Robert I. Berkowitz, MD; Ken Fujioka, MD; Stephen R. Daniels, MD, PhD; Alison G. Hoppin, MD; Stanford Owen, MD; Arlette C. Perry, PhD; Melinda S. Sothern, PhD; Cheryl L. Renz, MD; Mark A. Pirner, MD, PhD; Julia K. Walch, BS; Olga Jasinsky, MBA; Ann C. Hewkin, MSc; Vicky A. Blakesley, MD, PhD; Sibutramine Adolescent Study Group*
ClinicalTrials.gov identifier: NCT00261911.
Acknowledgments: The authors thank all the study investigators, as well as Knoll Pharmaceutical Company (now Abbott) for providing study drugs and sponsorship and Aimée Loar for support with statistical analysis.
Grant Support: By Knoll Pharmaceuticals (BASF Pharma), now Abbott.
Potential Financial Conflicts of Interest: Employment: C.L. Renz (Abbott), M.A. Pirner (Abbott), J.K. Walch (Abbott), O. Jasinsky (Abbott), A.C. Hewkin (Abbott), V.A. Blakesley (Abbott); Consultancies: R.I. Berkowitz (Abbott, Johnson & Johnson, Roche Laboratories, Sanofi-Aventis, Shionogi USA), K. Fujioka (Abbott), S.R. Daniels (Abbott); Honoraria: R.I. Berkowitz (Abbott, Roche Laboratories), K. Fujioka (Abbott); Stock ownership or options (other than mutual funds): C.L. Renz (Abbott), J.K. Walch (Abbott), O. Jasinsky (Abbott), A.C. Hewkin (Abbott); Grants received: R.I. Berkowitz (Abbott, Knoll Pharmaceuticals), K. Fujioka (Abbott), S.R. Daniels (Abbott), A.G. Hoppin (Abbott), V.A. Blakesley (Abbott); Patents pending: C.L. Renz (Abbott).
Requests for Single Reprints: Robert I. Berkowitz, MD, The Behavioral Health Center at The Children's Hospital of Philadelphia, 3440 Market Street, Suite 410, Philadelphia, PA 19104; e-mail, email@example.com.
Current Author Addresses: Dr. Berkowitz: The Behavioral Health Center at The Children's Hospital of Philadelphia, 3440 Market Street, Suite 410, Philadelphia, PA 19104.
Dr. Fujioka: Scripps Clinic, Suite 317, 12395 El Camino Real, San Diego, CA 92130.
Dr. Daniels: Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229.
Dr. Hoppin: Massachusetts General Hospital Weight Center, 50 Staniford Street, Boston, MA 02114.
Dr. Owen: Center for Health Management, 3300 15th Street, Gulfport, MS 39501.
Dr. Perry: University of Miami, 5202 University Drive, Coral Gables, FL 33124.
Dr. Sothern: Louisiana State University Health Sciences Center, 1600 Canal Street, Suite 800, New Orleans, LA 70112.
Dr. Renz and Ms. Hewkin: Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064.
Drs. Pirner and Blakesley, Ms. Walch, and Ms. Jasinsky: Abbott Laboratories, 200 Abbott Park Road, Abbott Park, IL 60064.
Author Contributions: Conception and design: R.I. Berkowitz, K. Fujioka, M.S. Sothern, C.L. Renz, V.A. Blakesley.
Analysis and interpretation of the data: R.I. Berkowitz, K. Fujioka, S.R. Daniels, C.L. Renz, M.A. Pirner, J.K. Walch, O. Jasinsky, A.C. Hewkin, V.A. Blakesley.
Drafting of the article: R.I. Berkowitz, K. Fujioka, S.R. Daniels, M.A. Pirner, J.K. Walch, O. Jasinsky, A.C. Hewkin.
Critical revision of the article for important intellectual content: R.I. Berkowitz, K. Fujioka, S.R. Daniels, A.G. Hoppin, S. Owen, M.S. Sothern, C.L. Renz, M.A. Pirner, V.A. Blakesley.
Final approval of the article: R.I. Berkowitz, K. Fujioka, S.R. Daniels, S. Owen, A.C. Perry, M.S. Sothern, C.L. Renz, M.A. Pirner, A.C. Hewkin, V.A. Blakesley.
Provision of study materials or patients: R.I. Berkowitz, A.G. Hoppin, S. Owen, A.C. Perry, M.S. Sothern, V.A. Blakesley.
Statistical expertise: A.C. Hewkin.
Obtaining of funding: R.I. Berkowitz, M.S. Sothern, V.A. Blakesley.
Administrative, technical, or logistic support: K. Fujioka, S.R. Daniels, A.C. Perry, M.S. Sothern, O. Jasinsky.
Collection and assembly of data: K. Fujioka, S.R. Daniels, A.C. Perry, M.S. Sothern, M.A. Pirner.
Berkowitz RI, Fujioka K, Daniels SR, Hoppin AG, Owen S, Perry AC, et al. Effects of Sibutramine Treatment in Obese Adolescents: A Randomized Trial. Ann Intern Med. 2006;145:81-90. doi: 10.7326/0003-4819-145-2-200607180-00005
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Published: Ann Intern Med. 2006;145(2):81-90.
Adolescent obesity is a major public health problem, with 15.5% of U.S. adolescents 12 to 19 years of age defined as overweight (>95th percentile for age- and sex-specific measures for body mass index [BMI]) (1-2). Overweight often leads to serious health consequences during childhood, such as hypertension, depression, and social exclusion (3). Recently, the incidence of type 2 diabetes, typically an adult disease, has dramatically increased in the pediatric population (4-6). Cardiovascular risk factors, such as dyslipidemia, insulin sensitivity, and hypertension, are also more prevalent in adolescents with a BMI greater than the 95th percentile than in those with a BMI less than the 85th percentile (7).
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