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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.