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Article History

Received: 16 June 2026

Accepted: 10 August 2026

First Online: 11 September 2026

Declarations

Conflict of Interest: Jesper N. Bech declares consulting fees: AstraZeneca; participation in advisory councils or committees: AG, AstraZeneca, and Bayer. Terry McCormack declares consulting/speaker fees: AstraZeneca, Daiichi Sankyo, Medtronic, and Novartis. Vivek Bhalla declares grants/consulting fees: AHA, Idorsia, Medtronic, and NIH; participation in advisory councils or committees: AHA, AMA, AstraZeneca, Bayer, Idorsia, and Medtronic; stock/shares: Nephrogen and Pyrames. Naomi R. Ben Dor declares consulting fees: AstraZeneca. Julian Segura declares consulting/speaker fees: AstraZeneca, Bayer, Menarini, MSD, Novartis, Novo Nordisk, Servier, and Vifor. Søren Hougaard Christiansen and Ina T. Andersen declare no personal conflict of interest. The present study was funded by a grant from AstraZeneca to Aarhus University. The Department of Clinical Epidemiology is involved in other studies with funding from various companies as research grants to (and administered by) Aarhus University. Clement Erhard, Kirsty M. Rhodes, Tom Norris, and Esteban Coto declare employment at the time of the study: AstraZeneca; stock/shares: AstraZeneca. Kirsty M. Rhodes is a current employee of GlaxoSmithKline and declares stock/shares. Joachim Weil declares consulting fees: AstraZeneca, Daiichi Sankyo, and Novartis; participation in advisory councils or committees: Medtronic and ReCor.

Ethical Approval: The EnligHTN study was conducted in accordance with the Declaration of Helsinki, International Conference on Harmonization of Good Clinical Practice, and applicable legislation on non-interventional and/or observational studies. The protocol for this study was approved by CPRD (protocol number 24_004211). Ethical approval was also provided by the ethics committee of San Carlos Clinic Hospital (Madrid, Spain; approval ID: 24/545-O-M_NoSP) and the Meuhedet Health Organization (Israel; approval ID: 0025–24-MEU). In the other participating countries, ethical approval was not required. Disease Analyzer (Germany) includes only anonymized data in compliance with the regulations of the applicable data protection laws. German law allows the use of anonymous EMR for research purposes. According to this legislation, it is not necessary to obtain informed consent from patients or approval from a medical ethics committee for this type of observational study that contains no directly identifiable data. Because patients were only queried as aggregates and no protected health information was available for queries, no institutional review board approval was required for the use of this database or the completion of this study. Use of IQVIA Ambulatory EMR-US linked with IQVIA PharMetrics® Plus Closed Health Plan claims (USA) is permitted under US law when data are de-identified and used under contractual and privacy safeguards. PharMetrics Plus contains HIPAA-compliant, de-identified claims. Once data are de-identified per HIPAA’s Safe Harbor or Expert Determination standards, HIPAA no longer requires individual authorization (consent) for secondary use and disclosure. IQVIA licenses these data to users under data use agreements that restrict re-identification and regulate use. Informed consent to use these de-identified data was not required. According to Danish law, no ethical committee approval is needed for registry-based non-interventional studies like EnligHTN. The study is covered by Aarhus University’s institutional registration according to the General Data Protection Regulation. Permission to analyze and publish these data was received by each database owner.