title: Weight changes in obese adults 6-months after discontinuation of double-blind zonisamide or placebo treatment.
abstract: We evaluated weight changes in obese patients at 6-months after they ended participation in a 12-month randomised controlled trial in which they received daily placebo, zonisamide 200 mg or zonisamide 400 mg, in addition to lifestyle counselling. Of the originally randomised 225 patients, 218 completed month-12 when study interventions were discontinued. For the 154 patients who returned for 6-month follow-up off-treatment, weight changes between month-12 and month-18 for placebo (n = 53), zonisamide 200 mg (n = 49) and zonisamide 400 mg groups (n = 52) were 0.5 kg [95% confidence interval (CI), -0.8 to 1.8; 0.7%], 1.5 kg (0.2-2.8; 1.6%; p = 0.26 vs. placebo) and 2.4 kg (1.1-3.7; 2.6%; p = 0.04 vs. placebo), respectively. Our results suggest that although zonisamide 400 mg daily for 12-months resulted in greater weight loss than with placebo, weight regain after discontinuation of interventions was greater in the zonisamide 400 mg group than placebo group.
authors.affiliation: Obesity Clinical Trials Programme, Duke University Medical Center, Durham, NC, USA.
authors.forename: J H
authors.initials: JH
authors.lastname: Shin
authors.forename: K M
authors.initials: KM
authors.lastname: Gadde
authors.forename: T
authors.initials: T
authors.lastname: Østbye
authors.forename: G A
authors.initials: GA
authors.lastname: Bray
mesh_terms: D000328:Adult; D019440:Anti-Obesity Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D015992:Body Mass Index; D015331:Cohort Studies; D003131:Combined Modality Therapy / Q000009:adverse effects; D004038:Diet, Reducing; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009657:North Carolina; D009765:Obesity / Q000178:diet therapy / Q000188:drug therapy / Q000628:therapy*; D010349:Patient Compliance; D010353:Patient Education as Topic; D015430:Weight Gain / Q000187:drug effects; D000078305:Zonisamide
chemical_list: D019440:Anti-Obesity Agents; D000927:Anticonvulsants; D007555:Isoxazoles; D000078305:Zonisamide
keywords: antiobesity drugs; obesity; weight loss; weight maintenance; weight regain; zonisamide