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Liraglutide 3 mg For Obesity: The SCALE Trial



saxendaThis week, the New England Journal of Medicine publishes the results of the SCALE Trial, a 56-week randomised controlled trial of liraglutide 3.0 mg vs. placebo (both groups got advice on diet and exercise), on weight loss and other metabolic variables.

The study, that enrolled about 3,700 subjects (70% of who completed the trial), showed greater clinically relevant weight loss in participants treated with liraglutide than with placebo.

Overall, at 56 weeks,

– 2 in 3 individuals on liraglutide achieved a 5% weight loss (compared to 1 in 4 on placebo).

– 1 in 3 individuals on liraglutide achieved a 10% weight loss (compared to 1 in 10 on placebo).

– 1 in 6 individuals on liraglutide achieved a 15% weight loss (compared to fewer than 1 in 20 on placebo).

The adverse effect profile was as expected from a GLP-1 analogue (mainly gastrointestinal and gall bladder related issues).

While liraglutide 3.o mg has now been approved as an anti-obesity agent in the US, Canada and Europe, its key downsides will likely be cost and the fact that it consists of a once-daily injection.

Obviously, as with any obesity treatment, discontinuation will likely result in weight regain (which is not unexpected, given that obesity, once established, becomes a chronic disease).

While in the US, where there are now 4 novel prescription medications for obesity, liraglutide 3.o mg will be the only novel anti-obesity drug available in Canada – a rather sorry state of affairs for those who need medical treatment for this condition.

Where exactly liraglutide will establish itself in the treatment of obesity in clinical practice remains to be seen (time will tell) – but for some patients at least (especially the high-responders), it will hopefully offer a useful adjunct to behavioural treatments.

@DrSharma
Edmonton, AB

Disclaimer: I have received honoraria for consulting and speaking from Novo Nordisk, the makers of liraglutide

 

 

3 Comments

  1. How many pounds did each group lose after 56 weeks?

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  2. The sponsor, Novo Nordisk, planned and performed the statistical analyses, provided editorial and writing assistance, and provided the trial drugs. (Methods)
    Dropout around 30% and LOCF, which has known positive influence (bias?) on the results.
    Why don’t you comment on this?

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    • Because I do not think that these factors are worthy of comment. The vast majority of clinical trials on new treatments are funded by industry (who else would fund them?). A 30% drop out rate is actually pretty good for obesity trials and whether LOCF over or underestimates the outcomes of these trials is still a matter of debate – which is why both outcomes are presented for readers of the paper to decide.

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