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Saturday, September 10, 2022

Hip Fractures Likely to Double by 2050 as Population Ages

 The annual incidence of hip fractures declined in most countries from 2005 to 2018, but this rate is projected to roughly double by 2050, according to a new study of 19 countries/regions.

The study by Chor-Wing Sing, PhD, and colleagues was presented on September 9 at the American Society of Bone and Mineral Research (ASBMR) 2022 Annual Meeting. The predicted increase in hip fractures is being driven by the aging population, with the population of those age 85 and older projected to increase 4.5-fold from 2010 to 2050, they note.

The researchers also estimate that from 2018 to 2050 the incidence of fractures will increase by 1.9-fold overall — more in men (2.4-fold) than in women (1.7-fold).

In addition, rates of use of osteoporosis drugs 1 year after a hip fracture were less than 50%, with less treatment in men. Men were also more likely than women to die within 1 year of a hip fracture.

The researchers conclude that "larger and more collaborative efforts among healthcare providers, policymakers, and patients are needed to prevent hip fractures and improve the treatment gap and post-fracture care, especially in men and the oldest old."

Aging Will Fuel Rise in Hip Fractures; More Preventive Treatment Needed

"Even though there is a decreasing trend of hip fracture incidence in some countries, such a percentage decrease is insufficient to offset the percentage increase in the aging population," senior co-author Ching-Lung Cheung, PhD, associate professor in the Department of Pharmacology and Pharmacy at the University of Hong Kong, explained to Medscape Medical News.

The takeaways from the study are that "a greater effort on fracture prevention should be made to avoid the continuous increase in the number of hip fractures," he said.

In addition, "although initiation of anti-osteoporosis medication after hip fracture is recommended in international guidelines, the 1-year treatment rate [was] well below 50% in most of the countries and regions studied. This indicates the treatment rate is far from optimal."

"Our study also showed that the use of anti-osteoporosis medications following a hip fracture is lower in men than in women by 30% to 67%," he said. "Thus, more attention should be paid to preventing and treating hip fractures in men."

"The greater increase in the projected number of hip fractures in men than in women "could be [because] osteoporosis is commonly perceived as a 'woman's disease,'" he speculated.

Invited to comment, Juliet Compston, MD, who selected the study as one of the top clinical science highlight abstracts at the ASBMR meeting, agrees that "there is substantial room for improvement" in osteoporosis treatment rates following a hip fracture "in all the regions covered by the study."

"In addition," she continues, "the wide variations in treatment rates can provide important lessons about the most effective models of care for people who sustain a hip fracture, for example, fracture liaison services."

Men Suffer as Osteoporosis Perceived to Be a "Woman's Disease"

The even lower treatment rate in men than women is "concerning and likely reflect the mistaken perception that osteoporosis is predominantly a disease affecting women," notes Compston, emeritus professor of bone medicine, University of Cambridge, UK.  

Also invited to comment, Peter R. Ebeling, MD, outgoing president of the ASBMR, said that the projected doubling of hip fractures "is likely mainly due to aging of the population, with increasing lifespan for males in particular. However, increasing urbanization and decreasing weight-bearing exercise as a result are likely to also contribute in developing countries."

"Unfortunately, despite the advances in treatments for osteoporosis over the last 25 years, osteoporosis treatment rates remain low and osteoporosis remains undiagnosed in postmenopausal women and older men," added Ebeling, from Monash University, Melbourne, Victoria, Australia, who was not involved with the research.

"More targeted screening for osteoporosis would help," he said, "as would treating patients for it following other minimal trauma fractures (vertebral, distal radius, and humerus, etc) since if left untreated about 50% of these patients will have hip fractures later in life."

"Some countries may be doing better because they have health quality standards for hip fracture (eg, surgery within 24 hours, investigation and treatment for osteoporosis). In other countries like Australia, bone density tests and treatment for osteoporosis are reimbursed, increasing their uptake."

The public health implications of this study are "substantial" according to Compston. "People who have sustained a hip fracture are at high risk of subsequent fractures if untreated. There is a range of safe, cost-effective pharmacological therapies to reduce fracture rate, and wider use of these would have a major impact on the current and future burden imposed by hip fractures in the elderly population."

Similarly, Ebeling noted that "prevention is important to save a huge health burden for patients and costs for society."

"Patients with minimal trauma fractures (particularly hip or spinal fractures) should be investigated and treated for osteoporosis with care pathways established in the hospitals, reaching out to the community [fracture liaison services]," he said.

Support for these is being sought under Medicare in the United States, he noted, and bone densitometry reimbursement rates also need to be higher in the United States.

Projections for Number of Hip Fractures to 2050

Previous international reviews of hip fractures have been based on heterogeneous data from more than 10 to 30 years ago, the researchers note.

They performed a retrospective cohort study using a common protocol across 19 countries/region, as described in an article about the protocol published in BMJ Open.

They analyzed data from adults aged 50 and older who were hospitalized with a hip fracture to determine 1) the annual incidence of hip fractures in 2008-2015; 2) the uptake of drugs to treat osteoporosis at 1 year after a hip fracture; and 3) all-cause mortality at 1 year after a hip fracture.

In a second step, they estimated the number of hip fractures that would occur from 2030 to 2050, using World Bank population growth projections.

The data are from 20 healthcare databases from 19 countries/regions: Oceania (Australia, New Zealand), Asia (Hong Kong, Japan, Singapore, South Korea, Taiwan, and Thailand), Northern Europe (Denmark, Finland, and UK), Western Europe (France, Germany, Italy, The Netherlands, and Spain), and North and South America (Canada, United States, and Brazil).

The population in Japan was under age 75. US data are from two databases: Medicare (age ≥ 65) and Optum.

Most databases (13) covered 90% to 100% of the national population, and the rest covered 5% to 70% of the population.

From 2008 to 2015, the annual incidence of hip fractures declined in 11 countries/regions (Singapore, Denmark, Hong Kong, Taiwan, Finland, UK, Italy, Spain, United States [Medicare], Canada, and New Zealand).

"One potential reason that some countries have seen relatively large declines in hip fractures is better osteoporosis management and post-fracture care," said Chor‐Wing Sing in a press release issued by ASBMR. "Better fall-prevention programs and clearer guidelines for clinical care have likely made a difference."

Hip fracture incidence increased in five countries (The Netherlands, South Korea, France, Germany, and Brazil) and was stable in four countries (Australia, Japan, Thailand, and United States [Optum]).

The UK had the highest rate of osteoporosis treatment at 1-year after a hip fracture (50.3%). Rates in the other countries/regions ranged from 11.5% to 37%.

Fewer men than women were receiving drugs for osteoporosis at 1 year (range 5.1% to 38.2% versus 15.0% to 54.7%).

From 2005 to 2018, rates of osteoporosis treatment at 1 year after a hip fracture declined in six countries, increased in four countries, and were stable in five countries.

All-cause mortality within 1 year of hip fracture was higher in men than in women (range 19.2% to 35.8% versus 12.1% to 25.4%).

"Among the studied countries and regions, the US ranks fifth with the highest hip fracture incidence," Cheung replied when specifically asked about this. "The risk of hip fracture is determined by multiple factors, eg, lifestyle, diet, genetics, as well as management of osteoporosis," he noted.

"Denmark is the only country showing no projected increase, and it is because Denmark had a continuous and remarkable decrease in the incidence of hip fractures," he added, which "can offset the number of hip fractures contributed by the population aging."

The study was funded by Amgen. Sing and Leung have reported no relevant financial relationships. One of the study authors is employed by Amgen.

ASBMR 2022 Annual Meeting. Presented September 9, 2022. Abstract 1017.  

https://www.medscape.com/viewarticle/980485

Pharmacist-Led Hypertension Clinics Able to Lower BP Within Weeks

 Across the country, nurse- and pharmacist-led hypertension clinics consistently found it feasible to get blood pressures (BPs) at or close to goal quickly -- within a matter of weeks, even -- according to single-center reports.

In posters presented here at the annual Hypertension Scientific Sessions hosted by the American Heart Association, researchers reported success with these multidisciplinary hypertension clinics across a range of geographic settings:

  • Registered nurse (RN)- and pharmacist-led clinic in Bozeman, Montana: 74% of 321 patients met BP goal within 12 weeks, with systolic BP dropping from 141.8 to 133.4 mmHg
  • Pharmacist-run clinic in rural Appalachia: 38 patients saw average BP fall significantly from around 160/85 to 140/80 mmHg after 6 months
  • Pharmacist-led clinic in Boston: 29 people had BP go from 155.2/89.7 to 132.1/77.6 mmHg after 6 weeks, with the proportion of people meeting BP goal rising to 31.0% from 0%
"I congratulate [the] efforts to not only provide additional evidence for the effectiveness of pharmacist-led hypertension management programs, but also raise awareness [and] encourage broader implementation and hopefully a push towards more autonomy and better reimbursement of pharmacist care on a national level," commented Florian Rader, MD, of Cedars-Sinai Medical Center in Los Angeles.

These clinics follow in the footsteps of the famous Los Angeles Barbershop Blood Pressure study conducted by Rader's institution. Reported in 2018, that study produced clinically important BP drops in African-American men by bringing in a prescribing pharmacist to their local barbershop appointments. Improvements in BP were observed at the 6-month mark.

"The reason for the success of this and other hypertension management programs is quite simple: focus on a specific disease, have clear treatment goals, and reach those with more frequent patient-healthcare provider interactions. In addition, most of such programs have evidence-based protocols for medication titration," Rader told MedPage Today.

However, there are challenges that make implementing these programs less feasible in some areas.

"One main barrier is that a pharmacist's scope of practice varies from state to state. In some states there are significant limitations to what a pharmacist can or cannot do and how their service is reimbursed," Rader noted, adding that the reimbursement is currently "sub-par."

Jordan Overstreet, DNP, APRN, of Bozeman Health in Montana, who reported her group's results with a multidisciplinary clinic, acknowledged that Montana pharmacists in particular are allowed collaborative practice agreements with physicians.

"Future work seeks to expand the reach of the clinic into our community with the implementation of an outside referral protocol. This would allow patients whose primary care provider practices outside the organization to receive innovative, guideline-directed hypertension care," she said.

Rader noted that as a whole, "ample" evidence supports pharmacy-led preventative cardiovascular programs being more effective and efficient than usual, physician only-led approaches to hypertension control.

Indeed, primary care physicians take on average 6-12 months to get patients to BP goal, according to Overstreet. Her nurse- and pharmacist-led clinic was started in 2019 in Bozeman, a small but growing city. Referred by primary care, patients visited the clinic where a registered pharmacist read and signed their charts, which were subsequently routed back to the primary care provider.

Study participants were followed every 2-4 weeks with visits with the hypertension RN until their BP and personal goals were met. As not all patients reached goal by 12 weeks, the center has added a nurse practitioner to treat patients requiring higher complexity of care, Overstreet noted.

Medication management was also a large component of the Appalachian and Boston programs.

The latter tested the impact of home BP monitoring coupled with a rapid, biweekly, pharmacist-led BP medication titration program. People with hypertension self-measured BP using a validated device twice a day for 1 week, then had their medications adjusted every 2 weeks until reaching goal or completing 6 weeks of follow-up.

Such aggressive titration appeared safe; there were no falls or instances of hypotension. One person had an electrolyte change requiring medication adjustment, and two people had significant changes in serum creatinine that required medication change, according to the poster by Anthony Ishak, PharmD, of Beth Israel Deaconess Medical Center in Boston.


Disclosures

Novartis Cosentyx: symptom improvements in hidradenitis suppurativa in pivotal Phase III

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-Cosentyx-R-shows-clinically-meaningful-symptom-improvements-in-patients-with-hidradenitis-41737395/

BeiGene: ESMO Session on islelizumab in First-Line Unresectable Hepatocellular Cancer

 BeiGene shared updates from its solid tumor development program for cornerstone PD-1 antibody tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris. Results from the Phase 3 RATIONALE 301 trial of tislelizumab versus sorafenib as first-line treatment in patients with unresectable hepatocellular carcinoma were accepted as a late-breaking abstract (LBA36) and presented at an oral session on Saturday, September 10. In the final analysis of 674 patients enrolled from Asia, Europe, and U.S., RATIONALE 301 met its primary endpoint of overall survival (OS) non-inferiority, with a median OS of 15.9 months for tislelizumab compared with an OS of 14.1 months for sorafenib (HR: 0.85 [95.003% CI: 0.712, 1.019]); superiority was subsequently tested, which was not met.

OS data were consistent across all pre-specified subgroups, including regions. In the RATIONALE 301 trial, tislelizumab was associated with a higher objective response rate (ORR) (14.3% vs. 5.4%) and more durable responses (median duration of response (DoR) 36.1 months vs.

11.0 months) compared with sorafenib. Median progression-free survival (PFS) for tislelizumab versus sorafenib was 2.1 months vs. 3.4 months respectively; HR: 1.11 [95% CI: 0.92, 1.33].

The safety profiles for tislelizumab and sorafenib treatments were consistent with previous studies, and tislelizumab demonstrated a comparatively favorable profile versus sorafenib with lower incidence rates of grade >3 adverse events (AEs) and AEs leading to discontinuation (48.2% vs 65.4% and 10.9% vs 18.5% respectively). AEs leading to death were low across both tislelizumab (4.4%) and sorafenib (5.2%) arm.

https://www.marketscreener.com/quote/stock/BEIGENE-LTD-26123632/news/BeiGene-Announces-Data-Presentations-at-ESMO-2022-Including-Late-Breaking-Oral-Presentation-for-Tisl-41737669/

Free Narcan, drug test strips distributed throughout W.Va

 Volunteers and public health workers set up shop in parks, churches, post offices and community centers Thursday for the largest event for overdose reversal drug training and distribution in West Virginia’s history.

It was the third time the state, which has seen the most opioid overdose deaths per capita out of any other in the U.S., hosted a “Save a Life Day” event. But it was the first time the effort has reached all 55 counties.

“People were reaching out to us and saying, ‘How can we do this in our community?’” said Stacy Kay, co-director of Charleston-based Solutions Oriented Addiction Response, an organization involved with planning the event. “People are really recognizing a need to have Narcan in their first aid kids.”

West Virginia has by far the nation’s highest overdose death rate, and four out of every five fatal overdoses in West Virginia in 2021 involved an opioid.

rganizers said they had at least 10,000 doses of Narcan — a name-brand overdose reversal drug — to distribute, along with a 10- to 15-minute training session on how to use it and other resources. Those materials also included CPR masks and informational pamphlets on how to identify signs of an opioid overdose. Narcan was provided by the state Office of Drug Control Policy.

West Virginia Drug Intervention Institute also provided over 10,000 fentanyl test strips to be distributed across the state. This year, the state Legislature decriminalized Fentanyl test strips, which help drug users identify fentanyl and other potentially deadly chemicals.

Kay said because of the stigma around substance use disorder, people have been made to feel shame in the past about carrying and picking up Narcan, which is available at pharmacies.

“How many people feeling that shame are going to walk in and ask for the help they need?” she said. “Even there, you’ll find stigma if you walk in and try to access it.”

Kay said you never know when you might need Narcan — it could be for a family member, a coworker or a stranger.

“One thing we should be doing is normalizing it — it’s like carrying an EpiPen,” she said. “By sharing our stories and getting out there talking about it publically, we’re taking the stigma away.

“It’s really just being that connection to care when they’re ready — just to promote the message that we believe that everybody deserves a second chance and every life is worth saving.”

The theme for this year’s event was “meeting people where they are.”

In addition to more than 180 locations throughout the state, mobile outreach teams were also deployed to hard-hit areas to provide Narcan and other resources to people who might not know about Save a Life Day or wouldn’t feel comfortable coming to one of the sites.

https://apnews.com/article/health-west-virginia-opioids-charleston-92ec35561fc0eb5b923da2d0970dabd2

Flood of migrant kids in NYC schools to fatten DOE coffers by $19M–plus

 The city Department of Education is rolling out the red carpet to asylum-seeking migrants, helping them cut through red tape to get at least 1,500 border-crossing kids enrolled in public schools

The influx of school-age children –  among the roughly 8,000 newcomers bused to Manhattan since May by Texas Gov. Greg Abbott – stands to help the enrollment-starved DOE reap millions of dollars in new revenue.

More than half – or $12,725 – of the DOE’s $25,334 per-student funding is picked up by the state and federal government, according to estimates provided by the watchdog Independent Budget Office.

Enrollment in NYC schools fell to just over 1 million students by the 2021-22 academic year –  a decline of 87,000 students over the past two years, the DOE confirmed. That loss in students translated to a yearly loss of roughly $1.1 billion in state and federal funding for the DOE, based on the IBO estimates. 

The 1,500 new students are expected to bring the nation’s largest school district $19.1 million in revenue, a figure likely to rise as the Adams administration welcomes more migrants, immigrants, and war refugees to the Big Apple, a so-called sanctuary city.

A picture of the entrance to the Red Cross at 520 West 49th Street.
NYC DOE confirmed that school enrollment fell under 1 million students by the 2021-2022 academic year.
Helayne Seidman

Councilman Joseph Borelli (R-Staten Island) said he opposes “illegal immigration” but called the city taking in migrants “an interesting way to get some state and federal per-capita funding for some of our under-enrolled schools.”

“I suppose if there’s a silver lining to the Biden migrant crisis, it’s this,” he said. 

But Leonie Haimson, director of the advocacy group Class Size Matters, said whatever new funds the city gets will not be enough to cover the migrants’ tremendous needs.

“The DOE will have to spend more than they would otherwise get just from increased enrollment,” Haimson said.

A mother and her child walking in Hells Kitchen in NYC.
Director of advocacy group Class Size Matters, Leonie Haimson, said the city’s funds will not be enough to cover the children’s needs.
Helayne Seidman

“These students will need additional services – including language instruction, and social workers to help with housing and food insecurity. Many of them are likely to have suffered interrupted education as well.” 

In a four-page memo sent to principals on Aug. 18, the DOE described the migrants as largely two-parent households with multiple children, almost all Spanish-speaking, and many now living in homeless shelters.

“The families and children arriving have undergone unknown levels of trauma to make this incredible journey to a city that for many represents hope, opportunity, and a chance to make a new life,” Chancellor David Banks wrote.

A photo of a hotel in NYC.
“The families and children arriving have undergone unknown levels of trauma to make this incredible journey to a city that for many represents hope, opportunity, and a chance to make a new life,” Chancellor David Banks wrote in a four-page memo.
Helayne Seidman

Migrant parents temporarily housed by the city at the Skyline Hotel in Hell’s Kitchen told The Post the DOE set up an office there to smooth the process of getting their children enrolled in school. The office has provided kids with backpacks, other school supplies, MetroCards, and bus schedules, they added.

“[Getting them into school] was very easy,” said Escarle Simancas, a Venezuelan-born migrant after enrolling her two boys. “They helped us with everything inside.” 

Another mother who recently arrived with her family from Venezuela said her son Andres will attend PS 5 in the Bronx, where he was placed in a dual-language program, taking classes one day in English and the next in Spanish. 

“He learns really quickly; he’s really smart,” the mom said.

https://nypost.com/2022/09/10/flood-of-migrant-kids-in-nyc-schools-to-boost-doe-funding/

DBV Tech Kickstarts Phase 3 Study Of Modified Viaskin Patch For Peanut Allergy

 

  • DBV Technologies SA  initiated Phase 3 study, VITESSE, using the modified Viaskin Peanut Patch in peanut-allergic children ages 4 to 7 years. 
  • DBV expects to enroll 600 subjects for participation in the VITESSE study, randomized 2:1 active to placebo. The first patient screened is expected in Q4 2022, with the last patient screened by year-end 2023. 
  • The Company anticipates that the topline results will read out in Q1 2025.
  • VITESSE is a Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years. 
  • The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at month 12.