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Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial.

Publication ,  Journal Article
Gadde, KM; Kopping, MF; Wagner, HR; Yonish, GM; Allison, DB; Bray, GA
Published in: Arch Intern Med
November 12, 2012

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

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Published In

Arch Intern Med

DOI

EISSN

1538-3679

Publication Date

November 12, 2012

Volume

172

Issue

20

Start / End Page

1557 / 1564

Location

United States

Related Subject Headings

  • Zonisamide
  • Young Adult
  • Weight Loss
  • Treatment Outcome
  • Retrospective Studies
  • Obesity
  • Middle Aged
  • Male
  • Isoxazoles
  • Humans
 

Citation

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Gadde, K. M., Kopping, M. F., Wagner, H. R., Yonish, G. M., Allison, D. B., & Bray, G. A. (2012). Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial. Arch Intern Med, 172(20), 1557–1564. https://doi.org/10.1001/2013.jamainternmed.99
Gadde, Kishore M., Mariko F. Kopping, H Ryan Wagner, Gretchen M. Yonish, David B. Allison, and George A. Bray. “Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial.Arch Intern Med 172, no. 20 (November 12, 2012): 1557–64. https://doi.org/10.1001/2013.jamainternmed.99.
Gadde KM, Kopping MF, Wagner HR, Yonish GM, Allison DB, Bray GA. Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial. Arch Intern Med. 2012 Nov 12;172(20):1557–64.
Gadde, Kishore M., et al. “Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial.Arch Intern Med, vol. 172, no. 20, Nov. 2012, pp. 1557–64. Pubmed, doi:10.1001/2013.jamainternmed.99.
Gadde KM, Kopping MF, Wagner HR, Yonish GM, Allison DB, Bray GA. Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial. Arch Intern Med. 2012 Nov 12;172(20):1557–1564.

Published In

Arch Intern Med

DOI

EISSN

1538-3679

Publication Date

November 12, 2012

Volume

172

Issue

20

Start / End Page

1557 / 1564

Location

United States

Related Subject Headings

  • Zonisamide
  • Young Adult
  • Weight Loss
  • Treatment Outcome
  • Retrospective Studies
  • Obesity
  • Middle Aged
  • Male
  • Isoxazoles
  • Humans