Intervention Review

Rimonabant for overweight or obesity

  1. Cintia Curioni1,*,
  2. Charles André2

Editorial Group: Cochrane Metabolic and Endocrine Disorders Group

Published Online: 18 OCT 2006

Assessed as up-to-date: 29 JUN 2006

DOI: 10.1002/14651858.CD006162.pub2


How to Cite

Curioni C, André C. Rimonabant for overweight or obesity. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD006162. DOI: 10.1002/14651858.CD006162.pub2.

Author Information

  1. 1

    Universidade do Estado do Rio de Janeiro, Instituto de Medicina Social, Rio de Janeiro, Brazil

  2. 2

    Federal University of Rio de Janeiro, Neurology, Rio de Janeiro, Brazil

*Cintia Curioni, Instituto de Medicina Social, Universidade do Estado do Rio de Janeiro, Rua São Francisco Xavier, 524 / 7º andar / bloco D - Maracanã, Rio de Janeiro, 20559-900, Brazil. c_curioni@uol.com.br.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 OCT 2006

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Worldwide, the prevalence of obesity and overweight in industrialized countries and in a substantial number of developing countries is increasing at an alarming rate. Rimonabant is a selective cannabinoid-1 receptor antagonist that has been investigated for its efficacy in reducing body weight and associated risk factors in obese people. Phase III trials are now under way to test the use of rimonabant for long-term weight-loss. Given the prevalence of overweight and obesity, it is important to establish the efficacy and safety of rimonabant.

Objectives

To assess the effects of rimonabant in overweight and obese people.

Search methods

MEDLINE, EMBASE, The Cochrane Library, LILACS, databases of ongoing trials and reference lists were used to identify relevant trials.

Selection criteria

Randomised controlled trials comparing rimonabant with placebo or other weight loss interventions in overweight or obese adults.

Data collection and analysis

Two reviewers independently assessed all potentially relevant citations for inclusion and methodological quality. The primary outcome measures were weight loss change, morbidity and adverse effects occurrence.

Main results

Four studies evaluating rimonabant 20 mg versus rimonabant 5 mg versus placebo in addition to a hypocaloric diet lasting at least one year were included. Compared with placebo, rimonabant 20 mg produced a 4.9 kg greater reduction in body weight in trials with one-year results. Improvements in waist circumference, high-density lipoprotein cholesterol, triglyceride levels and systolic and diastolic blood pressure were also seen. However, the results with rimonabant 5 mg demonstrated a weight reduction which was only 1.3 kg greater when compared with placebo. No clinically relevant effects on plasma lipids and blood pressure were found. Rimonabant 20 mg caused significant more adverse effects both of general and serious nature, especially of nervous system, psychiatric or gastro-intestinal origin. Attrition rates were approximately 40% at the end of one year.

Authors' conclusions

The use of rimonabant after one year produces modest weight loss of approximately 5%. Even modest amounts of weight loss may be potentially beneficial. The observed results should be interpreted with some caution, though, since the evaluated studies presented some deficiencies in methodological quality. Studies with longer follow-ups after the end of treatment and of more rigorous quality should be done before definitive recommendations can be made regarding the role of this new medication in the management of overweight or obese patients.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Rimonabant for overweight or obesity

Rimonabant is the first drug of a new class of medications that seems to reduce body weight and improve risk factors for diseases of the blood vessels and heart in people who are overweight or obese. We found four studies which evaluated weight loss, occurrence of disorders and adverse effects of treatment. The four studies involved 6625 people comparing rimonabant 20 mg with rimonabant 5 mg and placebo, in combination with a hypocaloric diet after one or two years of treatment. Greater weight loss and improvement in risk factors were seen after 20 mg of rimonabant. These results have to be interpreted with caution though, due to high discontinuation rates of study participants and the overall low quality of the included studies.
We conclude that: 1. average weight loss with rimonabant appears modest, and 2. more rigorous studies examining the efficacy and safety of rimonabant are required to fully evaluate the benefit risk ratio of this new drug.
In Europe, rimonabant is contraindicated for patients with severe depression and/or patients who are treated with antidepressive medications. Rimonabant is furthermore not recommended for patients with other untreated psychiatric conditions.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

Rimonabant對於超重或肥胖的效果

超重及肥胖之盛行率,在全世界的工業化國家和相當數量的開發中國家,均以驚人的速度在增加之中。Rimonabant為一種選擇性的cannabinoid−1受器拮抗劑,且其減低肥胖者之體重及相關危險因子的效果已經過研究。目前正在進行第三期的臨床試驗,來測試長期以rimonabant減輕體重的效果。以目前肥胖及超重的盛行率而言,確立rimonabant的藥效和安全性可說是非常重要的。

目標

為了評估Rimonabant對於超重及肥胖者的效果。

搜尋策略

我們利用MEDLINE、EMBASE、The Cochrane Library、LILACS、進行中試驗的資料庫和參考文獻清單來找出相關的試驗。最後的搜尋於2006年6月時進行。

選擇標準

我們選擇在超重或肥胖成人身上進行,比較rimonabant和安慰劑或其他減重方法的隨機對照試驗。

資料收集與分析

兩位回顧者獨立地評估所有可能相關的文獻,以決定是否收錄及評估方法學上的品質。其主要結果的比較為體重減輕的改變,罹病和不良作用的發生。

主要結論

結果共收錄了4個評估rimonabant 20毫克對rimonabant 5毫克或低卡飲食加上安慰劑,且持續至少1年的研究。與安慰劑相較,rimonabant 20毫克組在1年的試驗期間當中,減輕的體重多了4.9公斤。同時在腰圍、高密度脂蛋白膽固醇和三酸甘油酯的濃度、及收縮和舒張壓方面均有所改善。然而,rimonabant 5毫克組之體重減輕,與安慰劑組相較,僅多了1.3公斤;對於血脂及血壓,亦未產生有臨床意義的效果。Rimonabant 20毫克組明顯地產生了較多一般和嚴重的不良作用,特別是在於神經系統、精神及腸胃道方面。在1年結束之時,約有40%的受試者退出試驗。

作者結論

在使用rimonabant 1年之後,可小幅減輕約5%的體重。即便只有小幅的體重減輕也可能是有益的。然而,這些觀察的結果必須謹慎地解讀,因為收錄的研究在方法學上的品質均有所缺陷。以此一新藥對於超重或肥胖者的治療角色而言,在給予確定的建議之前,我們仍需在治療結束後進行更長期的追蹤,且品質更加嚴謹的研究。於歐洲,rimonabant被禁止用於患有嚴重憂鬱症和/或在接受抗憂鬱劑治療的患者身上。更進一步,rimonabant同時也不被建議使用於有其他未治療精神疾病的患者。

翻譯人

本摘要由臺灣大學附設醫院林志弘翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

在超重或肥胖的成人身上,使用20毫克之rimonabant可造成小幅的體重減輕。對超重或肥胖的人而言,rimonabant可說是在新一類的藥物中,首先被發現能減輕體重且改善血管及心臟疾病之危險因子者。我們發現了4個評估體重減輕、疾病的發生與治療的不良效果之研究。這4個比較使用rimonabant 20毫克、rimonabant 5毫克和安慰劑加上低卡飲食1到2年之後治療效果的研究,共收錄了6625人。在使用20毫克之rimonabant後,能減輕較多的體重和改善較多的危險因子。然而,因有許多的受試者中途退出,且收錄研究的品質較差,這些結果必須謹慎的解讀。我們總結出:1. Rimonabant可小幅的減輕體重;2. 我們需要更多嚴謹的研究來完整評估此一新藥的有效性與安全性。在歐洲,rimonabant被禁止用於患有嚴重憂鬱症和/或在接受抗憂鬱劑治療的患者身上。更進一步,rimonabant同時也不被建議使用於有其他未治療精神疾病的患者。