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What’s in the Water? Keeping Watch on Crypto
If it’s swimming season, it’s also Cryptosporidium season. The parasite, spread through feces of infected humans or animals, is the culprit in most disease outbreaks linked to water.
Between 2009 and 2017, Crypto-related outbreaks increased an average 13% per year, according to the CDC. In the 444 outbreaks reported, 7,465 people became sick, 287 people were hospitalized, and 1 person died. The CDC says these numbers are likely to be underestimates.
One-third of the outbreaks were in treated swimming water, including pools and water playgrounds. Smaller percentages were linked to contact with cattle, infected people in childcare settings, and raw milk or apple cider.
Crypto’s tough protective shell is the secret to its long life. It can survive for days even in chlorinated pools or on surfaces disinfected with chlorine bleach. Moreover, Cryptosporidium oocysts are immediately infectious upon excretion and are excreted in numbers multiple orders of magnitude higher than the human infectious dose (≤ 10 oocysts). Just a few germs can make someone sick—and there can be millions in a pool. Infection with Cryptosporidium can cause profuse, watery diarrhea that lasts for up to 3 weeks. It’s particularly dangerous for immunocompromised patients, leading to malnutrition and wasting.
The CDC has some advice for staying Crypto free:
- Don’t swim or let kids swim if anyone has diarrhea, and keep them home from daycare;
- Don’t swallow the water you swim in;
- Wash hands with soap and water after any contact with animals, especially animal feces (note: alcohol-based hand sanitizers are not effective against Crypto; hydrogen peroxide should be used in childcare settings to disinfect);
- Remove shoes worn in animal environments before going inside your home; and
- Drink only pasteurized milk or apple cider.
Although the numbers are still high, the CDC says testing has improved and might be helping with increased detection, especially since CryptoNet, the first US molecularly based surveillance system for a parasitic disease, was instituted. Based on DNA fingerprinting, it has already demonstrated that it can elucidate Cryptosporidium transmission chains in treated recreational water outbreaks, the CDC says, and has the potential to do the same for investigations in other Crypto outbreaks.
If it’s swimming season, it’s also Cryptosporidium season. The parasite, spread through feces of infected humans or animals, is the culprit in most disease outbreaks linked to water.
Between 2009 and 2017, Crypto-related outbreaks increased an average 13% per year, according to the CDC. In the 444 outbreaks reported, 7,465 people became sick, 287 people were hospitalized, and 1 person died. The CDC says these numbers are likely to be underestimates.
One-third of the outbreaks were in treated swimming water, including pools and water playgrounds. Smaller percentages were linked to contact with cattle, infected people in childcare settings, and raw milk or apple cider.
Crypto’s tough protective shell is the secret to its long life. It can survive for days even in chlorinated pools or on surfaces disinfected with chlorine bleach. Moreover, Cryptosporidium oocysts are immediately infectious upon excretion and are excreted in numbers multiple orders of magnitude higher than the human infectious dose (≤ 10 oocysts). Just a few germs can make someone sick—and there can be millions in a pool. Infection with Cryptosporidium can cause profuse, watery diarrhea that lasts for up to 3 weeks. It’s particularly dangerous for immunocompromised patients, leading to malnutrition and wasting.
The CDC has some advice for staying Crypto free:
- Don’t swim or let kids swim if anyone has diarrhea, and keep them home from daycare;
- Don’t swallow the water you swim in;
- Wash hands with soap and water after any contact with animals, especially animal feces (note: alcohol-based hand sanitizers are not effective against Crypto; hydrogen peroxide should be used in childcare settings to disinfect);
- Remove shoes worn in animal environments before going inside your home; and
- Drink only pasteurized milk or apple cider.
Although the numbers are still high, the CDC says testing has improved and might be helping with increased detection, especially since CryptoNet, the first US molecularly based surveillance system for a parasitic disease, was instituted. Based on DNA fingerprinting, it has already demonstrated that it can elucidate Cryptosporidium transmission chains in treated recreational water outbreaks, the CDC says, and has the potential to do the same for investigations in other Crypto outbreaks.
If it’s swimming season, it’s also Cryptosporidium season. The parasite, spread through feces of infected humans or animals, is the culprit in most disease outbreaks linked to water.
Between 2009 and 2017, Crypto-related outbreaks increased an average 13% per year, according to the CDC. In the 444 outbreaks reported, 7,465 people became sick, 287 people were hospitalized, and 1 person died. The CDC says these numbers are likely to be underestimates.
One-third of the outbreaks were in treated swimming water, including pools and water playgrounds. Smaller percentages were linked to contact with cattle, infected people in childcare settings, and raw milk or apple cider.
Crypto’s tough protective shell is the secret to its long life. It can survive for days even in chlorinated pools or on surfaces disinfected with chlorine bleach. Moreover, Cryptosporidium oocysts are immediately infectious upon excretion and are excreted in numbers multiple orders of magnitude higher than the human infectious dose (≤ 10 oocysts). Just a few germs can make someone sick—and there can be millions in a pool. Infection with Cryptosporidium can cause profuse, watery diarrhea that lasts for up to 3 weeks. It’s particularly dangerous for immunocompromised patients, leading to malnutrition and wasting.
The CDC has some advice for staying Crypto free:
- Don’t swim or let kids swim if anyone has diarrhea, and keep them home from daycare;
- Don’t swallow the water you swim in;
- Wash hands with soap and water after any contact with animals, especially animal feces (note: alcohol-based hand sanitizers are not effective against Crypto; hydrogen peroxide should be used in childcare settings to disinfect);
- Remove shoes worn in animal environments before going inside your home; and
- Drink only pasteurized milk or apple cider.
Although the numbers are still high, the CDC says testing has improved and might be helping with increased detection, especially since CryptoNet, the first US molecularly based surveillance system for a parasitic disease, was instituted. Based on DNA fingerprinting, it has already demonstrated that it can elucidate Cryptosporidium transmission chains in treated recreational water outbreaks, the CDC says, and has the potential to do the same for investigations in other Crypto outbreaks.
Bridging the “Digital Divide”
The “digital divide”: That is how the VA describes the situation of the 42% of veterans without reliable—or any—Internet access. The lack of access means they are effectively barred from participating in telehealth and other online services.
With the goal of “digital inclusion,” the Veterans Health Administration (VHA) is partnering with a variety of nongovernmental businesses. VHA and T-Mobile, for instance, host the VA Video Connect application, which connects veterans to health care providers on a secure line on all devices with T-Mobile for free.
Walmart, Philips, and Veteran Service Organizations have set up remote clinics for veterans to access telehealth services closer to their home; with those partners, the VHA also lends Internet-connected iPads to veterans who do not have home computers.
Now, the VHA is working with Microsoft and Internet service providers to bring broadband access to rural areas with large populations of veterans.
The initiatives will not only improve access to health care, but also open other avenues. Dr. Kevin Galpin, executive director of VHA Telehealth Services, says, “We really want veterans to have the opportunities that come with being connected. There is lots of value in being able to maintain social relationships, conduct job searches online, and connect with VA. We know limited access is a problem and we’re exploring a multitude of options.”
The “digital divide”: That is how the VA describes the situation of the 42% of veterans without reliable—or any—Internet access. The lack of access means they are effectively barred from participating in telehealth and other online services.
With the goal of “digital inclusion,” the Veterans Health Administration (VHA) is partnering with a variety of nongovernmental businesses. VHA and T-Mobile, for instance, host the VA Video Connect application, which connects veterans to health care providers on a secure line on all devices with T-Mobile for free.
Walmart, Philips, and Veteran Service Organizations have set up remote clinics for veterans to access telehealth services closer to their home; with those partners, the VHA also lends Internet-connected iPads to veterans who do not have home computers.
Now, the VHA is working with Microsoft and Internet service providers to bring broadband access to rural areas with large populations of veterans.
The initiatives will not only improve access to health care, but also open other avenues. Dr. Kevin Galpin, executive director of VHA Telehealth Services, says, “We really want veterans to have the opportunities that come with being connected. There is lots of value in being able to maintain social relationships, conduct job searches online, and connect with VA. We know limited access is a problem and we’re exploring a multitude of options.”
The “digital divide”: That is how the VA describes the situation of the 42% of veterans without reliable—or any—Internet access. The lack of access means they are effectively barred from participating in telehealth and other online services.
With the goal of “digital inclusion,” the Veterans Health Administration (VHA) is partnering with a variety of nongovernmental businesses. VHA and T-Mobile, for instance, host the VA Video Connect application, which connects veterans to health care providers on a secure line on all devices with T-Mobile for free.
Walmart, Philips, and Veteran Service Organizations have set up remote clinics for veterans to access telehealth services closer to their home; with those partners, the VHA also lends Internet-connected iPads to veterans who do not have home computers.
Now, the VHA is working with Microsoft and Internet service providers to bring broadband access to rural areas with large populations of veterans.
The initiatives will not only improve access to health care, but also open other avenues. Dr. Kevin Galpin, executive director of VHA Telehealth Services, says, “We really want veterans to have the opportunities that come with being connected. There is lots of value in being able to maintain social relationships, conduct job searches online, and connect with VA. We know limited access is a problem and we’re exploring a multitude of options.”
NIH Study Will Test New Preventive Drug for Multidrug-Resistant TB
Tuberculosis (TB) kills more people each year than any other infectious disease. Not only the patients, but their nearest and dearest are at risk, as well. They are more likely to acquire latent TB infection and many will progress to active TB.
NIH is launching a study to compare delamanid, a new drug for multidrug-resistant TB (MDR-TB) with isoniazid, the long-time standard. The study hypothesis is that prophylactic delamanid will better protect family and other household members of patients with MDR-TB. Existing treatments for MDR-TB are often highly toxic and poorly tolerated, putting patients at risk while curing them only about half the time. Delamanid is one of the first drugs available specifically to treat people with MDR-TB and the first formulation suitable for children.
“A highly effective preventive TB therapy for vulnerable household members of people with active MDR-TB disease would be a game-changer in TB care,” says Dr. Anneke Hesseling, MD, PhD, one of the study leaders.
The phase 3 trial, Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB), will take place at > 27 sites in at ≥ 12 countries. The researchers plan to enroll 2,158 adults being treated for confirmed active MDR-TB and 3,452 members of their households who are at high risk for developing active TB. The household members will be assigned randomly to receive oral delamanid daily for 26 weeks or oral isoniazid plus vitamin B6 daily for 26 weeks. All at-risk members of the same household will receive the same drug regimen.
Every 2 to 12 weeks, participating household contacts will have physical exams and other health assessments. The researchers will follow them for 96 weeks. Final results are expected in 2024.
TB is the leading cause of death among people with HIV. Both delamanid and isoniazid have minimal potential for interacting with antiretroviral drugs. Study participants with HIV who have not yet begun treatment will be referred to local health care providers for antiretroviral treatment.
Tuberculosis (TB) kills more people each year than any other infectious disease. Not only the patients, but their nearest and dearest are at risk, as well. They are more likely to acquire latent TB infection and many will progress to active TB.
NIH is launching a study to compare delamanid, a new drug for multidrug-resistant TB (MDR-TB) with isoniazid, the long-time standard. The study hypothesis is that prophylactic delamanid will better protect family and other household members of patients with MDR-TB. Existing treatments for MDR-TB are often highly toxic and poorly tolerated, putting patients at risk while curing them only about half the time. Delamanid is one of the first drugs available specifically to treat people with MDR-TB and the first formulation suitable for children.
“A highly effective preventive TB therapy for vulnerable household members of people with active MDR-TB disease would be a game-changer in TB care,” says Dr. Anneke Hesseling, MD, PhD, one of the study leaders.
The phase 3 trial, Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB), will take place at > 27 sites in at ≥ 12 countries. The researchers plan to enroll 2,158 adults being treated for confirmed active MDR-TB and 3,452 members of their households who are at high risk for developing active TB. The household members will be assigned randomly to receive oral delamanid daily for 26 weeks or oral isoniazid plus vitamin B6 daily for 26 weeks. All at-risk members of the same household will receive the same drug regimen.
Every 2 to 12 weeks, participating household contacts will have physical exams and other health assessments. The researchers will follow them for 96 weeks. Final results are expected in 2024.
TB is the leading cause of death among people with HIV. Both delamanid and isoniazid have minimal potential for interacting with antiretroviral drugs. Study participants with HIV who have not yet begun treatment will be referred to local health care providers for antiretroviral treatment.
Tuberculosis (TB) kills more people each year than any other infectious disease. Not only the patients, but their nearest and dearest are at risk, as well. They are more likely to acquire latent TB infection and many will progress to active TB.
NIH is launching a study to compare delamanid, a new drug for multidrug-resistant TB (MDR-TB) with isoniazid, the long-time standard. The study hypothesis is that prophylactic delamanid will better protect family and other household members of patients with MDR-TB. Existing treatments for MDR-TB are often highly toxic and poorly tolerated, putting patients at risk while curing them only about half the time. Delamanid is one of the first drugs available specifically to treat people with MDR-TB and the first formulation suitable for children.
“A highly effective preventive TB therapy for vulnerable household members of people with active MDR-TB disease would be a game-changer in TB care,” says Dr. Anneke Hesseling, MD, PhD, one of the study leaders.
The phase 3 trial, Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB), will take place at > 27 sites in at ≥ 12 countries. The researchers plan to enroll 2,158 adults being treated for confirmed active MDR-TB and 3,452 members of their households who are at high risk for developing active TB. The household members will be assigned randomly to receive oral delamanid daily for 26 weeks or oral isoniazid plus vitamin B6 daily for 26 weeks. All at-risk members of the same household will receive the same drug regimen.
Every 2 to 12 weeks, participating household contacts will have physical exams and other health assessments. The researchers will follow them for 96 weeks. Final results are expected in 2024.
TB is the leading cause of death among people with HIV. Both delamanid and isoniazid have minimal potential for interacting with antiretroviral drugs. Study participants with HIV who have not yet begun treatment will be referred to local health care providers for antiretroviral treatment.
IHS Announces Requirements to Increase Access to OUD Treatment
Native American communities have experienced the largest increase in drug overdose deaths of all racial/ethnic groups in the US. Between 1999 and 2015, drug overdose deaths rose > 500%. To help ensure that American Indians and Alaska Natives (AI/AN) get the treatment they need, the Indian Health Service (IHS) has released Special General Memorandum 2019-01: Assuring Access to Medication Assisted Treatment for Opioid Use Disorder. It requires all IHS federal facilities to:
- Identify opioid use disorder (OUD) treatment resources in their local areas;
- Create an action plan, no later than Dec. 11, 2019; and
- Provide or coordinate patient access to medication-assisted treatment (MAT), specifically increasing access to culturally appropriate prevention, treatment, and recovery support services.
MAT is a comprehensive evidence-based approach that combines pharmacologic interventions with substance abuse counseling and culturally sensitive social support.
The IHS has recently taken other steps to further facilitate MAT access in tribal communities. For example, it has added 3 FDA-approved medications to the National Core Formulary: buprenorphine, buprenorphine/naloxone, and injectable naltrexone, all of which relieve withdrawal symptoms and psychological cravings, supporting adherence to treatment and reducing illicit opioid use.
In addition, the IHS has published the Internet Eligible Controlled Substance Provider Designation Policy. This policy, established in 2018, is designed to increase access to treatment for AI/AN who live in rural or remote areas, where it can be difficult to access a provider with the necessary training and Drug Enforcement Administration approval to prescribe buprenorphine in an outpatient or office-based setting. Once approved, IHS, tribal, and urban Indian organization health care providers can prescribe controlled substances for MAT through telemedicine.
In 2018, the IHS also launched a new website (www.IHS.gov/opioids) to share information about opioids with patients, health care providers, tribal leaders, tribal and urban program administrators, and other community members. The site includes information on approaches to prevent opioid abuse, pain management, recovery tools, and funding opportunities.
Native American communities have experienced the largest increase in drug overdose deaths of all racial/ethnic groups in the US. Between 1999 and 2015, drug overdose deaths rose > 500%. To help ensure that American Indians and Alaska Natives (AI/AN) get the treatment they need, the Indian Health Service (IHS) has released Special General Memorandum 2019-01: Assuring Access to Medication Assisted Treatment for Opioid Use Disorder. It requires all IHS federal facilities to:
- Identify opioid use disorder (OUD) treatment resources in their local areas;
- Create an action plan, no later than Dec. 11, 2019; and
- Provide or coordinate patient access to medication-assisted treatment (MAT), specifically increasing access to culturally appropriate prevention, treatment, and recovery support services.
MAT is a comprehensive evidence-based approach that combines pharmacologic interventions with substance abuse counseling and culturally sensitive social support.
The IHS has recently taken other steps to further facilitate MAT access in tribal communities. For example, it has added 3 FDA-approved medications to the National Core Formulary: buprenorphine, buprenorphine/naloxone, and injectable naltrexone, all of which relieve withdrawal symptoms and psychological cravings, supporting adherence to treatment and reducing illicit opioid use.
In addition, the IHS has published the Internet Eligible Controlled Substance Provider Designation Policy. This policy, established in 2018, is designed to increase access to treatment for AI/AN who live in rural or remote areas, where it can be difficult to access a provider with the necessary training and Drug Enforcement Administration approval to prescribe buprenorphine in an outpatient or office-based setting. Once approved, IHS, tribal, and urban Indian organization health care providers can prescribe controlled substances for MAT through telemedicine.
In 2018, the IHS also launched a new website (www.IHS.gov/opioids) to share information about opioids with patients, health care providers, tribal leaders, tribal and urban program administrators, and other community members. The site includes information on approaches to prevent opioid abuse, pain management, recovery tools, and funding opportunities.
Native American communities have experienced the largest increase in drug overdose deaths of all racial/ethnic groups in the US. Between 1999 and 2015, drug overdose deaths rose > 500%. To help ensure that American Indians and Alaska Natives (AI/AN) get the treatment they need, the Indian Health Service (IHS) has released Special General Memorandum 2019-01: Assuring Access to Medication Assisted Treatment for Opioid Use Disorder. It requires all IHS federal facilities to:
- Identify opioid use disorder (OUD) treatment resources in their local areas;
- Create an action plan, no later than Dec. 11, 2019; and
- Provide or coordinate patient access to medication-assisted treatment (MAT), specifically increasing access to culturally appropriate prevention, treatment, and recovery support services.
MAT is a comprehensive evidence-based approach that combines pharmacologic interventions with substance abuse counseling and culturally sensitive social support.
The IHS has recently taken other steps to further facilitate MAT access in tribal communities. For example, it has added 3 FDA-approved medications to the National Core Formulary: buprenorphine, buprenorphine/naloxone, and injectable naltrexone, all of which relieve withdrawal symptoms and psychological cravings, supporting adherence to treatment and reducing illicit opioid use.
In addition, the IHS has published the Internet Eligible Controlled Substance Provider Designation Policy. This policy, established in 2018, is designed to increase access to treatment for AI/AN who live in rural or remote areas, where it can be difficult to access a provider with the necessary training and Drug Enforcement Administration approval to prescribe buprenorphine in an outpatient or office-based setting. Once approved, IHS, tribal, and urban Indian organization health care providers can prescribe controlled substances for MAT through telemedicine.
In 2018, the IHS also launched a new website (www.IHS.gov/opioids) to share information about opioids with patients, health care providers, tribal leaders, tribal and urban program administrators, and other community members. The site includes information on approaches to prevent opioid abuse, pain management, recovery tools, and funding opportunities.
Diabetes News: Mixed
After 20 years on the rise, new cases of diagnosed diabetes mellitus (DM) in the US have declined by 35%, from 1.7 million in 2008 to 1.3 million in 2017, according to CDC researchers. Not only that: The number of people living with diagnosed DM in the US has remained stable for the past 8 years.
The findings represent the longest decline in new DM cases and the longest sustained plateau in existing cases. Between 1990 and 2009, the number of people living with diagnosed diabetes (DD) rose 4.4% per year, peaked at 8.2 per 100 adults, then leveled off at 8 per 100 in 2017. The trends were similar across age groups, racial and ethnic groups, and genders.
In part, the plateau may be due to the fact that people with DM are living longer, the researchers suggest, pointing to recent reports of a decline in cardiovascular and all-cause mortality in adults with DD.
But maybe the work to “stem the tide of type 2 diabetes” is finally having an effect, says Ann Albright, PhD, director of the CDC Division of Diabetes Translation. She stresses the importance of “putting science-proven programs into action,” citing the National Diabetes Prevention Program as a prime example. But she adds, “We must also increase access to affordable, healthier foods, and safe places to be active.”
The news about the decrease in new diabetes cases comes simultaneously with findings from the Restoring Insulin Secretion (RISE) Adult and Pediatric Medication Studies, which found that type 2 diabetes mellitus (T2DM) progression slows during treatment but resumes after treatment stops.
The research, funded by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), was aimed at finding ways to preserve β-cell function. The adult study randomly assigned participants aged 20 to 65 years to receive long-acting insulin (glargine) for 3 months, followed by metformin for 9 months; liraglutide with metformin for 12 months; metformin alone for 12 months; or placebo. Participants’ β-cell function and blood glucose control improved on the treatments, with those in the liraglutide/metformin group showing the most improvement. But the improvements did not persist after treatment ended. “[T]reatment options were equally effective while people were actively on them,” says study chair Dr. Steven Kahn, from the VA Puget Sound Health Care System. “But people need to stay on treatment to maintain the benefits.”
The youth study (participants aged 10-19 years) study compared 3 months of insulin glargine, followed by metformin for 9 months, to metformin alone for 12 months. (Insulin glargine and metformin are the only FDA-approved drugs for young people with T2D ) β-cell function declined in the 2 pediatric treatment groups and even worsened after treatment ended. The studies support earlier evidence that T2DM affects young people differently and more aggressively than it does in adults, NIDDK Director Dr. Griffin Rodgers says.
Other research news is brighter for people at risk for type 1 diabetes mellitus (T1DM): An NIH-funded study found that treatment with teplizumab, an anti-CD3 monoclonal antibody, delayed clinical T1DM by ≥ 2 years.
Previous research had found that teplizumab slows the loss of β cells in people with recent-onset clinical T1DM, but the drug had not been tested in people without clinical disease. The researchers wanted to see whether early intervention would have a benefit for people at high risk. They compared a 14-day course of teplizumab with placebo in 76 participants aged 8 to 49 years who were relatives of people with T1DM, had at ≥ 2 types of DM-related autoantibodies, and had abnormal glucose tolerance.
During the trial, 72% of people on placebo developed clinical DM compared with 43% of those in the treatment group. The median time for the control participants to develop DM was just over 24 months vs 48 months in the teplizumab group. The effects of the drug were greatest in the first year after it was given, when 41% of the participants—mainly in the placebo group—developed clinical diabetes.
At-risk children and adolescents are known to progress to T1DM faster than adults, the researchers note. They say faster progression is associated with a highly active immune system, which may explain the impact of immune system-modulating drugs like teplizumab.
The study “illustrates how decades of research on the biology of T1D can lead to promising treatments that have a real impact on people’s lives,” NIDDK Director Rodgers says.
But the T1DM and T2DM studies, although highlighting areas of effectiveness, also underscore the continued need for new approaches to prevent and treat DM in young people.
Although the drop in new cases of T2DM are still unclear, the CDC researchers suggest that they are driven in part by increased awareness of DM prevention, changes in diet, changes in physical activity, and changes in diagnostic and screening practices. In other words, prevention also remains an urgent need.
After 20 years on the rise, new cases of diagnosed diabetes mellitus (DM) in the US have declined by 35%, from 1.7 million in 2008 to 1.3 million in 2017, according to CDC researchers. Not only that: The number of people living with diagnosed DM in the US has remained stable for the past 8 years.
The findings represent the longest decline in new DM cases and the longest sustained plateau in existing cases. Between 1990 and 2009, the number of people living with diagnosed diabetes (DD) rose 4.4% per year, peaked at 8.2 per 100 adults, then leveled off at 8 per 100 in 2017. The trends were similar across age groups, racial and ethnic groups, and genders.
In part, the plateau may be due to the fact that people with DM are living longer, the researchers suggest, pointing to recent reports of a decline in cardiovascular and all-cause mortality in adults with DD.
But maybe the work to “stem the tide of type 2 diabetes” is finally having an effect, says Ann Albright, PhD, director of the CDC Division of Diabetes Translation. She stresses the importance of “putting science-proven programs into action,” citing the National Diabetes Prevention Program as a prime example. But she adds, “We must also increase access to affordable, healthier foods, and safe places to be active.”
The news about the decrease in new diabetes cases comes simultaneously with findings from the Restoring Insulin Secretion (RISE) Adult and Pediatric Medication Studies, which found that type 2 diabetes mellitus (T2DM) progression slows during treatment but resumes after treatment stops.
The research, funded by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), was aimed at finding ways to preserve β-cell function. The adult study randomly assigned participants aged 20 to 65 years to receive long-acting insulin (glargine) for 3 months, followed by metformin for 9 months; liraglutide with metformin for 12 months; metformin alone for 12 months; or placebo. Participants’ β-cell function and blood glucose control improved on the treatments, with those in the liraglutide/metformin group showing the most improvement. But the improvements did not persist after treatment ended. “[T]reatment options were equally effective while people were actively on them,” says study chair Dr. Steven Kahn, from the VA Puget Sound Health Care System. “But people need to stay on treatment to maintain the benefits.”
The youth study (participants aged 10-19 years) study compared 3 months of insulin glargine, followed by metformin for 9 months, to metformin alone for 12 months. (Insulin glargine and metformin are the only FDA-approved drugs for young people with T2D ) β-cell function declined in the 2 pediatric treatment groups and even worsened after treatment ended. The studies support earlier evidence that T2DM affects young people differently and more aggressively than it does in adults, NIDDK Director Dr. Griffin Rodgers says.
Other research news is brighter for people at risk for type 1 diabetes mellitus (T1DM): An NIH-funded study found that treatment with teplizumab, an anti-CD3 monoclonal antibody, delayed clinical T1DM by ≥ 2 years.
Previous research had found that teplizumab slows the loss of β cells in people with recent-onset clinical T1DM, but the drug had not been tested in people without clinical disease. The researchers wanted to see whether early intervention would have a benefit for people at high risk. They compared a 14-day course of teplizumab with placebo in 76 participants aged 8 to 49 years who were relatives of people with T1DM, had at ≥ 2 types of DM-related autoantibodies, and had abnormal glucose tolerance.
During the trial, 72% of people on placebo developed clinical DM compared with 43% of those in the treatment group. The median time for the control participants to develop DM was just over 24 months vs 48 months in the teplizumab group. The effects of the drug were greatest in the first year after it was given, when 41% of the participants—mainly in the placebo group—developed clinical diabetes.
At-risk children and adolescents are known to progress to T1DM faster than adults, the researchers note. They say faster progression is associated with a highly active immune system, which may explain the impact of immune system-modulating drugs like teplizumab.
The study “illustrates how decades of research on the biology of T1D can lead to promising treatments that have a real impact on people’s lives,” NIDDK Director Rodgers says.
But the T1DM and T2DM studies, although highlighting areas of effectiveness, also underscore the continued need for new approaches to prevent and treat DM in young people.
Although the drop in new cases of T2DM are still unclear, the CDC researchers suggest that they are driven in part by increased awareness of DM prevention, changes in diet, changes in physical activity, and changes in diagnostic and screening practices. In other words, prevention also remains an urgent need.
After 20 years on the rise, new cases of diagnosed diabetes mellitus (DM) in the US have declined by 35%, from 1.7 million in 2008 to 1.3 million in 2017, according to CDC researchers. Not only that: The number of people living with diagnosed DM in the US has remained stable for the past 8 years.
The findings represent the longest decline in new DM cases and the longest sustained plateau in existing cases. Between 1990 and 2009, the number of people living with diagnosed diabetes (DD) rose 4.4% per year, peaked at 8.2 per 100 adults, then leveled off at 8 per 100 in 2017. The trends were similar across age groups, racial and ethnic groups, and genders.
In part, the plateau may be due to the fact that people with DM are living longer, the researchers suggest, pointing to recent reports of a decline in cardiovascular and all-cause mortality in adults with DD.
But maybe the work to “stem the tide of type 2 diabetes” is finally having an effect, says Ann Albright, PhD, director of the CDC Division of Diabetes Translation. She stresses the importance of “putting science-proven programs into action,” citing the National Diabetes Prevention Program as a prime example. But she adds, “We must also increase access to affordable, healthier foods, and safe places to be active.”
The news about the decrease in new diabetes cases comes simultaneously with findings from the Restoring Insulin Secretion (RISE) Adult and Pediatric Medication Studies, which found that type 2 diabetes mellitus (T2DM) progression slows during treatment but resumes after treatment stops.
The research, funded by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), was aimed at finding ways to preserve β-cell function. The adult study randomly assigned participants aged 20 to 65 years to receive long-acting insulin (glargine) for 3 months, followed by metformin for 9 months; liraglutide with metformin for 12 months; metformin alone for 12 months; or placebo. Participants’ β-cell function and blood glucose control improved on the treatments, with those in the liraglutide/metformin group showing the most improvement. But the improvements did not persist after treatment ended. “[T]reatment options were equally effective while people were actively on them,” says study chair Dr. Steven Kahn, from the VA Puget Sound Health Care System. “But people need to stay on treatment to maintain the benefits.”
The youth study (participants aged 10-19 years) study compared 3 months of insulin glargine, followed by metformin for 9 months, to metformin alone for 12 months. (Insulin glargine and metformin are the only FDA-approved drugs for young people with T2D ) β-cell function declined in the 2 pediatric treatment groups and even worsened after treatment ended. The studies support earlier evidence that T2DM affects young people differently and more aggressively than it does in adults, NIDDK Director Dr. Griffin Rodgers says.
Other research news is brighter for people at risk for type 1 diabetes mellitus (T1DM): An NIH-funded study found that treatment with teplizumab, an anti-CD3 monoclonal antibody, delayed clinical T1DM by ≥ 2 years.
Previous research had found that teplizumab slows the loss of β cells in people with recent-onset clinical T1DM, but the drug had not been tested in people without clinical disease. The researchers wanted to see whether early intervention would have a benefit for people at high risk. They compared a 14-day course of teplizumab with placebo in 76 participants aged 8 to 49 years who were relatives of people with T1DM, had at ≥ 2 types of DM-related autoantibodies, and had abnormal glucose tolerance.
During the trial, 72% of people on placebo developed clinical DM compared with 43% of those in the treatment group. The median time for the control participants to develop DM was just over 24 months vs 48 months in the teplizumab group. The effects of the drug were greatest in the first year after it was given, when 41% of the participants—mainly in the placebo group—developed clinical diabetes.
At-risk children and adolescents are known to progress to T1DM faster than adults, the researchers note. They say faster progression is associated with a highly active immune system, which may explain the impact of immune system-modulating drugs like teplizumab.
The study “illustrates how decades of research on the biology of T1D can lead to promising treatments that have a real impact on people’s lives,” NIDDK Director Rodgers says.
But the T1DM and T2DM studies, although highlighting areas of effectiveness, also underscore the continued need for new approaches to prevent and treat DM in young people.
Although the drop in new cases of T2DM are still unclear, the CDC researchers suggest that they are driven in part by increased awareness of DM prevention, changes in diet, changes in physical activity, and changes in diagnostic and screening practices. In other words, prevention also remains an urgent need.
Heart Valve Replacement for High-Risk Patients
Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication that can put transcatheter mitral valve replacement (TMVR) out of reach for many patients. But researchers from the National Heart, Lung and Blood Institute (NHLBI) and Emory University in Atlanta, Georgia, have developed a novel technique to essentially slice through the obstacle, increasing treatment options for high-risk patients.
TMVR is a less invasive alternative to open-heart surgery. Physicians replace the mitral valve by inserting an artificial valve via a catheter. In > 50% of patients, though, the heart leaflet is pushed back, blocking blood flow. In surgery, surgeons can cut out the leaflets when they replace valves, because they are looking at the open chest and the heart and can see the problem, says study author Jaffar Khan, MD, clinician at NHLBI.
The researchers describe their new method, LAMPOON, as “a transcatheter mimic of surgical chord-sparing leaflet resection.” LAMPOON involves intentional laceration of the anterior mitral valve leaflet. The operator inserts 2 catheters through the patient’s groin, up to the heart. A thread-sized electrified wire woven through the catheter splits open the leaflet.
In the LAMPOON study, the researchers evaluated the procedure’s results in 30 patients at high risk for surgical valve replacement and prohibitive risk of LVOT obstruction during TMVR.
Survival was 100%, and 30-day survival was 93% (compared with 38% reported with other methods). In all, 73% of patients met the primary outcome: a successful LAMPOON procedure followed by a successful TMVR without reintervention. No one had a stroke.
Every year > 20,000 people in the US die of heart valve disease. The researchers hope their innovative technique will help reduce that number.
Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication that can put transcatheter mitral valve replacement (TMVR) out of reach for many patients. But researchers from the National Heart, Lung and Blood Institute (NHLBI) and Emory University in Atlanta, Georgia, have developed a novel technique to essentially slice through the obstacle, increasing treatment options for high-risk patients.
TMVR is a less invasive alternative to open-heart surgery. Physicians replace the mitral valve by inserting an artificial valve via a catheter. In > 50% of patients, though, the heart leaflet is pushed back, blocking blood flow. In surgery, surgeons can cut out the leaflets when they replace valves, because they are looking at the open chest and the heart and can see the problem, says study author Jaffar Khan, MD, clinician at NHLBI.
The researchers describe their new method, LAMPOON, as “a transcatheter mimic of surgical chord-sparing leaflet resection.” LAMPOON involves intentional laceration of the anterior mitral valve leaflet. The operator inserts 2 catheters through the patient’s groin, up to the heart. A thread-sized electrified wire woven through the catheter splits open the leaflet.
In the LAMPOON study, the researchers evaluated the procedure’s results in 30 patients at high risk for surgical valve replacement and prohibitive risk of LVOT obstruction during TMVR.
Survival was 100%, and 30-day survival was 93% (compared with 38% reported with other methods). In all, 73% of patients met the primary outcome: a successful LAMPOON procedure followed by a successful TMVR without reintervention. No one had a stroke.
Every year > 20,000 people in the US die of heart valve disease. The researchers hope their innovative technique will help reduce that number.
Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication that can put transcatheter mitral valve replacement (TMVR) out of reach for many patients. But researchers from the National Heart, Lung and Blood Institute (NHLBI) and Emory University in Atlanta, Georgia, have developed a novel technique to essentially slice through the obstacle, increasing treatment options for high-risk patients.
TMVR is a less invasive alternative to open-heart surgery. Physicians replace the mitral valve by inserting an artificial valve via a catheter. In > 50% of patients, though, the heart leaflet is pushed back, blocking blood flow. In surgery, surgeons can cut out the leaflets when they replace valves, because they are looking at the open chest and the heart and can see the problem, says study author Jaffar Khan, MD, clinician at NHLBI.
The researchers describe their new method, LAMPOON, as “a transcatheter mimic of surgical chord-sparing leaflet resection.” LAMPOON involves intentional laceration of the anterior mitral valve leaflet. The operator inserts 2 catheters through the patient’s groin, up to the heart. A thread-sized electrified wire woven through the catheter splits open the leaflet.
In the LAMPOON study, the researchers evaluated the procedure’s results in 30 patients at high risk for surgical valve replacement and prohibitive risk of LVOT obstruction during TMVR.
Survival was 100%, and 30-day survival was 93% (compared with 38% reported with other methods). In all, 73% of patients met the primary outcome: a successful LAMPOON procedure followed by a successful TMVR without reintervention. No one had a stroke.
Every year > 20,000 people in the US die of heart valve disease. The researchers hope their innovative technique will help reduce that number.
VA Rolls Out New and Improved Veterans Community Care Program
Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.
The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.
“The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”
Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:
- needs a service not available at any VA medical facility;
- lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
- qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
- meets specific access standards for average drive time or appointment wait times.
The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.
In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”
One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”
The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.
The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.
A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.
Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.
The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.
“The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”
Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:
- needs a service not available at any VA medical facility;
- lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
- qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
- meets specific access standards for average drive time or appointment wait times.
The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.
In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”
One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”
The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.
The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.
A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.
Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.
The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.
“The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”
Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:
- needs a service not available at any VA medical facility;
- lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
- qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
- meets specific access standards for average drive time or appointment wait times.
The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.
In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”
One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”
The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.
The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.
A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.
CDC Updates Cancer Cluster Guidelines
In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.
But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.
The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.
“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.
The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.
In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.
But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.
The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.
“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.
The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.
In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.
But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.
The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.
“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.
The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.
Steroids May Not Benefit Patients With Mild Asthma
The gold-standard treatment is no more effective than placebo for patients with mild persistent asthma, say researchers from the Steroids in Eosinophil Negative Asthma (SIENA) study, funded by the National Heart, Lung, and Blood Institute.
The researchers divided 295 participants into groups based on low- or high-sputum eosinophil levels and assigned them randomly to each of 3 treatment groups for 12-week periods: inhaled steroids (mometasone), a long-acting muscarinic antagonist (LAMA) (tiotropium), or placebo.
Surprisingly, 221 participants—nearly 73%—were classified as having low-sputum eosinophils (< 2%), a much higher frequency than the researchers expected. And of those, the number who responded better to steroids was no different from the number responding to placebo. Of the Eos-low group, 60% had better symptom control with LAMA; 40% had better symptom control with placebo.
By contrast, patients classified as “Eos-high” were nearly 3 times as likely to respond to inhaled steroids compared with placebo.
Other research has indicated that about half the population with mild persistent asthma have < 2% sputum eosinophils and are not likely to respond well to steroids. But laboratory tests to measure sputum eosinophils are not routinely used in most clinics, the researchers say.
The difference between the groups is not large enough to conclude that patients are more likely to do better on LAMA drugs, the researchers say, but their study highlights the need to look for alternatives to inhaled steroids for patients with mild asthma.
The research underscores the value of customizing treatments to help people with asthma, said James Kiley, PhD, director of the Division of Lung Diseases at NHLBI. “This study adds to a growing body of evidence that different patients with mild asthma should be treated differently, perhaps using biomarkers like sputum eosinophils to select which drugs should be used—a precision medicine approach.”
The gold-standard treatment is no more effective than placebo for patients with mild persistent asthma, say researchers from the Steroids in Eosinophil Negative Asthma (SIENA) study, funded by the National Heart, Lung, and Blood Institute.
The researchers divided 295 participants into groups based on low- or high-sputum eosinophil levels and assigned them randomly to each of 3 treatment groups for 12-week periods: inhaled steroids (mometasone), a long-acting muscarinic antagonist (LAMA) (tiotropium), or placebo.
Surprisingly, 221 participants—nearly 73%—were classified as having low-sputum eosinophils (< 2%), a much higher frequency than the researchers expected. And of those, the number who responded better to steroids was no different from the number responding to placebo. Of the Eos-low group, 60% had better symptom control with LAMA; 40% had better symptom control with placebo.
By contrast, patients classified as “Eos-high” were nearly 3 times as likely to respond to inhaled steroids compared with placebo.
Other research has indicated that about half the population with mild persistent asthma have < 2% sputum eosinophils and are not likely to respond well to steroids. But laboratory tests to measure sputum eosinophils are not routinely used in most clinics, the researchers say.
The difference between the groups is not large enough to conclude that patients are more likely to do better on LAMA drugs, the researchers say, but their study highlights the need to look for alternatives to inhaled steroids for patients with mild asthma.
The research underscores the value of customizing treatments to help people with asthma, said James Kiley, PhD, director of the Division of Lung Diseases at NHLBI. “This study adds to a growing body of evidence that different patients with mild asthma should be treated differently, perhaps using biomarkers like sputum eosinophils to select which drugs should be used—a precision medicine approach.”
The gold-standard treatment is no more effective than placebo for patients with mild persistent asthma, say researchers from the Steroids in Eosinophil Negative Asthma (SIENA) study, funded by the National Heart, Lung, and Blood Institute.
The researchers divided 295 participants into groups based on low- or high-sputum eosinophil levels and assigned them randomly to each of 3 treatment groups for 12-week periods: inhaled steroids (mometasone), a long-acting muscarinic antagonist (LAMA) (tiotropium), or placebo.
Surprisingly, 221 participants—nearly 73%—were classified as having low-sputum eosinophils (< 2%), a much higher frequency than the researchers expected. And of those, the number who responded better to steroids was no different from the number responding to placebo. Of the Eos-low group, 60% had better symptom control with LAMA; 40% had better symptom control with placebo.
By contrast, patients classified as “Eos-high” were nearly 3 times as likely to respond to inhaled steroids compared with placebo.
Other research has indicated that about half the population with mild persistent asthma have < 2% sputum eosinophils and are not likely to respond well to steroids. But laboratory tests to measure sputum eosinophils are not routinely used in most clinics, the researchers say.
The difference between the groups is not large enough to conclude that patients are more likely to do better on LAMA drugs, the researchers say, but their study highlights the need to look for alternatives to inhaled steroids for patients with mild asthma.
The research underscores the value of customizing treatments to help people with asthma, said James Kiley, PhD, director of the Division of Lung Diseases at NHLBI. “This study adds to a growing body of evidence that different patients with mild asthma should be treated differently, perhaps using biomarkers like sputum eosinophils to select which drugs should be used—a precision medicine approach.”
Pregnancy-Related Deaths: A “Web of Missed Opportunities”
The causes of death differ throughout pregnancy and postpartum. Overall, heart disease and stroke cause > 1 in 3 deaths. At delivery, most deaths are due to obstetric emergencies, such as severe bleeding and amniotic fluid embolism. In the week after delivery, severe bleeding, high blood pressure, and infection are most common. But one-third of the deaths happen 1 week to 1 year after delivery, most often caused by cardiomyopathy.
The findings also confirm racial disparities, the CDC says. Black and Native American women were about 3 times as likely as white women to die of a pregnancy-related cause.
The researchers analyzed 2011-2015 national data on pregnancy mortality and 2013-2017 data from 13 state maternal mortality review committees. Their analysis revealed that most pregnancy-related deaths were preventable regardless of race or ethnicity. Each death represents a “web of missed opportunities,” the CDC says. The mortality review committees determined that each death was associated with several contributing factors, including lack of access to appropriate care, missed or delayed diagnoses, and lack of knowledge among patients and providers about warning signs.
The CDC offers advice on how to help keep patients safe during and after pregnancy. For example:
- Help patients manage their chronic conditions;
- Teach patients about warning signs; and
- Use tools to flag warning signs early so women can receive timely treatment
Hospitals also can standardize patient care, the CDC advises, including delivering high-risk women at hospitals with specialized providers and equipment. They can train nonobstetric providers to consider the patient’s recent pregnancy history. Importantly, health care practitioners should continue to provide high-quality care for mothers up to at least 1 year after birth.
The causes of death differ throughout pregnancy and postpartum. Overall, heart disease and stroke cause > 1 in 3 deaths. At delivery, most deaths are due to obstetric emergencies, such as severe bleeding and amniotic fluid embolism. In the week after delivery, severe bleeding, high blood pressure, and infection are most common. But one-third of the deaths happen 1 week to 1 year after delivery, most often caused by cardiomyopathy.
The findings also confirm racial disparities, the CDC says. Black and Native American women were about 3 times as likely as white women to die of a pregnancy-related cause.
The researchers analyzed 2011-2015 national data on pregnancy mortality and 2013-2017 data from 13 state maternal mortality review committees. Their analysis revealed that most pregnancy-related deaths were preventable regardless of race or ethnicity. Each death represents a “web of missed opportunities,” the CDC says. The mortality review committees determined that each death was associated with several contributing factors, including lack of access to appropriate care, missed or delayed diagnoses, and lack of knowledge among patients and providers about warning signs.
The CDC offers advice on how to help keep patients safe during and after pregnancy. For example:
- Help patients manage their chronic conditions;
- Teach patients about warning signs; and
- Use tools to flag warning signs early so women can receive timely treatment
Hospitals also can standardize patient care, the CDC advises, including delivering high-risk women at hospitals with specialized providers and equipment. They can train nonobstetric providers to consider the patient’s recent pregnancy history. Importantly, health care practitioners should continue to provide high-quality care for mothers up to at least 1 year after birth.
The causes of death differ throughout pregnancy and postpartum. Overall, heart disease and stroke cause > 1 in 3 deaths. At delivery, most deaths are due to obstetric emergencies, such as severe bleeding and amniotic fluid embolism. In the week after delivery, severe bleeding, high blood pressure, and infection are most common. But one-third of the deaths happen 1 week to 1 year after delivery, most often caused by cardiomyopathy.
The findings also confirm racial disparities, the CDC says. Black and Native American women were about 3 times as likely as white women to die of a pregnancy-related cause.
The researchers analyzed 2011-2015 national data on pregnancy mortality and 2013-2017 data from 13 state maternal mortality review committees. Their analysis revealed that most pregnancy-related deaths were preventable regardless of race or ethnicity. Each death represents a “web of missed opportunities,” the CDC says. The mortality review committees determined that each death was associated with several contributing factors, including lack of access to appropriate care, missed or delayed diagnoses, and lack of knowledge among patients and providers about warning signs.
The CDC offers advice on how to help keep patients safe during and after pregnancy. For example:
- Help patients manage their chronic conditions;
- Teach patients about warning signs; and
- Use tools to flag warning signs early so women can receive timely treatment
Hospitals also can standardize patient care, the CDC advises, including delivering high-risk women at hospitals with specialized providers and equipment. They can train nonobstetric providers to consider the patient’s recent pregnancy history. Importantly, health care practitioners should continue to provide high-quality care for mothers up to at least 1 year after birth.