Published online Dec 15, 2018. doi: 10.4239/wjd.v9.i12.252
Peer-review started: August 22, 2018
First decision: October 4, 2018
Revised: October 10, 2018
Accepted: November 15, 2018
Article in press: November 15, 2018
Published online: December 15, 2018
To evaluate the effect on cardiovascular outcomes of sodium-glucose co-transporter-2 (SGLT2) inhibitors in a real world setting by analyzing electronic medical records.
We used TriNetX, a global federated research network providing statistics on electronic health records (EHR). The analytics subset contained EHR from approximately 38 Million patients in 35 Health Care Organizations in the United States. The records of 46,909 patients who had taken SGLT2 inhibitors were compared to 189,120 patients with dipeptidyl peptidase (DPP) 4 inhibitors. We identified five potential confounding factors and built respective strata: elderly, hypertension, chronic kidney disease (CKD), and co-medication with either insulin or metformin. Cardiovascular events were counted as stroke (ICD10 code: I63) or myocardial infarction (ICD10: I21) occurring within three years after the first instance of the respective medication in the patients’ records.
Of the 46909 patients with SGLT2 inhibitors in their EHR, 1667 patients (3.6%) had an ICD code for stroke or for myocardial infarction within the first three years after the first instance of the medication. In the control group, there were 10680 events of 189120 patients (5.6%), which represents a risk ratio of 0.63 (95%CI: 0.60-0.66). The overall incidence of stroke or myocardial infarction in the strata with a potential confounding risk factor reached from 4.9% in patients taking metformin to 12.5% in the stratum with the highest risk (concomitant CKD). In all strata, the difference in risk of experiencing a cardiovascular event was similarly in favor of SGLT2 vs control, with Risk Ratio ranging from 0.62 to 0.81.
Real world data replicated the results from randomized clinical trials, confirmed the cardiovascular advantages of SGLT2 inhibitors, and showed its applicability to the US population.
Core tip: Cardiovascular advantages of sodium-glucose co-transporter-2 (SGLT2) inhibitors were shown in complex clinical trials or in countries with large registries. However, it was unclear whether these findings could be applied to routine medical practice in the US. This real world analysis from 46909 patients with SGLT2 inhibitors revealed a 0.63 (95%CI: 0.60-0.66) risk ratio of SGLT2 inhibitors compared to 189120 patients with dipeptidyl peptidase 4 inhibitors. This analysis of electronic health records could replicate the results of randomized clinical trials, which supports the usefulness of such real world studies (e.g., for long-term outcome or safety observations).