New therapy reduces chronic low back pain in large international study

A new study has found that tanezumab, a monoclonal antibody that inhibits nerve activity, provides relief in patients with chronic low back pain, one of the leading reasons why people seek medical care and the number one cause of disability worldwide.
“This demonstration of efficacy is a major breakthrough in the global search to develop non-opioid treatments for chronic pain,” said John Markman, M.D., director of the Translational Pain Research Program in the University of Rochester Medical Center (URMC) Department of Neurosurgery and lead author of the study which appears in the journal Pain. “There were also improvements in function linked to the reduction in pain severity.”
This is the first study that shows long-term relief for chronic low back pain with a single dose of tanezumab delivered under the skin once every two months. The study was conducted in 191 sites across eight countries in North America, Europe, and Asia.
Researchers are increasingly finding that certain proteins circulating in the bloodstream heighten the sensitivity of cells in the nervous system to pain. One of these proteins, called nerve growth factor (NGF), may explain why some individuals experience more intense and chronic back pain. Tanezumab is an NGF inhibitor.
The patients with chronic low back pain enrolled in this study did not previously have relief with at least three different types of pain medication, including opioids, and were considered “difficult-to-treat.” Patients with symptoms, signs, and x-ray evidence of moderate-to-severe osteoarthritis, a disorder commonly found in older patients with chronic low back pain, were excluded from the study.
Tanezumab has not been associated with the often serious adverse side effects seen with opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), which are often used to treat low back pain. However, this class of drugs has been linked to joint problems, which are sometimes serious enough to require joint replacement. Because of this concern, the researchers followed participants for an extended period and determined there was a low rate of serious joint problems requiring joint replacement.
“In the future, clinicians may have to weigh the different risks of lumbar fusion surgery, chronic opioid use, or NSAIDs against the unique risks of a rare but rapidly progressive form of joint problem associated with blocking nerve growth factor,” said Markman. “I expect that that the tradeoffs between benefit and risk will be different for osteoarthritis than for chronic low back pain.”

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Additional co-authors on the study include Robert Bolash with the Cleveland Clinic, Timothy McAlindon with Tufts Medical Center, Alan Kivitz with the Altoona Center for Clinical Research, Manuel Pombo-Suarez with University of Santiago, Spain, Seiji Ohtori with Chiba University, Japan, Frank Roemer with Boston University, David Li, Candace Bramson, Christine West, and Kenneth Verbug with Pfizer, and Lars Vikrup with Eli Lilly & Company. The study was funded by Pfizer and Eli Lilly & Company. Markman has received consulting fees from Eli Lilly and Pfizer and has previously received funding support for unrelated research from Pfizer.
https://www.eurekalert.org/pub_releases/2020-06/uorm-ntr061720.php

Smartphone app uses voice recordings to detect fluid in the lungs

Voice analysis by a smartphone app identifies lung congestion in heart failure patients, allowing early intervention before their condition deteriorates. The small study is presented today on HFA Discoveries, a scientific platform of the European Society of Cardiology (ESC).1
“Speech is personal and as such, very small changes (related to the same person) can be detected – for example, the ability of parents to notice health issues by listening to their kids,” said study author Professor Offer Amir, director of the Heart Institute, Hadassah Medical Centre, Jerusalem, Israel. “Today we report results of the first easy to use, non-invasive, personalised heart failure monitoring device. It requires a simple 30-second recording each day, in any language.”
Heart failure is one of the leading causes of morbidity and mortality, affecting more than 26 million people worldwide, and is the leading cause of hospitalisation in the US and Europe. Tight surveillance of patients could reduce related hospitalisations and deaths.
In patients with heart failure, the pumping function of the heart is not working as it should. The most common symptom is shortness of breath, which is caused by water congestion in the lungs. Congestion can be life-threatening and early identification is crucial.
Lung congestion causes subtle changes in speech patterns, which may be a tool for assessing clinical status. Speech processing is currently used in a number of ways, for example converting text to speech and automatic voice recognition. This study examined the ability of a novel mobile application to distinguish between congested and non-congested states.2
The study included 40 patients admitted to hospital with acute heart failure and lung congestion. Patients were asked to record five sentences into a standard smartphone upon admission and then again just prior to discharge when they were no longer congested. The duration of each recording was 2-5 seconds. The researchers found that the technology successfully distinguished between the congested state at admission and the non-congested state at discharge.
Professor Amir said the system could be used to monitor heart failure patients at home. Physicians prescribe the app, patients download it to their smartphone and submit voice recordings when they feel well so the app can create a personalised “healthy” model. Each day patients add a recording, which the app compares to the healthy model. Small deviations denoting the start of fluid accumulation generate an alert, which physicians pick up from a designated web portal.
“Those with early signs of lung congestion could receive adjustments to their treatment, thereby preventing the need for hospitalisation,” said Professor Amir. “As more speech samples are obtained, the model becomes increasingly sensitive to changes.”
He added: “During the current COVID-19 pandemic healthcare professionals are transitioning many outpatient visits for heart failure patients to telemedicine platforms, highlighting the importance of remote monitoring to reduce the risk of exposure to coronavirus.”
Funding: The study was funded by Cordio Medical Ltd.
Disclosures: Offer Amir serves as a medical consultant for Cordio Medical Ltd.
References and notes
1Abstract title: Speech analysis to evaluate acute heart failure patient clinical status.
2The app is called Cordio HearO™.
https://www.eurekalert.org/pub_releases/2020-06/esoc-sau061920.php

Novartis stops hydroxychloroquine clinical trial

Novartis (NYSE:NVS) says it is discontinuing its clinical trial of hydroxychloroquine as a treatment for COVID-19 patients after struggling to find participants.

The company started the trial in April and wanted to test the drug in 440 hospitalized patients, but enrollment was so slow that the clinical team would have been unlikely to collect meaningful data in a reasonable timeframe.

Novartis’ move follows this week’s U.S. Food and Drug Administration decision to revoke emergency use authorization for hydroxychloroquine against COVID-19, saying it was unlikely to help patients.

https://seekingalpha.com/news/3584737-novartis-stops-hydroxychloroquine-clinical-trial

NYU Langone creates virtual service to access cancer specialists

June 19, 2020

New York University Langone Health in New York City launched a service that will enable people to connect with cancer specialists virtually.

Dubbed the Suspicion of Cancer Virtual Clinic, the service enables new or existing patients to schedule a video visit with an oncology nurse practitioner. They can discuss their symptoms with the nurse practitioner, who then guides them on next steps. The nurse practitioner can schedule a follow-up video visit with a medical oncologist, hematologist, radiation oncologist or surgical oncologist, if needed.

“Cancer doesn’t stop just because we are in the middle of a global pandemic,” said Benjamin G. Neel, MD, PhD, director of NYU Langone’s Perlmutter Cancer Center. “With this new service, we want to make sure that people receive the diagnosis or care they need, especially during this challenging time.”

https://www.beckershospitalreview.com/oncology/nyu-langone-creates-virtual-service-to-access-cancer-specialists.html

Unique COVID-19 strain circulates in Chicago

A unique strain of COVID-19 is circulating in Chicago that may have infection characteristics that are different from the most common strain spreading worldwide, according to new research from Chicago-based Northwestern Medicine.

For the study, which has not yet been peer-reviewed, researchers genetically sequenced residual specimens from 88 patients tested for COVID-19 between March 14 and March 21. Preliminary results show some patients were infected with a COVID-19 strain linked to the early outbreak in China.

Others were infected with a strain commonly found in New York that appears to be the most dominant strain worldwide. Patients with this strain often have more virus present in their upper airways than those infected with the Chicago strain.

“This is the first clear evidence that genetic differences in the viruses are associated with differences in the characteristics of the infections that they cause,” lead author Egon Ozer, MD, PhD, a physician and assistant professor of infectious diseases at Northwestern University Feinberg School of Medicine, said in a press release emailed to Becker’s.

Chicago has become a “melting pot” for different COVID-19 strains since it is a major U.S. transportation hub, according to Dr. Ozer. He said the study’s findings could help guide vaccination strategies against the virus.

https://www.beckershospitalreview.com/public-health/unique-covid-19-strain-circulates-in-chicago.html

Loneliness has not increased among Americans during pandemic – study

The COVID-19 pandemic has not resulted in an uptick in loneliness among Americans, according to new research.

The research involves analysis of responses to three waves of a survey conducted by the American Psychological Association. The first wave was in late January and early February, before the pandemic began, as part of a study on loneliness, personality and health. The second wave was in March, after social-distancing recommendations had been issued. The third wave was in late April after most states had issued stay-at-home orders.

Overall, 1,545 Americans completed all three surveys.

Researchers found that there was no significant change in mean levels of loneliness across the three waves of the survey.

People in at-risk groups, including people living alone and those with chronic health conditions, reported feeling lonelier than other groups in the first survey, but their loneliness levels did not increase in the second and third waves of the survey, researchers said.

“We were surprised by the overall remarkable resilience in response to COVID-19,” said Martina Luchetti, PhD, study lead author and an assistant professor at the Florida State University College of Medicine in Tallahassee.

The study was published in the journal American Psychologist.

https://www.beckershospitalreview.com/public-health/loneliness-has-not-increased-among-americans-during-pandemic-study-finds.html

Fresenius Medical Care to Open 100 New Care Units in North America

Fresenius Medical Care AG & Co. KGaA said Friday that it will open 100 new transitional care units for kidney patients in North America.

The German health provider–which already has 65 transitional care units in operation–said the new units are designed to assist patients manage their care at home.

https://www.marketscreener.com/FRESENIUS-MEDICAL-CARE-AG-436087/news/Fresenius-Medical-Care-to-Open-100-New-Care-Units-in-North-America-30796207/