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Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity.
J Fam Pract 2001; 50(6):505-12JF

Abstract

OBJECTIVE

The researchers assessed the long-term weight reduction efficacy, tolerability, and safety of sibutramine used once daily in conjunction with behavior modification to treat mild to moderate obesity.

STUDY DESIGN

This was a double-blind randomized placebo-controlled parallel-group comparative study of sibutramine 10 mg or 15 mg (or placebo) once daily for 1 year, given with dietary advice.

POPULATION

A total of 485 obese men and women with uncomplicated obesity were included (mean age=42 years, mean body mass index=32.7 kg/m2).

OUTCOMES MEASURED

The outcomes were mean weight loss, percentage losing more than 5% or 10% of their body weight, and adverse drug effects.

RESULTS

Among patients completing the study, those taking sibutramine 10 mg or 15 mg had greater mean weight loss compared with placebo at 12-month assessment (P < or = .001). Changes in body weight from baseline to end point were -1.6 kg for those taking placebo, -4.4 kg for those taking sibutramine 10 mg (P < or =.01, last observation carried forward [LOCF]), and -6.4 kg for those taking sibutramine 15 mg (P < or =.001, LOCF). For placebo patients, 20% lost 5% or more of their body weight compared with 39% of patients taking sibutramine 10 mg and 57% taking sibutramine 15 mg. Only 7% of the patients taking placebo lost 10% or more of their body weight, compared with 19% taking sibutramine 10 mg and 34% taking sibutramine 15 mg (P <.001 for both 10 mg and 15 mg vs placebo, and for both > or =5% and > or =10%).

CONCLUSIONS

Sibutramine 10 mg or 15 mg once daily given with dietary advice produces and maintains statistically and clinically significantly greater weight loss than dietary advice alone (placebo) throughout a 12-month treatment period, and is safe and well tolerated.

Authors+Show Affiliations

Synexus LTD, Chorley, United Kingdom. ian.smith@synexus.co.ukNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11407998

Citation

Smith, I G., et al. "Randomized Placebo-controlled Trial of Long-term Treatment With Sibutramine in Mild to Moderate Obesity." The Journal of Family Practice, vol. 50, no. 6, 2001, pp. 505-12.
Smith IG, Goulder MA, Sibutramine Clinical Study 1047 Team. Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. J Fam Pract. 2001;50(6):505-12.
Smith, I. G., & Goulder, M. A. (2001). Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. The Journal of Family Practice, 50(6), pp. 505-12.
Smith IG, Goulder MA, Sibutramine Clinical Study 1047 Team. Randomized Placebo-controlled Trial of Long-term Treatment With Sibutramine in Mild to Moderate Obesity. J Fam Pract. 2001;50(6):505-12. PubMed PMID: 11407998.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. AU - Smith,I G, AU - Goulder,M A, AU - ,, PY - 2001/02/25/received PY - 2001/02/25/revised PY - 2001/6/16/pubmed PY - 2001/7/6/medline PY - 2001/6/16/entrez SP - 505 EP - 12 JF - The Journal of family practice JO - J Fam Pract VL - 50 IS - 6 N2 - OBJECTIVE: The researchers assessed the long-term weight reduction efficacy, tolerability, and safety of sibutramine used once daily in conjunction with behavior modification to treat mild to moderate obesity. STUDY DESIGN: This was a double-blind randomized placebo-controlled parallel-group comparative study of sibutramine 10 mg or 15 mg (or placebo) once daily for 1 year, given with dietary advice. POPULATION: A total of 485 obese men and women with uncomplicated obesity were included (mean age=42 years, mean body mass index=32.7 kg/m2). OUTCOMES MEASURED: The outcomes were mean weight loss, percentage losing more than 5% or 10% of their body weight, and adverse drug effects. RESULTS: Among patients completing the study, those taking sibutramine 10 mg or 15 mg had greater mean weight loss compared with placebo at 12-month assessment (P < or = .001). Changes in body weight from baseline to end point were -1.6 kg for those taking placebo, -4.4 kg for those taking sibutramine 10 mg (P < or =.01, last observation carried forward [LOCF]), and -6.4 kg for those taking sibutramine 15 mg (P < or =.001, LOCF). For placebo patients, 20% lost 5% or more of their body weight compared with 39% of patients taking sibutramine 10 mg and 57% taking sibutramine 15 mg. Only 7% of the patients taking placebo lost 10% or more of their body weight, compared with 19% taking sibutramine 10 mg and 34% taking sibutramine 15 mg (P <.001 for both 10 mg and 15 mg vs placebo, and for both > or =5% and > or =10%). CONCLUSIONS: Sibutramine 10 mg or 15 mg once daily given with dietary advice produces and maintains statistically and clinically significantly greater weight loss than dietary advice alone (placebo) throughout a 12-month treatment period, and is safe and well tolerated. SN - 0094-3509 UR - https://www.unboundmedicine.com/medline/citation/11407998/Randomized_placebo_controlled_trial_of_long_term_treatment_with_sibutramine_in_mild_to_moderate_obesity_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=11407998.ui DB - PRIME DP - Unbound Medicine ER -