Pilloxa is pleased to announce the inception of a single-armed and multicenter observational clinical trial ASTORIA*, which will test its digital patient-centric adherence solution in patients with cardiovascular disease, especially newly diagnosed patients with atrial fibrillation. The study, to be conducted as a multicenter trial with the University of Oslo as lead, is funded by an EU-grant from the EUROSTARS program and is also financially supported by Bayer. The aim is to 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 monitoring. This includes alerting the patient to take their medication as prescribed and relaying their adherence patterns for further analysis. The data gathered will enable further development of the solution to increase the quality and effectiveness of drug treatment in both the healthcare setting and during clinical trials. In total, 200 patients will be recruited and results from the trial are estimated to be reported in 2022.
The primary endpoint of this study is adherence to rivaroxaban as measured by the Pilloxa adherence solution. A dose 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**.
The principal investigator of ASTORIA, Dan Atar, Professor of Cardiology at the University of Oslo, comments: “Patients with atrial fibrillation carry an increased risk of developing serious and life-threatening events, a stroke being the most common. Fortunately, modern oral anticoagulant medicines have been shown to lower this risk, but it is of utmost importance that the patients take their medicine as prescribed. In the current trial, patients will be reminded when they need to take their medicine and relevant information around the treatment (e.g. time when the medicine was taken) will be automatically documented. Data documenting whether patients have taken these medications as prescribed provides a good overview in realtime 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.”
High adherence to anticoagulation treatment in atrial fibrillation patients is important for the prevention of thromboembolic complications and to reduce the risk of side-effects from the medication. Despite this, data has shown that patient adherence to their new oral anticoagulation (NOAC) medication gradually drops to 60% when evaluated after the first 12 months of treatment. Ensuring that patients take their medicine as prescribed is crucial as the effect of this new medicine on coagulation in the blood cannot be measured.
“That adherence to treatment is fundamental for any therapy to be successful is easy to accept but our research has shown that in practice, adherence is poor in many cases. The advantage of our technology, which we have developed and documented over the last 5 years, is that it can be added as a new layer without changing the organisation, running intensive training programs or making new, expansive investments”, says Francesco Mazzotta, CEO of Pilloxa. “Another advantage is that using our system does not bring any burden on the patient. Contrary to being a burden, it helps the patient to carry out the treatment in an easier and more efficient way. Patients also tend to be more engaged, and the automatic documentation enables efficient feedback with minimal administration between healthcare providers and the patient, a truly patient-centric solution.”
Francesco Mazzotta adds: ”If the study shows improved adherence rates with the use of Pilloxa, this would provide a strong argument for such devices to be implemented routinely for atrial fibrillation patients with an indication for use of long-term treatment with an oral anticoagulant. Furthermore, a positive result would also speak in favour of using Pilloxa’s solution in conjunction with treatment with other drugs where adherence rates to medication are central for enhanced outcomes. Given the importance of adherence to treatment for reliable testing of drug effects in early phase clinical trials, we are continuously exploring such investigations with industry partners.”
*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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