Addressing Fenofibrates’ Lack of Cardiovascular Benefit, With Payal Kohli, MD, FACC

Despite increasing evidence indicating their ineffectiveness and a recent decision by the 

 (FDA) to update their labeling information to reflect their lack of 

 benefit, fenofibrates are still actively being prescribed to reduce cardiovascular risk, both alone and in combination with statins.

On October 14, 2025, in response to a Citizen Petition from the organization HealthyWomen, the FDA changed the labels for fenofibrates, highlighting the fact that they are not associated with any cardiovascular benefits. Substantial evidence in support of this action was released as far back as November 2022, with the publication of the Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) study.

Despite this, fenofibrates are still widely prescribed for this indication. A 2021 Harris poll highlighted that >50% of all cardiologists and primary care providers surveyed believed that fenofibrates reduce cardiovascular risk. Additionally, this poll demonstrated that 38% of the cardiologists and 42% of the primary care providers believed that the FDA has approved taking fenofibrates with statins – this approval was overturned in 2016.

 met with Payal Kohli, MD, FACC, founder and medical director of Cherry Creek Heart and associate adjunct professor in the division of cardiology at Duke University School of Medicine, to discuss the impetus for the label change and what can be done for patients currently taking fenofibrates. Kohli spoke on the need for greater awareness surrounding the label change and action by clinicians to limit future prescriptions and thus potential harm.

“The most important thing is to really clarify the new evidence without creating patient alarm or eroding patient trust,” Kohli told 

. “Oftentimes, patients are scratching their heads and saying, ‘well, you told me to take this for the last 20 years, what’s changed?’ And this is where it’s really important to talk about some of the modern trials that have really put the nail in the coffin on the facts that fibrates, and fenofibrate specifically, are not cardiovascular risk-reducing agents.”

PROMINENT was a randomized, parallel, double-blind, placebo-controlled trial aiming to evaluate pemafibrate among patients with type 2 diabetes (T2D) and hypertriglyceridemia. Pemafibrate, a selective peroxisome proliferator-activated receptor a modulator, was expected to display cardioprotective effects among this patient group, as prior trials seemed to have indicated this.

Investigators included patients with T2D and triglyceride levels between 200 and 499 mg/dL, as well as high-density lipoprotein cholesterol (HDL-C) ≤40 mg/dL. Patients with type 1 diabetes, uncontrolled diabetes, untreated or inadequately treated hypo- or hyperthyroidism, severe 

, severe kidney disease, or severe liver disease were excluded. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, ischemic stroke, or coronary revascularization. Secondary outcomes included median change in triglyceride and apolipoprotein B levels from baseline, as well as all-cause mortality, venous thromboembolism, and any adverse renal event.

A total of 10,497 patients were enrolled in the study. Of these, 5240 patients were randomly assigned to receive pemafibrate 0.2 mg twice daily, while 5257 patients would receive matching placebo. Patients had a mean age of 64 years, and 46% had a duration of diabetes ≥10 years. Median follow-up duration was 3.4 years. Medan HDL-C was 33 mg/dL, and median LDL-C was 78 mg/dL. 96% of patients were on a statin during treatment.

Ultimately, the primary outcome occurred in 3.6% of the pemafibrate group versus 3.5% of the placebo group, illustrating no significant cardiovascular effect (

 = 0.67). All-cause mortality also occurred in 2.4% of the pemafibrate group versus 2.3% of the placebo group. Although the treatment arm saw substantially greater reductions in triglyceride, these data provided the primary impetus for HealthyWomen’s petition and the FDA’s recent decision to change label data.

“This really does emphasize the point that you don’t want to continue what is known as clinical inertia, where you just keep doing what you’ve been doing,” Kohli said. “You want to be active and thoughtful every time you see a patient, and to ask yourself, ‘Does they still need this medication?’ I don’t just continue it because it has been that way for a long time, and I don’t just continue because it treats the number – I want to try to treat the risk.”

Editor’s Note: Kohli reports disclosures with Amgen, GE/Skyword, Family Heart, Astra Zeneca, Bristol-Myers Squibb, Merck, and others.

US Food and Drug Administration. Final Response Letter from FDA CDER to HealthyWomen. 

. June 9, 2025. Accessed January 6, 2026. 

https://www.regulations.gov/document/FDA-2024-P-1988-0005

US Food and Drug Administration. Citizen Petition from HealthyWomen. 

. April 23, 2024. Accessed January 6, 2026. 

https://www.regulations.gov/document/FDA-2024-P-1988-0001

Bavry A, Bhatt D. Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients With Diabetes – PROMINENT. 

. February 27, 2023. Accessed January 6, 2026. 

https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2022/11/04/14/15/prominent

Videos

Kohli discusses the importance of the FDA’s recent label change and how clinicians can help reduce the continued prescription of ineffective medication.

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Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Pulmonology in 2025 was defined by long-awaited regulatory breakthroughs that expanded treatment options across some of the field’s most persistent areas of unmet need. FDA approvals spanned eosinophilic airway disease, fibrotic lung disorders, rare neoplastic conditions, and bronchiectasis, signaling a shift from symptom control toward disease modification, precision targeting, and less burdensome dosing strategies.

Biologics and immunotherapies continued to reshape care paradigms, with approvals such as mepolizumab for eosinophilic COPD and depemokimab-ulaa for severe asthma reinforcing biomarker-driven treatment across traditionally siloed diseases. At the same time, nerandomilast’s approval marked the first new therapy for idiopathic pulmonary fibrosis in more than a decade, while brensocatib became the first disease-modifying option for non–cystic fibrosis bronchiectasis—both milestones for patient populations long underserved by innovation.

Beyond approvals, 2025 also delivered important signals from trials, post hoc analyses, and updated guidelines that refined how clinicians think about airway inflammation, lung function, and exacerbation risk. Mixed late-stage data in COPD, emerging antifibrotic strategies, and renewed emphasis on guideline-based care made up a year of progress and recalibration, pointing pulmonology toward a more nuanced, trait-based, and patient-centered future.

FDA Approves Mepolizumab for Eosinophilic COPD

On May 22, the FDA has approved mepolizumab (Nucala) as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype. In the phase 3 MATINEE trial, mepolizumab demonstrated a statistically significant and clinically meaningful 21% reduction in the annualized rate of moderate or severe exacerbations (0.80 events per year) compared to placebo (1.01 events per year; rate ratio, 0.79; 95% CI, 0.66 to 0.94; 

 = .01), successfully meeting the primary endpoint.

FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

The FDA has approved GSK’s depemokimab-ulaa (Exdensur) as an add-on maintenance therapy for severe eosinophilic asthma in patients aged 12 years and older, introducing the first ultra–long-acting biologic in this space with twice-yearly dosing. The approval was supported by data from the phase 3 SWIFT-1 and SWIFT-2 trials demonstrating significant reductions inannualized asthma exacerbations compared with placebo while maintaining a safety profile comparable to standard of care.

Nerandomilast Nets First New FDA Approval for Idiopathic Pulmonary Fibrosis in Over 10 Years

The FDA has approved nerandomilast 9 mg and 18 mg (Jascayd; Boehringer Ingelheim) for adults with idiopathic pulmonary fibrosis, marking the first new IPF therapy approved in more than a decade. The decision was supported by phase 3 FIBRONEER-IPF data showing significantly reduced decline in forced vital capacity versus placebo, with a generally well-tolerated safety profile.

Zopapogene Imadenovec First Immunotherapy Approved for Recurrent Respiratory Papillomatosis

As of August 14, the FDA approved zopapogene imadenovec-drba (Papzimeos) for adults with recurrent respiratory papillomatosis, marking the first non-replicating adenoviral vector–based immunotherapy authorized for the disease. The decision was supported by phase 1/2 data showing a 51% complete response rate and substantial reductions in surgical interventions, with a generally well-tolerated safety profile.

FDA Approves First Bronchiectasis Therapy, Brensocatib, for Ages 12 and Up

As of August 12, the FDA approved brensocatib (Brinsupri) 10 mg and 25 mg for adults and adolescents aged 12 years and older with non–cystic fibrosis bronchiectasis, marking the first disease-modifying therapy for the condition. The decision was based on phase 3 ASPEN trial data showing a significant reduction in pulmonary exacerbations versus placebo, establishing a new treatment option targeting neutrophilic inflammation in this historically underserved disease.

Tezepelumab Fails Study Endpoint of Reducing Moderate-to-Severe COPD Exacerbations

Tezepelumab was not seen to reduce the annualized rate of moderate or severe COPD exacerbations, thus failing the primary endpoint of COURSE, a phase 2a trial (NCT04039113). Singh and colleagues found that the annualized rate of moderate or severe COPD exacerbations represented a nonsignificant change and thus did not meet the trial’s primary endpoint.

Genentech (Roche)’s Astegolimab Shows Mixed Data for COPD

Genentech reported mixed phase 3 results for astegolimab in COPD, with the ALIENTO trial showing a statistically significant 15.4% reduction in annualized exacerbation rate at 52 weeks, while the ARNASA trial failed to meet its primary endpoint despite a similar 14.5% reduction. Neither trial found no new safety signals, but the inconsistent efficacy results may challenge astegolimab’s regulatory path.

Taladegib Shows Potential to Improve FVC in Idiopathic Pulmonary Fibrosis

Taladegib (ENV-101) demonstrated a favorable safety profile and promising signals of efficacy in a phase 2a proof-of-concept trial in patients with idiopathic pulmonary fibrosis. Treatment was associated with improvements from baseline in forced vital capacity and multiple HRCT-based measures of fibrosis, supporting further clinical development in an area of ongoing unmet need.

Nerandomilast Meets Primary Endpoint in Improving FVC in Progressive Pulmonary Fibrosis

The FDA has approved nerandomilast (Jascayd) for adults with idiopathic pulmonary fibrosis, marking the first new IPF treatment approved in more than a decade. The oral PDE4B inhibitor demonstrated a significant slowing of lung function decline with a favorable safety profile in phase 3 trials, expanding therapeutic options for a disease with substantial unmet need.

Dupilumab Improves Small Airway Dysfunction in People With Type 2 Asthma

Dupilumab improved small airway dysfunction (SAD) among a population with type 2 high moderate-to-severe asthma, which could explain improvements in disease control, according to a post hoc analysis of the Phase 4 VESTIGE study presented at the 2025 AAAAI/WAO Joint Congress. Those treated with dupilumab reported significant improvements in SAD as measured by peripheral airway resistance and compliance.

Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management

In this HCPLive expert discussion moderated by Joseph Khabbaza, MD, clinicians examine how the FDA approval of mepolizumab for eosinophilic COPD could mark a turning point in a field long limited to symptom-focused therapies. Drawing on phase 3 MATINEE data, the panel highlights its potential to reduce exacerbations, limit systemic steroid exposure, and usher COPD care toward a more asthma-like, biomarker-driven precision model.

Going for GOLD: Updated COPD Guidelines with Gerard Criner, MD

COPD continues to pose a substantial global and US health burden, prompting updated 2024 GOLD guidelines that sharpen guidance on diagnosis, comorbidity management, and evidence-based care. In this Lungcast episode, Gerard Criner, MD, breaks down key updates, including renewed emphasis on spirometry, smoking cessation, pulmonary rehabilitation, and cardiovascular risk, highlighting how GOLD translates evolving science into practical, patient-centered recommendations.

The Biologic Era in COPD: What Mepolizumab Approval Means for Exacerbation Control

 expert discussion moderated by Joseph Khabbaza, MD, clinicians examine how the FDA approval of mepolizumab for eosinophilic COPD could mark a turning point in a field long limited to symptom-focused therapies. Drawing on phase 3 MATINEE data, the panel highlights its potential to reduce exacerbations, limit systemic steroid exposure, and usher COPD care toward a more asthma-like, biomarker-driven precision model.

Getting Through the Door: How COPD, Lung Cancer Screening Remains Minimal

Despite well-established screening tools and expanded eligibility criteria, COPD and lung cancer remain profoundly underdiagnosed in the US, with most patients still identified at advanced stages when survival benefits are limited. Experts point to systemic access gaps, clinician hesitation, and persistent disease stigma as key barriers, underscoring that improving outcomes in 2026 will depend less on new technology than on using the tools already proven to work.

Articles

Rheumatology in 2025 saw significant advancements with numerous FDA approvals and pivotal trial results, expanding treatment options for autoimmune, inflammatory, and neuromuscular diseases. New therapies addressed unmet needs in conditions like IgG4-related disease, giant cell arteritis, fibromyalgia, and lupus nephritis. The shift towards targeted immune modulation and non-immune-suppressive approaches was evident. Despite these advancements, experts emphasized the importance of integrated, multidisciplinary care and realistic expectations for new therapies, particularly in complex diseases, highlighting the need for continued innovation to improve patient outcomes.

The pulmonology year in review highlights FDA approvals and pivotal data readouts.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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Pulmonary Fibrosis

Pulmonology in 2025: Year in Review

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.

Two-year findings from a real-world Japanese patient cohort indicate deucravacitinib provides durable disease control in 

, although responses differ over time based on age and body mass index (BMI) of patients.

These findings were authored by such researchers as Teppei Hagino, MD, PhD, of Nippon Medical School Chiba Hokusoh Hospital. In the background of their analysis, Hagino and colleagues noted prior data suggesting those with a BMI of ≥ 25 kg/m

 had slightly diminished responses to this drug than patients with a BMI < 25 kg/m

Despite positive findings on deucravacitinib’s efficacy among those with psoriasis, the investigative team highlighted the lack of real-world data on its long-term use and the prior lack of awareness about BMI and/or age’s impact on such results.

“The aim of this study was to evaluate the 104 week…effectiveness of deucravacitinib 6 mg daily in patients with psoriasis, stratified by BMI (< 25 versus ≥ 25 kg/m2) or age (< 65 versus ≥ 65 years),” Hagino and coauthors wrote.

In the period between December 2022 - August 2025, the investigators carried out their prospective, single-center investigation in Japan. They involved patients in the age range of 15 years or older who also lived with moderate-to-severe psoriasis. All participants given once-per-day, oral deucravacitinib therapy at a dose of 6 mg for a maximum duration of 104 weeks. Some of the team’s subjects had previously been given apremilast or biologics prior to their using deucravacitinib.

After detailed consultations took place their treating clinicians, those involved in the analysis elected to begin deucravacitinib from among the available options for systemic agents. Hagino et al noted a portion of the data from this 104-week cohort, drawn from Weeks 16 - 52, had been published previously under the same study protocol. Additional participants were newly and prospectively involved for this more recent analysis.

Those included as participants were patients with moderate-to-severe psoriasis, psoriatic arthritis (PsA), or erythrodermic psoriasis. Individuals shifting directly from other systemic agents to deucravacitinib did so without a required washout period. For these patients, their PASI and sPGA scores recorded at the time of treatment switch were defined as baseline values at Week 0. At the time of their entry, the participants’ demographic and clinical variables were documented by the investigative team.

These would include BMI, age, sex, duration of disease, and the existence or absence of arthritis. Comorbid condition information, with conditions including smoking status, diabetes, heart disease, and prior exposure to systemic drugs including apremilast or biologics, was gathered by the team. At baseline, they looked at disease severity via patients’ Psoriasis Area and Severity Index (PASI) and static Physician’s Global Assessment (sPGA) scores.

There were 127 total participants with psoriasis who were provided  dail oral deucravacitinib 6 mg. Across the entire cohort, Hagino and colleagues noted their PASI scores indicated sustained disease improvements over the full 104-week treatment period. When stratified by age or by BMI, there was no statistically significant distinction observed in participants’ mean percentage PASI reduction between the cohorts at any time point.

The team highlighted data showing, between the 16 and 68-week marks, PASI score reductions and the proportions of subjects attaining PASI 75, PASI 90, or an absolute PASI score of 2 or below showed a tendency to be slightly greater in those with a BMI below 25.

 This was compared with subjects showing a BMI of 25 or higher, though Hagino and coauthors noted the reversal of this pattern reversed at later points in their analysis.

Throughout the 104-week follow-up, the investigators noted higher rates of complete or near-complete clearance, defined as PASI 100 or an absolute PASI score of 1 or less, consistently seen among those with BMI below 25.

 By the 104-week mark, PASI 100 and absolute PASI ≤1 were attained by 16.7% and 54.2% of individuals showing a BMI of <25, respectively. This was compared to rates of 0% and 40.0% among individuals with a BMI of ≥25.

In an analysis which was age-based, Hagino et al found the percentages of PASI reductions and the PASI 75 and PASI 90 rates were slightly higher in those aged 65 years or older versus younger subjects, after which this trend would reverse.

 By the 104-week mark, they found PASI 100 and absolute PASI ≤1 were seen among 28.6% and 57.1% of individuals below 65 years, respectively. Conversely, rates noted in participants aged 65 years or older were 0% and 46.7%, respectively.

“In conclusion, once daily deucravacitinib 6 mg showed sustained effectiveness for Japanese patients with psoriasis throughout 104 weeks in real-world analyses stratified by BMI or age,” the team concluded.

 “Early differences between age groups should be interpreted with caution because older patients had lower baseline PASI and the subgroup analyses were not adjusted for baseline severity.”

Okabe Y, Hagino T, Kanda N. Two-Year Real-World Effectiveness of Deucravacitinib 6 mg in Psoriasis: A Single-Center Analysis Stratified by Body Mass Index or Age in a Japanese Cohort. J Dermatol. 2026 Jan 5. 

Hagino T, Onda M, Kanda N, et al. Real-world 52-week effectiveness of deucravacitinib in psoriasis: A stratified analysis by age and body mass index. J Dermatol. 2025 Apr;52(4):663-671. 

Deucravacitinib demonstrates durable disease control in moderate-to-severe psoriasis over 104 weeks, with varying responses based on age and BMI. A Japanese cohort study involving 127 patients revealed sustained PASI score improvements, with no significant differences in mean percentage PASI reduction when stratified by age or BMI. However, patients with a BMI below 25 showed higher rates of complete or near-complete clearance. Age-based analysis indicated slightly higher PASI reductions in those aged 65 or older initially, but this trend reversed over time. The study emphasizes cautious interpretation of early differences due to baseline severity.

This study highlights the efficacy and safety of deucravacitinib 6 mg in psoriasis, with results stratified by body mass index and age in a Japanese patient cohort.

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.

Deucravacitinib 6 mg Effective in Patients with Psoriasis Over 2 Years

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

According to new research, among patients with acute kidney injury (AKI) on 

, moderate-stable, moderate-high stable, and high-decreasing serum creatinine trajectories were associated with an increased risk of 28-day mortality.

“The serum creatinine trajectory can serve as an important indicator for assessing the short-term and long-term mortality risks of patients (especially critically ill or post-operative patients), and has significant reference value for clinical prognosis judgment,” wrote study investigator Jian Huag, MD, research director from the Zhejiang University School of Medicine, and colleagues.

Serum creatinine, as a biomarker reflecting glomerular filtration function, has been widely used to assess renal function and diagnose kidney-related diseases. The latest evidence had suggested serum creatinine fluctuations were closely associated with the risk of death in CKD, but systematic trajectory typing research required further exploration.

In a retrospective study, investigators aimed to explore the association between serum creatinine trajectories and 28-mortality in AKI on CKD patients through group-based trajectory modeling. They leveraged data from the Medical Information Mart for Intensive Care-IV (MIMIC) database, containing de-identified health-related information of Intensive Care Unit (ICU) patients from Beth Israel Deaconess Medical Center.

Investigators measured and recorded serum creatinine > 3 times during the first 96 hours after admission to the ICU, and calculated the mean.

The study included 7852 patients with CKD who developed AKI during hospitalization, defined as an increase in serum creatinine of ≥ 0.3 mg/dL within 48 hours, or an increase in serum creatinine of ≥ 50% from baseline within 7 days.

Upon Group-Based Trajectory Modeling, investigators identified 5 trajectories:

Serum creatinine low-stable (Group G1): with levels maintained at approximately 1 and showing a stable trend

Serum Creatinine High-Decreasing (Group G2): with baseline levels > 8 and showing a decreasing trend

Serum Creatinine Moderate-Low Stable (Group G3) with levels maintained at approximately 1.3–1.5 and showing a stable trend

Serum Creatinine Moderate-Stable (Group G4) with levels maintained at approximately 2, and showing a stable trend

Serum Creatinine Moderate-High Stable (Group G5) with levels maintained at approximately 4 and showing a stable trend

In terms of comorbidities, group G5 had a significantly increased prevalence of diabetes and sepsis, G4 of chronic pulmonary disease and congestive heart failure, and G1 of cerebrovascular diseases. Regarding prognostic scores, group G1 had decreased Simplified Acute Physiology Score II and Sequential Organ Failure Assessment scores, while group G2 had a decreased Charlson Comorbidity Index Score.

Investigators saw significant differences among the 5 groups in white blood cells, blood urea nitrogen, anion gap, total calcium, glucose, potassium, sodium, bicarbonate, and chloride levels. Group G2 had the highest serum creatinine baseline levels and estimated glomerular filtration rate (eGFR) percentage change.

In fully adjusted analyses, compared with the low-stable trajectory group (G1), 28-day mortality risk was significantly increased in the high-decreasing group (G2) (Hazard Ratio [HR], 1.82; 95% Confidence Interval [CI], 1.18-2.82; 

 = .007), the moderate-stable group (G4) (HR, 1.45; 95% CI, 1.14-1.86; 

 = .003), and the moderate–high stable group (G5) (HR, 1.86; 95% CI, 1.36-2.54; 

Investigators identified a significant interaction between baseline serum creatinine and trajectory group. The association between moderate-stable (G4) and moderate–high stable (G5) trajectories and 28-day mortality was only observed among patients with baseline serum creatinine ≤ 1.8 mg/dL, which investigators suggested may reflect preserved baseline renal filtration, making subsequent trajectory abnormalities more prognostically meaningful.

“This finding provides a reference for clinical practice in formulating individualized prognostic assessment protocols for patients with different baseline serum creatinine levels,” concluded investigators.

Ying J, Zhou H, Zhang Y, Zhu S, Zhang G, Huang J. Association of different serum creatinine trajectories with 28-day mortality in patients with acute kidney injury on chronic kidney disease: based on the MIMIC-IV database. 

. Published online Autumn 2025:10.1186/s40001-02503632-x. doi:

https://doi.org/10.1186/s40001-025-03632-x

Horne KL, Packington R, Monaghan J, Reilly T, Selby NM. Three-year outcomes after acute kidney injury: results of a prospective parallel group cohort study. 

https://doi.org/10.1136/bmjopen-2016-015316

New research highlights the association between serum creatinine trajectories and 28-day mortality in patients with acute kidney injury on chronic kidney disease. The study identified five distinct serum creatinine trajectory groups, with moderate-stable, moderate-high stable, and high-decreasing trajectories linked to increased mortality risk. The findings underscore the prognostic value of serum creatinine trajectories, particularly in patients with preserved baseline renal filtration. This research provides a foundation for developing individualized prognostic assessment protocols based on baseline serum creatinine levels, enhancing clinical decision-making for critically ill patients.

Retrospective data suggest serum creatinine trajectories might predict 28-day mortality in acute kidney injury on chronic kidney disease. 


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.

Chronic Kidney Disease

Serum Creatinine Trajectories May Predict 28-Day Mortality in CKD

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 new study found that changing therapists or therapy approach does not offer additional benefit for adults with 

 who do not respond to initial psychotherapy.

 Further psychotherapy after initial non-response produces modest reductions in depressive symptoms.

Only about 40% of people experience a significant response to psychotherapy. One solution may be to switch therapists altogether. The Associated Clinic of Psychology (ACP) lists 11 signs that it may be time to switch therapists: feeling a lack of progress, being unable to speak openly, feeling unheard or misunderstood, mismatched therapeutic styles, unresolved issues, a personality clash, discomfort during sessions, changing goals or focus, frequent scheduling problems, lack of engagement, and a gut feeling.

 Changing therapists may provide other benefits, such as accelerating recovery when a patient requires a different therapeutic approach, or shortening the duration of depression, which may help limit feelings of hopelessness.

However, whether changing therapists actually improves depressive symptoms remains an open question. Emerging data suggest the benefit may be limited.

In this randomized controlled study, Maartje Miggiels, PhD candidate, from the Dimence Group and the department of psychiatry at Amsterdam UMC in the Netherlands, and colleagues, investigated whether continuing cognitive behavioral therapy (CBT) or short-term psychodynamic supportive therapy (SPSP) with the same therapist differs in effectiveness from 2 alternative strategies: switching therapists or switching both the therapist and the therapeutic approach.

 The primary outcome was depressive symptom severity, assessed via the Inventory of Depression Symptomatology-Self Report (IDS-SR).

This was the second phase of a randomized study published in 2021, which compared CBT with SPSP for MDD during the initial 16-session treatment phase. Participants were outpatients of 1 of 4 locations of Dimence, a specialized mental health care institution in the Netherlands.

The first phase showed favorability of SPSP over CBT, with an estimated mean post-treatment difference of 2.54 (95% CI, -0.63 to 5.72). SPSP also showed favorable remission rates over CBT (9.0% vs 20.5%; 

 =.01). Response rates did not differ significantly between SPSP vs CBT (23.6% vs 20.7%; 

This second phase randomized 163 non-responders 1:1:1 to either continue treatment with the same therapist, switch to a different therapist, or switch both therapist and treatment method.

 Participants were offered an additional 16 sessions over 8 weeks.

The study showed a modest but statistically significant reduction in depressive symptoms after continuing psychotherapy (mean change, -5.23; 95% CI, -7.27 to -3.12). However, investigators observed no significant differences in symptom reduction, response, or remission rates between the 3 treatment strategies.

“Switching therapist or both therapist and method does not appear to offer additional benefit, but also does not hinder outcomes,” investigators concluded.

 “These findings suggest that there is no one-size-fits-all switching strategy that is suitable for all non-responders.”

 hosted a peer exchange with Andrew J. Cutler, MD, Sagar V. Parikh, MD, FRCPC, and Gregory Mattingly, MD, on switching treatment vs augmenting strategies in MDD.

They discussed what point psychiatrists should start to think about switching or starting a new treatment and at what point you would augment.

“It’s one of the mysteries of what we do in clinical practice, and I don’t think there’s a right or a wrong answer,” Mattingly said.

 “If you’d asked me 20 years ago, I would’ve quite often started something new. I’ve become a fan of augmentation strategies more and more over the course of my practice.”

He described different augmentation strategies, such as adding a medicine or augmenting with psychotherapy or exercise.

“It’s important to know when you can augment and when you can start a new treatment option,” Mattingly continued.

 “If we see zero benefit, obviously we’re going to start something new. I think if we see an intolerable adverse effect, we’re going to start something new. It’s that group in the middle, they’re partially better, but not all the way better. And quite often I like that option of being able to augment something on top.”

Miggiels M, Ten Klooster P, Beekman A, et al. A randomized controlled trial testing the effects of sequential psychotherapy in depression: Changing therapist, or both therapist and method?. 

Switching Therapists: 11 Signs It’s Time To Go. Associated Clinic of Psychology. Published on February 21, 2024. Accessed January 6, 2026. 

https://acp-mn.com/about-acp/blog/switching-therapists/ 

Miggiels M, Ten Klooster P, Beekman A, et al. The D*Phase-study: Comparing short-term psychodynamic psychotherapy and cognitive behavioural therapy for major depressive disorder in a randomised controlled non-inferiority trial. 

Cutler A, Mattingly G, and Parikh S. Switching Treatment vs Augmenting Strategies in MDD. 

 Published on January 27, 2023. Accessed January 6, 2026. 

https://www.hcplive.com/view/switching-treatment-vs-augmenting-strategies-in-mdd

A recent study explored the effectiveness of changing therapists or therapy approaches for adults with major depressive disorder (MDD) who do not initially respond to psychotherapy. The study found that continuing therapy, regardless of switching therapists or methods, resulted in modest symptom reduction, with no significant differences between strategies. This suggests that switching therapists or approaches may not offer additional benefits. The study highlights the complexity of treatment decisions in MDD, emphasizing the need for personalized strategies, including potential augmentation with medication or other therapies.

A study found no differences in depressive symptom reduction when nonresponders continued therapy, switched therapists, or changed both therapist and treatment approach.

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.

Switching Therapists for Psychotherapy Offers No Advantage in MDD

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.

Catch up on IBD steroid exposure risk, intensive weight loss before colorectal cancer surgery, a new chronic idiopathic constipation treatment option, and more.

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

5 Gastroenterology Headlines You Missed in December 2025

Johnson & Johnson plans to initiate a phase 3 study based off the positive data.

Lupus

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Nipocalimab Reduces SLE Disease Activity, Meeting JASMINE Study End Point

Amer Zeidan, MD, is a professor of medicine and the chief of the Division of Hematologic Malignancies at Yale University.

Zeidan discusses the interim results from the ongoing phase 1/2 trial, highlighting bexmarilimab’s efficacy in combination with azacitidine SoC.

Hematology

Bexmarilimab Safe and Efficacious in Treating Myelodysplastic Syndromes, With Amer Zeidan, MD

A cross-sectional study in CKD suggests patients undergoing hemodialysis have increased social frailty and depression compared to transplant recipients. 


Chronic Kidney Disease Paired With Social Frailty May Increase Depression Risk  

Two phase 3 trials met their primary and secondary endpoints in patients with moderate-to-severe plaque psoriasis on envudeucitinib.

ONWARD Studies: Oral Envudeucitinib Treatment Effective, Safe for Psoriasis

Crohn’s & Colitis Foundation survey findings show 18% of young adults with IBD work extra hours to afford care and > 1 in 3 are not confident navigating insurance.

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Switching Therapists for Psychotherapy Offers No Advantage in MDD