Category: 8. Health

  • Q2 2025 Recap: Nephrology News and Updates

    Q2 2025 Recap: Nephrology News and Updates

    The second quarter of 2025 brought a flurry of regulatory activity and major clinical trial updates underscoring the rapidly evolving landscape in nephrology. From IgA nephropathy (IgAN) and C3 glomerulopathy (C3G) to lupus nephritis (LN) and focal segmental glomerulosclerosis (FSGS), a string of FDA actions—including multiple Priority Review designations, a novel autoinjector approval, and an accelerated approval for a new class of therapy in IgAN—signal increasing momentum for therapeutic innovation across a range of kidney diseases.

    Meanwhile, the 62nd European Renal Association (ERA 2025) Congress served as a showcase for emerging data that could shape future standards of care. Highlights included 52-week results from VALIANT supporting pegcetacoplan’s benefit in C3G/primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), CONFIDENCE trial findings backing dual initiation of finerenone and empagliflozin in chronic kidney disease (CKD) and type 2 diabetes, and sibeprenlimab’s 51% proteinuria reduction in IgAN.

    Here’s a recap of what made headlines in Q2 of 2025:

    Renal FDA News

    FDA Accepts Pegcetacoplan (Empaveli) sNDA for C3G, IC-MPGN

    Starting Q2 on a high note, on April 1, 2025, Apellis Pharmaceuticals announced the FDA accepted and granted Priority Review designation to the Company’s supplemental New Drug Application (sNDA) for pegcetacoplan (Empaveli) for C3G and IC-MPGN. Supported by positive 26-week results from the phase 3 VALIANT trial, a Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2025, has been assigned.

    Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

    The next day, on April 2, 2025, the FDA granted accelerated approval to atrasentan (Vanrafia), a once-daily, non-steroidal, oral treatment, for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression. Notably, the decision marked the FDA’s first approval for a selective endothelin A receptor antagonist for reducing protein in IgAN and came without any requirement for a Risk Evaluation Mitigation Strategy (REMS) program for use.

    Related: Understanding Atrasentan (Vanrafia) for IgA Nephropathy, with Richard Lafayette, MD

    FDA Accepts Sparsentan (Filspari) sNDA for Focal Segmental Glomerulosclerosis

    On May 15, 2025, the FDA accepted Travere Therapeutics’ sNDA for traditional approval of sparsentan (Filspari) for the treatment of FSGS, supported by results from the phase 3 DUPLEX Study and the phase 2 DUET Study. With the acceptance, the FDA assigned a PDUFA target action date of January 13, 2026, and indicated plans to hold an advisory committee meeting to discuss the application.

    FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy

    On May 27, 2025, the FDA accepted and granted priority review to Otsuka Pharmaceutical Development & Commercialization’s Biologics License Application (BLA) for sibeprenlimab for the treatment of IgAN, which was supported by data from the phase 3 VISIONARY trial and the phase 2 ENVISION trial. With the acceptance, the FDA assigned a PDUFA target action date of November 28, 2025.

    FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis

    On June 24, 2025, the FDA approved a 200 mg/mL autoinjector of GlaxoSmithKline’s belimumab (Benlysta), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for subcutaneous injection in patients ≥ 5 years of age with active LN who are receiving standard therapy. Initially approved for pediatric patients with active systemic lupus erythematosus in 2024, the approval of the belimumab autoinjector for LN offers patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home.

    Top Nephrology News from ERA 2025

    Pegcetacoplan Sustains Proteinuria Reductions in C3G, IC-MPGN at 52 Weeks

    Extended data from the phase 3 VALIANT trial presented at ERA 2025 support the sustained efficacy and safety of pegcetacoplan (Empaveli) in patients with C3G or IC-MPGN, including adolescents and adults with native or transplanted kidneys. Specifically, the 52-week results show continued proteinuria reduction and eGFR stabilization in both treatment-naïve and crossover groups. An FDA decision on its approval for this indication is expected by July 28, 2025.

    CONFIDENCE: SGLT2i and Finerenone Effective, Safe to Initiate Simultaneously in CKD

    Findings from the CONFIDENCE trial presented at ERA 2025 suggest simultaneous initiation of finerenone (Kerendia) and empagliflozin (Jardiance) is well-tolerated and associated with a greater reduction in urinary albumin to creatinine ratio (UACR) than either therapy alone among patients with CKD and type 2 diabetes.

    Related: Kidney Compass: CONFIDENCE Trial at ERA 2025, with Rajiv Agarwal, MD, MS

    Sibeprenlimab Halves Proteinuria in IgAN in Phase 3 VISIONARY Trial

    Findings from an interim analysis of the phase 3 VISIONARY trial show use of sibeprenlimab was associated with a 51.2% reduction in proteinuria at 9 months relative to placebo therapy among patients with IgAN, according to an interim analysis of the phase 3 VISIONARY trial. With its BLA acceptance in May, a decision on sibeprenlimab’s approval for IgAN is expected by November 28, 2025.

    Related: Kidney Compass: Sibeprenlimab and the VISIONARY Trial, with Vlado Perkovic, MBBS, PhD, at ERA 2025

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  • Researchers 3D print breast tissue to better understand lactation

    Researchers 3D print breast tissue to better understand lactation

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    According to ETH Zurich, researchers are developing a model in the lab made from human breast milk cells, with the hope that it will help them understand how breast milk is made – a little-researched area of female biology.

    Human breast milk is uniquely adapted to meet an infant’s nutritional needs. Surprisingly, we still know very little about how milk is even made in the breast. A team of ETH Zurich researchers led by Marcy Zenobi-Wong, Professor of Tissue Engineering and Biofabrication, wants to change that. In the lab, Zenobi-Wong and her team developed tiny replicas of lactating breast tissue. This involved isolating cells from human breast milk that are naturally found in milk. Some of the cells from lactating breast tissue and the so-called lactocytes – the cells in breast tissue that produce milk – end up in breast milk during lactation.

    The centrepiece of the research project is a novel tissue model that the researchers produced using a special light printing process. The volumetric bioprinting process involves a laser beam that is shone into a liquid from several angles. The liquid then hardens precisely where the light dose accumulates. In seconds, this gives rise to small structures that are similar to real milk ducts and alveoli, where the milk is produced in the breast. The material used comes from bovine udder tissue and contains similar components to human breast tissue.

    The researchers populated these mini milk ducts with cells that they extracted directly from human breast milk. These mammary epithelial cells formed a dense layer of cells on the inside wall of the milk ducts. As the researchers were able to demonstrate, this resulted in functional tissue: the cells began producing typical milk components, such as β-casein and milk fat globules.

    3D model of a ductal-alveolar unit of the human mammary gland: On the left is a digital design, and on the right, the real-life structure created using advanced volumetric 3D printing and visualised with a light sheet microscope. Illustration: Amelia Hasenauer / ETH Zurich.

    “It took several attempts to find out how we could best make the cells grow. Many of my colleagues were surprised to learn that milk-epithelial cells could grow at all,” said Amelia Hasenauer, doctoral student in Zenobi-Wong’s team and first author of the external study, published in the journal Science Advances.

    Despite the impressive findings, the two researchers emphasise that they are not yet producing complete breast milk. “We have identified the first components, but milk is made up of hundreds of different ones, including complex sugars, proteins, lipids, immune cells, and living microorganisms,” said Zenobi-Wong.

    “Above all, our cell culture model is designed to help better understand the lactation process. I know many women who have struggled to breastfeed. Our model could one day help find answers,” said Hasenauer.

    The model allows lactating cells to be observed and manipulated under controlled conditions in the lab for the first time. This opens up an array of possibilities. Besides lactation research, other possible areas that could be studied are the impact of medications and chemicals on lactation and models of breast cancer.

    “The next step is to increase the throughput of the milk collection, something which is achievable through 3D printing,” said Zenobi-Wong.

    The work by Zenobi-Wong’s research group is an example of how little scientific research has been carried out on certain processes in the female body. Models like the new breast tissue printing could change that. Unlike many other biomedical studies, this research isn’t based on invasive surgery or animal experiments, but on cells that occur naturally in breast milk. This makes it easier, ethically justifiable, and accessible to such research topics.

    Both researchers hope that their work will bring greater visibility not only to the topic of lactation, but also to a whole range of long-neglected areas of women’s health. “There are so many unanswered questions, from endometriosis to mastitis and fertility issues,” said Zenobi-Wong. “It all warrants more scientific attention.”

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  • Cancer Incidence and Epidemiological Trends in Punjab: A Population-Based Registry Analysis for State-Level Health Policy

    Cancer Incidence and Epidemiological Trends in Punjab: A Population-Based Registry Analysis for State-Level Health Policy


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  • Tiny plastic particles found in human egg and sperm fluids

    Tiny plastic particles found in human egg and sperm fluids

    Tiny bits of plastic no wider than a human hair have turned up in some unexpected places, including the human bloodstream.

    Now, data presented at the European Society of Human Reproduction and Embryology meeting shows that these fragments have breached the fluids that surround eggs and travel with sperm.


    The research team led by Dr. Emilio Gómez‑Sánchez of Next Fertility Murcia in Spain scanned follicular fluid from 29 women and seminal fluid from 22 men.

    The experts found microplastics in 69 percent of the women and 55 percent of the men they studied. According to Dr. Gómez‑Sánchez, the team was surprised to find that the particles were so widespread.

    Plastics in human reproductive fluids

    The study detected polymers such as polytetrafluoroethylene and polypropylene, materials better known for slick frying pans and food packaging. Seeing them next to human eggs turns a theoretical hazard into a measurable one.

    Back in 2021, Italian obstetricians spotted twelve plastic fragments in every placenta they examined, confirming that particles smaller than five millimeters can cross the maternal‑fetal boundary.

    Similarly sized particles have been uncovered deep in lung tissue removed during surgery, proving that inhalation is a realistic delivery route for plastic dust.

    Researchers in the Netherlands have even measured plastic mass circulating in human blood samples, an observation that explains how fragments migrate to distant tissues.

    How plastics enter the human body

    Most people take in plastic flecks by eating, drinking, or breathing, because everyday products shed invisible dust whenever they are heated, abraded, or exposed to sunlight.

    Once swallowed or inhaled, particles small enough can slip through the gut wall or the thin air‑blood membrane in the lungs.

    Animal studies suggest that fragments under one micrometer can enter cells directly, whereas larger shards get trapped in tissue and spark local irritation. Either way, they bypass the body’s usual waste filters.

    Laboratory work on mice shows that digestive uptake rises when microplastics hitchhike on fats, a detail that matters for fertility research because reproductive hormones ride on similar lipid highways.

    The overlap raises worry that plastics may act as endocrine mimics or carriers for other chemicals.

    Dr. Gómez‑Sánchez’s team avoided laboratory contamination by collecting every human sample in glass vials and verifying the absence of background plastic. This means the polymers they found were genuine residents, not stray lab dust.

    Plastic harms fertility

    Mice exposed to polystyrene fragments shed sperm with damaged DNA and sluggish movement, effects traced to oxidative stress that overwhelms antioxidant defenses.

    Separate work on rodent Leydig cells shows shriveled mitochondria after nanoplastic exposure, which throttles testosterone production and shrinks litter sizes.

    Reviews published in 2024 concluded that microplastics can disrupt the hypothalamic‑pituitary‑gonadal axis, leading to hormonal imbalances and faulty egg maturation.

    Because human oocytes develop over months, chronic exposure could matter more than a short spike. That makes the repeated detection of PTFE in both eggs and sperm especially noteworthy.

    Plastic levels in eggs and sperm

    In the current data set, PTFE appeared in 31 percent of sampled egg fluid and 41 percent of semen. PP ranked second among women and polystyrene second among men, with polyethylene terephthalate also present but in smaller numbers.

    Annual plastic output has climbed from under two million tons in 1950 to about 460 million in 2019, a 230‑fold jump documented by the Minderoo‑Monaco Commission on Plastics and Human Health.

    Each uptick in production increases litter, weathering, and fragment release, tightening the feedback loop between plastics and people. Reproductive cells, delicate by design, stand on the front line.

    Gómez‑Sánchez reported that most reproductive samples contained only one or two plastic particles, amounts considered low compared with overall debris in the fluids. Yet fertility specialists note that even trace metals can derail embryo development, so particle counts alone may not predict risk.

    Human fertility research must include plastics

    “They should be considered an additional argument in favor of avoiding the generalized use of plastics in our daily lives,” said Professor Carlos Calhaz‑Jorge of the University of Lisbon. He also noted that further research is needed to prove causation.

    The research team will now study hundreds of patients and link particle loads to embryo quality during in vitro fertilization cycles. Those correlations could supply the first direct human evidence beyond laboratory rodents.

    They plan lifestyle questionnaires to test whether habits such as heavy bottled‑water use or microwaving food in plastic correlate with higher particle counts. The approach could convert abstract exposure theory into personal advice.

    “Microplastics are just one variable in a complex equation,” said Dr. Gómez‑Sánchez. He urges moderation of plastic use rather than alarm. 

    Simple habits to lower exposure

    Switching from plastic bottles to glass or stainless steel lowers ingestion because heat and time no longer leach particles from container walls. Replacing scratched nonstick pans can cut PTFE flakes in the diet.

    Researchers advise skipping plastic cutting boards and using ceramic or bamboo instead, because knife action liberates shavings that cling to food. Letting take‑out cool before transferring it from polystyrene boxes also helps.

    Air purifiers with HEPA filters capture airborne fibers shed by synthetic textiles, a step especially useful for nurseries. Regular vacuuming with a sealed system keeps particles from resuspending.

    These tweaks are not foolproof, yet they come with side benefits like removing chemical additives that ride on plastic dust. They buy time while science sorts out the clinical stakes.

    Efforts to cut human plastics pollution

    Public‑health researchers argue that personal choices alone cannot outrun a supply chain making more than a billion pounds of new plastic every day.

    Negotiators at the United Nations are hammering out a global treaty that could cap production and streamline recycling.

    Dr. Philip Landrigan of Boston College calls the treaty a once‑in‑a‑generation chance to protect human health, because curbing output remains the only sure way to slow microplastic fallout. He points to the emerging fertility data as evidence that time is short.

    Whether lawmakers act or not, the science of sub‑visible plastic is moving fast thanks to sharper imaging tools and nanomechanical sensors. Studies that once took months now finish in days, filling the literature with fresh clues.

    Every new dataset sharpens the same picture: plastics weather into dust, the dust goes everywhere, and living tissue keeps no closed doors. Eggs and sperm, it turns out, are no exception.

    The study is published in the journal Human Reproduction.

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  • Exploring the Sociodemographic Factors Influencing Women’s Experiences With Domestic Violence and Their Help-Seeking Behaviors at the National Guard Health Hospitals

    Exploring the Sociodemographic Factors Influencing Women’s Experiences With Domestic Violence and Their Help-Seeking Behaviors at the National Guard Health Hospitals


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  • Easy Ways To Regulate Your Cortisol Levels in the Morning and Have a Stress-Free Day

    Easy Ways To Regulate Your Cortisol Levels in the Morning and Have a Stress-Free Day

    “One recommendation that has worked very well for me, and that I give to all my patients, is to eliminate coffee as the first intake in the morning,” says de la Peña. “On a biochemical level, it exacerbates the natural cortisol spike that we all experience at the start of the day.”

    Instead, consider a nutritious, slow energy-releasing breakfast, one you enjoy and that makes you feel good for both physical and mental wellbeing. If you drink your coffee even a little later, you’ll experience its benefits all while avoiding those spikes. “Coffee contains caffeine, which is a natural stimulant,” nutritionist Mugdha Pradhan, founder of iThrive, previously told Vogue. “This means it can boost your metabolism by increasing the body’s heart rate and energy expenditure. That’s why drinking coffee in the morning—about 90 minutes after waking up—works well, because it syncs up with the body’s natural cortisol rhythm.”

    If you want to cut out coffee, you can choose herbal teas, chicory, or matcha instead.

    Other tips for stabilizing your cortisol levels

    These are certainly some pretty general recommendations for reducing cortisol, and the reality is that not everyone relaxes in the same way. A meditation session or yoga class can be an anti-stress balm for some, while for others, trying to focus on the present moment or doing the tree pose can be a challenge that actually destabilizes their cortisol levels.

    Truth is, finding universal tips and tricks for keeping your cortisol levels stable first thing in the morning and when leaving the house is tough. “Recommendations depends a lot on what helps each person to calm their nervous system,” explains de la Peña. “Some people will do better listening to music with headphones, others reading, while some are so tired that they take advantage of the subway ride to sleep and relax. Everyone knows what works best for them to cope with the situation, but what is really important is their level of self-care.” Ultimately: You have to know what personally relaxes and de-stresses you, and consistently seek it out.

    Still, there’s one very simple remedy: “When you realize you’re feeling high-stress and at speed, taking a deep breath is the best way to let our brain know that everything is okay,” she says. “It’s easy and free.”

    Keep breakfasts sacred

    Some people prefer to eat breakfast when they get to the office, or to practice intermittent fasting and do it later, but having a leisurely breakfast is one of the fundamental principles of slow mornings that help keep cortisol spikes at bay. “This way, you let your body know that there is nothing more urgent at that moment than to put the focus on you, to wake up calmly, to be thankful for another day, and to do whatever feels best for you in order to have a good day,” says de la Peña. “When I had high cortisol levels in the morning, I would feel so stressed I couldn’t even eat. Today, for me, breakfast is a sacred and symbolic act towards myself that sends an important message to my brain every morning: You come first, the rest can wait!”


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  • Dr Hankins Investigates Erectile Dysfunction Risk After Prostate Cancer Radiation

    Dr Hankins Investigates Erectile Dysfunction Risk After Prostate Cancer Radiation

    Prostate cancer under the microscope: © heitipaves – stock.adobe.com

    A new study led by Ryan Hankins, MD, urologist at MedStar Georgetown University Hospital, suggests that rectal spacers used during prostate cancer radiation therapy may help reduce the long-term prevalence of erectile dysfunction (ED). While rectal spacers are commonly used to protect the rectum from radiation exposure, this research offers the first large-scale real-world evidence that their benefits may extend to preserving sexual function in patients with prostate cancer.1

    Rectal spacers have already been shown in clinical trials to reduce rectal toxicity during prostate radiotherapy (RT), improving overall treatment tolerance. However, until now, their impact on erectile function had not been explored using national real-world data. The new study evaluates the association between rectal spacer use and ED diagnoses among prostate cancer patients receiving RT, using a robust dataset spanning thousands of US counties.

    The analysis drew on Medicare 5% and 100% standard analytic files, covering adult patients treated with intensity-modulated radiation therapy, brachytherapy, stereotactic body radiation therapy, or proton therapy between 2015 and 2022. Researchers focused on the proportion of patients diagnosed with ED in the years following treatment, comparing it with the proportion of patients in each county who had received rectal spacers during RT 1 to 5 years prior.

    The study included 247,250 patients with prostate cancer across 3132 US counties. On average, 1.3% of patients treated with RT were diagnosed with ED annually. Notably, rectal spacer use rose significantly during the study period, from just 2.9% in 2015 to 18.9% by 2022. Researchers used zero-inflated Poisson regression models to assess the association, controlling for various demographic and socioeconomic factors at both the patient and population levels.

    After adjusting for these variables, the results showed that counties with higher rectal spacer usage saw significantly lower rates of ED diagnoses 4 to 5 years later. Specifically, a 10-percentage point increase in rectal spacer utilization was associated with a 7.7% reduction in ED diagnosis after four years (P <.001) and an 8.4% reduction after five years (P =.006), suggesting a delayed but meaningful protective effect.

    “We do believe that the use of rectal spacers may actually decrease the incidence of being diagnosed with erectile dysfunction after treatment with radiation therapy,” explained Hankins in an interview with Targeted OncologyTM.

    A close-up of a microscope lens capturing a vibrant blue cancer cell, symbolizing the groundbreaking findings: © catalin – stock.adobe.com

    Future research will aim to better understand the biological mechanisms behind this time lag and explore the impact of rectal spacers in long-term, patient-level clinical trials.

    In the interview, Hankins further discussed these findings supporting the long-term benefit of rectal spacing in preserving sexual function in patients with prostate cancer who are undergoing prostate RT.

    Targeted OncologyTM: Can you discuss the rationale behind investigating the association between rectal spacer use during prostate radiotherapy and subsequent diagnosis of erectile dysfunction using this large dataset?

    Hankins: We use rectal spacers to help prevent [adverse events] from radiation therapy for prostate cancer. The spacers [were] developed to help with rectal toxicity, primarily to prevent rectal toxicity from radiation therapy. We are seeing now that there may be other benefits

    There have been some studies to show that there are benefits to bladder symptoms, but now we’re seeing that there may be benefits to erectile dysfunction diagnoses in patients treated for prostate cancer that have received rectal spacers, which is very interesting.

    Your study utilized county-level data. What were the key considerations that led you to choose this approach rather than individualized patient-level analysis?
    These are large datasets that are readily available. So, this is based on diagnoses that are reported—or really government-reported diagnosis codes. And so, we can dive into large datasets to see if we can find associations with improvement in these side effects. And that’s really why we used this information.

    The study really was able to include 247,000 men, nearly a quarter of a million prostate cancer patients, that were treated with radiation therapy across over 3,000 US counties.

    Were you surprised by the 4- to 5-year delay in ED reduction? What did you expect going into this?

    We were very surprised when we saw this. With prostate cancer treatment using radiation therapy, we know that there can be a delay, sometimes, in treatment [adverse events]. But it was very surprising to see that there may be a delay in even benefit with regard to these treatment-related [adverse events].

    How clinically significant is the 7% to 8% reduction in erectile dysfunction prevalence with increased spacer use?

    There are various rates of erectile dysfunction after radiation therapy in the published literature, and it ranges somewhere between 20% and 37% or so. So, when you see somewhere around a 7% to 8% reduction in the incidence of the diagnosis of erectile dysfunction after the treatment of prostate cancer, I think that really is somewhat significant, or a very interesting thing that we should continue to look into.

    What other findings were significant or important to note?

    I think the most interesting issue is that of why there is such a delay that we see in the decreased incidence of the diagnosis of erectile dysfunction. It is important to note that using this diagnosis and county-level data, there is a possible association here. It does not necessarily mean that there’s causation or causative factors. We need to look into this a bit further. And I think personalized further research into this topic is warranted.

    Which controlled factors most influenced your findings?

    It is hard to know using this type of dataset what factors influenced these findings. But we know that this is a comparative study of patients that received rectal spacers in comparison to patients that don’t receive rectal spacers. We really cannot make a definitive comment on what findings led to this. However, we do believe that the use of rectal spacers may actually decrease the incidence of being diagnosed with erectile dysfunction after treatment with radiation therapy.

    What is the main message for oncologists from this study?

    I think we have great evidence now, and evolving evidence, that shows multiple benefits for the use of rectal spacers in patients that have prostate cancer and are planning or considering radiation therapy as a definitive treatment. I think it just adds to the body of literature that shows we do recommend patients receive a rectal spacer. It’s a minimally invasive procedure that’s done in the office under local anesthesia, and it can have significant benefits for patients.

    We think that it’s an important thing patients should consider having done. I think that radiation oncologists and urologists should be versed in doing it and understanding the benefits.

    And we saw that during this, just looking at this data, there was an increase in the utilization of spacers from between 3% 5 years prior, up to 20.9% by 2022. So, there’s an increase in the utilization year over year, and I think that will just continue to occur as physicians become more versed in placing rectal spacers and the benefits that it has.

    What are the next steps for research?

    Really looking into this, and ideally into long-term, prospective, comparative trials, that’s going to be the most important thing. This is a study looking at diagnosis codes and with available Medicare 5% and 100% standard analytic file datasets. However, more intense research and long-term studies on patients receiving treatment is really going to be warranted and needed to know and really parse out the details here.

    REFERENCE:
    Hankins RA, Sato R, Mehta P, Bhattacharyya S, Ezekwekwu E, Collins S. Real-world U.S. county-level analysis of erectile dysfunction diagnosis following radiation therapy for localized prostate cancer: The impact of rectal spacer utilization. J Urol. 2025;213(5S):e1327. doi:10.1097/01.JU.0001110184.48142.9e.03

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  • The surprising link between hearing loss, loneliness, and lifespan

    The surprising link between hearing loss, loneliness, and lifespan

    Hearing loss doesn’t just affect how people hear the world — it can also change how they connect with it.

    A new study from the USC Caruso Department of Otolaryngology – Head and Neck Surgery, part of Keck Medicine of USC, published today in JAMA Otolaryngology – Head & Neck Surgery, is the first to link hearing aids and cochlear implants, surgically implanted devices that help those with profound hearing loss perceive sound, to improved social lives among adults with hearing loss.

    “We found that adults with hearing loss who used hearing aids or cochlear implants were more socially engaged and felt less isolated compared to those who didn’t use them,” said Janet Choi, MD, MPH, an otolaryngologist with Keck Medicine and lead researcher of the study. “This suggests that hearing devices may help prevent the social disconnection and broader health consequences that can follow untreated hearing loss.”

    Hearing loss affects an estimated 40 million American adults, yet many go untreated. When left unaddressed, hearing loss can make communication difficult, leading people to withdraw from conversations and social activities, according to Choi.

    Previous research has shown that over time, social withdrawal can reduce mental stimulation and increase the risk of loneliness, anxiety, depression, cognitive decline and dementia. It has also linked chronic social isolation to biological and neurological changes, including increased brain inflammation and alterations in brain structure.

    “Understanding the link between hearing loss, hearing device use and social isolation is crucial,” said Choi. “Until this study, it has been unclear whether hearing devices could help reverse the isolation.”

    Choi and her fellow researchers conducted a comprehensive, systematic review and meta-analysis of 65 previously published studies, encompassing over five thousand participants, on how hearing aids and cochlear implants affect three key measures: social quality of life, perceived social handicap, which refers to the limitations and frustrations hearing loss can create in social situations, and loneliness.

    The researchers found that adults using hearing devices feel more socially connected and less limited in social situations. They are better able to engage in group conversations and feel more at ease in noisy or challenging listening environments. Participants also reported feeling less socially handicapped by their hearing loss, with fewer barriers and frustrations during interactions and an improved ability to stay engaged without feeling excluded. This increased confidence can help users connect more easily with family, friends and colleagues, leading to stronger feelings of belonging and reduced social anxiety. The study also suggested hearing devices may reduce loneliness, although further research is needed in this area, according to Choi.

    Those with cochlear implants reported the most improvement in their social quality of life. This is likely because cochlear implants offer greater hearing restoration than hearing aids, especially for individuals with more severe hearing loss. As a result, they may experience more noticeable improvements in social engagement once their hearing is restored.

    While it was outside the scope of the study to measure how better social lives relate to improved cognitive outcomes, Choi believes there may be a connection, as previous research has found managing hearing loss may be key to reducing the risk of cognitive decline and dementia. “While our study didn’t directly measure cognitive outcomes, the improvements we saw in communication and social engagement suggest that by restoring clearer communication, hearing devices may help preserve cognitive health by keeping the brain more actively involved and people more connected,” Choi said.

    This research follows a January 2024 study by Choi showing that adults with hearing loss who use hearing aids have an almost 25% lower risk of mortality, suggesting that treating hearing loss can improve lifespan as well as social quality of life.

    “These new findings add to a growing body of research showing that hearing health is deeply connected to overall well-being,” said Choi. “We hope this encourages more people to seek treatment and helps clinicians start conversations with patients about how hearing devices can improve their quality of life.”

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  • Advancements in Essential Thrombocythemia: Targeting External Proteins

    Advancements in Essential Thrombocythemia: Targeting External Proteins

    In an interview, Aaron T. Gerds, MD, hematologist-oncologist at Cleveland Clinic and assistant professor in the Department of Medicine, School of Medicine, at Case Western Reserve University, discusses the unmet needs in the treatment of essential thrombocythemia (ET), as well as novel methods for approaching disease treatment.

    ET has very few commercially available treatments today. There is only 1 FDA-approved drug for ET: anagrelide (Agrylin). However, anagrelide is often inadequate, with some prospective trials even suggesting that hydroxyurea is superior, according to Gerds. Providers will also use interferons off-label.

    This year’s European Hematology Association (EHA) conference featured a significant abstract on ropeginterferon for ET, marking a big year for ET research. ET is usually a less-studied disease because it is less common than other hematologic malignancies, and patients often have very good survival rates, sometimes approaching that of the normal population.

    However, Gerds emphasizes that this doesn’t mean ET is without risk. The disease can progress to acute leukemia, also known as blast-phase myeloproliferative neoplasm (MPN), or to myelofibrosis, which involves an enlarging spleen, increased symptom burden, and cytopenias. ET itself can cause many symptoms for patients, especially those with higher platelet counts. These include constitutional symptoms like headaches, fevers, night sweats, and weight loss. Patients can also have an increased risk of bleeding events due to acquired von Willebrand syndrome. Therefore, effective therapies are lacking, and the consequences of this disease need to be addressed.

    To Gerds, what providers and patients really need are therapies that routinely change the course of the disease. While the average survival for an ET patient is good, it’s not perfect, and there are high-risk patients. Developing new therapies that can truly modify the disease, either eliminating it or at least lengthening the runway for these patients, would be incredibly important.

    As konwledge about MPNs grows, research is focusing less on morphologic features—like too many red cells in polycythemia vera (PV), too many platelets in ET, or scar tissue in the bone marrow in myelofibrosis. Instead, researchers are thinking more about the driver mutation. Patients with MPNs typically have 1 of 3 driver mutations: JAK2, calreticulin (CALR), or MPL. Clinically, these three entities behave differently.

    CALR-mutant protein is external to the cell. When the protein mutates, it gets stuck on the thrombopoietin receptor, Gerds explains. As the receptor is built and pushed to the cell surface, the mutated protein remains, activating the pathway. Because it’s external, it’s amenable to different forms of attack, such as monoclonal antibodies, bispecific antibodies, cellular therapy, CAR T-cells, or even vaccine therapy.

    This discovery has led to a clear pivot towards these types of treatments for this subset of MPN patients. A straightforward approach is to develop a monoclonal antibody that targets this external protein, similar to how there are monoclonal antibodies for almost everything else, like rituximab (Rituxan) in hematology. Monoclonal antibodies can disrupt JAK-STAT signaling, effectively starving these cells of the signal they need to divide, grow, and survive. It may also recruit immune cells, leading to some cell death via the immune system.

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