Using genetic testing to prevent adverse drug reactions in primary care

A Multi-gene Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice: Open-label, Mayo Clinic Multisite (Mayo Clinic Health System-Rochester Primary Care), Controlled, Implementation Study Taking the Results of the PREPARE Study Into Minnesota (PREPARE-Mayo)

This study tests whether genetic testing can help doctors choose the right medications and dosages for patients to prevent harmful side effects when they start new prescriptions.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06322238 on ClinicalTrials.gov

What this trial studies

This study aims to implement pre-emptive pharmacogenomic testing to guide the selection and dosing of 39 commonly prescribed medications. By analyzing a panel of clinically relevant pharmacogenomic markers, the study seeks to reduce the occurrence of adverse drug reactions (ADRs) associated with specific medications. Participants will be followed for 48 weeks to assess the effectiveness of this approach in a primary care setting. The study focuses on patients receiving their first prescription for these drugs and involves saliva donation for genetic analysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are receiving their first prescription for one of the targeted medications in a primary care setting.

Not a fit: Patients who have previously undergone pharmacogenomic testing for the relevant genes or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of adverse drug reactions in patients, leading to safer and more effective medication management.

How similar studies have performed: Other studies have shown promise in using pharmacogenomic testing to improve drug safety and efficacy, indicating that this approach is both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

* Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Subject must be ≥ 18 years old
2. Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care.
3. Subject is able and willing to take part and willing to be followed up on for 48 weeks
4. Subject is able to donate saliva
5. Subject has signed informed consent
6. Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email

Exclusion Criteria:

1. For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel
2. Pregnant or lactating (to be verbally confirmed with the patient)
3. Life expectancy estimated to be less than three months as determined by patient receiving hospice care
4. Duration of index drug total treatment length is planned to be less than seven consecutive days.
5. Current inpatients
6. Unable to consent to the study
7. Unwilling to take part
8. Subject has no permanent address
9. Subject has no current primary care provider
10. Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
11. Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
12. Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
13. History of a liver transplant or an allogeneic hematopoietic stem cell transplant
14. DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Isa Houwink, M.D., Ph.D. — Mayo Clinic

Conditions Pharmacogenomic Drug Interaction; Side Effect of Drug; Ineffective Drug Action; Drug Metabolism, Poor, CYP2D6-Related; Drug Metabolism, Poor, CYP2C19-Related; pharmacogenomics; PGx; CPIC