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; for the 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.
Increased prevalence of adolescent obesity requires effective treatment options beyond behavior therapy.
To see whether sibutramine reduced weight more than placebo in obese adolescents who were receiving a behavior therapy program.
12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002.
33 U.S. outpatient clinics.
498 participants 12 to 16 years of age with a body mass index (BMI) that was at least 2 units more than the U.S. weighted mean of the 95th percentile based on age and sex, to the upper limit of 44 kg/m2.
Site-specific behavior therapy plus 10 mg of sibutramine or placebo. Blinded study medication dose was uptitrated to 15 mg or placebo at month 6 if initial BMI was not reduced by 10%.
Body mass index, waist circumference, body weight, fasting lipid and glycemic variables, safety, and tolerability.
Seventy-six percent of patients in the sibutramine group and 62% of patients in the placebo group completed the study. The estimated mean treatment group difference at month 12 (linear mixed-effects model) favored sibutramine for change from baseline in BMI (−2.9 kg/m2 [95% CI, −3.5 to −2.2 kg/m2]) and body weight (−8.4 kg [CI, −9.7 to −7.2 kg]) (P < 0.001 for both). The sibutramine group had greater improvements in triglyceride levels, high-density lipoprotein cholesterol levels, insulin levels, and insulin sensitivity (P ≤ 0.001 for all). The rate of tachycardia was greater with sibutramine vs. placebo (12.5% vs. 6.2%; difference, 6.3 percentage points [CI, 1.0 to 11.7 percentage points]) but did not lead to increased withdrawal (2.4% vs. 1.5%; difference, 0.9 percentage point [CI, −1.7 to 3.5 percentage points]).
The 1-year study duration precluded assessment of long-term weight maintenance and putative health benefits and harms, and 24% and 38% of the sibutramine and placebo groups, respectively, did not complete follow-up.
Sibutramine added to a behavior therapy program reduced BMI and body weight more than placebo and improved the profile of several metabolic risk factors in obese adolescents.
*For members of the Sibutramine Adolescent Study Group, see the Appendix.
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. ;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.
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