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Long-term pharmacotherapy for obesity and overweight.

Abstract

BACKGROUND

Worldwide prevalence rates of obesity and overweight are rising and safe and effective treatment strategies are urgently needed. A number of anti-obesity agents have been studied in short-term clinical trials, but long-term efficacy and safety need to be established.

OBJECTIVES

To assess/compare the effects and safety of approved anti-obesity medications in clinical trials of at least one-year duration.

SEARCH STRATEGY

MEDLINE, EMBASE, the Cochrane Controlled Trials Register, the Current Science Meta-register of Controlled Trials, and reference lists of original studies and reviews were searched. Date of last search was December 2002. Drug manufacturers and two obesity experts were contacted in to detect unpublished trials. No language restrictions were imposed.

SELECTION CRITERIA

Double-blind, randomised controlled weight loss and weight maintenance trials of approved anti-obesity agents that 1) enrolled adult overweight or obese patients, 2) included a placebo control group or compared two or more anti-obesity drugs 3) used an intention-to-treat analysis, and 4) had a minimum follow-up period of one year. Abstracts and pseudo-randomised trials were not included.

DATA COLLECTION AND ANALYSIS

Two reviewers independently assessed all potentially relevant citations for inclusion and methodological quality. The primary outcome measure was weight loss.

MAIN RESULTS

Of the eight anti-obesity agents investigated, only orlistat and sibutramine trials met inclusion criteria. Eleven orlistat weight loss studies (four of which reported a second year weight maintenance phase) and five sibutramine studies (three weight loss and two weight maintenance trials) were included. Attrition rates averaged 33% during the weight loss phase of orlistat trials and 43% in sibutramine studies. All patients received lifestyle modification as a co-intervention. Compared to placebo, orlistat-treated patients lost 2.7 kg (95% CI: 2.3 kg to 3.1 kg) or 2.9% (95% CI: 2.3 % to 3.4%) more weight and patients on sibutramine experienced 4.3 kg (95% CI: 3.6 kg to 4.9 kg) or 4.6% (95% CI: 3.8% to 5.4%) greater weight loss. The number of patients achieving ten percent or greater weight loss was 12% (95% CI: 8% to 16%) higher with orlistat and 15% (95% CI: 4% to 27%) higher with sibutramine therapy. Weight loss maintenance results were similar. Orlistat caused gastrointestinal side effects and sibutramine was associated with small increases in blood pressure and pulse rate.

REVIEWERS' CONCLUSIONS

Studies evaluating the long-term efficacy of anti-obesity agents are limited to orlistat and sibutramine. Both drugs appear modestly effective in promoting weight loss; however, interpretation is limited by high attrition rates. Longer and more methodologically rigorous studies of anti-obesity drugs that are powered to examine endpoints such as mortality and cardiovascular morbidity are required to fully evaluate any potential benefit of such agents.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Division of Clinical Pharmacology, Sunnybrook and Women's College Health Sciences Center, Room E2-42, 2075 Bayview Avenue, Toronto, Ontario, Canada, M4N 3M5.

    ,

    Source

    MeSH

    Anti-Obesity Agents
    Appetite Depressants
    Body Weight
    Cyclobutanes
    Humans
    Lactones
    Obesity
    Orlistat
    Randomized Controlled Trials as Topic
    Weight Loss

    Pub Type(s)

    Journal Article
    Meta-Analysis
    Review
    Systematic Review

    Language

    eng

    PubMed ID

    15266516

    Citation

    Padwal, R, et al. "Long-term Pharmacotherapy for Obesity and Overweight." The Cochrane Database of Systematic Reviews, 2004, p. CD004094.
    Padwal R, Li SK, Lau DC. Long-term pharmacotherapy for obesity and overweight. Cochrane Database Syst Rev. 2004.
    Padwal, R., Li, S. K., & Lau, D. C. (2004). Long-term pharmacotherapy for obesity and overweight. The Cochrane Database of Systematic Reviews, (3), p. CD004094.
    Padwal R, Li SK, Lau DC. Long-term Pharmacotherapy for Obesity and Overweight. Cochrane Database Syst Rev. 2004;(3)CD004094. PubMed PMID: 15266516.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Long-term pharmacotherapy for obesity and overweight. AU - Padwal,R, AU - Li,S K, AU - Lau,D C W, PY - 2004/7/22/pubmed PY - 2004/12/16/medline PY - 2004/7/22/entrez SP - CD004094 EP - CD004094 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 3 N2 - BACKGROUND: Worldwide prevalence rates of obesity and overweight are rising and safe and effective treatment strategies are urgently needed. A number of anti-obesity agents have been studied in short-term clinical trials, but long-term efficacy and safety need to be established. OBJECTIVES: To assess/compare the effects and safety of approved anti-obesity medications in clinical trials of at least one-year duration. SEARCH STRATEGY: MEDLINE, EMBASE, the Cochrane Controlled Trials Register, the Current Science Meta-register of Controlled Trials, and reference lists of original studies and reviews were searched. Date of last search was December 2002. Drug manufacturers and two obesity experts were contacted in to detect unpublished trials. No language restrictions were imposed. SELECTION CRITERIA: Double-blind, randomised controlled weight loss and weight maintenance trials of approved anti-obesity agents that 1) enrolled adult overweight or obese patients, 2) included a placebo control group or compared two or more anti-obesity drugs 3) used an intention-to-treat analysis, and 4) had a minimum follow-up period of one year. Abstracts and pseudo-randomised trials were not included. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed all potentially relevant citations for inclusion and methodological quality. The primary outcome measure was weight loss. MAIN RESULTS: Of the eight anti-obesity agents investigated, only orlistat and sibutramine trials met inclusion criteria. Eleven orlistat weight loss studies (four of which reported a second year weight maintenance phase) and five sibutramine studies (three weight loss and two weight maintenance trials) were included. Attrition rates averaged 33% during the weight loss phase of orlistat trials and 43% in sibutramine studies. All patients received lifestyle modification as a co-intervention. Compared to placebo, orlistat-treated patients lost 2.7 kg (95% CI: 2.3 kg to 3.1 kg) or 2.9% (95% CI: 2.3 % to 3.4%) more weight and patients on sibutramine experienced 4.3 kg (95% CI: 3.6 kg to 4.9 kg) or 4.6% (95% CI: 3.8% to 5.4%) greater weight loss. The number of patients achieving ten percent or greater weight loss was 12% (95% CI: 8% to 16%) higher with orlistat and 15% (95% CI: 4% to 27%) higher with sibutramine therapy. Weight loss maintenance results were similar. Orlistat caused gastrointestinal side effects and sibutramine was associated with small increases in blood pressure and pulse rate. REVIEWERS' CONCLUSIONS: Studies evaluating the long-term efficacy of anti-obesity agents are limited to orlistat and sibutramine. Both drugs appear modestly effective in promoting weight loss; however, interpretation is limited by high attrition rates. Longer and more methodologically rigorous studies of anti-obesity drugs that are powered to examine endpoints such as mortality and cardiovascular morbidity are required to fully evaluate any potential benefit of such agents. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/15266516/full_citation L2 - https://doi.org/10.1002/14651858.CD004094.pub2 DB - PRIME DP - Unbound Medicine ER -