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FDA briefing document: NDA 22529.
K. Gadde, Deborah Franciscy, H. Wagner, K. Krishnan (2003)
Zonisamide for weight loss in obese adults: a randomized controlled trial.JAMA, 289 14
T. Wadden, D. West, L. Delahanty, J. Jakicic, Jack Rejeski, D. Williamson, R. Berkowitz, D. Kelley, Christine Tomchee, James Hill, S. Kumanyika (2006)
The Look AHEAD Study: A Description of the Lifestyle Intervention and the Evidence Supporting ItObesity, 14
D. Simons-Morton, E. Obarzanek, J. Cutler (2006)
Obesity research--limitations of methods, measurements, and medications.JAMA, 295 7
FDA briefing document : NDA 22529 . Lorqess ( lorcaserin hydrochloride ) tablets , 10 mg . Endocrinologic and Metabolic Drugs Advisory Committee Meeting — May 10 , 2012
D. Allison, K. Gadde, W. Garvey, C. Peterson, M. Schwiers, T. Najarian, P. Tam, B. Troupin, W. Day (2011)
Controlled-Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP)Obesity (Silver Spring, Md.), 20
M. Mifflin, S. Jeor, L. Hill, B. Scott, S. Daugherty, Y. Koh (1990)
A new predictive equation for resting energy expenditure in healthy individuals.The American journal of clinical nutrition, 51 2
(2002)
The Diabetes Prevention Program (DPP): description of lifestyle intervention.Diabetes care, 25 12
David Booth (2000)
Analysis of Incomplete Multivariate DataTechnometrics, 42
(2006)
DelahantyL
F. Greenway, K. Fujioka, Raymond Plodkowski, S. Mudaliar, M. Guttadauria, J. Erickson, Dennis Kim, E. Dunayevich (2010)
Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trialThe Lancet, 376
TA Wadden, DS West, L Delahanty (2006)
The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it [published correction appears in Obesity (Silver Spring). 2007;15(5):1339]., 14
Behavior Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) Study Group
Guidance for industry developing products for weight management.
F. Pi‐Sunyer, L. Aronne, H. Heshmati, J. Devin, J. Rosenstock, for Group (2006)
Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial.JAMA, 295 7
T. Wadden, J. Foreyt, G. Foster, James Hill, S. Klein, P. O'Neil, M. Perri, F. Pi‐Sunyer, C. Rock, Janelle Erickson, Holly Maier, Dennis Kim, E. Dunayevich (2011)
Weight Loss With Naltrexone SR/Bupropion SR Combination Therapy as an Adjunct to Behavior Modification: The COR‐BMOD TrialObesity, 19
M. Elobeid, M. Padilla, Theresa McVie, O. Thomas, D. Brock, B. Musser, K. Lu, C. Coffey, R. Desmond, M. St-Onge, K. Gadde, S. Heymsfield, D. Allison (2009)
Missing Data in Randomized Clinical Trials for Weight Loss: Scope of the Problem, State of the Field, and Performance of Statistical MethodsPLoS ONE, 4
M. Franz, J. Vanwormer, A. Crain, J. Boucher, T. Histon, W. Caplan, Jill Bowman, Nicolas Pronk (2007)
Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up.Journal of the American Dietetic Association, 107 10
J. Douketis, C. Macie, L. Thabane, D. Williamson (2005)
Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practiceInternational Journal of Obesity, 29
E. Leblanc, Elizabeth O’Connor, E. Whitlock, Carrie Patnode, Tanya Kapka (2011)
Effectiveness of Primary Care–Relevant Treatments for Obesity in Adults: A Systematic Evidence Review for the U.S. Preventive Services Task ForceAnnals of Internal Medicine, 155
D. Ryan, R. Kushner (2010)
The state of obesity and obesity research.JAMA, 304 16
N. Lazar (2003)
Statistical Analysis With Missing DataTechnometrics, 45
G. Gadbury, C. Coffey, D. Allison (2003)
Modern statistical methods for handling missing repeated measurements in obesity trial data: beyond LOCFObesity Reviews, 4
Martin Gibson, R. Little, D. Rubin (1989)
Statistical Analysis with Missing Data.The Statistician, 38
Steven Smith, N. Weissman, C. Anderson, Matilde Sánchez, E. Chuang, Scott Stubbe, H. Bays, W. Shanahan (2010)
Multicenter, placebo-controlled trial of lorcaserin for weight management.The New England journal of medicine, 363 3
Guidance for industry developing products for weight management. Draft guidance, Revision 1
Huston Gj (1987)
The Hospital Anxiety and Depression Scale.The Journal of rheumatology, 14 3
D. Rubin, N. Schenker (1991)
Multiple imputation in health-care databases: an overview and some applications.Statistics in medicine, 10 4
ORIGINAL INVESTIGATION A 1-Year Randomized Controlled Trial Kishore M. Gadde, MD; Mariko F. Kopping, MS, RD; H. Ryan Wagner II, PhD; Gretchen M. Yonish, MPH, RD; David B. Allison, PhD; George A. Bray, MD Background: Obese individuals who have failed to P = .79 vs placebo) for 200 mg of zonisamide, and −7.3 achieve adequate weight loss with lifestyle changes have kg (−9.0 to −5.6 kg; −6.8%; P = .009 vs placebo) for 400 limited nonsurgical therapeutic options. We evaluated mg of zonisamide. In the categorical analysis, 23 (31.1%) the efficacy and tolerability of zonisamide, an antiepi- assigned to placebo, 26 (34.2%; P = .72) assigned to 200 leptic drug, for enhancing weight loss in obese patients mg of zonisamide, and 41 (54.7%; P = .007) assigned to receiving diet and lifestyle guidance. 400 mg of zonisamide achieved 5% or greater weight loss; for 10% or greater weight loss, the corresponding num- Methods: This was a 1-year, randomized, double-blind, bers were 6 (8.1%), 17 (22.4%; P = .02), and 24 (32.0%; placebo-controlled trial conducted from January 9, 2006, P .001). Gastrointestinal, nervous system, and psychi- through September 20, 2011, at Duke University Medical atric adverse events occurred at a
JAMA Internal Medicine – American Medical Association
Published: Nov 12, 2012
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