NRI Welcomes Dr. Leibowitz
Mark Leibowitz, M.D. joins NRI as a Principal Investigator with approximately 25 years of research experience and previous leadership roles as Medical Director for research sites located in California and Texas. His research experience includes participation in an estimated 500 studies from Phase I-IV across a variety of indications. Additionally, he has conducted highly complex studies in healthy subjects and patient populations including continuous cerebrospinal fluid studies, First in Man, Single and Multiple Ascending Dose studies, and Ethnic bridging programs. NRI is pleased to have Dr. Leibowitz join the team as one of our key Principal Investigators across all NRI Sites.
NRI Awarded with the Flagship Site Award from Medpace
It is an honor and privilege to announce NRI’s collaboration and selection into Medpace’s Site Flagship program. This Site Flagship program is a special award based on NRI’s high quality data and ability to meet or exceed study timelines on a consistent basis. We look forward to a successful partnership with Medpace.
Exenatide once weekly improved 24-hour glucose control and reduced glycemic variability in metformin-treated patients with type 2 diabetes: a randomized, placebo-controlled trial
Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study.
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Sensor-enabled atorvastatin therapy lowers cholesterol, increases adherence in type 2 diabetes, hypertension
ORLANDO, Fla. — Patients with type 2 diabetes and hypertension using sensor-enabled atorvastatin therapy that communicated with a cloud-based digital health platform achieved a greater reduction in cholesterol and improved medication adherence vs. patients receiving usual care.
The sensor-enabled medication, developed by Proteus Digital Health, is a combination of an ingestible sensor about the size of a grain of sand coencapsulated with a medication at a compounding pharmacy, said Juan Pablo Frias, MD, FACE, president and CEO of the National Research Institute in Los Angeles, speaking during an oral presentation session. The patient wears a sensor-enabled patch, described by Frias as the size of a standard bandage, that senses when the medication is taken and sends a signal to an application on a mobile device. The technology has been cleared as an FDA device, he said, though he could not offer information on its cost.
“The patch not only senses when the medication is taken, but also serves as a pedometer, so it gives an indication of patient activity as well as patient rest, and provides some very interesting and useful reports to the patient when they’ve missed medications as well as number of steps and the rest that they’re getting,” Frias said.
The data are sent to the patient and, when enabled, are sent to a cloud platform, allowing health care providers to view the patient’s Web portal and pull customized reports.
“We could follow a panel of patients that were taking these sensor-enabled medications, and also, when an individual patient comes to clinic … I would have a customized report that I could review with the patient to talk about any issues with adherence or not meeting their lifestyle goals,” Frias said.
In previous uncontrolled studies with other sensor-enabled therapeutic agents, patient-adherence and outcomes were shown to improve vs. those prescribed usual care, Frias said. In this prospective, cluster randomized, pilot study conducted at 16 sites, researchers analyzed data from 103 patients with uncontrolled type 2 diabetes (HbA1c of at least 7%) and hypertension (systolic blood pressure 140 mm Hg), prescribed metformin and/or sulfonylurea therapy (insulin users were excluded) and at least two antihypertensive drugs (mean age, 60 years; 53% women; 30% Hispanic). Researchers randomly assigned patients to sensor-enabled therapy for all their prescribed medications, used in conjunction with the digital health platform for 4 of 12 weeks or 12 full weeks, or usual care for 12 weeks, based on 2:1 cluster randomization. The cohort was assessed at 4 and 12 weeks; Frias presented lipid and blood pressure data from week 4. Primary outcome for this subanalysis was changes in LDL and total cholesterol at week 4 in a subset of digital health patients assigned sensor-enabled atorvastatin (n = 40) and a subset of usual care patients prescribed conventional statin therapy (n = 20).
Mean baseline LDL and total cholesterol values for digital health patients were 103.4 mg/dL and 176.6 mg/dL, respectively; values for usual care were 95.3 mg/dL and 172.9 mg/dL, respectively.
Digital health patients had a greater reduction in LDL (–29.7 mg/dL) compared with usual care (–1.3 mg/dL); mean difference was –28.4 mg/dL (95% CI, –45.8 to –11).
Digital health patients also saw a greater reduction in total cholesterol (–34.8 mg/dL) vs. patients assigned usual care (–8.2 mg/dL); mean difference was –26.7 mg/dL (95% CI, –47.1 to –6.3).
Within the digital health arms, a mean of 84% adhered to sensor-enabled statin therapy, Frias said. Adherence counseling and patient education were also higher in the digital health vs. control group, according to case reports, Frias said.
Over 90% of 31 survey respondents agreed the digital platform was easy to learn and use, helped them with taking medicines more regularly, and improved conversations with their providers, Frias said.
“From my personal perspective … [the study] really was unique, and the patients certainly enjoyed doing it,” Frias said. “It really did involve [patients] more in their care, and in our patients we did see improvements in these [clinical] outcomes, more than likely due to enhancement in adherence, not only in medication taking, but also in their physical activity.”
Study co-author Naunihal Virdi, MD, FACP, head of medical science at Proteus Digital Health, said the tiny sensor is made of magnesium and copper, with a “silicon wafer” in between.
“The way it functions is almost like a potato battery,” Virdi said, responding to a question about the sensor’s safety. “When you swallow it, it gets in contact with fluid, and little voltage forms between the two metals. That voltage powers the chip that sends the signal.”
The device was found to be safe in hundreds of patients through 20,000 ingestions, with only transient gastrointestinal side effects or skin irritations at the patch site reported, Virdi said. – by Regina Schaffer
Frias JP, et al. Abstract #518. Presented at: The American Association for Clinical Endocrinologists Annual Scientific & Clinical Congress; May 25-29, 2016; Orlando, Fla.
Disclosure: Frias reports consulting for Astra Zeneca, CeQur, Johnson & Johnson, Proteus Digital Health and Sanofi, and receiving study grants from Abbvie, Amgen, Astra