Pharmacogenetic Testing at Community Pharmacy

Pharmacogenetic Testing Clinical Trial

— OffiGene  

Official title:

Randomised Controlled Study of the Efficacy and Acceptability of a Pharmacogenetic Test in the Management of Patients Treated With Escitalopram.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210321
• Other study ID #: OffiGene01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Chantal Csajka, Pre
• Phone: +4121 314 42 63
• Email: chantal.csajka[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the clinical impact of reducing treatment failure rates after using genetic information targeting CYP2C19 in validating escitalopram prescription. 5 pharmacies in the canton of Vaud (Lausanne, Switzerland) will participate in the study.

The study will also explored the ability to perform the test in community pharmacy, physician and pharmacist approval of prescription changes, patient acceptance of the test and dose changes, the economic impact of the test, the association between genetic polymorphisms and therapeutic failures and the degree of satisfaction, barriers and facilitators by stakeholders.

Description:

Response to medication depends on many clinical, demographic, environmental, and genetic factors. Non-genetic factors that are often considered when prescribing treatments address not only drug-drug interactions, but also the patient's environment, comorbidities, gender, and age. Genetic factors, which are not commonly considered during prescribing except for some drugs, account for 15-30% of the variability in drug response. From a pharmacokinetic point of view, genetic polymorphisms are likely to modify drug absorption, metabolism, transport and elimination. Data from the literature indicate that the concentration profiles of many drugs are genetically influenced. It is also well known that genetic polymorphisms that alter the targeting of some drugs can alter drug response, especially in oncology.

Personalization of medicine is a fundamental approach to treating patients individually. Pilot studies to integrate pharmacogenetics into practice are already being conducted in hospitals, and some pharmacies abroad offer pharmacogenetic testing, as in Canada and Germany.

In Switzerland, a new Ordinance on Genetic Analysis Act was passed on September 23, 2022, allowing pharmacists to carry out genetic testing in the medical field.Because of the increasing evidence of the influence of CYP2C19 genetic polymorphisms on the efficacy and toxicity of escitalopram, the high prevalence of prescription of this drug in the treatment of depression, the prevalence of genetic polymorphisms in the Caucasian population (30% ultra-rapid metabolizers and 4% poor metabolizers) and the potential costs to public health, this drug was chosen as a prototype for this pilot project.

Therefore, investigators want to conduct a pilot study to evaluate the efficacy, safety, feasibility, and cost-effectiveness of pharmacy-based genetic testing as part of patient care management and identified barriers to using such tests.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must consent to participate in the study,

• Must sign consent,

• Must be able to follow and understand the study procedures,

• Initiation of escitalopram treatment for unipolar depression with or without anxiety

Exclusion Criteria:

• Other condition than depression (such as panic disorder)

• Escitalopram treatment already received

• Not able to consent to participate in the study.

Related Conditions & MeSH terms

• Pharmacogenetic Testing

Intervention

Other:
• Prescription of escitalopram using pharmacogenetic testing
Adjustment of escitalopram treatment according to pharmacogenetic results obtained by genetic testing for cytochrome CYP 2C19 (alleles *2, *3 and *17)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

References & Publications (11)

Berm EJ, Looff Md, Wilffert B, Boersma C, Annemans L, Vegter S, Boven JF, Postma MJ. Economic Evaluations of Pharmacogenetic and Pharmacogenomic Screening Tests: A Systematic Review. Second Update of the Literature. PLoS One. 2016 Jan 11;11(1):e0146262. doi: 10.1371/journal.pone.0146262. eCollection 2016. — View Citation

CHUV - Département oncologie. Une médecine sur mesure grâce à l'analyse génétique des tumeurs. 30.07.2018

Eichelbaum M, Ingelman-Sundberg M, Evans WE. Pharmacogenomics and individualized drug therapy. Annu Rev Med. 2006;57:119-37. doi: 10.1146/annurev.med.56.082103.104724. — View Citation

Evans WE, McLeod HL. Pharmacogenomics--drug disposition, drug targets, and side effects. N Engl J Med. 2003 Feb 6;348(6):538-49. doi: 10.1056/NEJMra020526. No abstract available. — View Citation

Ionova Y, Ashenhurst J, Zhan J, Nhan H, Kosinski C, Tamraz B, Chubb A. CYP2C19 Allele Frequencies in Over 2.2 Million Direct-to-Consumer Genetics Research Participants and the Potential Implication for Prescriptions in a Large Health System. Clin Transl Sci. 2020 Nov;13(6):1298-1306. doi: 10.1111/cts.12830. Epub 2020 Jul 21. — View Citation

Loi sur l'analyse génétique : renforcement de la protection contre les abus, (2022).

Phillips KA, Veenstra DL, Oren E, Lee JK, Sadee W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA. 2001 Nov 14;286(18):2270-9. doi: 10.1001/jama.286.18.2270. — View Citation

Prof. Dr Theo Dingermann, Prof. Dr. Dieter Steinhilber. Stratipharm [cited 2022 03.06]. Available from: https://www.stratipharm.de/.

U.S. Food and Drug Administration. Table of pharmacogenomic biomarkers in drug labeling. https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling/. Accessed November, 15 2022.

Veronika Litinski RD, PH. D., Boyko Kabakchiev, PH. D., Lou Carsley, Liz Garman, Gil McGowan, Gouri Mukerjee, PH. D. Pillcheck 2021 [Available from: https://www.pillcheck.ca/.

Zhou Y, Ingelman-Sundberg M, Lauschke VM. Worldwide Distribution of Cytochrome P450 Alleles: A Meta-analysis of Population-scale Sequencing Projects. Clin Pharmacol Ther. 2017 Oct;102(4):688-700. doi: 10.1002/cpt.690. Epub 2017 May 26. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in the intervention and control groups who experienced a treatment failure on escitalopram.	Number of escitalopram treatment failures in patients with escitalopram prescription based on CYP2C19 genetic testing information versus the control group prior to normal care. Treatment failure is defined here as discontinuation, dose change, or treatment change.	20 months