Phentermine/Topiramate for the Treatment of Adolescent Obesity
Open accessAbstract
BACKGROUND: Antiobesity medication may be useful for the treatment of pediatric obesity, yet few safe and effective options exist. We evaluated phentermine/topiramate (PHEN/TPM) for weight management in adolescents with obesity. METHODS: This 56-week, randomized, double-blind trial enrolled adolescents 12 to less than 17 years of age with obesity. Participants were randomly assigned 1:1:2 to receive either placebo (n=56), mid-dose PHEN/TPM (7.5 mg/46 mg; n=54), or top-dose PHEN/TPM (15 mg/92 mg; n=113), respectively. All participants received lifestyle therapy. The primary end point was mean percent change in body-mass index (BMI) from randomization to week 56. RESULTS: ; 54.3% were female. The primary end point of percent change in BMI at week 56 showed differences from placebo of -10.44 percentage points (95% CI, -13.89 to -6.99; P<0.001) and -8.11 percentage points (95% CI, -11.92 to -4.31; P<0.001) for the top and mid doses of PHEN/TPM, respectively. Differences from placebo in percent change in triglycerides nominally favored PHEN/TPM (mid dose, -21%; 95% CI, -40 to -2; and top dose, -21%; 95% CI, -38 to -4), as did differences in percent change in high-density lipoprotein cholesterol (HDL-C) (mid dose, 10%; 95% CI, 3 to 18; and top dose, 9%; 95% CI, 2 to 15). The incidence of participants reporting at least one adverse event was 51.8%, 37.0%, and 52.2% in the placebo, mid-dose, and top-dose groups, respectively. Serious adverse events were reported for two participants in the top-dose group. CONCLUSIONS: PHEN/TPM at both the mid and top doses offered a statistically significant reduction in BMI and favorably impacted triglyceride and HDL-C levels in adolescents with obesity. (Funded by VIVUS LLC, with project support provided by Covance LLC; ClinicalTrials.gov number, NCT03922945.).
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Phentermine/topiramate ER is FDA-approved for ≥12 years in the U.S. but not approved by EMA.
“FDA-approved for ≥ 12 years in the U.S.; not approved by EMA.”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [115]
The Introduction (page unavailable) says the FDA approved phentermine/topiramate for adults in July 2012. The Methods and Abstract describe a trial in adolescents aged 12 to less than 17, but do not establish FDA approval for ages 12 and older. No passage found addresses EMA approval. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn that trial, adverse events were common but comparable to placebo; serious events occurred in two participants receiving the top dose.
“Adverse events were common but comparable to placebo; serious events occurred in two participants receiving the top dose [115].”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [115]
The Results, Safety section reports adverse events in 51.8% of placebo participants and 52.2% of top-dose participants, and serious adverse events in two participants assigned to the top-dose group (Supplementary Appendix, p. 10). But one of those participants had never received more than the mid dose when the events occurred, so saying both were receiving the top dose is inaccurate. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn that trial, improvements in triglycerides and HDL-C favored active treatment.
“Improvements in triglycerides and HDL-C also favored active treatment.”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [115]
In adolescents with obesity (mean age 14.0 years, BMI 37.8 kg/m2), phentermine/topiramate significantly reduced BMI at 56 weeks versus placebo by −10.4 and −8.1% points for the top and mid doses, respectively (P<0.001).
“In adolescents with obesity (mean age 14.0 years, BMI 37.8 kg/m²), phentermine/topiramate significantly reduced BMI at 56 weeks versus placebo by − 10.4 and − 8.1% points for the top and mid doses, respectively (P < 0.001).”
From Precision obesity medicine: A phenotype-guided framework for pharmacologic therapy across the lifespan (2025) · cites this paper as [115]
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References 19 · Cited by 169
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- [1]Sumithran P, Prendergast LA, Delbridge E, Long-term persistence of hormonal adaptations to weight loss. N Engl J Med 2011; 365: 1597– 1604. DOI: 10.1056/NEJMoa1105816. 22029981 · DOI · Paper page
- [2]Maclean PS, Bergouignan A, Cornier MA, Jackman MR. Biology’s response to dieting: the impetus for weight regain. Am J Physiol Regul Integr Comp Physiol 2011; 301: R581– R600. DOI: 10.1152/ajpregu.00755.2010. 21677272 PMC3174765 · DOI
- [3]Cardel MI, Atkinson MA, Taveras EM, Holm JC, Kelly AS. Obesity treatment among adolescents: a review of current evidence and future directions. JAMA Pediatr 2020; 174: 609– 617. DOI: 10.1001/jamapediatrics.2020.0085. 32202626 PMC7483247 · DOI
- [4]Styne DM, Arslanian SA, Connor EL, Pediatric obesity-assessment, treatment, and prevention: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2017; 102: 709– 757. DOI: 10.1210/jc.2016-2573. 28359099 PMC6283429 · DOI
- [5]Grossman DC, Bibbins-Domingo K, Curry SJ, Screening for obesity in children and adolescents: US Preventive Services Task Force recommendation statement. JAMA 2017; 317: 2417– 2426. DOI: 10.1001/jama.2017.6803. 28632874 · DOI
- [6]Ells LJ, Rees K, Brown T, Interventions for treating children and adolescents with overweight and obesity: an overview of Cochrane reviews. Int J Obes 2018; 42: 1823– 1833. DOI: 10.1038/s41366-018-0230-y. 30301964 · DOI
- [7]Chanoine JP, Hampl S, Jensen C, Boldrin M, Hauptman J. Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial. JAMA 2005; 293: 2873– 2883. DOI: 10.1001/jama.293.23.2873. 15956632 · DOI · Paper page
- [9]Srivastava G, Fox CK, Kelly AS, Clinical considerations regarding the use of obesity pharmacotherapy in adolescents with obesity. Obesity (Silver Spring) 2019; 27: 190– 204. DOI: 10.1002/oby.22385. 30677262 PMC6449849 · DOI
- [10]Gadde KM, Allison DB, Ryan DH, Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet 2011; 377: 1341– 1352. DOI: 10.1016/S0140-6736(11)60205-5. 21481449 · DOI · Paper page
- [11]Allison DB, Gadde KM, Garvey WT, Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity (Silver Spring) 2012; 20: 330– 342. DOI: 10.1038/oby.2011.330. 22051941 PMC3270297 · DOI · Paper page
- [13]Hsia DS, Gosselin NH, Williams J, A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine/topiramate in adolescents with obesity. Diabetes Obes Metab 2020; 22: 480– 491. DOI: 10.1111/dom.13910. 31696603 · DOI
- [15]Rajjo T, Almasri J, Al Nofal A, The association of weight loss and cardiometabolic outcomes in obese children: systematic review and meta-regression. J Clin Endocrinol Metab 2017; 102: 758– 762. DOI: 10.1210/jc.2016-2575. 28359092 · DOI
- [16]Kumar S, King EC, Christison AL, Health outcomes of youth in clinical pediatric weight management programs in POWER. J Pediatr 2019; 208: 57– 65.e4. DOI: 10.1016/j.jpeds.2018.12.049. 30853195 · DOI
- [17]Appelhans BM, French SA, Martin MA, Lui K, Janssen I. Attenuated efficacy of pediatric obesity treatment during the COVID-19 pandemic. Obesity (Silver Spring) 2022; 30: 45– 49. 34739182 PMC8661682
- Authors
- Kelly, A. S., Bensignor, M. O., Hsia, D. S., Shoemaker, A. H., Shih, W., Peterson, C., & Varghese, S. T.
- Affiliations
- University of Minnesota (US)
- Pennington Biomedical Research Center (US)
- Vanderbilt University Medical Center (US)
- VIVUS LLC, Campbell, CA
- Venue
- NEJM Evidence
- Publisher
- Massachusetts Medical Society
- Published
- 2022-05-24
- Volume
- 1
- Issue
- 6
- ISSN
- 2766-5526 (ISSN-L)
- PMC
- PMC10035585
- OpenAlex
- W4225146163
- Cited by
- 169
- References
- 19
- Citations by year
- 2026: 33 · 2025: 40 · 2024: 49 · 2023: 38 · 2022: 9
- FWCI
- 20.34
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- NEJM Evidence (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (K23DK129721)
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- phentermine/topiramate, adolescent obesity, childhood obesity, anti-obesity drugs, body mass index reduction, triglycerides, HDL cholesterol, lifestyle therapy, drug dosing, adverse events, weight management, drug safety and efficacy, obesity pharmacotherapy, drug repurposing, drug abuse
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