Real world data on the cardiovascular (CV) safety and effectiveness of linagliptin (LINA) complement trial data from CARMELINA, which showed CV safety, and CAROLINA (results pending). As part of a 5-year (05/2011-12/2016) post-marketing monitoring program, using 2 large insurance claims databases, we assessed the risk of a composite CV (cCV) outcome (hospitalization for myocardial infarction, stroke, unstable angina, or coronary revascularization). We identified three 1:1 propensity score (PS)-matched cohorts of type 2 diabetes mellitus patients who initiated linagliptin or a comparator [other DPP-4is (n=39,834 pairs), pioglitazone (PIO; n=29,646 pairs), or sulfonylureas (SU; n=25,285 pairs). We estimated pooled HR and 95% CI controlling for over 180 baseline characteristics. After PS-matching, patient characteristics were similar (Table 1) and mean follow-up was 0.8 years. LINA had a similar risk of the cCV outcome compared to other DPP-4is [HR (95% CI) = 0.90 (0.80-1.02)] and PIO [HR (95% CI) = 0.99 (0.86-1.13)], but was associated with a reduced risk compared to SU [HR (95% CI) = 0.77 (0.66-0.90)] (Table 1). Results were robust across numerous sensitivity analyses. These real-world data show that LINA has reassuring effectiveness and safety on a cCV outcome compared to other DPP-4is and PIO, and is associated with a decreased risk compared to SU.


E. Patorno: Research Support; Self; National Institute on Aging. Other Relationship; Self; Boehringer Ingelheim International GmbH. C. Gopalakrishnan: None. M. Mahesri: None. K.G. Brodovicz: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. D. Bartels: Employee; Self; BI X GmbH, Boehringer Ingelheim International GmbH. A. Meyers: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. J. Barberio: None. J. Liu: None. S. Schneeweiss: Consultant; Self; Aetion, WHISCON, LLC.


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