ALZHEIMER DISEASE

AAN's ethical guidance on recently approved aducanumab

The controversial approval of Alzheimer disease drug, aducanumab, by the US FDA has prompted The American Academy of Neurology (AAN) to issue a position statement in a special Neurology article. This statement was developed by a joint committee between the AAN and the Child Neurology Society called the Ethics, Law, and Humanities Committee. AAN President Orly Avitzur, MD, summarizes the methods and goals of the statement: "Using ethical principles to create this position statement, the AAN aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care." Furthermore, Winston Chiong, MD, University of California San Francisco, who authored the statement, expressed some concerns: "This is a high-cost drug that was approved by the FDA without convincing evidence of benefits and with known harms, so the purpose of this position statement is to offer ethical guidance on how neurologists can help patients make informed decisions about this treatment."

Throughout the paper, Chiong stresses the importance of clear communication between clinicians and potential participants about the risks of drug trials. Regarding aducanumab, the position statement dissects key study elements such as results, safety, adverse reactions, study characteristics, and price of the drug. Although aducanumab does not restore cognitive function, it was successful in reducing beta-amyloid plaques. When present in abnormal levels, these plaque buildups between neurons can disrupt cell function. Conversely, Chiong emphasizes the risk of brain inflammation, brain microhemorrhages, and brain hemorrhage from aducanumab treatment. The drug is estimated to cost over $100,000 per year.

The AAN position statement expresses concern about the trial as well. It discloses that aducanumab was approved by the FDA based on two studies that showed little to no benefit for patients. Further research is needed to better understand how the various forms of beta-amyloid influence Alzheimer disease. Additionally, there is still significant research and clinical trials to perform on aducanumab when treating the incurable, progressive neurologic disorder.

https://dgnews.docguide.com/aan-issues-ethical-guidance-aducanumab

RESPIRATORY TRACT INFECTIONS

Cold season: Is zinc effective?

Jennifer Hunter, PhD, BMed, of Western Sydney University's NICM Health Research Institute in New South Wales, Australia, and colleagues recently conducted a meta-analysis of 28 randomized controlled trials on the effectiveness of zinc against colds, but not COVID-19. The trials included 5,446 adults who had received zinc in a variety of formulations and methods including oral, sublingual, and nasal spray. The researchers analyzed whether zinc prevented or treated respiratory tract infections. Results reveal cold symptoms resolved 2 days earlier with sublingual or intranasal zinc compared with placebo. Additionally, participants who used sublingual or topical nasal zinc early in the course of illness were 1.8 times more likely to recover than those who used a placebo.

Despite these promising results, Hunter pointed out that zinc might not reduce the risk of developing a cold because "it might well be that when inoculating people to make sure they get infected, you give them a really high dose of the virus. [This] doesn't really mimic what happens in the real world." It is also important to note that some studies have found severe and occasionally permanent loss of smell associated with the use of nasal gels or sprays containing zinc.

"Up until now, we all commonly thought that zinc's role was only for people who were zinc deficient," Hunter concluded, "and now we've got some signals pointing towards its potential role as an anti-infective and anti-inflammatory agent in people who don't have zinc deficiency."

While zinc is proven to be effective for children with diarrhea and may slightly shorten the duration of infections, more research should be performed to confirm the use of zinc treatment for colds. However, it can be used for short-term symptom relief in those not at risk for suboptimal zinc absorption.

http://www.mdedge.com/familymedicine/article/248410/infectious-diseases/does-zin

DRUG OVERDOSE

ED strategies to close prescription gaps

The CDC reported drug overdoses in America have increased 28.5% between April 2020 and April 2021. Despite this jump, a Michigan Medicine study published in Annals of Emergency Medicine found most patients treated for opioid overdoses in EDs don't receive naloxone and buprenorphine. The study team analyzed 149,000 ED visits for opioid overdose between August 2019 and April 2021. The data revealed a large gap in ED and follow-up care, with only 8.5% of patients receiving buprenorphine for opioid addiction and 7.4% receiving overdose rescue prescription, naloxone.

After reviewing these findings, Kao-Ping Chua, MD, PhD, lead author of the study and assistant professor of pediatrics at Michigan Medicine, urges clinicians to increase prescriptions. "In light of the record levels of opioid overdose deaths, the low levels of naloxone and buprenorphine prescribing are simply unacceptable," Chua said. "Clinicians are missing critical opportunities to save lives both in the emergency department and during follow-up after overdose visits."

"The same standard we use in caring for patients after anaphylaxis and preparing them with a potentially life-saving prescription should also be applied to patients after an opioid overdose," noted Keith Kocher, MD, MPH, senior author of the paper and associate professor of emergency medicine at Michigan Medicine. "There are several points of intervention along a path to reducing potential harm after an overdose," he added. "The emergency department has a role to play, as do providers in the outpatient setting. These may not always be the same solutions in every setting or community, but the bottom line is that we need to do better."

Both Chua and Kocher recommend that due to challenges with obtaining buprenorphine waivers, emergency physicians should at least prescribe naloxone to patients. Aside from their study, the group also created ED guides and training sessions to assist physicians and help them prepare to prescribe buprenorphine while meeting federal requirements. They have also provided thousands of free naloxone kits for EDs and created lists of pharmacies that have "standing orders" for naloxone in many Michigan counties, which allow patients to access the drug without a prescription.

https://labblog.uofmhealth.org/lab-report/less-than-10-of-opioid-overdose-patien

COVID-19 TREATMENT

Dexamethasone aids COVID-19 recovery in males

A new study from the University of Calgary reveals how anti-inflammatory drug, dexamethasone, drastically improves COVID-19 infections in males versus females. The multidisciplinary study published in Nature Medicine and led by Jeff Biernaskie, PhD, professor, Comparative Biology and Experimental Medicine in the Faculty of Veterinary Medicine, and Bryan Yipp, MD, associate professor, Department of Critical Care Medicine, Cumming School of Medicine, researched thousands of ICU patients' immune responses to the drug. To tackle the unsettling observation and many unanswered questions in relation to COVID-19, Yipp and Biernaskie sought to better understand how the steroid mostly helped males. The study was supported by the Thistledown Foundation and by the Calgary Firefighters Burn Treatment Society.

In the investigation, RNs, NPs, clinicians, and physicians collected blood samples from both patients with and without COVID-19 who were admitted to Calgary ICUs in severe respiratory distress. Using single-cell RNA sequencing and bioinformatics techniques, researchers documented cellular behaviors at different stages and measured treatment effects.

"We found that the males derived benefit from the steroids, and the females, at both the cellular level and at the population level, received limited benefit," Yipp noted.

"What we found was that specifically in males, we see an exaggerated neutrophil interferon response, that is significantly restrained when a patient is given dexamethasone," Biernaskie elaborated. "But with females, relative to males, their neutrophil interferon response was much more tempered, so dexamethasone had little effect." Yipp and Biernaskie believe it's important to find effective COVID-19 treatments for both males and females.

http://www.ucalgary.ca/news/ucalgary-study-shows-why-drug-used-treat-critically-