Currently submitted to: JMIR Diabetes
Date Submitted: Mar 7, 2024
Open Peer Review Period: Mar 14, 2024 - May 9, 2024
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comparing insulin vs GLP-1, DPP-4, SGLT-2 on 5-year incident heart failure for patients with type 2 diabetes mellitus: a real-world evidence study using insurance claims
ABSTRACT
Background:
Type 2 diabetes mellitus (T2D) is a common health issue, with heart failure (HF) being the common and lethal long-term complication. Although insulin is widely used for the treatment of T2D, evidence regarding the efficacy of insulin compared to non-insulin therapies on incident heart failure risk is missing among randomized clinical trials. Real-world evidence on insulin’s effect on long-term heart failure may supplement existing guidelines on the management of T2D.
Objective:
This study compared the insulin therapy versus other medications on heart failure (HF) among T2D patients using real-world data (RWD) extracted from insurance claims.
Methods:
We employed doubly robust Augmented Inverse Probability Weighted estimation that extensively adjusted for high-dimensional confounding factors in both the propensity score and outcome regression models, using a data-driven approach for feature selection implemented through a LASSO sparsity penalty in each model.
Results:
After adjusting for broad list of confounders, insulin was found to be associated with 11.8% [95% CI: 11.0%-12.7%] higher 5-year HF rate compared to patients receiving GLP-1, 12.0% [95% CI: 11.5%-12.4%] higher 5-year HF rate compared to DPP-4, and 15.1% [95% CI: 14.3%-16.0%] higher 5-year HF rate compared to SGLT-2. Subgroup analysis shows the insulin effect with a higher HF rate is significant in subgroup with high baseline HF risk but not significant in subgroup with low baseline HF risk.
Conclusions:
This study generated real-world evidence on the association with higher 5-year heart failure rate of insulin therapy compared to GLP-1, DPP-4, and SGLT-2 based on claims data. These findings also demonstrated the value of real-world data for comparative effectiveness studies to complement established guidelines. On the other hand, the study shares the common limitation of observational studies. Even though high-dimensional confounders are adjusted, remaining confounding may exist and induce bias in analysis.
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