Cardiovascular safety of linagliptin compared to other oral glucose lowering agents in patients with type 2 diabetes: a sequential monitoring program in routine care

E Patorno, C Gopalakrishnan, K G Brodovicz, A Meyers, D B Bartels, J Liu, M Kulldorff, S Schneeweiss
Diabetes, Obesity & Metabolism 2019 April 2

BACKGROUND: There are limited real-world data on the comparative cardiovascular (CV) safety of linagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i) available since May 2011.

OBJECTIVES: We aimed to evaluate the safety of linagliptin vs. other glucose-lowering medications in a multi-year monitoring program using insurance claims data.

METHODS: In two commercial U.S. claims databases, we identified three pairwise 1:1 propensity score (PS) matched cohorts of type 2 diabetes (T2D) patients ≥18 years initiating linagliptin or a comparator [other DPP-4i (n=31,492 pairs), pioglitazone (n=23,316 pairs), or 2nd generation sulfonylureas (n=19,731 pairs)] between May 2011 and December 2015. The primary endpoint was the risk of a composite CV outcome (hospitalization for myocardial infarction, stroke, unstable angina, or coronary revascularization). We estimated pooled hazard ratios (HR) and 95% confidence intervals (CI) controlling for >100 baseline characteristics.

RESULTS: Patient characteristics were well balanced after PS-matching. Mean age was 55 years and mean follow-up was 0.8 years. Linagliptin had a similar risk of the composite CV outcome compared to other DPP-4is (HR = 0.91; 95% CI = 0.79-1.05) and pioglitazone (0.98; 0.84-1.15), and showed a reduced risk of CV outcomes compared to 2nd generation sulfonylureas (0.76; 0.64-0.92). Key findings signaled at the first interim analysis in June 2013 and solidified during ongoing monitoring through 2015.

CONCLUSION: Analyses from a large monitoring program in routine care of patients with T2D, showed that linagliptin had similar cardiovascular safety compared to other DPP-4i and pioglitazone, and a reduced cardiovascular risk compared to sulfonylureas. This article is protected by copyright. All rights reserved.

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