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Table 4 Incidence and incidence rates of primary, secondary, and tertiary endpoints

From: Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme

  Linagliptin (n= 3319) Active comparators* (n= 943) Placebo (n= 977) Total comparators (n= 1920)
  Incidence n (%) Incidence rate (per 1000 years) Incidence n (%) Incidence rate (per 1000 years) Incidence n (%) Incidence rate (per 1000 years) Incidence n (%) Incidence rate (per 1000 years)
Primary endpoints:         
   CV death, stroke, MI, or UAP with hospitalization 11 (0.3) 5.3 20 (2.1) 21.2 3 (0.3) 7.0 23 (1.2) 16.8
Secondary endpoints:         
   CV death, stroke, or MI 10 (0.3) 4.8 18 (1.9) 19.1 2 (0.2) 4.7 20 (1.0) 14.6
   All major CV events 26 (0.8) 12.6 26 (2.8) 27.6 6 (0.6) 14.1 32 (1.7) 23.4
   FDA-custom MACE 9 (0.3) 4.3 16 (1.7) 16.9 3 (0.3) 7.0 19 (1.0) 13.9
Tertiary endpoints:         
   CV death 2 (0.06) 1.0 2 (0.2) 2.1 0 0 2 (0.1) 1.5
   MI 6 (0.2) 2.9 6 (0.6) 6.3 1 (0.1) 2.3 7 (0.4) 5.1
   Stroke 2 (0.06) 1.0 10 (1.1) 10.6 1 (0.1) 2.3 11 (0.6) 8.0
   TIA 1 (0.03) 0.5 3 (0.3) 3.2 1 (0.1) 2.3 4 (0.2) 2.9
   UAP with hospitalization 1 (0.03) 0.5 2 (0.2) 2.1 1 (0.1) 2.3 3 (0.2) 2.2
   UAP without hospitalization 1 (0.03) 0.5 1 (0.1) 1.1 0 0 1 (0.05) 0.7
   SAP 13 (0.4) 6.3 5 (0.5) 5.3 3 (0.3) 7.0 8 (0.4) 5.8
   Total mortality 4 (0.1) 1.9 3 (0.3) 3.2 0 0 3 (0.2) 2.2
  1. *Glimepiride (n = 781), voglibose (n = 162).
  2. CV, cardiovascular; FDA, Food and Drug Administration; MACE, major adverse CV events; MI, myocardial infarction; SAP, stable angina pectoris; TIA, transient ischaemic attack; UAP, unstable angina pectoris.