Table 1.
Baseline characteristics by history of thyroid disease status
| Characteristic | History of thyroid disease |
p value* |
||||
|---|---|---|---|---|---|---|
| Hypothyroidism (n = 1,656) | Hyperthyroidism (n = 321) | No Disease (n = 16,044) | Hypo vs No | Hyper vs No | Overall | |
| Age, median (25th, 75th) (years) | 73 (66, 79) | 69 (62, 76) | 70 (62, 76) | <0.0001 | 0.8382 | <0.0001 |
| Women | 1001 (60.4%) | 167 (52.0%) | 5145 (32.1%) | <0.0001 | <.0001 | <0.0001 |
| Region of enrollment | <0.0001 | <.0001 | <0.0001 | |||
| North America | 695 (42.0%) | 56 (17.4%) | 3710 (23.1%) | |||
| Latin America | 290 (17.5%) | 36 (11.2%) | 3131 (19.5%) | |||
| Europe | 544 (32.9%) | 177 (55.1%) | 6477 (40.4%) | |||
| Asia | 127 (7.7%) | 52 (16.2%) | 2726 (17.0%) | |||
| Systolic BP, median (25th, 75th) (mm Hg) | 130 (120, 140) | 130 (120, 140) | 130 (120, 140) | 0.0028 | 0.4882 | 0.0099 |
| Weight, median (25th, 75th) (kilograms) | 80 (69, 95) | 78 (66, 90) | 82 (70, 96) | 0.0526 | <.0001 | <0.0001 |
| Prior Myocardial Infarction | 235 (14.2%) | 46 (14.3%) | 2276 (14.2%) | 0.9884 | 0.9451 | 0.9976 |
| Prior stroke, transient ischemic attack, or systemic embolism | 319 (19.3%) | 74 (23.1%) | 3110 (19.4%) | 0.9056 | 0.1002 | 0.2540 |
| Heart failure or reduced left ventricular ejection fraction | 478 (28.9%) | 108 (33.6%) | 5764 (35.9%) | <.0001 | 0.3988 | <0.0001 |
| Hypertension requiring treatment | 1472 (88.9%) | 289 (90.0%) | 13981 (87.1%) | 0.0420 | 0.1250 | 0.0435 |
| Prior clinically relevant or spontaneous bleeding | 378 (22.8%) | 66 (20.6%) | 2582 (16.1%) | <.0001 | 0.0315 | <0.0001 |
| History of fall within previous year | 132 (8.7%) | 13 (4.3%) | 601 (4.1%) | <.0001 | 0.8573 | <0.0001 |
| Diabetes Mellitus | 473 (28.6%) | 81 (25.2%) | 3956 (24.7%) | 0.0005 | 0.8125 | 0.0022 |
| End-organ damage | 96 (5.8%) | 18 (5.6%) | 650 (4.1%) | 0.0007 | 0.1644 | 0.0017 |
| Type of Atrial fibrillation | <.0001 | 0.0140 | <0.0001 | |||
| Paroxysmal | 312 (18.8%) | 63 (19.6%) | 2359 (14.7%) | |||
| Persistent or permanent | 1344 (81.2%) | 258 (80.4%) | 13682 (85.3%) | |||
| Atrial fibrillation/Flutter | 1333 (81.1%) | 256 (80.3%) | 13670 (85.7%) | <.0001 | 0.0066 | <0.0001 |
| Heart rate in atrial fibrillation/Flutter, median (25th, 75th) (beats per minute) | 77 (67, 90) | 80 (68, 92) | 79 (69, 90) | 0.0005 | 0.7391 | 0.0020 |
| Sinus rhythm | 262 (15.9%) | 56 (17.6%) | 2043 (12.8%) | 0.0003 | 0.0121 | 0.0001 |
| HR in sinus rhythm, median (25th, 75th) (beats per minute) | 61 (55, 67) | 64 (56, 71) | 62 (56, 70) | 0.0542 | 0.7259 | 0.1391 |
| Prior vitamin K antagonist use for >30 days | 1101 (66.5%) | 241 (75.1%) | 8978 (56.0%) | <0.0001 | <0.0001 | <0.0001 |
| CHADS2 score, mean (standard deviation) | 2.21 (1.12) | 2.20 (1.17) | 2.11 (1.10) | 0.0002 | 0.2773 | 0.0005 |
| CHADS2 score | 0.0005 | 0.6900 | 0.0033 | |||
| ≤1 | 493 (29.8%) | 108 (33.6%) | 5532 (34.5%) | |||
| 2 | 622 (37.6%) | 110 (34.3%) | 5718 (35.6%) | |||
| ≥3 | 541 (32.7%) | 103 (32.1%) | 4794 (29.9%) | |||
| Medications at randomization | ||||||
| ACE inhibitor or angiotensin receptor blocker | 1116 (67.8%) | 235 (74.4%) | 11331 (71.9%) | 0.0005 | 0.3263 | 0.0013 |
| Amiodarone | 185 (11.2%) | 18 (5.7%) | 1824 (11.6%) | 0.6915 | 0.0012 | 0.0050 |
| Beta-blocker | 1067 (64.8%) | 226 (71.5%) | 10076 (63.9%) | 0.4583 | 0.0052 | 0.0166 |
| Aspirin | 447 (27.0%) | 86 (26.8%) | 5048 (31.5%) | 0.0002 | 0.0741 | 0.0002 |
| Clopidogrel | 41 (2.5%) | 7 (2.2%) | 289 (1.8%) | 0.0533 | 0.6135 | 0.1427 |
| Digoxin | 483 (29.3%) | 106 (33.5%) | 5189 (32.9%) | 0.0033 | 0.8118 | 0.0126 |
| Any calcium channel blocker | 573 (34.8%) | 107 (33.9%) | 4842 (30.7%) | 0.0006 | 0.2292 | 0.0017 |
| Statin | 808 (49.1%) | 141 (44.6%) | 6481 (41.1%) | <.0001 | 0.2083 | <0.0001 |
| Nonsteroidal anti-inflammatory agent | 206 (12.5%) | 31 (9.8%) | 1278 (8.1%) | <.0001 | 0.2724 | <0.0001 |
| Gastric antacid drugs | 430 (26.1%) | 80 (25.3%) | 2828 (17.9%) | <.0001 | 0.0007 | <0.0001 |
| Antithyroid preparations | 2 (0.1%) | 71 (22.1%) | 0 (0.0%) | |||
| Thyroid preparations | 1200 (72.5%) | 0 (0.0%) | 0 (0.0%) | |||
| Iodine preparations | 7 (0.4%) | 0 (0.0%) | 1 (0.0%) | |||
| Any thyroid therapy | 1202 (72.6%) | 71 (22.1%) | 1 (0.0%) | |||
| Renal function | <.0001 | 0.3563 | <0.0001 | |||
| Normal (80 ml/min) | 535 (32.3%) | 129 (40.2%) | 6765 (42.2%) | |||
| Mild impairment (>50–80 ml/min) | 710 (42.9%) | 140 (43.6%) | 6667 (41.6%) | |||
| Moderate impairment (>30–50 ml/min) | 356 (21.5%) | 47 (14.6%) | 2326 (14.5%) | |||
| Severe impairment (≤30 ml/min) | 48 (2.9%) | 1 (0.3%) | 220 (1.4%) | |||
*
Exploratory.Data presented as no. (%), unless otherwise indicated.ACE = angiotensin converting enzyme; AF = atrial fibrillation; ARB = angiotensin receptor blocker; BP = blood pressure; bpm = beats per minute; HF = heart failure; HR = heart rate; LVEF = left ventricular ejection fraction; MI = myocardial infarction; SD = standard deviation; SE = systemic embolism; TIA = transient ischemic attack; VKA = vitamin K antagonist.