Miscellaneous respiratory disorders Archives - MPR Tue, 30 Apr 2024 17:12:22 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 https://www.empr.com/wp-content/uploads/sites/7/2023/03/cropped-empr-32x32.jpg Miscellaneous respiratory disorders Archives - MPR 32 32 ACTEMRA https://www.empr.com/drug/actemra/ Tue, 03 Jan 2023 20:18:12 +0000 https://www.empr.com/drug/actemra/ ACTEMRATocilizumab 20mg/mL (vial); soln for IV infusion after dilution; 162mg/0.9mL (prefilled syringe, autoinjector); soln for SC inj; both: preservative-free.]]> ACTEMRA]]> ACTHAR GEL https://www.empr.com/drug/acthar-gel/ Mon, 06 Feb 2023 21:00:52 +0000 https://www.empr.com/drug/h-p-acthar-gel/ Acute Cardiac Event Reported in 22.4% of Seniors Hospitalized With RSV https://www.empr.com/home/news/acute-cardiac-event-reported-in-22-4-of-seniors-hospitalized-with-rsv/ Tue, 16 Apr 2024 13:00:00 +0000 https://www.empr.com/?p=218738 Risk for experiencing acute cardiac event higher for adults with underlying cardiovascular disease

]]>
HealthDay News — More than 22% of older hospitalized adults with respiratory syncytial virus (RSV) infection experience an acute cardiac event, according to a study published online April 15 in JAMA Internal Medicine.

Rebecca C. Woodruff, PhD, MPH, from the US Centers for Disease Control and Prevention in Atlanta, and colleagues conducted a cross-sectional study examining surveillance data from the RSV Hospitalization Surveillance Network. To estimate the weighted period prevalence of acute cardiac events, cases of RSV infection in adults aged 50 years and older within 12 states over 5 RSV seasons were examined.

A total of 6248 hospitalized adults with laboratory-confirmed RSV infection were included. The researchers found that the weighted estimated prevalence of experiencing a cardiac event was 22.4%, with weighted estimated prevalence of 15.8, 7.5, 1.3, 1.1, and 0.6% for acute heart failure, acute ischemic heart disease, hypertensive crisis, ventricular tachycardia, and cardiogenic shock, respectively. The risk for experiencing an acute cardiac event was higher for adults with underlying cardiovascular disease (33.0 vs 8.5%; adjusted risk ratio [aRR], 3.51). Of the hospitalized adults with RSV infection, 18.6 and 4.9% required intensive care unit (ICU) admission and died, respectively; those who experienced an acute cardiac event had higher risks for ICU admission and in-hospital death (aRRs, 1.54 and 1.77, respectively).

“Acute cardiac events contribute substantially to the burden of RSV disease; whether RSV vaccination can prevent these complications is an important question as the impact of these vaccines is evaluated,” the authors write.

Abstract/Full Text (subscription or payment may be required)

Editor’s Note (subscription or payment may be required)

]]>
Antibiotics Not Helpful for Cough Due to Lower Respiratory Tract Infection https://www.empr.com/home/news/antibiotics-not-helpful-for-cough-due-to-lower-respiratory-tract-infection/ Fri, 26 Apr 2024 13:00:00 +0000 https://www.empr.com/?post_type=healthday&p=219402 Despite patient beliefs, no impact seen on severity, duration of cough.

]]>
HealthDay News — Antibiotics have no measurable impact on the severity or duration of cough due to acute lower respiratory tract infection (LRTI) among adults presenting to primary care or urgent care, according to a study published online April 15 in the Journal of General Internal Medicine.

Daniel J. Merenstein, MD, from Georgetown University Medical Center in Washington, D.C., and colleagues evaluated the impact of antibiotic use on the duration and severity of LRTI. The analysis included 718 adult patients presenting to US primary or urgent care sites with a chief complaint of cough and symptoms consistent with LRTI.

The researchers reported that 29% of presenting patients had an antibiotic prescribed at baseline, most commonly amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin. In patients with viral, bacterial, or mixed infections, provision of an antibiotic had no effect on the duration or overall severity of cough. However, antibiotic receipt did cut the likelihood of a follow-up visit (14.1 vs 8.2%; adjusted odds ratio, 0.47). Patients receiving an antibiotic were also significantly more likely to receive a systemic corticosteroid (31.9 vs 4.5%) and an albuterol inhaler (22.7 vs 7.6%). Patients believed that an antibiotic would cut the duration of their illness by nearly 4 days.

“Patients had unrealistic expectations regarding the duration of LRTI and the effect of antibiotics which should be the target of antibiotic stewardship efforts,” the authors write.

Abstract/Full Text (subscription or payment may be required)

]]>
Antibiotics Show Little Benefit in Children Without Nasopharyngeal Bacterial Pathogens https://www.empr.com/home/news/antibiotics-show-little-benefit-in-children-without-nasopharyngeal-bacterial-pathogens/ Tue, 08 Aug 2023 13:00:00 +0000 https://www.empr.com/?p=201936

Findings show greater benefit in symptom resolution with detected bacterial pathogens but not color of nasal discharge.

]]>

HealthDay News — In children with acute sinusitis, antibiotic treatment had minimal benefit for those without nasopharyngeal bacterial pathogens, according to a study published in the July 25 issue of the Journal of the American Medical Association.

Nader Shaikh, MD, MPH, from the University of Pittsburgh, and colleagues conducted a clinical trial in which 515 children (aged 2 to 11 years) diagnosed with acute sinusitis based on clinical criteria were randomly assigned to oral amoxicillin (90mg/kg/day) and clavulanate (6.4mg/kg/day; 254 patients) or placebo (256 patients) for 10 days. Daily symptom burden was compared between the groups to see if there were differences by nasopharyngeal colonization with bacterial pathogen or color of the nasal discharge.

The researchers found that the mean symptom scores were significantly lower in children in the amoxicillin and clavulanate group (9.04 vs 10.60 in the placebo group) and the length of time to symptom resolution was significantly lower for children in the antibiotic group (7.0 vs 9.0 days). The benefit from antibiotic treatment was greater in children with nasopharyngeal pathogens detected vs those with pathogens detected (between-group difference in mean symptom scores, −1.95 vs −0.88). Efficacy did not differ significantly based on whether colored nasal discharge was present vs not present (the between-group difference was −1.62 vs −1.70).

“Testing for specific bacteria on presentation may represent a strategy to reduce antibiotic use in this condition,” the authors write.

Abstract/Full Text (subscription or payment may be required)

Editorial 1 (subscription or payment may be required)

Editorial 2 (subscription or payment may be required)

]]>
BRONCHITOL https://www.empr.com/drug/bronchitol/ Thu, 22 Jul 2021 11:57:42 +0000 https://www.empr.com/drug/bronchitol/ Mannitol 40mg; per cap; pwd for oral inhalation; with inhaler.]]> ]]> CDC Recommends RSV Vaccine Abrysvo for Use During Pregnancy to Protect Infants https://www.empr.com/home/news/cdc-recommends-rsv-vaccine-abrysvo-for-use-during-pregnancy-to-protect-infants/ Mon, 25 Sep 2023 14:56:33 +0000 https://www.empr.com/?p=207228 Abrysvo is currently available in a kit containing a vial of lyophilized antigen component, a prefilled syringe containing diluent and a vial adapter.]]>

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommends the use of Abrysvo™ (respiratory syncytial virus vaccine) for active immunization of pregnant individuals at 32 through 36 weeks gestational age, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.

Abrysvo is an unadjuvanted bivalent vaccine containing recombinant RSV prefusion F (preF) A and RSV preF B. The approval for maternal immunization was based on data from the phase 3 MATISSE trial (ClinicalTrials.gov Identifier: NCT04424316).

“This is another new tool we can use this fall and winter to help protect lives,” said CDC Director Dr. Mandy Cohen. “I encourage parents to talk to their doctors about how to protect their little ones against serious RSV illness, using either a vaccine given during pregnancy, or an RSV immunization given to your baby after birth.”

Abrysvo is currently available in a kit containing a vial of lyophilized antigen component, a prefilled syringe containing diluent and a vial adapter. Prior to intramuscular administration, the lyophilized antigen component should be reconstituted with the sterile water diluent component.

Abrysvo is also indicated for the prevention of LRTD caused by RSV in individuals 60 years of age and older. 

]]>
Climate Change Will Negatively Impact Children’s Health https://www.empr.com/home/news/climate-change-will-negatively-impact-childrens-health/ Mon, 11 Mar 2024 13:00:00 +0000 https://www.empr.com/?p=216858 Strongest association seen for increase in preterm birth with increasing temperatures.

]]>
HealthDay News — Children will have increased prevalence of disease due to anthropogenic climate change, according to a review published online February 21 in Science of the Total Environment.

Lewis J.Z. Weeda, from University of Western Australia in Perth, and colleagues conducted a systematic literature review and meta-analysis to identify which climate-health relationships pose the greatest threats to children.

Based on 163 included studies, the researchers found that the strongest association was increasing risk (60%, on average) for preterm birth from exposure to temperature extremes. Respiratory disease, mortality, and morbidity were also influenced by climate changes. Compared with temperature effects, the effects of different air pollutants on health outcomes were considerably smaller, but 80% of pollutant studies found at least a weak effect. Protective factors against climate-related child-health threats included economic stability and strength, access to quality health care, adequate infrastructure, and food security. Local geographical, climate, and socioeconomic conditions were tied to variance in threats to these services.

“Our quantification of the impact of various aspects of climate change on child health can contribute to the planning of mitigation that will improve the health of current and future generations,” the authors write.

Abstract/Full Text

]]>
Current Surge Noted in RSV Infection, Especially in Older Children https://www.empr.com/home/news/current-surge-noted-in-rsv-infection-especially-in-older-children/ Wed, 17 May 2023 13:00:00 +0000 https://www.empr.com/?p=196947

Greater proportion of children hospitalized in 2022 to 2023 were aged 2 to younger than 5 years and aged 5 to younger than 12 years.

]]>

HealthDay News — There is a current surge in respiratory syncytial virus (RSV) infections, especially among older children, according to a research letter published online May 15 in JAMA Pediatrics.

Suchitra Rao, MBBS, from the University of Colorado School of Medicine and Children’s Hospital Colorado in Aurora, and colleagues compared the age distribution of children hospitalized with RSV during 2018 to 2019, 2019 to 2020, 2021 to 2022, and 2022 to 2023 (2020 to 2021 was excluded as there was only one hospitalization).

Data were included for 2809 children. The researchers found that 97.5 and 98.8% of hospitalizations during 2021 to 2022 and 2022 to 2023, respectively, were directly related to RSV infection. Over these periods, age distributions differed significantly, with a median age of 11.0 vs 18.5 months prior to 2022 to 2023 vs the first 6 weeks of the 2022 to 2023 period. A greater proportion of children hospitalized with RSV in 2022 to 2023 were aged 2 years to younger than 5 years and aged 5 years to younger than 12 years compared with prior periods (34.2 vs 23.4% and 9.7 vs 5.0%, respectively). During 2021 to 2022 and 2022 to 2023, the proportion of hospitalized children with RSV admitted to the intensive care unit was 27.1 and 36.0%, respectively, with a median length of stay of 3.0 and 3.8 days, respectively.

“These findings support the hypothesis that lack of previous exposure to RSV during the COVID-19 pandemic may be associated with the current surge in RSV infections among an older cohort of susceptible children,” the authors write.

Two authors disclosed financial ties to the biopharmaceutical industry.

Abstract/Full Text

]]>
Diabetes Tied to Identifiable Vocal Changes https://www.empr.com/home/news/diabetes-tied-to-identifiable-vocal-changes/ Mon, 04 Dec 2023 14:00:00 +0000 https://www.empr.com/?p=211254 Voice analysis may be effective for screening or monitoring of diabetes.

]]>
HealthDay News — Vocal changes appear to occur in individuals with type 2 diabetes mellitus (T2DM) vs those without diabetes, according to a study published online in the December issue of Mayo Clinic Proceedings: Digital Health.

Jaycee M. Kaufman, from Klick Inc. in Toronto, and colleagues investigated the potential of voice analysis as a prescreening or monitoring tool for T2DM. Voices were compared for 267 participants without diabetes (79 women and 113 men) and those with diabetes (18 women and 57 men).

The researchers observed significant differences between voice recordings of men and women with and without diabetes, both for the entire dataset and in an age-matched and body mass index (BMI)-matched sample. Overall, pitch and pitch standard deviation achieved the highest predictive accuracy. For women, relative average pertubation jitter was also significant, as were intensity and 11-point amplitude perturbation quotient shimmer for men. When combining these features with age and BMI, the optimal prediction models achieved accuracies of 0.75 for women and 0.70 for men in the age-matched and BMI-matched sample.

“Voice analysis shows potential as a prescreening or monitoring tool for T2DM, particularly when combined with other risk factors associated with the condition,” the authors write.

Several authors are employees of Klick Inc., the source of funding for the study, and one author is listed as an inventor on two patents for the estimation of blood glucose using voice.

Abstract/Full Text

]]>
Doctor Gets First US Lung-Liver Transplant for Advanced Lung Cancer https://www.empr.com/home/news/doctor-gets-first-us-lung-liver-transplant-for-advanced-lung-cancer/ Fri, 29 Mar 2024 13:00:00 +0000 https://www.empr.com/?p=217945 HealthDay News — Dr Gary Gibbon didn’t have long to live.

A harsh cocktail of chemotherapy, radiation and immunotherapy for his advanced lung cancer had permanently destroyed his lungs and caused irreparable damage to his liver.

But Gibbon, a 69-year-old resident of Santa Monica, California, remains alive thanks to a groundbreaking, combined lung-liver transplant, according to his doctors at Northwestern Medicine in Chicago.

“I’ve been a physician for decades, and we tend to be conservative at times with our treatment plans, which is why the enormity of the science that went into this procedure is awe-inspiring to me,” Gibbon, a pulmonologist-allergist-immunologist, said in a Northwestern news release.

Gibbon calls the landmark surgery his “Triple L”; 2 lungs and a liver.

“To our knowledge, this is the first known case in the nation where a patient with advanced lung cancer has successfully received a combined lung-liver transplant,” said Dr Ankit Bharat, chief of thoracic surgery and director of the Northwestern Medicine Canning Thoracic Institute. Bharat performed Gibbon’s lung transplant.

Gibbon was born in Cape Town, South Africa, but spent the last 33 years in private practice in Santa Monica before he fell ill.

In March 2023, Gibbon started coughing and losing weight. A chest X-ray revealed stage 3 lung cancer.

Doctors went after the cancer hard, subjecting Gibbon to brutal rounds of chemo, radiation and immunotherapy.

By mid-July, Gibbon was hospitalized with septic shock, pneumonia and multiple organ failure. His lungs were irreversibly scarred by the immunotherapy, and he would need them replaced.

“As a pulmonologist, I never imagined I’d ever need a lung transplant, let alone for lung cancer,” Gibbon said.

Northwestern University offers a first-of-its-kind clinical program called Double Lung Replacement and Multidisciplinary Care (DREAM), and Gibbon turned to doctors there to save his life.

While evaluating Gibbon, Northwestern doctors found the immunotherapy had also caused liver cirrhosis.

A 4-hour medical flight delivered Gibbon to Chicago on September 10, where he awaited donor organs in the ICU at Northwestern Memorial Hospital.

After 12 days on the transplant wait list, Gibbon received his new lungs and liver from the same donor during a 10-hour surgical procedure.

Surgeons implanted the new lungs first, while the donor liver was kept alive outside the body thanks to a machine that pumps warm, oxygenated and nutrient-enriched blood through the organ, a technology the docs call “liver in a box.”

The liver-sustaining technology gave Bharat sufficient time to meticulously remove Gibbon’s damaged lungs as well as all the cancer.

Bharat had to remove both cancer-ridden lungs, and then wash out the airways and the chest cavity before transplanting in the new lungs.

During this process, Gibbon was on full heart and lung bypass, Bharat said.

“These patients can have billions of cancer cells in the lungs, so we must be extremely meticulous to not let a single cell spill into the patient’s chest cavity or blood stream,” Bharat said. “We believe this technique can help reduce the risk of recurrence, which we learned through our experience with pioneering COVID-19 lung transplants.”

Six months after surgery, Gibbon has no signs of cancer in his body and does not require any further treatment, his doctors said.

Gibbon will remain in Chicago through the summer so his transplant team can closely monitor him.

“This DREAM program is new territory for transplantation and the fact that I could experience it and have a wonderful outcome makes me feel so blessed,” Gibbon said. “I wouldn’t be here today without Northwestern Medicine.”

More information

The American Cancer Society has more about lung cancer.

SOURCE: Northwestern University, news release, March 28, 2024

]]>
DUPIXENT https://www.empr.com/drug/dupixent/ Mon, 29 Jan 2024 15:36:03 +0000 https://www.empr.com/drug/dupixent/ DUPIXENTDupilumab 200mg/1.14mL, 300mg/2mL; soln for SC inj; preservative-free.]]> DUPIXENT]]> ESBRIET https://www.empr.com/drug/esbriet/ Thu, 22 Jul 2021 11:35:53 +0000 https://www.empr.com/drug/esbriet/ ESBRIET TABLETS https://www.empr.com/drug/esbriet-tablets/ Thu, 22 Jul 2021 11:44:24 +0000 https://www.empr.com/drug/esbriet-tablets/ FDA Panel to Again Weigh Merit of Decongestant That Many Call Useless https://www.empr.com/home/news/fda-panel-to-again-weigh-merit-of-decongestant-that-many-call-useless/ Tue, 07 Mar 2023 14:00:00 +0000 https://www.empr.com/?p=192586

Agency's Nonprescription Drugs Advisory Committee will meet in April to consider the effectiveness of the oral version of phenylephrine

]]>

HealthDay News — Consumers have been using the common over-the-counter oral decongestant phenylephrine for years, but that may not continue much longer. The US Food and Drug Administration has asked a panel of its advisers to reassess the drug’s effectiveness. The medication’s safety is not in question, just whether it actually does what it claims to do.

The FDA Nonprescription Drugs Advisory Committee will meet in April to consider the effectiveness of the oral version of phenylephrine. The same panel had decided the drug “may be effective” in a 2007 meeting following federal efforts to fight illegal manufacturing of methamphetamine, which required the decongestant known as pseudoephedrine to be sold behind pharmacy counters, CBS News reported.

The FDA initially received a new petition to withdraw the medication back in 2015, submitted by University of Florida pharmacy professors Leslie Hendeles and Randy Hatton. The duo had cited new data that showed phenylephrine was not more effective than a placebo. “Let me be clear, oral phenylephrine is not a safety risk,” Hatton told CBS News. “It just doesn’t work.”

In 2022, both professors questioned the FDA inaction on their 2015 petition in a commentary in the Annals of Pharmacotherapy. “I get it. Risk takes priority. But eight years is long enough to wait, you know what I mean? That’s millions and millions of dollars wasted on ineffective drugs,” Hatton said, noting that other drugs are more effective at treating congestion, including nasal spray forms of phenylephrine, CBS News reported. “When you take it orally, it goes to the gut. And as it’s being absorbed through the gut, there are two enzymes that metabolize it to such a great extent that essentially a very miniscule amount makes it into the bloodstream,” Hatton explained.

Not everyone agrees with the push to potentially remove phenylephrine products from the marketplace. “Phenylephrine has been used safely and effectively as a nasal decongestant by American families for generations, and FDA regulations recognize it as safe and effective,” the industry trade group Consumer Healthcare Products Association said in a statement to CBS News.

Meanwhile, the American Academy of Allergy, Asthma & Immunology weighed in on the issue last year, saying in a statement that keeping the drug in the marketplace “does a disservice to patients who might be prone to taking higher doses than recommended,” CBS News reported. It may also delay efforts to get more effective medication, that statement noted.

The FDA did not immediately respond to the request for comment from CBS News.

CBS News Article

]]>
FDA Says Repaired Sleep Apnea Machines Still Carry Health Risks https://www.empr.com/home/news/fda-says-repaired-sleep-apnea-machines-still-carry-health-risks/ Tue, 11 Apr 2023 13:00:00 +0000 https://www.empr.com/?p=195057 Obstructive sleep apnea

Agency warns reworked CPAP, BiPAP machines may deliver inaccurate or insufficient therapy.

]]>
Obstructive sleep apnea

HealthDay News — The US Food and Drug Administration has issued another warning about certain sleep apnea machines made by Philips Respironics. Already the subject of a 2021 recall, some of the company’s repaired continuous positive airway pressure (CPAP) machines may still be dangerous to use, the agency said in an alert issued Friday.

The original problem with some of the machines was that foam that is meant to dull noise was breaking off from inside the machine and going into the mouths of people using the unit for sleep apnea. Inhaling the foam can cause “serious injury, which can be life-threatening,” Philips noted in its original recall notice.

The latest issue with some of the machines is that the company gave repaired machines the wrong or duplicate serial numbers, the latest FDA alert said. That may lead to the devices delivering the wrong prescription to sleep apnea patients. If receiving the wrong prescription, patients may not receive any CPAP benefits.

Philips’ Friday statement acknowledged the repair issues, including that a “limited amount [1200] of remediated first-generation DreamStation CPAP devices had been incorrectly programmed with either an incorrect serial number or a duplicate serial number.” The company is notifying patients if their machines may provide them with the wrong prescriptions.

The FDA has tracked complaints numbering 98,000 since the 2021 recall. People have reported having respiratory problems, pneumonia, dizziness, chest pain, infections, and cancer. The company said it has received 43 complaints about the repaired machines. No one has reported injury or death.

More than 20 different Philips devices have been recalled, including the A-Series BiPAP ventilators, the DreamStation CPAP machines, and the Trilogy 100 and 200 style ventilators.

More Information

]]>
FDA Urges Public to Use Heimlich Not ‘Anti-Choking’ Devices to Save Lives https://www.empr.com/home/news/fda-urges-public-to-use-heimlich-not-anti-choking-devices-to-save-lives/ Wed, 24 Apr 2024 13:00:00 +0000 https://www.empr.com/?p=219209 Unpacking and figuring out how to use an anti-choking device can waste valuable time, the agency said

]]>
HealthDay News — The US Food and Drug Administration is advising people to use the Heimlich maneuver to aid a choking victim and not rely on over-the-counter anti-choking devices.

“The safety and effectiveness of over-the-counter anti-choking devices have not been established; they are not FDA approved or cleared,” the agency said in a safety communication issued Monday.

The FDA admitted that it is “not aware of any serious injuries reported with the use of these devices, and no deaths have been associated with the use of anti-choking devices.” However, the agency is concerned that fumbling with these one-use-only devices could cost precious time in an emergency.

The leading device, the $70 LifeVac, comes with a mask that fits over a person’s nose or mouth and attaches to a plunger-like bellows. Pushing the bellows down and then quickly up creates a vacuum to clear the airway.

The LifeVac website contains a “Hall of Saves” presenting thousands of cases in which the device has saved a child or adult from choking, as well as a page devoted to medical journal articles about the gadget.

The company informs consumers that the LifeVac is “FDA registered as a Class II medical device,” adding that “it is exempt from premarket clearance. The FDA does not require a premarket review of the LifeVac device. Currently, in the United States, all portable suction devices are required to be registered with the FDA, not approved.”

Still, the FDA says people should not rely on these devices because established choking rescue protocols, which rely on the Heimlich, “have a high rate of success and can be carried out immediately without devices, saving valuable time.”

More Information

]]>
Guidelines Developed for Respiratory Management of Neuromuscular Disease https://www.empr.com/home/news/guidelines-developed-for-respiratory-management-of-neuromuscular-disease/ Fri, 17 Mar 2023 12:59:00 +0000 https://www.empr.com/?p=193202 Lungs Heart

Pulmonary function tests may be beneficial every six months, may be of use in initiating noninvasive ventilation when indicated

]]>
Lungs Heart

HealthDay News — In an American College of Chest Physicians clinical practice guideline and expert panel report, published online March 13 in CHEST, recommendations are presented for the respiratory management of patients with neuromuscular disease (NMD), including the use of pulmonary function testing every 6 months and initiating noninvasive ventilation (NIV) when clinically indicated.

Akram Khan, MD, from the Oregon Health & Science University in Portland, and colleagues developed recommendations to address the respiratory management of NMD. Fifteen graded recommendations, one good practice statement, and one consensus-based statement were generated based on 128 studies.

The authors note that there is limited evidence of best practices for respiratory management in NMD, which is mainly based on observational data in amyotrophic lateral sclerosis. Pulmonary function tests every six months may be beneficial and have use for initiation of NIV when clinically indicated. Patients with chronic respiratory failure and sleep-disordered breathing related to NMD may benefit from an individualized approach to NIV. Polysomnography or overnight oximetry can help guide initiation of NIV, when resources allow. The authors also provide guidance for mouthpiece ventilation, transition to home mechanical ventilation, salivary secretion management, and airway clearance therapies.

“Respiratory muscle weakness is a serious concern in patients with neuromuscular diseases. It can lead to inadequate ventilation, nighttime hypoventilation and the inability to mobilize secretions, which is frequently the cause of death in this population,” Khan said in a statement. “We anticipate this guideline will standardize and improve the care provided to patients with neuromuscular diseases and subsequent weakness.”

Financial ties to Cytokinetics and Biogen were disclosed.

Abstract/Full Text (subscription or payment may be required)

]]>
Heat-Related Deaths Could Break Records This Year in Phoenix, America’s Hottest City https://www.empr.com/home/news/heat-related-deaths-could-break-records-this-year-in-phoenix-americas-hottest-city/ Tue, 26 Sep 2023 13:02:00 +0000 https://www.empr.com/?p=207286

Roughly 75% of Maricopa County's confirmed heat deaths were at bus stops, in yards, driveways, parking lots, and parks.

]]>

HealthDay News — Phoenix, already the hottest major city in the nation, experienced its most scorching summer on record this year, new data show. And that will likely prompt the highest number of heat-associated deaths ever reported in the city in one year.

At this point, Maricopa County public health officials have confirmed 289 heat-associated deaths, the Associated Press reported. As of September 16, another 262 deaths are under investigation for being heat-associated.

Amid a historic heat wave from Texas across New Mexico and Arizona to the California desert, Phoenix had its three hottest months since record-keeping started in 1895. July had a 31-day streak of days that were at or above 110 degrees Fahrenheit. In 1974, the previous record of 18 straight days was set. For June, July, and August, the daily average temperature in this huge metro area was 97 degrees F, up from 96.7 degrees F three years ago, the AP reported.

It can take weeks and months to confirm whether deaths were heat-related. By this same time last year, there were 80 fewer confirmed heat-associated deaths and 46 fewer under investigation. In late 2022, the county had confirmed 378 heat-associated deaths, but that swelled to 425 after investigations concluded.

Roughly 75% of Maricopa County’s confirmed heat deaths were at bus stops, in yards, driveways, parking lots, and parks. Another 74 deaths happened indoors, including 63 in homes where air conditioning was not working or on, the AP reported. About 44% of the deaths were among people who were homeless.

Phoenix is hot even now, but temperatures have been gradually dropping, mostly below 100 degrees F, with some variation, the AP reported.

Associated Press Article

]]>
Indigenous Children Continue to Experience High Rates of RSV https://www.empr.com/home/news/indigenous-children-continue-to-experience-high-rates-of-rsv/ Mon, 17 Jul 2023 13:00:00 +0000 https://www.empr.com/?p=200659

Annual respiratory syncytial virus-associated hospitalization rates varied from 35.7 to 132.3 per 1000 children aged younger than 6 months.

]]>

HealthDay News — American Indian/Alaska Native (AI/AN) children experience high rates of respiratory syncytial virus (RSV)-associated acute respiratory illness (ARI) hospitalization, according to a study published online July 14 in Pediatrics.

Jessica E. Atwell, PhD, MPH, from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues conducted active, facility-based surveillance for ARI among hospitalized AI/AN children in November 2019 to May 2020. A total of 324 children younger than 5 years old from Chinle, Arizona (Navajo Nation); Whiteriver, Arizona (White Mountain Apache Tribal lands); and Anchorage and the Yukon-Kuskokwim (YK) Delta regions of Alaska who met the World Health Organization case definition for extended severe ARI were enrolled.

The researchers found that 53% of the children tested RSV-positive. One-third of RSV-associated hospitalizations occurred in infants younger than 6 months. The mean length of stay varied from 3.5 to 5.7 days (Chinle and YK Delta, respectively) among those who were RSV-positive, and use of supplemental oxygen varied from 70 to 100% (Anchorage and Whiteriver, respectively). Per 1000 children younger than 6 months old, the annual RSV-associated hospitalization rates ranged from 35.7 to 132.3 for Anchorage and YK Delta, respectively. For children younger than 5 years old, the rates ranged from 7.7 to 32.7 for Anchorage and YK Delta, respectively.

“These findings show that AI/AN children continue to experience high rates of RSV-associated ARI hospitalization,” the authors write. “Improvements in the socioeconomic determinants of health for AI/AN children and RSV-prevention products are urgently needed.”

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text

]]>
Inspire Therapy Approved for OSA in Pediatric Patients With Down Syndrome https://www.empr.com/home/news/medical-technology/inspire-therapy-approved-for-osa-in-pediatric-patients-with-down-syndrome/ Tue, 21 Mar 2023 15:00:00 +0000 https://www.empr.com/?p=193527 Inspire therapy is a fully implanted neurostimulation device that consists of a small generator, a sensing lead, and a stimulation lead.]]>

The Food and Drug Administration (FDA) has expanded the approval of Inspire therapy to include pediatric patients 13 years of age and older with Down syndrome who have obstructive sleep apnea (OSA) with an apnea hypopnea index between 10 and 50, and do not have the ability to benefit from continuous positive airway pressure (CPAP). Previously, the therapy was only approved for adults 18 years of age and older.

Inspire therapy is a fully implanted neurostimulation device that consists of a small generator, a sensing lead, and a stimulation lead. The device is placed under the skin of the neck and chest during a same-day, outpatient procedure. The device senses breathing patterns and mildly stimulates key airway muscles to keep the airway open during sleep.

The safety and effectiveness of Inspire was evaluated in a clinical trial that included 42 patients with Down syndrome and persistent severe OSA (ClinicalTrials.gov Identifier: NCT02344108). Findings showed that upper airway stimulation was safely performed in these patients and resulted in high rates of response and improved quality of life.

“When the first study of this device was published on adults, I realized it could potentially help kids with Down syndrome,” said study investigator Dr Christopher Hartnick, Director, Pediatric Airway, Voice, and Swallowing Center in the Division of Pediatric Otolaryngology at Mass Eye and Ear in Boston. “Through the years, we have been able to leverage the technology and lead a series of clinical trials that have provided the necessary safety and efficacy data to gain the FDA approval. This is a very important step in our treatment pathways for these children who are disproportionately impacted by obstructive sleep apnea and have few treatment options.”

]]>
March 2024: Notable Drug Approvals https://www.empr.com/general-medicine/march-2024-notable-drug-approvals/ Thu, 11 Apr 2024 19:03:36 +0000 https://www.empr.com/?p=218573

Drug

Pharmacologic Class

Indication

More Information

Cardiovascular Disease
Opsynvi (macitentan and tadalafil) An endothelin receptor antagonist and a phosphodiesterase 5 inhibitor Treatment of pulmonary arterial hypertension in adult patients of WHO functional class II-III. Opsynvi, a Single-Tablet Combo Therapy for PAH, Gets FDA Approval
Praluent (alirocumab) Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor As an adjunct to diet and other low density lipoprotein cholesterol-lowering therapies in pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia to reduce LDL-C. Praluent Approved for Pediatric Patients With Heterozygous Familial Hypercholesterolemia
Tryvio (aprocitentan) Endothelin receptor antagonist Treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. FDA Approves Tryvio for Patients With Resistant Hypertension
Wegovy (semaglutide) Glucagon-like peptide-1 receptor agonist To reduce the risk of major adverse cardiovascular events including cardiovascular death, nonfatal myocardial infarction or nonfatal stroke in adults with established cardiovascular disease and either overweight or obesity. Wegovy Approved to Reduce MACE Risk in Obese, Overweight Adults
Winrevair (sotatercept-csrk) Recombinant activin receptor type IIA-Fc fusion protein Treatment of adults with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. Winrevair Approved for Pulmonary Arterial Hypertension
Dermatological Disorders
Letybo (letibotulinumtoxinA-wlbg) Acetylcholine release inhibitor and a neuromuscular blocking agent Treatment of moderate to severe glabellar lines in adults. Letybo Approved to Treat Moderate to Severe Glabellar Lines
Spevigo (spesolimab-sbzo) Interleukin-36 receptor antagonist Treatment of generalized pustular psoriasis in adult and pediatric patients 12 years of age and older and weighing at least 40kg. Spevigo Gets Expanded Approval for Generalized Pustular Psoriasis
Gastrohepatic Disorders
Livmarli (maralixibat) Ileal bile acid transporter inhibitor Treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis. Livmarli Approved for Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis
Rezdiffra (resmetirom) Thyroid hormone receptor-β selective agonist Treatment of adults with noncirrhotic nonalcoholic steatohepatitis with moderate to advanced liver fibrosis. FDA Approves Rezdiffra for Nonalcoholic Steatohepatitis With Liver Fibrosis
Hematologic Disorders
Vafseo (vadadustat) Hypoxia-inducible factor prolyl hydroxylase inhibitor Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least 3 months. Vafseo Approved for Anemia Due to CKD in Patients on Dialysis
Infectious Diseases
Edurant PED (rilpivirine) Non-nucleoside reverse transcriptase inhibitor Treatment of HIV-1 in combination with other antiretroviral agents in treatment-naïve children 2 years of age and older, weighing at least 14kg with HIV-1 RNA less than or equal to 100,000 copies/mL. Edurant PED Approved for Pediatric Patients With HIV-1
Metabolic Disorders
Lenmeldy (atidarsagene autotemcel) Autologous hematopoietic stem cell-based gene therapy Treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy Lenmeldy Approved for Children With Metachromatic Leukodystrophy
Musculoskeletal Disorders
Duvyzat (givinostat) Histone deacetylase inhibitor Treatment of patients 6 years of age and older with Duchenne muscular dystrophy. Duvyzat, a Nonsteroidal Treatment for Duchenne Muscular Dystrophy, Gets FDA Approval
Jubbonti (denosumab-bbdz) RANK ligand inhibitor To treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. FDA Approves Denosumab Biosimilars Jubbonti and Wyost
Tyenne (tocilizumab-aazg) Interleukin-6 receptor antagonist To treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs; adults with giant cell arteritis; and patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis. FDA Approves Tocilizumab Biosimilar for IV and Subcutaneous Administration
Neurologic Disorders
Ultomiris (ravulizumab-cwvz)
Long-acting C5 complement inhibitor
Treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive. FDA Approves Ultomiris for Neuromyelitis Optica Spectrum Disorder
Oncology
Besponsa (inotuzumab ozogamicin)
CD22-directed antibody and cytotoxic drug conjugate
Treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia in pediatric patients 1 year and older. Besponsa Approved for Pediatric Patients With Acute Lymphoblastic Leukemia
Breyanzi (lisocabtagene maraleucel)
CD19-directed genetically modified autologous T-cell immunotherapy
Treatment  of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase  inhibitor and a B-cell lymphoma 2 inhibitor. CAR T-Cell Therapy Breyanzi Approved for Relapsed/Refractory CLL or SLL
Brukinsa (zanubrutinib)
Bruton tyrosine kinase inhibitor
Treatment of relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy. Brukinsa Gets Accelerated Approval for Relapsed, Refractory Follicular Lymphoma
Elahere (mirvetuximab soravtansine-gynx)
Folate receptor alpha-directed antibody and microtubule inhibitor conjugate
Treatment of adults with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens. Elahere Gets Full Approval for Platinum-Resistant Ovarian Cancer
Iclusig (ponatinib)
Kinase inhibitor
Treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy. Iclusig Plus Chemotherapy Gets Accelerated Approval for Newly Diagnosed Ph+ ALL
Opdivo (nivolumab)
Programmed death receptor-1 blocking antibody
In combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma. Opdivo Plus Chemotherapy Approved for First-Line Tx of Urothelial Carcinoma
Rybrevant (amivantamab-vmjw)
Bispecific EGF and MET receptor-directed antibody
Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test. Rybrevant Combo Approved as First-Line Tx for NSCLC With EGFR Exon 20 Insertion Mutations
Tevimbra (tislelizumab)
Programmed death receptor-1 blocking antibody
Treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a programmed death-ligand 1 inhibitor. Tevimbra Approved for Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Wyost (denosumab) RANK ligand inhibitor To prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. FDA Approves Denosumab Biosimilars Jubbonti and Wyost
Respiratory Disorders
Xhance (fluticasone propionate)
Corticosteroid
Treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. Xhance Approved for Chronic Rhinosinusitis Without Nasal Polyps

]]>
Maternal COVID-19 Vaccination May Reduce Neonatal Respiratory Distress https://www.empr.com/home/news/maternal-covid-19-vaccination-may-reduce-neonatal-respiratory-distress/ Thu, 25 Jan 2024 14:00:00 +0000 https://www.empr.com/?p=214481 The odds of neonatal respiratory distress were higher for unvaccinated mothers versus those vaccinated before infection.

]]>
HealthDay News — Maternal COVID-19 vaccination is associated with reduced frequency of neonatal respiratory distress (RD), according to a study published online January 24 in Nature Communications.

Olivia M. Man, from the David Geffen School of Medicine at the University of California in Los Angeles, and colleagues examined the association between maternal COVID-19 vaccination and neonatal RD using a longitudinal cohort of mother-infant pairs. The study included 221 mothers with laboratory-confirmed SARS-CoV-2 during pregnancy and 227 exposed fetuses.

The researchers found that SARS-CoV-2-exposed uninfected (SEU) infants had unusually high rates of RD (17%), with an odds ratio of 3.06 for RD in term neonates born to unvaccinated individuals compared with those born to individuals vaccinated before maternal infection. A robust inflammatory response associated with ciliary dysregulation and enhanced immunoglobulin E production was seen in a proteomic analysis among SEU infants with RD.

“Maternal vaccination against COVID-19 reduced maternal disease severity and the frequency of neonatal RD. Pregnant persons should be encouraged to receive mRNA COVID-19 vaccines, regardless of history of prior COVID-19 infection,” the authors write. “More research is needed to understand the impact of maternal COVID-19 vaccination on long-term infant health and development, including chronic pulmonary conditions.”

Abstract/Full Text

]]>
Merck’s 21-Valent Pneumococcal Conjugate Vaccine Gets FDA’s Priority Review https://www.empr.com/home/news/drugs-in-the-pipeline/mercks-21-valent-pneumococcal-conjugate-vaccine-gets-fdas-priority-review/ Tue, 19 Dec 2023 18:15:00 +0000 https://www.empr.com/?p=212807 The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for V116, an investigational 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older.

The application is supported by data from several phase 3 studies in the V116 clinical development program. Specifically, the STRIDE-3  (ClinicalTrials.gov Identifier: NCT05425732) and STRIDE-6 (ClinicalTrials.gov Identifier: NCT05420961) studies, which evaluated the safety and immunogenicity of V116 in pneumococcal vaccine-naïve adults and adults 50 years of age and older who previously received a pneumococcal vaccination at least 1 year prior to study enrollment (n=717), respectively.

Findings from both studies demonstrated that V116 elicited robust immune responses in vaccine-naïve and previously vaccinated individuals. Among vaccine-naïve adults in STRIDE-3, V116 elicited noninferior immune responses compared with PCV20 (pneumococcal 20-valent conjugate vaccine) for serotypes common to both vaccines. The safety profile of V116 was comparable to the comparators (PCV20, PCV15 [pneumococcal 15-valent conjugate vaccine], or PPSV23 [pneumococcal 23-valent vaccine]) in both studies.

The Company will share additional findings from clinical trials at future congresses. A clinical program overview of V116 can be found here.

“If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease,” said Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We look forward to discussing the data that support our filing with the FDA and are working with urgency to bring this potential new preventative measure to adult patients.”

A Prescription Drug User Fee Act target date of June 17, 2024 has been set for the application.

The FDA previously granted Breakthrough Therapy designation to V116 for this indication.

]]>
Motavizumab, Nirsevimab, Palivizumab Beneficial for RSV Prevention https://www.empr.com/home/news/motavizumab-nirsevimab-palivizumab-beneficial-for-rsv-prevention/ Wed, 08 Mar 2023 14:00:00 +0000 https://www.empr.com/?p=192619

Significant reductions seen in RSV-related infections, RSV-related hospitalizations for three monoclonal antibodies versus placebo

]]>

HealthDay News — Significant benefits are seen with motavizumab, nirsevimab, and palivizumab for prevention of respiratory syncytial virus (RSV) in infants and children, according to a review published online February 17 in JAMA Network Open.

Mingyao Sun, from The First Hospital of Lanzhou University in China, and colleagues conducted a systematic review and network meta-analysis to compare the efficacy and safety of monoclonal antibodies for prevention of RSV infection in infants and children. Data were included from 15 randomized clinical trials involving 18,395 eligible participants; data from 14 trials with 18,042 participants were synthesized.

The researchers found that based on moderate- to high-certainty evidence, nirsevimab, palivizumab, and motavizumab were associated with significantly reduced RSV-related infections (−123, −108, and −136 infections per 1000 participants, respectively) and RSV-related hospitalizations (−54, −39, and −48 per 1000 participants, respectively) compared with placebo. Both motavizumab and palivizumab were associated with significant reductions in intensive care unit admissions (−8 and −5 per 1000 participants, respectively) and supplemental oxygen use (−59 and −55 per 1,000 participants), and nirsevimab was associated with significantly reduced supplemental oxygen use (−59 per 1000 participants) based on moderate-certainty evidence. All-cause mortality and drug-related adverse events did not differ significantly between the groups. No significant benefits for the outcomes of interest were seen for suptavumab.

“These findings suggest that motavizumab, nirsevimab, and palivizumab are associated with reduced rates of RSV infections and hospitalizations,” the authors write. “Similar results were observed in the rate of supplemental oxygen use.”

Abstract/Full Text

]]>