Document Detail


Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial.
MedLine Citation:
PMID:  23147455     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Obese individuals who have failed to achieve adequate weight loss with lifestyle changes have limited nonsurgical therapeutic options. We evaluated the efficacy and tolerability of zonisamide, an antiepileptic drug, for enhancing weight loss in obese patients receiving diet and lifestyle guidance.
METHODS: This was a 1-year, randomized, double-blind, placebo-controlled trial conducted from January 9, 2006, through September 20, 2011, at Duke University Medical Center. A total of 225 obese (mean [SD] body mass index, 37.6 [4.9]) participants included 134 women (59.6%) and 91 men (40.4%) without diabetes mellitus. (Body mass index is calculated as weight in kilograms divided by height in meters squared.) Interventions were daily dosing with placebo (n = 74), 200 mg of zonisamide (n = 76), or 400 mg of zonisamide (n = 75), in addition to diet and lifestyle counseling by a dietitian for 1 year. Primary outcome was change in body weight at 1 year.
RESULTS: Of the 225 randomized patients, 218 (96.9%) provided 1-year follow-up assessments. Change in body weight was -4.0 kg (95% CI, -5.8 to -2.3 kg; least squares mean, -3.7%) for placebo, -4.4 kg (-6.1 to -2.6 kg; -3.9%; P = .79 vs placebo) for 200 mg of zonisamide, and -7.3 kg (-9.0 to -5.6 kg; -6.8%; P = .009 vs placebo) for 400 mg of zonisamide. In the categorical analysis, 23 (31.1%) assigned to placebo, 26 (34.2%; P = .72) assigned to 200 mg of zonisamide, and 41 (54.7%; P = .007) assigned to 400 mg of zonisamide achieved 5% or greater weight loss; for 10% or greater weight loss, the corresponding numbers were 6 (8.1%), 17 (22.4%; P = .02), and 24 (32.0%; P < .001). Gastrointestinal, nervous system, and psychiatric adverse events occurred at a higher incidence with zonisamide than with placebo.
CONCLUSION: Zonisamide at the daily dose of 400 mg moderately enhanced weight loss achieved with diet and lifestyle counseling but had a high incidence of adverse events.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00275834
Authors:
Kishore M Gadde; Mariko F Kopping; H Ryan Wagner; Gretchen M Yonish; David B Allison; George A Bray
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Archives of internal medicine     Volume:  172     ISSN:  1538-3679     ISO Abbreviation:  Arch. Intern. Med.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-13     Completed Date:  2013-03-12     Revised Date:  2013-11-14    
Medline Journal Info:
Nlm Unique ID:  0372440     Medline TA:  Arch Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1557-64     Citation Subset:  AIM; IM    
Affiliation:
Obesity Clinical Trials Program, Duke University Medical Center, Durham, NC 27710, USA. kishore.gadde@duke.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00275834
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Antioxidants / administration & dosage
Body Mass Index
Dose-Response Relationship, Drug
Double-Blind Method
Female
Follow-Up Studies
Humans
Isoxazoles / administration & dosage*
Male
Middle Aged
Obesity / drug therapy*
Retrospective Studies
Treatment Outcome
Weight Loss / drug effects*
Young Adult
Grant Support
ID/Acronym/Agency:
5R01 DK67352/DK/NIDDK NIH HHS; R01 DK067352/DK/NIDDK NIH HHS
Chemical
Reg. No./Substance:
0/Antioxidants; 0/Isoxazoles; 68291-97-4/zonisamide
Comments/Corrections
Comment In:
Dtsch Med Wochenschr. 2013 Feb;138(6):245   [PMID:  23479794 ]
JAMA. 2013 Aug 14;310(6):637-8   [PMID:  23942682 ]
Arch Intern Med. 2012 Nov 12;172(20):1565   [PMID:  23070045 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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