Accepted for Publication: July 6, 2012.
Published Online: October 15, 2012. doi:10.1001/2013.jamainternmed.99
Author Contributions:Study concept and design: Gadde, Wagner, Allison, and Bray. Acquisition of data: Gadde, Kopping, and Yonish. Analysis and interpretation of data: Wagner and Gadde. Drafting of the manuscript: Gadde and Kopping. Critical revision of the manuscript for important intellectual content: Gadde, Kopping, Wagner, Yonish, Allison, and Bray. Statistical analysis: Wagner. Obtained funding: Gadde. Administrative, technical, and material support: Gadde and Kopping. Study supervision: Gadde.
Conflict of Interest Disclosures: All authors have completed and submitted the International Committee of Medical Journal Editors Form for Disclosure of Potential Conflicts of Interest. Dr Gadde reported receiving grants from Bristol Myers Squibb, Forest Laboratories, National Institute of Diabetes and Digestive and Kidney Diseases, Pfizer, and Vivus in the past 36 months. He has been awarded several patents in the name of his institution for use of zonisamide as monotherapy and in combination with other drugs for treatment of obesity, as well as weight gain associated with psychotropic drugs; these patents have been licensed to Orexigen Therapeutics by his institution. Consequent to the licensing agreement, Dr Gadde owns equity in Orexigen, which is developing zonisamide and bupropion combination therapy for obesity, based on his patents. However, to the best of Dr Gadde's knowledge, no commercial entity has announced plans to develop zonisamide monotherapy for obesity or other applications claimed in his patents. Dr Allison has had financial interests with Arena Pharmaceuticals, EnteroMedics, Frontiers Foundation, Federal Trade Commission, Jason Pharmaceuticals, Kraft Foods, Mead Johnson Nutrition, Mead Johnson & Company, Medifast, Orexigen Therapeutics, Sage Publications, University of Arizona, University of Wisconsin, Vivus, Wolters Kluwer Pharma Solutions, and Paul, Weiss, Rifkind, Wharton & Garrison LLP. Dr Bray reported that he has been a consultant to Abbott Laboratories and Takeda Global Research Institute; is an advisor to Medifast, Herbalife, and Global Direction in Medicine; and has received royalties for the Handbook of Obesity.
Funding/Support: This study was supported by grant 5R01 DK67352 from the National Institute of Diabetes and Digestive and Kidney Diseases to Dr Gadde.
Role of the Sponsors: The sponsor had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Disclaimer: The views expressed in this article are those of the authors and do not necessarily represent the official views of the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, or the US Department of Health and Human Services.
Additional Contributions: We thank all the patients who participated in this trial. We are grateful to Catherine Gang, MPH, RD (Duke University Medical Center), for data collection and dietary counseling; Jonathan R. Davidson, MD (professor emeritus, Duke University), for monitoring data safety on a periodic basis for the entire duration of patient participation; and Andrew W. Brown, PhD (University of Alabama at Birmingham), for valuable comments during critical revision of the manuscript. Ms Gang and Dr Davidson were compensated for their services from the grant. Dr Brown received no compensation.