Proteus unveils outcomes data to demonstrate medication adherence benefits to payers

Ingestible sensor pill, patch and iPad app--Courtesy of Proteus

Patient compliance with long-term drug regimens is notoriously poor--particularly in populations with chronic conditions that require consistent, routine care in order to avoid disease progression. Technology to improve patients taking their medications now abounds, everything from smart inhalers to digital pills to apps promise to offer improvements.

The latest advance in this effort is interim data from a pilot study by Proteus Digital Health that aims to demonstrate improvement in patient outcomes from use of its Proteus Discover technology that offers sensor-enabled drugs that are tracked by a wearable patch that transmits data on time of ingestion, heart rate, physical activity and rest to an app. Proteus already has gained a series of regulatory go-aheads, both in the U.S. and Europe, for its medication adherence tech.

The interim data shows that in patients with uncontrolled hypertension and Type 2 diabetes, the addition of Proteus Discover to a drug regimen results in statistically significant reductions in blood pressure and low-density lipoprotein-cholesterol (LDL), both of which are risk factors for cardiovascular events.

"The promising results from the pilot study demonstrate that this innovative digital approach to therapy optimization is not only patient-centered, but can lead to improved clinical outcomes," said Proteus CMO George Savage in a statement. "The findings suggest that deploying a panel of medicines that reflect the needs of patients and physicians can move the needle in treatment optimization."

After four weeks, 85% of subjects in the digital medicine arm of 72 patients achieved their blood pressure target--that's opposed to the usual care 24-patient arm in which only 33% did. The digital medicine arm also had a larger reduction in diastolic blood pressure and LDL than usual care.

The 96-patient, 12-week study enrolled patients with uncontrolled hypertension and Type 2 diabetes who had failed at least two antihypertensive medications plus metformin and/or sulfonylurea. The randomized, control trial adds Proteus Discover to an existing medication regimen for four or 12 weeks, with a control group receiving usual medical care.

Dr. George Savage, Proteus chief medical officer

The primary outcome in the trial is change in systolic blood pressure. Secondary outcomes include change in diastolic blood pressure and the proportion of subjects to achieve a target blood pressure of less than 140/90 mm Hg. The study also includes a patient subset specifically on sensor-enabled version of the cholesterol-lowering atorvastatin.

Final study data are slated to be published later this year. Proteus is also partnering with its customers to produce further real-world clinical and economic data; it hopes to demonstrate its usefulness in optimizing treatments and improving patient outcomes.

- here is the release