Assessing the representativeness of trials of Sodium-glucose Cotransporter-2 inhibitors in type 2 diabetes: a comparison of individual-level trial data and people newly prescribed treatment in a Welsh routine care database

While people with comorbidity are under-represented in most trials compared to a Welsh routine care population, the large cardiovascular outcome trials are more representative of SGLT2i-treated patients and have similar rates of serious adverse events. Therefore, while our findings support calls for caution regarding trial representativeness, the criticism that trials are not representative does not apply equally to all trials. Our results broadly support the applicability of cardiovascular outcome trials to people currently treated with SGLT2i within routine clinical practice.

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Publication Details

Journal
BMC Medicine
Published
2025-11-26
DOI
https://doi.org/10.1186/s12916-025-04492-2
Primary Topic
Diabetes Treatment and Management
Type
article
Field-Weighted Citation Impact
0.00

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article

Assessing the representativeness of trials of Sodium-glucose Cotransporter-2 inhibitors in type 2 diabetes: a comparison of individual-level trial data and people newly prescribed treatment in a Welsh routine care database

Khalid Alsallumi, Daniel R. Morales, Lili Wei, David McAllister et al.
BMC Medicine
Diabetes Treatment and Management
article

Assessing the representativeness of trials of Sodium-glucose Cotransporter-2 inhibitors in type 2 diabetes: a comparison of individual-level trial data and people newly prescribed treatment in a Welsh routine care database

Khalid Alsallumi, Daniel R. Morales, Lili Wei, David McAllister, John L. Petrie, Elaine Butterly, Ryan McChrystal, Amanda Adler, Jennifer Susan Lees, Bruce Guthrie, Peter Hanlon, Heather Wightman, Saleh Ali Almazam, Michael Sullivan, Eric T. Whalley, Naveed Sattar
article en

Abstract

While people with comorbidity are under-represented in most trials compared to a Welsh routine care population, the large cardiovascular outcome trials are more representative of SGLT2i-treated patients and have similar rates of serious adverse events. Therefore, while our findings support calls for caution regarding trial representativeness, the criticism that trials are not representative does not apply equally to all trials. Our results broadly support the applicability of cardiovascular outcome trials to people currently treated with SGLT2i within routine clinical practice.

BMC MedicineVol. 23(1)
University of Dundee (GB), Umm al-Qura University (SA), University of Oxford (GB), Genomics (United Kingdom) (GB), University of Glasgow (GB), University of Edinburgh (GB)
Eli Lilly and Company, Yale University, Janssen Research and Development
Openalex Percentile: Top 51%
Diabetes Treatment and Management
DOIOpen Access PDFOpenAlex
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