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Abstract
Objective To assess the eligibility of patients participating in DISCOVER (a 3-year, prospective, observational study program of 15 992 patients with type 2 diabetes [T2D] initiating a second-line glucose-lowering therapy across 38 countries) for four cardiovascular outcomes trials (CVOTs) of sodium–glucose cotransporter 2 inhibitors (CANagliflozin cardioVascular Assessment Study [CANVAS], Dapagliflozin effect on CardiovascuLAR Events trial [DECLARE-TIMI 58], EMPAgliflozin cardiovascular OUTCOME event trial [EMPA-REG OUTCOME], and eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial [VERTIS-CV]).
Research design and methods In this cross-sectional analysis, baseline characteristics of DISCOVER patients were compared with the inclusion and exclusion criteria of the CVOTs to assess patient eligibility, overall and in four regions (Asia-Pacific, Europe, Latin America, and Middle East and Africa).
Results Overall, 11 385 patients (71.2%) had sufficient data for the analysis; 56.1% were men. The mean age and time since T2D diagnosis were 57.4 and 5.6 years, respectively. The mean glycated hemoglobin level was 8.3%. DISCOVER patients were younger, and fewer had a history of cardiovascular disease, than those enrolled in the CVOTs. Eligibility varied across the CVOTs; the proportion of eligible DISCOVER patients was highest for DECLARE-TIMI 58 (40.5%), followed by CANVAS (19.9%), VERTIS-CV (7.2%), and EMPA-REG OUTCOME (7.1%); 54.6% of patients were not eligible for any CVOT. Eligibility for each CVOT varied across regions, which was explained by the differing proportions of patients with established cardiovascular disease.
Conclusions In a large, international population of patients with T2D initiating a second-line glucose-lowering therapy, DECLARE-TIMI 58 was the most inclusive CVOT, suggesting that its study population will be more representative of patients encountered in routine clinical practice than those of CANVAS, EMPA-REG OUTCOME, and VERTIS-CV.
- adult diabetes
- general research
- sodium glucose cotransporter
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Footnotes
Contributors The proposal for the analysis was developed by SP and FS and reviewed by all authors. The general content of the manuscript was agreed upon by all authors. The statistical analysis was conducted by FT. The first draft of the manuscript was developed by SP and critically reviewed by all authors. All authors approved the final version of the manuscript before its submission. An AstraZeneca team reviewed the manuscript during its development and could make suggestions. However, the final content was determined by the authors. SP is the guarantor of this work.
Funding The DISCOVER and DECLARE‑TIMI 58 studies are funded by AstraZeneca. The CANVAS study is funded by Janssen. The EMPA-REG OUTCOME study is funded by Boehringer Ingelheim and Eli Lilly. The VERTIS-CV study is funded by Merck Sharp & Dohme and Pfizer.
Competing interests SP is an employee of Oxford PharmaGenesis. PF, JM, EW, and FS are employees of AstraZeneca. NH is a former employee of AstraZeneca. LJ has received honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche, Sanofi, and Takeda, and research support from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Roche, and Sanofi. KK has received honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche, and Sanofi, and research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche, and Sanofi, and also acknowledges support from the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care – East Midlands (NIHR CLAHRC – EM) and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre. FT is an employee of the Mid America Heart Institute, which received institutional funding from AstraZeneca.
Patient consent for publication Not required.
Ethics approval The DISCOVER study protocol was approved by the appropriate clinical research ethics committees in each participating country and by the relevant institutional review boards at each site. The protocol complies with the Declaration of Helsinki, the International Conference on Harmonization on Good Clinical Practice, and the local regulations for clinical research.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement DISCOVER data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure