Assessing the representativeness of trials of Sodium-glucose Cotransporter- 2 inhibitors in type 2 diabetes Article Swipe
Peter Hanlon
,
Heather Wightman
,
Michael Sullivan
,
Jennifer S. Lees
,
Elaine Butterly
,
Lili Wei
,
Ryan McChrystal
,
Eric T. Whalley
,
Saleh Ali M. Almazam
,
Khalid Alsallumi
,
J Petrie
,
Amanda Adler
,
Naveed Sattar
,
Daniel R. Morales
,
Bruce Guthrie
,
David McAllister
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.21203/rs.3.rs-7365260/v1
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.21203/rs.3.rs-7365260/v1
Background Randomised controlled trials are often criticised for excluding people with multiple long-term conditions. This study used individual participant data for 25 trials of sodium glucose co-transporter-2 inhibitors (SGLT2i) to compare baseline characteristics, comorbidities, and event rates between trial participants and community SGLT2i-treated people in routine care. Methods Trials were identified through a systematic review with subsequent application for individual-level data. Community SGLT2i-treated people in routine care were identified from the Secure Anonymised Information Linkage (SAIL) databank (Wales, UK). For each trial, we applied the eligibility criteria to the community SGLT2i-treated populations. We then (i) assessed the proportion eligible/ineligible for each trial, (ii) compared age, sex and number of comorbidities between trial participants and those eligible/ineligible in routine care, (iii) compared rates of serious adverse events in the trials to the expected rate in community SGLT2i-treated participants, and (iv) compared the rate of major adverse cardiovascular events (MACE), all-cause mortality, non-cardiovascular mortality, and estimated glomerular filtration rate (eGFR) slope between trial and community participants. Results The number of comorbidities was consistently lower in trial populations compared to community SGLT2i-treated who met trial eligibility criteria. Compared with other trial populations, participants in the large cardiovascular outcome trials (CANVAS, CANVAS-R, CREDENCE and EMPA-REG) levels of comorbidity were higher; comorbidity differences were smaller; and serious adverse event rates were broadly similar to the expected rate based on the community. For the remaining trials, the serious adverse event rate was lower in the trials than the expected rate based on community SGLT2i-treated participants. In the cardiovascular outcome trials, rates of MACE, mortality and decline in eGFR slope were similar or higher in trial populations. Conclusion While people with comorbidity are under-represented compared to routine care populations in most trials, 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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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.21203/rs.3.rs-7365260/v1
- https://www.researchsquare.com/article/rs-7365260/latest.pdf
- OA Status
- gold
- References
- 21
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4413738745
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4413738745Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.21203/rs.3.rs-7365260/v1Digital Object Identifier
- Title
-
Assessing the representativeness of trials of Sodium-glucose Cotransporter- 2 inhibitors in type 2 diabetesWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-08-27Full publication date if available
- Authors
-
Peter Hanlon, Heather Wightman, Michael Sullivan, Jennifer S. Lees, Elaine Butterly, Lili Wei, Ryan McChrystal, Eric T. Whalley, Saleh Ali M. Almazam, Khalid Alsallumi, J Petrie, Amanda Adler, Naveed Sattar, Daniel R. Morales, Bruce Guthrie, David McAllisterList of authors in order
- Landing page
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https://doi.org/10.21203/rs.3.rs-7365260/v1Publisher landing page
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https://www.researchsquare.com/article/rs-7365260/latest.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://www.researchsquare.com/article/rs-7365260/latest.pdfDirect OA link when available
- Concepts
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Representativeness heuristic, Type 2 diabetes, Cotransporter, Diabetes mellitus, Internal medicine, Medicine, Sodium, Chemistry, Endocrinology, Pharmacology, Mathematics, Statistics, Organic chemistryTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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21Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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