Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors: Comparing Trial and Real World Use (Study Protocol)

McGovern, Andrew; Feher, Michael; Munro, N.; Lusignan, Simon de

doi:10.1007/s13300-017-0229-8

Cited by 4 publications

(2 citation statements)

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“…CVD cases include a diagnosis of one or more of the following conditions: coronary artery disease (including myocardial infarction and angina), atrial fibrillation (AF), peripheral arterial disease, stroke, transient ischaemic attack and congestive cardiac failure (online supplementary appendix 1 , Read code list 28 ). We included hypertension in our analysis of CVD.…”

Section: Methodsmentioning

confidence: 99%

Incidence and prevalence of cardiovascular disease in English primary care: a cross-sectional and follow-up study of the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC)

et al. 2018

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ObjectivesTo describe incidence and prevalence of cardiovascular disease (CVD), its risk factors, medication prescribed to treat CVD and predictors of CVD within a nationally representative dataset.DesignCross-sectional study of adults with and without CVD.SettingThe Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) is an English primary care sentinel network. RCGP RSC is over 50 years old and one of the oldest in Europe. Practices receive feedback about data quality. This database is primarily used to conduct surveillance and research into influenza, infections and vaccine effectiveness but is also a rich resource for the study of non-communicable disease (NCD). The RCGP RSC network comprised 164 practices at the time of study.ResultsData were extracted from the records of 1 275 174 adults. Approximately a fifth (21.3%; 95% CI 21.2% to 21.4%) had CVD (myocardial infarction (MI), angina, atrial fibrillation (AF), peripheral arterial disease, stroke/transient ischaemic attack (TIA), congestive cardiac failure) or hypertension. Smoking, unsafe alcohol consumption and obesity were more common among people with CVD. Angiotensin system modulating drugs, 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors (statins) and calcium channel blockers were the most commonly prescribed CVD medications. Age-adjusted and gender-adjusted annual incidence for AF was 28.2/10 000 (95% CI 27.8 to 28.7); stroke/TIA 17.1/10 000 (95% CI 16.8 to 17.5) and MI 9.8/10 000 (95% CI 9.5 to 10.0). Logistic regression analyses confirmed established CVD risk factors were associated with CVD in the RCGP RSC network dataset.ConclusionsThe RCGP RSC database provides comprehensive information on risk factors, medical diagnosis, physiological measurements and prescription history that could be used in CVD research or pharmacoepidemiology. With the exception of MI, the prevalence of CVDs was higher than in other national data, possibly reflecting data quality. RCGP RSC is an underused resource for research into NCDs and their management and welcomes collaborative opportunities.

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Section: Methodsmentioning

confidence: 99%

Incidence and prevalence of cardiovascular disease in English primary care: a cross-sectional and follow-up study of the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC)

et al. 2018

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“…The major strength of this study is direct comparison of baseline characteristics among different SGLT2i new users from the largest multi-institutional cohort of outpatients with type 2 diabetes in Taiwan, which allowed us to explore the discrepancies between current evidence and real-world data. The limitation is the potentially missing data on inclusion/exclusion criteria from the EMPA-REG OUTCOME trial, VERTIS-CV trial, DECLARE-TIMI 58 trial and CANVAS program in our EMR records 39. A number of patients may have a condition of interest without documentation in our database, such as current tobacco use with at least five cigarettes/day.…”

Section: Discussionmentioning

confidence: 99%

Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients?

Shao

Lin

Chang

et al. 2019

BMJ Open Diab Res Care

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ObjectiveThis study evaluated the characteristics of new users of sodium glucose co-transporter 2 inhibitors (SGLT2i) in clinical practice to assess the applicability of the findings from clinical trials (Empagliflozin, Cardiovascular Outcomes and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial, Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 trial, Canagliflozin Cardiovascular Assessment Study (CANVAS) program and the Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes (VERTIS-CV) trial) and multinational observational studies (CVD-REAL Nordic study and CVD-REAL 2 study).Research design and methodsWe conducted a retrospective cohort study using the largest electronic medical records database from seven hospitals in Taiwan. We included adult patients with type 2 diabetes initiating canagliflozin, dapagliflozin and empagliflozin between 1 January 2018 and 31 August 2019. We compared the patient characteristics with SGLT2i to examine the data representativeness of clinical trials and to evaluate channeling uses between canagliflozin, dapagliflozin and empagliflozin.ResultsWe identified a cohort of 11 650 patients newly initiating SGLT2i, 49.9% of whom received empagliflozin. However, only 18.7%, 19.2%, 50.4% and 57.3% of real-world SGLT2i new users were included in the EMPA-REG OUTCOME trial, VERTIS-CV trial, DECLARE-TIMI 58 trial and CANVAS program, respectively. Reasons for exclusion were largely reduced cardiovascular disease risks in real-world patients, namely 72.8%, 73.6% and 34.2% for EMPA-REG OUTCOME trial, VERTIS-CV trial and DECLARE-TIMI 58 trial and CANVAS program, respectively. However, hemoglobin A1c out of range accounted for the most frequent reason (25.0%) for exclusion of real-world patients from the CANVAS program. We found channeling uses in different SGLT2i, for example, more patients receiving empagliflozin (15.3%) and canagliflozin (19.6%) had poorer renal functions (eg, estimated glomerular filtration rate <60 mL/min/1.73 m2), compared with dapagliflozin (9.3%).ConclusionsThe findings provide clear evidence that results from current studies may be less applicable to real-world patients. Further studies are required to support the concept of real-world cardiovascular event protection through SGLT2i.

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Sodium-Glucose Co-transporter 2 (SGLT2) Inhibitor: Comparing Trial Data and Real-World Use

et al. 2017

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IntroductionThe first cardiovascular safety trial in the sodium-glucose co-transporter-2 (SGLT2) inhibitor drug class, the Empagliflozin Cardiovascular Outcomes and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial, demonstrated significant cardiovascular risk reduction with empagliflozin. It is currently not clear what proportions of people with type 2 diabetes (T2DM) have the same high cardiovascular risk as those included in the trial, and will therefore be likely to experience the same cardiovascular benefit. We aimed to identify and describe the proportion of people with T2DM from a representative English national population who have the comparable high cardiovascular risk to those included in the EMPA-REG trial.MethodA cross-sectional analysis of cardiovascular risk in people with T2DM and a subgroup prescribed SGLT2 inhibitors. Patients were identified from the Royal College of General Practitioners Research and Surveillance Centre database. Cardiovascular risk factors were identified from electronic patient records.ResultsFrom 1,238,909 patients at 128 GP practices, we identified 60,327 adults with T2DM (mean age 66.1 years, SD 13.9) of whom 55.6% were male. From these 1642 (2.7%) people had been initiated on an SGLT2 inhibitor (mean age 58.1 years, SD 10.4; 58.8% male). In the complete T2DM group only 15.7% (95% CI 15.5–16.0%) had the same high cardiovascular risk as those included in the EMPA-REG trial. In those already initiated on SGLT2 inhibitors this proportion was 11.1% (95% CI 9.8–12.4%). Whilst the proportion was higher in the oldest age groups, in those 70+ years old less than a quarter met the EMPA-REG trial high cardiovascular risk criteria.ConclusionsThe EMPA-REG trial results are applicable only to a small proportion of people with T2DM and a smaller proportion of those currently treated with SGLT2 inhibitors. Additional data are required to identify any cardiovascular benefit in people with lower cardiovascular risk.FundingAstraZeneca.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0254-7) contains supplementary material, which is available to authorized users.

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Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors: Comparing Trial and Real World Use (Study Protocol)

Cited by 4 publications

References 26 publications

Incidence and prevalence of cardiovascular disease in English primary care: a cross-sectional and follow-up study of the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC)

Incidence and prevalence of cardiovascular disease in English primary care: a cross-sectional and follow-up study of the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC)

Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients?

Sodium-Glucose Co-transporter 2 (SGLT2) Inhibitor: Comparing Trial Data and Real-World Use

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