2026-07-18T18:31:57Zhttps://riubu.ubu.es/oai/requestoai:riubu.ubu.es:10259/119172026-07-17T00:05:30Zcom_10259_11209com_10259_5086com_10259_2604col_10259_11210
Stewart, Stefan
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Seco-Meseguer, Enrique
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Diago-Sempere, Elena
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Marín-Candón, Alicia
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Carmona, Montserrat
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Estébanez, Miriam
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López-Fernández, Luis A
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Imaz-Iglesia, Iñaki
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del Mar García Saiz, María
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Laserna-Mendieta, Emilio J
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Peiró, Ana M
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Farré, Magí
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Rodriguez-Jimenez, Consuelo
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Saiz-Rodriguez, Miriam
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Sanabria-Cabrera, Judith
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Rosas-Alonso, Rocío
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Abad-Santos, Francisco
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Pedrosa, Lucia
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Carcas, Antonio J
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García García, Irene
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Borobia, Alberto M
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2026-07-16T10:38:30Z
2026-07-16T10:38:30Z
2024-11
2044-6055
https://hdl.handle.net/10259/11917
10.1136/bmjopen-2024-089823
2044-6055
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.
This study was funded by the Instituto de Salud Carlos III (ISCIII) through the project code PMP22/00055 and by Next Generation EU funds, which finance the actions of the Recovery and Resilience Facility (RRF).
eng
BMJ
BMJ Open. 2024, V. 14, n. 11, art. 089823
https://doi.org/10.1136/ bmjopen-2024-089823
Atribución-NoComercial 4.0 Internacional
http://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
Medicina personalizada
Farmacogenómica
Precision medicine
Pharmacogenomics
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
info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
BMJ Open
14
11
THUMBNAIL
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10259/11917
oai:riubu.ubu.es:10259/11917
2026-07-17 02:05:30.41
Repositorio Institucional de la Universidad de Burgos
bubrep@ubu.es
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