Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A randomized, placebo-controlled phase 2a trial evaluating SPL026, an intravenous formulation of dimethyltryptamine (DMT), met its primary endpoint in adults with moderate-to-severe 

, demonstrating a statistically significant reduction in depressive symptoms at 2 weeks compared with placebo. The findings represent one of the first controlled trials of a short-acting psychedelic in MDD.

 SPL026 (intravenous dimethyltryptamine, DMT)

 Short-acting serotonergic agonist; 5-HT2A receptor agonist

 Moderate-to-severe major depressive disorder

 –7.35 MADRS point difference vs placebo at Week 2 (

 (≥50% MADRS reduction at Week 2): 35% vs 12%

 No treatment-related serious adverse events reported

 SPL026 not advancing; informing HLP004 Phase 2 GAD program

“We have shown that a single dose of SPL026 is safe, effective and durable, with treatment effects comparable to other promising interventional treatments often requiring much longer treatment sessions,” lead investigator David Erritzoe, MD, PhD, from Imperial’s Department of Brain Sciences, said in a statement, “Although such early trial results should always be interpreted with some caution, these data show the promise of DMT as a potentially more cost-effective treatment for clinical depression than related serotonergic agonists with longer psychoactive action due to the shorter dosing sessions.”

SPL026 is an intravenous formulation of DMT, a short-acting serotonergic psychedelic that acts primarily as a 5-HT2A receptor agonist. Unlike psilocybin, which typically produces psychoactive effects lasting 4 to 6 hours, intravenous DMT has a substantially shorter duration of acute subjective effects, often less than 30 minutes.

In the double-blind stage of the study, a single 21.5-mg intravenous infusion of SPL026 administered over 10 minutes resulted in a mean difference of –7.35 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 2 compared with placebo (95% CI, –13.62 to –1.08; 

=.023). Treatment effects were detectable as early as week 1, with a mean difference of –10.75 points (95% CI, –16.95 to –4.55; 

 =.002). Response rates, defined as ≥5 0% reduction in MADRS score at week 2, were 35% in the SPL026 arm versus 12% with placebo. Remission rates (MADRS ≤ 10) were 29% vs12%, respectively.

The study enrolled 34 participants (mean age 32.8 years; 29.4% female; predominantly White) with a mean depression duration of 10.5 years. Participants were randomized 1:1 to receive SPL026 (n = 17) or placebo (n = 17) in conjunction with supportive psychotherapy that included preparation and integration sessions. The primary endpoint was the change in MADRS score from baseline to week 2.

In an open-label extension, all participants were eligible to receive SPL026 2 weeks after the initial dose, with antidepressant effects reported as persisting up to 3 months post–first dose. Some participants reportedly maintained benefits up to 6 months, although detailed long-term subgroup data were not announced. The therapy was generally well tolerated, with no reports of treatment-related serious adverse events.

Although SPL026 demonstrated proof-of-concept efficacy, Helus Pharma indicated it is not advancing the intravenous formulation in its current form. Instead, mechanistic and clinical insights from the trial are informing the development of HLP004, a proprietary novel serotonergic agonist under investigation for generalized anxiety disorder (GAD), with phase 2 topline data anticipated in the first quarter of 2026. The company is also advancing HLP003 in phase 3 development as adjunctive therapy for MDD; that program has received Breakthrough Therapy designation from the FDA.

“This publication represents an important validation of short-acting serotonergic agonists as a clinically meaningful approach in mental health treatments,” said Michael Cola, chief executive officer of Helus Pharma, in a statement. “The findings provide clinical proof-of-concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility. We look forward to reporting topline data from our Phase 2 study of HLP004 in generalized anxiety disorder later this quarter.”

Nature Medicine Publishes Helus Pharma’s Randomized, Placebo-Controlled Phase 2a Trial of SPL026 in Major Depressive Disorder. Helus Phama. Published on February 17, 2026. Accessed on February 19, 2026. 

https://www.globenewswire.com/news-release/2026/02/17/3239141/0/en/Nature-Medicine-Publishes-Helus-Pharma-s-Randomized-Placebo-Controlled-Phase-2a-Trial-of-SPL026-in-Major-Depressive-Disorder.html

Articles

A single 21.5-mg IV infusion of SPL026 (DMT) plus supportive psychotherapy produced a statistically significant and clinically meaningful MADRS reduction versus placebo in moderate-to-severe MDD, with separation by week 1 and sustained benefit at week 2. Acute psychoactive effects were brief (<30 minutes), supporting a shorter-session psychedelic model. In 34 participants, response and remission rates favored SPL026, and tolerability was acceptable without treatment-related serious adverse events. Despite proof-of-concept efficacy, development is shifting toward next-generation serotonergic agonists.

A phase 2a randomized, placebo-controlled study shows –7.35 MADRS difference at 2 weeks with SPL026 compared with placebo. However, the study is not advancing.


News

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clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Intravenous DMT (SPL026) Demonstrates Significant MDD Reduction in Phase 2a Trial

Andres Hurtado-Lorenzo, PhD, is VP of IBD Ventures and Translational Research at the Crohn’s & Colitis Foundation.

Intermittent Fasting for Crohn’s Disease? New Clinical Trial Explained

Interest in dietary management of Crohn’s disease has long focused on identifying specific foods that trigger symptoms or promote remission, but a growing body of research is expanding that conversation beyond food composition alone. Increasingly, investigators are examining whether meal timing may influence inflammation, metabolic health, and the gut microbiome in patients with inflammatory bowel disease.

In a recent randomized clinical trial published in 

, researchers evaluated time-restricted feeding as a complementary strategy in adults with Crohn’s disease, adding new rigor to a field eager for validated lifestyle interventions.

In discussing the findings, Andres Hurtado-Lorenzo, PhD, VP of IBD Ventures and Translational Research at the Crohn’s & Colitis Foundation, emphasized that traditional dietary strategies in Crohn’s disease have largely focused on what patients should eat. While he says that food quality remains central, emerging science now suggests that when people eat may be equally important.

“Multiple studies in the context of other diseases have shown that meal timing can independently influence circadian regulated immune and metabolic pathways, microbial balance and adipose tissue biology, even without changes in calorie intake or nutrient composition,” Hurtado-Lorenzo explained. “In Crohn's disease, the intersection of chronic immune dysregulation, disturbances in gut microbiota, and high prevalence of overweight and obesity establishes a strong case for examining time based dietary interventions such as intermittent fasting.”

The 12-week randomized controlled trial evaluated the effects of a 16:8 time-restricted feeding protocol, in which participants fasted for 16 hours and consumed all meals within an 8-hour window. Investigators assessed the impact on clinical disease activity, body composition, and systemic inflammation in adults with Crohn’s in clinical remission and overweight or obesity.

Results showed that over 12 weeks, BMI decreased significantly in the time-restricted feeding group compared with controls (Δ –0.9 ± 0.03 kg/m2 vs +0.6 ± 0.3 kg/m2; 

 <.001). Energy intake and diet quality (Mediterranean Diet Index) did not differ between groups or across time, suggesting BMI reduction occurred independent of caloric restriction and diet quality.

Clinical disease activity as measured by the Harvey–Bradshaw Index also improved significantly in the time-restricted feeding group (Δ –2 ± 4 vs –0.5 ± 2; 

 = .02), with a 40% decrease in stool frequency and 50% reduction in abdominal discomfort, which was not observed in controls.

Additionally, compared with controls, the time-restricted feeding group exhibited significant reductions in serum adipokines, including leptin, plasminogen activator inhibitor-1, and adipsin (all, 

 < .05). Further analysis revealed ​​greater BMI loss correlated positively with both anti-inflammatory cytokines (interleukin [IL]1RA, IL4; 

 = 0.78) and pro-inflammatory cytokines (IL2, IL12p40, IL12p70; 

Hurtado-Lorenzo pointed to the magnitude and speed of change as being among the most striking findings from the study. From a mechanistic standpoint, he outlined 2 primary processes underlying these effects, metabolic remodeling and autophagy, and further hypothesized that fasting-induced autophagy could play a therapeutic role in Crohn’s due to its potential contribution to disease pathogenesis.

“Importantly, this is the first randomized clinical trial to demonstrate a benefit of intermittent fasting in patients with Crohn's disease, providing rigorous evidence in the field that is hungry for validated lifestyle strategies,” Hurtado-Lorenzo said. “In my opinion, this approach meets a real clinical need of sustaining remission by offering a practical solution in synergy with pharmacological treatment strategies for Crohn's disease.”

Crohn’s & Colitis Foundation of America. Intermittent fasting cut Crohn’s disease activity by 40% and halved inflammation in randomized clinical trial. February 9, 2026. Accessed February 19, 2026. 

https://www.eurekalert.org/news-releases/1114988

Haskey N, Ye J, Lewis A, Yousuf M, Reimer RA, Raman M. Time-Restricted Feeding Reduces Body Mass Index, Visceral Adiposity, Systemic Inflammation, and Clinical Disease Activity in Adults With Crohn's Disease: A Randomized Controlled Study. 

. Published online February 9, 2026. doi:10.1053/j.gastro.2025.11.008

Videos

Hurtado-Lorenzo explains the growing interest in meal timing as a potential lifestyle intervention for Crohn’s and recent trial data supporting its utility in this patient population.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Strategic Alliance Partnership

Meal Timing and Crohn’s Disease: Clinical Implications of Intermittent Fasting, With Andres Hurtado-Lorenzo, PhD

Janani Rangaswami, MD, FAHA, a nephrologist with expertise in cardiovascular- kidney medicine; Professor of Medicine, George Washington University, Washington DC; Co-chair, Scientific Advisory Group of the AHA's presidential advisory on CKM Health.

An estimated 90% of US adults fall somewhere along the cardiovascular-kidney-metabolic (CKM) spectrum, a framework clinicians are increasingly applying as new therapies, including GLP-1 receptor agonists for CKD, expand options for managing overlapping risk.

Introduced in a 2023 presidential advisory, the CKM model formalizes the interconnected relationship between cardiovascular disease, chronic kidney disease (CKD), obesity, diabetes, and metabolic dysfunction. Rather than viewing these conditions in isolation, the framework stages risk across a continuum from individuals without overt disease to those with advanced cardiovascular and kidney complications.

The framework has gained additional urgency as new therapies, including GLP-1 receptor agonists recently approved for CKD, provide clinicians with more tools to address overlapping metabolic and cardiorenal risk.

For Janani Rangaswami, MD, FAHA, professor of medicine at George Washington University and co-chair of the advisory’s scientific writing group, the shift reflects what clinicians are already seeing in daily practice.

In routine clinical practice, where do you most often see cardiovascular disease, CKD, and diabetes converge in the same patients, and how does that overlap influence management decisions?

So I think the overlap is so significant that after the framework of cardiovascular-kidney metabolic syndrome was put out by the American Heart Association — and I am co-chair of that scientific advisory group that wrote that presidential advisory in 2023 — the analysis of data in the United States shows that 90% of Americans are living with at least a stage of CKM syndrome. And you know, CKM syndrome encompasses the entire spectrum of risk, starting from people who have no risk factors or cardiovascular disease, going all the way through obesity, vascular risk factors, subclinical disease, and clinical cardiovascular disease.

And so in any healthcare setting — primary care, specialty care between cardiology, nephrology, and endocrinology — this is the bulk of practice. When you look at a specialty like in my practice, when I see individuals with kidney disease, diabetes alone is responsible for close to 50% of the cause behind that kidney disease. And then when you add in obesity and metabolic dysfunction and hypertension, all of these really come together very heavily. So that's why understanding that interconnectedness is so important between these three elements.

From a cardiorenal perspective, what did the approval of semaglutide in patients with CKD signal about how we are beginning to approach metabolic risk across both heart and kidney disease?

I think that was such an important development, because with the new therapies, and particularly with the GLPs, our approach to the management of kidney disease has evolved. When we didn't have some of these foundational classes — you know, the SGLT2 inhibitors came first, we have non-steroidal MRAs, and of course the incretin class therapies — a lot of the management of coexistent metabolic factors like diabetes or obesity was just like controlling A1c or counseling about weight management, and fully recognizing that obesity played such an important piece. But there were really no definitive therapies the way we have today.

Now, the standard of care across these foundational classes of therapies goes beyond just treating the risk factor. So while the GLPs in semaglutide are very effective for A1c management and weight management, the FLOW trial — which was the pivotal trial that led to the labeled approval of semaglutide in kidney disease with type 2 diabetes — showed that this therapy saved lives, hearts, and kidneys.

In patients with high and very high-risk kidney disease who are high risk for both kidney failure and cardiovascular events, there was consistent benefit seen for prevention of worsening kidney function needing dialysis and transplant. There was also consistent reduction in rates of cardiovascular adverse events, and there was a mortality benefit. So now these therapies do multiple things — they address everything from improving lifespan to improving health outcomes, heart and kidney, and then even beyond.

Because as we now know, semaglutide, apart from the weight loss perspective, also has liver benefits. So in metabolic liver disease, that's another area where you see another organ benefit. And we also know that in people without diabetes, in the SELECT trial, there is a primary cardiovascular benefit in non-diabetic but overweight or obese individuals. So truly, it's like a whole health approach. Even if the label is for kidney disease, we're benefiting all of these different aspects.

Given that cardiology is often the first specialty managing metabolic risk, how have you seen clinicians currently incorporating GLP-1 receptor agonists when kidney disease is also present?

Patients who may qualify for the kidney indication very likely also qualify for the other indications. If you look for the other indications, you will find them. It depends — sometimes patients in my practice have already been initiated, perhaps for weight management, or somebody has been screened for liver disease, and they have already been initiated on the therapy. Or sometimes I am the person initiating it for the kidney perspective.

We're also seeing that there's more liberal use now, with more access to therapy, so early on even if patients met the indication, access was a problem. Now we're seeing that improve, which is very reassuring. The nice thing about therapies like semaglutide is that there are multiple reasons, multiple clinical touch points, and multiple different types of clinicians who can initiate, and the benefits are still going to be accrued across multiple organ systems.

How do you clinically position GLP-1 receptor agonists alongside established therapies such as SGLT2 inhibitors and RAAS blockade in patients with both CKD and high cardiovascular risk?

 Not only do these therapies have multiple organ benefits, but patients with overlapping conditions, obesity, diabetes, kidney disease, and cardiovascular disease, will not just be eligible for one of these classes, but for multiple classes.

When you look at the design of the major trials that show these benefits, and the types of patients they included, there’s significant overlap. For example, in the FLOW trial, semaglutide was tested versus placebo on top of RAS inhibition and risk factor control. In the SGLT2 inhibitor trials, for the most part, that is true as well. There weren’t that many individuals in the GLP trials who were also on SGLT2 inhibitors, about 15%, but we know these therapies appear to be additive.

One plus one equals two. When we combine these therapies, we get the full benefit you would expect. In individuals at the very high end of the spectrum of risk, whether from a cardiovascular or kidney perspective, they are eligible for multiple therapies because they will still have adverse outcomes if left on just one class. This opens the discussion for a whole new era for the concept of combination therapies across multiple foundational classes, RAAS inhibition, GLPs, SGLT2 inhibitors, and non-steroidal MRAs, especially in type 2 diabetes plus kidney disease, all of which have high-level evidence for benefit.

Editor’s Note: Rangaswami reports relevant disclosures with the American Heart Association.

Chang R, Parekh T, Hagan KK, Javed Z, Ostrominski JW. State-Level Prevalence of Cardiovascular-Kidney-Metabolic Syndrome Stages in the United States, 2011 to 2023. 

https://doi.org/10.1016/j.jacadv.2025.101754

National Kidney Foundation. FDA Approves Ozempic for Type 2 Diabetes and Chronic Kidney Disease. National Kidney Foundation. Published February 20, 2025. 

https://www.kidney.org/news-stories/fda-approves-ozempic-type-2-diabetes-and-chronic-kidney-disease

An estimated 90% of US adults fall along the cardiovascular-kidney-metabolic (CKM) continuum, reflecting pervasive overlap among obesity, diabetes, CKD, and cardiovascular disease. The CKM framework, introduced by the AHA in 2023, stages risk from no overt disease to advanced cardiorenal complications and supports integrated management across specialties. Semaglutide’s CKD indication, supported by FLOW, signals a shift from risk-factor control toward therapies delivering kidney, cardiovascular, and mortality benefits, with additional hepatic and non-diabetic cardiovascular advantages.

CKM syndrome affects nearly 90% of US adults, highlighting the need to manage cardiovascular, kidney, and metabolic risk together.


Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Why Cardiovascular, Kidney, Metabolic Risk Must Be Managed Together, With Janani Rangaswami, MD, FAHA

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Bimekizumab therapy for individuals with 

 may improve patient-reported outcomes (PROs) and health-related quality of life as early as 4 weeks and through 3 years of use, new data suggest.

These findings on bimekizumab’s use in psoriasis were authored by such investigators as Matthias Augustin, MD, PhD, of the University Medical Center Hamburg-Eppendorf’s Institute for Health Services Research in Dermatology and Nursing (IVDP), and published in 

. According to Augustin et al, the BE RADIANT study was the first phase 3 analysis to evaluate dual inhibition of interleulin (IL)-17F and IL-17A versus IL-17A alone, by making a comparison of the impact and safety of bimekizumab with secukinumab.

“Herein, we report an in-depth post hoc analysis of short- and long-term PROs, as well as concurrent achievement of clinical and health-related quality of life outcomes, in patients with moderate to severe plaque psoriasis from the BE RADIANT phase 3b trial,” Augustin and coauthors wrote.

The investigative team highlighted several key facts about the BE RADIANT study, noting the multicenter, phase 3, randomized clinical trial also involved an open-label extension (OLE). It was made up a 48-week double-blind treatment period followed by a 96-week OLE, with a total of 3 years of therapy being included. Those assessed were initially assigned to be treated either with bimekizumab or secukinumab. At the 48-week mark, during entry into the OLE, subjects originally randomized to bimekizumab continued the same therapy (continuous bimekizumab cohort). Meanwhile, those assigned to secukinumab shifted to bimekizumab (secukinumab/bimekizumab cohort).

Outcomes included patient-reported skin pain, pruritus, and scaling symptoms, evaluated via the Psoriasis Symptoms and Impacts Measure (P-SIM). Additionally, the investigators looked at rates of complete skin clearance (Psoriasis Area and Severity Index [PASI] = 0) achievement and minimal quality-of-life impact (Dermatology Life Quality Index [DLQI] 0/1) attainment. Efficacy through the 1-year mark was assessed via nonresponder imputation, and data from years 1 - 3 were assessed via modified nonresponder imputation.

Those involved in the continuous bimekizumab arm were given 320 mg every 4 weeks through Week 16, and this was followed by dosing every 4 or 8 weeks through the first year and into the OLE period. Subjects initially treated with secukinumab received 300 mg every 4 weeks through Year 1, after which they shifted to bimekizumab 320 mg every 4 or 8 weeks. By the 64-week mark, all subjects were on bimekizumab, administered every 8 weeks. At the point of baseline, 373 individuals were randomized to bimekizumab and 370 to secukinumab; 336 and 318 individuals, respectively, were entered into the OLE.

How Effective is Bimekizumab for Psoriasis?

By the 4-week mark, Augustin and colleagues noted a greater proportion of those in the bimekizumab group saw a complete resolution of their symptoms compared with those on secukinumab.

Specifically, the team observed the absence of itching by 34.0% of those in the bimekizumab arm versus 25.1% of those in the secukinumab arm; a lack of skin pain was noted among 74.5% versus 222 60.0%; and a lack of scaling by 46.1% versus 21.6%, respectively.

Such differences persisted through the 1-year mark. Pruritus was still absent in 60.9% of those on bimekizumab versus 48.1% of those on secukinumab (nominal 

 < .001). In a similar set of findings, Augustin et al found 78.6% versus 70.8% had no skin pain (nominal 

 = .01), and 70.5% versus 49.7% saw no scaling (nominal 

Simultaneous PASI = 0 and DLQI 0/1 attainment was also observed by the investigative team more commonly among the bimekizumab cohort. At the 4-week mark, 11.5% in the bimekizumab group were shown to have achieved both endpoints compared with 4.6% in the secukinumab cohort (nominal 

 < .001). By the 1-year mark, such rates rose to 61.7% versus 42.7%, respectively (nominal 

 < .001). Among the individuals entered into the OLE, the high rates of complete symptom resolution on the P-SIM (score = 0) were sustained through the 3-year mark.

By the OLE’s initiation, concurrent PASI = 0 and DLQI 0/1 responses were noted by the investigators among 69.2% of continuous bimekizumab-treated individuals and 48.5% of individuals switching from secukinumab. Following the transition to bimekizumab, the response rates in the secukinumab/bimekizumab arm were noted to have improved. Additionally, by Year 3, similarly high proportions were maintained in both the continuous bimekizumab group and the switch group (62.2% and 63.8%, respectively).

“Many patients treated with bimekizumab had concurrent improvements in clinical outcomes and PROs, both of which are important for informing treatment decisions, suggesting that bimekizumab’s high clinical efficacy translates into benefits to patient-perceived symptoms and health-related quality of life,” the team concluded.

Augustin M, Feldman SR, Warren RB, et al. Three-Year Patient-Reported Outcomes From Bimekizumab for Plaque Psoriasis: The BE RADIANT Randomized Clinical Trial With Open-Label Extension. JAMA Dermatol. Published online February 18, 2026. 

Reich K, Warren RB, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. 

Dual IL-17A/IL-17F blockade with bimekizumab produced rapid, clinically meaningful improvements in plaque psoriasis symptoms and health-related quality of life versus IL-17A inhibition alone. In BE RADIANT, patient-reported pruritus, skin pain, and scaling improved by Week 4 and differences versus secukinumab persisted through Year 1. Across the open-label extension, symptom resolution on P-SIM and concurrent complete clearance (PASI 0) with minimal QoL impact (DLQI 0/1) were sustained through 3 years. Switching from secukinumab to bimekizumab improved composite outcomes.

In the phase 3b BE RADIANT trial and its open-label extension, bimekizumab treatment led to durable improvements in patient-reported outcomes over 3 years.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

BE RADIANT Trial: Bimekizumab Effective for Psoriasis After 3 Years of Use

Justin Ezekowitz, MD, is a professor of medicine at University of Alberta and a cardiologist at the University of Alberta Hospital and Mazankowski Alberta Heart Institute

Sodium Restrictions May Only Benefit Patients at Low Risk of HF, With Justin Ezekowitz, MD

A recent secondary analysis of the SODIUM-HF trial has indicated potential heterogeneity of treatment (HTE) effects from dietary sodium restriction across baseline risk quartiles of patients with or at risk of 

Restriction of dietary sodium is frequently recommended for patients with HF, despite a lack of data explicitly proving the impact of sodium restriction on patient-centered outcomes. SODIUM-HF compared usual care with sodium dietary restriction of <1500 mg/d in patients with HF. Ultimately, the trial was neutral for the primary endpoint of cardiovascular-related hospital admission, cardiovascular-related emergency department visits, or all-cause death.

“What we took away from the overall SODIUM-HF trial was that for some patients, there may be a loosening of recommendations around dietary sodium as an intervention, and that it may, for some patients, improve quality of life,” Justin Ezekowitz, MD, professor of medicine in cardiology at the University of Alberta and co-director of the Canadian VIGOUR Center, told 

 in an exclusive interview. “However, it doesn’t change clinical events, such as cardiovascular death, all-cause mortality, or heart failure hospitalizations. Now, however, when we looked at that in a secondary analysis, we identified that the intervention and its outcomes did vary across different risk quartiles.”

SODIUM-HF was an international, open-label, randomized controlled trial conducted at 26 sites in 6 countries. Enrolled patients were aged ≥18 years with chronic heart failure – defined as New York Heart Association (NYHA) functional class 2-3 – and receiving optimally tolerated guideline-directed medical therapy. Following enrollment, a total of 806 patients were randomly assigned in a 1:1 ratio to either a low-sodium diet (n = 397) or usual care (n = 409).

During the 12-month study period, median sodium intake decreased from 2286 mg/day (interquartile range [IQR] 1653-3005) to 1658 mg/day (1301-2189) in the low sodium group versus 2119 mg/day (1673-2804) to 2073 mg/day (1541-2900) in the usual care group. By month 12, all-cause mortality occurred in 22 patients in the low sodium diet group and 17 in the usual care group (HR, 1.38; 95% CI, 0.73-2.6; 

 = .32), cardiovascular-related hospitalization occurred in 40 patients in the low sodium diet group and 51 patients in the usual care group (HR, 0.82; 95% CI, 0.54-1.24; 

 = .36), and cardiovascular-related emergency department visits occurred in 17 patients in the low sodium diet group and 15 in the usual care group (HR, 1.21; 95% CI, 0.6-2.41; 

Ezekowitz and colleagues utilized the full dataset of SODIUM-HF for the present analysis, including the same 806 patients. The team used a risk-based approach based on the Meta-Analysis Global Group in Chronic (MAGGIC) HF risk score. The quartiles used were 0.036 to 0.102 (low), >0.102 to 0.147 (medium-low), >0.147 to 0.209 (medium-high), and >0.209 to 0.591 (high).

Investigators found strong evidence for the interaction between MAGGIC quartile and intervention, particularly for the medium-low MAGGIC quartile (0.95 probability; % in region of practical equivalence [ROPE] 0.05). Additionally, the primary endpoint – a composite of cardiovascular-related hospital admission, cardiovascular-related emergency department visit, or all-cause death within 12 months – occurred more frequently in the high MAGGIC quartile (probability of benefit of 0.07, %ROPE of 0.05).

Ultimately, despite these results, Ezekowitz and colleagues stated that this analysis should not change practice. However, they call for further research on the effects of sodium restriction in HF, potentially embedding the HTE concept in its design. Ezekowitz also stated that the uniform application of dietary sodium restrictions as an intervention should be reconsidered.

“The largest trial we’ve ever done in this area is, in fact, the SODIUM-HF trial, and it shows that it was neutral for a clinical outcome,” Ezekowitz told 

. “If that is our benchmark for what we implement in clinical practice, then we shouldn’t make broad, sweeping recommendations for all patients now that we recognize that we don’t operate in a vacuum. We should really think about the next trials that need to be done.”

Editor's Note: Ezekowitz reports disclosures with Bayer, Merck, Amgen, Sanofi, Novartis, Cytokinetics, and others.

Zampieri FG, Rathwell S, McAlister FA, et al. Heterogeneity in Treatment Effects in the Reduction of Dietary Sodium to Less Than 100 mmol in Heart Failure (SODIUM-HF): A Secondary Post Hoc Analysis. J Card Fail. 2026;32(2):371-381. 

Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022;399(10333):1391-1400. 

Ezekowitz discusses his recent secondary analysis of the SODIUM-HF trial, highlighting the MAGGIC analysis data that implied a very limited benefit.

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Targeting CD28 and CD154 pathways, dual blockade with belatacept and dazodalibep offers potential to improve adherence in kidney transplant recipients.



Dual Costimulation Blockade May Eliminate Daily Oral Immunosuppression in Kidney Transplant

Phase 3 COMP006 shows significant MADRS reduction at week 6, signaling potential benefit in treatment-resistant depression.

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD

Edward Barnes, MD, MPH, is an associate professor of medicine in the division of gastroenterology and hepatology and co-director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of North Carolina at Chapel Hill.

Barnes reviews 3-year VIVID-2 data showing durable remission, steroid-free control, and stable safety with mirikizumab in moderate-to-severe Crohn’s disease. 

3-Year Efficacy, Safety of Mirikizumab in Crohn’s Disease: Insights From VIVID-2, With Edward Barnes, MD, MPH

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Positive results from a follow-up preclinical study of Thykamine show dose-dependent effects on key pathological hallmarks of MASH.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Thykamine Shows Disease-Modifying Potential in MASH Using Liver-on-a-Chip Platform

Interim data from the investigator-initiated trial showed treatment with a single dose of YOLT-202 led to rapid, dose-dependent increases in AAT levels to normal range.

Alpha-1 antitrypsin deficiency

Single Dose YOLT-202 Gene-Editing Therapy Increases Functional AAT Levels in AATD

Muthiah Vaduganathan, MD, MPH, is a cardiologist specializing in cardiorenal metabolism at Brigham and Women's Hospital in Boston, MA. Vaduganathan is a member of Practical Cardiology's advisory board and co-host of Don't Miss a Beat, a podcast presented by Inside Cardiology.

Experts explain how uACR and eGFR testing reveals hidden CKD, links to heart risk, and guides early, patient-centered care.

Video Series

CKD Guidelines and Adherence Across Specialties

Abraham Kazemi, MD, is the director of Cosmetic and Laser Dermatology for Virginia’s Pinnacle Dermatology sites.

This segment of the latest Skin of Color Savvy episode highlights discoid lupus in skin of color, housing barriers, and Medicaid navigation.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

Addressing Discoid Lupus in Skin of Color: Clinical and Social Challenges

Learn how uACR and eGFR uncover hidden CKD, sharpen cardiovascular risk, and guide patient-friendly conversations for earlier, smarter care.

Addressing Chronic Kidney Disease (CKD) Prevalence and Patient Awareness in Cardiorenal Metabolic Care

Targeting CD28 and CD154 pathways, dual blockade with belatacept and dazodalibep offers a new mechanistic approach in kidney transplant care.

Mechanistic Rationale for Dual Costimulation Blockade, Belatacept, Dazodalibep in Kidney Transplantation

Ahmad Anouti, MD, is a pediatric resident at the University of Texas Southwestern in the Physician Scientist Training Program.

Anouti outlines why early bilirubin testing and emerging serum markers are key to improving prognosis in biliary atresia.

Latest News

Intravenous DMT (SPL026) Demonstrates Significant MDD Reduction in Phase 2a Trial

Meal Timing and Crohn’s Disease: Clinical Implications of Intermittent Fasting, With Andres Hurtado-Lorenzo, PhD

Why Cardiovascular, Kidney, Metabolic Risk Must Be Managed Together, With Janani Rangaswami, MD, FAHA

BE RADIANT Trial: Bimekizumab Effective for Psoriasis After 3 Years of Use

Sodium Restrictions May Only Benefit Patients at Low Risk of HF, With Justin Ezekowitz, MD