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

Trial Summary

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 data supports the effectiveness of the Genetic Testing Panel for reducing medication side effects?

Research shows that pharmacogenomic (PGx) testing can help doctors choose the right medication and dose for patients, reducing the risk of side effects and improving treatment outcomes. This testing is especially useful for patients taking multiple medications or those with complex medical conditions. ^{1 2 3 4 5}

Is genetic testing for reducing medication side effects safe for humans?

Genetic testing, like the PGx panel test, is generally safe and is used to predict how people might react to medications, helping to avoid bad side effects. It has been used safely in various settings, including with children and people with complex medical conditions. ^{2 3 4 6 7}

How does genetic testing help reduce medication side effects?

Genetic testing, specifically pharmacogenomic (PGx) testing, is unique because it helps predict how a person will respond to a medication, allowing for personalized treatment plans that minimize side effects. This approach is different from traditional treatments, which often use a one-size-fits-all method without considering individual genetic differences. ^{1 2 3 4 7}

What is the purpose of this trial?

The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').

Research Team

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

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Striking a balance in communicating pharmacogenetic test results: promoting comprehension and minimizing adverse psychological and behavioral response. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of the Implementation of Pharmacogenomic Testing in a Pediatric Tertiary Care Setting. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Professional perspectives about pharmacogenetic testing and managing ancillary findings. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Public perspectives about pharmacogenetic testing and managing ancillary findings. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Multiple-Pharmacogenes Testing for the Prevention of Adverse Drug Reactions in People Living with HIV. [2022]