title: Safety and efficacy of linagliptin in patients with type 2 diabetes mellitus and coronary artery disease: Analysis of pooled events from 19 clinical trials.
abstract: 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.
  
  
  
  Patient-level data were pooled from randomized, placebo-controlled clinical trials of linagliptin (5mg, monotherapy or combination therapy). Safety/efficacy analyses were conducted for patients with CAD and ≥12 and ≥24weeks of treatment, respectively.
  
  
  
  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 24weeks, 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).
  
  
  
  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.
authors.affiliation: University Hospital Aachen, Aachen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Lehrke
authors.affiliation: Keenan Research Centre in the Li Ka Shing Research Institute, St. Michael's Hospital, University of Toronto, Toronto, Canada.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Leiter
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Hehnke
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Thiemann
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
authors.forename: Amit
authors.initials: A
authors.lastname: Bhandari
authors.affiliation: Boehringer Ingelheim Corporation, Biberach, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Meinicke
authors.affiliation: Boehringer Ingelheim Norway KS, Asker, Norway. Electronic address: odd_erik.johansen@boehringer-ingelheim.com.
authors.forename: Odd Erik
authors.initials: OE
authors.lastname: Johansen
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000150:complications*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D000069476:Linagliptin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D000069476:Linagliptin
keywords: Coronary artery disease; Dipeptidyl peptidase-4 inhibitor; Drug safety; Heart failure; Linagliptin; Type 2 diabetes mellitus