BACKGROUND: There are limited real world data on the cardiovascular (CV) safety and effectiveness of linagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i) approved in the U.S. in May 2011.
METHODS: Within two U.S. claims databases (05/2011-12/2015), we identified three pairwise 1:1 propensity score (PS)-matched cohorts of type 2 diabetes mellitus patients ≥18 years initiating linagliptin or a comparator [other DPP-4is (n=31,492 pairs), pioglitazone (n=23,316 pairs), or sulfonylureas (n=19,731 pairs)], and compared 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 >180 baseline characteristics.
RESULTS: After PS-matching, patient characteristics were similar (Figure 1). Mean age was about 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 (95% CI) = 0.91 (0.79-1.05)] and pioglitazone [HR (95% CI) = 0.98 (0.84-1.15)], but showed a decreased risk compared to sulfonylureas [HR (95% CI) = 0.76 (0.64-0.92)].
CONCLUSIONS: An interim analysis of a monitoring program in routine care, with planned future analyses involving increasing numbers of patients, showed that linagliptin has similar effectiveness and safety on a CV composite outcome compared to other DPP-4is and pioglitazone, and a meaningfully decreased risk compared to sulfonylureas.