38M Patients' EHR Data Replicated Clinical Trial Results

The data-driven health-tech company TriNetX has successfully leveraged real-world data on patients with diabetes to generate real-world evidence to replicate results from randomized clinical trials, a new study found.

The research, led by Manfred Paul Stapff, M.D., Ph.D., chief medical officer of TriNetX in Cambridge, Massachusetts, evaluated the effects of cardiovascular outcomes of sodium-glucose co-transporter-2 (SGLT2) inhibitors in a real-world setting by analyzing tens of millions of electronic health records (EHRs).

The team used TriNetX, its namesake research network that provides statistics from EHRs, and gathered medical data from approximately 38 million patients in 35 different healthcare organizations in the U.S. Close to 47,000 patients who took SGLT2 were compared to more than 189,000 patients with dipeptidyl peptidase (DPP) 4 inhibitors.

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Both medications are used for the treatment of diabetes.

Cardiovascular outcomes were considered a stroke or myocardial infarction that occurred within three years after the first instance of medication in the patients’ records.

Based on the study, almost 2,000 patients (3.6 percent) who took SGLT2 had a code representing a cardiovascular event after taking the medication, compared to almost 11,000 patients (5.6 percent) in the DPP4 group. The risk ratio was 0.63.

In five different strata — age, hypertension, chronic kidney disease and co-medication with insulin or metformin — the risks of a cardiovascular event were less for those using SGLT2 with risk ratios ranging from 0.62 to 0.81.

“The results showed that this type of analysis using real-world data could replicate results coming from much more complex and costly studies,” Stapff said.

According to the U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D., who recently proposed a new framework to advance the use of real-world evidence across drug and biologic development efforts, real-world data generated from EHRs can offer new opportunities to create evidence and better understand clinical outcomes.

The analysis of EHRs could replicate the results of randomized clinical trials, which highlights its potential usefulness in real-world studies and applicability to the U.S. population.

TriNetX has three real-world data-based solutions — Research, Download and Analyze. Research measures the effectiveness of treatments to identify which has better outcomes for a given population. Download offers real-world clinical data that is aggregated from healthcare organizations. Analyze gives access to longitudinal clinical data and uses real-world evidence of outcomes across distinct patient populations.

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