Aim
To evaluate the safety of linagliptin versus other glucose‐lowering medications in a multi‐year monitoring programme using insurance claims data.
Methods
In two commercial US claims databases, we identified three pairwise 1:1 propensity‐score (PS)‐matched cohorts of patients with type 2 diabetes (T2D) aged ≥18 years initiating linagliptin or a comparator (other dipeptidyl peptidase‐4 [DPP‐4] inhibitors [n = 31 492 pairs], pioglitazone [n = 23 316 pairs], or second‐generation sulphonylureas [n = 19 731 pairs]) between May 2011 and December 2015. The primary endpoint was the risk of a composite cardiovascular (CV) outcome (hospitalization for myocardial infarction, stroke, unstable angina, or coronary revascularization). We estimated pooled hazard ratios (HRs) and 95% confidence intervals (CIs), controlling for >100 baseline characteristics.
Results
Patient characteristics were well balanced after PS‐matching. The mean age was 55 years and mean follow‐up was 0.8 years. Linagliptin conferred a similar risk of the composite CV outcome compared to other DPP‐4 inhibitors (HR 0.91, 95% CI 0.79‐1.05) and pioglitazone (HR 0.98, 95% CI 0.84‐1.15), and showed a reduced risk of CV outcomes compared to second‐generation sulphonylureas (HR 0.76, 95% CI 0.64‐‐0.92). Key findings were signalled at the first interim analysis in June 2013 and solidified during ongoing monitoring until 2015.
Conclusion
Analyses from a large monitoring programme in routine care of patients with T2D, showed that linagliptin had similar CV safety compared to other DPP‐4 inhibitors and pioglitazone, and a reduced CV risk compared to sulphonylureas.