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Phase IV adaptive randomised clinical trials evaluating efficacy and cost-efficacy of pre-emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHARMGx Master Protocol and PREVESTATGx nested clinical trial

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Autores de IDIVAL

  • María Del Mar García Saiz

    Autor

Autores ajenos al IDIVAL

  • Stewart S
  • Seco-Meseguer E
  • Diago-Sempere E
  • Marín-Candón A
  • Carmona M
  • Estébanez M
  • López-Fernández LA
  • Imaz-Iglesia I
  • Laserna-Mendieta EJ
  • Peiró AM
  • Farré M
  • Rodriguez-Jimenez C
  • Saiz-Rodriguez M
  • Sanabria-Cabrera J
  • Rosas-Alonso R
  • Abad-Santos F
  • Pedrosa L
  • Carcas AJ
  • García García I
  • Borobia AM
  • iPHARMGx study group

Abstract

Introduction Genetic variations impact drug response, driving the need for personalised medicine through pre-emptive pharmacogenetic testing. However, the adoption of pre-emptive pharmacogenetic testing for commonly prescribed drugs, such as statins, outside of tertiary hospitals is limited due to a lack of pharmacoeconomic evidence to support widespread implementation by healthcare policy-makers. The Spanish Consortium for the Implementation of Pharmacogenetics (iPHARMGx Consortium) addresses this by developing a clinical trial master protocol that will govern multiple nested adaptive clinical trials that compare genotype-guided treatments to standard care in specific drug-gene-population triads, asses their cost-efficacy and identify novel biomarkers through advanced sequencing techniques. The first of these studies aims to assess whether a pre-emptive statin therapy genotyping scheme reduces the incidence of statin-associated muscle symptoms (SAMS) in a population at risk of cardiovascular disease susceptible of receiving high-intensity or moderate-intensity doses of statins: The PREVESTATGx trial.Methods and analysis the PREVESTATGX trial is a multicentre, adaptive randomised controlled pragmatic phase IV clinical trial nested to the iPHARMGx master protocol with two parallel arms, aiming for superiority. Randomisation will be conducted on an individual basis with a centralised approach and stratification by centre. After inclusion in the trial and genotyping has been performed, subjects will be randomly allocated to experimental group (pharmacogenetic genotype-guided statin prescription) or standard-of-care statin prescription (as deemed by attending physician). The main objective is to assess the efficacy of a statin pre-emptive genotyping strategy in reducing the incidence of SAMS. A total of 225 subjects will be recruited among the 10 participating centres if no futility/efficacy boundary is reached in the prespecified interim analyses. Recruitment will be carried out during a 12-month period and subjects will be followed for a 9-month period.Ethics and dissemination The PREVESTATGx trial received ethical approval on 24 April 2024. Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences. Trial results will be submitted for publication in an open-access peer-reviewed medical speciality-specific publication.Trial registration number EU CT number: 2023-509418-12-00/Clinical trial Identifier (ClinicalTrials.gov): NCT06262685. Protocol version 1.2 12 April 2024 (includes non-substantial modification number 14 June 2024). Trial registration of this study can be located at both the EU Clinical Trials Register available from https:// euclinicaltrials.eu/search-for-clinical-trials/?lang=en and https://clinicaltrials.gov. Registration on both websites was done before the enrolment of the first patient complying with European regulations. EU Clinical Trials Register is a primary registry according to the WHO.

Datos de la publicación

ISSN/ISSNe:
2044-6055, 2044-6055

BMJ Open  BMJ PUBLISHING GROUP

Tipo:
Article
Páginas:
-
PubMed:
39510769

Citas Recibidas en Web of Science: 1

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Keywords

  • CLINICAL PHARMACOLOGY; Lipid disorders; PUBLIC HEALTH; Clinical Trial; GENETICS

Campos de Estudio

Proyectos asociados

Proyecto iPHARMGx: Estudio colaborativo nacional para evaluar la efectividad y eficiencia de la implementación de biomarcadores farmacogenéticos mediante una estrategia de genotipado anticipado en el SNS

Investigador Principal: Mª Blanca Sánchez Santiago

PMP22/00055 . FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO LA PAZ . 2024

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