Real-World Data in an Observational Medical Outcomes Partnership/Common Data Model (OMOP/CDM) Platform: Assessing the Impact of Statins on Reducing the Need for Dialysis of Diabetic Patients Treated with ARBs/ACE Inhibitors

Background: Diabetics are at high risk of developing kidney dysfunction. Angiotensin receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs) are often employed to mitigate the risk of kidney disease progression. Statins also show promise in reducing the risk of chronic kidney disease (CKD) progression. This study examines the impact of statins on reducing the need for dialysis among diabetic patients treated with ACEIs or ARBs, utilizing the OMOP CDM framework within the Hospital Israelita Albert Einstein in São Paulo/Brazil. Methods: This retrospective, observational cohort study at a single hospital used the OMOP CDM framework to analyze electronic health records of diabetic patients treated with ACEIs/ARBs, from 2017 to 2023. Adult Type 2 Diabetes Mellitus patients receiving ACEIs/ARBs, and possibly statins were included. Statistical analyses using Python involved Chi-square and Mann-Whitney U tests, and multivariate logistic regression, ensuring significance with p-values less than 0.05. Results: Out of 55,764 diabetic patients using ACEIs or ARBs, 36,378 (65.2%) were taking statins. Statin users were older (median [range], 65 years [53–75] vs. 45 years [35–59]; P < 0.01) and predominantly male (56% vs. 44%; P < 0.001). Logistic regression adjusted for age and sex showed that statin users had a lower dialysis rate (0.20% vs. 2.88%; P < 0.001 - Table 1) Conclusion: The data suggest that statin therapy was associated with a reduced need for dialysis in high-risk diabetic patients with ACEIs/ARBs. The OMOP CDM framework was an easy way to simplify and accelerate analysis of large amount of data, in an integrated and protected environment, highlighting its value in advanced medical research. Baseline demographics - Variables Statin Users(n = 36,378) Nonstatin users(n = 19,386) P Value Age, years median [IQR] 65 [53;75] 45 [35;59] < 0.01 Sex (Male) n(%) 20.311 (56%) 8.574 (44%) < 0.001 Dialysis n(%) 73 (0.20%) 559 (2.88%) < 0.001