Pharmacogenomic Informed Statin Prescribing

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how genetic testing can help improve the use of statins, which are medications that lower cholesterol and reduce the risk of heart disease. Many patients, especially veterans aged 40 to 75 with diabetes or heart disease, do not take statins because they worry about side effects or don't believe they will benefit from them. The trial aims to communicate the results of genetic tests that can show which patients are likely to benefit most from statins without experiencing significant side effects. By providing this information, the hope is to improve patients' understanding of their risk for heart disease and encourage them to take statins, ultimately lowering their cholesterol levels and reducing heart disease risk.

To be eligible for the trial, participants must be veterans between the ages of 40 and 75, have diabetes or heart disease, and not currently be taking statins. They should also have an upcoming appointment with their primary care doctor and must be able to speak English. Participants can expect to undergo genetic testing, and the results will be shared with them to help make informed decisions about their treatment. It's important to note that certain health conditions and treatments may exclude individuals from participating in the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients will be included in the analysis if they:
• • Are a Veteran
• • Aged 40-75 years
• • Diabetes mellitus or cardiovascular disease (coronary, cerebral, or peripheral artery disease)
• • An upcoming primary care appointment in the next 4 months
• • No active statin prescription (any time/dose, VA, or non-VA) in the prior 6 months
• • English speaking
• • At least 1 current active VA prescription
• • At least 1 primary care appointment within the prior 2 years
• Exclusion Criteria:
• • Non-Veterans
• • End-stage renal disease
• • History of rhabdomyolysis
• • Active treatment for non-dermatologic cancer
• • Known, prior SLCO1B1 genetic test results
• • Liver cirrhosis
• • Palliative care or hospice in 1-year prior to admission, during hospital stay, or at discharge
• • Active prescription for PCSK9 inhibitor
• • Inability to provide informed consent due to language impairment, cognitive disease, or other similar factors at the discretion of the research assistant or project coordinator.
• • Active enrollment in a different, interventional clinical trial, at the discretion of PI.
• • History of allogeneic stem cell transplant or liver transplant.
• * Documentation of specific adverse drug reactions thought to be attributed to statins:
• • Myopathy with associated elevation in creatinine kinase \> 10x upper limit of normal
• • Angioedema
• • Elevated AST/ALT
• • Others at discretion of PI