TABLE 1.
Baseline data by treatment group1
| Standardized lifestyle intervention across all treatment groups |
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| Entire cohort (CONQUER study) |
Long-term treatment (SEQUEL study) |
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| PHEN/TPM CR |
PHEN/TPM CR |
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| Placebo(n = 994) | 7.5/46(n = 498) | 15/92(n = 995) | Placebo(n = 227) | 7.5/46(n = 153) | 15/92(n = 295) | |
| Age (y) | 51.2 ± 10.32 | 51.1 ± 10.4 | 51.0 ± 10.7 | 52.7 ± 9.8 | 52.2 ± 10.6 | 51.2 ± 10.4 |
| Women [n (%)] | 695 (69.9) | 349 (70.1) | 693 (69.6) | 147 (64.8) | 106 (69.3) | 195 (66.1) |
| Race [n (%)] | ||||||
| White | 861 (86.6) | 429 (86.1) | 850 (85.4) | 198 (87.2) | 134 (87.6) | 244 (82.7) |
| African | 114 (11.5) | 56 (11.2) | 122 (12.3) | 28 (12.3) | 17 (11.1) | 44 (14.9) |
| Asian | 6 (0.6) | 5 (1.0) | 11 (1.1) | 0 | 1 (0.7) | 5 (1.7) |
| American Indian or Alaskan native | 4 (0.4) | 6 (1.2) | 8 (0.8) | 2 (0.9) | 1 (0.7) | 0 |
| Native Hawaiian or other Pacific Islander | 2 (0.2) | 2 (0.4) | 3 (0.3) | 0 | 1 (0.7) | 2 (0.7) |
| Other | 12 (1.2) | 5 (1.0) | 8 (0.8) | 1 (0.4) | 0 | 3 (1.0) |
| Ethnicity [n (%)] | ||||||
| Hispanic or Latino | 128 (12.9) | 70 (14.1) | 130 (13.1) | 42 (18.5) | 25 (16.3) | 56 (19.0) |
| Not Hispanic or Latino | 866 (87.1) | 428 (85.9) | 865 (86.9) | 185 (81.5) | 128 (83.7) | 239 (81.0) |
| Weight (kg)3 | 103.3 ± 18.1 | 102.6 ± 18.2 | 103.0 ± 17.6 | 101.1 ± 18.9 | 102.2 ± 18.4 | 101.9 ± 18.9 |
| BMI (kg/m2)3 | 36.7 ± 4.6 | 36.2 ± 4.4 | 36.6 ± 4.5 | 36.0 ± 4.8 | 36.1 ± 4.5 | 36.2 ± 4.7 |
| Waist circumference (cm)3 | 113.4 ± 12.2 | 112.6 ± 12.5 | 113.2 ± 12.2 | 113.0 ± 12.5 | 112.9 ± 12.3 | 112.2 ± 12.3 |
| Blood pressure (mm Hg)3 | ||||||
| Systolic | 128.9 ± 13.5 | 128.3 ± 13.8 | 127.9 ± 13.4 | 128.5 ± 14.3 | 127.8 ± 11.4 | 127.3 ± 13.7 |
| Diastolic | 81.1 ± 9.2 | 80.6 ± 8.8 | 80.1 ± 9.1 | 79.9 ± 9.7 | 80.1 ± 8.8 | 80.1 ± 8.8 |
| Heart rate (bpm)3 | 72.1 ± 9.9 | 72.1 ± 10.1 | 72.6 ± 10.1 | 70.6 ± 10.5 | 72.0 ± 9.6 | 73.0 ± 10.3 |
| Total cholesterol (mg/dL)4 | 205.3 ± 41.7 | 201.6 ± 37.9 | 205.1 ± 40.4 | 203.5 ± 41.9 | 201.8 ± 35.8 | 201.9 ± 38.6 |
| LDL cholesterol (mg/dL)5 | 123.8 ± 36.1 | 120.8 ± 33.8 | 123.7 ± 35.5 | 123.1 ± 36.6 | 121.7 ± 32.7 | 121.5 ± 35.4 |
| HDL cholesterol (mg/dL)6 | 48.8 ± 13.8 | 48.5 ± 12.8 | 49.0 ± 13.7 | 49.5 ± 14.7 | 48.6 ± 13.3 | 48.7 ± 12.8 |
| Triglycerides (mg/dL)7 | 163.6 ± 75.8 | 161.2 ± 75.4 | 162.0 ± 73.4 | 154.4 ± 66.7 | 157.2 ± 71.5 | 158.1 ± 72.0 |
| Fasting glucose (mg/dL)8 | 106.5 ± 23.5 | 105.8 ± 20.7 | 105.9 ± 21.6 | 109.3 ± 24.4 | 110.7 ± 25.3 | 108.2 ± 24.1 |
| Glycated hemoglobin (%)9 | 5.9 ± 0.8 | 5.8 ± 0.7 | 5.9 ± 0.8 | 6.0 ± 0.9 | 6.0 ± 0.9 | 6.0 ± 0.8 |
| Subjects with [n (%)] | ||||||
| Depression history | 179 (18.0) | 81 (16.3) | 165 (16.6) | 42 (18.5) | 35 (22.9) | 55 (18.6) |
| Hypertension10 | 524 (52.7) | 261 (52.4) | 520 (52.3) | 120 (52.9) | 71 (46.4) | 154 (52.2) |
| Hypertriglyceridemia11 | 354 (35.6) | 180 (36.1) | 363 (36.5) | 80 (35.2) | 48 (31.4) | 105 (35.6) |
| T2D12 | 159 (16.0) | 68 (13.7) | 166 (16.7) | 55 (24.2) | 26 (17.0) | 64 (21.7) |
| Metabolic syndrome | 698 (70.2) | 353 (70.9) | 679 (68.2) | 152 (67.0) | 107 (69.9) | 192 (65.1) |
Baseline values for SEQUEL subjects were measured at the start of CONQUER. bpm, beats per minute; PHEN/TPM CR, controlled-release phentermine/topiramate; T2D, type 2 diabetes; 7.5/46, 7.5 mg phentermine/46 mg controlled-release topiramate; 15/92, 15 mg phentermine/92 mg controlled-release topiramate.
Mean ± SD (all such values).
Among CONQUER subjects, baseline weight, BMI, waist circumference, blood pressure, and heart rate values were missing for 2 subjects: one in the placebo group and one in the 15/92 group.
Among CONQUER subjects at baseline, there were missing values for 2 subjects (one for placebo, one for 15/92).
Among CONQUER subjects at baseline, there were missing values for 7 subjects (4 for placebo, 3 for 15/92).
Among CONQUER subjects at baseline, there were missing values for 2 subjects (one for placebo, one for 15/92).
Among CONQUER subjects at baseline, there were missing values for 2 subjects (one for placebo, one for 15/92).
Among CONQUER subjects at baseline, there were missing values for 11 subjects (4 for placebo, 7 for 15/92).
Among CONQUER subjects at baseline, there were missing values for 9 subjects (5 for placebo, 4 for 15/92).
Subjects with hypertension were those with systolic blood pressure ≥140 and ≤160 mm Hg (≥130 and ≤160 mm Hg if diabetic) or diastolic blood pressure ≥90 and ≤100 mm Hg (≥85 and ≤100 mm Hg if diabetic) or who were taking ≥2 antihypertensive medications and had blood pressure <140/90 mm Hg.
Subjects with hypertriglyceridemia were those with fasting triglycerides between 200 and 400 mg/dL or who were taking ≥2 lipid-lowering medications and had fasting triglycerides of <200 mg/dL.
Subjects with diabetes were those with an established diagnosis of T2D, managed with lifestyle measures, metformin therapy, or both.