In severe hypertriglyceridemia, participants tracked symptoms in eight domains beyond everything EQ-5D-5L and PROMIS measured.
Participants chose their own symptoms and treatments to follow at home, in their own words, on their own schedule. A fasting triglyceride panel and a hospital admission structurally cannot see what they reported. If your launch argument rests on unmet need beyond acute pancreatitis, this is where that evidence sits.
What the triglyceride number does not record
Severe hypertriglyceridemia has been treated as a lab value with one complication. As therapy development moves further into this population, a launch argument needs evidence of unmet need. Beyond acute pancreatitis, that evidence has been thin, and sHTG has often been described as asymptomatic.
The condition is measured on a fasting panel and on the attacks that reach a hospital. A triglyceride level is a single moment, drawn on a schedule the clinic sets. An acute pancreatitis episode is an event that requires care. Validated instruments add the patient's voice at limited intervals, and they ask the patient to look back.
Most of the burden sits between those points. In an analysis of 113 participants in the 500 to 879 mg/dL cohort, 80% had never experienced an acute pancreatitis episode. Across the full 183-participant cohort, the most tracked symptom domains were cognitive symptoms, anxiety and fatigue, and none of the three appears on a lipid panel.
The Research
The full inventory of symptoms participants named
183 adults with severe hypertriglyceridemia in a six-month study, stratified at 500 to 879 mg/dL and at 880 mg/dL and above. Participants selected 63+ symptoms across 17 domains at enrollment. Every domain the study's PRO instruments measured appeared in the tracking data, and eight more appeared alongside them: gastrointestinal, dermatological, ophthalmologic, urinary, neurological, endocrine and metabolic, cardiovascular, musculoskeletal.
Home-reported severity against PROMIS 29+2
Participants rated the symptoms they had chosen on a 0 to 5 severity scale, and those ratings sat alongside PROMIS 29+2 and PROMIS Cognitive Function 4a. Fatigue severity and PROMIS fatigue scores moved together in both triglyceride cohorts. Among participants who tracked difficulty remembering things, mean cognitive function T-scores came in at 37.0 and 39.9. The population norm on that measure is 50.
Who enrolls, and what they bring with them
126 adults with severe hypertriglyceridemia, ages 21 to 74, at the point of enrollment. Type 2 diabetes in 46% and hypertension in 41%, so most were managing more than one condition at once. Statins were the most reported treatment class. 22% selected no symptoms at all to track at enrollment, and the spread on treatments selected was almost as wide as the average itself.
What we do
See more of our published work here.
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Participants use a configuration developed with patients and adapted for severe hypertriglyceridemia. [PENDING: confirm whether the sHTG in-app experience was co-designed with sHTG patients, in which case this reads "designed in collaboration with sHTG patients and caregivers", Connie] Participants are able to track symptoms, treatments and day to day change, at a cadence and level of detail that matters to them, including severity against their own baseline, home measurement and lab-adjacent entries, and dietary and treatment context.
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Severe hypertriglyceridemia between acute events is continuous rather than episodic, so participants log trend and fluctuation against their own baseline rather than discrete events. The platform can also prompt a participant when symptom severity exceeds their own baseline, which they confirm or dismiss. Where an acute pancreatitis episode occurs, participants can record it alongside the daily record.
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Monthly check-ins can be administered, such as PROMIS 29+2, PROMIS Cognitive Function 4a and EQ-5D-5L, through the platform, making it easy for patients to complete regularly and ensuring that patient-defined outcomes are tied to a recognized benchmark.
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Each program is scoped to your specific objectives, whether that is establishing burden, demonstrating therapy impact, reading an early signal quickly, or following a condition over years. Configuring the patient experience to match the objective is what makes the resulting dataset publishable and actionable rather than merely interesting.
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Enrollment draws on Folia's existing platform population, Folia's clinician network, patient advocacy partners, and your own site network or patient lists. In severe hypertriglyceridemia, enrollment ran through clinician referral, community channels and social channels.
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Regular insights delivered on a monthly basis and at interim and final stages provide the evidence to support research objectives, a view into changes in the treatment or condition burden landscape, and the research-grade outcomes to support publication opportunities.
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Get a complete picture of patient experience by combining day to day HROs captured in Folia studies with clinical data captured in claims, EMR, and medical devices through tokenization and integrations.
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Folia Health is HIPAA and GDPR compliant. SOC 2. FDA 21 CFR Part 11.
The questions your data can't answer
What do patients feel on the days between panels?
What changes when triglycerides come down?
Which symptoms would patients name if no one handed them a list?
Why do patients skip or stop a therapy on a given day?
Folia will build a concept proposal against your severe hypertriglyceridemia endpoints. A defined study design, population, measurement strategy and deliverables, specific to your asset and your evidence question.
Request a concept proposal for your severe hypertriglyceridemia program