Table 2.
Metabolic characteristics and body composition in patients with lipodystrophy before and after initiation or withdrawal of metreleptin
| Initiation | Withdrawal | ||||||
|---|---|---|---|---|---|---|---|
| Baseline (n = 17) | 2 weeks (n = 16) | 6 months (n = 15) | P | Baseline (n = 8) | 2 weeks (n = 8) | P | |
| Leptin (ng/dL) | 3.9 (0.6,12.8) | 66.7 (51,85.1) | 135 (117.3,173.4) | <0.00012w,6m | 43.7 (16.6,96.6) | 0.5 (0.2,1.8) | <0.0001 |
| Total cholesterol (mg/dL) | 230 ± 113 | 166 ± 47 | 157 ± 53 | 0.042w,6m | 129 ± 32 | 123 ± 29 | 0.3 |
| Triglycerides (mg/dL) | 488 (231 1116) | 300 (164 600) | 248 (118 497) | 0.022w,6m | 137 (78 215) | 145 (99 361) | 0.3 |
| Glucose (mg/dL) | 156 ± 44 | 147 ± 47 | 130 ± 38 | 0.016m | 97 ± 18 | 105 ± 33 | 0.6 |
| Insulin sensitivitye (mg/kgFFM/min) | 4.9 ± 3.1 | 5.6 ± 2.4a | 8.2 ± 3.9b | 0.0042w,6m | 10.9 ± 4.1 | 6.4 ± 1.8 | 0.01 |
| Urinary glucose excretion (g/24 h) | 5.3 (0.2,10.3) | 1.8 (0.2,7.2) | 0.3 (0.1,2.1)c | 0.0076m | 0.2 (0.1,0.7) | 0.2 (0.05,2.4) | 0.56 |
| Lean body mass (kg) | 51 ± 9 | 51 ± 10a | 49 ± 10 | 0.0056m | 52 ± 16 | 52 ± 15 | 0.98 |
| Fat mass (kg) | 17 ± 11 | 17 ± 11a | 14 ± 11d | 0.0092w | 4.1 ± 1.2 | 4.2 ± 0.9 | 0.76 |
| Body fat (%) | 22 ± 11 | 22 ± 11a | 19 ± 11d | 0.12 | 7.1 ± 1.7 | 7.2 ± 1.3 | 0.75 |
Data show the mean ± SD for normally distributed metrics and median (interquartile range: 25th, 75th) for nonnormally distributed metrics. Patients in the initiation cohort have data prior to initiation of metreleptin (baseline), and after 2 weeks and 6 months of metreleptin administration. Patients in the withdrawal cohort have data during metreleptin treatment, and after 2 weeks of metreleptin withdrawal. +Overall P-value (P) for linear mixed-effects regression is shown. 2wP < 0.05 for 2 weeks vs baseline. 6mP < 0.05 for 6 months vs baseline.
a n=15.
b n=14.
c n=13.
d n=12.
e Insulin sensitivity measured as glucose disposal during a hyperinsulinemic, euglycemic clamp.