Table 1. Baseline Characteristics of the Participants Randomly Assigned to Receive Double Placebo, Aspirin Alone, Polypill Alone, or Polypill plus Aspirin.* .
| Characteristic | Double Placebo (N = 1421) | Aspirin Alone (N = 1431) | Polypill Alone (N = 1432) | Polypill plus Aspirin (N = 1429) |
|---|---|---|---|---|
| Age — yr | 64.1±6.8 | 63.7±6.7 | 64.1±6.4 | 63.8±6.5 |
| Female sex — no. (%) | 757 (53.3) | 746 (52.1) | 777 (54.3) | 745 (52.1) |
| Geographic distribution — no. (%) | ||||
| India or Bangladesh | 755 (53.1) | 760 (53.1) | 760 (53.1) | 759 (53.1) |
| Philippines, Malaysia, or Indonesia | 479 (33.7) | 477 (33.3) | 478 (33.4) | 479 (33.5) |
| Colombia | 121 (8.5) | 122 (8.5) | 125 (8.7) | 121 (8.5) |
| Canada | 30 (2.1) | 35 (2.4) | 33 (2.3) | 33 (2.3) |
| Tanzania | 10 (0.7) | 10 (0.7) | 10 (0.7) | 9 (0.6) |
| Tunisia | 26 (1.8) | 27 (1.9) | 26 (1.8) | 28 (2.0) |
| Cardiovascular risk factor — no. (%) | ||||
| Reported hypertension or systolic blood pressure >140 mm Hg |
1179 (83.0) | 1220 (85.3) | 1199 (83.7) | 1192 (83.4) |
| Reported diabetes or glucose level >126 mg/dl (7.0 mmol/liter) |
527 (37.1) | 503 (35.2) | 543 (37.9) | 522 (36.5) |
| Impaired fasting glucose ≥110–126 mg/dl (6.1–7.0 mmol/liter) |
97 (6.8) | 101 (7.1) | 109 (7.6) | 98 (6.9) |
| Current smoking | 115 (8.1) | 138 (9.6) | 123 (8.6) | 136 (9.5) |
| INTERHEART Risk Score† | 17.9±4.8 | 17.8±4.7 | 18.0±4.8 | 17.9±4.7 |
| Physiological variables | ||||
| Heart rate — beats/min | 77.1±10.9 | 77.3±10.5 | 77.0±10.5 | 76.6±10.5 |
| Blood pressure — mm Hg | ||||
| Systolic | 144.4±17.2 | 144.7±16.8 | 144.7±16.9 | 144.3±16.6 |
| Diastolic | 83.6±9.6 | 83.7±9.9 | 84.2±9.9 | 84.1±9.4 |
| Cholesterol — mg/dl | ||||
| Total | 196.4±46.9 | 196.1±45.1 | 196.7±45.6 | 195.5±44.9 |
| LDL | 120.7±41.9 | 120.8±40.1 | 121.2±40.7 | 120.0±40.2 |
| HDL | 48.2±13.5 | 47.1±11.9 | 47.7±13.0 | 47.9±13.6 |
| Triglycerides — mg/dl | 143.2±70.8 | 148.7±82.8 | 146.4±70.6 | 144.7±72.3 |
| Fasting plasma glucose — mg/dl | 113.5±43.0 | 114.4±46.6 | 114.9±45.5 | 114.5±44.9 |
| Creatinine — mg/dl | 0.9±0.3 | 0.9±0.3 | 0.9±0.3 | 0.9±0.3 |
| Body-mass index‡ | 25.6±4.6 | 25.7±4.8 | 26.1±4.9 | 25.8±4.6 |
| Waist-to-hip ratio | ||||
| Among women | 0.91±0.07 | 0.91±0.07 | 0.91±0.07 | 0.91±0.08 |
| Among men | 0.96±0.07 | 0.96±0.06 | 0.96±0.06 | 0.96±0.07 |
| Medication use — no. (%) | ||||
| Antihypertensive drug | 155 (10.9) | 156 (10.9) | 161 (11.2) | 157 (11.0) |
| Calcium-channel blocker | 137 (9.6) | 141 (9.9) | 153 (10.7) | 138 (9.7) |
| Aspirin or clopidogrel | 2 (0.1) | 1 (0.1) | 0 | 2 (0.1) |
| Oral anticoagulant | 4 (0.3) | 2 (0.1) | 2 (0.1) | 8 (0.6) |
| Insulin | 35 (2.5) | 29 (2.0) | 24 (1.7) | 29 (2.0) |
| Oral hypoglycemic agent | 302 (21.3) | 292 (20.4) | 310 (21.6) | 314 (22.0) |
| Statin | 0 | 0 | 1 (0.1) | 0 |
| Other lipid-lowering agent | 1 (0.1) | 0 | 0 | 2 (0.1) |
*
Plus-minus values are means ±SD. Percentages may not total 100 because of rounding. To convert the values for cholesterol to millimoles per liter, multiply by 0.0259. To convert the values for triglycerides to millimoles per liter, multiply by 0.01129. To convert the values for glucose to millimoles per liter, multiply by 0.05551. To convert the values for creatinine to micromoles per liter, multiply by 88.4. HDL denotes high-density lipoprotein, and LDL low-density lipoprotein.
†
The scale for the INTERHEART Risk Score ranges from 0 to 48, with higher scores indicating greater cardiovascular risk.
‡
The body-mass index is the weight in kilograms divided by the square of the height in meters.