2026 Southeastern Residency Conference

Pharmacogenomics-Guided Statin Reinitiation in Veterans with History of Statin-Associated Muscle Symptoms
De’Vaughn Vaughn, Jennifer Clark
Fayetteville VA Health Care Center – Fayetteville, NC
 
Background/Purpose: Statin-associated muscle symptoms (SAMS) are a leading cause of statin discontinuation, leaving high-risk patients undertreated for atherosclerotic cardiovascular disease (ASCVD) prevention. Pharmacogenomic (PGx) testing can identify genetic variants that increase SAMS risk: SLCO1B1 encodes a hepatic uptake transporter affecting systemic exposure to all statins; ABCG2 encodes an efflux transporter modulating absorption and disposition of rosuvastatin; and CYP2C9 encodes a phase 1 metabolizing enzyme responsible for oxidation of fluvastatin and, to a lesser extent, other statins. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines provide therapeutic recommendations for statin selection and dosing based on these genotypes to improve safety, adherence and effectiveness of statin therapy. The purpose of this quality improvement project is to evaluate the role of PGx-guided, clinical pharmacist led statin reinitiation in veterans with history of SAMS and high ASCVD risk.
Methodology: This single-center, prospective cohort study enrolled 91veterans at the Fayetteville, NC VA Coastal Health Care System who had previously discontinued statin therapy due to reported SAMS. Eligible patients were identified through a statin adverse drug event (ADE) dashboard and had high ASCVD risk (history of type 2 diabetes mellitus and/or coronary artery disease) with prior exposure to no more than 3 statins. Veterans were contacted by the pharmacy resident and project preceptor via telephone and provided informed consent for PGx testing through Baylor Genetics. Following receipt of genotype results for SLCO1B1, ABCG2, and CYP2C9, patients were re-contacted and their PGx results were reviewed. Individualized statin recommendations were provided based on identified genetic variants. The primary outcome was the percentage of Veterans successfully reinitiated on statin therapy following PGx-guided recommendations. Secondary outcomes included rate of statin adherence at 4-6-week follow-up, rate of SAMS recurrence, and percentage of Veterans with LDL goal attainment of < 100mg/dL. 
Results: Of 91 eligible Veterans, 50 (55%) consented to PGx testing. Among those tested, 33 (66%) were successfully reinitiated on statin therapy, meeting the primary outcome. PGx testing identified SLCO1B1 decreased function in 12/33 (36%), ABCG2 decreased function in 4/33 (12%), and no actionable variants in 17/33 (52%). At the time of analysis, 21/33 (64%) Veterans had completed 4–6-week CPP follow-up, with 21/21 (100%) reporting adherence to statin therapy. Five Veterans (15%) discontinued therapy prior to follow-up: 3 due to SAMS recurrence (9%), 1 due to headache, and 1 due to epistaxis in the setting of anticoagulation. Among 12 Veterans with paired lipid data who continued therapy, mean LDL decreased from 134 mg/dL to 79 mg/dL (mean reduction: 56 mg/dL). Nine of 12 (75%) achieved LDL <100 mg/dL post-reinitiation. Of the 10 Veterans with baseline LDL >100 mg/dL, 7 (70%) achieved LDL < 100 mg/dL following PGx-guided statin reinitiation. Lipid data collection remains ongoing, with 20 Veterans awaiting post-statin lipid panels.
Conclusions: PGx-guided statin reinitiation resulted in a 66% reinitiation rate among consented Veterans, with a SAMS recurrence rate of only 9% comparing favorably to published recurrence rates of up to 30% with empiric rechallenge. All Veterans who reached 4–6-week follow-up remained adherent to therapy, and 75% of those with paired lipid data achieved LDL < 100 mg/dL. These early findings suggest that PGx-guided, clinical pharmacist-led statin reinitiation is a feasible and effective strategy for closing the treatment gap in high-risk Veterans with prior SAMS. Limitations include incomplete lipid data, lack of standardized baseline labs, and a small sample size. Continued follow-up and lipid panel collection will further define the durability of these outcomes.