The Japanese company CureApp has recently announced the results of a Phase III multicenter randomized controlled clinical trial of their digital therapeutics for hypertension, which was jointly researched by CureApp and a team led by Professor Kazuomi Kario at Jichi Medical University. Results of this study showed a statistically significant difference in mean systolic blood pressure over a 24-hour period of treatment in the 12th week of intervention treatment, demonstrating a hypotensive effect.
This is the first Phase III clinical trial of treating hypertension with digital therapeutics completed in the world, representing an important step in the area of hypertension treatment, which is expected to play a pivotal role in providing medical care tailored to individuals and in promoting drug-free treatments that do not rely on medications, being a new track.
CureApp’s Phase III clinical trial of treating hypertension with digital therapeutics
In early April last year, CureApp launched a Phase III multicenter randomized controlled clinical trial of digital therapeutics for hypertension in Japan with various partners.
The study aimed to evaluate the efficacy and safety of digital therapeutics in patients with essential hypertension who have not received an orally administered antihypertensive drug treatment. Recruited patients with essential hypertension were randomized into two groups: those in the trial group used digital therapeutics and had lifestyle changes set according to the Guidelines for the Management of Hypertension 2019, and those in the control group only adopted said lifestyle habit changes without using digital therapeutics.
The primary criterium for evaluation was the change from the baseline in mean 24-hour systolic blood pressure at 12 weeks after treatment began, as measured by ambulatory blood pressure monitoring (ABPM).
CureApp previously launched nicotine dependency digital therapeutic app: CureApp SC, which was the first app of its kind to be covered by insurance in Japan. Based on the results of the above Phase III multicenter randomized controlled clinical trial, CureApp will work to receive marketing approval from the regulator for the product.
Hypertension is the highest risk factor for cerebral and cardiovascular diseases. An estimated of nearly 100,000 people die of hypertension-induced diseases every year. In Japan, hypertension is found in some 43 million people, and only around 12 million people have their blood pressure properly controlled.
While lifestyle improvements are vital for treating hypertension, maintaining such improvements is largely dependent on patients’ values and motivation, workplace and home environment, and other factors. Such improvements are often difficult to sustain and present challenges for effective intervention by medical institutions.
In response to the above, new digital therapeutics based on mobile technology automatically delivers treatment guidance personalized to patients, and this form of treatment helps patients reduce/avoid using hypotensive drugs, change their mindset and behavior and develop the most appropriate lifestyle habits based on an IoT blood pressure monitor and lifestyle habit logs, and notifications prompting behavioral changes.
New track of digital therapeutics
The FDA approved reSET, the world’s first digital therapy prescription product for patients with substance use disorder (SUD) in 2018. Since then, four additional digital therapies have been marketed globally for patients with opioid use disorder, tumor patients, patients with chronic insomnia, and children with attention deficit hyperactivity disorder.
Digital therapeutic products are software products that have been proven through clinical evidence to prevent, manage and treat certain medical disorders and diseases. Many global pharmaceutical giants such as MSD, Pfizer, Sanofi, and Amgen are focusing on this segment.
Like common drugs, all digital therapeutic products must be reviewed by regulators for marketing and certified by regulators regarding the safety, efficacy, and possible usage.
Digital therapeutics is still in a very early stage of development worldwide at least for the time being, and this new track has gradually emerged in developed countries. The products can achieve functions including disease prevention, disease management, and disease treatment.
Based on the success in Phase III clinical trial of treating hypertension, the new digital therapeutics of CureApp from Japan for this chronic disease will be launched globally. In the future, there is big room for imagination in the combination of digital therapeutics and smart devices for the treatment of depression, anxiety, autism, Alzheimer’s disease, etc., which is noteworthy.
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