{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T02:57:00Z","timestamp":1779245820179,"version":"3.51.4"},"reference-count":46,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,8,17]],"date-time":"2025-08-17T00:00:00Z","timestamp":1755388800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,8,17]],"date-time":"2025-08-17T00:00:00Z","timestamp":1755388800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:p>With the increasing volume of clinical evidence derived from large\u2010scale Asian real\u2010world data (RWD) and the growing interest in its use in regulatory decision\u2010making, 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 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\u2010user 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\u2010specified 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 \u2265\u20091 binary agreement metric. Five out of six emulations indicated superiority when the corresponding CVOT only demonstrated non\u2010inferiority. Results from emulations were more concordant with Asian\u2010specific 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.<\/jats:p>","DOI":"10.1002\/cpt.70027","type":"journal-article","created":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T06:52:58Z","timestamp":1755499978000},"page":"1265-1274","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Emulating Six Cardiovascular Outcome Trials of Antidiabetic Drugs in Individuals with Type 2 Diabetes: Analyses Based on Real\u2010World Databases from Korea and Taiwan"],"prefix":"10.1002","volume":"119","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5297-8826","authenticated-orcid":false,"given":"Hwa Yeon","family":"Ko","sequence":"first","affiliation":[{"name":"School of Pharmacy Sungkyunkwan University  Suwon South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0736-4726","authenticated-orcid":false,"given":"Philip C. M.","family":"Au","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research University of Hong Kong  Hong Kong City Hong Kong"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8640-3593","authenticated-orcid":false,"given":"Michael Chun\u2010Yuan","family":"Cheng","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences College of Medicine, National Cheng Kung University  Tainan Taiwan"},{"name":"Population Health Data Center National Cheng Kung University  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6233-9144","authenticated-orcid":false,"given":"Ching\u2010Lung","family":"Cheung","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research University of Hong Kong  Hong Kong City Hong Kong"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0101-7328","authenticated-orcid":false,"given":"Ahhyung","family":"Choi","sequence":"additional","affiliation":[{"name":"School of Pharmacy Sungkyunkwan University  Suwon South Korea"},{"name":"Harvard\u2010MIT Center for Regulatory Science Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7995-7408","authenticated-orcid":false,"given":"Miyuki Hsing\u2010Chun","family":"Hsieh","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences College of Medicine, National Cheng Kung University  Tainan Taiwan"},{"name":"Population Health Data Center National Cheng Kung University  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6678-0941","authenticated-orcid":false,"given":"Han Eol","family":"Jeong","sequence":"additional","affiliation":[{"name":"School of Pharmacy Sungkyunkwan University  Suwon South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5852-7652","authenticated-orcid":false,"given":"Edward Chia\u2010Cheng","family":"Lai","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences College of Medicine, National Cheng Kung University  Tainan Taiwan"},{"name":"Population Health Data Center National Cheng Kung University  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7445-8806","authenticated-orcid":false,"given":"Brian Meng\u2010Hsun","family":"Li","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences College of Medicine, National Cheng Kung University  Tainan Taiwan"},{"name":"Population Health Data Center National Cheng Kung University  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8645-1942","authenticated-orcid":false,"given":"Kenneth K. C.","family":"Man","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research University of Hong Kong  Hong Kong City Hong Kong"},{"name":"Research Department of Practice and Policy, School of Pharmacy University College London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4369-7381","authenticated-orcid":false,"given":"Jeremy A.","family":"Rassen","sequence":"additional","affiliation":[{"name":"Aetion  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2841-0338","authenticated-orcid":false,"given":"Daniel Hsiang\u2010Te","family":"Tsai","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences College of Medicine, National Cheng Kung University  Tainan Taiwan"},{"name":"Population Health Data Center National Cheng Kung University  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7761-7090","authenticated-orcid":false,"given":"Shirley V.","family":"Wang","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital, Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8242-0014","authenticated-orcid":false,"given":"Ian C. K.","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research University of Hong Kong  Hong Kong City Hong Kong"},{"name":"Research Department of Practice and Policy, School of Pharmacy University College London  London UK"},{"name":"Aston Pharmacy School Aston University  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1010-7525","authenticated-orcid":false,"given":"Ju\u2010Young","family":"Shin","sequence":"additional","affiliation":[{"name":"School of Pharmacy Sungkyunkwan University  Suwon South Korea"},{"name":"Department of Biohealth Regulatory Science Sungkyunkwan University  Suwon South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7829-4131","authenticated-orcid":false,"given":"Sohee","family":"Park","sequence":"additional","affiliation":[{"name":"School of Pharmacy Sungkyunkwan University  Suwon South Korea"},{"name":"Aston Pharmacy School Aston University  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,8,17]]},"reference":[{"key":"e_1_2_11_1_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb1609216"},{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2083"},{"key":"e_1_2_11_3_1","unstructured":"European Medicines Agency.Real\u2010world evidence framework to support EU regulatory decision\u2010making: 2nd report on the experience gained with regulator\u2010led studies from February 2023 to February 2024. EMA 180299(2024)."},{"key":"e_1_2_11_4_1","unstructured":"US Food and Drug Administration. Framework for FDA's real\u2010world evidence program<https:\/\/www.fda.gov\/media\/120060\/download>. (2018) Accessed August 1 2024."},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2398"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.120.051718"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-221915"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.01586-2020"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2255"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5222"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/2168479018763591"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2252"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.4221"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2022-070717"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2304"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S196293"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S426485"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.13772"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.18269"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1501352"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1307684"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1812389"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504720"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611925"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1603827"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40471-015-0053-5"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-0788"},{"issue":"1","key":"e_1_2_11_28_1","first-page":"S158","article-title":"9. Pharmacologic approaches to glycemic treatment: standards of Care in Diabetes\u20102024","volume":"47","year":"2024","journal-title":"Diabetes Care"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1186"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1633"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2023-076460"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2016.04.055"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14075"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.029190"},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc20-2926"},{"key":"e_1_2_11_36_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14865"},{"key":"e_1_2_11_37_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-0598"},{"key":"e_1_2_11_38_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-0746"},{"key":"e_1_2_11_39_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.108.790048"},{"key":"e_1_2_11_40_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2215609"},{"key":"e_1_2_11_41_1","unstructured":"US Food and Drug Administration. Diversity action plans to improve enrollment of participants from underrepresented populations in clinical studies guidance for industry<https:\/\/www.fda.gov\/media\/179593\/download>. (2024) Accessed August 1 2024."},{"key":"e_1_2_11_42_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc19-2419"},{"key":"e_1_2_11_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dsx.2020.04.051"},{"key":"e_1_2_11_44_1","first-page":"799","article-title":"Data resource profile: the National Health Information Database of the National Health Insurance Service in South Korea","volume":"46","author":"Cheol Seong S.","year":"2017","journal-title":"Int. J. Epidemiol."},{"key":"e_1_2_11_45_1","doi-asserted-by":"publisher","DOI":"10.4178\/epih.e2018062"},{"key":"e_1_2_11_46_1","doi-asserted-by":"publisher","DOI":"10.1210\/endrev\/bnab007"}],"container-title":["Clinical Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70027","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpt.70027","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpt.70027","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T13:57:51Z","timestamp":1779199071000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70027"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,17]]},"references-count":46,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1002\/cpt.70027"],"URL":"https:\/\/doi.org\/10.1002\/cpt.70027","archive":["Portico"],"relation":{},"ISSN":["0009-9236","1532-6535"],"issn-type":[{"value":"0009-9236","type":"print"},{"value":"1532-6535","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,17]]},"assertion":[{"value":"2025-02-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}