Emulating a Randomized Clinical Trial (TECOS) Using Real-World Data to Assess the Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes
Speaker(s)
Rascon Velasco V1, Argoubi R1, Berliner E2, Furegato M3, Medina P4
1Oracle Life Sciences, Paris, 75, France, 2Oracle Life Sciences, Kansas City, MO, USA, 3Oracle Life Sciences, Este, France, 4Oracle Life Sciences, Paris, Paris, France
Presentation Documents
OBJECTIVES: We assessed the potential of using a large US claims database to emulate the TECOS - Trial Evaluating Cardiovascular Outcomes with Sitagliptin clinical trial in a type-2 diabetic population aged ≥50, assessing the effects of adding sitagliptin to usual care on major cardiovascular events (MACE) using second-generation sulfonylureas as proxy for placebo.
METHODS: Oracle’s US claims collects data from over 160 payers including commercial, Medicare Advantage, and Medicaid data across all states including 150million patients. Inclusion/exclusion criteria from TECOS were adapted for population selection. First prescription date of sitagliptin or 2G-sulfonylurea was considered as cohort entry. Patients were excluded if they qualified in both exposure categories. Baseline characteristics including cardiovascular and diabetes-related complications were determined at index-date while study outcomes were determined at 12 months after index-date. 1:1 Propensity score matching was performed. Standardized mean differences were estimated pre- and post-matching. Descriptive analysis and Cox proportional hazards model were performed.
RESULTS: We identified 47,859 individuals of which 13,621 were sitagliptin and 34,238 2G-sulfonylureas users. Mean age in the treated group was 63.9(8.6) and 64.1(8.7) in the reference group, of which were followed up for a mean duration of 1614 and 1566 days, respectively. 13,614 pairs of exposed and non-exposed patients were identified, who were balanced on 74 baseline covariates. During the first year of follow-up among matched patients followed for at least one year, 44.1% of sitagliptin and 44.0% 2G-sulfonylureas patients experienced a MACE event. For the matched participants, the multivariable-adjusted Hazard Ratios for MACE events related to the use of sitagliptin was 1.00(95%CI, 0.97 1.04;p=0.981).
CONCLUSIONS: This study did not identify any statistical differences in the risk of cardiovascular outcomes associated to sitagliptin compared to 2G-sulfonylureas, confirming findings from the TECOS trial. This proves the possibility of complementing drug development and regulatory approval with real-world evidence studies.
Code
MSR37
Topic
Clinical Outcomes, Epidemiology & Public Health, Methodological & Statistical Research, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment, Confounding, Selection Bias Correction, Causal Inference, Safety & Pharmacoepidemiology
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity), Drugs