Genetic Testing for Reducing Medication Side Effects

(PREPARE-Mayo Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Hospice care, CKD, Liver failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if genetic testing can reduce medication side effects. It uses a PGx panel test to guide the choice and dosage of 39 common drugs, potentially reducing adverse drug reactions. Participants will receive the genetic test either immediately or after a delay to compare outcomes. Those who have recently started a new prescription and can provide a saliva sample may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop your current medications. However, it focuses on testing for new prescriptions, so you might not need to stop existing medications.

What prior data suggests that the PGx panel test is safe?

Research has shown that PGx panel testing is generally safe for people. One study examined reports from 3,303 individuals and found that PGx testing, which uses DNA to predict medication reactions, helped manage side effects for many. This testing examines genes that influence drug interactions in the body, helping to reduce unwanted side effects before they occur.

Another study indicated that using a panel with just three genes could reduce side effects in three out of four cases where PGx testing could alter outcomes. This suggests the test is well-tolerated and effective in preventing harmful reactions.

The PGx panel is not a medication but a tool to help doctors choose the right medicine and dose. It focuses on preventing side effects rather than causing them. Overall, PGx testing appears to be a safe and useful way to manage medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PGx panel test because it promises to personalize medication choices by using genetic information to reduce side effects. Unlike standard treatments that often rely on a one-size-fits-all approach, this test aims to tailor medications based on a person's genetic makeup, potentially improving safety and effectiveness. This genetic testing could revolutionize how we choose and dose medications, leading to fewer adverse reactions and better patient outcomes.

What evidence suggests that the PGx panel test is effective for reducing medication side effects?

Research has shown that pharmacogenomic (PGx) testing can reduce harmful reactions to medications by customizing drug choices based on a person's genetic makeup. One study found 10,718 adverse drug reactions in 3,303 patients, suggesting that a PGx panel could lower these numbers. In this trial, participants in the PGx testing arm will receive immediate PGx testing to help doctors predict their reactions to certain medications, aiming to prevent side effects and enhance treatment effectiveness. Participants in the delayed PGx testing arm will receive the testing later. By examining genes involved in drug processing and movement, PGx testing aims to reduce side effects and improve medication outcomes. These findings highlight PGx testing's potential to make medications safer and more effective. ^{1 2 6 7 8}

Who Is on the Research Team?

Isa Houwink, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who often experience poor drug metabolism, resistance to medications, or adverse interactions and side effects from commonly prescribed drugs. It's aimed at seeing if testing their genes before prescribing medication can help.

Inclusion Criteria

I am getting my first prescription for a specific drug listed in a table.

Computer literacy measured by active use of the patient portal or email

Subject is able and willing to take part and be followed up on for 48 weeks

Exclusion Criteria

I am unable to give consent for the study myself.

My liver is severely damaged (Child-Pugh C) or I have cirrhosis.

I have had a liver transplant or a stem cell transplant from a donor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PGx Testing

Implementation of pre-emptive pharmacogenomic testing to guide dose and drug selection for 39 commonly prescribed drugs

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after PGx testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PGx panel test

Trial Overview The study tests whether using a PGx panel test (which checks how your genes affect your response to drugs) on patients can prevent bad reactions and improve the choice of dosage and medication for 39 common drugs.

How Is the Trial Designed?

Group I: PGx testing arm Experimental Treatment 1 Intervention

Group II: Delayed PGx testing arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Implementing single or multiple pharmacogenetic (PGx) testing before prescribing HIV medications could prevent approximately 68 serious adverse drug reactions (ADRs) annually, with a number needed to screen (NNS) of 40 to avoid one serious ADR.

Both single and multiple-PGx testing strategies could save about 35% and 40% of the costs associated with treating ADRs, respectively, making them potentially cost-effective options compared to no PGx testing, with incremental cost-effectiveness ratios (ICERs) of 146,319 THB/QALY and 152,014 THB/QALY, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Multiple-Pharmacogenes Testing for the Prevention of Adverse Drug Reactions in People Living with HIV. Turongkaravee, S., Praditsitthikorn, N., Ngamprasertchai, T., et al.[2022]

Pharmacogenetic (PGx) testing can help predict how well a patient will respond to medications and whether they might experience side effects, but the way results are communicated is crucial for patient understanding.

Using standard terms like 'poor metabolizer' can confuse patients and lead to anxiety, which may negatively affect their willingness to follow medication plans, highlighting the need for clearer communication from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Striking a balance in communicating pharmacogenetic test results: promoting comprehension and minimizing adverse psychological and behavioral response. Haga, SB., Mills, R., Bosworth, H.[2021]

Health professionals showed a positive interest in pharmacogenetic (PGx) testing, but primary care physicians (PCPs) expressed concerns about its clinical utility, insurance coverage, and the complexities of communicating incidental disease risk information.

The study highlighted a need for better educational resources and clear guidelines to help PCPs effectively use PGx testing, as many felt obligated to disclose ancillary disease risks but were unsure how to interpret these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional perspectives about pharmacogenetic testing and managing ancillary findings. Haga, SB., Tindall, G., O'Daniel, JM.[2021]

Pharmacogenomic (PGx) panel testing can provide more comprehensive insights than single gene testing, revealing multiple genetic abnormalities that may affect treatment decisions for various conditions.

In a case study of a breast cancer patient, PGx panel testing identified a higher risk for clotting related to standard cancer treatments, highlighting its potential to prevent medication-related problems and reduce future healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional Utility of Pharmacogenomics (PGx) Panel Testing in a CYP2D6 Normal Metabolizer with a History of Breast Cancer. Schuh, MJ.[2022]

Pharmacogenomic (PGx) testing is increasingly used in psychiatry to help guide medication decisions, potentially improving treatment response and identifying patients at risk for side effects.

Despite its benefits, the implementation of PGx testing in clinical practice faces challenges, and more research is needed to determine the best ways to integrate it into psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. Brown, L., Eum, S., Haga, SB., et al.[2021]

A focus group study with 45 participants showed strong enthusiasm for pharmacogenetic (PGx) testing, indicating a positive public attitude towards its potential to improve treatment outcomes.

Participants expressed concerns about privacy and the psychological impact of receiving unexpected ancillary disease risk information, highlighting the need for clear communication between patients and healthcare providers regarding the benefits and risks of PGx testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public perspectives about pharmacogenetic testing and managing ancillary findings. Haga, SB., Tindall, G., O'Daniel, JM.[2021]

In a study of 172 children at The Hospital for Sick Children, pharmacogenomic (PGx) testing revealed that 36.8% of patients in the point-of-care cohort had genetic profiles that required changes to their standard medication dosages, highlighting the importance of personalized medicine.

In the preemptive cohort, 80% of children were advised to follow nonstandard treatment regimens based on whole-genome sequencing, demonstrating the potential of PGx testing to optimize drug therapy and reduce adverse reactions in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Implementation of Pharmacogenomic Testing in a Pediatric Tertiary Care Setting. Cohn, I., Manshaei, R., Liston, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10942860/

A review of real-world evidence on preemptive ... Overall, 10,718 ADRs were reported in 3303 patients. The PGx panel included genes responsible for drug metabolism, transport, and receptor ...

2. asapdx.com asapdx.com/pgx-panel

PGx Panel PGX testing aims to prevent side effects or adverse reactions while achieving the best results from prescription medications.

3. fulgentgenetics.com fulgentgenetics.com/pgx-comprehensive

PGx Comprehensive NGS Panel Overview: Fulgent's Pharmacogenetic (PGx) tests give clinicians the tools to better understand how their patients will respond to certain medications.

4. illumina.com illumina.com/areas-of-interest/pharmacogenomics.html

Pharmacogenomics (PGx) | Benefits, research solutions, & ... Reduce adverse drug reactions; Speed time to achieving the therapeutic benefit of a drug; Decrease the chance of side effects or dependency. Decrease the cost ...

5. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3704

Navigating Pharmacogenomic Testing in Practice: Who to Test ... There is increasing attention on the clinical utility and value of pharmacogenetic (PGx) testing to individualize medication management.

6. medicover-genetics.com medicover-genetics.com/our-genetic-tests/pharmacogenomics/pharmacogenomic-preventive-panel/

Pharmacogenomic Preventive Panel Our PGx Preventive Panel provides clear, evidence-based results to guide drug and dose selection before issues arise. It can help: ○ Reduce the risk of ADRs ○ ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11949333/

Pharmacogenetics and adverse drug reports - PubMed Central Using a panel of only three genes could potentially mitigate three in every four PGx modifiable side effects. Based on our findings, Psychiatry ...

8. fulgentgenetics.com fulgentgenetics.com/pgx

Fulgent Pharmacogenetic Testing (PGx) With PGx testing, you can learn about potential adverse reactions before an individual ever takes a drug, reducing the risk of "trial-and-error" prescribing.