Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Comple

Study Funding

This study is supported by an unrestricted grant from Regeneron.

Background/Synopsis

Familial hypercholesterolemia (FH) confers a markedly increased risk of ASCVD and mortality if untreated or undertreated. Appropriate lipid lowering therapy relies on the clinician to recognize that a patient could benefit, prescribe the medication, and then use guideline recommended dosage levels. In 2022, the ACC revised their guidelines for using non-statins in patients at high and very high risk with LDL goals less than 70mg/dL and 55 mg/dL respectively. However, on a national level, very few patients with suspected FH ever reach these goals. We previously presented a pilot study where we identified patients in the Atlantic Health System (AHS) EPIC health record with the highest LDLs and reached out to their PCPs to enroll in our lipid clinic, first using EPIC letter, followed by EPIC chat. We found that EPIC chat generated a response rate of 28% compared to a prior response rate of 6.5% using Epic letter; we concluded that using EPIC chat as a method of outreach could help identify and treat the highest risk patients with suspected FH. The ALLTOP study is being initiated as a quality improvement project to address the prevalence of dyslipidemia and cardiometabolic comorbidities among existing AHS patients, particularly those who may be living with undiagnosed/untreated FH.

Objective/Purpose

Develop a model for primary and secondary prevention that integrates updated treatment gui-delines for patients with suspected FH.

Methods

600 potential participants will be screened and recruited through outreach to PCPs via secure EPIC chat and enrolled on an ongoing, rolling basis until 250 patients are obtained. Baseline LDL-C is taken at the initial visit and patients will be treated with the standard of care. An Advanced Practice Registered Nurse (APRN) will be directing the clinic under physician supervision. Follow-up visits will be scheduled every three to six months, with lab draws scheduled at 24 and 48 weeks to compare baseline LDL-C and goal LDL-C, respectively.

Results

The primary endpoint will be the proportion of patients that maintain LDL-C 100 mg/dL after 24 weeks and 48 weeks. The secondary end point will be the proportion of patients that maintain LDL-C <70 mg/dL, LDL-C 55mg/dL, and overall percent reduction in LDL cholesterol.

Conclusions

The ALLTOP study will examine the benefit of comprehensive, wrap around, supportive care to lower elevated LDL and sustain healthy levels through 36 months from baseline enrollment using an APRN-led intervention. By screening patients in the EHR, reaching out to their PCPs via secure EPIC chat, and enrolling them in ALLTOP, we plan to show that we can reduce their LDL levels close to the 2022 ACC guidelines.