La première pierre dans le jardin.

Les habitués de ce blog doivent se souvenir des deux notes (ici et ici) que j’avais rédigées sur le rimonabant (Acomplia®), molécule « miracle » contre un syndrome forgé de toutes pièces pour l’occasion, le « syndrome cardio-métabolique ».

 

Je remarquais toutefois que le magnifique plan communication mis en place par Sanofi-Aventis ne parvenait toutefois pas à cacher des résultats assez maigres des essais « RIO ». Par ailleurs, la FDA (autorité de santé américaine) tarde toujours à  donner son feu vert  à sa commercialisation aux EU...

 

Le 18/10, « The heart.org » relatait la parution d’une méta-analyse dans la « Cochrane Library » confirmant cette impression.

Je n’ai jamais évoqué cette immense base de données, mais la « Cochrane Library » est en fait le temple de l’ « Evidence Based Medicine » qui représente le fondement à l’heure actuelle de la recherche médicale.

Elle est réputée pour son sérieux et sa rigueur scientifique.

L’accès au papier est malheureusement payant, je n’ai pu lire que l’abstract.

Je l’ai reproduit ci-dessous, c’est bref mais saignant.

 

Si on résume encore plus brutalement : les 4 études RIO, que tant de « leaders d’opinion » ont loué sans restriction sont méthodologiquement défaillantes.

 

En conclusion, des études jugées non rigoureuses ont montré une baisse de poids de 4.9 Kg sur un an (ce qui est loin d’être remarquable), avec des effets secondaires parfois « sérieux ».Les auteurs suggèrent de mettre en place des études dignes de ce nom pour statuer correctement sur la balance risque/bénéfice de ce traitement.

 

Attendons la réponse des auteurs du programme « RIO »….

Mais je crains que la suite de la carrière du rimonabant soit difficile.

  
 

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 Rimonabant for overweight or obesity

 

C Curioni and C André

 

Cochrane Database of Systematic Reviews 2006 Issue 4 (Status: New)

Copyright © 2006 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

DOI: 10.1002/14651858.CD006162.pub2   This version first published online: 18 October 2006 in Issue 4, 2006

Date of Most Recent Substantive Amendment: 24 August 2006

 

This record should be cited as: 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.

Next

 

Abstract

 

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 strategy

MEDLINE, EMBASE, The Cochrane Library, LILACS, databases of ongoing trials and reference lists were used to identify relevant trials. The last search was conducted in June 2006.

 

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

Rimonabant 20 mg produces modest weight loss among adults with 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.