New Severe Asthma Guidelines Recommend FeNO Monitoring

If your patients end up on high dose asthma therapy or have frequent exacerbations, reassessment is needed.  Exhaled nitric oxide testing provides a method for non-invasive point of care assessment for asthma and asthma control and can help direct therapy for severe asthma.  The latest iteration of GINA guidelines acknowledges this. Dr. Susarla

In a significant advancement in the treatment of severe asthma, the latest diagnosis and management guide from the Global Initiative for Asthma (GINA) makes new recommendations for assessment tools.

The new guide now recommends fractional exhaled nitric oxide (FeNO) monitoring as an assessment tool to determine whether patients who are on high-dose inhaled corticosteroids or low-dose oral corticosteroids have residual inflammation.

In a statement accompanying the new guidelines, Dr. Helen Reddel, Chair of the GINA Science Committee and a research leader at the Woolcock Institute of Medical Research in Sydney, Australia, explained that difficult-to-treat and severe asthma are currently high priority due to their “physical, emotional and financial burden for patients and their families.”

 “Clinicians in both low and high income countries need practical advice about how to assess and treat patients for whom conventional asthma therapies don’t seem to be working, and about how treatment strategies, including biologic therapies if available, can be implemented into patient care,” Reddel said.

Utilizing FeNO measurements can provide a potential predictor of positive responses to anti-immunoglobulin E (anti-IgE) therapy for patients with severe, allergic asthma, and is a tool to identify refractory type 2 inflammation in patients on high-dose inhaled corticosteroids therapy.

“The new GINA guidelines build on an earlier US Agency for Healthcare Research and Quality (AHRQ) report in terms of the strength of FeNO as a practical tool that improves outcomes for asthma patients,” said David Acheson, Senior Vice President of US Commercial at Circassia Pharmaceuticals, Inc., a specialty pharmaceutical company focused on respiratory disease which announced the new recommendations on December 5.

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CPAP or Surveillance Device?

An unfortunate spin on an extremely useful technology that can strengthen doctor/patient relationship and improve sleep apnea outcomes when used properly.  Step off regulators!  Dr. Susarla

Last March, Tony Schmidt discovered something unsettling about the machine that helps him breathe at night. Without his knowledge, it was spying on him.

From his bedside, the device was tracking when he was using it and sending the information not just to his doctor, but to the maker of the machine, to the medical supply company that provided it and to his health insurer.

Schmidt, an information technology specialist from Carrollton, Texas, was shocked. "I had no idea they were sending my information across the wire."

Schmidt, 59, has sleep apnea, a disorder that causes worrisome breaks in his breathing at night. Like millions of people, he relies on a continuous positive airway pressure, or CPAP, machine that streams warm air into his nose while he sleeps, keeping his airway open. Without it, Schmidt would wake up hundreds of times a night; then, during the day, he'd nod off at work, sometimes while driving and even as he sat on the toilet.

"I couldn't keep a job," he said. "I couldn't stay awake." The CPAP, he said, saved his career, maybe even his life.

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Excess Weight Increases Asthma Risk

Proximity to holidays purely coincidental.  Nonetheless, watch the pounds folks! Dr. Susarla

Children who are overweight or obese are at increased risk for asthma, researchers report.

A retrospective study, published in Pediatrics, included 507,496 children followed for an average of four years. None of the children had incidents of asthma before the start of the study.

The researchers divided the children into three groups: overweight, defined as the 85th to 94th percentile for weight; obese, the 95th percentile or higher; and normal weight, the 25th to 64th percentile.

The study controlled for age, race, health insurance, food allergies, medications and other factors, and found that compared with children of normal weight, the overweight were 17 percent more likely to have been given a diagnosis of asthma and to take an asthma medication. The obese were 30 percent more likely.

The researchers estimate that 23 to 27 percent of asthma cases in obese children can be attributed to the obesity itself. Among all the children, 10 to 13 percent of asthma cases were attributable to obesity.

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Does anesthesia in children cause developmental delay?

Many parents I counsel regarding need for flexible bronchoscopy hesitate when they realize anesthesia is involved, albeit even for a short procedure.  This study suggests risk may be exaggerated. Dr. Susarla

Young children who had surgical procedures with general anesthesia prior to primary school entry did not have an increased risk of detectable adverse neurodevelopment outcomes compared with their siblings who did not have surgery, according to a Canadian analysis.

After adjusting for confounding factors, no significant differences were found between exposed and unexposed children in early developmental vulnerability or in each of the major domains of the Early Development Instrument (EDI), a teacher-assessed measure of primary school readiness, reported James O'Leary, MD, and co-authors of the Hospital for Sick Children in Toronto, writing in JAMA Pediatrics.

"These findings further support that exposure to anesthesia and surgery in early childhood is not associated with detectable adverse child development outcomes," O'Leary told MedPage Today.

But "while the findings are generalizable to the majority of young children who have a single surgical procedure performed, it is still not known whether children with repeated or lengthy exposures to surgery and anesthesia are at increased risk of altered neurodevelopment," he added.

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Xyrem, narcolepsy therapy for adults AND children

Narcolepsy is debilitating.  In the right child with narcolepsy, sodium oxybate can be life changing.  Dr. Susarla


Sodium oxybate (Xyrem) has been approved by the US Food and Drug Administration (FDA) for the treatment of cataplexy and excessive daytime sleepiness in pediatric patients aged 7 to 17 years old with narcolepsy.

Sodium oxybate is a central nervous system depressant administered as an oral solution and can be given either alone or in combination with other central nervous system depressants. These can include opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit central nervous system depressants.

The recommended dose for sodium oxybate is 0.5 g/mL, which may only be dispensed to patients enrolled in the XYREM REMS Program because of the risk of serious outcomes that can occur from inappropriate prescribing, misuse, abuse, and diversion.

Narcolepsy resources:

narcolepsynetwork.org

healthysleep.med.harvard.edu/narcolepsy/resources

morethantired.com

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Welcome Dupixent!

When new anti-asthma biologics come to the door, always give them a welcome seat. Here is an anti- atopic dermatitis monoclonal antibody that also shuts down a key component of the allergy airway inflammation pathway, now a 12 and up asthma therapy.  Dr. Susarla

Dive Brief:

• Sanofi and Regneron have won an expanded U.S. approval for Dupixent in asthma, securing another indication for the biologic drug which the companies are counting on to deliver blockbuster sales. 
• On Friday, the Food and Drug Administration OK'd the drug for moderate-to-severe asthma patients with an eosinophilic phenotype, or with oral corticosteroid-dependent asthma regardless of phenotype, the companies said. The new indication adds to Dupixent's previously approved use for moderate-to-severe atopic dermatitis.
• Clinical results supporting the approval showed Dupixent cut severe asthma attacks by 67% compared to placebo in patients with high eosinophil counts. Among patients with lower levels of the inflammation marker, however, Dupixent did not separate from placebo in statistical comparison. 

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Digital Devices for Insomnia? Researchers say YES

Cognitive behavioral therapy is an intervention the incorporates coping strategies and behavioral modifications to treat a variety of conditions including insomnia.  When done properly it has been shown to be as effective as pharmacotherapy. Dr. Susarla

Digitally delivered cognitive-behavioral therapy not only improved insomnia, but also provided “around-the-clock” health, psychological, and quality-of-life improvements, according to investigators.

Compared with control subjects, patients who used a cognitive-behavioral therapy (CBT) program and associated iPhone app had small improvements in functional health and psychological well-being and large improvements in sleep-related quality of life, the investigators reported.

Those changes were mediated by a large improvement in insomnia, according to Colin A. Espie, PhD, professor of sleep medicine at the University of Oxford (England), and his colleagues.

“These findings indicate that digital CBT improves both daytime and nighttime aspects of insomnia, lending further weight to the clinical guideline recommendation of CBT as the treatment of choice for insomnia,” Dr. Espie and his colleagues reported in JAMA Psychiatry.

Their study included 1,711 adults with symptoms of insomnia that were self-reported and a score of 16 or less on the Sleep Condition Indicator (SCI), which has a range of 0-32. A total of 853 were randomized to receive digital CBT, of whom 413 completed six scheduled 20-minute sessions; an additional 276 adults completed at least one session. The control arm included 858 individuals randomized to sleep hygiene education, of whom 759 went on to receive that intervention.

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