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Table 5 Subgroup analyses of primary endpoint for linagliptin versus total comparators based on Cox hazard model and CMH test

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, patients with events/total patients Total comparators, patients with events/total patients Cox HR (95% CI) CMH RR (95% CI)
Age (years)*
   < 65 6/2390 9/1371 0.40 (0.14-1.14) 0.49 (0.19-1.27)
   ≥ 65 5/929 14/549 0.28 (0.10-0.79) 0.43 (0.18-1.03)
Gender
   Male 7/1782 20/1126 0.25 (0.10-0.60) 0.31 (0.13-0.71)
   Female 4/1537 3/794 0.96 (0.21-4.37) 1.00 (0.32-3.17)
Race
   White 8/1981 22/1187 0.28 (0.12-0.63) 0.32 (0.15-0.70)
   Black 0/46 0/31 n.a. 1.00 (0.29-3.50)
   Asian 3/1292 1/702 1.63 (0.17-15.7) 1.20 (0.34-4.26)
Use of rescue medication
   No 8/3006 20/1666 0.29 (0.12-0.66) 0.37 (0.17-0.80)
   Yes 3/313 3/254 0.80 (0.16-3.96) 0.91 (0.32-2.61)
Investigator-reported hypoglycaemia*
   No 11/3048 16/1604 0.39 (0.18-0.86) 0.45 (0.22-0.94)
   Yes 0/271 7/316 n.a. 0.58 (0.13-2.58)
Framingham 10-year CV risk score
   ≤ 15% 4/2395 5/1323 0.50 (0.13-1.90) 0.68 (0.24-1.95)
   > 15% 7/923 18/597 0.31 (0.13-0.75) 0.40 (0.18-0.90)
  1. *Exploratory analyses (all others pre-specified analyses).
  2. CI, confidence interval; CMH, Cochran-Mantel-Haenszel; CV, cardiovascular; HR, hazard ratio; n.a., not applicable; RR, risk ratio.