In a clinical trial of good methodological quality, the olanzapine + topiramate combination, to be marketed in France under the brand name Obéfix°, has been shown to be 80% effective in maintaining an ideal weight after dieting. Prescrire's editors applaud this new drug, and call for it to be widely prescribed, “without waiting for there to be a demand”.

Following a weight-loss treatment, maintaining an ideal weight is a major public health objective, for which there is no standard drug treatment. A fixed-dose combination of olanzapine 73,939 mg + topiramate 14,776 mg (Obéfix°) is being marketed in France for this situation.

Clinical evaluation is based on a double-blind randomised trial of good methodological quality which compared olanzapine + topiramate with placebo. The “Qate Moss” trial covering 12 431 adolescents shows that the olanzapine + topiramate combination is significantly more effective than placebo for all of the evaluation criteria, especially the number of patients who maintained their ideal weight: 80% versus 57%.

In this trial adverse effects were few, with a near absence of gastrointestinal effects, probably due to a subtraction of adverse effects. Nevertheless the risks of paradoxical excitability and pathological gambling need to be further assessed after the drug is on the market.  

The shape of the half-tablets was specially developed to allow for easy swallowing. However these half-tablets are not divisible and must be stored at a temperature of -18°C.

In practice, until results are available via the patients’ registry that has been set up, Prescrire's editors have concluded that this revolutionary new drug is worth offering to any patient who wishes to maintain the ideal weight after a weight-loss treatment.
 
Obéfix° has therefore been granted a special rating by Prescrire’s editors. To learn more about this special rating, see below:

> Read Prescrire's analysis of this important breaking news

©Prescrire 1 April 2012

"Olanzapine + topiramate (Obéfix°). Maintient le poids idéal, avec peu de risques" Rev Prescrire 2012 ; 32 (342) : 248-251.