Stockholm, Sweden, March 9, 2022: Digital health company Pilloxa today announced that the First Patient First Visit milestone has been reached in the ASTORIA* study – a single-armed and multicenter observational clinical trial in which their digital patient-centric adherence solution is being tested in cardiovascular disease patients, namely newly diagnosed patients with atrial fibrillation. Professor Dan Atar from the University of Oslo is the sponsor of the study, financial support is provided by an EU-grant from the EUROSTARS program and Bayer.
The primary objective of the study is to assess the rate of adherence to rivaroxaban, an oral anticoagulant dosed once daily, in a study population of newly diagnosed atrial fibrillation using the Pilloxa box. Atrial fibrillation increases the risk of formation of blood clots in the heart and adherence to oral anticoagulants in patients with atrial fibrillation is of utmost importance to prevent the formation of these blood clots, that can be transported with the blood to the brain (causing stroke) and to other parts of the body. Non-adherence to medication increases the risk of hospitalization and mortality of patients, as well being a substantial economic burden for health care systems. The data gathered in this study will contribute to more knowledge on patient adherence, potentially with improvements in patient well-being.
The study will also further validate Pilloxa’s full suite of medication support services – including their adherence app enhanced with mobile communication and a digitally connected pillbox – to enable remote patient support. This includes alerting the patient to take their medication as prescribed and relaying their adherence patterns for further analysis. Furthermore, the results will likely enable further development of the Pilloxa solution in various other settings.
In the study, a dose of rivaroxaban for atrial fibrillation, taken from the Pilloxa medication dispensing box and measured by the adherence solution, will be considered adherent if taken on the same day as the planned dose (within a +/- 12 hour window). For additional, secondary endpoints, see below**. In total, 200 patients will be recruited and results from the trial are now estimated to be reported in 2024.
The principal investigator of ASTORIA, Dan Atar, Professor of Cardiology at the University of Oslo, comments: “We have reached an important milestone with inclusion of the first patient in the ASTORIA study. It will be interesting to see the impact that the technology supporting this trial has in supporting our patients with atrial fibrillation to take their anticoagulant medicines as prescribed. Data documenting whether patients have taken these medications as prescribed provides a good overview in real-time of patient adherence to medical treatment. It is anticipated that this knowledge will provide reassurance to the patient, relatives, and to the prescribing doctor. We also hope to learn how we can improve the quality of future clinical trials, a field in need of improvement when it comes to documenting the intake of drugs.”
Helena Ronnqvist, CEO of Pilloxa, states that: “This is an exciting milestone for everyone involved in the project, especially after the unexpected events of the past two years. We look forward to continuing to support patients with atrial fibrillation in adherence during their treatment journey with the potential to prevent complications and reduce the risk of medication side-effects. This trial will hopefully further demonstrate the effectiveness of using our software solutions and smart pillbox within the field, making it a breakthrough in patient support and drug intake documentation.”
* ASTORIA: ASsessment of Adherence TO Medication in AtRIAl Fibrillation – an eMonitoring Drug Dispensing Device Study
** Additional, secondary endpoints are:
- Adherence will also be determined using the Norwegian Prescription Database, and a comparison will be made between the study population and a comparator population. For data from the registry, a Medication Possession Rate (MPR) of > 80% is considered to represent good adherence.
- Rates of persistence and reasons for non-persistence
- Risk factors for non-adherence and non-persistence in these patients, such as age, gender, socio-economic group, etc.
- Patient-reported outcome regarding the use of the Pilloxa app and smart pillbox (ease of use etc)
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Pilloxa is a technological, regulatory, and legal platform for healthcare and pharma to create dynamic apps to support patients and learn from user data. Partners include Bayer, Chiesi, Sandoz, and Karolinska University Hospital.
To learn more about Pilloxa’s new product offering, explore their solutions at www.pilloxa.com.