A randomized, placebo‐controlled crossover trial of phentermine‐topiramate ER in patients with binge‐eating disorder and bulimia nervosa

Objective Open trials suggest phentermine/topiramate ER (PHEN/TPM‐ER), food and drug administration (FDA) approved for obesity, has utility for binge eating. With no randomized controlled trials (RCTs) yet performed, this trial aimed to evaluate PHEN/TPM‐ERs efficacy and safety in a crossover RCT fo...

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Published in:The International journal of eating disorders 2020-02, Vol.53 (2), p.266-277
Main Authors: Safer, Debra L., Adler, Sarah, Dalai, Shebani Sethi, Bentley, Jason P., Toyama, Hannah, Pajarito, Sarah, Najarian, Thomas
Format: Article
Language:English
Subjects:
Binge eating
binge‐eating disorder
Bulimia
bulimia nervosa
clinical trial
crossover
eating disorder treatment
Eating disorders
obesity
phentermine
Qsymia
topiramate
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Summary:Objective Open trials suggest phentermine/topiramate ER (PHEN/TPM‐ER), food and drug administration (FDA) approved for obesity, has utility for binge eating. With no randomized controlled trials (RCTs) yet performed, this trial aimed to evaluate PHEN/TPM‐ERs efficacy and safety in a crossover RCT for patients with binge‐eating disorder (BED) or bulimia nervosa (BN). Method Participants were randomized to 12‐weeks PHEN/TPM‐ER (3.75 mg/23 mg–15 mg/92 mg) or placebo followed by 2‐weeks drug washout, then 12‐week crossover. Demographics, vitals, eating disorder behaviors, mood, and side effects were measured. Primary outcome was objective binge‐eating (OBE) days/4‐weeks; secondary outcomes included binge abstinence. Mixed‐effect models estimated treatment effects, with fixed effects adjusting for treatment, study period, and diagnosis. Results The 22 adults (BED = 18, BN = 4) were female (96%), Caucasian (55%), aged 42.9 (SD = 10.1) years with body mass index = 31.1 (SD = 6.2) kg/m2. Baseline OBE days/4‐weeks decreased from 16.2 (SD = 7.8) to 4.2 (SD = 8.4) after PHEN/TPM‐ER versus 13.2 (SD = 9.1) after placebo (p 
ISSN:0276-3478
1098-108X
DOI:10.1002/eat.23192