Search This Blog

Wednesday, July 10, 2024

Remission, relapse of anxiety, depression in older adults after Cognitive Behavioural Therapy: 10-year follow-up

 

Highlights

  • Assessed the durability of CBT among older adults 10 years after treatment

  • Compared effects to an active control group

  • CBT was associated with higher remission, lower relapse and chronic non-response.

  • CBT has long-lasting benefits for anxiety and depression in older adults.

Abstract

Background

This study examined the long-term durability of cognitive behaviour therapy (CBT) for older adults with comorbid anxiety and depression 10 years after treatment, in comparison to an active control group.

Method

Participants from a randomised controlled trial for older adults with comorbid anxiety and depression (Wuthrich et al., 2016) were re-contacted. Participants had received either group CBT or an active control treatment (Discussion Group). The final sample (N = 54; Aged 70–84, Mage = 76.07, SD = 3.83; 59 % of the eligible original sample) completed a diagnostic interview, cognitive assessment and self-report measures of symptoms and quality of life.

Results

CBT was associated with significantly improved long-term (10-year) efficacy for reducing anxiety and depression in older adults compared to the Discussion group. Effects included higher rates of remission (58 % remission of all diagnoses vs 27 %, 88 % of all depressive diagnoses vs 54 %, 63 % of all anxiety diagnoses vs 35 %, 67 % of primary diagnosis vs 42 %), lower rates of relapse (25–31 % vs 50–78 %) and lower rates of chronic treatment-resistance (8 % primary disorder vs 39 %, 21 % any disorder vs 58 %). Participants who showed an acute treatment response at post-treatment were 7–9 times more likely to be in remission after 10 years than those with residual symptoms.

Limitations

Results may not generalise to those who do not complete CBT, and the time trajectory of symptom change is unclear.

Conclusions

Long-term improvements in symptoms are specific to CBT. Results provide compelling evidence for CBT as an effective and durable treatment for late-life anxiety and depression.

https://www.sciencedirect.com/science/article/pii/S0165032724007511?via%3Dihub

Vibegron Benefit Extends to Men on Benign Prostatic Hyperplasia Meds

 Men pharmacologically treated for benign prostatic hyperplasia (BPH) experienced significant improvements in overactive bladder (OAB) symptoms after treatment with vibegron (Gemtesa), according to results from a phase III randomized trialopens in a new tab or window

.

After 12 weeks of treatment, vibegron recipients experienced significant reductions in average daily micturition episodes (-2.04 with vibegron vs -1.30 with placebo, P<0.0001) and average daily urgency episodes (-2.88 vs -1.93 respectively, P<0.0001), thus meeting the COURAGE trial's co-primary endpoints, reported Janet Owens-Grillo, PhD, MS, of Sumitomo Pharma America, and colleagues.

"This suggests that vibegron is similarly efficacious at reducing OAB symptoms in patients with and without coexisting BPH and may work additively with pharmacologic BPH treatment consisting of α-blockers with or without 5α-reductase inhibitors," the authors wrote in the Journal of Urologyopens in a new tab or window.

They noted that vibegron showed efficacy as early as week 2 and maintained it through week 24 in COURAGE. Additionally, they said, vibegron was generally safe and well tolerated given that adverse event (AE) rates were similar between treatment and placebo groups.

These results were broadly consistent with those from the EMPOWUR trialopens in a new tab or window that had established vibegron's efficacy and safety in a phase III study in overactive bladder. That study led to vibegron being FDA approved to treat OAB with symptoms of urinary frequency, urgency, and urge urinary incontinence (UUI).

The question in COURAGE was whether this selective β3-adrenergic receptor agonist would improve OAB symptoms in men undergoing treatment for BPH.

In addition to meeting the study's primary endpoints, Owens-Grillo and colleagues reported that participants receiving vibegron were more likely to experience both ≥50% and ≥75% reductions in urgency episodes at all time points compared with placebo -- these ≥50% and ≥75% thresholds having been associated with clinical meaningfulness, based on the prior literature.

Vibegron was also associated with a significant reduction in mean daily nocturia episodes (-0.88 vs -0.66, P=0.002), UUI episodes (-2.19 vs -1.39, P=0.003), International Prostate Symptom Score-storage scores (-3.0 vs -2.1, P<0.0001), and volume voided per micturition (25.63 mL vs 10.56 mL, P<0.0001).

The demonstrated reduction in nocturnal frequency was highlighted as "lending credence to the importance of storage symptoms as a contributor to nocturnal urinary events," according to Roger Dmochowski, MD, MMHC, of Vanderbilt University Medical Center in Nashville, Tennessee.

"Mixed urinary symptomatology arising from outlet obstruction with associated bladder over-activity occurs in substantial numbers of men in the at-risk age groups for benign prostatic destruction," he wrote in an accompanying editorial commentopens in a new tab or window.

"Storage dysfunction, however, may present in men without discernible outlet concerns, and therefore critical emphasis is placed on the clinician to differentiate symptom etiology (obstructive, irritative, or mixed) prior to definitive intervention to assure patient awareness and adequate informed consent as to risk of persistent storage symptoms after surgical intervention for the outlet (if indicated)," Dmochowski stressed.

The COURAGE trial was conducted at 82 sites in North America and Europe. Eligible participants were men ≥45 years of age with persistent OAB symptoms (≥8 micturitions and ≥3 urgency episodes per day) for ≥2 months, and previously diagnosed BPH treated with a stable dose of an α-blocker with or without a 5α-reductase inhibitor.

Out of 1,105 men who were randomized, 1,104 received ≥1 dose of study medication and 87.3% completed the trial. The full analysis set included 1,080 participants (538 randomized to vibregon and 542 to placebo).

The mean age of the study cohort was 67 years. The majority were white (87.6%) and from the U.S. (56%).

About two-thirds of patients had pre-existing hypertension and one-quarter had incontinence at baseline. The mean number of daily micturitions at baseline was 11.3 and 11.7 in the vibegron and placebo groups, and the mean number of daily urgency episodes was 9.0 and 9.3 in the two groups, respectively.

Regarding safety, 45.0% and 39.0% of patients receiving vibegron and placebo, respectively, experienced at least one treatment-emergent adverse event (TEAE). Among the most frequent ones were hypertension (9.0% vs 8.3%), COVID-19 (4.0% vs 3.1%), urinary tract infection (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%). TEAEs leading to study discontinuation occurred in 2.9% of patients in the vibegron group and 2.7% in the placebo group.

Serious adverse events (AEs) occurred in 4.3% and 2.9% of patients receiving vibegron and placebo, respectively, with no serious AEs considered to be treatment-related by the COURAGE authors.

In the vibegron group, six participants were diagnosed with five distinct neoplasms including basal cell carcinoma in two patients; and one patient each developing pancreatic adenocarcinoma, adenocarcinoma of the colon with metastatic hepatic mass, metastatic renal cell carcinoma, and plasma call myeloma. In the placebo group, one patient was diagnosed with bladder transitional cell carcinoma.

All neoplasms were diagnosed within 80 days of starting the study and none were considered treatment-related by investigators.

Disclosures

The study was supported by Sumitomo Pharma America.

Owens-Grillo and several co-authors are employees of Sumitomo Pharma America.

Dmochowski had no disclosures.

Primary Source

Journal of Urology

Source Reference: opens in a new tab or windowStaskin D, et al "Efficacy and safety of vibegron for persistent symptoms of overactive bladder in men being pharmacologically treated for benign prostatic hyperplasia: Results from the phase 3 randomized controlled COURAGE trial" J Urol 2024; DOI:10.1097/JU.0000000000003999.

Secondary Source

Journal of Urology

Source Reference: opens in a new tab or windowDmochowski R "Editorial comment" J Urol 2024; DOI: 10.1097/JU.0000000000004021.


https://www.medpagetoday.com/urology/bph/111033

Pennsylvania County That Just Might Be 2024's 'Ground Zero'

 by Salena Zito via RealClearPolitics,

ERIE, Pennsylvania — Despite 40,000 people leaving this city since 1970 (10,000 of them between 2000 and 2016) and having the unfortunate distinction of being the home of the poorest zip code in the state – “ride or die” Erie residents, especially young people who have left for better opportunities only to come back to raise their families here, are a real thing.

They are reshaping the way the city moves and shakes as well as its politics, in what is perhaps not just the most important county in Pennsylvania in determining who will be the next president – but arguably the most important county in the country.

It is a city and county in economic flux, situated halfway between New York City and Chicago along one of the Great Lakes. It has two major interstates, a massive port, and access to robust freight and passenger railroad service. Once a powerhouse of heavy industry, Erie is in the process of remaking itself as the center of “Eds and Meds” (universities and world-renowned hospitals), light manufacturing, and tourism.

Yet the collective memory of what they used to do here is a palpable undercurrent – especially among union workers who, for generations, called Erie’s sprawling 340-acre General Electric locomotive plant their second home. The slow erosion of the good-paying jobs that employed 25,000 in the 60s and dwindled to the current 3,000 has taken its toll emotionally as well as politically.

Still, the people here have been in Erie for generations – often living in close proximity to parents and grandparents, aunts and uncles, cousins, and childhood friends who they believe make their lives richer because of that multi-generational influence.

Erie, which will surprise everyone who has never been here, is the home of one of the most beautiful beaches in the country, located along the shores of popular Presque Isle State Park. The city is lined with 13 miles of bike trails and seven miles of sandy beaches and boasts the state’s only seashore.

For blue-collar residents of western Pennsylvania, eastern Ohio, and the panhandle of West Virginia, Erie is their “Jersey Shore,” complete with the same amenities of camping, seashore cabins, an amusement park along the beaches, and of course, dozens of diners.

The voters here are important. Very important, as Sen. John Fetterman told me in an interview. Every statewide election in Pennsylvania comes down to what Erie voters decide to do.

Once a solid county for Democrats in statewide gubernatorial elections as well as federal elections for president, U.S. Senate, and Congress, Erie shocked the world when the county went from supporting President Obama by a whopping 16 percentage points in 2012 to supporting Donald Trump in 2016 by 40,000 votes.

Four years later, Biden would win the county by roughly the same amount; in between, Democrats Josh Shapiro and John Fetterman would also win the county for governor and U.S. Senate, and a Republican won the county executive’s race for the first time in decades.

In short – win Erie, you win the state. The question is, going into the presidential election, who is winning the hearts and minds of Erie’s swing voters? Because where they go and what is on their minds heading into the election will tell us not just how Pennsylvania is doing, but also how states like Michigan, Wisconsin, Nevada, and Arizona might go, states that are a little less Democratic than the Keystone State.

At Gordon’s butcher shop, owner Kyle Bohrer is sitting with several swing voters who have voted for Trump, Biden, and third-party candidates, and who, with the exception of one voter – his own father – are all fatigued with both Biden and Trump.

Bohrer, 43, is a diamond in the rough – and the kind of outside-the-box thinker that cities like Erie need by the thousands. A fourth-generation Erie resident, he has owned one of Unishippers franchises, a logistics company that, as he says, keeps the family’s lights on.

In 2019, he decided to purchase a meat market called Gordon’s Butcher and Market, a 2,000-square-foot iconic local store that had been in business for 50 years, but was in decline. He bought it, he says, purely on sentiment.

Bohrer went all in, and today the business rivals the top-of-the-line meat markets seen across the country. There is also a spectacular restaurant called Firestone, a bar, a six-pack section stacked with craft beer, and an upscale wine store – all located in one high-end building.

A true homer, Bohrer never left Erie despite the city’s decay, instead throwing his energy into creating a cultural touchstone. The father of three loves bringing people together at his restaurant, even those who hold wildly different political viewpoints.

“I think it is important to be able to have discussions like this, and I think perhaps places like New York or D.C. or Los Angeles think we cannot because they cannot, but look at us here, we all come at this from different political views and we can discuss it, laugh at it and move on,” he said.

Bohrer is center-right; his worldview is moderate and pragmatic, but because he owns a business, he declines to voice whom he supports. Scott Carnes, seated to his left – physically and politically – is more than happy to.

The civil engineer, also 43, is married and the father of two young daughters ages 2 and 5; Carnes grew up in Erie, left for western New York for 10 years, then lived in Pittsburgh for 12 years until he and his wife and family moved back here last year.

“My wife got a job at Erie Insurance and I was able to work remote, which gave us the ability to move, so we came back,” explained Carnes. He says he has voted Democrat all of his life, “The most important issue to me is the economy, an issue ironically that puts me more in line with the Republicans,” he said. But the Biden-Trump debate took its toll.

“I am hoping Biden drops out. I think he’s absolutely going to lose if he stays in. He’s clearly too old to be running the country in my opinion,” he said. Yet if Biden stays in, he would still vote for him: “That is how much I despise Trump.”

Jacqueline Williams is a CPA and small business owner, born and raised in Erie. Williams left here to attend college and then moved to Pittsburgh to start her career before returning with her husband Adam, who is sitting beside her, to raise their family.

The striking mother of a teenager and a 7-year-old said she and her husband run a tax strategy business. “We try to help small business owners save as much as possible on their taxes, legally. And so, the way that the future government goes about changing what was enacted is important to me,” she explained.

One of her biggest concerns heading into the election is Biden’s insistence that he will end the Trump tax breaks for family incomes above $400,000. “So that is definitely going to have an impact on small business owners. The tax brackets are shrinking. They were wider before. Right now, we’re in lower marginal tax brackets, so we’re going to be going into higher ones more quickly, with that change,” she told me.

Williams says if the Trump tax breaks end, then bonus depreciation, which she said is already declining, goes away.

“Which is an incentive to invest in your business,” injects Adam, an attorney.

William says we’re working through a time where we want small business owners to create more opportunities, “And when you take away the tax breaks, that’s harder for them to do,” she explains, adding that it can lead to a snowball effect with small businesses either closing, not investing in their businesses, laying workers off, or not hiring at all.

“It becomes an overall negative, not just for our clients but for my entire community,” she said.  

Williams, 40, has always been a Republican. She voted for Trump in 2016 and voted third party in 2020, and even though she thinks both Trump and Biden are too old, because of the tax implications, she says she will vote for Trump.

Her husband says he will not.

Like Kyle Bohrer, Adam says he and his wife came home to make a difference. “We wanted to have an impact. My belief was, you would be able to look back on the timeline of Erie, and see what we’ve done, and say, ‘We are in the position that we’re in, partially because of the work that those people did.’”

He added, laughing, “So, yeah, that’s a little meta.”

Adam explains that what he loves best about Erie depends on the day. “The name of our law firm is Rust Belt Business Law. We changed the name a few years ago. And the whole idea is, if I wanted my life to be easy, I would go and start a business law firm in Miami, or Silicon Valley, or New York, or Chicago, or you name it,” he said, naming big cities with people with more money to spend.

“The thought was, there are values that this region holds that aren’t held in other places. And you talked about it with understanding. But I think it’s work ethic … I think it’s culture. And our clients are business owners that reflect the values and culture of where they were raised, and how they were raised and we really buy into those values … We believe that all else being equal, hard work will prevail over waiting for something to happen,” he said.

As for this election, he’s leaning toward one of the independent candidates. “Because I am not inspired,” he said. “I’m voting for what I believe in. So many people treat politics like sports, and they’ve got to be part of the winning team. Well, for me, it’s more about what really matters to me. And I believe I would be out of integrity with myself if I voted for either of the two front runners.”

Joe Bohrer is Kyle’s father. A tool and die maker born and raised in Erie, he’s never left to live elsewhere. Joe started his political awareness as a Democrat and began moving away from the party with each election.

“By the time Reagan came along, I was a full Republican,” he said.

Joe is all-in for Trump. He longs for a time when the dignity of work mattered, not just locally, but in the national conversation about hard work. Inflation is his top concern – he says high prices are hurting him.

“I can kind of blame Republicans and Democrats with their spending. So, the more money you spend that you don’t have, it has to diminish buying power. Because there’s not any more goods, but you have more money to spend on goods that aren’t being produced. Especially coming off of COVID,” he said.

He does not understand why Biden doesn’t embrace talking directly to the middle class about inflation. He doesn’t understand his shouting, either.

It used to be Democrats, I felt, were anti-establishment,” he said. “Now I feel like it’s the opposite. They are establishment.

For more than two hours, they all discussed their love of their community and how they could better impact it, all within the framework of having very different political worldviews.

Kyle Bohrer says he understands Erie is going to be ground zero for the election – not just for the state but for the entire country. “That is a lot of pressure for voters. I think the candidate who shows they understand the concerns here will translate to other cities and towns like ours and resonate.”

Until then, Bohrer says, “Buckle your seatbelts, Erie, it’s going to be a bumpy ride.”

Salena Zito is a reporter for the Washington Examiner, Wall Street Journal contributor, and co-author of “The Great Revolt: Inside the Populist Coalition Reshaping American Politics.”

https://www.zerohedge.com/political/pennsylvania-county-just-might-be-2024s-ground-zero

CVRx plunges, Sight Sciences jumps on proposed Medicare rate changes

 CVRx (CVRX) stock plunged 31% while Sight Sciences (SGHT) shares jumped 14% following the release of Medicare's proposed reimbursement rates.

https://seekingalpha.com/news/4123405-cvrx-plunges-sight-sciences-jumps-on-proposed-medicare-rate-changes

Teva upped to Buy from Hold by Argus

 Target $20

https://finviz.com/quote.ashx?t=TEVA&ty=c&ta=1&p=d

STAAR Surgical said targeted in takeover by larger rival Alcon - source

 STAAR Surgical (NASDAQ: STAA) has been approached by larger rival Alcon (NYSE: ALC) about takeover of the company. according to sources.

https://www.streetinsider.com/Hot+M+and+A/STAAR+Surgical+said+targeted+in+takeover+by+larger+rival+Alcon+-+source/23450906.html

Over 2,000 pounds frozen Canada chicken products recalled over listeria concerns: USDA

 The US Department of Agriculture (USDA) recently announced that some frozen ready-to-eat chicken products are being recalled over listeria-related concerns.

In a press release published on Friday, the USDA explained that the Canada-based importer Al Safa US LLC is recalling over 2,000 pounds of chicken kebabs and patties.

Officials are concerned that the food items may contain the bacteria Listeria monocytogenes, which causes listeriosis.

The chicken products were prepared in Canada on June 5 before being imported to the US later that month.

According to the USDA, the two impacted products are the following:

  • Al Safa Halal Charcoal Grilled Chicken Seekh Kebab Grilled, Minced, Chicken Patty Kebab with “NOV 30 25” and “0605404” printed on a sticker on the outside of the package.
  • Al Safa Halal Fully Cooked Chicken Chapli Kebab Seasoned Chicken Patty with “NOV 30 25” and “0605416” printed on a sticker on the outside of the package.
The USDA explained that the Canada-based importer Al Safa US LLC is recalling over 2,000 pounds of chicken kebabs and patties.USDA
“The products subject to recall bear establishment number ‘866’ inside the Canadian mark of inspection,” the agency added.

“These items were shipped to retail locations nationwide.”

According to officials, an issue was detected when the USDA’s Food Safety and Inspection Service (FSIS) investigators performed “routine product testing” in an Al Safa facility.

“The results indicated the product may be contaminated with Listeria monocytogenes,” the press release said.

Some of Al Safa’s chicken kebab products are impacted by the recall.USDA

The FSIS asks consumers who purchased the product to dispose of the packages or return them for a refund.

“FSIS is concerned that some product may be in consumers’ freezers,” the statement read.

“Consumers who have purchased these products are urged not to consume them.”

The chicken products were prepared in Canada on June 5 before being imported to the US later that month.USDA

The USDA noted that no illnesses associated with the products have been reported yet, but listeriosis can prove deadly to pregnant women, older adults and people with weakened immune systems.

“Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms,” the USDA explained.

“Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.”

Fox News Digital reached out to Al Safa for comment, but did not immediately hear back.

https://nypost.com/2024/07/10/business/usda-recalls-over-2000-pounds-of-frozen-chicken-from-canada-based-importer-al-safa-us-llc/