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The goal is to further confirm Pilloxas’ full range of drug support services, including their smartphone enhanced adhesion software and digitally linked pillbox, to enable remote patient tracking.
FREMONT, CA: Pilloxa, a digital health organization, announced the launch of ASTORIA, a single-armed and multicenter observational clinical trial. Its digital patient-centric adherence approach will be tested in patients with cardiovascular disease, including newly diagnosed patients with atrial fibrillation.
The research, which is to be undertaken as a multicenter trial with the University of Oslo as lead, is financed by an EU grant from the EUROSTARS program and is also financially sponsored by Bayer. The goal is to further confirm Pilloxas’ full range of drug support services, including their smartphone enhanced adhesion software and digitally linked pillbox, to enable remote patient tracking.
This involves alerting the patient to take their drug as indicated and relaying adherence trends for further study. The evidence obtained would make it easier to better establish a solution to improve the quality and efficacy of opioid delivery in the hospital environment and during clinical trials. A total of 200 patients will be enrolled, and the study’s findings are expected to be announced in 2022. The primary endpoint of this analysis is conformity to rivaroxaban as determined by the adhesion solution of Pilloxa. The dosage would be deemed adhesive if taken on the same day as the scheduled dose (within a +/-12 hour window).
“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,” stated the principal investigator of ASTORIA, Dan Atar, Professor of Cardiology, University of Oslo. “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 therapy in patients with atrial fibrillation is critical for preventing thromboembolic problems and reducing the risk of side effects from the drug. Despite this, statistics have shown that patient adherence to a New Oral Anticoagulation (NOAC) drug steadily declines to 60 percent within the first 12 months of therapy. Ensuring that patients take their medication as recommended is essential, as the effect of this new medicine on blood coagulation cannot be determined.
“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 organization, running intensive training programs or making new, expansive investments”, says Francesco Mazzotta, CEO, Pilloxa. “Another advantage is that using our system does not bring any burden onto 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.”
“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 oral anticoagulant. Furthermore, a positive result would also speak in favor of using Pilloxas solution in conjunction with treatment with other drugs where adherence rates to medication is 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,” adds Mazzotta.