Report from the 5th cardiovascular outcome trial (CVOT) summit

Schnell, Oliver; Standl, Eberhard; Cos, Xavier; Heerspink, Hiddo J.L.; Itzhak, Baruch; Lalić, Nebojša; Nauck, Michael A.; Ceriello, Antonio

doi:10.1186/s12933-020-01022-7

Cited by 20 publications

(13 citation statements)

References 42 publications

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“…[ 14 , 15 ] CVOTs, most of which are pragmatic RCTs, play a key role in the development of clinical practice guidelines for diabetes. [ 9 , 16 – 19 ] However, recent studies have reported that CVOTs do not adequately represent real-world patient populations. [ 20 , 21 ]…”

Section: Introductionmentioning

confidence: 99%

Population diversity of cardiovascular outcome trials and real-world patients with diabetes in a Chinese tertiary hospital

Zhou

Zhang

et al. 2021

Chinese Medical Journal

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Background: Recent cardiovascular outcome trials (CVOTs) changed the therapeutic strategy of guidelines for type 2 diabetes. We compared the characteristics of patients from real-world hospital settings with those of participants in recent pragmatic randomized trials. Methods: This electronic medical record (EMR)-based retrospective observational study investigated the data of patients with diabetes from inpatient and outpatient settings in West China Hospital of Sichuan University from January 1, 2011, to June 30, 2019. We identified patients meeting the inclusion criteria of a pragmatic randomized trial (EMPA-REG OUTCOME) based on EMRs and compared their baseline characteristics with those of the trial participants. The cutoff for the clinical significance of each characteristic was set as its minimal clinically important difference based on expert consultation. Results: We included 48,257 inpatients and 36,857 outpatients with diabetes and found that 8389 (17.4%) inpatients and 2646 (7.2%) outpatients met the inclusion criteria for the EMPA-REG OUTCOME trial. Compared with the trial population, the real-world inpatients meeting the eligibility criteria of the EMPA-REG OUTCOME had similar age, blood pressure, and lipid profiles but comprised of fewer males, metformin users, anti-hypertensive drug users, and aspirin users, and had a lower body mass index. The group of outpatients meeting the eligibility criteria had fewer males, similar age, fewer metformin users, fewer insulin users, fewer anti-hypertensive drug users, and fewer aspirin users compared with the trial population. Conclusions: The trial population in EMPA-REG OUTCOME represents only a small portion of patients with diabetes from the inpatient and outpatient departments of a Chinese tertiary medical center. Evidence localization in different clinical settings and validation are essential to enabling extrapolation of the results from CVOTs in patients with diabetes to Chinese clinical practice.

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Section: Introductionmentioning

confidence: 99%

Population diversity of cardiovascular outcome trials and real-world patients with diabetes in a Chinese tertiary hospital

Zhou

Zhang

et al. 2021

Chinese Medical Journal

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“…As in previous years [ 33 – 37 ], we present and summarise key aspects discussed at the sixth edition of the CVOT Summit in October 2020, which was the first to be held virtually. The CVOT Summit—Cardiovascular and Renal Outcomes 2020 was an interdisciplinary platform, which was also organized in conjunction with four study groups: Primary Care Diabetes Europe (PCDE, www.pcdeurope.org ), European Diabetic Nephropathy Study Group (EDNSG, www.ednsg.org ), the Incretin Study Group ( www.easd-incretin.ku.dk ), and the Working Group Diabetes & Herz ( www.ddg.org ).…”

Section: Introductionmentioning

confidence: 99%

Report from the CVOT Summit 2020: new cardiovascular and renal outcomes

Schnell

Cos²,

Cosentino

et al. 2021

Cardiovasc Diabetol

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The 6th Cardiovascular Outcome Trial (CVOT) Summit “Cardiovascular and Renal Outcomes 2020” was the first to be held virtually on October 29–30, 2020. As in previous years, this summit served as reference meeting for in-depth discussions on the topic of recently completed and presented major outcome trials. This year, focus was placed on the outcomes of VERTIS-CV, EMPEROR-Reduced, DAPA-CKD, and FIDELIO-DKD. Trial implications for diabetes management and the impact on new treatment algorithms were highlighted for diabetologists, cardiologists, endocrinologists, nephrologists, and general practitioners. Discussion evolved from major outcome trials using SGLT-2 inhibitors for treatment and prevention of heart failure and chronic kidney disease in people with and without diabetes, to additional therapy options for chronic kidney disease with a novel mineralocorticoid receptor antagonist. Furthermore, challenges in diabetes management like COVID-19 and obesity, as well as novel treatment strategies and guidelines, were discussed.The 7th Cardiovascular Outcome Trial Summit will be held virtually on November, 18–19, 2021 (http://www.cvot.org).

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“…Prevention of cardiovascular disease is a major objective of diabetes care [ 1 ]. In the past decade, cardiovascular outcome trials (CVOTs) have been performed in patients with type 2 diabetes (T2D) with the primary aim of demonstrating safety of glucose lowering medications (GLMs) concerning the risk of cardiovascular events [ 2 , 3 ]. Some of these CVOTs were designed to test superiority and some eventually found lower rates of cardiovascular events among patients randomized to active GLM compared to those randomized to placebo plus standard care [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Transposition of cardiovascular outcome trial effects to the real-world population of patients with type 2 diabetes

Sciannameo

Berchialla

Avogaro

et al. 2021

Cardiovasc Diabetol

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Background Transferring results obtained in cardiovascular outcome trials (CVOTs) to the real-world setting is challenging. We herein transposed CVOT results to the population of patients with type 2 diabetes (T2D) seen in routine clinical practice and who may receive the medications tested in CVOTs. Methods We implemented the post-stratification approach based on aggregate data of CVOTs and individual data of a target population of diabetic outpatients. We used stratum-specific estimates available from CVOTs to calculate expected effect size for the target population by weighting the average of the stratum-specific treatment effects according to proportions of a given characteristic in the target population. Data are presented as hazard ratio (HR) and 95% confidence intervals. Results Compared to the target population (n = 139,708), the CVOT population (n = 95,816) was younger and had a two to threefold greater prevalence of cardiovascular disease. EMPA-REG was the CVOT with the largest variety of details on stratum-specific effects, followed by TECOS, whereas DECLARE and PIONEER-6 had more limited stratum-specific information. The post-stratification HR estimate for 3 point major adverse cardiovascular event (MACE) based on EMPA-REG was 0.88 (0.74–1.03) in the target population, compared to 0.86 (0.74–0.99) in the trial. The HR estimate based on LEADER was 0.88 (0.77–0.99) in the target population compared to 0.87 (0.78–0.97) in the trial. Consistent results were obtained for SUSTAIN-6, EXSCEL, PIONEER-6 and DECLARE. The effect of DPP-4 inhibitors observed in CVOTs remained neutral in the target population. Conclusions Based on CVOT stratum-specific effects, cardiovascular protective actions of glucose lowering medications tested in CVOTs are transferrable to a much different real-world population of patients with T2D.

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Report from the 5th cardiovascular outcome trial (CVOT) summit

Cited by 20 publications

References 42 publications

Population diversity of cardiovascular outcome trials and real-world patients with diabetes in a Chinese tertiary hospital

Population diversity of cardiovascular outcome trials and real-world patients with diabetes in a Chinese tertiary hospital

Report from the CVOT Summit 2020: new cardiovascular and renal outcomes

Transposition of cardiovascular outcome trial effects to the real-world population of patients with type 2 diabetes

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