Characteristic | Patients without a nonfatal MI during the trial randomized to sitagliptin or placebo N = 14,055 | Patients with a nonfatal MI during the trial | P-value* | |
---|---|---|---|---|
Sitagliptin N = 289 | Placebo N = 302 | |||
Age at randomization (years)a | 65.0 (60.0, 71.0) | 67.0 (62.0, 74.0) | 66.0 (60.0, 72.0) | 0.1414 |
Female | 4161 (29.6%) | 56 (19.4%) | 75 (24.8%) | 0.1103 |
Hispanic or Latino | 1754 (12.5%) | 17 (5.9%) | 22 (7.3%) | 0.4924 |
Race | 0.4603 | |||
 White | 9472 (67.4%) | 235 (81.3%) | 234 (77.5%) |  |
 Black | 422 (3.0%) | 10 (3.5%) | 14 (4.6%) |  |
 Asian | 3184 (22.7%) | 38 (13.1%) | 42 (13.9%) |  |
 Other | 977 (7.0%) | 6 (2.1%) | 12 (4.0%) |  |
Region | 0.5023 | |||
 Latin America | 1445 (10.3%) | 10 (3.5%) | 11 (3.6%) |  |
 Asia Pacific and other | 4377 (31.1%) | 98 (33.9%) | 84 (27.8%) |  |
 Western Europe | 1977 (14.1%) | 48 (16.6%) | 50 (16.6%) |  |
 Eastern Europe | 3822 (27.2%) | 63 (21.8%) | 68 (22.5%) |  |
 North America | 2434 (17.3%) | 70 (24.2%) | 89 (29.5%) |  |
Durationb of type 2 diabetes (years) | 10.0 (5.0, 16.0) | 11.0 (6.0, 18.0) | 11.0 (6.0, 16.0) | 0.3233 |
Diabetes therapy at baseline (alone or in combination) | ||||
 Sulfonylurea | 6394 (45.5%) | 110 (38.1%) | 125 (41.4%) | 0.4085 |
 Metformin | 11,501 (81.8%) | 212 (73.4%) | 235 (77.8%) | 0.2069 |
 Thiazolidinedione | 376 (2.7%) | 9 (3.1%) | 9 (3.0%) | 0.9245 |
 Insulin | 3208 (22.8%) | 98 (33.9%) | 98 (32.5%) | 0.7063 |
Preexisting vascular disease | 13,975 (99.4%) | 288 (99.7%) | 302 (100.0%) | 0.4890 |
Coronary artery disease | 10,312 (73.4%) | 261 (90.3%) | 269 (89.1%) | 0.6208 |
Cerebrovascular disease | 3445 (24.5%) | 72 (24.9%) | 65 (21.5%) | 0.3289 |
Peripheral arterial disease | 2348 (16.7%) | 40 (13.8%) | 42 (13.9%) | 0.9814 |
Prior MI | 5899 (42.0%) | 171 (59.2%) | 170 (56.3%) | 0.4790 |
Prior congestive heart failure | 2511 (17.9%) | 62 (21.5%) | 61 (20.2%) | 0.7072 |
Previous atrial fibrillation/flutter | 1086 (7.7%) | 32 (11.1%) | 45 (14.9%) | 0.1670 |
NYHA classification | 0.3241 | |||
 1 | 510 (20.3%) | 16 (25.8%) | 8 (13.1%) |  |
 2 | 1256 (50.0%) | 24 (38.7%) | 30 (49.2%) |  |
 3 | 339 (13.5%) | 6 (9.7%) | 10 (16.4%) |  |
 4 | 11 (0.4%) | 1 (1.6%) | 1 (1.6%) |  |
 Not available | 395 (15.7%) | 15 (24.2%) | 12 (19.7%) |  |
Qualifying HbA1c (mmol/mol) | 55.2 (50.8, 60.7) | 56.1 (51.0, 61.7) | 55.2 (51.9, 59.6) | 0.3239 |
Qualifying HbA1c (%) | 7.2 (6.8, 7.7) | 7.3 (6.8, 7.8) | 7.2 (6.9, 7.6) | 0.3239 |
eGFR (mL/min/1.73Â m2) | 73.0 (60.0, 88.0) | 68.5 (55.0, 84.0) | 69.0 (56.0, 88.0) | 0.2918 |
Urine albumin creatinine ratio (g/mol creatinine) | 10.6 (3.5, 35.0) | 12.2 (5.3, 52.7) | 13.8 (5.3, 43.9) | 0.9026 |
Heart rate (bpm) | 72.0 (65.0, 79.0) | 70.0 (62.0, 78.0) | 71.0 (62.0, 80.0) | 0.0595 |
Body mass index (kg/m2) | 29.5 (26.3, 33.2) | 29.8 (26.6, 33.5) | 30.4 (27.2, 34.3) | 0.1480 |
Weight (kg) | 83.0 (71.0, 96.0) | 85.0 (75.0, 98.0) | 88.5 (75.0, 100.0) | 0.1517 |
Height (cm) | 168.0 (160.0, 174.2) | 169.4 (163.2, 175.3) | 170.0 (162.6, 176.0) | 0.5036 |
Cigarette smoking status | 0.9049 | |||
 Current | 1589 (11.3%) | 44 (15.2%) | 43 (14.2%) |  |
 Former | 5575 (39.7%) | 129 (44.6%) | 133 (44.0%) |  |
 Never | 6891 (49.0%) | 116 (40.1%) | 126 (41.7%) |  |
Systolic blood pressure (mmHg) | 133.0 (124.0, 145.0) | 136.0 (124.0, 146.0) | 135.0 (124.0, 148.0) | 0.9803 |
Diastolic blood pressure (mmHg) | 79.0 (70.0, 84.0) | 77.0 (68.0, 82.0) | 76.0 (68.0, 85.0) | 0.3050 |
LDL-C | 84.0 (65.0, 109.0) | 81.0 (63.0, 99.6) | 82.1 (65.6, 108.1) | 0.4128 |
Medications taken at time of randomization | ||||
 Statins | 11,213 (79.8%) | 238 (82.4%) | 248 (82.1%) | 0.9408 |
 ACE inhibitors or angiotensin receptor blockers | 11,040 (78.5%) | 238 (82.4%) | 255 (84.4%) | 0.4959 |
 Diuretics | 5727 (40.7%) | 127 (43.9%) | 150 (49.7%) | 0.1633 |
 Calcium channel blockers | 4730 (33.7%) | 104 (36.0%) | 118 (39.1%) | 0.4386 |
 Beta blockers | 8876 (63.2%) | 210 (72.7%) | 221 (73.2%) | 0.8881 |
 Aspirin | 11,027 (78.5%) | 244 (84.4%) | 235 (77.8%) | 0.0403 |