Table 1. Baseline Characteristics and Nonfatal Incidents in Trial Events in the 45 029 Participants With Cognitive Function Assessed at the Final Follow-up Visit.
| Characteristic | Randomized Clinical Trial | ||||
|---|---|---|---|---|---|
| HPS (n = 20 536) | SEARCH (n = 12 064) | HPS2-THRIVE | All (n = 58 273) | ||
| European Cohort (n = 14 741) | Chinese Cohort (n = 10 932) | ||||
| No. of randomized participants who survived to end of trial | 17 701 | 10 130 | 14 046 | 10 097 | 51 974 |
| Cognitive assessment at final follow-up, No. (%) | 15 926 (90.0) | 8879 (87.7) | 12 310 (87.6) | 7914 (78.4) | 45 029 (86.6) |
| Characteristics of participants with cognitive assessment at final follow-up | |||||
| Age at entry, mean (SD), y | 63.4 (8.4) | 63.3 (8.6) | 65.1 (7.1) | 61.8 (7.2) | 63.6 (8.0) |
| Age group age at entry, No. (%) | |||||
| <60 y | 5165 (32.4) | 3065 (34.5) | 2816 (22.9) | 3403 (43.0) | 14 449 (32.1) |
| 60-69 y | 6741 (42.3) | 3718 (41.9) | 5952 (48.4) | 3121 (39.4) | 19 532 (43.4) |
| ≥70 y | 4020 (25.2) | 2096 (23.6) | 3542 (28.8) | 1390 (17.6) | 11 048 (24.5) |
| Age at cognitive assessment, mean (SD), y | 68.2 (8.4) | 69.8 (8.6) | 68.0 (7.1) | 65.2 (7.3) | 67.9 (8.0) |
| Baseline characteristics | |||||
| Female, No. (%) | 4120 (25.9) | 1463 (16.5) | 1739 (14.1) | 1365 (17.2) | 8687 (19.3) |
| Townsend deprivation index, mean (SD)a | −0.48 (3.18) | −0.94 (2.97) | NA | NA | −0.65 (3.11) |
| Systolic blood pressure, mean (SD), mm Hg | 144 (23) | 137 (21) | 144 (20) | 141 (22) | 142 (22) |
| Current smoker, No. (%) | 2065 (13.0) | 975 (11.0) | 1674 (13.6) | 1873 (23.7) | 6587 (14.6) |
| Current alcohol use, No. (%) | 9606 (60.3) | 5648 (63.6) | 7803 (63.4) | 1157 (14.6) | 24 214 (53.8) |
| Prior disease at entry, No. (%) | |||||
| MI | 6457 (40.5) | 8879 (100) | 8789 (71.4) | 5405 (68.3) | 29 530 (65.6) |
| Other CHD and no MI | 8826 (55.4) | 0 | 1102 (9.0) | 1063 (13.4) | 10 991 (24.4) |
| Peripheral vascular disease | 4896 (30.7) | 184 (2.1) | 2111 (17.1) | 340 (4.3) | 7531 (16.7) |
| Cerebrovascular disease | 2372 (14.9) | 520 (5.9) | 2911 (23.6) | 2720 (34.4) | 8523 (18.9) |
| Diabetes at entry | 4505 (28.3) | 815 (9.2) | 2647 (21.5) | 3024 (38.2) | 10 991 (24.4) |
| LDL cholesterol level, mean (SD), mg/dLb | 76.1 (23.9) | 96.5 (23.2) | 67.2 (16.6) | 58.7 (15.8) | 74.5 (24.3) |
| Nonfatal in-trial events, No. (%) | |||||
| Disabling stroke | 203 (1.3) | 22 (0.2) | 24 (0.2) | 37 (0.5) | 286 (0.6) |
| Mild stroke (not disabling) | 329 (2.1) | 217 (2.4) | 150 (1.2) | 215 (2.7) | 911 (2.0) |
| TIA | 449 (2.8) | 209 (2.4) | 145 (1.2) | 69 (0.9) | 872 (1.9) |
| MI | 662 (4.2) | 565 (6.4) | 369 (3.0) | 224 (2.8) | 1820 (4.0) |
| Coronary revascularization | 1027 (6.4) | 930 (10.5) | 573 (4.6) | 425 (5.4) | 2955 (6.6) |
| Noncoronary revascularization | 693 (4.4) | 217 (2.4) | 338 (2.7) | 38 (0.5) | 1286 (2.8) |
| Heart failure | 352 (2.2) | 208 (2.3) | 136 (1.1) | 263 (3.3) | 959 (2.1) |
| Onset of diabetesc | 545 (4.8) | 1019 (12.6) | 588 (6.1) | 433 (8.8) | 2585 (7.6) |
| TICS-m score at final follow-up, mean (SD)d | 24.1 (4.2) | 24.3 (4.1) | 25.4 (3.9) | 24.1 (4.2) | 24.5 (4.2) |
| Verbal fluency score at final follow-up, mean (SD)e | 21.5 (7.3) | 22.5 (7.4) | 23.3 (6.9) | 19.4 (6.3) | 21.8 (7.2) |
Abbreviations: CHD, coronary heart disease; HPS, Heart Protection Study; HPS2-THRIVE, Treatment of HDL (High-Density Lipoprotein) to Reduce the Incidence of Vascular Events; LDL, low-density lipoprotein; MI, myocardial infarction; NA, not applicable; SEARCH, Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine; TIA, transient ischemic attack; TICS-m, Modified Telephone Interview for Cognitive Status.
SI conversion factor: To convert cholesterol to millimoles per liter, multiply by 0.0259.
Only available in HPS and SEARCH. Ranges from −6.25 to 10.26, with higher scores indicating greater degree of deprivation.
At randomization in HPS (during simvastatin treatment, 40 mg/d) and SEARCH (during simvastatin treatment, 20 mg/d) and at the baseline visit in HPS2-THRIVE (during simvastatin treatment, 40 mg/d, with or without ezetimibe).
The denominator for the percentages excludes those with diabetes at entry.
Scores range from 0 to 39, with higher scores indicating greater cognitive ability.
Scores range from 0 to 72, with higher scores indicating greater verbal fluency.