Technology has been instrumental in shifting patients from passive participants to active, empowered leaders in their healthcare journeys. 

Today, patients can use apps to book appointments, communicate with providers through online portals, and monitor their health using tools like Apple Watches, Fitbits, Oura Rings, and other devices.

The COVID-19 pandemic accelerated the adoption of telemedicine during the early months of 2020. Virtual visits allow patients to access care conveniently, reducing travel and exposure risks, although physical appointments remain essential for complex conditions.

Wearables and health apps offer real-time insights, helping patients visualize their progress, drive sustainable behavior changes, and collaborate with their care teams. Meanwhile, extended reality (XR) technologies are revolutionizing healthcare by offering immersive training and hands-on simulations.

Technology also has the power to address disparities in underserved communities. Affordable, user-friendly tools—such as artificial intelligence (AI)-driven diagnostics and wearable stethoscopes—can enable non-medical professionals to gather actionable health data, facilitating the early detection of chronic conditions like cardiovascular disease.

These tools improve access to care, enhance confidence in self-management, and foster collaboration between patients and providers.

The Rise of Telemedicine: Lessons from COVID-19

One of the major effects of COVID-19 was the rapid acceleration of technology adoption in healthcare. Telemedicine, which allows patients to receive care remotely through various technologies, 

 until March 2020, when Congress lifted numerous regulations in response to the SARS-CoV-2 pandemic, leading to rapid expansion. 

 showed that telemedicine encounters increased by 766% within the first three months of the pandemic — skyrocketing from 0.3% of all interactions in March to June 2019 to 23.6% in March to June 2020.

While the serious phase of the pandemic has passed, telemedicine is now a lasting part of American healthcare.

“Before the pandemic, if a doctor suggested a virtual visit, most patients would have resisted, insisting on an in-person appointment,” said Ugo Nwachukwu, PharmD, a pharmacy manager at Walmart Store 2258. “COVID, however, has shifted this mindset and normalized virtual care.”

Patients can now consult with their doctors from the comfort of their homes, reducing the need to travel and minimizing exposure risks. Similarly, the use of e-prescribing has soared since the pandemic. Instead of requiring a physical prescription, doctors can send prescriptions directly to pharmacies, cutting down on errors and making the process more efficient.

This transformation isn’t limited to virtual doctor visits. Companies like Walmart have embraced technology to streamline healthcare access.

“Patients can schedule a flu vaccine appointment online at a time that’s convenient for them,” Nwachukwu said. “They can then combine it with their regular errands, stopping by the pharmacy for a quick five-minute vaccine appointment before continuing their shopping.

Technology has also improved the quality of care. Patients can now easily access their medical records, track what’s missing, and take steps to stay on top of their health. The healthcare industry has adapted remarkably quickly to these changes, as have patients and providers.

When Antoine Keller, M.D., a surgeon and founder of the non-profit HeartSense, was in medical school in the late 80s and early 90s, his professor used to say, “There’s no substitute for being in front of the patient — talking to them and touching them. That’s the hallmark of medical care.”

However, he explained that during COVID-19, providers realized a virtual visit could be just as effective as an in-person one in certain cases. Telehealth appointments can make workflows much more efficient and save patients hours they’d otherwise spend in an office for something that doesn’t require a physical examination.

That said, there are advantages and disadvantages to both approaches. In areas like cardiovascular care, for example, being physically present matters — it allows doctors to gather critical information that can’t always be captured virtually.

Ultimately, the decision between telemedicine and in-person care depends on the acuity of the problem and the doctor-patient relationship. Telemedicine works well for routine follow-ups or less complex issues. For more serious conditions, physical visits remain essential.

XR technologies — virtual, augmented, and mixed reality — offer a breakthrough in surgical training by overcoming traditional limitations. The impact is transformative: fewer errors, better adherence, and improved outcomes that empower providers, patients, and caregivers.

This isn’t just another tech innovation — it’s a redefinition of what it means to care,” said Heather Gervais, chief executive officer of Osso VR. “Instead of navigating through complexity, patients step into immersive, hands-on experiences where they can practice administering an injection or managing a medical device.”

She emphasized how the shift to this practical solution can make treatments more manageable, enhance care, and increase accessibility.

 that evaluated the factors influencing the acceptance and use of XR in surgical training, the technology enhanced surgical training by improving skill development and procedural precision. However, although user-friendly designs and positive social influences support adoption, investigators noted overcoming financial and resource barriers remains essential.

“In the next 5 to 10 years, XR technology and immersive education will become a cornerstone of patient care,” predicts Gervais. “Technology, such as a virtual reality headset, will be as common as smartphones, offering patients instant access to at-home care instructions and realistic simulations. They’ll be able to practice as often as needed, risk-free and on their own terms.”

Digital tools offer significant benefits for patients. Among the key advantages is their ability to show people exactly what’s going on with their health, which helps engage and empower them. These tools allow patients to take control and visualize their health progress, empowering sustainable behavior change.

“I have no doubt that AI will become the standard of care,” said Arti Masturzo, MD, chief medical officer at CCS. “Today, we’re mainly seeing AI utilized in ‘safe’ ways in healthcare — to help with streamlining clinical notes, identifying high-risk patient populations, and more. But I see that changing swiftly as the general public becomes more familiar with AI in their day-to-day lives and as more evidence comes to market proving the effectiveness and safety of AI in healthcare.”

Although AI adoption in healthcare will take time, thoughtful implementation and education are critical to building trust and ensuring its success.

“AI technologies have the potential to reduce the cost of designing medicines for disorders with well-defined genetic causes,” said Anne Carpenter, Ph.D., senior director of the Imaging Platform, Institute Scientist, Broad Institute of MIT and Harvard. “So, I see it becoming more and more feasible for companies and even patient-led foundations to develop drugs for less common disorders.”

 touted continued glucose monitoring (CGM) as a groundbreaking approach to identifying prediabetes — defined as the intermediary stage between normal glucose homeostasis and diabetes — which currently affects approximately 720 million people globally.

In addition to tracking blood sugar levels, CGM devices can help patients learn more about how their lifestyle and decisions impact their levels, health, and overall well-being. They can be used to detect and prevent diabetes by using data to drive behavior changes through tailored therapeutic interventions. Despite some challenges with cost and the need for training and education, CGM may revolutionize prediabetes management.

“Personally, as a patient and a clinician, I am also seeing high value in not just utilizing health wearables as self-education and self-change tools but also as a way to encourage collaborative care between patient and physicians,” said Masturzo. “For example, I recently won my battle with breast cancer. As part of my self-care regimen, I utilized a wearable and the data it captured as a tool to drive better care collaboration with my clinical care team.”

To ensure privacy and data protection while using wearable devices or utilizing apps, Masturzo recommends using HIPPA-compliant apps or those with strong encryption to protect their data, updating the apps regularly, and not sharing sensitive health information on unsecured networks, such as coffee shops and airports.

Digital Tools for Underserved Communities

Keller believes it is important to recognize the current healthcare infrastructure in underserved communities, such as community centers and churches. If these organizations were equipped with affordable, easy-to-use technology, such as the Eko Heart stethoscope he recommends, non-medical professionals would be able to significantly expand their missions.

assessing the impact of wearable stethoscopes

, which were developed in the early 2000s, highlighted the potential of the devices to transform cardiovascular health management by allowing for early diagnosis and self-monitoring. The device was designed to be comfortable and lightweight so patients would be able to wear the device for extended periods — sometimes up to a week — without tubing, earpieces, or traditional displays. They “bridge the data gap between clinics and patients’ homes” by providing the core functions of a traditional stethoscope while utilizing modern technology.

Keller emphasized this technology needs to be inexpensive to expand the accessibility and must be easily reproducible — something that can be used by individuals without medical expertise to gather useful, actionable information.

“This is critical because one of the biggest challenges we face is workforce shortages — particularly when addressing the most common medical issue in America: cardiovascular disease,” Keller explained. “By training non-healthcare professionals with tools that can gather actionable information, we can identify chronic cardiovascular conditions early and encourage patients to seek care from qualified experts.”

However, he notes many doctors are hesitant about AI because of concerns over its accuracy and potential risks. For example, if AI identifies a condition that a doctor overlooks, there’s a fear of liability or missed diagnoses. It becomes information overload for physicians. Additionally, many communities have a skepticism towards the medical establishment. To mitigate this, he and his team work relentlessly to foster relationships and engage with community health infrastructures so that they can provide these tools and help manage the vast population of individuals with undiagnosed cardiovascular disease.

AI has the potential to revolutionize preventive care, helping patients identify risks earlier and collaborate with providers for proactive care. In the coming years, wearable devices, XR, and AI will become integral tools for both patients and providers.

Thoughtful implementation of these technologies — rooted in transparency, privacy, and patient trust — will empower individuals to take charge of their health while preserving the critical human connection at the heart of medicine.

Articles

Technology is transforming healthcare by empowering patients and enhancing care delivery. Telemedicine, accelerated by COVID-19, has become a staple, offering convenience and efficiency. Wearables and health apps provide real-time health insights, promoting behavior change and collaboration with care teams. XR technologies are revolutionizing medical training, improving outcomes. In underserved communities, affordable tech like AI-driven diagnostics and wearable stethoscopes can bridge healthcare gaps. The future of digital health lies in AI, wearables, and XR, with a focus on transparency, privacy, and patient trust to maintain the human connection in medicine.

How Digital Health Tools, AI, and Wearables are Transforming Care and Self-Management

The FDA has approved Humacyte’s acellular tissue engineered vessel-tyod (ATEV) therapy, under the name Symvess, for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.

“Today’s approval provides an important additional treatment option for individuals with vascular trauma, produced using advanced tissue engineering technology,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a statement.

“The FDA remains committed to facilitating the development of innovative products that offer potentially life-saving benefits for patients with severe injuries.”

The therapy is indicated to help provide revascularization when autologous vein grafting or implantation of a synthetic graft is not feasible. The ATEV is composed of human extracellular matrix (ECM) proteins typically found in human blood vessels and is a sterile, acellular tissue engineered vessel. Human vascular smooth muscle cells derived from human aortic tissue are utilized in the ATEV’s tissue engineering process.

“Currently available treatment options are limited for vascular trauma, which can lead to severe and potentially life-threatening complications,” Nicole Verdun, MD, director of the Office of Therapeutic Products in CBER, added.

“Today’s decision to approve a new therapeutic product based on novel medical technology represents important progress in addressing a significant unmet medical need.”

The ATEV was approved based on data from the pivotal Phase 2/3, prospective, single arm, multicenter V005 study in patients with life- or limb-threatening vascular trauma, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program.

In the study, 54 patients received the ATEV to repair an arterial vessel in the extremity. Of these patients, 36 (67%) retained primary patency (blood flow present without any intervention) and 39 (72%) retained secondary patency (at least one intervention required to maintain blood flow) at day 30. Within the first 30 days, 5 patients (9%) underwent amputation of the treated limb, and by the end of the study at month 36, 8 (15%) patients underwent amputation of the treated limb.

The ATEV has been used to repair traumatic injuries including car accidents, gunshot wounds, blast wounds, and industrial accidents by vascular and trauma surgeons in Level 1 Trauma centers throughout the United States, Israel, and Ukraine, with high rates of patency, or blood flow, and low rates of amputation and infection. These findings were published in 

“The approval of a vascular conduit that resists infection and remodels into native arteries is an extraordinary technological advancement that will have a huge impact on the quality of trauma care around the world,” investigator Charles J. Fox, MD, FACS, Director of Vascular Surgery, University of Maryland Capital Region, said in a statement.

“SYMVESS is perfectly sized to treat most injuries, has excellent handling properties, and reduces time necessary to save both life and limbs. The Humacyte team has responsibly and scientifically solved a major clinical problem that I believe will reduce the amputation rate for traumatic vascular injury. They should be congratulated on an accomplishment that will undoubtedly advance our specialty to the next level.”

Common adverse events (AEs) include thrombosis, fever, pain, and anastomotic stenosis. Serious AEs that may occur include graft rupture, anastomotic failure and thrombosis. Transmission of infectious diseases or infectious agents can occur from the human donor cells and human and bovine reagents used in manufacturing the ATEV, although donor eligibility requirements are in place to prevent the transmission of infectious diseases.

“The FDA approval of SYMVESS will make it the preferred conduit for complex vascular injuries, and particularly those at risk for infection,” investigator Ernest E. Moore, MD, FACS, Director of Research, Ernest E. Moore Shock Trauma Center at Denver Health, added.

“I look forward to using SYMVESS in my practice.”

The ATEV previously also received Priority Review and Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, and is also designated as a Priority Product by the U.S. Department of Defense, which allowed expedited development under Public Law 115-92 for a product that may diagnose, treat or prevent serious or life-threatening diseases or conditions facing American military personnel.

REFERENCES
1. FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities. News release. FDA. December 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-acellular-tissue-engineered-vessel-treat-vascular-trauma-extremities#

2. Humacyte Announces FDA Approval of SYMVESS™ (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma. News release. Humacyte. December 19, 2024. https://uk.finance.yahoo.com/news/humacyte-announces-fda-approval-symvess-034700671.html

3. Moore EE, Curi M, Namias N, et al. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. Published online November 20, 2024. doi:10.1001/jamasurg.2024.4893

The FDA has approved Humacyte's acellular tissue engineered vessel (ATEV) therapy, Symvess, for urgent revascularization in extremity arterial injuries when autologous vein grafts are not feasible. This approval is based on data from a pivotal Phase 2/3 study and real-world evidence from wartime injuries. Symvess, composed of human extracellular matrix proteins, has shown high patency rates and low amputation rates. It is recognized for its infection resistance and ability to remodel into native arteries, offering a significant advancement in trauma care.

The ATEV therapy, named Symvess, provides revascularization when autologous vein graft or implantation of a synthetic graft is not feasible. 

FDA Approves First Acellular Tissue Vessel Therapy for Extremity Vascular Trauma  

 may improve the diagnostic abilities of the convolutional neural network model and clinicians, according to new findings, although high dynamic range (HDR) images simulating HDR smartphone technologies have led to diminished diagnostic performance among both.

These data resulted from an analysis in which investigators sought to assess the impact of varying image qualities on the diagnostic capabilities of physicians and on a convolutional neural network model. Some of these included HDR-enhanced dermoscopic images.

The research was led in part by A.I. Oloruntoba, from the School of Public Health and Preventive Medicine at Monash University in Melbourne, Australia. Oloruntuba et al. highlighted that convolutional neural networks are a unique deep learning model made for visual data analysis and that these networks have mirrored the diagnostic skill of dermatologists in their evaluations of benign and malignant lesions on patient skin.

“This study evaluates the potential effects of varying image qualities, including HDR-enhanced dermoscopic images on the diagnostic capabilities of [convolutional neural network] models and clinicians,” Oloruntoba and colleagues wrote.

This study was made up of 2 parts, with investigators using a cross-sectional comparative design and evaluating the diagnostic capabilities of a convolutional neural network and its diagnostic accuracy. They also looked at confidence levels and clinical management decisions of dermatology professionals when reviewing images of different degrees of quality.

The investigative team invited, between May - August 2023, a set of 42 dermatology consultants, registrars, and residents to take part in the research. They would look at 101 lesions, with each being represented by 3 images of differing quality.

Those participating in this analysis looked at around 150 images in each session, with the 2 sessions being spaced out by the team at least 6 weeks apart. This was to minimize the likelihood of the subjects recognizing lesions based on image quality distinctions alone.

These images which were implemented in the team’s analysis originated from the Department of Dermatology and Allergy Centre at Odense University Hospital. They had been collected in the period between January - October 2018 as part of a teledermatology study and predominantly were of patients with Fitzpatrick skin types II and III.

All of the research team’s data, including their dermoscopic images and participant information such as years of experience in dermoscopy and devices utilized, were managed through REDCap. Following a review of each dermoscopic image, those participating in the analysis answered multiple-choice questions related to the classification of lesions.

Specifically, subjects would identify lesions within 1 of 8 predefined disease categories, determine whether they were benign or malignant, rate their level of confidence on a 5-point scale, and decide upon appropriate strategies for management.

The investigators found that in binary classification tasks, clinicians achieved their highest diagnostic skill level with high-quality images. They noted that these subjects achieved a sensitivity of 77.3%, specificity of 63.1%, and accuracy level of 70.2%.

In a similar vein, the research team determined that higher quality images led to the best results in multi-class classification. The team highlighted that this led to the highest specificity (91.9%) and level of accuracy (51.5%).

Notably, while clinicians were shown to have outperformed the model in binary classification tasks when assessing lower- and medium-quality images, their performance on the higher quality images was found to be comparable to the learning model.

However, the team added that in multi-class classification, the model had significantly outperformed physicians when assessing higher quality images (

“Given our study's finding that AI performance decreases with lower image quality, these models can alert clinicians when image quality may compromise diagnostic accuracy,” they wrote. “This can be particularly useful in addressing clinician confidence and reliance on image quality, ensuring more accurate assessments.”

Oloruntoba AI, Asghari-Jafarabadi M, Mar V, et al. Assessment of image quality on the diagnostic performance of clinicians and deep learning models: Cross-sectional comparative reader study. J Eur Acad Dermatol Venereol. 2024 Dec 10. doi: 10.1111/jdv.20462. Epub ahead of print. PMID: 39655640.

Esteva A, Kuprel B, Novoa RA, Ko J, Swetter SM, Blau HM, et al. Dermatologist-level classification of skin cancer with deep neural networks. Nature. 2017; 542(7639): 115–118.

The study evaluated the impact of image quality on the diagnostic performance of clinicians and convolutional neural network models in dermatology. High-quality dermoscopic images improved diagnostic accuracy for both clinicians and AI models, while HDR images reduced performance. Clinicians outperformed AI in binary classification with lower-quality images, but AI excelled in multi-class classification with high-quality images. The study suggests AI models can alert clinicians to potential diagnostic inaccuracies due to poor image quality, enhancing clinician confidence and accuracy in assessments.

These data resulted from an investigation of the effect of varying image qualities on the diagnostic abilities of a convolutional neural network (CNN) model and clinicians.

Study Highlights Necessity of Image Quality for Deep Learning Model Diagnostic Success

Topline data from the Phase 3 REDEFINE 1 trial found CagriSema, a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, achieved superior weight loss versus placebo in adults with 

Announced by Novo Nordisk on December 20, 2024, the trial achieved its primary endpoint with a superior weight loss of 22.7% after 68 weeks of treatment but still fell short of the ≥25% weight loss expected by the company in earlier discussions.

“We are encouraged by the weight loss profile of CagriSema demonstrating superiority over both semaglutide and cagrilintide in monotherapy in the REDEFINE 1 trial,” Martin Holst Lange, executive vice president for development at Novo Nordisk, said in a statement. “This was achieved even though only 57% of patients reached the highest CagriSema dose.”

The REDEFINE Phase 3 clinical development program comprises 2 pivotal trials enrolling approximately 4600 adults with overweight and obesity.

 In REDEFINE 1, 3417 people with obesity or overweight and ≥1 comorbidity, with a mean baseline body weight of 106.9 kg, were randomized to once-weekly subcutaneous CagriSema, or to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg and placebo.

Based on a flexible dosing protocol, Novo Nordisk indicated patients could modify their dosing throughout the trial. After 68 weeks, 57.3% of the CagriSema cohort were on the highest dose, compared with 82.5% for cagrilintide 2.4 mg and 70.2% for semaglutide 2.4 mg.

In evaluating the effect of treatment adherence, those treated with CagriSema achieved a superior weight loss of 22.7% after 68 weeks, compared with a 11.8% reduction with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone.

Further analyses found that 40.4% of patients who received CagriSema achieved a ≥25% weight loss after 68 weeks, compared with 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg, and 0.9% with placebo.

After measuring the treatment effect irrespective of adherence, Novo Nordisk reported people treated with CagriSema achieved a superior weight loss of 20.4% compared to a reduction of 11.5% with cagrilintide 2.4 mg, 14.9% with semaglutide 2.4 mg and 3.0% with placebo.

Safety data regarding CagriSema found the drug appeared to be safe and well-tolerated, with most common adverse events being gastrointestinal-related. Most adverse events were identified by Novo Nordisk as mild to moderate and lessened over time, remaining consistent with other GLP-1 receptor agonists in the drug class.

Overall, these data matched, but did not exceed, the expected weight loss in the obesity drug market, particularly compared with Eli Lilly and Company's tirzepatide (Zepbound). Data from the SURMOUNT-1 trial found tirzepatide led to an average weight loss of ~23% in clinical trials.

 A recent head-to-head trial, SURMOUNT-5, found tirzepatide achieved a mean weight reduction of 20.2% versus 13.7% with semaglutide 2.4 mg (Wegovy).

In the release, Novo Nordisk announced results from the second Phase 3 trial, REDEFINE 2, in adults with type 2 diabetes (T2D) and obesity or overweight are anticipated for the first half of next year.

“With the insights obtained from the REDEFINE 1 trial, we plan to further explore the additional weight loss potential of CagriSema,” Lange added.

CagriSema demonstrates superior weight loss in adults with obesity or overweight in the REDEFINE 1 trial. Novo Nordisk. December 20, 2024. Accessed December 20, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=915082.

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1). Clinicaltrials.gov. Accessed December 20, 2024. https://clinicaltrials.gov/study/NCT05567796?cond=obesity&term=REDEFINE+1&rank=1.

Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity. 

. 2022;387(3):205-216. doi:10.1056/NEJMoa2206038

Campbell P. Surmount-5: Tirzepatide bests semaglutide in head-to-head weight loss trial. HCP Live. December 4, 2024. Accessed December 20, 2024. https://www.hcplive.com/view/surmount-5-tirzepatide-best-semaglutide-in-head-to-head-weight-loss-trial.

CagriSema, a combination of cagrilintide and semaglutide, demonstrated superior weight loss in the Phase 3 REDEFINE 1 trial, achieving a 22.7% reduction in body weight over 68 weeks compared to placebo. Despite not meeting the anticipated ≥25% weight loss, CagriSema outperformed its individual components and placebo. Safety data indicated the drug was well-tolerated, with mostly mild to moderate gastrointestinal side effects. The results align with market expectations, comparable to Eli Lilly's tirzepatide. Further exploration of CagriSema's weight loss potential is planned.

CagriSema, a fixed dose of cagrilintide 2.4 mg and semaglutide 2.4 mg, achieved statistically significant weight loss after 68 weeks versus placebo.

CagriSema Achieves 22.7% Weight Loss in Phase 3 REDEFINE 1 Trial

Retransplantation in patients originally transplanted due to 

 offers good graft and patient survival and yields similar or better outcomes compared with patients transplanted for other liver diseases, according to findings from a recent study.

Leveraging data from the Nordic Liver Transplant Registry (NLTR) for transplants completed between 1982 and 2022, the study found liver retransplantation in patients with PSC and recurrent PSC does not represent a futile use of liver grafts and should therefore be encouraged in national and international liver transplant programs.

A chronic liver disease in which the bile ducts inside and outside the liver become inflamed and scarred, there is currently no cure for PSC. Treatment seeks to address narrowed or blocked bile ducts and relieve associated symptoms and complications of PSC, but liver transplantation may be necessary for cases leading to liver failure. However, PSC can recur after liver transplantation, potentially leading to graft failure and requiring retransplantation.

“A liver retransplant can be technically demanding and raises questions related to both health economics and ethical aspects in organ allocation policies. Given the challenges with recurrent PSC, it is important to establish whether the outcomes following retransplantation in patients originally transplanted for PSC are acceptable and comparable to retransplantation for other etiologies,” Espen Melum, MD, PhD, a professor of medicine at the University of Oslo and a senior consultant at Oslo University Hospital, and colleagues wrote.

 “Outcomes of retransplantation in patients with PSC have not been well documented, and recent findings are not consistent between cohorts and may be affected by study size and selection of the appropriate comparison groups.”

To address this gap in knowledge, investigators assessed data from the NLTR for adult liver transplant recipients in Denmark, Estonia, Finland, Iceland, Norway, and Sweden between 1982 and 2022. They compared data for patients listed with PSC as the primary transplant indication to patients transplanted due to nonviral, non-malignant, and non-acute liver diseases.

Between 1982 and 2022, 8486 patients recorded in NLTR received a first liver transplant and 866 (10.2%) also underwent retransplantation. Of these patients, 185 had PSC and 208 had other liver disease etiologies, including alcoholic (22%), autoimmune (17%), metabolic-cryptogenic (23%), and other cholestatic liver diseases (25%).

Investigators observed an increased rate of retransplantation in the PSC group versus the comparison group (18.9% vs 10.1%, respectively; 

 = .011). Additionally, the PSC group had longer graft survival following the first liver transplant than the comparison group (log-rank 

 <.001), with a median survival of 4.1 years versus 0.4 years. Urgent retransplantation after the primary transplant was also less frequent in the PSC group (10% vs 34%; 

Patients undergoing retransplantation in the PSC group had better graft survival than the comparison group. The graft survival at 1, 5, 10, 15, and 20 years post retransplantation in the PSC group were 85%, 73%, 61%, 41%, and 36%, respectively, while the numbers in the comparison group were 66%, 54%, 44%, 33%, and 17% (log-rank 

Investigators called attention to a significant difference between PSC and the comparison group for patient survival (log-rank 

 <.001). In multivariate analysis, donor age was a significant predictor of graft survival, while blood group mismatch and transplant year were significant predictors of patient survival.

Of note, retransplantation for recurrence of PSC had similar and better outcomes for graft and patient survival compared to other etiologies. Specifically, patients in the recurrent PSC group had survival rates of 87%, 79%, 59%, and 43% at 1, 5, 10, and 15 years post retransplantation versus 69%, 60%, 56%, and 47% in the comparison group (log-rank 

 = .09). Additionally, patients with PSC recurrence had statistically significantly improved survival compared with the comparison group (log-rank 

Investigators also pointed out the mortality rates following retransplantation in the PSC group were 5% at 90 days and 33% at 5 years while the corresponding rates in the comparison group were 10% and 52% (

 <.001). The 90-day mortality was similar in the recurrent PSC group and the comparison group (

 = .35), while the 5-year mortality in the recurrent PSC group was significantly lower (

“Our data suggest that retransplantation in PSC has a good performance in terms of graft and patient survival compared to other etiologies and does not represent futile use of liver grafts,” investigators concluded.

 “While we seek new and effective treatment strategies for PSC and rPSC, retransplantation in patients originally transplanted for PSC should be performed when needed and encouraged in the national and international liver transplant programs.”

Molinaro A, Engesæter LK, Jorns C, et al. Outcome of Liver Retransplantation in Patients With Primary Sclerosing Cholangitis. 

National Institutes of Health. Primary Sclerosing Cholangitis. February 2022. Accessed December 19, 2024. https://www.niddk.nih.gov/health-information/liver-disease/primary-sclerosing-cholangitis

Retransplantation in patients with primary sclerosing cholangitis (PSC) demonstrates favorable graft and patient survival rates, comparable or superior to those with other liver diseases. Analysis of data from the Nordic Liver Transplant Registry (1982-2022) indicates that PSC retransplantation is not a futile use of liver grafts. The study highlights better graft survival and lower mortality rates in PSC patients compared to other etiologies. Factors such as donor age and blood group mismatch influence outcomes. The findings support encouraging PSC retransplantation in liver transplant programs globally.

Retransplantation outcomes were similar or better in patients with PSC compared with patients with other liver disease etiologies.

New Data Supports Liver Retransplantation for Patients with PSC Recurrence

 has approved olezarsen (TRYNGOLZA), an investigational RNA-targeted medicine, as an adjunct to diet to reduce triglycerides in adults with 

Announced by Ionis Pharmaceuticals, on December 19, 2024, olezarsen marks the first-ever FDA-approved therapy to significantly reduce triglyceride levels and acute pancreatitis events in adults with FCS when used in conjunction with an appropriate diet (≤20 grams of daily fat.

“With no treatment options previously available, we were limited to relying only on extremely strict diet and lifestyle changes as the sole preventative treatment option,” said investigator Alan Brown, MD, clinical professor of medicine at Rosalind Franklin University of Medicine and Science. "The FDA approval of [olezarsen] is an important moment for people living with FCS, their families and physicians who now, for the first time, have a treatment that significantly lowers triglycerides and decreases the risk of potentially life-threatening acute pancreatitis events, as an adjunct to a low-fat diet."

A rare, genetic disease defined by severely elevated triglycerides, FCS impacts an estimated 1 to 13 people per million in the US.

 Without an FDA-approved therapy, people with FCS are typically nonresponsive to triglyceride-lowering treatment and remain at high risk of acute pancreatitis and other chronic health issues. Instead, these individuals rely on highlight-restrictive nutrition management to manage the disease’s risks.

Olezarsen is designed to lower the body's production of apoC-III, a protein produced in the liver that regulates triglyceride metabolism in the blood.

 The FDA accepted the NDA for olezarsen in June 2024 and granted the medicine Priority Review, setting a December PDUFA date without requiring an advisory committee meeting.

 Its application in FCS was centered on data from the randomized, double-blind, placebo-controlled Phase 3 BALANCE trial, demonstrating a significant reduction in fasting triglyceride levels with olezarsen treatment.

The BALANCE trial measured the safety and efficacy of olezarsen 80 mg and 50 mg versus placebo over 53 weeks.

 The trial involved 66 patients with genetically identified FCS, with 21, 22, and 23 individuals randomized to olezarsen 80 mg, olezarsen 50 mg, and placebo once monthly, respectively.

This patient population had a mean triglyceride level of 2630 mg/dL, with the majority female, White, and had a normal body mass index (BMI). BALANCE’s dual primary endpoints were the difference between olezarsen 80 mg and placebo, and olezarsen 50 mg and placebo, in the percent change in fasting triglyceride levels from baseline to 6 months.

Upon analysis, triglyceride levels at 6 months were significantly reduced with the 80 mg dose of olezarsen compared with placebo (–42.5%; 

 = .0084), while the 50 mg dose did not achieve statistical significance (−22.4%; 95% CI, −47.2 to 2.5; 

These BALANCE data showed reductions from baseline to 12 months were further improved, with olezarsen showing a placebo-adjusted 57% mean reduction in triglycerides.

Secondary endpoint analysis linked the use of olezarsen 80 mg to a 73.7% reduction in mean apolipoprotein C-III (APOC3) level from baseline to month 6, while olezarsen 50 mg achieved a 65.5% reduction, compared with placebo. Safety analyses at 53 weeks showed that 7 patients experienced 11 episodes of acute pancreatitis in the placebo group, compared with a single episode in the pooled olezarsen group (rate ratio [RR], 0.12; 95% CI, 0.02 to 0.66).

At the time of NDA acceptance, Ionis also announced the completion of enrollment for the Phase 3 CORE, CORE2, and ESSENCE trials for severe hypertriglyceridemia, with expected results in the second half of 2025.

"Today's FDA approval of [olezarsen] heralds the arrival of the first-ever FCS treatment in the U.S. – a transformational moment for patients and their families," Brett P. Monia, PhD, chief executive officer of Ionis, added in a statement. "For the first time, adults with FCS can now access a treatment that substantially reduces triglycerides and the risk of debilitating and potentially life-threatening acute pancreatitis."

TryngolzaTM (Olezarsen) approved in U.S. as first-ever treatment for adults living with familial chylomicronemia syndrome as an adjunct to Diet. Ionis Pharmaceuticals, Inc. December 19, 2024. Accessed December 19, 2024. https://ir.ionis.com/news-releases/news-release-details/tryngolzatm-olezarsen-approved-us-first-ever-treatment-adults.

Vaezi Z, Amini A. Familial Hypercholesterolemia. [Updated 2022 Sep 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK556009/

Campbell P. FDA grants priority review for Olezarsen in familial chylomicronemia syndrome. HCP Live. June 25, 2024. Accessed December 17, 2024. https://www.hcplive.com/view/fda-grants-priority-review-for-olezarsen-in-familial-chylomicronemia-syndrome.

Campbell P. Olezarsen shows ability to reduce triglycerides for patients with FCS in balance trial. HCP Live. September 29, 2024. Accessed December 17, 2024. https://www.hcplive.com/view/olezarsen-shows-ability-to-reduce-triglycerides-for-patients-with-fcs-in-balance-trial.

The FDA has approved olezarsen (TRYNGOLZA) as the first treatment for familial chylomicronemia syndrome (FCS), a rare genetic disorder characterized by elevated triglycerides. Olezarsen, an RNA-targeted therapy, significantly reduces triglyceride levels and acute pancreatitis risk when combined with a low-fat diet. The approval is based on the Phase 3 BALANCE trial, which demonstrated substantial triglyceride reduction with olezarsen 80 mg. The trial also showed a significant decrease in apolipoprotein C-III levels and a lower incidence of acute pancreatitis compared to placebo.

Olezarsen ushers in a new era of care as the first therapy to receive FDA approval for adults with familial chylomicronemia syndrome as an adjunct to diet.

Olezarsen Earns First-Ever FDA Approval for Familial Chylomicronemia Syndrome

Yehuda Handelsman, MD: Insulin Resistance in Cardiometabolic Disease and DCRM 2.0

22nd Annual World Congress Insulin Resistance Diabetes & Cardiovascular Disease (WCIRDC)

, Yehuda Handelsman, MD, medical director and principal investigator for The Metabolic Institute of America (TMIOA) and chair and program director for WCIRDC, discussed key insights from this year’s meeting, including the foundational role of 

 in cardiometabolic, renal, and hepatic complications. Handelsman highlighted the multifaceted nature of insulin resistance, exploring its causes—such as elevated cortisol levels—and its link to comorbidities like kidney disease and bone health, particularly involving parathyroid hormone.

Handelsman also introduced the Diabetes CardioRenal Metabolic (DCRM) 2.0 Recommendations, an updated, internationally focused guideline designed to address the interconnected nature of diabetes, cardiovascular, renal, and metabolic diseases. Unlike traditional guidelines that are discipline-specific, DCRM 2.0 was developed in collaboration by over 50 specialists, including endocrinologists, cardiologists, nephrologists, and primary care physicians. He noted this version is an expansion of its 2022 predecessor by incorporating new areas such as pulmonary disease, inflammation, obesity, and technology while maintaining a streamlined, easy-to-follow format for diagnosis, prevention, and management of multi-system conditions.

Since its publication, Handlesman indicated DCRM 2.0 has gained significant global traction, becoming the most-cited paper in the journal’s history. In particular, Handelsman emphasized its international adaptability, with presentations already occurring across Europe, Asia, and major conferences such as the American Heart Association (AHA) Scientific Sessions 2024. Overall, the comprehensive recommendations seek to provide practical, integrated care frameworks to improve outcomes for patients with complex cardiometabolic diseases.

Relevant disclosures for Handelsman include Amarin, Amgen, BI-Lilly, Novo Nordisk, Sanofi, and others.

Handlesman Y. Everything IR - Cardiometabolic Diseases. Presented at the 22nd Annual World Congress Insulin Resistance Diabetes & Cardiovascular Disease (WCIRDC). Los Angeles, California. December 12-14, 2024.

Handlesman Y. DRCM 2.0. Presented at the 22nd Annual World Congress Insulin Resistance Diabetes & Cardiovascular Disease (WCIRDC). Los Angeles, California. December 12-14, 2024.

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Yehuda Handelsman, MD highlights insulin resistance’s role in cardiometabolic disease and introduces DCRM 2.0 as a global, multi-specialty care framework.

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Zealand Pharma’s glepaglutide for the treatment of adult patients with 

Announced on December 19, 2024, the CRL ​​states the New Drug Application (NDA) did not meet the full requirements for substantial evidence to establish the efficacy and safety of the to-be-marketed dose of glepaglutide. As a result, the FDA recommends Zealand Pharma conduct an additional clinical trial to provide further evidence to confirm the efficacy and safety of glepaglutide at the to-be-marketed dose.

“While we are certainly disappointed in the FDA’s decision, we remain confident that the data showed robust and compelling evidence of both efficacy and safety for glepaglutide treatment. We remain firm in our belief that glepaglutide provides a significant advance in GLP-2-based therapies for the potential treatment of SBS patients who are dependent on parenteral support,” David Kendall, MD, chief medical officer of Zealand Pharma, said in a press release.

According to a press release from Zealand, the company expects to initiate a single phase 3 trial in 2025 that is anticipated to support marketing authorizations for glepaglutide in geographies outside the US and the EU and provide further confirmatory evidence for a regulatory resubmission in the US.

A long-acting GLP-2 analog, glepaglutide received orphan drug designation from the FDA on October 24, 2017, based on phase 2 data demonstrating its impact on fecal wet weight output as well as energy, fluid, and electrolyte absorption.

Its NDA was supported by data from the phase 3 EASE program, including 4 clinical trials: EASE-1, EASE-2, EASE-3, and EASE-4.

EASE-1 was a randomized, double-blind phase 3 trial that evaluated the safety and efficacy of once- and twice-weekly subcutaneous administration of glepaglutide 10 mg compared with placebo in 106 patients with SBS and intestinal failure who were dependent on PS ≥ 3 days per week. Results showed twice-weekly glepaglutide significantly reduced the total weekly volume of PS at 24 weeks as compared with placebo (

= .0039). While once-weekly glepaglutide also resulted in a numeric reduction in weekly PS, it did not reach statistical significance.

At 24 weeks, the average reduction in PS from baseline was 5.13 liters/week for patients treated with glepaglutide twice weekly and 3.13 liters/week for patients treated with glepaglutide once weekly, versus 2.85 liters/week for patients treated with placebo. Among the study participants who were treated with glepaglutide, 9 were completely weaned off PS, while no placebo-treated patients were able to discontinue PS.

An extension trial of EASE-1, EASE-2 is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once or twice weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with glepaglutide in EASE-2. Results from an interim analysis conducted when all patients had completed ≥ 6 months of treatment showed clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS.

Additionally, EASE-3 is evaluating glepaglutide administered once weekly using an auto-injector. Findings from an interim analysisconducted in the first 43 patients rolled over from EASE-2 showed that the reduction in prescribed PS was generally maintained.

EASE-4 is a phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake.

“We are committed to working with the agency to align on the path toward a regulatory approval, so that we can bring glepaglutide to patients in the U.S. In parallel, we expect to proceed with our current plans for a European Marketing Authorization Application submission in 2025,” Kendall said.

Global News Wire. U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome. December 19, 2024. Accessed December 19, 2024. https://www.globenewswire.com/news-release/2024/12/19/3000220/0/en/U-S-Food-and-Drug-Administration-issues-Complete-Response-Letter-for-the-glepaglutide-New-Drug-Application-for-the-treatment-of-short-bowel-syndrome.html

Biospace. Zealand Pharma submits New Drug Application to the US FDA for glepaglutide in short bowel syndrome. December 22, 2023. Accessed December 19, 2024. https://www.biospace.com/zealand-pharma-submits-new-drug-application-to-the-us-fda-for-glepaglutide-in-short-bowel-syndrome

Biospace. U.S. FDA Grants Orphan Drug Designation To Zealand Pharma’s Glepaglutide for the Treatment of Short Bowel Syndrome. October 24, 2017. Accessed December 19, 2024. https://www.biospace.com/u-s-fda-grants-orphan-drug-designation-to-zealand-pharma-s-glepaglutide-for-the-treatment-of-short-bowel-syndrome

The FDA issued a Complete Response Letter to Zealand Pharma for glepaglutide, a GLP-2 analog for short bowel syndrome, indicating the need for additional clinical trials to confirm its efficacy and safety. Despite the setback, Zealand Pharma remains confident in glepaglutide's potential, citing robust phase 3 trial data. The company plans a new phase 3 trial in 2025 to support global marketing authorizations and a US regulatory resubmission. Glepaglutide has shown promise in reducing parenteral support dependency, with some patients completely weaned off.

FDA Issues CRL to Glepaglutide for Short Bowel Syndrome, Cites Insufficient Evidence

The rapid level of enrollment in a recent 

 study highlights that intentional and strategic approaches to trial design and conduct can lead to greater participation and retention of participants with skin of color.

This ad hoc quality improvement assessment of the VISIBLE study was authored in part by Andrew Alexis, MD, MPH, of Weill Cornell Medicine’s department of dermatology in New York. Alexis et al. sought to explore whether an innovative trial design can lead to the removal of barriers to recruiting and retaining individuals with psoriasis and skin of color.

The investigators of this assessment further noted that the demographic composition of most prior dermatology research was not reflective of the US’s diverse population, as well as the country’s disease epidemiology.

“This report discusses innovative strategies used in the ongoing VISIBLE trial to overcome barriers to recruiting and retaining participants with [skin of color] and to address the unmet needs of diverse populations with [skin of color],” Alexis and colleagues wrote.

The Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety (VISIBLE) trial was described by the investigative team as a landmark in clinical research as the first large-scale, double-blind, randomized, placebo-controlled analysis specifically designed to look into psoriasis and treatment outcomes across all skin tones in those with skin of color.

The study was designed to assess guselkumab’s efficacy and safety. A variety of objective assessments in this ad hoc assessment of the VISIBLE study were used, as well as patient-reported parameters, with investigators examining participant recruitment and retention strategies used in the trial.

VISIBLE enrolled a total of 211 subjects, with the group’s mean age being 43 years, 36% of the population being female, and 64% being male. The study looked at individuals with skin of color and moderate-to-severe plaque psoriasis between August 2022 - March 2023.

The research team implemented both objective methods, such as colorimetry to determine subjects’ Fitzpatrick skin types, and self-reported data. The VISIBLE study achieved noteworthy results, with the investigators highlighting that there was an enrollment rate approximately 7 times faster than historical psoriasis studies.

Participants were asked by the team to identify their own racial and ethnic backgrounds. The research team noted that their representation was 29.9% Asian, 0.5% American Indian or Alaska Native, 11.4% Black, 6.2% Middle Eastern, 44.5% Hispanic or Latino, 0.5% Pacific Islander or Native Hawaiian, 5.7% multiracial, and 1.4% those labeled as other.

All participants identified as a race or ethnicity other than White, the investigators noted, and more than half of them had skin tones classified within the darker range of the Fitzpatrick scale (types IV-VI).

The VISIBLE analysis introduced several innovative approaches: assessing genetic and comorbidity biomarkers specific to populations with diverse skin types, tracking any post-inflammatory changes in pigment with combined objective and subjective evaluations, and prioritizing selection of sites based on diverse demographics and investigator expertise.

Additionally, the study also incorporated trainings in cultural competency with the aim of enhancing recruitment and retention. They also gathered patient-reported data in participants’ native languages and carried out blinded central reviews with the aim of accuracy and consistency in their tests of efficacy for those with skin of color and psoriasis.

These strategies were said to have collectively enhanced the trial’s reliability, inclusivity, and relevance for addressing psoriasis in diverse populations.

The VISIBLE study, a landmark trial in dermatology, focused on psoriasis treatment outcomes across diverse skin tones, particularly in individuals with skin of color. It achieved rapid enrollment and retention by employing innovative strategies, such as cultural competency training, diverse site selection, and the use of both objective and subjective assessments. The study's demographic composition was notably diverse, with all participants identifying as non-White. The findings aim to address clinical care gaps and inform best practices for inclusive dermatology research, enhancing the trial's reliability and relevance for diverse populations.

The VISIBLE study’s findings indicate that specific strategies may yield more diverse populations in clinical trials for patients with psoriasis and other conditions.

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