Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors
NCT ID: NCT02993614
Last Updated: 2021-02-18
Study Results
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Basic Information
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COMPLETED
99999 participants
OBSERVATIONAL
2017-11-30
2020-12-17
Brief Summary
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Detailed Description
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CVD-REAL is a comparative effectiveness study that aims to compare new users of SGLT-2 inhibitors with new users of other glucose-lowering drugs with regard to the risk of all-cause mortality and clinically relevant CV outcomes (including stroke, myocardial infarction, and hospitalization for heart failure) respectively. The study is based on data from 12 countries across four major world regions.
The study is conducted using data from claims, medical records and national health registries from twelve countries combined in two waves. CVD-REAL 1 includes Germany, Denmark, Norway, Sweden, United Kingdom (UK) and United States of America (USA). CVD-REAL 2 comprises Australia, Canada, Israel, Japan, Singapore and South Korea. The study will collect data from approximately 4 million patients from the time they start treatment with a SGLT-2 inhibitor or another glucose-lowering drug (index date) to the end of the follow-up period.
The Study Population will consist of new users of SGLT-2i and other glucose lowering drugs respectively. These will be compared with all-cause mortality, hospitalization for heart failure, myocardial infarction and stroke during the follow-up period. In addition certain other cardiovascular and renal outcomes will be assessed descriptively in the two groups respectively.
The study period will range from launch of the first SGLT-2i in each of the countries and end at latest available data in each data source.
All-cause mortality and the incidence of cardiovascular events will be compared between new users of SGLT-2 inhibitors and the comparator arm using a hazard ratio (relative risk) and corresponding 95% confidence interval. The analysis will be performed using the Cox proportional hazards model or some other appropriate method.
Matching by propensity scores will be used to balance the potential confounding covariates between the SGLT-2i group and the reference group to ensure that the two groups are as similar as possible at baseline.To achieve sufficient power, a meta-analysis will be applied to integrate the point estimates from each of the individual database analyses and calculate an overall weighted estimate and corresponding 95% CI.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* T2DM diagnosis on or prior to the index date
* ≥ 18 years old at index date
* \> 1 year data history in the database prior to the index date
Exclusion Criteria
* Patients with gestational diabetes within 1 year before index date
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Wilmington, Delaware, United States
Research Site
Melbourne, D1690r00015, Australia
Research Site
Mississauga, D1690r00015, Canada
Research Site
Gentofte Municipality, D1690r00015, Denmark
Research Site
Espoo, D1690r00015, Finland
Research Site
Ulm, D1690r00015, Germany
Research Site
Raanana, D1690r00015, Israel
Research Site
Rome, D1690r00015, Italy
Research Site
Tokyo, D1690r00015, Japan
Research Site
Oslo, D1690r00015, Norway
Research Site
Porto, D1690r00015, Portugal
Research Site
Singapore, D1690r00015, Singapore
Research Site
Seoul, D1690r00015, South Korea
Research Site
Madrid, D1690r00015, Spain
Research Site
Södertälje, D1690r00015, Sweden
Research Site
Taipei, D1690r00015, Taiwan
Research Site
Luton, D1690r00015, United Kingdom
Countries
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References
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Khunti K, Kosiborod M, Kim DJ, Kohsaka S, Lam CSP, Goh SY, Chiang CE, Shaw JE, Cavender MA, Tangri N, Franch-Nadal J, Holl RW, Jorgensen ME, Norhammar A, Eriksson JG, Zaccardi F, Karasik A, Magliano DJ, Thuresson M, Chen H, Wittbrodt E, Bodegard J, Surmont F, Fenici P; CVD-REAL Investigators and Study Group. Cardiovascular outcomes with sodium-glucose cotransporter-2 inhibitors vs other glucose-lowering drugs in 13 countries across three continents: analysis of CVD-REAL data. Cardiovasc Diabetol. 2021 Jul 31;20(1):159. doi: 10.1186/s12933-021-01345-z.
Nicolucci A, Candido R, Cucinotta D, Graziano G, Rocca A, Rossi MC, Tuccinardi F, Manicardi V. Generalizability of Cardiovascular Safety Trials on SGLT2 Inhibitors to the Real World: Implications for Clinical Practice. Adv Ther. 2019 Oct;36(10):2895-2909. doi: 10.1007/s12325-019-01043-z. Epub 2019 Aug 13.
Cavender MA, Norhammar A, Birkeland KI, Jorgensen ME, Wilding JP, Khunti K, Fu AZ, Bodegard J, Blak BT, Wittbrodt E, Thuresson M, Fenici P, Hammar N, Kosiborod M; CVD-REAL Investigators and Study Group. SGLT-2 Inhibitors and Cardiovascular Risk: An Analysis of CVD-REAL. J Am Coll Cardiol. 2018 Jun 5;71(22):2497-2506. doi: 10.1016/j.jacc.2018.01.085.
Kosiborod M, Lam CSP, Kohsaka S, Kim DJ, Karasik A, Shaw J, Tangri N, Goh SY, Thuresson M, Chen H, Surmont F, Hammar N, Fenici P; CVD-REAL Investigators and Study Group. Cardiovascular Events Associated With SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL 2 Study. J Am Coll Cardiol. 2018 Jun 12;71(23):2628-2639. doi: 10.1016/j.jacc.2018.03.009. Epub 2018 Mar 11.
Kosiborod M, Cavender MA, Fu AZ, Wilding JP, Khunti K, Holl RW, Norhammar A, Birkeland KI, Jorgensen ME, Thuresson M, Arya N, Bodegard J, Hammar N, Fenici P; CVD-REAL Investigators and Study Group*. Lower Risk of Heart Failure and Death in Patients Initiated on Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study (Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors). Circulation. 2017 Jul 18;136(3):249-259. doi: 10.1161/CIRCULATIONAHA.117.029190. Epub 2017 May 18.
Related Links
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Publication in "Circulation"
CSP\_D1690R00015.
Other Identifiers
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D1690R00015
Identifier Type: -
Identifier Source: org_study_id
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