Long-term Safety, REMS Data, and Echo Monitoring for oHCM Therapies

Real-world experience with cardiac myosin inhibitors under Risk Evaluation and Mitigation Strategy (REMS) programs provides critical insight into the safety profile of these agents outside the controlled environment of clinical trials.

Matthew Martinez, MD, discusses a large, REMS-guided analysis of more than 6000 patients that informed his understanding of the incidence, severity, and reversibility of left ventricular ejection fraction (LVEF) decline. He now quotes patients an approximate risk of LVEF reduction on the order of 4% to 7%, while acknowledging the need for further refinement of risk prediction. The same data suggest that REMS infrastructure—though unfamiliar to many cardiologists—helps standardize monitoring and maintain appropriate safety margins in routine practice.

Mariko Harper, MD, notes that, despite the boxed warning and patient concern about heart failure, REMS registry data have shown a very low rate of clinically meaningful LVEF decline with heart failure hospitalization, approximately 0.5% among more than 11,000 patients over several years when drugs are used according to protocol. This allows her to reassure informed patients who present having read the label and online resources. Both clinicians question whether current monitoring schedules are more intensive than necessary, particularly early 4-week echocardiograms and routine 6

month follow-up imaging in clinically stable patients on long-standing doses. They observe that most clinically meaningful changes correlate with recognized triggers such as infection, new medications, or atrial fibrillation rather than occurring unpredictably in otherwise stable individuals.

In this segment, Martinez and Harper propose a more risk-adapted approach to imaging-based surveillance, emphasizing symptom-triggered assessment and targeted evaluation in higher-risk periods while potentially de-emphasizing rigid time-based echocardiography in stable patients. They also describe how patient-reported symptoms usually precede concerning echocardiographic findings, suggesting that well-structured clinical follow-up and patient education may be at least as important as frequent imaging. Their discussion highlights how REMS-generated data can both reinforce the value of structured safety programs and guide thoughtful simplification of monitoring protocols over time.

Videos

Martinez and Harper review real-world REMS data on cardiac myosin inhibitors, refine approaches to safety monitoring, and question how frequently echocardiography is truly needed in stable oHCM patients.

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Video Series

Implementing Cardiac Myosin Inhibitors in oHCM: Workflow and Team-Based Care

Effective implementation of cardiac myosin inhibitor therapy for oHCM depends heavily on systems of care rather than on the prescribing physician alone. Mariko Harper, MD, describes a dedicated cardiac myosin inhibitor clinic in Washington State staffed by a cardiac pharmacist who functions in many ways like an advanced practice provider. This pharmacist leads initiation, titration, drug–drug interaction review, and REMS documentation, while nurse coordinators manage direct lines of communication, scheduling, and coordination of echocardiography. Advance scheduling of the first several echocardiograms at the time of therapy planning, with flexibility to adjust as needed, provides clarity for patients and staff.

Matthew Martinez, MD, highlights the role of telemedicine for interim visits, which allows efficient, geographically flexible follow-up and facilitates rapid response to clinical or imaging changes. He and Harper emphasize that experienced sonographers, nurses, advanced practice providers, and pharmacists must function as equal partners in a “team sport,” with explicit empowerment to escalate concerns such as suspected atrial fibrillation or unexpected gradient patterns. Over time, as volumes increase, team members train newer staff, transforming what initially feels like a challenging REMS-driven process into a predictable, streamlined workflow after the first several patients.

Martinez and Harper also offer granular practical advice, such as coordinating the actual start date of therapy with the timing of follow-up echocardiography and patient support. They encourage patients to contact the nurse coordinator as soon as the initial shipment is received so that day 1 dosing and subsequent imaging timelines can be aligned. Martinez often recommends initiating therapy on a Sunday evening to maximize weekday availability for early follow-up and to ensure that questions about tolerability arise during regular clinic hours. This segment provides a detailed operational blueprint for clinicians seeking to integrate cardiac myosin inhibitors into everyday oHCM practice while maintaining high safety and patient satisfaction standards.

Martinez and Harper outline practical workflows for initiating and titrating cardiac myosin inhibitors, emphasizing multidisciplinary team structure, telemedicine, and logistics around REMS and imaging.

Emily McDonald, MD, MSc, is an associate professor of medicine at McGill University.

Vancomycin Taper for Recurrent C. difficile Infection: What Clinicians Need to Know

Recurrent infection is widely regarded as one of the most frustrating and costly challenges in the management of 

 infection (CDI), which affects an estimated 450,000 patients annually in the United States and carries substantial morbidity and healthcare costs.

For many patients, the illness does not end after the first episode. According to the US Centers for Disease Control and Prevention, about 1 in 9 people who get CDI will get it again in the subsequent 2-8 weeks.

"It's very unpleasant, can be quite morbid for patients, and once you've had a C difficile infection, unfortunately, there's a risk that it can come back over and over again,” Emily McDonald, MD, MSc, an associate professor of medicine at McGill University, explained to 

. “You can imagine how that can be pretty traumatic for patients, difficult to manage, and costly to the healthcare system, so it remains a big problem.”

 explored a potential strategy to reduce these recurrences: using an initial vancomycin taper regimen after standard therapy. Results suggest a 4-week vancomycin pulse and taper regimen may offer a safe and accessible treatment option to delay or prevent early CDI recurrence.

McDonald and colleagues performed the parallel-design, double-blind clinical trial at 12 hospitals in Canada and enrolled adults with a first episode or first recurrence of CDI. For inclusion, patients were required to have clinical CDI with laboratory confirmation and to have improved by day 10 of treatment.

All patients received a 2-week pulse of vancomycin standardized at 125 mg orally 4 times a day at the time of recruitment and were then random;ly assigned to receive either vancomycin taper, 125 mg orally twice a day for 7 days and then 125 mg once a day for 7 days, or an equivalent schedule of placebo capsules.

The primary outcome was the posterior probability of superiority of the vancomycin pulse and taper regimen to prevent rCDI at day 56. A secondary outcome was recurrence at day 38. Binary outcomes were analyzed using a bayesian generalized linear model with minimally informative priors yielding log relative risk (RR) with 95% bayesian credible intervals (CrIs).

The trial was stopped early due to feasibility of recruitment. Among 265 participants (n = 135 in the intervention group; n = 130 in the control group), recurrence at day 56 occurred in 14.8% of the vancomycin pulse and taper group compared with 17.7% of the vancomycin pulse group (adjusted RR, 0.84; 95% CrI, 0.48-1.45; posterior probability of superiority, 73.8%).

Recurrence at day 38 occurred in 6.7% of the vancomycin pulse and taper group compared with 15.4% of the vancomycin pulse group (adjusted RR, 0.43; 95% CrI, 0.19-0.89; posterior probability of superiority, 99.0%).

McDonald noted that findings have important implications in a treatment landscape that increasingly includes fidaxomicin, a guideline-preferred therapy that has demonstrated lower recurrence rates than vancomycin in prior studies. However, fidaxomicin remains significantly more expensive and less accessible in many healthcare systems.

According to McDonald, the results suggest that if clinicians are already planning to use vancomycin, extending therapy with a taper may be a practical strategy to reduce early recurrence risk. However, whether the taper approach ultimately proves comparable to fidaxomicin over longer follow-up remains an open question.

“I think it depends on what you have available, what the patient can afford, and your healthcare system,” McDonald said. “If you're using vancomycin, I would use the taper. I think it's a reasonable option compared to fidaxomicin, but that's a hypothesis. We don't know the answer for day 56.”

Editors’ Note: McDonald reports relevant disclosures with Fond de Recherche Sante Quebec.

McDonald EG, Butler-Laporte G, Brophy JM, et al. Initial Vancomycin Taper for the Prevention of Recurrent 

 Infection: A Randomized Clinical Trial. 

 2026;9(2):e2560495. doi:10.1001/jamanetworkopen.2025.60495

US Centers for Disease Control and Prevention. After C. diff: Caring for Yourself and Others. December 13, 2024. Accessed March 16, 2026. 

https://www.cdc.gov/c-diff/after/index.html

McDonald discusses new trial data suggesting an initial vancomycin taper may reduce early recurrence of C difficile infection.

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Vancomycin Taper Strategies to Prevent C Difficile Recurrence, With Emily McDonald, MD, MSc

Comprehensive oHCM Follow-up: Hub-and-Spoke Care and 4-Pillar Framework

As oHCM prevalence and recognition increase, the limited capacity of specialized centers necessitates collaborative care models. Mariko Harper, MD, advocates for a hub-and-spoke strategy in which HCM centers of excellence provide initial diagnosis, risk stratification, and treatment planning, then partner closely with community cardiologists who assume much of the ongoing imaging, rhythm monitoring, and general cardiovascular management. Virtual initial consultations allow for early education, efficient planning of on-site testing, and tailored delegation of which assessments should occur locally versus at the referral center. Patients typically value annual visits to the expert center for complex counseling, genetic and family screening updates, and information on emerging therapies and clinical trials.

Matthew Martinez, MD, introduces a four-pillar framework he uses to structure follow-up encounters. The first pillar is symptom assessment, with attention to new, progressive, or changing limitations, including patients who underreport symptoms because of uncertainty about next steps. The second pillar is arrhythmia surveillance, particularly atrial fibrillation and ventricular tachycardia, both for symptom control and sudden cardiac death risk stratification. The third pillar involves family-based care, focusing on genetic testing where appropriate, periodic imaging of first-degree relatives, and reassessment of family history as life circumstances evolve. The fourth pillar centers on lifestyle, encompassing exercise prescriptions, weight management, nutrition, and pregnancy planning when relevant.

Within this structure, Martinez and Harper discuss practical use of stress echocardiography to detect latent obstruction even in patients deemed nonobstructive for many years, as well as the growing role of natriuretic peptides such as NT-proBNP in flagging changes in hemodynamics or unveiling new processes such as diastolic dysfunction or concomitant amyloidosis. They describe MRI at 3- to 5-year intervals in many patients for fibrosis assessment and risk stratification, and yearly echocardiography in most individuals—more frequently when on titrated medical therapy. This segment illustrates how Martinez and Harper integrate advanced diagnostics, collaborative care, and structured clinical frameworks to deliver comprehensive, long-term management for patients and families affected by oHCM.

Martinez and Harper describe a hub-and-spoke model for HCM care, follow-up cadence, and a structured “4-pillar” framework for longitudinal management, including imaging, biomarkers, and family-based risk strategies.



Long-Term Safety of Roflumilast Cream for Children, With Lawrence Eichenfield, MD

New long-term INTEGUMENT-OLE open-label extension trial data reinforce roflumilast cream .05% (ZORYVE) as a durable, well-tolerated non-steroidal medication for children aged 2 - 5 years living with atopic dermatitis, with efficacy continuing to build over the full 56-week study period.

In the second half of his discussion with the team at 

, Eichenfield, chief of pediatric and adolescent dermatology at Rady Children's Hospital–San Diego, highlighted what those new results could mean in practice and their significance among this patient population.

One of the most clinically notable observations from the extension study was that efficacy did not plateau after initial response. The continued to improve over time, and Eichenfield pointed to this trajectory as a reflection of the sustained anti-inflammatory action of roflumilast as a topical PDE4 inhibitor. While the earlier 4-week INTEGUMENT-PED trial established differentiation from vehicle, this longer observation window demonstated patients who had not yet attained clear or almost-clear status at the 4-week mark continued to improve as the drug’s use continued.

Even children who had been on vehicle in the initial trial and subsequently crossed over to active treatment caught up relatively quickly, Eichenfield highlighted. Beyond direct inflammation suppression, Eichenfield also described the mechanism as working to improve patients’ skin barriers and reducing their levels of pruritus. This effectively de-amplifyies the interconnected cycle of inflammation, dysfunction of barrier, and itch representing patients’ atopic dermatitis-related burdens.

On the question of tolerability, a heightened concern given the body surface area-to-weight ratio in toddlers and preschoolers, Eichenfield characterized these new findings as reassuring. More than 97% of those evaluated showed no evidence of local irritation at any evaluation point across the 56-week period, he noted, and caregiver-reported stinging or burning was documented in fewer than 1.8% of children at any single point in time.

Additionally, Eichenfield distinguished between tolerability and safety as distinct dimensions. He described, on the safety side, treatment-emergent adverse events, such as upper respiratory infections at 8.7%, pyrexia, and nasopharyngitis, as occurring at consistent rates with what is expected in any cohort of 2- to 5-year-olds followed over a full year. Eichenfield described serious adverse events as rare, noting a lack of such events being deemed treatment-related.

Contextualizing these data within the broader management landscape, Eichenfield pointed to this age group as having had historically very few approved non-steroidal medication options, while carrying a disproportionately high disease burden. He acknowledged concerns about topical corticosteroids, whether fully warranted or not, are a real-world driver of hesitancy among caregivers. Having a therapy designed for clinicians and families to use as needed with genuine comfort, Eichenfield argued, has the potential to meaningfully shift how well atopic dermatitis is controlled early in life.

Disclosures: Eichenfield previously reported receiving personal fees from Pfizer Inc; grant funding from AbbVie, Arcutis Biotherapeutics, Bausch + Lomb, Castle Biosciences, Dermavant Sciences Inc, Galderma SA, Pfizer Inc, Regeneron, and Sanofi SA and consulting for ASLAN Pharmaceuticals, AbbVie, Almirall, SA, Arcutis Biotherapeutics, Arena Pharmaceuticals Inc, Dermavant Sciences Inc, Galderma SA, Incyte Corporation, LEO Pharma A/S, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi SA, and UCB; and serving on the board of directors of Forté Pharma.

Smith T. New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children. HCPLive. March 10, 2026. Accessed March 16, 2026. 

https://www.hcplive.com/view/new-long-term-data-announced-roflumilast-cream-atopic-dermatitis-in-children

Eichenfield L. On New Roflumilast Cream Data for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD. HCPLive. March 16, 2026. 

https://www.hcplive.com/view/on-new-roflumilast-cream-data-atopic-dermatitis-children-lawrence-eichenfield-md

This segment of Eichenfield's interview highlights long-term safety findings on roflumilast cream .05% for children 2 - 5 years old with atopic dermatitis.

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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.

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Allergy experts weigh ruxolitinib, tapinarof, and roflumilast—new nonsteroidal creams that reshape atopic dermatitis care beyond steroids.

From First Flare to Treatment-Free Intervals: Prescribing Nonsteroidal Topicals for Atopic Dermatitis

Kathryn Berlacher, MD, MS, is the clinical & strategic director of cardiology at UPMC and the chair of ACC 2026.

This conference preview with Kathryn Berlacher, MD, MS, and Kristen Campbell, PharmD, highlights the top 6 trials to watch at ACC 2026.

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Conference Preview: American College of Cardiology Scientific Sessions 2026, With Kathryn Berlacher, MD, MS, and Kristen Campbell, PharmD

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Introducing ABCs in Dermatology, with Lindsay Ackerman, MD, and Chris Bunick, MD, PhD

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Investigational RNA interference therapy targeting prekallikrein enters accelerated regulatory pathway as phase 2 trial evaluates long-acting prophylaxis for HAE.

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Data from the ACCESS II trial, ACCESS extension study, and a body composition study provide an early look at efficacy and safety data of a new investigational oral GLP-1.

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Interim Results from ACCESS Program of Aleniglipron Shows Weight Loss Efficacy

This interview highlights key points regarding new data on roflumilast cream 0.05% in children aged 2 to 5 years with atopic dermatitis.

On New Roflumilast Cream Data for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Psoriasis severity goes beyond BSA: IGA, DLQI and high-impact areas redefine “moderate,” guiding when to move from topicals to systemic therapy.

Identifying and Managing Patients with Moderate Psoriasis

Martinez and Harper discuss the limits of current therapies, the role of septal reduction procedures versus cardiac myosin inhibitors, and the complexities of managing younger and childbearing-age patients with oHCM.

Latest News

Long-term Safety, REMS Data, and Echo Monitoring for oHCM Therapies

Implementing Cardiac Myosin Inhibitors in oHCM: Workflow and Team-Based Care

Vancomycin Taper Strategies to Prevent C Difficile Recurrence, With Emily McDonald, MD, MSc

Comprehensive oHCM Follow-up: Hub-and-Spoke Care and 4-Pillar Framework

Long-Term Safety of Roflumilast Cream for Children, With Lawrence Eichenfield, MD