Table 2.
Demographic and patient baseline characteristics (ITT Population)
| CharacteristicMean ± SD or n (%*) | Vildagliptin N = 28,442 | Comparator N = 15,349 | Total N = 43,791 |
|---|---|---|---|
| Mean age (years) | 57.9 ± 11.8 | 57.6 ± 11.7 | 57.8 ± 11.8 |
| Age group ≥ 65 years | 8542 (30.0) | 4375 (28.5) | 12,917 (29.5) |
| Gender | |||
| Male | 15,623 (54.9) | 8367 (54.5) | 23,990 (54.8) |
| Female | 12,819 (45.1) | 6982 (45.5) | 19,801 (45.2) |
| Race | |||
| Caucasian | 14,454 (50.8) | 6461 (42.1) | 20,915 (47.8) |
| Black | 137 (0.5) | 86 (0.6) | 223 (0.5) |
| Asian | 7813 (27.5) | 6307 (41.1) | 14,120 (32.2) |
| Native American | 318 (1.1) | 60 (0.4) | 378 (0.9) |
| Pacific islander | 6 (0.0) | 1 (0.0) | 7 (0.0) |
| Other | 5714 (20.1) | 2434 (15.9) | 8148 (18.6) |
| Region | |||
| East Asia | 1661 (5.8) | 740 (4.8) | 2401 (5.5) |
| Europe | 15,582 (54.8) | 6491 (42.3) | 22,073 (50.4) |
| Latin America | 3065 (10.8) | 781 (5.1) | 3846 (8.8) |
| Middle East | 2513 (8.8) | 2266 (14.8) | 4779 (10.9) |
| India | 5621 (19.8) | 5071 (33.0) | 10,692 (24.4) |
| Mean BMI (kg/m2) | 29.3 ± 5.3 | 28.4 ± 4.8 | 29.0 ± 5.1 |
| BMI group: n (%) | |||
| BMI < 25 | 5234 (19.0) | 3494 (23.7) | 8728 (20.6) |
| BMI 25–< 30 | 11,928 (43.2) | 6757 (45.8) | 18,685 (44.1) |
| BMI 30–< 35 | 6899 (25.0) | 3213 (21.8) | 10,112 (23.9) |
| BMI ≥ 35 | 3525 (12.8) | 1292 (8.8) | 4817 (11.4) |
| Missing | 856 (3.0) | 593 (3.9) | 1449 (3.3) |
| Mean baseline HbA1c (%) | 8.2 ± 1.3 | 8.2 ± 1.3 | 8.2 ± 1.3 |
| HbA1c group: n (%) | |||
| HbA1c ≤ 8.0% | 14,670 (54.4) | 7831 (53.3) | 22,501 (54.1) |
| HbA1c> 8.0–9.0% | 7001 (26.0) | 4117 (28.0) | 11,118 (26.7) |
| HbA1c ≥ 9.0% | 5275 (19.6) | 2733 (18.6) | 8008 (19.2) |
| Missing | 1496 (5.3) | 668 (4.4) | 2164 (4.9) |
| Mean duration of T2DM (years) | 5.5 ± 5.4 | 5.4 ± 5.2 | 5.5 ± 5.2 |
| Duration of T2DM group: n (%) | |||
| < 5 | 16,454 (57.9) | 9114 (59.4) | 25,568 (58.4) |
| 5–< 10 | 7539 (26.5) | 4007 (26.1) | 1156 (26.4) |
| ≥ 10 | 4446 (15.6) | 2228 (14.5) | 6674 (15.2) |
| Missing | 3 (0.0) | 0 (0.0) | 3 (0.0) |
| Renal impairment group (eGFR)† | |||
| Normal | 7470 (49.8) | 3893 (47.8) | 11,363 (49.1) |
| Mild | 6579 (43.9) | 3695 (45.3) | 10,274 (44.4) |
| Moderate | 876 (5.8) | 511 (6.3) | 1387 (6.0) |
| Severe | 72 (0.5) | 52 (0.6) | 124 (0.5) |
| Missing | 13,445 (47.3) | 7198 (46.9) | 20,643 (47.1) |
| Underlying conditions (patient ‘type’)‡ | |||
| Cardiovascular disease | 21,467 (75.5) | 10,722 (69.9) | 32189 (73.5) |
| Pulmonary disease | 1328 (4.7) | 550 (3.6) | 1878 (4.3) |
| Liver disease | 1503 (5.3) | 559 (3.6) | 2062 (4.7) |
| Diabetes complications | 2209 (7.8) | 1146 (7.5) | 3355 (7.7) |
| Mixed/inflammatory/skin disease | 2615 (9.2) | 1018 (6.6) | 3633 (8.3) |
Percentage (%) calculated as percentage of total available observations; percentage for missing values reported as percentage of total population N.
eGFR (MDRD, ml/min/1.73 m2): > 80 = normal, ≥ 50 to ≤ 80 = mild, ≥ 30 to < 50 = moderate, < 30 = severe renal impairment.
Patients can belong to multiple types.
CVD patient–Any of the following medical conditions present: Myocardial Infarction, Angina Pectoris, Ischaemic Heart Disease, Transient Ischaemic Attack, Stroke, Peripheral Vascular Disease, Hypertension, Dyslipidaemia, Hyperlipidaemia, Congestive Heart Failure, Impaired Renal Function or Oedema or any of the following drugs received: Aspirin and other Antiplatelet Drug, Anticoagulants, ACE Inhibitors, ARBS, Calcium Channel Blockers, Beta Blockers, Other Antihypertensive Agents, Thiazide/Loop diuretics, Other diuretics, Statins, Fibrates, Digoxin, Nitrates or Anti Arrhythmics.
Pulmonary patient–Any of the following medical conditions present: Chronic Obstructive Pulmonary Disease or Asthma or any of the following drugs received: Medications for Obstructive Airway Disorders or Systemic corticosteroids.
Liver patient–Any of the following medical conditions present: Hepatic Steatosis, Viral Hepatitis, Alcoholic Fatty Liver, Jaundice or Alcoholism.
Diabetic patient–Any of the following medical conditions present: Skin Ulcer, Diabetic Nephropathy, Hypoglycaemia, Diabetic Neuropathy or Diabetic Retinopathy.
Mix/inflammatory/skin patient–Any of the following medical conditions present: Skin Blister, Skin Infection, Skin Lesion, Skin Rash, Drug Allergy, Angioedema or Myalgia or any of the following drugs received: Antidepressants, Gonadotropins, Hormones (i.e., oral contraceptives, hormone replacement therapies, etc.) or Non-steroidal Anti-inflammatory Agent.