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Table 4 Baseline demographics and clinical characteristics, including CV risk factors, of the main study cohort in the linagliptin safety analysis (of adjudicated events)

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

  Linagliptin (n = 5847) *Active comparators (n = 937) Placebo (n = 2675) Total comparators (n = 3612)
Gender, % of patients Male/female 54.4/45.6 62.5/37.5 54.3/45.7 56.5/43.5
Age, years 59 ± 11 60 ± 10 58 ± 11 59 ± 10
BMI, kg/m2 29.0 ± 5.2 29.5 ± 4.8 29.5 ± 5.3 29.5 ± 5.2
Race, % of patients
White 58.2 70.3 57.2 60.6
Black 3.7 1.9 6.8 5.5
Asian 38.1 27.7 36.0 33.8
HbA1c, mmol/mol 65 ± 10 61 ± 9 67 ± 10 65 ± 10
HbA1c, % 8.1 ± 0.9 7.8 ± 0.9 8.3 ± 0.9 8.1 ± 0.9
FPG, mmol/L 9.2 ± 2.5 9.2 ± 2.2 9.3 ± 2.7 9.3 ± 2.6
Diabetes duration, % of patients
≤1 year 13.4 8.4 14.5 13.0
1–5 years 31.7 38.8 27.3 30.3
>5 years 54.9 52.7 58.2 56.8
Previous oral glucose-lowering agents, % of patients
None 16.4 9.6 19.4 16.8
1 43.2 64.1 39.0 45.5
2 39.3 26.1 40.0 36.0
≥3 1.1 0.1 2.1 1.6
Antidiabetic drugs at enrolment, % of patients
Metformin only 31.8 60.1 20.7 31.0
Metformin + other antidiabetic agents 38.1 25.2 38.2 34.9
Sulfonylurea only 6.5 2.0 8.0 6.5
Sulfonylurea + other antidiabetic agents 0.7 1.0 0.6 0.7
Insulin only 3.8 0.0 9.3 6.9
Insulin + other antidiabetic agents <0.1 0.0 0.0 0.0
CV risk factors, % of patients
Metabolic syndrome 46.5 67.7 46.6 52.1
Coronary artery disease 11.8 12.3 14.1 13.6
Cerebrovascular disease 3.6 4.2 4.9 4.7
Peripheral artery disease 3.1 3.3 4.2 4.0
Hypertension 63.9 73.0 65.7 67.6
Ex-/current smoker 23.0/14.4 29.7/15.8 22.4/13.4 24.3/14.0
Microalbuminuria, % (UACR >30 to ≤300 mg/g) 24.3 21.6 23.0 22.7
Renal function based on eGFR (MDRD formula),% of patients
Normal (≥90) 43.5 43.3 41.1 41.7
Mildly impaired (60 to <90) 45.5 49.8 43.5 45.1
Moderately impaired (30 to <60) 8.9 6.8 10.8 9.7
Severely impaired (<30) 1.9 0.0 4.1 3.0
CV medication, % of patients
Acetyl-salicylic acid 31.8 32.3 34.5 33.9
Antihypertensive 60.9 69.6 62.0 64.0
Lipid-lowering therapy 41.7 49.0 43.6 45.0
Any of the above 72.7 81.6 73.9 75.9
Framingham 10-year CV risk score
Score, % 9.7 ± 8.2 11.7 ± 8.6 9.6 ± 8.4 10.2 ± 8.5
Score >15%, % of patients 24.5 38.1 25.8 29.0
  1. BMI, body mass index; CV, cardiovascular; eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; MDRD, Modification of Diet in Renal Disease; UACR, urinary albumin:creatinine ratio.
  2. *Glimepiride (n = 775), voglibose (n = 162).
  3. International Diabetes Federation definition.
  4. Values are mean ± SD, unless otherwise stated.