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A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa.
Int J Eat Disord. 2020 02; 53(2):266-277.IJ

Abstract

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 < .0001), with abstinence rates = 63.6% on PHEN/TPM-ER versus 9.1% on placebo (p < .0001). Weight changes = -5.8 kg on PHEN/ TPM-ER versus +0.4 kg on placebo. Drop-out = 2 (9%) on PHEN/TPM-ER and 2 (9%) on placebo, with few side effects. Vital sign changes with PHEN/TPM-ER were minimal and similar to placebo. Responses were not significantly different for BED versus BN.

DISCUSSION

This first RCT to evaluate the efficacy and safety of PHEN/TPM-ER for BED/BN found this drug combination significantly more effective at reducing binge eating than placebo and well tolerated. However, with only four participants with BN, findings regarding the safety of PHEN/TPM-ER in patients with BN must be taken with caution.

TRIAL REGISTRATION

Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824.

Authors+Show Affiliations

Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, California.Department of Psychology, Palo Alto University, Palo Alto, California.Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.Najarian Center for Obesity, Los Osos, California.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

31721257

Citation

Safer, Debra L., et al. "A Randomized, Placebo-controlled Crossover Trial of Phentermine-topiramate ER in Patients With Binge-eating Disorder and Bulimia Nervosa." The International Journal of Eating Disorders, vol. 53, no. 2, 2020, pp. 266-277.
Safer DL, Adler S, Dalai SS, et al. A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa. Int J Eat Disord. 2020;53(2):266-277.
Safer, D. L., Adler, S., Dalai, S. S., Bentley, J. P., Toyama, H., Pajarito, S., & Najarian, T. (2020). A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa. The International Journal of Eating Disorders, 53(2), 266-277. https://doi.org/10.1002/eat.23192
Safer DL, et al. A Randomized, Placebo-controlled Crossover Trial of Phentermine-topiramate ER in Patients With Binge-eating Disorder and Bulimia Nervosa. Int J Eat Disord. 2020;53(2):266-277. PubMed PMID: 31721257.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa. AU - Safer,Debra L, AU - Adler,Sarah, AU - Dalai,Shebani Sethi, AU - Bentley,Jason P, AU - Toyama,Hannah, AU - Pajarito,Sarah, AU - Najarian,Thomas, Y1 - 2019/11/13/ PY - 2019/07/14/received PY - 2019/09/28/revised PY - 2019/10/14/accepted PY - 2019/11/14/pubmed PY - 2020/7/1/medline PY - 2019/11/14/entrez KW - Qsymia KW - binge-eating disorder KW - bulimia nervosa KW - clinical trial KW - crossover KW - eating disorder treatment KW - obesity KW - phentermine KW - topiramate SP - 266 EP - 277 JF - The International journal of eating disorders JO - Int J Eat Disord VL - 53 IS - 2 N2 - 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 < .0001), with abstinence rates = 63.6% on PHEN/TPM-ER versus 9.1% on placebo (p < .0001). Weight changes = -5.8 kg on PHEN/ TPM-ER versus +0.4 kg on placebo. Drop-out = 2 (9%) on PHEN/TPM-ER and 2 (9%) on placebo, with few side effects. Vital sign changes with PHEN/TPM-ER were minimal and similar to placebo. Responses were not significantly different for BED versus BN. DISCUSSION: This first RCT to evaluate the efficacy and safety of PHEN/TPM-ER for BED/BN found this drug combination significantly more effective at reducing binge eating than placebo and well tolerated. However, with only four participants with BN, findings regarding the safety of PHEN/TPM-ER in patients with BN must be taken with caution. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824. SN - 1098-108X UR - https://www.unboundmedicine.com/medline/citation/31721257/A_randomized,_placebo-controlled_crossover_trial_of_phentermine-topiramate_ER_in_patients_with_binge-eating_disorder_and_bulimia_nervosa L2 - https://doi.org/10.1002/eat.23192 DB - PRIME DP - Unbound Medicine ER -