Safety and efficacy of linagliptin in patients with type 2 diabetes mellitus and coronary artery disease: Analysis of pooled events from 19 clinical trials.

Aims To examine the safety and efficacy of linagliptin in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD) using pooled data from the global clinical trials program. Methods Patient-level data were pooled from randomized, placebo-controlled clinical trials of linagliptin (5 mg, monotherapy or combination therapy). Safety/efficacy analyses were conducted for patients with CAD and ≥ 12 and ≥ 24 weeks of treatment, respectively. Results The safety analysis included 19 trials (linagliptin, n = 451; placebo, n = 272) and the efficacy analysis, 12 trials (linagliptin, n = 328; placebo, n = 198); mean (± standard deviation) exposure to study treatment was 212 (144) days linagliptin and 245 (171) days placebo. Occurrence of cardiac adverse events (AEs) was similar for linagliptin- and placebo-treated patients (9.1% and 9.2%, respectively); exposure-adjusted incidence rates (per 100 patient-years) were 16.6 and 14.0, respectively. Overall incidence of AEs was numerically lower with linagliptin than placebo. After 24 weeks, mean adjusted change (standard error) from baseline glycosylated hemoglobin was − 0.64% (0.04) with linagliptin vs. –0.08% (0.05) with placebo ( P < .001). Conclusions This comprehensive pooled analysis showed that addition of linagliptin to treatment regimens of patients with T2DM and CAD was not associated with an increased incidence of cardiac AEs, was well tolerated, and was effective. [ABSTRACT FROM AUTHOR]