Emulating 6 Cardiovascular Outcome Trials of Antidiabetic Drugs in Individuals with Type 2 Diabetes: Analyses Based on Real-World Databases from Korea and Taiwan

Abstract

With the increasing volume of clinical evidence derived from large-scale Asian real-world data (RWD) and the growing interest in its use in regulatory decision-making, it is important to conduct benchmarking exercises that evaluate whether studies using Asian RWD can generate similar conclusions as randomized controlled trials (RCTs). We aimed to assess whether observational studies based on Korea and Taiwan RWD can yield comparable results with trials 54 by emulating six cardiovascular outcome trials (CVOTs) of antidiabetic drugs in individuals with type 2 diabetes (T2D). We emulated six CVOTs using nationwide claims of Korea and Taiwan. An active comparator, new-user design was applied, and observational analogues to the eligibility criteria and outcomes of the corresponding RCT were implemented. Propensity score matching was utilized to balance the treatment groups. Hazard ratios and 95% confidence intervals (CI) were estimated and compared with corresponding RCT estimates. We used three pre-specified binary agreement metrics that have been used in prior benchmarking studies to define concordance in results. Results from each of the six emulations were concordant with the corresponding CVOT on ≥ 1 binary agreement metric. Five out of six emulations indicated superiority when the corresponding CVOT only demonstrated non-inferiority. Results from emulations were more concordant with Asian specific results from RCT, with four emulations meeting all agreement metrics. In this binational study using two Asian healthcare claims data, emulations yielded comparable clinical conclusions with the corresponding RCT, increasing the confidence in the validity of RWE studies in patients with T2D using these databases.

Divisions: College of Health & Life Sciences > Aston Pharmacy School
College of Health & Life Sciences
Funding Information: This research was supported by a grant (RS-2024-00393167) from the Ministry of Food and Drug Safety, South Korea, in 2024–2028.
Publication ISSN: 1532-6535
Data Access Statement: No additional data is available to the public.
Last Modified: 01 Aug 2025 15:21
Date Deposited: 01 Aug 2025 14:47
PURE Output Type: Article
Published Date: 2025-07-28
Accepted Date: 2025-07-28
Authors: Ko, Hwa Yeon
Au, Philip C. M.
Cheng, Michael C-Y
Cheung, Ching Lung
Choi, Ahhyung
Hsieh, Miyuki Hsing-Chun
Jeong, Han Eol
Lai, Edward Chia-Cheng
Li, Brian M-H
Man, Kenneth K. C.
Rassen, Jeremy A.
Tsai, Daniel Hsiang-Te
Wang, Shirley V.
Wong, Ian C. K. (ORCID Profile 0000-0001-8242-0014)
Shin, Ju-Young
Park, Sohee (ORCID Profile 0000-0001-7829-4131)

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License: Creative Commons Attribution Non-commercial No Derivatives


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