M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.

Less severe sepsis goes unrecognized in hospitals

Early identification of sepsis remains suboptimal
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Less severe sepsis goes unrecognized in hospitals

SAN DIEGO – Although hospitals in recent years have done a good job catching severe sepsis, less severe cases are falling through the cracks and ultimately proving fatal, according to a retrospective database study presented at an international conference of the American Thoracic Society.

That’s probably the main reason investigators at Kaiser Permanente Northern California (KPNC) found that up to half of hospital deaths are sepsis related. Of 14,206 adult inpatient deaths at KPNC hospitals between 2010 and 2012, 36.9% had sepsis-related codes. When the team included patients without sepsis codes but with evidence of both infection and acute organ failure – implying sepsis – the number rose to 55.9%.

Frontline Medical News
Dr. Vincent Liu says that although mortality has fallen for patients with severe sepsis, there’s still a long way to go in catching and treating less severe cases in time.

Most patients had indications of sepsis at admission, and patients with initially less severe sepsis made up the majority of sepsis deaths. About 56% of sepsis-related deaths were in people with normal blood pressure and normal or intermediate serum lactate levels (less than 4 mmol/L) on admission. Patients who met the criteria for early goal-directed therapy at admission, but for whatever reason did not get it, accounted for 21% of the deaths (JAMA 18 May 2014 [doi:10.1001/jama.2014.5804]).

The story was similar when the team looked at 143,312 deaths in the 2010 Healthcare Cost and Utilization Project Nationwide Inpatient Sample, which captures about 20% of U.S. community hospitals: 34.7% had sepsis codes, and 52% had codes or evidence of both infection and acute organ failure.

Sepsis could have been the final common pathway in already-ill patients, but the numbers hint that at least in some cases, sepsis that could have been extinguished early got out of hand before it was recognized.

The Surviving Sepsis Campaign and other efforts "have had a huge impact on how we treat the most severely ill sepsis patients. We’ve seen about a halving of mortality in the past 15 years. Now we need to broaden our perspective to focus intervention on the less severely ill, who tend to be less severe up front and underidentified," said lead investigator Dr. Liu, with the KPNC division of research, Oakland, Calif.

Based on the results, KPNC has started applying its sepsis bundle to patients with intermediate-lactate levels, "but there is very limited data about the benefit of bundle care in less severe sepsis patients, so we are still tracking our outcomes," he said. There’s also a culture shift involved, which includes heightening clinician awareness, updating communication protocols, and other measures, Dr. Liu said in presenting the results.

There’s a role for more research dollars as well, and education efforts to make the public aware of sepsis and the need for early intervention, similar to what’s been done for stroke, he said.

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Dr. Steven Simpson

Dr. Steven Q. Simpson, FCCP, comments: "These national data corroborate data from nearly every individual hospital that has looked at the phenomenon in the Kansas Sepsis Project and other quality improvement efforts with which I work personally.

It is clear that early identification of severe sepsis and aggressive intervention remain suboptimal in U.S. hospitals, in spite of a decade of attempts by numerous organizations, including CHEST, the Surviving Sepsis Campaign, the New York Hospital Association, and others to make providers aware of the need. One hopes that the press engendered by these findings helps to focus more attention in that direction and helps to prevent unnecessary deaths."

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Dr. Steven Simpson

Dr. Steven Q. Simpson, FCCP, comments: "These national data corroborate data from nearly every individual hospital that has looked at the phenomenon in the Kansas Sepsis Project and other quality improvement efforts with which I work personally.

It is clear that early identification of severe sepsis and aggressive intervention remain suboptimal in U.S. hospitals, in spite of a decade of attempts by numerous organizations, including CHEST, the Surviving Sepsis Campaign, the New York Hospital Association, and others to make providers aware of the need. One hopes that the press engendered by these findings helps to focus more attention in that direction and helps to prevent unnecessary deaths."

Body


Dr. Steven Simpson

Dr. Steven Q. Simpson, FCCP, comments: "These national data corroborate data from nearly every individual hospital that has looked at the phenomenon in the Kansas Sepsis Project and other quality improvement efforts with which I work personally.

It is clear that early identification of severe sepsis and aggressive intervention remain suboptimal in U.S. hospitals, in spite of a decade of attempts by numerous organizations, including CHEST, the Surviving Sepsis Campaign, the New York Hospital Association, and others to make providers aware of the need. One hopes that the press engendered by these findings helps to focus more attention in that direction and helps to prevent unnecessary deaths."

Title
Early identification of sepsis remains suboptimal
Early identification of sepsis remains suboptimal

SAN DIEGO – Although hospitals in recent years have done a good job catching severe sepsis, less severe cases are falling through the cracks and ultimately proving fatal, according to a retrospective database study presented at an international conference of the American Thoracic Society.

That’s probably the main reason investigators at Kaiser Permanente Northern California (KPNC) found that up to half of hospital deaths are sepsis related. Of 14,206 adult inpatient deaths at KPNC hospitals between 2010 and 2012, 36.9% had sepsis-related codes. When the team included patients without sepsis codes but with evidence of both infection and acute organ failure – implying sepsis – the number rose to 55.9%.

Frontline Medical News
Dr. Vincent Liu says that although mortality has fallen for patients with severe sepsis, there’s still a long way to go in catching and treating less severe cases in time.

Most patients had indications of sepsis at admission, and patients with initially less severe sepsis made up the majority of sepsis deaths. About 56% of sepsis-related deaths were in people with normal blood pressure and normal or intermediate serum lactate levels (less than 4 mmol/L) on admission. Patients who met the criteria for early goal-directed therapy at admission, but for whatever reason did not get it, accounted for 21% of the deaths (JAMA 18 May 2014 [doi:10.1001/jama.2014.5804]).

The story was similar when the team looked at 143,312 deaths in the 2010 Healthcare Cost and Utilization Project Nationwide Inpatient Sample, which captures about 20% of U.S. community hospitals: 34.7% had sepsis codes, and 52% had codes or evidence of both infection and acute organ failure.

Sepsis could have been the final common pathway in already-ill patients, but the numbers hint that at least in some cases, sepsis that could have been extinguished early got out of hand before it was recognized.

The Surviving Sepsis Campaign and other efforts "have had a huge impact on how we treat the most severely ill sepsis patients. We’ve seen about a halving of mortality in the past 15 years. Now we need to broaden our perspective to focus intervention on the less severely ill, who tend to be less severe up front and underidentified," said lead investigator Dr. Liu, with the KPNC division of research, Oakland, Calif.

Based on the results, KPNC has started applying its sepsis bundle to patients with intermediate-lactate levels, "but there is very limited data about the benefit of bundle care in less severe sepsis patients, so we are still tracking our outcomes," he said. There’s also a culture shift involved, which includes heightening clinician awareness, updating communication protocols, and other measures, Dr. Liu said in presenting the results.

There’s a role for more research dollars as well, and education efforts to make the public aware of sepsis and the need for early intervention, similar to what’s been done for stroke, he said.

SAN DIEGO – Although hospitals in recent years have done a good job catching severe sepsis, less severe cases are falling through the cracks and ultimately proving fatal, according to a retrospective database study presented at an international conference of the American Thoracic Society.

That’s probably the main reason investigators at Kaiser Permanente Northern California (KPNC) found that up to half of hospital deaths are sepsis related. Of 14,206 adult inpatient deaths at KPNC hospitals between 2010 and 2012, 36.9% had sepsis-related codes. When the team included patients without sepsis codes but with evidence of both infection and acute organ failure – implying sepsis – the number rose to 55.9%.

Frontline Medical News
Dr. Vincent Liu says that although mortality has fallen for patients with severe sepsis, there’s still a long way to go in catching and treating less severe cases in time.

Most patients had indications of sepsis at admission, and patients with initially less severe sepsis made up the majority of sepsis deaths. About 56% of sepsis-related deaths were in people with normal blood pressure and normal or intermediate serum lactate levels (less than 4 mmol/L) on admission. Patients who met the criteria for early goal-directed therapy at admission, but for whatever reason did not get it, accounted for 21% of the deaths (JAMA 18 May 2014 [doi:10.1001/jama.2014.5804]).

The story was similar when the team looked at 143,312 deaths in the 2010 Healthcare Cost and Utilization Project Nationwide Inpatient Sample, which captures about 20% of U.S. community hospitals: 34.7% had sepsis codes, and 52% had codes or evidence of both infection and acute organ failure.

Sepsis could have been the final common pathway in already-ill patients, but the numbers hint that at least in some cases, sepsis that could have been extinguished early got out of hand before it was recognized.

The Surviving Sepsis Campaign and other efforts "have had a huge impact on how we treat the most severely ill sepsis patients. We’ve seen about a halving of mortality in the past 15 years. Now we need to broaden our perspective to focus intervention on the less severely ill, who tend to be less severe up front and underidentified," said lead investigator Dr. Liu, with the KPNC division of research, Oakland, Calif.

Based on the results, KPNC has started applying its sepsis bundle to patients with intermediate-lactate levels, "but there is very limited data about the benefit of bundle care in less severe sepsis patients, so we are still tracking our outcomes," he said. There’s also a culture shift involved, which includes heightening clinician awareness, updating communication protocols, and other measures, Dr. Liu said in presenting the results.

There’s a role for more research dollars as well, and education efforts to make the public aware of sepsis and the need for early intervention, similar to what’s been done for stroke, he said.

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Less severe sepsis goes unrecognized in hospitals
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Key clinical point: Have a high index of suspicion for less severe sepsis at hospital admission.

Major finding: About 56% of sepsis-related deaths are in people with normal blood pressure and normal or intermediate serum lactate levels (less than 4 mmol/L) on admission.

Data source: A retrospective database study of about 7 million adult hospitalizations.

Disclosures: The work was funded by the Kaiser Foundation, the Department of Veterans Affairs, and others. One author disclosed personal fees from industry sources. Dr. Liu and the other authors said they had no financial disclosures.

No benefit found for acetylcysteine in IPF

Improving quality of life in IPF patients
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No benefit found for acetylcysteine in IPF

SAN DIEGO - At 60 weeks, there was no significant difference in the change in FVC between 133 patients randomized to acetylcysteine 600 mg three times daily and 131 randomized to placebo (–0.18 L and –0.19 L, respectively; P = .77). There were no significant differences between the acetylcysteine group and the placebo group in rates of death (4.9% vs. 2.5%, respectively; P =.30) or acute exacerbations (2.3% in each group; P greater than .99) (N. Eng. J. Med. 2014 May 18 [doi: 10.1056/NEJMoa1401739]).

“Our results are applicable only to patients with idiopathic pulmonary fibrosis [IPF] who met the inclusion and exclusion criteria of this trial, and not to patients with more advanced disease or other forms of idiopathic interstitial pneumonia or interstitial lung disease,” said the researchers, all members of the Idiopathic Pulmonary Fibrosis Clinical Research Network and led by Dr. Ganesh Raghu, FCCP, director of the interstitial lung disease/sarcoid/pulmonary fibrosis program at the University of Washington, Seattle.

The study originally included a third arm in which patients received prednisone, azathioprine, and acetylcysteine, but it was halted after the data and safety monitoring board saw an increased risk of hospitalization and death, which led to a National Institutes of Health warning against use of the combination for IPF.

Overall, cardiac problems were more common in the acetylcysteine group than in the placebo patients (6.8% vs. 1.5%; P = .03), but gastrointestinal disorders were less common (0% vs. 4.6%; P = .01). There were trends favoring acetylcysteine in 6-minute walk distance and quality of life measures. Patients in the acetylcysteine group reported having better mental well-being.

Baseline characteristics were well matched in the two groups. Mean age was 67 years; 22% were women; 96% were white. Mean baseline FVC was 73% of the predicted value, and mean carbon monoxide diffusing capacity was 45% of the predicted value. Mean distance on the 6-minute walk test was 373 m.

At 60 weeks, 90.4% of the acetylcysteine group and 94.4% of the placebo group reported taking more than 80% of the recommended doses of the study drug.

“It is reasonable to shift our understanding of the pathogenesis of this disease,” Dr. Gary M. Hunninghake, director of the sarcoidosis and granulomatous lung disease service at Brigham and Women’s Hospital, Boston, wrote in an editorial (N. Eng. J. Med. 2014 May 18 [doi: 10.1056/NEJMe1403448]). IPF “is a disease perpetuated by aberrant wound healing, rather than primarily by chronic inflammation. With new understanding comes new hope.”

aotto@frontlinemedcom.com

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Dr. Vera DePalo

Dr. Vera DePalo, FCCP, comments: This article addresses possible treatments in idiopathic pulmonary fibrosis (IPF). IPF can be particularly disabling. Therapies continue to be investigated in an attempt to improve quality of life and functional status. In one of the studies, Dr. Raghu reports no significant difference in the change in forced vital capacity (FVC) between the oral acetylcysteine-treated group and the control group at 60 weeks. However, in an industry-funded trial, the investigational tyrosine kinase inhibitor, nintedanib, helped to preserve FVC compared with placebo. This result lends hope for a trend of improved quality of life in IPF patients.
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Dr. Vera DePalo

Dr. Vera DePalo, FCCP, comments: This article addresses possible treatments in idiopathic pulmonary fibrosis (IPF). IPF can be particularly disabling. Therapies continue to be investigated in an attempt to improve quality of life and functional status. In one of the studies, Dr. Raghu reports no significant difference in the change in forced vital capacity (FVC) between the oral acetylcysteine-treated group and the control group at 60 weeks. However, in an industry-funded trial, the investigational tyrosine kinase inhibitor, nintedanib, helped to preserve FVC compared with placebo. This result lends hope for a trend of improved quality of life in IPF patients.
Body


Dr. Vera DePalo

Dr. Vera DePalo, FCCP, comments: This article addresses possible treatments in idiopathic pulmonary fibrosis (IPF). IPF can be particularly disabling. Therapies continue to be investigated in an attempt to improve quality of life and functional status. In one of the studies, Dr. Raghu reports no significant difference in the change in forced vital capacity (FVC) between the oral acetylcysteine-treated group and the control group at 60 weeks. However, in an industry-funded trial, the investigational tyrosine kinase inhibitor, nintedanib, helped to preserve FVC compared with placebo. This result lends hope for a trend of improved quality of life in IPF patients.
Title
Improving quality of life in IPF patients
Improving quality of life in IPF patients

SAN DIEGO - At 60 weeks, there was no significant difference in the change in FVC between 133 patients randomized to acetylcysteine 600 mg three times daily and 131 randomized to placebo (–0.18 L and –0.19 L, respectively; P = .77). There were no significant differences between the acetylcysteine group and the placebo group in rates of death (4.9% vs. 2.5%, respectively; P =.30) or acute exacerbations (2.3% in each group; P greater than .99) (N. Eng. J. Med. 2014 May 18 [doi: 10.1056/NEJMoa1401739]).

“Our results are applicable only to patients with idiopathic pulmonary fibrosis [IPF] who met the inclusion and exclusion criteria of this trial, and not to patients with more advanced disease or other forms of idiopathic interstitial pneumonia or interstitial lung disease,” said the researchers, all members of the Idiopathic Pulmonary Fibrosis Clinical Research Network and led by Dr. Ganesh Raghu, FCCP, director of the interstitial lung disease/sarcoid/pulmonary fibrosis program at the University of Washington, Seattle.

The study originally included a third arm in which patients received prednisone, azathioprine, and acetylcysteine, but it was halted after the data and safety monitoring board saw an increased risk of hospitalization and death, which led to a National Institutes of Health warning against use of the combination for IPF.

Overall, cardiac problems were more common in the acetylcysteine group than in the placebo patients (6.8% vs. 1.5%; P = .03), but gastrointestinal disorders were less common (0% vs. 4.6%; P = .01). There were trends favoring acetylcysteine in 6-minute walk distance and quality of life measures. Patients in the acetylcysteine group reported having better mental well-being.

Baseline characteristics were well matched in the two groups. Mean age was 67 years; 22% were women; 96% were white. Mean baseline FVC was 73% of the predicted value, and mean carbon monoxide diffusing capacity was 45% of the predicted value. Mean distance on the 6-minute walk test was 373 m.

At 60 weeks, 90.4% of the acetylcysteine group and 94.4% of the placebo group reported taking more than 80% of the recommended doses of the study drug.

“It is reasonable to shift our understanding of the pathogenesis of this disease,” Dr. Gary M. Hunninghake, director of the sarcoidosis and granulomatous lung disease service at Brigham and Women’s Hospital, Boston, wrote in an editorial (N. Eng. J. Med. 2014 May 18 [doi: 10.1056/NEJMe1403448]). IPF “is a disease perpetuated by aberrant wound healing, rather than primarily by chronic inflammation. With new understanding comes new hope.”

aotto@frontlinemedcom.com

SAN DIEGO - At 60 weeks, there was no significant difference in the change in FVC between 133 patients randomized to acetylcysteine 600 mg three times daily and 131 randomized to placebo (–0.18 L and –0.19 L, respectively; P = .77). There were no significant differences between the acetylcysteine group and the placebo group in rates of death (4.9% vs. 2.5%, respectively; P =.30) or acute exacerbations (2.3% in each group; P greater than .99) (N. Eng. J. Med. 2014 May 18 [doi: 10.1056/NEJMoa1401739]).

“Our results are applicable only to patients with idiopathic pulmonary fibrosis [IPF] who met the inclusion and exclusion criteria of this trial, and not to patients with more advanced disease or other forms of idiopathic interstitial pneumonia or interstitial lung disease,” said the researchers, all members of the Idiopathic Pulmonary Fibrosis Clinical Research Network and led by Dr. Ganesh Raghu, FCCP, director of the interstitial lung disease/sarcoid/pulmonary fibrosis program at the University of Washington, Seattle.

The study originally included a third arm in which patients received prednisone, azathioprine, and acetylcysteine, but it was halted after the data and safety monitoring board saw an increased risk of hospitalization and death, which led to a National Institutes of Health warning against use of the combination for IPF.

Overall, cardiac problems were more common in the acetylcysteine group than in the placebo patients (6.8% vs. 1.5%; P = .03), but gastrointestinal disorders were less common (0% vs. 4.6%; P = .01). There were trends favoring acetylcysteine in 6-minute walk distance and quality of life measures. Patients in the acetylcysteine group reported having better mental well-being.

Baseline characteristics were well matched in the two groups. Mean age was 67 years; 22% were women; 96% were white. Mean baseline FVC was 73% of the predicted value, and mean carbon monoxide diffusing capacity was 45% of the predicted value. Mean distance on the 6-minute walk test was 373 m.

At 60 weeks, 90.4% of the acetylcysteine group and 94.4% of the placebo group reported taking more than 80% of the recommended doses of the study drug.

“It is reasonable to shift our understanding of the pathogenesis of this disease,” Dr. Gary M. Hunninghake, director of the sarcoidosis and granulomatous lung disease service at Brigham and Women’s Hospital, Boston, wrote in an editorial (N. Eng. J. Med. 2014 May 18 [doi: 10.1056/NEJMe1403448]). IPF “is a disease perpetuated by aberrant wound healing, rather than primarily by chronic inflammation. With new understanding comes new hope.”

aotto@frontlinemedcom.com

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No benefit found for acetylcysteine in IPF
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Key clinical point: Acetylcysteine treatment of idiopathic pulmonary fibrosis is no better than placebo.

Major finding: At 60 weeks, there was no significant difference in the change in forced vital capacity between 133 patients who had been randomized to acetylcysteine 600 mg three times daily and 131 randomized to placebo (-0.18 L and -0.19 L, respectively; P = .77).

Data source: Randomized, placebo-controlled trial.

Disclosures: The work was funded by the National Heart, Lung, and Blood Institute, among others. Dr. Raghu cited grant support and personal fees from Gilead, as well as personal fees from Biogen, Boehringer Ingelheim, and other companies. The other authors disclosed payments for services from those or other companies. Dr. Hunninghake had no disclosures.

Investigational agent preserves vital capacity

Improving quality of life in IPF patients
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Investigational agent preserves vital capacity

SAN DIEGO – Compared with placebo, the investigative tyrosine kinase inhibitor nintedanib helped preserve forced vital capacity in patients with idiopathic pulmonary fibrosis, according to phase III results presented at an international conference of the American Thoracic Society.

Across two trials, 1,066 patients were randomized 3:2 to 150 mg of nintedanib twice daily or placebo for 52 weeks. In INPULSIS-1, the adjusted annual rate of change in forced vital capacity (FVC) was –114.7 mL with nintedanib versus –239.9 mL with placebo (difference 125.3 mL; 95% confidence interval, 77.7-172.8; P less than .001). In INPULSIS-2, the rate of change was –113.6 mL with nintedanib versus –207.3 mL with placebo (difference 93.7 mL; 95% CI, 44.8 to 142.7; P less than .001).

"The curves for changes from baseline in FVC over time in the nintedanib and placebo groups separated early in the two studies and continued to diverge over time," the researchers wrote (N. Engl. J. Med. 2014 May 18 [doi:10.1056/NEJMoa1402584]). MIs were reported in five (1.6%) nintedanib patients and one (0.5%) placebo patient in the first trial and five (1.5%) nintedanib patients and one (0.5%) placebo patient in the second. Two MIs in the nintedanib groups and one in the placebo groups were fatal.

Idiopathic pulmonary fibrosis (IPF) is a serious disease "for which there are currently no FDA-approved treatments. We are all very excited by these data because they suggest evidence of nintedanib’s impact on lung function loss in patients with IPF. Overall, [it’s] a positive message that we are making progress," said lead investigator Dr. Luca Richeldi, chair of interstitial lung disease at the University of Southampton (England).

Results were mixed on secondary endpoints. There was no significant between-group difference in death from any cause or respiratory causes; 5.5% of nintedanib patients and 7.8% of placebo patients died. Likewise, the time to first acute exacerbation and progression on the St. George’s Respiratory Questionnaire (SGRQ) were significantly delayed only in INPULSIS-2, not INPULSIS-1. On pooled analysis, nintedanib offered no advantage over placebo in time to first exacerbation (hazard ratio, 0.64; 95% CI, 0.39-1.05; P = .08) or mean 52-week change from baseline SGRO.

The "difference in the key secondary endpoint between [the trials] was not explained by the differences in baseline characteristics." Exacerbations "are relatively rare events in patients with [IPF] who are in clinical trials and are difficult to assess and categorize, which may explain some of the heterogeneity in our findings," the researchers said.

About 62% of nintedanib patients versus 18% of placebo patients reported diarrhea. Liver enzyme levels three times above normal were found in 5% of nintedanib patients and less than 1% of placebo patients.

Eighty percent of the subjects were men. Average age was 67 years. Baseline FVC was 80% of predicted value in all study arms.

aotto@frontlinemedcom.com

Body


Dr. Vera DePalo

Dr. Vera DePalo, FCCP, comments: This article addresses possible treatments in idiopathic pulmonary fibrosis (IPF). IPF can be particularly disabling. Therapies continue to be investigated in an attempt to improve quality of life and functional status. In one of the studies, Dr. Raghu reports no significant difference in the change in forced vital capacity (FVC) between the oral acetylcysteine-treated group and the control group at 60 weeks. However, in an industry-funded trial, the investigational tyrosine kinase inhibitor, nintedanib, helped to preserve FVC compared with placebo. This result lends hope for a trend of improved quality of life in IPF patients.
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Dr. Vera DePalo

Dr. Vera DePalo, FCCP, comments: This article addresses possible treatments in idiopathic pulmonary fibrosis (IPF). IPF can be particularly disabling. Therapies continue to be investigated in an attempt to improve quality of life and functional status. In one of the studies, Dr. Raghu reports no significant difference in the change in forced vital capacity (FVC) between the oral acetylcysteine-treated group and the control group at 60 weeks. However, in an industry-funded trial, the investigational tyrosine kinase inhibitor, nintedanib, helped to preserve FVC compared with placebo. This result lends hope for a trend of improved quality of life in IPF patients.
Body


Dr. Vera DePalo

Dr. Vera DePalo, FCCP, comments: This article addresses possible treatments in idiopathic pulmonary fibrosis (IPF). IPF can be particularly disabling. Therapies continue to be investigated in an attempt to improve quality of life and functional status. In one of the studies, Dr. Raghu reports no significant difference in the change in forced vital capacity (FVC) between the oral acetylcysteine-treated group and the control group at 60 weeks. However, in an industry-funded trial, the investigational tyrosine kinase inhibitor, nintedanib, helped to preserve FVC compared with placebo. This result lends hope for a trend of improved quality of life in IPF patients.
Title
Improving quality of life in IPF patients
Improving quality of life in IPF patients

SAN DIEGO – Compared with placebo, the investigative tyrosine kinase inhibitor nintedanib helped preserve forced vital capacity in patients with idiopathic pulmonary fibrosis, according to phase III results presented at an international conference of the American Thoracic Society.

Across two trials, 1,066 patients were randomized 3:2 to 150 mg of nintedanib twice daily or placebo for 52 weeks. In INPULSIS-1, the adjusted annual rate of change in forced vital capacity (FVC) was –114.7 mL with nintedanib versus –239.9 mL with placebo (difference 125.3 mL; 95% confidence interval, 77.7-172.8; P less than .001). In INPULSIS-2, the rate of change was –113.6 mL with nintedanib versus –207.3 mL with placebo (difference 93.7 mL; 95% CI, 44.8 to 142.7; P less than .001).

"The curves for changes from baseline in FVC over time in the nintedanib and placebo groups separated early in the two studies and continued to diverge over time," the researchers wrote (N. Engl. J. Med. 2014 May 18 [doi:10.1056/NEJMoa1402584]). MIs were reported in five (1.6%) nintedanib patients and one (0.5%) placebo patient in the first trial and five (1.5%) nintedanib patients and one (0.5%) placebo patient in the second. Two MIs in the nintedanib groups and one in the placebo groups were fatal.

Idiopathic pulmonary fibrosis (IPF) is a serious disease "for which there are currently no FDA-approved treatments. We are all very excited by these data because they suggest evidence of nintedanib’s impact on lung function loss in patients with IPF. Overall, [it’s] a positive message that we are making progress," said lead investigator Dr. Luca Richeldi, chair of interstitial lung disease at the University of Southampton (England).

Results were mixed on secondary endpoints. There was no significant between-group difference in death from any cause or respiratory causes; 5.5% of nintedanib patients and 7.8% of placebo patients died. Likewise, the time to first acute exacerbation and progression on the St. George’s Respiratory Questionnaire (SGRQ) were significantly delayed only in INPULSIS-2, not INPULSIS-1. On pooled analysis, nintedanib offered no advantage over placebo in time to first exacerbation (hazard ratio, 0.64; 95% CI, 0.39-1.05; P = .08) or mean 52-week change from baseline SGRO.

The "difference in the key secondary endpoint between [the trials] was not explained by the differences in baseline characteristics." Exacerbations "are relatively rare events in patients with [IPF] who are in clinical trials and are difficult to assess and categorize, which may explain some of the heterogeneity in our findings," the researchers said.

About 62% of nintedanib patients versus 18% of placebo patients reported diarrhea. Liver enzyme levels three times above normal were found in 5% of nintedanib patients and less than 1% of placebo patients.

Eighty percent of the subjects were men. Average age was 67 years. Baseline FVC was 80% of predicted value in all study arms.

aotto@frontlinemedcom.com

SAN DIEGO – Compared with placebo, the investigative tyrosine kinase inhibitor nintedanib helped preserve forced vital capacity in patients with idiopathic pulmonary fibrosis, according to phase III results presented at an international conference of the American Thoracic Society.

Across two trials, 1,066 patients were randomized 3:2 to 150 mg of nintedanib twice daily or placebo for 52 weeks. In INPULSIS-1, the adjusted annual rate of change in forced vital capacity (FVC) was –114.7 mL with nintedanib versus –239.9 mL with placebo (difference 125.3 mL; 95% confidence interval, 77.7-172.8; P less than .001). In INPULSIS-2, the rate of change was –113.6 mL with nintedanib versus –207.3 mL with placebo (difference 93.7 mL; 95% CI, 44.8 to 142.7; P less than .001).

"The curves for changes from baseline in FVC over time in the nintedanib and placebo groups separated early in the two studies and continued to diverge over time," the researchers wrote (N. Engl. J. Med. 2014 May 18 [doi:10.1056/NEJMoa1402584]). MIs were reported in five (1.6%) nintedanib patients and one (0.5%) placebo patient in the first trial and five (1.5%) nintedanib patients and one (0.5%) placebo patient in the second. Two MIs in the nintedanib groups and one in the placebo groups were fatal.

Idiopathic pulmonary fibrosis (IPF) is a serious disease "for which there are currently no FDA-approved treatments. We are all very excited by these data because they suggest evidence of nintedanib’s impact on lung function loss in patients with IPF. Overall, [it’s] a positive message that we are making progress," said lead investigator Dr. Luca Richeldi, chair of interstitial lung disease at the University of Southampton (England).

Results were mixed on secondary endpoints. There was no significant between-group difference in death from any cause or respiratory causes; 5.5% of nintedanib patients and 7.8% of placebo patients died. Likewise, the time to first acute exacerbation and progression on the St. George’s Respiratory Questionnaire (SGRQ) were significantly delayed only in INPULSIS-2, not INPULSIS-1. On pooled analysis, nintedanib offered no advantage over placebo in time to first exacerbation (hazard ratio, 0.64; 95% CI, 0.39-1.05; P = .08) or mean 52-week change from baseline SGRO.

The "difference in the key secondary endpoint between [the trials] was not explained by the differences in baseline characteristics." Exacerbations "are relatively rare events in patients with [IPF] who are in clinical trials and are difficult to assess and categorize, which may explain some of the heterogeneity in our findings," the researchers said.

About 62% of nintedanib patients versus 18% of placebo patients reported diarrhea. Liver enzyme levels three times above normal were found in 5% of nintedanib patients and less than 1% of placebo patients.

Eighty percent of the subjects were men. Average age was 67 years. Baseline FVC was 80% of predicted value in all study arms.

aotto@frontlinemedcom.com

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Major finding: In the first trial, the adjusted annual rate of change in FVC was –114.7 mL with nintedanib versus –239.9 mL with placebo. In the second, the rate of change was –113.6 mL with nintedanib versus –207.3 mL with placebo.

Data source: Randomized, controlled trials involving patients with IPF.

Disclosures: Boehringer Ingelheim and the British National Health Service funded the work. Dr. Richeldi disclosed ties with InterMune, MedImmune, Roche, Takeda, Biogen Idec, Sanofi Aventis, ImmuneWorks, and Shionogi. Some coauthors disclosed ties with Boehringer Ingelheim, maker of nintedanib.

VIDEO: Helping MS patients regain use of their limbs

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DALLAS – Constraint-induced movement therapy – a technique fairly well known for stroke – helps patients with hemiparetic multiple sclerosis, too.

Instead of favoring their good arm, patients are taught to use their affected arm. Once they learn how, the results seem to be self-perpetuating. That might be why Dr. Victor W. Mark and his colleagues at the University of Alabama at Birmingham found that the benefits of even a 10-day course of therapy persist for several years. They also found that constraint-induced movement therapy appears to help restore brain volume lost to MS.

Dr. Mark explained the technique and his findings at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

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DALLAS – Constraint-induced movement therapy – a technique fairly well known for stroke – helps patients with hemiparetic multiple sclerosis, too.

Instead of favoring their good arm, patients are taught to use their affected arm. Once they learn how, the results seem to be self-perpetuating. That might be why Dr. Victor W. Mark and his colleagues at the University of Alabama at Birmingham found that the benefits of even a 10-day course of therapy persist for several years. They also found that constraint-induced movement therapy appears to help restore brain volume lost to MS.

Dr. Mark explained the technique and his findings at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

DALLAS – Constraint-induced movement therapy – a technique fairly well known for stroke – helps patients with hemiparetic multiple sclerosis, too.

Instead of favoring their good arm, patients are taught to use their affected arm. Once they learn how, the results seem to be self-perpetuating. That might be why Dr. Victor W. Mark and his colleagues at the University of Alabama at Birmingham found that the benefits of even a 10-day course of therapy persist for several years. They also found that constraint-induced movement therapy appears to help restore brain volume lost to MS.

Dr. Mark explained the technique and his findings at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Copaxone lipoatrophy far more common than reported

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DALLAS – The risk of lipoatrophy with glatiramer acetate is greater than 60%, according to a review of 73 multiple sclerosis patients at one clinic.

The risk is "substantially higher than previously reported and [is] often the sole factor prompting patients to switch to another MS [disease-modifying therapy]. Our data also suggest that a heightened risk of lipoatrophy is an inherent autoimmune problem and is not necessarily mitigated by vigilant injection-site rotation. The psychological consequences may be significant," said investigator Dr. Ronald Bailey, director of the MS clinic at the Riverside (Calif.) Medical Clinic.

Dr. Ronald Bailey

A total of 46 glatiramer acetate (GA, Copaxone) patients (63%) developed lipoatrophy, an injection-site indentation that can be deep and disfiguring; 35 (76%) of them used an autoinjector. Once noted, the dents didn’t improve during a 3-year observation period, which included photographic documentation and instructions on how to inject the drug every 3 months.

In some patients, lipoatrophy developed within the first 3 months of starting the shots and was noted at multiple injection sites, which prompted the team to suspect that an autoimmune reaction was at work. "Upon GA treatment discontinuation, lipoatrophy remained permanent," he noted.

Lipoatrophy "appears to progress, even when you stop the injections. It’s a pretty impressive disfiguration. It’s important to emphasize [with patients] that this isn’t necessarily going to be remedied with plastic surgery. [However,] if patients were stable, most of them thought that this was a small price to pay to be in remission," Dr. Bailey said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

GA labeling reports the risk of lipoatrophy to be 2% with the 20-mg/mL daily formulation, which has been on the market for almost 2 decades, and 0.5% with the 40-mg/mL three times weekly option, which was approved by the Food and Drug Administration in 2014. Lipoatrophy "is thought to be permanent. There is no known therapy. To assist in possibly minimizing these events, the patient should be advised to follow proper injection technique and to rotate injection sites with each injection," according to the GA label, which is in contrast with the Riverside finding that site rotation wasn’t much help.

Most of the patients at the clinic were women, in keeping with MS epidemiology, and 40 (55%) opted for the autoinjector, specifically the Autoject 2; the device’s labeling notes that the autoinjector can "help with hard-to-reach areas on your body." Perhaps, by helping patients reach those difficult areas, the autoinjector makes it easier to miss the proper subcutaneous fat layer. That might have something to do with the problem, Dr. Bailey said, but the team simply reported their observations and didn’t report any statistical analysis of the findings, so it’s impossible to discern causes, he noted.

The findings aren’t new for some. The "prevalence of lipoatrophy [is] much higher than expected," one team noted several years ago (Can. J. Neurol. Sci. 2004;31:58-63).

No one knows why GA seems to cause lipoatrophy. Maybe "an elevation in tumor necrosis factor–alpha ... causes a dedifferentiation of adipocytes in [subcutaneous] tissue," Dr. Bailey said.

He is a paid spokesman for Genzyme, Biogen, and Teva, the maker of GA. There was no outside funding for the project.

aotto@frontlinemedcom.com

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DALLAS – The risk of lipoatrophy with glatiramer acetate is greater than 60%, according to a review of 73 multiple sclerosis patients at one clinic.

The risk is "substantially higher than previously reported and [is] often the sole factor prompting patients to switch to another MS [disease-modifying therapy]. Our data also suggest that a heightened risk of lipoatrophy is an inherent autoimmune problem and is not necessarily mitigated by vigilant injection-site rotation. The psychological consequences may be significant," said investigator Dr. Ronald Bailey, director of the MS clinic at the Riverside (Calif.) Medical Clinic.

Dr. Ronald Bailey

A total of 46 glatiramer acetate (GA, Copaxone) patients (63%) developed lipoatrophy, an injection-site indentation that can be deep and disfiguring; 35 (76%) of them used an autoinjector. Once noted, the dents didn’t improve during a 3-year observation period, which included photographic documentation and instructions on how to inject the drug every 3 months.

In some patients, lipoatrophy developed within the first 3 months of starting the shots and was noted at multiple injection sites, which prompted the team to suspect that an autoimmune reaction was at work. "Upon GA treatment discontinuation, lipoatrophy remained permanent," he noted.

Lipoatrophy "appears to progress, even when you stop the injections. It’s a pretty impressive disfiguration. It’s important to emphasize [with patients] that this isn’t necessarily going to be remedied with plastic surgery. [However,] if patients were stable, most of them thought that this was a small price to pay to be in remission," Dr. Bailey said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

GA labeling reports the risk of lipoatrophy to be 2% with the 20-mg/mL daily formulation, which has been on the market for almost 2 decades, and 0.5% with the 40-mg/mL three times weekly option, which was approved by the Food and Drug Administration in 2014. Lipoatrophy "is thought to be permanent. There is no known therapy. To assist in possibly minimizing these events, the patient should be advised to follow proper injection technique and to rotate injection sites with each injection," according to the GA label, which is in contrast with the Riverside finding that site rotation wasn’t much help.

Most of the patients at the clinic were women, in keeping with MS epidemiology, and 40 (55%) opted for the autoinjector, specifically the Autoject 2; the device’s labeling notes that the autoinjector can "help with hard-to-reach areas on your body." Perhaps, by helping patients reach those difficult areas, the autoinjector makes it easier to miss the proper subcutaneous fat layer. That might have something to do with the problem, Dr. Bailey said, but the team simply reported their observations and didn’t report any statistical analysis of the findings, so it’s impossible to discern causes, he noted.

The findings aren’t new for some. The "prevalence of lipoatrophy [is] much higher than expected," one team noted several years ago (Can. J. Neurol. Sci. 2004;31:58-63).

No one knows why GA seems to cause lipoatrophy. Maybe "an elevation in tumor necrosis factor–alpha ... causes a dedifferentiation of adipocytes in [subcutaneous] tissue," Dr. Bailey said.

He is a paid spokesman for Genzyme, Biogen, and Teva, the maker of GA. There was no outside funding for the project.

aotto@frontlinemedcom.com

DALLAS – The risk of lipoatrophy with glatiramer acetate is greater than 60%, according to a review of 73 multiple sclerosis patients at one clinic.

The risk is "substantially higher than previously reported and [is] often the sole factor prompting patients to switch to another MS [disease-modifying therapy]. Our data also suggest that a heightened risk of lipoatrophy is an inherent autoimmune problem and is not necessarily mitigated by vigilant injection-site rotation. The psychological consequences may be significant," said investigator Dr. Ronald Bailey, director of the MS clinic at the Riverside (Calif.) Medical Clinic.

Dr. Ronald Bailey

A total of 46 glatiramer acetate (GA, Copaxone) patients (63%) developed lipoatrophy, an injection-site indentation that can be deep and disfiguring; 35 (76%) of them used an autoinjector. Once noted, the dents didn’t improve during a 3-year observation period, which included photographic documentation and instructions on how to inject the drug every 3 months.

In some patients, lipoatrophy developed within the first 3 months of starting the shots and was noted at multiple injection sites, which prompted the team to suspect that an autoimmune reaction was at work. "Upon GA treatment discontinuation, lipoatrophy remained permanent," he noted.

Lipoatrophy "appears to progress, even when you stop the injections. It’s a pretty impressive disfiguration. It’s important to emphasize [with patients] that this isn’t necessarily going to be remedied with plastic surgery. [However,] if patients were stable, most of them thought that this was a small price to pay to be in remission," Dr. Bailey said at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

GA labeling reports the risk of lipoatrophy to be 2% with the 20-mg/mL daily formulation, which has been on the market for almost 2 decades, and 0.5% with the 40-mg/mL three times weekly option, which was approved by the Food and Drug Administration in 2014. Lipoatrophy "is thought to be permanent. There is no known therapy. To assist in possibly minimizing these events, the patient should be advised to follow proper injection technique and to rotate injection sites with each injection," according to the GA label, which is in contrast with the Riverside finding that site rotation wasn’t much help.

Most of the patients at the clinic were women, in keeping with MS epidemiology, and 40 (55%) opted for the autoinjector, specifically the Autoject 2; the device’s labeling notes that the autoinjector can "help with hard-to-reach areas on your body." Perhaps, by helping patients reach those difficult areas, the autoinjector makes it easier to miss the proper subcutaneous fat layer. That might have something to do with the problem, Dr. Bailey said, but the team simply reported their observations and didn’t report any statistical analysis of the findings, so it’s impossible to discern causes, he noted.

The findings aren’t new for some. The "prevalence of lipoatrophy [is] much higher than expected," one team noted several years ago (Can. J. Neurol. Sci. 2004;31:58-63).

No one knows why GA seems to cause lipoatrophy. Maybe "an elevation in tumor necrosis factor–alpha ... causes a dedifferentiation of adipocytes in [subcutaneous] tissue," Dr. Bailey said.

He is a paid spokesman for Genzyme, Biogen, and Teva, the maker of GA. There was no outside funding for the project.

aotto@frontlinemedcom.com

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Key clinical point: The rate of lipoatrophy with glatiramer acetate may be much higher than reported in the drug’s label.

Major finding: Of 73 glatiramer acetate patients, 46 (63%) developed lipoatrophy, sometimes within 3 months of starting the shots.

Data Source: Patient observation every 3 months for 3 years.

Disclosures: The lead investigator is a paid spokesman for Teva, the maker of Copaxone. There was no outside funding for the project.

No need to hospitalize febrile immunosuppressed kids who are otherwise well

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No need to hospitalize febrile immunosuppressed kids who are otherwise well

VANCOUVER, B.C. – Immunosuppressed children with fever who are otherwise well can be managed as outpatients pending culture results, and don’t need to be routinely admitted to the hospital, according to a retrospective review from the Children’s Hospital of Michigan, Detroit.

Among 103 admissions involving 60 immunosuppressed children with fever above 38.3º C, 79 (76.6%) admissions were of children who were okay outside of the fever, and 24 (23.4%) were of children who presented with low blood pressure, tachycardia, abnormal cardiac/chest auscultation, abdominal tenderness, or abnormal lab results.

Dr. Tej Mattoo

The children who were doing well didn’t really need to go into the hospital, according to Dr. Tej K. Mattoo, the study’s senior investigator. Five admissions were of children ultimately diagnosed with strep pharyngitis, two with otitis media, and two with urinary tract infections. There were just two positive cultures in the group, both urine, and no positive chest x-rays. Outpatient management would have been fine, Dr. Mattoo said at the annual meeting of the Pediatric Academic Societies.

Admission turned out to be the wise choice, however, in 20 of 24 (83.3%) cases with significant presentations. Among them were eight cases of pneumonia, five abscesses, and one case each of peritonitis, sepsis, and acute gastritis. There were two positive blood cultures, four positive urine cultures, three positive wound cultures, one positive peritoneal culture, and a positive Clostridium difficile test.

The research team concluded that "immunosuppressed renal patients with high fever and insignificant clinical findings do not need routine hospitalization; they could be sent home with appropriate counseling/follow-up after culture specimens are collected."

The findings help define who can be safely sent home, and who needs to go upstairs, said Dr. Mattoo, chief of pediatric nephrology and hypertension at Children’s.

"The way it works now is that we routinely admit children on immunosuppression who have high fever. Once they are in, they stay in hospital at least for 3 days as you wait for the culture results. It turns out that about 75% of the patients in our study could have been managed as outpatients. A lot of it depends on a good history and physical. When things other than the fever are normal, that gives you a high comfort level to tell parents ‘I can send your child home’ " with appropriate outpatient care and pledges to bring the child back if things get worse and to check up on culture results in a few days, he said.

The average age at admission was 9 years, and about 60% of the admissions were boys. The children had nephrotic syndrome, systemic lupus erythematosus, or kidney transplants. Most were on two or three immunosuppressives, generally some combination of prednisone, mycophenolate mofetil, and tacrolimus/sirolimus. Patients with diabetes, cardiorespiratory disease, or lupus flares were excluded from the investigation.

Dr. Mattoo has no disclosures relevant to the study, and the work had no outside funding.

aotto@frontlinemedcom.com

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VANCOUVER, B.C. – Immunosuppressed children with fever who are otherwise well can be managed as outpatients pending culture results, and don’t need to be routinely admitted to the hospital, according to a retrospective review from the Children’s Hospital of Michigan, Detroit.

Among 103 admissions involving 60 immunosuppressed children with fever above 38.3º C, 79 (76.6%) admissions were of children who were okay outside of the fever, and 24 (23.4%) were of children who presented with low blood pressure, tachycardia, abnormal cardiac/chest auscultation, abdominal tenderness, or abnormal lab results.

Dr. Tej Mattoo

The children who were doing well didn’t really need to go into the hospital, according to Dr. Tej K. Mattoo, the study’s senior investigator. Five admissions were of children ultimately diagnosed with strep pharyngitis, two with otitis media, and two with urinary tract infections. There were just two positive cultures in the group, both urine, and no positive chest x-rays. Outpatient management would have been fine, Dr. Mattoo said at the annual meeting of the Pediatric Academic Societies.

Admission turned out to be the wise choice, however, in 20 of 24 (83.3%) cases with significant presentations. Among them were eight cases of pneumonia, five abscesses, and one case each of peritonitis, sepsis, and acute gastritis. There were two positive blood cultures, four positive urine cultures, three positive wound cultures, one positive peritoneal culture, and a positive Clostridium difficile test.

The research team concluded that "immunosuppressed renal patients with high fever and insignificant clinical findings do not need routine hospitalization; they could be sent home with appropriate counseling/follow-up after culture specimens are collected."

The findings help define who can be safely sent home, and who needs to go upstairs, said Dr. Mattoo, chief of pediatric nephrology and hypertension at Children’s.

"The way it works now is that we routinely admit children on immunosuppression who have high fever. Once they are in, they stay in hospital at least for 3 days as you wait for the culture results. It turns out that about 75% of the patients in our study could have been managed as outpatients. A lot of it depends on a good history and physical. When things other than the fever are normal, that gives you a high comfort level to tell parents ‘I can send your child home’ " with appropriate outpatient care and pledges to bring the child back if things get worse and to check up on culture results in a few days, he said.

The average age at admission was 9 years, and about 60% of the admissions were boys. The children had nephrotic syndrome, systemic lupus erythematosus, or kidney transplants. Most were on two or three immunosuppressives, generally some combination of prednisone, mycophenolate mofetil, and tacrolimus/sirolimus. Patients with diabetes, cardiorespiratory disease, or lupus flares were excluded from the investigation.

Dr. Mattoo has no disclosures relevant to the study, and the work had no outside funding.

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Immunosuppressed children with fever who are otherwise well can be managed as outpatients pending culture results, and don’t need to be routinely admitted to the hospital, according to a retrospective review from the Children’s Hospital of Michigan, Detroit.

Among 103 admissions involving 60 immunosuppressed children with fever above 38.3º C, 79 (76.6%) admissions were of children who were okay outside of the fever, and 24 (23.4%) were of children who presented with low blood pressure, tachycardia, abnormal cardiac/chest auscultation, abdominal tenderness, or abnormal lab results.

Dr. Tej Mattoo

The children who were doing well didn’t really need to go into the hospital, according to Dr. Tej K. Mattoo, the study’s senior investigator. Five admissions were of children ultimately diagnosed with strep pharyngitis, two with otitis media, and two with urinary tract infections. There were just two positive cultures in the group, both urine, and no positive chest x-rays. Outpatient management would have been fine, Dr. Mattoo said at the annual meeting of the Pediatric Academic Societies.

Admission turned out to be the wise choice, however, in 20 of 24 (83.3%) cases with significant presentations. Among them were eight cases of pneumonia, five abscesses, and one case each of peritonitis, sepsis, and acute gastritis. There were two positive blood cultures, four positive urine cultures, three positive wound cultures, one positive peritoneal culture, and a positive Clostridium difficile test.

The research team concluded that "immunosuppressed renal patients with high fever and insignificant clinical findings do not need routine hospitalization; they could be sent home with appropriate counseling/follow-up after culture specimens are collected."

The findings help define who can be safely sent home, and who needs to go upstairs, said Dr. Mattoo, chief of pediatric nephrology and hypertension at Children’s.

"The way it works now is that we routinely admit children on immunosuppression who have high fever. Once they are in, they stay in hospital at least for 3 days as you wait for the culture results. It turns out that about 75% of the patients in our study could have been managed as outpatients. A lot of it depends on a good history and physical. When things other than the fever are normal, that gives you a high comfort level to tell parents ‘I can send your child home’ " with appropriate outpatient care and pledges to bring the child back if things get worse and to check up on culture results in a few days, he said.

The average age at admission was 9 years, and about 60% of the admissions were boys. The children had nephrotic syndrome, systemic lupus erythematosus, or kidney transplants. Most were on two or three immunosuppressives, generally some combination of prednisone, mycophenolate mofetil, and tacrolimus/sirolimus. Patients with diabetes, cardiorespiratory disease, or lupus flares were excluded from the investigation.

Dr. Mattoo has no disclosures relevant to the study, and the work had no outside funding.

aotto@frontlinemedcom.com

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Key clinical point: If immunosuppressed children with fever are otherwise fine, they probably don’t need to be admitted.

Major finding: Of 103 hospital admissions of immunosuppressed children for fever, 79 (76.6%) could have been managed as outpatients.

Data Source: Retrospective review.

Disclosures: The senior investigator has no relevant disclosures, and the work didn’t receive any outside funding.

VIDEO: Vitamin D helps with optic neuritis, too

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DALLAS – Sufficient vitamin D levels – serum 25-hydroxyvitamin D concentrations greater than 80 nmol/L – appeared to protect against edema of the retinal nerve fiber layer in a prospective cohort study of patients with acute optic neuritis.

An adequate vitamin D level also protected against thinning of the retinal nerve fiber layer (RNFL) ganglion cell layer and other poor outcomes after 6 months in the study of 49 patients (some of whom had multiple sclerosis), according to researchers at the University of Calgary (Alta.).

The team correlated vitamin D levels with optical coherence tomography findings. Vitamin D is known to have anti-inflammatory effects, so it’s the chronic benefit that was surprising, lead investigator Dr. Jodie Burton explained at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

It’s just one more reason that it’s a good idea to check vitamin D levels, and supplement them if necessary, Dr. Burton said.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

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DALLAS – Sufficient vitamin D levels – serum 25-hydroxyvitamin D concentrations greater than 80 nmol/L – appeared to protect against edema of the retinal nerve fiber layer in a prospective cohort study of patients with acute optic neuritis.

An adequate vitamin D level also protected against thinning of the retinal nerve fiber layer (RNFL) ganglion cell layer and other poor outcomes after 6 months in the study of 49 patients (some of whom had multiple sclerosis), according to researchers at the University of Calgary (Alta.).

The team correlated vitamin D levels with optical coherence tomography findings. Vitamin D is known to have anti-inflammatory effects, so it’s the chronic benefit that was surprising, lead investigator Dr. Jodie Burton explained at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

It’s just one more reason that it’s a good idea to check vitamin D levels, and supplement them if necessary, Dr. Burton said.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

DALLAS – Sufficient vitamin D levels – serum 25-hydroxyvitamin D concentrations greater than 80 nmol/L – appeared to protect against edema of the retinal nerve fiber layer in a prospective cohort study of patients with acute optic neuritis.

An adequate vitamin D level also protected against thinning of the retinal nerve fiber layer (RNFL) ganglion cell layer and other poor outcomes after 6 months in the study of 49 patients (some of whom had multiple sclerosis), according to researchers at the University of Calgary (Alta.).

The team correlated vitamin D levels with optical coherence tomography findings. Vitamin D is known to have anti-inflammatory effects, so it’s the chronic benefit that was surprising, lead investigator Dr. Jodie Burton explained at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

It’s just one more reason that it’s a good idea to check vitamin D levels, and supplement them if necessary, Dr. Burton said.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

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VIDEO: How to talk to patients about MS drug risks

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VIDEO: How to talk to patients about MS drug risks

DALLAS – Patients with multiple sclerosis have likely already heard the worst about their treatment options from the Internet; they need help balancing risks and benefits.

The key is offering them options, knowing what problems need to be discussed, and monitoring treatment beyond what’s usually recommended on product labeling, said Dr. Donna Graves, an MS specialist at the University of Texas Southwestern Medical Center, Dallas. She shared her tips – and also a heads-up about alemtuzumab, which might be approved for MS as soon as this fall – at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

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DALLAS – Patients with multiple sclerosis have likely already heard the worst about their treatment options from the Internet; they need help balancing risks and benefits.

The key is offering them options, knowing what problems need to be discussed, and monitoring treatment beyond what’s usually recommended on product labeling, said Dr. Donna Graves, an MS specialist at the University of Texas Southwestern Medical Center, Dallas. She shared her tips – and also a heads-up about alemtuzumab, which might be approved for MS as soon as this fall – at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

DALLAS – Patients with multiple sclerosis have likely already heard the worst about their treatment options from the Internet; they need help balancing risks and benefits.

The key is offering them options, knowing what problems need to be discussed, and monitoring treatment beyond what’s usually recommended on product labeling, said Dr. Donna Graves, an MS specialist at the University of Texas Southwestern Medical Center, Dallas. She shared her tips – and also a heads-up about alemtuzumab, which might be approved for MS as soon as this fall – at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

aotto@frontlinemedcom.com

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: Evidence backs marijuana for multiple sclerosis

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DALLAS – It might come as a surprise to learn how many good studies there are to support marijuana for multiple sclerosis, especially for subjective symptoms. The data are summarized in recent MS complementary and alternative medicine guidelines from the American Academy of Neurology.

But most of those studies were done using standardized products not available in the United States, which means that U.S. providers have to give advice in a country in which marijuana types and products vary considerably. It comes down to a case-by-case approach, Dr. Allen C. Bowling of the Colorado Neurological Institute, Englewood, explained in a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

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DALLAS – It might come as a surprise to learn how many good studies there are to support marijuana for multiple sclerosis, especially for subjective symptoms. The data are summarized in recent MS complementary and alternative medicine guidelines from the American Academy of Neurology.

But most of those studies were done using standardized products not available in the United States, which means that U.S. providers have to give advice in a country in which marijuana types and products vary considerably. It comes down to a case-by-case approach, Dr. Allen C. Bowling of the Colorado Neurological Institute, Englewood, explained in a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

DALLAS – It might come as a surprise to learn how many good studies there are to support marijuana for multiple sclerosis, especially for subjective symptoms. The data are summarized in recent MS complementary and alternative medicine guidelines from the American Academy of Neurology.

But most of those studies were done using standardized products not available in the United States, which means that U.S. providers have to give advice in a country in which marijuana types and products vary considerably. It comes down to a case-by-case approach, Dr. Allen C. Bowling of the Colorado Neurological Institute, Englewood, explained in a video interview at a meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

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VIDEO: Glycogen storage disease – easy to miss, easy to fix

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VIDEO: Glycogen storage disease – easy to miss, easy to fix

VANCOUVER, B.C. – Recently, it’s become clear that milder forms of glycogen storage disease (GSD) – a genetic aberration in sugar metabolism – can cause problems with attention, mood, and growth that are easy to mistake for something else. GSD type 9 is a particularly potent imposter that occurs in boys and men only.

Once recognized, the solution is easy – cornstarch doses about every 4 hours. At the annual meeting of the Pediatric Academic Societies, a team lead by Dr. David A. Weinstein, a professor of pediatric endocrinology and the director of the glycogen storage disease program at the University of Florida, Gainesville, reported that a new, slow-release form of cornstarch called Glycosade lets patients skip their night dose so they can get a full 8 hours of sleep.

At the meeting, Dr. Weinstein told us how to recognize, diagnose, and treat glycogen storage disease, and a little bit about how effective intervention can change the lives of people who have it.

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VANCOUVER, B.C. – Recently, it’s become clear that milder forms of glycogen storage disease (GSD) – a genetic aberration in sugar metabolism – can cause problems with attention, mood, and growth that are easy to mistake for something else. GSD type 9 is a particularly potent imposter that occurs in boys and men only.

Once recognized, the solution is easy – cornstarch doses about every 4 hours. At the annual meeting of the Pediatric Academic Societies, a team lead by Dr. David A. Weinstein, a professor of pediatric endocrinology and the director of the glycogen storage disease program at the University of Florida, Gainesville, reported that a new, slow-release form of cornstarch called Glycosade lets patients skip their night dose so they can get a full 8 hours of sleep.

At the meeting, Dr. Weinstein told us how to recognize, diagnose, and treat glycogen storage disease, and a little bit about how effective intervention can change the lives of people who have it.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

VANCOUVER, B.C. – Recently, it’s become clear that milder forms of glycogen storage disease (GSD) – a genetic aberration in sugar metabolism – can cause problems with attention, mood, and growth that are easy to mistake for something else. GSD type 9 is a particularly potent imposter that occurs in boys and men only.

Once recognized, the solution is easy – cornstarch doses about every 4 hours. At the annual meeting of the Pediatric Academic Societies, a team lead by Dr. David A. Weinstein, a professor of pediatric endocrinology and the director of the glycogen storage disease program at the University of Florida, Gainesville, reported that a new, slow-release form of cornstarch called Glycosade lets patients skip their night dose so they can get a full 8 hours of sleep.

At the meeting, Dr. Weinstein told us how to recognize, diagnose, and treat glycogen storage disease, and a little bit about how effective intervention can change the lives of people who have it.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

aotto@frontlinemedcom.com

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