Panelists discuss how emerging treatment modalities including digital therapeutics and novel pharmaceutical agents represent an exciting new frontier that could elevate the standard of care for schizophrenia patients when combined with traditional approaches.

Emerging Treatment Modalities and Elevating Standard of Care in Schizophrenia

Video content above is prompted by the following: 

The current landscape of schizophrenia treatment represents an exciting frontier with multiple emerging therapeutic modalities under investigation. Beyond xanomeline/trospium chloride, researchers are exploring various novel compounds including aloterant, SEP-363856, ulotaront, and ACP-204, each targeting different neurobiological pathways. Digital therapeutics represent another promising avenue, particularly for addressing cognitive and negative symptoms that have been challenging to treat with traditional pharmacological approaches. This convergence of pharmaceutical innovation and digital health technologies offers unprecedented opportunities for comprehensive treatment strategies.

The paradigm shift in schizophrenia treatment extends beyond individual medications to encompass a broader tool kit approach for health care providers. Like contractors who utilize both traditional tools and modern equipment, clinicians must embrace established therapies and emerging interventions to provide optimal patient care. The integration of novel pharmacological agents with digital therapeutics, cognitive behavioral therapy, and other evidence-based interventions creates possibilities for personalized treatment approaches that address the complex, multifaceted nature of schizophrenia.

Elevating the standard of care requires ongoing education, advocacy, and early adoption of proven therapeutic innovations. Health care providers have a responsibility to educate patients, families, and caregivers about all available treatment options, ensuring informed decision-making and optimal outcomes. The combination of new mechanisms of action, improved safety profiles, and complementary therapeutic modalities positions the field to address previously unmet needs in schizophrenia treatment. This evolution toward earlier intervention with more effective, tolerable treatments offers hope for significantly improving long-term outcomes and quality of life for individuals living with schizophrenia.

Panelists discuss how emerging treatment modalities including digital therapeutics and novel pharmaceutical agents represent an exciting new frontier that could elevate the standard of care for patients with schizophrenia when combined with traditional approaches.

 Hara Oyedeji, PMHNP-BC, APRN, MSN, MSEd 

Raffi Tachdjian, MD, MPH, FAAAAI, FACAAI: 

Let’s switch gears to barriers in the use of biologics in clinical practice. Dr White, do you see any trends or utilization differences, with the penetration of therapeutics, into the lives of patients with severe asthma, moderate to severe asthma, eosinophilic asthma, and difficult-to-treat asthma, among primary care providers or physicians vs the specialists?

In terms of thinking about how you titled this section, the barriers, I haven’t seen much of a trend of use in primary care physicians for biologics. There are multiple reasons for that. There’s a lot of what we’ve outlined, how complex it can be to decide what agent you might start a patient on. There’s going to be a barrier there. There’s definitely going to be a barrier in the ability to get insurance approval because these require some specialization in terms of the office staff and nursing staff shepherding it through the approval process. A lot of primary care practices may not have that infrastructure built in. I haven’t seen a big uptake in my area with primary care physicians using respiratory biologics.

But what I have seen is a lot more willingness to use these biologics at the point where it’s determined that they’re necessary. Because previously, 5 or 6 years ago, there was this sense that you’d start 1 or 2 of your worst patients on this and see how things would go for them, if these made a big change. In the allergy and immunology space, I definitely think we’ve seen a lot of comfort, recognizing that once a patient is poorly controlled, we need to think about these biologics. We have a lot of comfort using them now. They’re very safe. They’re very effective.

The other group I’ve seen a lot of uptick in is with our pulmonary colleagues, who also see a lot of asthma. Before these newer biologic agents, they may not have been using omalizumab in their practices for a variety of reasons, but now they’re much more willing and comfortable using these. It’s the same idea, reserving it for not just the very worst of the worst or the steroid-dependent asthmatics but also starting to more routinely consider this. At my institution, Scripps Health, it’s been great. We have a lot of sharing patients. Patients may have some confusion about what might be the best biologic, so they consult with us and still have a lot of their care directed by pulmonary. Those are the trends. I’ll bet it’s different in different parts of the country. Dr Chase and Dr Siri, I’m curious if you’ve noticed anything or any trends in your own practices.

 Overall we’ve seen similar trends with primary care providers. There’s a better awareness among primary care providers, who know that patients are coming and asking about these medications. Some have been talking with family members or friends who may have exposure to them. Others have been seeing television commercials of individuals breathing better, and wondering how they can be in that same category. The uptake has been higher with pulmonary colleagues over time. I hope they’ve learned that everyone in allergy is very friendly. A call to inquire about whether this patient is a good candidate for a biologic is much more common than ever before.

 There’s increased recognition from allergists that we’re allergy, asthma, and immunology experts. We’ve seen a lot of good collaboration with our pulmonary colleagues as well as our primary care doctors. Primary care has so many challenges, such as limited time. It’s helpful that there has been an increased movement toward biologics. There’s more understanding and education into what’s considered uncontrolled, what we accept as a number of exacerbation rates and corticosteroid systemic burdens over time. It’s been really helpful.

Raffi Tachdjian, MD, MPH, FAAAAI, FACAAI:

 A couple of weeks ago, I had a patient come in on a follow-up with his wife and son. I thought, “They must be on their way to go shopping or to a restaurant.” It was the son who said, “Thank you for giving me my father back, because now I can play sports with him. He can breathe.” My patient was nodding; he’s a man of a few words. Those scenarios validate why we’re doing this and pushing the science to get better outcomes. Better outcomes, but not at the risk of worse adverse effects.

Dr Chase, earlier you described that give and take, the benefits and risks with the corticosteroids. With that in mind, what can be done to increase the availability of biologics in scenarios where patients need them and suffer from the deleterious effect?

That’s a great question. This is on all of us to educate our patients right off the bat. I love to tell patients, “Don’t worry.” I always have a couple of backup plans if we think they’re going toward the point of needing more assertive therapies in terms of biologics. That education is great. With settings like this, we all get to talk together, engage one another, learn from one another, and think more about how we can better educate our colleagues on the fact that these biologics exist. They’re there for us to use, and we wield them all the time. Let us be helpful to you if we can.

Access has always been an issue. For many individuals, access can be getting to a provider in an area that’s within a reasonable distance. We’ve seen some uptake with telemedicine with the pandemic, and that’s been lovely. But for an issue like asthma, we sometimes need to see patients in the office. However, all these biologics now, with the exception of reslizumab, can be self-administered. That’s huge. That’s what patients want: to take medication in the comfort of their own home, on their own time, knowing that there aren’t safety concerns about it.

With this group here, we’ve gotten very quickly comfortable with biologics being another step in the armamentarium we use to treat patients. We look at someone as they walk in the door and think, “I’ll bet they’re going to need a biologic at some point.” We’ve all done that. Now we have lots of years of safety and efficacy data. Hearing stories from patients validate that this was the right decision to make the right approach.

Finally, there’s the overall thinking about being part of the conversation. We need to let others know that this isn’t a field that’s stagnant. We’re getting new breakthroughs all the time. We need to encourage research further on asthma as a main issue for individuals in the United States and worldwide. There are even more to come. There are barriers, but there are lots of reasons to be excited about the future of asthma.

Experts discuss the use of biologic treatment in asthma by primary care physicians vs pulmonology specialists as well as overcoming barriers to biologic use through patient and physician education.

Trends in Biologic Treatment of Asthma

Andrew White, MD

We’ve covered a lot of ground here today. I want to thank everyone for this rich and informative discussion. Before we conclude, I’d love to get final thoughts from each of you. Perhaps we can start with you, Angelos.

Angelos Halaris, MD, PhD, APA, ACNP, CINP: 

Thank you. This was a great idea and a great panel. It’s too bad we didn’t have 6 hours or longer to get more in depth about these very apt questions and issues you raised, Steve. I’d like to conclude by saying we need to help the public, including our patients and colleagues, raise their level of awareness of depressive illness in general, and the state of the art about what we can do. I’m not going to use the word pandemic because it has a different connotation, but it’s a very widespread problem worldwide.

Thanks to the [COVID-19] pandemic, the latest statistics as reported by the AMA [American Medical Association] a couple of days ago showed that of those who have been infected with COVID-19, about a third of them go on to develop clinical depression, anxiety, possibly substance abuse, suicidality, and even neurological sequelae. We have a serious situation here, and it behooves us to make the public and our colleagues—psychiatric and more so nonpsychiatric colleagues—aware that we have a real problem. There are a lot of things we can do. We’ve got to work as a team. We have to be cooperative and open-minded. Doing anything we can to help our patients be safe, get better, and have a life offers the best gratification of my entire career.

That’s an important message, Angelos. Hopefully this discussion we’re having today that will be shared with our colleagues will go some distance toward accomplishing that. Thank you. Lisa, do you have final thoughts?

Yes. Somewhat riffing off of what Angelos said, before the COVID-19 pandemic, the WHO [World Health Organization] said that in 2020, depression would be the leading cause of disability. That was before the pandemic ever happened. It’s 2021; no new data are out there, but each of us can hazard a guess as to where major depressive disorder lies. The overarching message for me is of love and patient-centered care. We’re living in times where there’s heightened sensitivity to everything. There’s a lot of talk in the community about who should be delivering care and what kind of care. But at the end of the day, each of us has made a commitment to mankind to help end suffering. If we keep that first, we’ll all make the world a better place.

Those are beautiful sentiments, Lisa. Thank you. Patricia?

 I definitely agree with what my colleagues have said here on the panel. We really need to look at integrative care. Because depression is going to be so much more prominent in the next 5 to 10 years, we need to look and be able to identify patients who are suffering from depression and start treatment earlier. One of the biggest issues is that treatment is withheld and not started earlier. That’s why we’re seeing so many patients who later are resistant to medication as well. Refer early, educate yourself, and please don’t be scared of the new treatments we have: racemic ketamine, esketamine, and all the other things coming down the pike that we are very excited about. Don’t be afraid. Educate yourself. Know that there are other treatment options for your patients, and they deserve to be considered if they’re the right patient.

Thank you, Patricia. Thank all of you. And thank you for watching this 

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Closing thoughts regarding a discussion on improving the management of patients with treatment-resistant depression using newer treatment approaches in a more standardized fashion. 

Integrated Care and Treatment-Resistant Depression 

Angelos Halaris, MD, PhD, APA, ACNP, CINP

Douglas DiRuggiero, DMSc, MHS, PA-C, a certified physician assistant who is known for his clinical experience in dermatology, spoke at the 

 about tips for healthcare providers in dealing with difficult 

 editorial team, features a discussion regarding such cases, advice from DiRuggiero on how to deal with said cases, and additional information related to psoriasis management. DiRuggiero also provided specific examples of such cases to highlight real-world evidence for those interested in such advice.

Dealing with Difficult or Unique Psoriasis Cases, with Douglas DiRuggiero, DMSc, MHS, PA-C

“When I approach a patient that I think has psoriasis, the first tip is to make sure that it is psoriasis, and that's because successful treatments are always gonna be targeted towards the right diagnosis,” DiRuggiero explained. “...Part of my session that I presented at the beginning was looking at some very unusual presentations of psoriasis with a plaque that has central clearing, what we call ‘annular psoriasis.’ A very unusual presentation.”

DiRuggiero noted that once a diagnosis is determined, an assessment of other co-morbid conditions is needed, with examples such as joint involvement or GI involvement being given. If a patient had inflammatory bowel disease, for example, DiRuggiero noted that such a case may require avoidance of a certain class of therapeutics for such a reason.

“So right up front, I give them hope that we can choose a multitude of products that we think will get them almost all the way clear and keep them clear almost all the time,” DiRuggiero said. “Then we started going through some questions and talking about the different classes of monoclonal antibodies or oral treatments that are out, that are systemic, to try to really get them the clearance and improvement in their skin, or their skin and joints, that they would they would want to have.”

Later, DiRuggiero was asked to provide specific examples of such cases and asked about the management of these patients’ psoriasis.

“Some unique cases would be based on severity,” DiRuggiero explained. “[For] someone who comes in with almost 90% body surface area covered, what do you do with a patient like that? Again, it's giving them hope and saying that we've got systemic therapies that can be very, very helpful. Unique cases [could also be] patients who present with pretty significant joint problems, where they already have two sausage digits or dactylitis, and have psoriatic arthritis and psoriasis.”

Other examples of unique cases highlighted in this interview included severe cases with small levels of BSA but located in high-impact areas such as the genitalia or scalp.

“I presented a case that was in literature, not my case, of a woman who had crusted, Norwegian scabies that was being mistreated as psoriasis,” DiRuggiero said. “It looked like psoriasis. You looked at photographs…it had thick plaques on the chest. So that was one where you had to put on your thinking cap, so to speak.”

For additional information related to this topic, view the full video segment posted above.

The quotes used in this interview summary were edited for clarity.

This interview from the 2025 New Wave Dermatology Conference features DiRuggiero discussing challenging psoriasis cases and tips for healthcare providers.

Douglas DiRuggiero, DMSc, MHS, PA-C

Importance of Multispecialty Communication in Hypercortisolism Management and Referrals

Video content above is prompted by the following:

What is the role of primary care clinicians in identifying and screening patients for hypercortisolism?

How does hypercortisolism affect mental health? How can primary care clinicians help identify patients with mental health conditions who might be at risk for hypercortisolism?

How does hypercortisolism contribute to osteoporosis and an increased risk of fractures?

Experts discuss the role of primary care clinicians in identifying and screening patients for hypercortisolism, how hypercortisolism affects mental health and how primary care clinicians can identify at-risk patients, and how hypercortisolism contributes to osteoporosis and an increased risk of fractures.

John Anderson, MD

Patrick J. Strollo, MD, from the University of Pittsburgh Medical Center

HCPLive Five at SLEEP 2025 

 SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies,

 from June 9 – 11th in Seattle, Washington, to share new sleep medicine data.

As a part of HCPLive’s on-site coverage, the editorial team conducted > 15 interviews on various topics, from new pharmacotherapy treatments for OSA and AI in sleep medicine to changes to the restless legs syndrome (RLS) guidelines and the association between napping and mortality risk in older adults.

In this edition of the HCPLive Five, the team captured the top 5 interviews at the meeting, featuring research on a VeNS device for insomnia and PTSD, latest pharmacotherapy developments for sleep apnea, new RLS guidelines, the link between naps and mortality risk, and AD109 for obstructive sleep apnea (OSA).

VeNS Device Improves PTSD, Insomnia Symptoms in RCT, with Peter Colvonen, PhD

Peter Colvonen, PhD, an associate clinical professor at the University of California, San Diego, presented results from a randomized controlled trial showing that vestibular nerve stimulation (VeNS) significantly improved PTSD and insomnia symptoms. The 12-week trial involved over 380 adults with PTSD, many of whom face years-long waits for 1-on-1 therapy.

VeNS, a non-invasive, at-home device, led to significantly greater reductions in PTSD and Insomnia Severity Index scores compared to a sham. Colvonen emphasized its potential as an interim solution for patients stuck on long waitlists, highlighting VeNS as a scalable option to stabilize symptoms until gold-standard care becomes available.

Latest Pharmacotherapy Developments for Sleep Apnea, with Danny Eckert, PhD

Danny Eckert, PhD, a professor at Flinders University, highlighted emerging pharmacotherapies for obstructive sleep apnea (OSA), addressing both anatomical and non-anatomical causes. The FDA-approved GLP-1 agonist tirzepatide helps reduce OSA in obese patients through weight loss.

For non-obese individuals, AD109, a combination of aroxybutynin and atomoxetine, showed promise in a phase 3 trial, resolving OSA in 25% of patients. Eckert also discussed potassium channel blockers that reset airway reflexes and acetazolamide, which lowers loop gain and reduces OSA severity. These advances mark a shift toward personalized, drug-based OSA treatments, especially for patients who struggle with traditional therapies like CPAP.

RLS Guidelines Advise Against Dopamine Agonists, With John Winkelman, MD, PhD

John Winkelman, MD, PhD, chief of the sleep disorders clinical research program at Massachusetts General Hospital, discussed the AASM’s updated restless legs syndrome (RLS) guidelines, which now advise against routine use of dopamine agonists due to high augmentation risk. Up to 50% of patients on these drugs may experience symptom worsening over five years. The guidelines recommend iron therapies and alpha-2-delta ligands (gabapentin, gabapentin enacarbil, pregabalin) instead.

Winkelman emphasized identifying and managing exacerbating factors like antidepressants, antihistamines, or sleep apnea. He advises a slow, careful taper of dopamine agonists over 6–12 months, warning patients of temporary worsening but long-term improvement once off the medication.

Naps at Noon Linked to Mortality Risk in Older Adults, with Chenlu Gao, PhD

Chenlu Gao, PhD, from Massachusetts General Hospital and Harvard Medical School, presented findings linking longer, irregular, and early afternoon naps to increased all-cause mortality in middle-to-older adults. Using UK Biobank data from over 86,000 participants, the study found that greater nap duration, high day-to-day variability, and naps between 11 am–3 pm were associated with higher mortality risk over an 8-year follow-up.

Gao emphasized the study was observational and not causal—napping patterns may reflect underlying health issues like sleep disorders or chronic illness. She advised clinicians to address root causes of excessive napping rather than eliminating naps entirely.

AD109 Improves OSA in Phase 3 SynAIRgy Trial, With Patrick Strollo, MD

Patrick Strollo, MD, from the University of Pittsburgh Medical Center, presented phase 3 SynAIRgy trial results showing that AD109, a once-daily oral neuromuscular modulator, significantly improved obstructive sleep apnea (OSA). In the 26-week trial of 646 participants intolerant of CPAP, AD109 reduced apnea-hypopnea index (AHI) by 55.6% and improved oxygenation measures. More than half of participants had reduced OSA severity, and 22.3% achieved full disease control (AHI < 5).

AD109, a first-in-class combination of aroxybutynin and atomoxetine, works by enhancing upper airway muscle tone during sleep. Apnimed plans to submit an FDA application in early 2026, with additional phase 3 data expected later in 2025.

Sleep experts gathered at SLEEP 2025 to discuss advancements in sleep medicine, including new treatments and guidelines. Key topics included a VeNS device for PTSD and insomnia, pharmacotherapy for sleep apnea, updated RLS guidelines, and the link between napping and mortality risk. The VeNS device showed promise in reducing PTSD and insomnia symptoms, while new pharmacotherapies like AD109 and tirzepatide offered hope for OSA patients. Updated RLS guidelines advised against dopamine agonists, and research linked irregular naps to increased mortality risk, emphasizing the need to address underlying health issues.

Check out the top 5 interviews from SLEEP 2025.

Patrick J. Strollo, MD

Using Biomarkers to Monitor ATTR-CM

Summary for Physicians: Long-Term Monitoring in ATTR-CM and Biomarkers Used

 (transthyretin amyloid cardiomyopathy) involves regular clinical assessments, imaging studies, and biomarker evaluations to track disease progression and manage complications. Key aspects of monitoring include:

Regular assessment of cardiac symptoms such as heart failure, arrhythmias, and functional status

Monitoring for signs of organ involvement beyond the heart, as ATTR-CM can affect other organs, such as the liver and nervous system

 to assess left ventricular function and wall thickness

 to evaluate myocardial involvement and amyloid deposits

 to detect amyloid deposition in the heart

N-terminal pro B-type natriuretic peptide (NT-proBNP):

 A marker for heart failure, often elevated in ATTR-CM

 Can indicate myocardial injury or stress, which may be elevated in patients with ATTR-CM

 Helpful in distinguishing ATTR-CM from other forms of amyloidosis, such as light chain amyloidosis

 Can be elevated in systemic inflammation associated with amyloidosis

TTR genetic testing and serum TTR concentration

 may help to confirm the diagnosis and assess familial risk.

, including exercise tolerance and quality of life (using tools such as the 6-minute walk test and patient-reported outcome measures).

Monitoring these biomarkers, alongside clinical and imaging evaluations, helps physicians track the progression of ATTR-CM, adjust therapies, and intervene early in cases of disease progression or complications. Regular follow-up is essential for optimizing management and improving patient outcomes.

Panelists discuss how long-term monitoring in transthyretin amyloid cardiomyopathy (ATTR-CM) involves regular clinical assessments, imaging studies, and biomarker evaluations—such as NT-proBNP, troponin, and TTR testing—to track disease progression, manage complications, and optimize patient outcomes.

Prem Soman, MD, PhD, FACC, FRCP

Let’s talk about the elephant in the room. We’ve been bouncing around it a little. Let’s talk about vaccine hesitancy and how you guys address that in education standpoints as well as how that can impact vaccination compliance or resistance. What’s your language? What’s your methodology around noticing that? Do you notice it? Do people say it to you? Do you feel it? How do you work down that road to try to convince people to get a vaccine?

Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP:

 This is my baby. This is my doctoral work, so I love this stuff. A couple of things that I want people to know is that studies are pretty clear these days that even people who are vaccine proponents now feel the need to question science and vaccines. Every provider should expect what used to be a 30-second recommendation to now take 5 minutes because people feel the need to ask the questions about it. Even though they’re going to take it, they feel the need. There’s more vaccine hesitancy out there.

The other thing is that we talked about strong recommendations. We call it presumptive vs participatory. In a study, they followed providers who asked, “How do you feel about getting your shots today?” It shouldn’t surprise you that less than 10% of people took their shots. But when the provider said, “You’re due for 2 shots today. It’s okay to give them together,” 80% of people took those vaccines.

My last point on vaccine hesitancy is that you have to be prepared that people are going to ask about it. Take a deep breath and answer their questions. There are going to be the 4% of the population who are vaccine refusers. I’ve learned from all of my research that you will never move those folks. They believe in something that none of us can even fathom, but they come up with it. If they want to believe something, they’re going to google it and find research to support their beliefs. You’re never going to move them.

It’s the movable middle that we have to focus on. That’s the 20% to 40% of the population who will go based on a trusted source, as JAM [Jacinda Abdul-Mutakabbir, PharmD] mentioned. If they trust you and you make that recommendation, they’ll listen. Focus on the movable middle. The ones who march in and say, “What vaccines do I need? Give them to me,” are a provider’s dream. “Sure, give me everything I need.” With people in the middle, we have to take a breath, meet them where they’re at, be honest with them, give them what they’re asking, and don’t go into too much detail.

 Yes. I’ve also seen people talk about how sometimes it takes more than 1 interaction with a patient to convince them. Maybe they come in and you tell them, “You need this vaccine today,” and they say, “Absolutely not.” But by the end of the appointment, they say, “Tell me more about it and I’ll think about it for next time.” We see this with patients in the clinic with other vaccines as well. “I’m not ready to get 5 vaccines today, but I’ll get 1 next time.” We think, “OK, we’ll take what we can get. Let’s just start off on the right foot.” Sometimes it takes persistence and patience, which we don’t all have at this point in the pandemic. But there are people who can be swayed if we take the time, ask them multiple times, and not give up on them.

 Yes. We use a Z code in our charts for vaccine refusal by patient or parent. That’s a signal to the nurse practitioner who sees them next that there’s been a vaccine that they didn’t get the last time, and to take a look at the note and try to follow up on that conversation.

Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP, and Madeline King, PharmD, BCIDP, provide insight on vaccine hesitancy among patients and the importance of increasing vaccine uptake to protect against SARS-CoV-2.

Addressing Vaccine Hesitancy and Uptake for SARS-CoV-2

Rodney Rohde, SV, SM, MB (ASCP), FACSc

 You mentioned clinical data. Reggie, are you familiar with the published data, especially from the ICONIC trial, which allowed the FDA approval of these drugs for children with Alagille syndrome?

 I have some knowledge. I love the name of the trial. ICONIC sounds iconic. Interestingly, it’s one of what I call backward placebo-controlled trials. It’s a medication withdrawal trial—that’s the fancy name—where everybody up front received the drug openly, indifferent to the usual trial where half the patients get the drug up front and half don’t. In this one, everybody got it up front. Supposedly, this improves or diminishes the subjective bias of itching.

Patients received maralixibat 380 µg/kg once a day for 18 weeks. Half the patients were continued on therapy, and in the other half, the medicine was removed. No one knew who was in which group. That was done for 4 weeks. Then everybody got back on open label for an extended period of time, up to 48 weeks. That’s where the ICONIC trial stopped. There’s an ongoing long-term arm of this trial, but ICONIC stopped at 48 weeks.

The take-home message was that in the first 18 weeks of open label, their ItchRO [Itch Reported Outcome] score dropped by almost 2 points. One point is considered clinically important in validation of the ItchRO, so a drop in 2 points is quite significant. As you might have imagined, during the 2 to 4 weeks where the drug was withdrawn, the effect remained in those who continued on drug. But in those where the drug was withdrawn, their itch scores rose back to baseline, clearly suggesting that this medicine was helping the itch.

Furthermore, after everybody gets on open label again, even the patients on placebo get back on the drug, and their ItchRO scores improve. The differences in improvement during the open labels and placebo are pretty dramatic. If you look at these patients at a year out, about 80% of the patients experienced a greater than or equal to 20% reduction in serum bile acids. Serum bile acid reduction was correlated to improved pruritus.

The medicine showed not only improvement in itch but also improvement in the serum bile acids, which may be getting a little off topic or to the next topic. There’s a conversation about serum bile acids being a biomarker of liver outcome. If you lower your serum bile acids, you might get more bang for your buck. You might get rid of the pruritus, but you might also be able to improve or prevent progression of the liver disease, although that might be a question for another one of these conversations. That’s a summary of the efficacy data of ICONIC.

Of course, you have to talk about adverse events, which did happen. As you might imagine, the most common were GI [gastrointestinal] related. Vomiting, abdominal pain, and diarrhea occurred in 50%-plus of the patients on treatment. Fortunately, these adverse events rarely led to drug discontinuation. They were quite tolerable, so the vast majority of patients were able to complete the trial. In the ongoing long-term arm, that seems to be the norm.

 Reggie, thank you for very nicely summarizing it. The drug, of course, was maralixibat.

Regino Gonzalez-Peralta, MD, reviews clinical implications from the phase 2 ICONIC trial evaluating the use of maralixibat for the management of Alagille syndrome in pediatric patients.

Using Maralixibat for the Management of Pediatric ALGS

Ryan T. Fischer, MD

Panelists discuss how lifestyle modifications, particularly sodium restriction and plant-based diets, form the foundation of resistant hypertension management, with innovative approaches like teaching kitchens and food-as-medicine programs being more effective than traditional diet counseling.

Lifestyle vs Medical Treatment

Lifestyle modifications form the essential foundation for resistant hypertension management, with sodium restriction being particularly crucial as these patients tend to avidly retain sodium. Dietary counseling should focus on practical, actionable advice rather than complex numerical targets, emphasizing elimination of added salt, adoption of plant-based diets rich in fruits and vegetables, and avoidance of processed foods high in sodium and preservatives.

Innovative approaches to dietary education, such as teaching kitchens with culinary demonstrations, show promise in helping patients implement sustainable dietary changes. The DASH diet and Mediterranean dietary patterns have demonstrated significant blood pressure reductions of up to 8 mm Hg when properly implemented. Health care providers should dedicate 3 to 4 minutes per visit to dietary counseling, using simple guidelines like the “plate method” (half vegetables/fruits, quarter lean protein, quarter whole grains) and avoiding the “four bad whites” (sugar, flour, rice, potato) plus salt.

Emerging lifestyle interventions beyond traditional recommendations include guided breathing exercises, isometric grip strength training, acupuncture, and air filtration to reduce pollutant exposure. While these interventions may not cure hypertension independently, they can provide additive benefits when combined with traditional approaches. Weight loss through any method, including newer GLP-1 receptor agonists, consistently produces significant blood pressure reductions often preceding glucose improvements in diabetic patients.

Authors