Pharmacogenomic Testing for High Cholesterol

Recruiting at 1 trial location

Overseen By Deepak Voora, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: PCSK9 inhibitors

Disqualifiers: End-stage renal disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

410 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with high cholesterol who are not taking statins, which are drugs that lower cholesterol. Researchers use genetic testing (pharmacogenomic testing) to predict who will benefit most from statins and who might experience fewer side effects. The goal is to enhance how individuals perceive their risk of heart disease and their willingness to take statins. Veterans with diabetes or heart disease, who have not recently taken statins and have an upcoming primary care appointment, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could personalize cholesterol treatment and improve patient outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have an active statin prescription in the past 6 months and cannot be on a PCSK9 inhibitor.

What prior data suggests that pharmacogenomic testing for statin prescribing is safe?

Research shows that genetic testing can help doctors select the most suitable cholesterol-lowering drug, known as a statin, for each individual. This testing helps doctors assess a patient's likelihood of benefiting from statins or experiencing side effects.

The test examines a gene called SLCO1B1, which affects how a person responds to statins, particularly concerning muscle pain, a common side effect. One study found that using this genetic information increased the likelihood of patients continuing their statin treatment and achieving lower levels of "bad" cholesterol.

The test is safe and straightforward, requiring only a simple genetic test. Statins are already widely used to lower cholesterol, and this testing personalizes their use. It aims to reduce side effects by helping doctors choose the right type and dose of statin for each person.

Overall, genetic testing for statins is considered safe and can enhance the effectiveness and tolerability of statin therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pharmacogenomic Informed Statin Prescribing approach for high cholesterol because it personalizes treatment based on a patient's genetic makeup. Unlike standard statin prescriptions, which follow a one-size-fits-all model, this method uses genetic testing to predict how effectively a patient will respond to specific statin types and doses. This personalized approach aims to optimize the efficacy of statins while minimizing potential side effects, offering a tailored treatment plan that could improve outcomes and reduce the risk of cardiovascular disease for patients.

What evidence suggests that pharmacogenomic informed statin prescribing is effective for high cholesterol?

Research shows that genetic testing can help doctors customize statin prescriptions for individuals. This trial includes a genetic testing arm where participants will undergo testing to determine their potential response to statins, which lower cholesterol. Studies have found that nearly half of those taking statins could benefit from this personalized approach. It helps identify who might experience better results or fewer side effects. For example, genetic testing can reveal if someone is at risk for muscle problems from statins like simvastatin. By addressing these issues, genetic testing can increase comfort with statin use and improve adherence, ultimately lowering cholesterol and reducing heart disease risk. This personalized method aims to make statin use more effective and safer for everyone. ^{1 5 6 7 8}

Who Is on the Research Team?

Deepak Voora, MD

Principal Investigator

Durham VA Medical Center, Durham, NC

Dawn M. Bravata, MD

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Are You a Good Fit for This Trial?

This trial is for individuals with high cholesterol who are at risk for cardiovascular disease (CVD) but may be hesitant to take statins due to concerns about their effectiveness or potential side effects. Participants should not currently be on statin therapy.

Inclusion Criteria

Patients who are Veterans

English speaking

I have a primary care appointment scheduled within the next 4 months.

Exclusion Criteria

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

Non-Veterans

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guideline-based statin recommendations with or without pharmacogenomic test results

12 months

Regular visits as per primary care schedule

Follow-up

Participants are monitored for changes in LDL-cholesterol levels and adherence to statin therapy

3 months

Implementation Planning

Development of an implementation blueprint package for dissemination to Veterans and VHA facilities

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacogenomic Informed Statin Prescribing

Trial Overview The study tests whether genetic testing can help predict the benefits and risks of taking statins, potentially improving patient acceptance and adherence by personalizing treatment plans based on individual genetic profiles.

How Is the Trial Designed?

Group I: Genetic testing arm Experimental Treatment 1 Intervention

The intervention involves: genetic testing; interpretation; and prior to and shortly following an upcoming appointment, communication to patients and providers about the patients' predicted statin efficacy and toxicity, genetic risk for CVD, and individualized recommended statin type/dose.

Group II: Control Active Control 1 Intervention

The control condition involves receipt of a report highlighting the risk of cardiovascular disease and benefits of statins (without genetic test results).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06568601

Pharmacogenomic Informed Statin Prescribing Improve acceptance of guideline-directed statin therapy through delivery of statin pharmacogenomic test results that communicates statin efficacy and toxicity.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5055044/

Pharmacogenomics of statins: understanding susceptibility to ... The only clinically relevant pharmacogenetic test regarding statin toxicity is SLCO1B1 521C and its relevance is limited to simvastatin myopathy.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2773490

Effect of Pharmacogenetic Testing for Statin Myopathy Risk ... This randomized clinical trial examines the impact of delivering SLCO1B1 pharmacogenetic results to physicians on low-density lipoprotein ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCGEN.121.003503

Pharmacogenomic Study of Statin-Associated Muscle ... This study comprises the largest discovery exome-wide and genome-wide association study for atorvastatin- or rosuvastatin-mediated SAMS to date.

5. amjmed.com amjmed.com/article/S0002-9343(23)00430-8/fulltext

Pharmacogenomics of Statins: A View from ChatGPT Emerging evidence points to pharmacogenomics, the study of how an individual's genetic composition affects their drug response, as a promising ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7716196/

Effect of Pharmacogenetic Testing for Statin Myopathy Risk ... This randomized clinical trial examines the impact of delivering SLCO1B1 pharmacogenetic results to physicians on low-density lipoprotein cholesterol levels.

7. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141709635

IIR 21-040 – HSR Study - VA Health Systems Research Important prior work by our group demonstrates that pharmacogenomic testing for statin toxicity is feasible, improves patients' perceptions of statin therapy, ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCGEN.118.002228

Effects of Delivering SLCO1B1 Pharmacogenetic ... Delivery of SLCO1B1 pharmacogenetic testing that addresses statin myalgia improved statin reinitiation and LDLc but did not improve self-reported statin ...