Table 2.
Weight-loss pharmacotherapy with current US Food and Drug Administration approval for use in adolescents with obesity.
| Generic (Trade) Name | Mechanism | Age | Dose | Weight-Related Efficacy | Comorbidity Impact | Adverse Effects |
|---|---|---|---|---|---|---|
| Orlistat (Xenical®) | Inhibition of pancreatic and gastric lipase | ≥12 years | 120 mg three times daily by mouth with meals | Wt: −2.5 kg (−4.3, −0.7); BMI: −0.79 kg/m2 (−1.08, −0.51) [101] |
FG, HDL, LDL, TG: NS; SBP: NS, DBP: −0.51 vs. +1.3 vs. placebo; ALT: NR [104] | Abdominal pain, steatorrhea, flatus, fecal urgency and incontinence, and fat-soluble vitamin deficiency |
| Phentermine alone (Adipex-P®, Lomaira™) | Reduces norepinephrine reuptake to stimulate neurons in hypothalamus | >16 years | 15 mg, 30 mg, or 37.5 mg daily, oral | Wt: −3.6 kg (range −0.6 to −6.0) [105] (review, adult studies) | HbA1c, HDL, LDL, TG, SBP, DBP: NS, ALT: NR [106] (observational study, adults) | Insomnia, dry mouth, tremor, headache, dizziness, mood alteration, heart rate and blood pressure elevation |
| Phentermine/topiramate extended-release (Qsymia®) | Topiramate: suppresses appetite by augmenting GABA activity in brain | ≥12 years | 7.5 mg/46 mg or 15 mg/92 mg |
% change in BMI at 56 weeks vs. placebo: −8.11% (−11.92, −4.31%) and −10.44% (−13.89, −6.99%) for top and mid-doses [107] |
HbA1c: NS, HDL: +10% and +9% for mid- and top-dose; LDL: NS; TG: −21% for mid- and top-dose; SBP, DBP: NS; ALT: NR [107] | Topiramate: reversible cognitive dysfunction, paresthesia, metabolic acidosis; teratogenic (orofacial defects) and may decrease oral Contraceptive efficacy; counseling, serial pregnancy testing recommended [108] |
| Liraglutide (Saxenda®) | GLP-1 RA | ≥12 years | 3.0 mg subcutaneous once daily | BMI SDS at 56 weeks vs. placebo: −0.22 (−0.37, −0.08); relative: −4.64% (−7.14, −2.14); BMI reduction of ≥5% 43.3% vs. 18.7% [109] |
HbA1c: NS; HDL, LDL, TG: NS; SBP, DBP: NS; ALT: NR [109] | Nausea, vomiting, diarrhea; increased heart rate from baseline; hypoglycemia in adolescents without type 2 diabetes (15%) |
| Semaglutide (Wegovy®) | GLP-1 RA | ≥12 years | 2.4 mg subcutaneous once weekly |
Mean change in BMI from baseline to week 68 vs. placebo: −16.7% (−20.3, −13.2%); Weight reduction of ≥5% 73% vs. 18% [85] |
HbA1c: −0.3%; HDL: NS, LDL: −7.0 mg/dL, TG: −30.2 mg/dL; SBP, DBP: NS; ALT: −14.1 IU/mL [85] | Nausea, vomiting, diarrhea |
| Setmelanotide (Imcivree®) | Melanocortin-4-receptor agonist | ≥6 years with BBS or POMC, PCSK1, LEPR deficiency | 3 mg subcutaneous once daily |
POMC, LEPR: ≥10% weight loss in 80% of POMC and 45% of LEPR participants [110] | % change from baseline for (1) POMC or (2) LEPR (Clement): FG: (1) −17.2%, (2) NS; HDL: (1) +45.0%, (2) +19.6%; LDL: (1) NS, (2) −10.0%; TG: (1) −36.6%, (2) NS; SBP, DBP: (1) NS, (2) NS; ALT: NR [110] |
New/worsened depression or suicidal ideation; sexual adverse reactions; skin hyperpigmentation (most common); injection site reaction; nausea, vomiting |
| BBS: 7.9% average BMI loss [111] | % change from baseline: FG, HbA1c: NR; HDL: +4.3%; LDL: −8.8%; TG: −10.7%; SBP, DBP: NR; ALT: NR [111] |
Numbers in parentheses denote 95% CI unless otherwise indicated. NS, non-significant; NR: not reported. FG, fasting glucose; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; TG, triglycerides; SBP and DBP, systolic and diastolic blood pressure; ALT, alanine aminotransferase. GLP-1 RA, glucagon-like peptide-1 receptor agonist. BBS, Bardet–Biedl Syndrome.