(174) Impact of Cardiovascular Medications on Non-Traumatic Amputation Rates in Type 2 Diabetes: Insights from a Large-Scale Retrospective Real-World Data Analysis

Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by hyperglycemia due to defects in insulin secretion, insulin action, or both. It is a growing global epidemic, with an estimated 537 million people living with T2DM worldwide. There is growing evidence to suggest that other cardiovascular medications may have a role in the management of diabetic neuropathy, for example the FIELD study demonstrated that long-term use of fenofibrate reduced overall neuropathy and increased the reversal of pre-existing neuropathy in T2DM.

Objectives: This study investigates the impact of cardiovascular medications on the incidence of non-traumatic amputation in patients with T2DM. This study leverages retrospective, real-world data (RWD) to bridge the gap between clinical trial findings and actual clinical outcomes, offering critical insights on these medications in diverse, real-world patient populations.

Methods: A retrospective study was conducted using large-scale real-world data from 1.2 billion patients, focusing on T2DM patients over 18 years with 365 days prior observation. Data from IQVIA™ US and Japan, formatted in the Observational Medical Outcomes Partnership (OMOP) common data model, were used, encompassing claims, hospital, and electronic medical records (EMR) data. The study period spanned from January 1, 2015, to December 31, 2022 and the time-at-risk is 15 years from index date. The analysis focused on patients prescribed statins, fenofibrates, anti-hypertensives, aspirin, and GLP-1/SGLT2 inhibitors, without concurrent use of other study drugs.

Results: The analysis revealed a statistically significant reduction in incidence proportion of non-traumatic amputation when patients were prescribed to statins (0.32-4.91 per 100k patients) and fenofibrates (0.37-5.65 per 100k) compared to anti-hypertensives (0.68-4.59 per 100k), aspirin (0.88-2.67 per 100k) and GLP-1/SGLT2i's (0.40-3.38 per 100k). Assessing different types of RWD in the US, our results show that incidence rates across all drugs were considerably higher for in Hospital EMRs (0.66-2.78 per 100k) compared to the Claims (0.33-1.29 per 100k) and Outpatient databases (0.16-0.35 per 100k).

Conclusions: This study underscores the value of RWD in enhancing our understanding of the real-world implications of medication use in T2DM management. Continued research, employing rigorous experimental designs and advanced statistical techniques like propensity score matching and negative controls, are needed for more definitive comparative analysis. Additionally, the variance in incidence rates across different data sources underscores the importance of considering the context of healthcare settings in evaluating drug effectiveness.