Christie Ballantyne, MD

RX Review: Barriers, Real-World Implementation, and Future Directions in FCS

Despite boasting a pair of US Food and Drug Administration-approved therapies for 

, the disease still represents a significant area of unmet need in cardiology. 

, host Viet Le, DMSc, PA-C, a preventive cardiology PA at Intermountain Health and the former president of the Academy of Physician Associates in Cardiology, and panelist Christie Ballantyne, MD, chief of cardiovascular research at Baylor College of Medicine and principal investigator of the PALISADE trial, examine real-world barriers that continue to challenge optimal FCS management. 

Ballantyne notes that, despite advances in diagnosis and therapy, many patients still face obstacles related to genetic testing access, payer authorization, and fragmented care. These challenges can delay treatment initiation, even when patients meet clinical criteria. Accurate documentation and the use of validated diagnostic scoring systems are essential for navigating payer requirements, particularly after the approvals of olezarsen (Tryngolza) in late 2024, and plozasiran (Redemplo) on November 18, 2025, which both require clear diagnostic justification before coverage is granted.

The discussion turns toward practical strategies to improve real-world implementation. Ballantyne underscores the need for structured workflows that integrate primary care clinicians, lipid specialists, dietitians, and cardiologists. He highlights how early referrals, consistent follow-up, and comprehensive patient support can significantly reduce delays and improve adherence to therapy. Education remains a cornerstone of this effort, both for clinicians who may be unfamiliar with FCS and for patients who must manage a complex, lifelong condition.

The segment concludes with a hopeful outlook. Le and Ballantyne emphasize the future of FCS management will likely be defined by earlier diagnosis, improved care coordination, and ongoing innovation in therapy and testing. With the availability of targeted treatments for the first time, clinicians now have tools can meaningfully shift the trajectory of this severe condition. Continued investment in awareness, education, and interdisciplinary communication will be essential to ensure patients fully benefit from advancements introduced in 2025 and beyond.


Relevant disclosures for Ballantyne include Arrowhead Pharmaceuticals, Inois, Merck, Novartis, Novo Nordisk, New Amsterdam, Esperion, AstraZeneca, Eli Lilly, and others. Relevant disclosures for Le include Amarin, Bayer, Esperion, Idorsia, Janssen, Novo Nordisk, Novartis, Lexicon Pharmaceuticals, and Pfizer.

Arrowhead Pharmaceuticals. Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) - Arrowhead Pharmaceuticals, Inc. Arrowhead Pharmaceuticals, Inc. Published November 19, 2025. Accessed November 25, 2025. 

https://arrowheadpharma.com/news-press/arrowhead-pharmaceuticals-announces-fda-approval-of-redemplo-plozasiran-to-reduce-triglycerides-in-adults-with-familial-chylomicronemia-syndrome-fcs/

Virani SS, Morris PB, Agarwala A, et al. 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia: A Report of the American College of Cardiology Solution Set Oversight Committee. 

US Food and Drug Administration. FDA approves Tryngolza (olezarsen). U.S. Food and Drug Administration. Published December 19, 2024. Accessed November 25, 2025. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-reduce-triglycerides-adult-patients-familial-chylomicronemia-syndrome

Videos

RX Review: Monitoring and Safety Considerations in FCS

As the cardiology community embraces the new, targeted-therapy era of management for 

, an integral aspect of conversations becomes safety and monitoring considerations.

, Le and Ballantyne shift attention to the safety considerations that accompany modern FCS therapies. Ballantyne reviews common adverse events encountered with injectable triglyceride-lowering agents, including olezarsen and plozasiran. These include injection site reactions, mild flu-like symptoms, transient hyperglycemia, and rare systemic complications. He notes safety profiles observed during clinical trials have been generally favorable, especially when compared with older triglyceride-lowering therapies. Regular monitoring, including lipid panels and periodic blood glucose assessments, provides an essential foundation for tracking response and detecting emerging issues early.

The conversation addresses the importance of patient counseling in promoting safe and sustained therapy use. Ballantyne emphasizes that clinicians should prepare patients for expected injection site reactions and reassure them that most reactions are mild and manageable. Structured follow-up visits allow clinicians to assess tolerability, address concerns, and adjust therapy as needed. Le and Ballantyne stress open communication improves adherence and helps ensure safety events do not lead to unnecessary discontinuation of therapy.

This segment concludes by outlining the central role of interdisciplinary collaboration in safety monitoring. Ballantyne reiterates safety monitoring is not merely a formality but a core component of modern FCS management ensuring patients benefit fully from these advanced therapies.


Explore the critical role of nutrition and pharmacologic therapies in managing hypertriglyceridemia and preventing pancreatitis effectively.

RX Review: Integrating New Therapies in FCS Treatment Algorithms

With new approvals, the most obvious question for clinicians often becomes: How do I fit this into treatment algorithms? 

This same question is being posed by cardiologists across the US as the field welcomed the second approval for 

 with the US Food and Drug Administration approval of plozasiran (Redemplo) in November 2025. 
In part 5 of our 

, host Viet Le, DMSc, PA-C, a preventive cardiology PA at Intermountain Health and the former president of the Academy of Physician Associates in Cardiology,  and panelist Christie Ballantyne, MD, chief of cardiovascular research at Baylor College of Medicine and principal investigator of the PALISADE trial, explore how the approvals of olezarsen (Tryngolza) and plozasiran reshape treatment algorithms for FCS. 

Ballantyne explains while these agents represent major scientific milestones, they must be incorporated with careful attention to patient needs and existing management principles. Historically, strict dietary restriction has been the cornerstone of therapy, often requiring patients to maintain extremely low-fat intake. Despite the availability of potent medications, Ballantyne reiterates nutritional management remains foundational because it supports medication effectiveness and helps mitigate triggers for pancreatitis.

The segment then focuses on practical integration of therapy. Ballantyne highlights the importance of consistent lipid monitoring and clear communication between lipid specialists, cardiologists, and nutritionists. Medication selection may vary according to patient preference, access considerations, safety profiles, and prior treatment response. The conversation underscores clinicians should provide structured education to ensure patients understand the ongoing role of diet, even when receiving advanced therapies.

Explore how the latest FDA approvals impact the management of FCS.

RX Review: Understanding Plozasiran’s Role in FCS Management

The US Food and Drug Administration's November 2025 approval of plozasiran (Redemplo) marks a significant shift in the landscape of 

, with the field now entering an era with multiple approved therapies following the 2024 approval of olezarsen (Tryngolza).

, host Viet Le, DMSc, PA-C, a preventive cardiology PA at Intermountain Health and the former president of the Academy of Physician Associates in Cardiology, welcomes Christie Ballantyne, MD, chief of cardiovascular research at Baylor College of Medicine and principal investigator of the PALISADE trial, focus on plozasiran and its role in contemporary FCS management. 

Ballantyne begins by reviewing the mechanism of action of small interfering RNA therapies and how they modulate pathways independent of lipoprotein lipase activity. This mechanism is particularly valuable for patients with FCS, who lack functional LPL-mediated triglyceride clearance. Ballantyne highlights clinical studies have shown substantial reductions in median triglyceride levels along with meaningful decreases in pancreatitis episodes, outcomes were historically unattainable with earlier therapies.

Plozasiran received FDA approval on November 18, 2025, making it the second disease-targeted therapy available for individuals with FCS, following the approval of olezarsen in late 2024. Ballantyne compares the therapeutic classes, noting distinctions between antisense oligonucleotides such as olezarsen and siRNA agents such as plozasiran. Differences in dosing frequency, safety profiles, and trial endpoints may influence clinician decision-making. Le and Ballantyne underscore even with potent new agents, ongoing lifestyle management remains important, particularly in preventing secondary complications.

The discussion closes by highlighting how plozasiran expands treatment options for a historically underserved population. Ballantyne remarks the approval signals a new era in FCS therapy and demonstrates the value of precision approaches to rare metabolic diseases. The segment emphasizes specialist involvement is essential for optimal integration of plozasiran into clinical practice. With 2 FDA-approved therapies, clinicians now have the ability to tailor therapy based on patient characteristics, response patterns, and safety considerations.

Panelists break down the potential role of plozasiran in FCS based on the PALISADE trial. 

Christie Ballantyne, MD

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