr. Smith-Bindman and colleagues noted as a limitation of their study the fact that treatment assignment could not be blinded. The study was funded by the Agency for Healthcare Research and Quality; none of its authors declared financial conflicts of interest.

A meta-analysis of clinical trial data has revealed few differences among antiepileptic drugs in reducing the frequency of secondary generalized tonic-clonic seizures.

Claire Hemery of University Claude Bernard, Lyon, France, and her associates studied results from 13 randomized, controlled trials evaluating seven antiepileptic drugs used as adjunct therapy in patients with drug-resistant focal epilepsy (Epilepsia 2014 Sept. 2 [doi:10.1111/epi.12765]). The included trials measured the responder rate, or proportion of patients with 50% or greater reduction in seizure frequency from baseline, for all seizures and secondary generalized tonic-clonic seizures (SGTCS) in particular. SGTCS affect about a third of patients with drug-resistant focal epilepsy and are the main cause of sudden unexpected death in this patient group.

Only three AEDs – lacosamide, perampanel, and topiramate – were shown to be more effective than placebo in responder criteria for SGTCS when used as add-on therapies, with a relative risk of 1.83 for lacosamide (95% confidence interval, 1.19-2.83), 1.41 for perampanel (95% CI, 1.14-1.74), and 1.89 for topiramate (95% CI, 1.34-2.65). Although Ms. Hemery and her colleagues identified one AED, pregabalin, to be significantly less effective than lacosamide, perampanel, or topiramate in reducing SGTCS in this patient group, confidence intervals overlapped for the other study drugs. The researchers wrote that the infrequent and irregular occurrence of SGTCS presented statistical challenges, noting that phase III clinical trials of AEDs “are not designed and powered to appropriately evaluate” this type of seizure. The investigators argued that their findings reinforce the need “to develop alternative designs for the evaluation of new therapeutic interventions in epilepsy, especially in at-risk patients with seizure-related complications and/or comorbidities.”

Ms. Hemery reported no disclosures related to her study, which had no outside funding. One of Ms. Hemery’s coauthors, Dr. Philippe Ryvlin, disclosed receiving fees from Pfizer, Sanofi-Aventis, GlaxoSmithKline, Janssen-Cilag, UCB, Eisai, and Valeant. The study’s corresponding author, Dr. Sylvain Rheims, disclosed receiving fees or funding from UCB, Eisai, GlaxoSmithKline, and Cyberonics.

A meta-analysis of clinical trial data has revealed few differences among antiepileptic drugs in reducing the frequency of secondary generalized tonic-clonic seizures.

Claire Hemery of University Claude Bernard, Lyon, France, and her associates studied results from 13 randomized, controlled trials evaluating seven antiepileptic drugs used as adjunct therapy in patients with drug-resistant focal epilepsy (Epilepsia 2014 Sept. 2 [doi:10.1111/epi.12765]). The included trials measured the responder rate, or proportion of patients with 50% or greater reduction in seizure frequency from baseline, for all seizures and secondary generalized tonic-clonic seizures (SGTCS) in particular. SGTCS affect about a third of patients with drug-resistant focal epilepsy and are the main cause of sudden unexpected death in this patient group.

Only three AEDs – lacosamide, perampanel, and topiramate – were shown to be more effective than placebo in responder criteria for SGTCS when used as add-on therapies, with a relative risk of 1.83 for lacosamide (95% confidence interval, 1.19-2.83), 1.41 for perampanel (95% CI, 1.14-1.74), and 1.89 for topiramate (95% CI, 1.34-2.65). Although Ms. Hemery and her colleagues identified one AED, pregabalin, to be significantly less effective than lacosamide, perampanel, or topiramate in reducing SGTCS in this patient group, confidence intervals overlapped for the other study drugs. The researchers wrote that the infrequent and irregular occurrence of SGTCS presented statistical challenges, noting that phase III clinical trials of AEDs “are not designed and powered to appropriately evaluate” this type of seizure. The investigators argued that their findings reinforce the need “to develop alternative designs for the evaluation of new therapeutic interventions in epilepsy, especially in at-risk patients with seizure-related complications and/or comorbidities.”

Ms. Hemery reported no disclosures related to her study, which had no outside funding. One of Ms. Hemery’s coauthors, Dr. Philippe Ryvlin, disclosed receiving fees from Pfizer, Sanofi-Aventis, GlaxoSmithKline, Janssen-Cilag, UCB, Eisai, and Valeant. The study’s corresponding author, Dr. Sylvain Rheims, disclosed receiving fees or funding from UCB, Eisai, GlaxoSmithKline, and Cyberonics.

A meta-analysis of clinical trial data has revealed few differences among antiepileptic drugs in reducing the frequency of secondary generalized tonic-clonic seizures.

Claire Hemery of University Claude Bernard, Lyon, France, and her associates studied results from 13 randomized, controlled trials evaluating seven antiepileptic drugs used as adjunct therapy in patients with drug-resistant focal epilepsy (Epilepsia 2014 Sept. 2 [doi:10.1111/epi.12765]). The included trials measured the responder rate, or proportion of patients with 50% or greater reduction in seizure frequency from baseline, for all seizures and secondary generalized tonic-clonic seizures (SGTCS) in particular. SGTCS affect about a third of patients with drug-resistant focal epilepsy and are the main cause of sudden unexpected death in this patient group.

Only three AEDs – lacosamide, perampanel, and topiramate – were shown to be more effective than placebo in responder criteria for SGTCS when used as add-on therapies, with a relative risk of 1.83 for lacosamide (95% confidence interval, 1.19-2.83), 1.41 for perampanel (95% CI, 1.14-1.74), and 1.89 for topiramate (95% CI, 1.34-2.65). Although Ms. Hemery and her colleagues identified one AED, pregabalin, to be significantly less effective than lacosamide, perampanel, or topiramate in reducing SGTCS in this patient group, confidence intervals overlapped for the other study drugs. The researchers wrote that the infrequent and irregular occurrence of SGTCS presented statistical challenges, noting that phase III clinical trials of AEDs “are not designed and powered to appropriately evaluate” this type of seizure. The investigators argued that their findings reinforce the need “to develop alternative designs for the evaluation of new therapeutic interventions in epilepsy, especially in at-risk patients with seizure-related complications and/or comorbidities.”

Ms. Hemery reported no disclosures related to her study, which had no outside funding. One of Ms. Hemery’s coauthors, Dr. Philippe Ryvlin, disclosed receiving fees from Pfizer, Sanofi-Aventis, GlaxoSmithKline, Janssen-Cilag, UCB, Eisai, and Valeant. The study’s corresponding author, Dr. Sylvain Rheims, disclosed receiving fees or funding from UCB, Eisai, GlaxoSmithKline, and Cyberonics.

Combination treatment with GLP-1 agonist and basal insulin helps diabetes patients achieve glycemic control without increasing their risk of hypoglycemia or weight gain, a new meta-analysis has found.

The research, published online Sept. 12 in The Lancet, suggests that glucagon-like peptide-1 (GLP-1) agonists, injectable agents currently used mainly as second- or third-line treatments after oral diabetes therapies have failed, might merit a more prominent role in the treatment pathway in combination with basal insulin.

The authors of the meta-analysis, led by Conrad Eng of Mount Sinai Hospital, Toronto, analyzed results from 15 studies enrolling 4,348 patients with type 2 diabetes. All the studies compared GLP-1 agonists, including exenatide (Byetta), liraglutide (Victoza), and albiglutide (Tanzeum), and basal insulin with other regimens, which included oral agents with or without insulin, and insulin-only regimens.

A GLP-1 agonist plus basal insulin was associated with a reduction of 0.44% in more lowering of hemoglobin A1c and a near doubling in the likelihood of achieving a target HbA1c of 7% or below (relative risk, 1.92), compared with other diabetes treatments. No increased risk of hypoglycemia was seen associated with the GLP-1 and basal insulin regimens, and a mean reduction in weight of 3.22 kg was seen for these compared to the other treatments. Compared with full basal-bolus insulin regimens, a GLP-1 agonist plus basal insulin was seen associated with minimal reduction in HbA1c (–0.1%), but with lower risk of hypoglycemia (RR 0.67) and a reduction in mean weight of 5.66 kg.

The meta-analysis yielded “robust and consistent findings that lend support to the benefits of GLP-1 agonist and basal insulin combination treatment. Indeed, this consistency is apparent despite the fact that these studies differ in several ways, including the antidiabetic treatments assessed, the background oral antidiabetic drugs, the GLP-1 preparation under study, and the sequence of its initiation in relation to that of basal insulin,” Mr. Eng and his colleagues wrote. They acknowledged as limitations of their study the open-label design, industry funding, and short duration of some of the included clinical trials.

The study had no outside funding; one coauthor, Dr. Bernard Zinman, reported financial relationships with Novo Nordisk, Boehringer Ingelheim, Merck, Eli Lilly, AstraZeneca, Jansen, Takeda, and Sanofi-Aventis. Dr. Ravi Retnakaran, corresponding author, disclosed past compensation from Novo Nordisk and Merck.

Combination treatment with GLP-1 agonist and basal insulin helps diabetes patients achieve glycemic control without increasing their risk of hypoglycemia or weight gain, a new meta-analysis has found.

The research, published online Sept. 12 in The Lancet, suggests that glucagon-like peptide-1 (GLP-1) agonists, injectable agents currently used mainly as second- or third-line treatments after oral diabetes therapies have failed, might merit a more prominent role in the treatment pathway in combination with basal insulin.

The authors of the meta-analysis, led by Conrad Eng of Mount Sinai Hospital, Toronto, analyzed results from 15 studies enrolling 4,348 patients with type 2 diabetes. All the studies compared GLP-1 agonists, including exenatide (Byetta), liraglutide (Victoza), and albiglutide (Tanzeum), and basal insulin with other regimens, which included oral agents with or without insulin, and insulin-only regimens.

A GLP-1 agonist plus basal insulin was associated with a reduction of 0.44% in more lowering of hemoglobin A1c and a near doubling in the likelihood of achieving a target HbA1c of 7% or below (relative risk, 1.92), compared with other diabetes treatments. No increased risk of hypoglycemia was seen associated with the GLP-1 and basal insulin regimens, and a mean reduction in weight of 3.22 kg was seen for these compared to the other treatments. Compared with full basal-bolus insulin regimens, a GLP-1 agonist plus basal insulin was seen associated with minimal reduction in HbA1c (–0.1%), but with lower risk of hypoglycemia (RR 0.67) and a reduction in mean weight of 5.66 kg.

The meta-analysis yielded “robust and consistent findings that lend support to the benefits of GLP-1 agonist and basal insulin combination treatment. Indeed, this consistency is apparent despite the fact that these studies differ in several ways, including the antidiabetic treatments assessed, the background oral antidiabetic drugs, the GLP-1 preparation under study, and the sequence of its initiation in relation to that of basal insulin,” Mr. Eng and his colleagues wrote. They acknowledged as limitations of their study the open-label design, industry funding, and short duration of some of the included clinical trials.

The study had no outside funding; one coauthor, Dr. Bernard Zinman, reported financial relationships with Novo Nordisk, Boehringer Ingelheim, Merck, Eli Lilly, AstraZeneca, Jansen, Takeda, and Sanofi-Aventis. Dr. Ravi Retnakaran, corresponding author, disclosed past compensation from Novo Nordisk and Merck.

Combination treatment with GLP-1 agonist and basal insulin helps diabetes patients achieve glycemic control without increasing their risk of hypoglycemia or weight gain, a new meta-analysis has found.

The research, published online Sept. 12 in The Lancet, suggests that glucagon-like peptide-1 (GLP-1) agonists, injectable agents currently used mainly as second- or third-line treatments after oral diabetes therapies have failed, might merit a more prominent role in the treatment pathway in combination with basal insulin.

The authors of the meta-analysis, led by Conrad Eng of Mount Sinai Hospital, Toronto, analyzed results from 15 studies enrolling 4,348 patients with type 2 diabetes. All the studies compared GLP-1 agonists, including exenatide (Byetta), liraglutide (Victoza), and albiglutide (Tanzeum), and basal insulin with other regimens, which included oral agents with or without insulin, and insulin-only regimens.

A GLP-1 agonist plus basal insulin was associated with a reduction of 0.44% in more lowering of hemoglobin A1c and a near doubling in the likelihood of achieving a target HbA1c of 7% or below (relative risk, 1.92), compared with other diabetes treatments. No increased risk of hypoglycemia was seen associated with the GLP-1 and basal insulin regimens, and a mean reduction in weight of 3.22 kg was seen for these compared to the other treatments. Compared with full basal-bolus insulin regimens, a GLP-1 agonist plus basal insulin was seen associated with minimal reduction in HbA1c (–0.1%), but with lower risk of hypoglycemia (RR 0.67) and a reduction in mean weight of 5.66 kg.

The meta-analysis yielded “robust and consistent findings that lend support to the benefits of GLP-1 agonist and basal insulin combination treatment. Indeed, this consistency is apparent despite the fact that these studies differ in several ways, including the antidiabetic treatments assessed, the background oral antidiabetic drugs, the GLP-1 preparation under study, and the sequence of its initiation in relation to that of basal insulin,” Mr. Eng and his colleagues wrote. They acknowledged as limitations of their study the open-label design, industry funding, and short duration of some of the included clinical trials.

The study had no outside funding; one coauthor, Dr. Bernard Zinman, reported financial relationships with Novo Nordisk, Boehringer Ingelheim, Merck, Eli Lilly, AstraZeneca, Jansen, Takeda, and Sanofi-Aventis. Dr. Ravi Retnakaran, corresponding author, disclosed past compensation from Novo Nordisk and Merck.