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Table 9 Subgroup analyses of primary end point for linagliptin versus total comparators based on proportional Cox hazards model and CMH test

From: Cardiovascular safety of linagliptin in type 2 diabetes: a comprehensive patient-level pooled analysis of prospectively adjudicated cardiovascular events

 

Linagliptin,patients with events/total patients

Total comparators,patients with events/total patients

Cox HR (95% CI)

Incidence ratio (95% CI) CMH Test

Age (years)

≤50

5/1288

3/781

1.31 (0.31–5.58)

1.11 (0.47–2.63)

51 to <65

26/2817

26/1740

0.75 (0.43–1.30)

0.86 (0.52–1.41)

65 to 75

26/1418

29/902

0.78 (0.46–1.32)

0.84 (0.52–1.37)

≥75

3/324

4/189

0.63 (0.14–2.85)

0.88 (0.37–2.08)

Gender

Male

42/3183

50/2039

0.69 (0.45–1.04)

0.73 (0.49–1.08)

Female

18/2664

12/1573

1.22 (0.58–2.55)

1.27 (0.68–2.36)

Race

    

White

46/3405

49/2190

0.78 (0.52–1.17)

0.83 (0.56–1.23)

Black

4/215

1/200

3.92 (0.44–35.08)

1.50 (0.55–4.11)

Asian

10/2227

12/1222

0.59 (0.25–1.37)

0.76 (0.39–1.49)

Use of rescue medication

No

43/5080

46/2824

0.70 (0.46–1.07)

0.75 (0.50–1.12)

Yes

17/767

16/788

1.10 (0.56–2.19)

1.11 (0.64–1.91)

Investigator-reported hypoglycemia

No

48/5197

37/2918

0.86 (0.56–1.32)

0.97 (0.65–1.45)

Yes

12/650

25/694

0.79 (0.39–1.59)

0.78 (0.41–1.47)

Framingham 10-year CV risk score

≤15%

20/3797

24/2438

0.65 (0.36–1.18)

0.76 (0.45–1.29)

>15%

36/1433

38/1046

0.85 (0.54–1.35)

0.91 (0.60–1.39)

Baseline microalbuminuria

Normal (≤30 mg/g)

25/3610

25/2389

0.84 (0.48–1.47)

0.91 (0.56–1.50)

Elevated (>30 to ≤300 mg/g)

21/1248

21/771

0.75 (0.41–1.38)

0.83 (0.49–1.41)

High (>300 mg/g)

6/280

14/241

0.43 (0.16–1.11)

0.63 (0.31–1.26)

  1. CI, confidence interval; CV, cardiovascular; HR, hazard ratio; CMH test, Cochran-Mantel-Haenszel test with treatment arm continuity correction.