Table 1.
Characteristics of sample and changes in weight status, BMI, blood pressure, and heart rate over time.
| Baseline | Change at 1 Month | Change at 3 Months | Change at 6 Months | |||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| Phentermine + SOC | SOC | Treatment Effect* (95% CI) |
p-value | Treatment Effect* (95% CI) |
p-value | Treatment Effect* (95% CI) |
p-value | |
| n | 25 | 274 | P+SOC (25) SOC (274) | P+SOC (20) SOC (171) | P+SOC (11) SOC (96) | |||
| Sex (male) | 6 (24.0%) | 109 (39.8%) | – | – | – | – | – | – |
| Age at Visit (years) | 16.1 (1.33) | 14.9 (1.63) | – | – | – | – | – | – |
| BMI Percentile (%) | 99.9 (0.6) | 100.0 (0.4) | – | – | – | – | – | – |
| -Class 1 Obesity | 6 (24.0%) | 39 (14.2%) | – | – | – | – | – | – |
| -Class 2 Obesity | 4 (16.0%) | 123 (44.9%) | – | – | – | – | – | – |
| -Class 3 Obesity | 15 (60.0%) | 112 (40.9%) | – | – | – | – | – | – |
| Height (cm) | 166 (8.98) | 166 (9.55) | 0.18 (−0.05,0.42) | 0.127 | 0.32 (−0.17,0.80) | 0.204 | 0.67 (−0.15,1.49) | 0.109 |
| Weight (kg) | 114 (22.2) | 106 (21.0) | −1.41 (−2.45,−0.36) | 0.008 | −2.56 (−4.39,−0.73) | 0.006 | −3.23 (−5.95,−0.52) | 0.020 |
| BMI (kg/m2) | 41.2 (6.9) | 38.1 (5.5) | −0.62 (−1.00,−0.24) | 0.002 | −1.14 (−1.76,−0.51) | <0.001 | −1.57 (−2.78,−0.36) | 0.011 |
| - % change | – | – | −1.61 (−2.59,−0.64) | 0.001 | −2.94 (−4.51,−1.37) | <0.001 | −4.05 (−7.06,−1.03) | 0.009 |
| BMI Z-score | 2.44 (0.31) | 2.44 (0.27) | −0.03 (−0.05,−0.01) | 0.016 | −0.06 (−0.10,−0.01) | 0.010 | −0.09 (−0.16,−0.02) | 0.019 |
| Percent of the 95th Percentile | 144 (23.9) | 139 (20.0) | −1.99 (−3.38,−0.60) | 0.007 | −4.09 (−6.13,−2.05) | <0.001 | −5.71 (−9.86,−1.56) | 0.010 |
| Systolic BP (mmHg) | 120 (9.28) | 122 (12.4) | 0.24 (−2.8,3.28) | 0.878 | 1.44 (−3.03,5.91) | 0.528 | −1.18 (−7.58,5.22) | 0.717 |
| Diastolic BP (mmHg) | 70.5 (7.65) | 70.7 (10.3) | −0.74 (−3.82,2.34) | 0.638 | 1.53 (−2.90,5.96) | 0.498 | 4.12 (−3.3,11.54) | 0.276 |
| Heart Rate (bpm) | 81.6 (12.3) | 82.2 (13.2) | 3.82 (−0.17,7.80) | 0.060 | 8.53 (1.59,15.47) | 0.016 | 6.92 (−2.1,15.95) | 0.133 |
*
Treatment effect is change Phentermine + SOC with SOC subtracted. Analyses are further adjusted for age, gender, and baseline BMI. Data are presented as mean (SD) or n (%). Abbreviations (in order of appearance): SOC = Standard of care; P+SOC = Phentermine + Standard of care; BMI = Body mass index; Class 1 obesity = 95th percentile to <20% of 95th percentile; Class 2 obesity = ≥20% of the 95th percentile and <40% of the 95th percentile; Class 3 obesity = ≥40% of the 95th percentile ; BP = Blood Pressure