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Effects of Sibutramine Treatment in Obese Adolescents: A Randomized Trial

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*
[+] Article and Author Information

From The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania; Scripps Clinic, San Diego, California; University of Cincinnati College of Medicine and Children's Hospital Medical Center, Cincinnati, Ohio; Massachusetts General Hospital, Boston, Massachusetts; Center for Health Management, Gulfport, Mississippi; University of Miami School of Education, Coral Gables, Florida; Louisiana State University Health Sciences Center and Pennington Research Center, New Orleans, Louisiana; and Abbott Laboratories, Abbott Park, Illinois.


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, berkowitz@email.chop.edu.

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.


Ann Intern Med. 2006;145(2):81-90. doi:10.7326/0003-4819-145-2-200607180-00005
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Our study is the first large multicenter study to report the effect of sibutramine pharmacotherapy on weight loss in obese adolescents. The addition of sibutramine to a behavior therapy program in our 12-month, placebo-controlled study conducted in obese adolescents 12 to 16 years of age resulted in statistically significant improvements in BMI. At month 12, the estimated mean change in BMI for sibutramine plus behavior therapy was −3.1 kg/m2 versus −0.3 kg/m2 for placebo plus behavior therapy (P < 0.001 by linear mixed-effects model).

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Figures

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Figure 1.
Study flow diagram.PPP

Data on participants who did not pass the screening process were not collected. Eight participants (5 sibutramine recipients and 3 placebo recipients) did not record any postbaseline data, and we excluded them from the modified intention-to-treat population data set. The proportions of participants who prematurely discontinued treatment because of an adverse event were 23 of 368 patients (6%) in the sibutramine group and 7 of 130 patients (5%) in the placebo group (  = 0.83). *Patients were randomly assigned to the sibutramine or placebo group in a 3:1 ratio. †   = 0.80 vs. placebo (chi-square test). ‡   = 0.001 vs. placebo (chi-square test).

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Figure 2.
Mean (± SE) changes in body mass index (BMI) from baseline to each visit.P

All data are estimated means from the linear mixed-effects model. The model indicated statistically significant differences between treatment groups at all postbaseline visits (  < 0.001). An additional visit occurred at month 6.5 after possible dose uptitration, which resulted in a smaller visit window for month 6 compared with other visits after month 1, leading to a reduction in participants recording data at month 6.

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Summary for Patients

Effects of Drug Treatment for Obesity in Adolescence

The summary below is from the full report titled “Effects of Sibutramine Treatment in Obese Adolescents. A Randomized Trial.” It is in the 18 July 2006 issue of Annals of Internal Medicine (volume 145, pages 81-90). The authors are R.I. Berkowitz, K. Fujioka, S.R. Daniels, A.G. Hoppin, S. Owen, A.C. Perry, M.S. Sothern, C.L. Renz, M.A. Pirner, J.K. Walch, O. Jasinsky, A.C. Hewkin, and V.A. Blakesley, for the Sibutramine Adolescent Study Group.

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