Heart Failure Clinical Trial
Official title:
Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors and the Risk of Cardiovascular Events Among Patients With Type 2 Diabetes: a Multicenter Cohort Study
NCT number | NCT03939624 |
Other study ID # | Q18-06 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | October 1, 2019 |
Verified date | January 2024 |
Source | Canadian Network for Observational Drug Effect Studies, CNODES |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to compare the risk of cardiovascular events associated with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in comparison with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. The investigators will carry out separate population-based cohort studies using health care databases in seven Canadian provinces and the United Kingdom. The study cohort will be defined by the initiation of a SGLT2 inhibitor or a DPP-4 inhibitor after SGLT2 inhibitors entered the market. Patients will be followed up until the occurrence of a cardiovascular event. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of cardiovascular events in users of SGLT2 inhibitors. The investigators hypothesize that the use of SGLT2 inhibitors will be associated with a decreased risk of cardiovascular events in comparison with the use of DPP-4 inhibitors.
Status | Completed |
Enrollment | 419734 |
Est. completion date | October 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who received a prescription for a SGLT2 inhibitor or DPP-4 inhibitor on or after the date of the first dispensation of a SGLT2 inhibitor at each site and on or before June 30, 2018 (or latest date of data availability at each site) Exclusion Criteria: - Patients who received both a first prescription for a SGLT2 inhibitor and a DPP-4 inhibitor on the same date - Patients with missing sex - Patients aged less than 18 years at cohort entry date (<19 years in Alberta and <66 years in Ontario) - Patients with less than 365 days of healthcare coverage prior to cohort entry date - Patients with date inconsistencies or no follow-up |
Country | Name | City | State |
---|---|---|---|
Canada | Lady Davis Institute for Medical Research, Jewish General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Canadian Network for Observational Drug Effect Studies, CNODES | Canadian Institutes of Health Research (CIHR), Drug Safety and Effectiveness Network, Canada |
Canada,
Brunetti VC, St-Jean A, Dell'Aniello S, Fisher A, Yu OHY, Bugden SC, Daigle JM, Hu N, Alessi-Severini S, Shah BR, Ronksley PE, Lix LM, Ernst P, Filion KB; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Characteristics of ne — View Citation
Filion KB, Lix LM, Yu OH, Dell'Aniello S, Douros A, Shah BR, St-Jean A, Fisher A, Tremblay E, Bugden SC, Alessi-Severini S, Ronksley PE, Hu N, Dormuth CR, Ernst P, Suissa S; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. So — View Citation
Lix LM, Sobhan S, St-Jean A, Daigle JM, Fisher A, Yu OHY, Dell'Aniello S, Hu N, Bugden SC, Shah BR, Ronksley PE, Alessi-Severini S, Douros A, Ernst P, Filion KB. Validity of an algorithm to identify cardiovascular deaths from administrative health records — View Citation
Suissa S, Moodie EE, Dell'Aniello S. Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores. Pharmacoepidemiol Drug Saf. 2017 Apr;26(4):459-468. doi: 10.1002/pds.4107. Epub 2016 Sep 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial infarction | Patients hospitalized for myocardial infarction recorded as the most responsible diagnosis or present on admission in the hospitalization record with the following ICD-10-CA codes: I21.x. | Patients will be followed from the date of study cohort entry until hospitalization for myocardial infarction, treatment discontinuation, death, end of healthcare coverage, or for up to 64 months, whichever occurs first. | |
Primary | Ischemic stroke | Patients hospitalized for ischemic stroke recorded as the most responsible diagnosis or present on admission in the hospitalization record with the following ICD-10-CA codes: I63.x, I64.x. | Patients will be followed from the date of study cohort entry until hospitalization for ischemic stroke, treatment discontinuation, death, end of healthcare coverage, or for up to 64 months, whichever occurs first. | |
Primary | Cardiovascular death | Cardiovascular death will be defined using the following algorithm:
In-hospital death with a cardiovascular diagnosis (ICD-10-CA: I00.x-I77.x (except I46.9)) recorded as the most responsible diagnosis or present on admission; or Out-of-hospital death (including death in the emergency department) without: Documentation of cancer (ICD-9-CM: 140-172, 174-209; ICD-10-CA: C00-C43, C45-C97) in hospital, emergency department or physician claims data in the prior year; or Documentation of trauma (ICD-9-CM: 800-999, E000-E999; ICD-10-CA: S00-T98, V01-Y98) in hospital, emergency department or physician claims data in the preceding month. In a sensitivity analysis, the algorithm will be validated in the sites with access to vital statistics data with cause of death. |
Patients will be followed from the date of study cohort entry until death, treatment discontinuation, end of healthcare coverage, or for up to 64 months, whichever occurs first. | |
Secondary | All-cause mortality | Patients will be followed from the date of study cohort entry until death, treatment discontinuation, end of healthcare coverage, or for up to 64 months, whichever occurs first. | ||
Secondary | Heart failure | Patients hospitalized for heart failure recorded as the most responsible diagnosis in the hospitalization record with the following ICD-10-CA codes: I11.0, I13.0, I13.2, I50.x. | Patients will be followed from the date of study cohort entry until hospitalization for heart failure, treatment discontinuation, death, end of healthcare coverage, or for up to 64 months, whichever occurs first. |
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