Observational Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Dec 15, 2018; 9(12): 252-257
Published online Dec 15, 2018. doi: 10.4239/wjd.v9.i12.252
Using real world data to assess cardiovascular outcomes of two antidiabetic treatment classes
Manfred Paul Stapff
Manfred Paul Stapff, CMO, TriNetX Inc., Cambridge, MA 02140, United States
Author contributions: Stapff MP developed the scientific concept, literature search, study design, applied the data querying, result interpretation, scientific discussion, and prepared the manuscript.
Institutional review board statement: As a federated network TriNetX received a waiver from Western IRB since only aggregated counts, statistical summaries of de-identified information, but no protected health information is received, and no study specific activities are performed in retrospective analyses.
Informed consent statement: This was an observational study based on analyses of anonymized electronic medical records describing real world treatment. No intervention or any study specific activity was done. Therefore, no informed consent was necessary and would even have been not feasible considering the anonymized and retrospective character of the analysis.
Conflict-of-interest statement: The author is employee of TriNetX Inc., the data network and analytics platform used for this publication. TriNetX as a company was not involved in the design of the study; the collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication. The author does not declare conflicting interests (including but not limited to commercial, personal, political, intellectual, or religious interests).
STROBE statement: The author has read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author to: Manfred Paul Stapff, MD, PhD, Chief Medical Officer, CMO, TriNetX Inc., 125 Cambridgepark Drive, Ste 500, Cambridge, MA 02140, United States. manfred.stapff@trinetx.com
Telephone: +1-857-2856043
Received: August 22, 2018
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
Core Tip

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).