Can real-world data improve heart drug management? That’s what Amgen and partner Datos Health are hoping to find out with a new U.S. study in heart failure patients.
While typical pharma apps track adherence—when and whether a patient took medicine—Amgen and Datos are adding patient vitals, including blood pressure, heart rate and daily physical activity, to the mix.
The study gives patients an FDA-approved continuous blood pressure monitor and a connected smart scale. Participants also will complete regularly scheduled surveys. Working with seven leading U.S. teaching hospitals, the study targets recent heart attack sufferers to gear up with the digital equipment when they leave the hospital.
Amgen and Datos' goal is to figure out whether the remote platform can deliver better and more personalized medication management. The idea is that more information will help physicians tweak drugs and dosages to better match a patient's needs.
Chronic heart failure care is often complex, with multiple prescription drugs and lifestyle changes necessary. Amgen is testing a similar remote tracking app in Europe for heart attack patients, although that study is more focused on increasing access to cardiac rehabilitation.
“How can we harness digital therapeutics with drugs and how can we reach the best outcome for patients using these tools? And not only looking at drug adherence,” Datos Health CEO Uri Bettesh said.
Study co-chair Akshay Desai, M.D., at Harvard Medical School, said in a press release that use of the digital health data "can lead to earlier initiation, up-titration, or determination of end-of-dose adjustments for guideline-based heart failure therapies and achieve optimal tolerated doses for individual therapies.”
While the ultimate goal for heart failure patients is better med management and fewer repeat heart attacks, the remote platform may also give Amgen an edge with physicians looking for the most effective tools for their patients—and themselves.
The remotely collected passive data gives doctors an encyclopedia of real-word empirical data along with the patient-reported insights between visits.
Datos believes the bigger shift to digitally collected remote data, including monitoring patients’ vitals, can help fine-tune doctors’ treatment decisions.
"Doctors (can) make better decisions on an individual patient’s health and especially on their medication,” Bettesh said.
Amgen isn’t the only pharma Datos is working with. It created a different remote monitoring program with Takeda for inflammatory bowel disease patients, Bettesh said.
Datos’ no-coding-required remote system gives pharma and healthcare providers a simple way to set up go-with-medication app studies, he said. Users can program them with or without vitals’ monitoring equipment and set up scheduled patient surveys daily, weekly or at will, for instance.