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Wednesday, May 8, 2024

'Vast Majority of Adults At Risk for Cardiovascular-Kidney-Metabolic Syndrome'

TOPLINE:

Nearly 90% of adults were at risk of developing cardiovascular-kidney-metabolic (CKM) syndrome between 2011 and 2020, according to new research published in JAMA.

METHODOLOGY:

In 2023, the American Heart Association defined cardiovascular-kidney-metabolic (CKM) syndrome to acknowledge how heart and kidney diseases, diabetes, and obesity interact and are increasingly co-occurring conditions.
Researchers used data from the National Health and Nutrition Examination Survey between 2011 and 2020.
More than 10,000 adults over age 20 years were included; all of them received a physical and fasting laboratory measurements and self-reported their cardiovascular disease (CVD) status.
Researchers created categories for risk, ranging from 0 (no risk factors) to 4, using factors such as kidney disease, obesity, and hypertension.

TAKEAWAY:

Nearly 90% of participants met the criteria for having a stage of the CKM syndrome, with rates remaining steady throughout the study period.
Almost half of people met the criteria for stage 2 (having metabolic risk factors like hypertension or moderate- to high-risk chronic kidney disease).
14.6% met the criteria for advanced stage 3 (very high-risk chronic kidney disease or a high risk for 10-year CVD) and stage 4 CKM syndrome (established CVD) combined.
Men, adults over age 65 years, and Black individuals were at a greater risk for advanced stages of the CKM syndrome.

IN PRACTICE:

"Equitable health care approaches prioritizing CKM health are urgently needed," the study authors wrote.

SOURCE:

The study was led by Muthiah Vaduganathan, MD, MPH, cardiologist and researcher at Brigham and Women's Hospital, Harvard Medical School, Boston.

LIMITATIONS:

Established CVD statuses were self-reported. Some data that would indicate advanced CKM stages were not available (eg, cardiac biomarkers, echocardiography, and coronary angiography), which may have led to an underestimation of rates.

DISCLOSURES:

One author received grants from Bristol Myers Squibb-Pfizer outside the submitted work. Vaduganathan received grants from and was an advisor and committee trial member for various pharmaceutical companies outside the submitted work. The authors reported no other disclosures.

https://www.medscape.com/viewarticle/vast-majority-adults-risk-cardiovascular-kidney-metabolic-2024a10008u9

Diabetes/Weight Loss Med Linked to Repeat Spinal Surgery

The diabetes/weight loss drug semaglutide is associated with a significantly greater risk for repeat operations in patients with diabetes who require lumbar surgery, a new study suggests.

The risk for additional surgeries was even higher among patients taking the popular weight loss and diabetes drug for longer periods of time.

Investigators say the study provides the first evidence on the impact of semaglutide on spine surgery.

"The expectation was [that] we would see patients doing better after surgery, less wound complications, and other things, and in our diabetic patients we did not see that and saw increased odds of needing additional surgeries," investigator Syed I. Khalid, MD, neurosurgery resident at University of Illinois Chicago, told Medscape Medical News.

The findings were presented on May 3 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.

Additional Surgery at Year 1

The new study used the all-payer Mariner database to identify patients aged 18-74 years with type 2 diabetes who underwent elective one- to three-level transforaminal lumbar interbody fusions (TLIFs) between January 2018 and October 2022.

Patients were matched in a 3:1 ratio for age, sex, hypertension, obesity, smoking history, chronic kidney disease, osteoporosis, insulin use, and spinal fusion level, resulting in 447 patients with semaglutide use and 1334 with no semaglutide use. More than half (56%) were female, 62% used insulin, and 81% underwent single-level TLIF.

Total medical complications were higher in the semaglutide group, at 13.4%, compared with 7.7% in the no-semaglutide group (odds ratio [OR], 1.85). This was driven by higher rates of urinary tract infection (6.7% vs 2.5%) and acute kidney injury (6.3% vs 3.9%), two complications observed with semaglutide in other studies, Khalid said.

Total surgical complications, however, were lower in patients taking semaglutide, at 3.8% vs 5.2% in those who did not (OR, 0.73).

Patients taking semaglutide vs those who were not using semaglutide had fewer wound healing complications (5 vs 31), hematoma (1 vs 9), surgical-site infections (12 vs 44), and cerebrospinal fluid leaks (2 vs 3).

Still, people taking semaglutide were nearly 12 times more likely to have an additional lumbar surgery at 1 year than did those who did not use the drug (27.3% vs 3.1%; OR, 11.79; 95% CI, 8.17-17.33).

Kaplan-Meier plots revealed a striking divergence of these populations when semaglutide exposure for more than or less than 9 months was examined (log-rank P < .0001).

Currently under review for publication, this study provides the first evidence on the impact of semaglutide on spine surgery, Khalid said. A second follow-up paper, also under review, looked only at patients with patients morbidly obesity without diabetes who had taken semaglutide for weight loss.

"In nondiabetic, morbidly obese patients undergoing spine surgery, we see a similar trend," Khalid said.

Sarcopenia the Cause?

The additional surgeries were primarily extensions of constructs, with additional surgery and fusion at more levels, Khalid noted.

"The idea is that it could be the fact there is sarcopenia or muscle loss that's taking place in conjunction with fat loss that's causing that to happen," Khalid said.

The mechanism remains speculative, but evidence from other areas examining frailty states has shown that those patients have weaker bones, sarcopenia, and worse outcomes with spine surgery, he noted.

The investigators plan to use artificial intelligence to evaluate changes in body composition after semaglutide use in patients who underwent imaging prior to spine surgery or even before back pain occurred. Because these medications are uptitrated over time, follow-up studies will also look at whether this change takes place with a certain dose, Khalid added.

On the basis of the current analysis of generic semaglutide alone, it's not possible to say whether the use of other glucagon-like peptide 1 (GLP-1) receptor agonists will result in similar findings, but "the odds of a class effect are high," Khalid said.

Commenting on the findings for Medscape Medical News, Walavan Sivakumar, MD, director of neurosurgery at Pacific Neuroscience Institute, Los Angeles, noted that the timing of surgery is already an issue for patients taking semaglutide and other GLP-1 receptor agonists following recent guidance from the American Society of Anesthesiologists that suggests stopping GLP-1 receptor agonists prior to elective surgery to reduce the risk for complications associated with anesthesia.

"It's an incredibly topical point and seems to be something showing up on a daily basis for clinicians all throughout neurosurgery," Sivakumar said. "It's thought-provoking and a great first start."

Sivakumar also observed that frailty is a hot topic in all of neurosurgery. "That's a major, major point that's showing an impact on all surgical outcomes and it's being heavily studied in the neurosurgical subsets right now. So that's definitely a possible correlating factor."

Khalid reported no financial relationships. Sivakumar reported serving as a consultant for Stryker.

https://www.medscape.com/viewarticle/diabetes-weight-loss-med-linked-repeat-spinal-surgery-2024a10008vn

Eledon Drug Shows Safety In Early Organ Transplant Study

Tuesday, Eledon Pharmaceuticals Inc

ELDN+7.08%

+ Free Alerts

announced that the first participant in an investigator-led clinical trial has received an islet cell transplant and is being treated with tegoprubart for the prevention of pancreatic islet cell transplant rejection in type 1 diabetes patients.

The company also reported updated data from its ongoing Phase 1b trial as of April 2024 from 13 participants, demonstrating that tegoprubart is generally safe and well-tolerated and supports tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation.

Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – measured above 60 mL/min/1.73m2 at all reported time points after day 30.

Two subjects completed 12 months on therapy post-transplant and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one year.

To date, three subjects discontinued the study because of hair loss and fatigue, viral infection, and rejection, respectively.

There have been no cases of graft loss or death.

Eledon is currently conducting a Phase 1b trial, the Phase 2 BESTOW trial, and a Long-Term Safety and Efficacy extension study to evaluate tegoprubart for the prevention of organ rejection in kidney transplant patients.

Concurrently, Eledon Pharmaceuticals announced a private placement of approximately $50 million, offering 13.1 million shares at $2.37 per share and pre-funded warrants at $2.369 per underlying share, which are exercisable to purchase 7.99 million shares.

HC Wainwright suggests that islet cell transplantation could be a promising way to reverse type 1 diabetes by restoring metabolic control without relying on insulin injections. The analyst highlights tegopruibart’s potential to decrease or replace intensive anti-rejection drugs without causing side effects.

HC Wainwright reiterates the Buy rating, and with increased confidence in tegoprubart’s probability of advancement into a pivotal study, it has raised the price target from $13 to $16.

The analyst continues to look for the potential signing of a licensing collaboration agreement, including an upfront payment worth up to $100 million, for further development and commercialization of tegoprubart around the 2025 timeframe as a future catalyst.

https://www.benzinga.com/analyst-ratings/analyst-color/24/05/38680636/nano-cap-eledon-pharmaceuticals-investigational-drug-shows-safety-in-early-organ-tr

Medical Debt-Relief Can Backfire on Patients

Americans collectively owe some $220 billion in medical debt. In response, a growing number of states, including New Jersey and Connecticut, are using public funds to relieve those debts.

Gov. Josh Shapiro, D-Pa., proposed doing something similar in his state earlier this year.

But is canceling medical debt the best way to help cash-strapped Americans?

Not according to an eye-opening new study published last month by the National Bureau of Economic Research.

The analysis finds that the benefits of medical debt-relief range from modest to non-existent — a conclusion the study's authors called "sobering."

It's yet another counterexample to the progressive dictum that government assistance is the best response to most social problems — and health policy problems, in particular.

In this case, the best evidence suggests that funneling taxpayer dollars into medical debt-relief is a waste of money.

Despite the headline numbers, medical debt just isn't as widespread as progressives assert. According to the NBER paper, two in five Americans hold some form of medical debt. And most of them owe less than $2,500.

Only 6% of American adults, meanwhile, owe over $1,000 in medical debt, the Kaiser Family Foundation reported earlier this year.

And yet, no less than 15 states and municipalities have devoted huge sums of public money to medical debt relief at a total cost of $8 billion.

Another five governments are weighing similar reforms which, if passed, would bring that total to $13 billion, the NBER study's authors note.

These programs raise a number of nagging questions.

Why should medical debt get special treatment compared to, say, credit card debt or auto loans? Based purely on the numbers, it would appear that Americans' cumulative $1.13 trillion in credit card debt would be the far more urgent financial problem.

It's safe to assume that, were so many Americans not swimming in credit card debt, they might find it easier able to keep up with their medical bills — or all their other bills, for that matter. Yet few, if any, policymakers have suggested government-backed credit card debt-relief programs.

Medical debt forgiveness looks even more dubious as a policy goal in light of the NBER paper's findings.

According to the study, the very things one would expect such a debt-relief program to achieve — improved financial security and mental well-being, for instance — haven't materialized.

Drawing on data from the non-profit RIP Medical Debt (now Undue Medical Debt) — the organization behind most of the current medical debt relief efforts around the country — the authors evaluated the effects of debt forgiveness on 83,401 people between 2018 and 2020.

They found that medical debt forgiveness provides "no improvements in financial well-being or mental health from medical debt relief, reduced repayment of medical bills, and, if anything, a perverse worsening of mental health."

That's an astoundingly poor outcome for a set of programs which, collectively, cost taxpayers billions of dollars.

Why might debt forgiveness actually discourage medical bill repayment?

The authors suggest that "[i]f persons who receive debt relief expect additional debt relief in the future, they will be less likely to pay future medical bills" — a dynamic which makes perfect sense, in retrospect.

As for the mental health consequences of these reforms — perhaps the most baffling finding — the authors speculate that the policies "may have worsened mental health by raising the salience of recipients' financial deprivation without meaningfully addressing their underlying economic situations."

In short, even relatively straightforward government interventions in the healthcare system like public medical debt relief can backfire, leaving patients and taxpayers no better off —and potentially worse off.

Sally C. Pipes is president, CEO, and the Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is "False Premise, False Promise: The Disastrous Reality of Medicare for All," (Encounter Books 2020).

https://www.newsmax.com/sallypipes/pennsylvania-nber-shapiro/2024/05/07/id/1163781/

Crash Data Involving New Truck, Bus Drivers Getting Worse

By John Gallagher of FreightWaves

Deaths resulting from large-truck crashes where newly licensed drivers are involved continue to rise, according to recent government data, but a proposed safety requirement that could help reduce those deaths will likely be delayed again.

The percentage of fatal large-truck and bus crashes involving new-entrant carriers climbed from 4.6% to 7.4% from 2017 to 2022, according to a snapshot of Federal Motor Carrier Safety Administration data taken at the end of 2023.

In 2022, those crashes resulted in 494 deaths and over $5.5 billion in costs.

“Unfortunately this trend continues among recent new-entrant program graduates,” said Kelly Stowe, an engineer with FMCSA, referring to the agency’s New Entrant Safety Assurance Program.

During FMCSA’s safety research forum on Thursday, Stowe presented a new internal agency analysis comparing crash rates for carriers that made it through the agency’s 18-month new-entrant program to crash rates of a control group of randomly selected established carriers of similar fleet size.

The data showed that motor carriers operating within 24 months of graduating from the new-entrant program had twice as many total crashes and nearly twice as many fatal crashes per 100 power units as established carriers.

“So even after completing [FMCSA’s] new-entrant program — which includes having to pass a safety audit — newer carriers are still getting in crashes at a higher frequency than more established carriers,” Stowe said. “If we can educate these carriers early on and make sure they understand the requirements and expectations before they begin operations, we can prevent some of these crashes from occurring.”

But Stowe acknowledged that despite the concerning trend, FMCSA has yet to establish a written proficiency exam, mandated by Congress in 2012, that must be passed before a motor carrier can be registered with the U.S. Department of Transportation. “The deadline for meeting this requirement was April 2014 — we’re 10 years late,” she said.

Stowe also noted that the timeline for a proposed rulemaking to establish the proficiency exam, which was scheduled to begin in July with publication in the Federal Register, “will likely slip. It’s a high-level work plan and it’s subject to change.”

While based on dated studies, there is evidence that such a requirement could significantly reduce injuries and fatalities involving new-entrant motor carrier crashes.

Stowe summarized findings from studies completed in 2006 and 2012 comparing companies undergoing training prior to receiving operating authority with control groups that did not.

Not only did trained-carrier drivers have much lower crash rates, but they also tended to “remain in business substantially longer,” Stowe said.

“We have an opportunity with this program to improve new-entrant motor carrier safety and hopefully carry those safety improvements over to the more established carrier population over time.”

https://www.zerohedge.com/economics/crash-data-involving-new-truck-bus-drivers-getting-worse