U-PGx PREPARE: Making effective treatment optimization accessible to every european citizen
Every patient is different, and so is their response to certain drugs. While a certain medication might show good efficacy in one person without causing any adverse drug events, another patient might experience insufficient efficacy or adverse reactions when taking the same drug. These differences in drug response are partly attributable to individual genetic differences, so-called ‘pharmacogenomic (PGx) variants’. Testing patients for these PGx variants allows healthcare providers to provide their patients with a more personalized drug therapy, ultimately helping to increase the efficacy and safety of medical treatments.
What is PREPARE?
PREPARE (Preemptive Pharmacogenomic Testing for Preventing Adverse Drug Reactions) is a clinical study initiated by the U-PGx (Ubiquitous Pharmacogenomics) consortium to implement and evaluate the impact of pharmacogenomic testing on therapy outcomes in seven European clinical centres.
What is the goal of PREPARE?
The goal of PREPARE is to show that pre-emptively testing patients for an entire panel of clinically relevant PGx markers will result in an overall reduction in the number of clinically relevant drug-genotype associated adverse drug reactions. Pre-emptive testing means that the testing is performed before a certain drug is prescribed. This means that the results can be used by your physician or pharmacist to select the correct drug or dose for you. Furthermore, the cost-effectiveness of testing patients for an entire panel of relevant markers at once will be evaluated.
How will PREPARE achieve this goal?
Within 3 years, starting from January 1, 2017, 8,100 patients will be pre-emptively tested for more than 40 clinically relevant PGx markers across 13 important pharmacogenes. For 4,050 patients assigned to the study group, their test results will be used by their healthcare providers to guide the dose and drug selection for over 40 commonly prescribed drugs. The other half of patients assigned to the control group will receive standard of care during the study period but will be provided with their test results after the study ends. Data on therapy outcome and other parameters collected during the study period will be analyzed in 2020.
Which institutions are participating in PREPARE?
The following institutions are participating in the PREPARE study:
|Netherlands||Leiden University Medical Center, Department of Clinical Pharmacy & Toxicology||Dr. Jesse J. Swen|
|Spain||San Cecilio University Hospital, Department of Pharmacy and Department of Cardiology||Dr. Cristina Lucía Davila Fajardo|
|Austria||Medical University of Vienna, Division of Nephrology and Dialysis||Prof. Gere Sunder-Plassmann|
|Greece||University of Patras, Department of Pharmacy||Prof. George P. Patrinos|
|Slovenia||University of Ljubljana||Prof. Vita Dolzan|
|UK||Royal Liverpool University Hospital||Prof. Sir Munir Pirmohamed|
|Italy||Centro di Riferimento Oncologico, National Cancer Institute in Aviano||Dr. Giuseppe Toffoli|
Where can I find more information about pharmacogenomics and the PREPARE study?
We are happy we could pique your interest. If you want to find out more about the PREPARE study, please feel free to have a look at our FAQ section. For questions concerning your participation in PREPARE, please refer to your local study team. If you wish to learn more about pharmacogenomics and its clinical applications, please find some resources in our download section.
Patient Counterpatients participating
Frequently Asked Questions
Frequently Asked Questions - Patients
Your PGx results can be used by your physician to make your medical therapy more personalized. Based on your PGx results you may receive a smaller or higher dosage of a certain drug or your physician may prescribe you a different drug substance because you are at higher risk for adverse drug reactions.
Once a patient decides to enter the study he or she will be asked for a blood draw or a saliva sample. From this blood or saliva we are able to perform the PGx test.
If you are in the genetic test group, your results will be returned to your doctor or pharmacist within 3 working days. After this time, your doctor or pharmacist may contact you with your personalized prescription – which may be a different dosage or different drug than you may have received when you started you medication. In the time between your blood or saliva collection and the personalized prescription, your doctor will prescribe your medication as he or she usually does (without taking your DNA into account) so that there is no delay in treatment. Additionally, you will also be given a card on which your DNA results will be printed. You will be asked to show this card to all doctors and pharmacists during the study. They may be able to use your results to personalize additional new prescriptions.
No, the PGx variants tested in the context of PREPARE focus solely on estimating how you will respond to certain medications.
No, PGx test results have lifelong validity. Your PGx test results can be used to optimize your therapy throughout your entire lifespan whenever a relevant medication is prescribed.
Unfortunately, it is not possible to include you in the study on request. Only patients who receive a first prescription of one of the drugs relevant to the study during their treatment at one of the participating institutions and who fulfill all other inclusion criteria will be contacted by their local study team.
If you are in the standard of care group, you will receive your test results only once the study is complete. This means that your doctor will prescribe your medication as he or she usually does (without taking your DNA into account). If you wish, you will also receive a card that contains an overview of your PGx results once the study is finished.
The safety-code card is a pocket card that contains a quick overview of your PGx test results. Furthermore, the card contains a QR code that can be scanned by you or your healthcare provider with, e.g., a smartphone to quickly retrieve PGx-based dosing recommendations relevant to you. If you were assigned to the study group, your card is handed out to you by your local study team when your PGx test results are ready. Please take care of this card, and don’t forget to show it to your healthcare provider every time you receive a new prescription. If you were assigned to the standard of care group, you may receive your safety-code card once the study is finished. For more information on the safety-code card, please visit http://www.safety-code.org.
Frequently Asked Questions – Professionals
What is the study design of PREPARE?
PREPARE is designed as a multi-center, open, randomized, cross-over study. The sequence of study and control arm is randomized per country to minimize the influence of time dependent variables.
The 7 participating countries were randomized to start with:
1) Implementing pre-emptive PGx testing to guide drug and dose selection (study arm): Greece, Slovenia and Spain
2) Providing standard clinical care (control arm): Netherlands, Austria, Italy and UK
Patients who receive a first prescription for any of the drugs relevant to the study during their treatment at one of the participating institutions and who fulfill all other inclusion criteria are contacted by their local study teams.
|Therapeutic group||Generic name|
|Cholesterol – lowering||Atorvastatin|
|Immuno – suppressive||Azathioprine|
|Oestrogen containing drugs *|
* only if a 2nd prescription, not for primary inclusion
Patients are asked to provide a blood or saliva sample which is analyzed for over 40 variants across 13 important PGx genes. Genotyping is performed with an array specifically designed for the PREPARE study using the LGC SNPline platform.
In the PREPARE study, pharmacogenomic dosing guidelines authored by the Dutch Pharmacogenetics Working Group (DPWG) are used for PGx-based prescribing. To assist healthcare providers in using their patients’ PGx results to optimize their therapy, all recommendations relevant to the individual patient are included in the their written PGx report. Furthermore, all relevant recommendations can be accessed by healthcare providers via scanning the QR code of the personal safety-code card that each patient assigned to the study group receives.
The safety-code card is a pocket card that is handed out to all patients assigned to the study group and that contains a quick overview of his or her PGx test results. Furthermore, the card contains a QR code that can be scanned by healthcare providers with, e.g., a smartphone to quickly retrieve PGx-based dosing recommendations relevant to the respective patient. In the context of PREPARE, the safety-code card serves as an auxiliary tool to maximize the accessibility and sharing of PGx results within and between different healthcare settings and healthcare professionals. For more information on the safety-code card, please visit http://www.safety-code.org.
Web resources and download material
- Patient information leaflet
- J. J. Swen et al., “Pharmacogenetics: From Bench to Byte— An Update of Guidelines,” Clinical Pharmacology & Therapeutics, vol. 89, no. 5, pp. 662–673, Mar. 2011.
- J. J. Swen et al., “Pharmacogenetics: From Bench to Byte,” Clinical Pharmacology & Therapeutics, vol. 83, no. 5, pp. 781–787, May 2008.
- C. H. van der Wouden et al., “Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium,” Clin. Pharmacol. Ther., vol. 101, no. 3, pp. 341–358, Mar. 2017.
- E. Cecchin, R. Roncato, H. J. Guchelaar, G. Toffoli, and for the Ubiquitous Pharmacogenomics Consortium, “Ubiquitous Pharmacogenomics (U-PGx): The time for implementation is now. An Horizon2020 program to drive pharmacogenomics into clinical practice,” Curr Pharm Biotechnol, 02 2017.
- Web resources
- Pharmacogenomics Knowledgebase (PharmGKB)
- U-PGx Video: Watch a video prepared by the U-PGx consortium that visualises the idea of personalised medicine and pre-emptive PGx testing.
- Download material