Axokine only causes 3.4 lbs more weight loss than placebo after one year

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Friday, September 10, 2004 7:13 am Email this article
People injected with the drug Axokine only lost 3.4 pounds more after a year than those given a placebo. The average weight loss was 7.9 pounds for those given Axokine compared to 4.5 pounds for those given a placebo.

A previous study found that Axokine caused an average weight loss of 10.1 pounds in three months.

The results of the one year study suggest that Axokine is not very effective long-term, especially considering the drug has to be injected.

Results of phase III trial that involved 1968 people, average weight 235 lbs

These are the preliminary results of a phase III trial that involved 1467 people injected with Axokine, and 501 people injected with a placebo. The average weight for all participants was approximately 235 pounds. Body mass index (BMI) ranged from 30 to 55 for people without obesity-related health problems, and 27 to 55 for those who did.

Problem: Two-thirds of people develop antibodies to the drug

One problem is that roughly two-thirds of people develop antibodies to the drug after about three months of use which results in less weight loss.

Those who did NOT develop antibodies versus those who DID: 12.6 lbs vs 6.4 lbs

The average weight loss for the roughly one-third of people who did not develop antibodies to Axokine was 12.6 pounds compared to 6.4 pounds for those who did develop antibodies compared to 4.5 pounds for those given a placebo.

Early responders who did NOT develop antibodies: 7.2 pounds greater than placebo; 19.4 lbs vs 12.2 lbs

Early responders, defined as people who lost at least 4 pounds in the first month, lost the most weight.

Early responders who did NOT develop antibodies to Axokine lost an average of 7.2 pounds more than early responders given a placebo.

Early responders who did NOT develop antibodies lost an average of 19.4 pounds versus 10.6 pounds for early responders who DID develop antibodies compared to 12.2 pounds for early responders given a placebo.

Early responders who DID develop antibodies lost 1.6 lbs LESS than early responders on placebo

Note that early responders who DID developed antibodies lost LESS weight than early responders on placebo.

Only 1 out of every 11 people given Axokine (9 percent) were early responders who did NOT develop antibodies

Unfortunately, only one out of every eleven people given Axokine (9%) were early responders who did not develop antibodies.

In other words, more than 90 percent of people given Axokine will not fit this profile.

Axokine as effective as Meridia and Xenical in 9% of people, but only half as effective in the other 91%

Dr. Louis Aronne, Clinical Associate Professor at Weill-Cornell University Medical College, and Director of the Comprehensive Weight Control Program at New York Presbyterian Hospital was quoted as saying, “Axokine appears to be generally well-tolerated, and in the 30% of Axokine-treated patients who did not develop antibodies, the efficacy was comparable to currently available drugs.”

I have a lot of respect for Dr. Aronne, however, I see the results of this study slightly differently.

To me, the results of this study say that Axokine is roughly as effective as Meridia (sibutramine) and Xenical (orlistat) in 9% of people, but only half as effective in the other 91%.

One study found Meridia (sibutramine) causes 7.5 pounds more weight loss than diet alone, and a review paper concluded that Meridia (sibutramine) causes 9.5 pounds more weight loss than placebo.

Regarding Xenical (orlistat), one study found Xenical (orlistat) causes 7.2 pounds more weight loss than diet alone, and a review paper concluded that Xenical (orlistat) causes 5.9 pounds more weight loss than placebo.

Comments: Axokine not very effective for over 90% of people

Axokine does not appear to be very effective for over 90 percent of people. 

What is Axokine?

Axokine is a drug being developing by the drug company Regeneron Pharmaceuticals for the potential treatment of obesity according to their website.

Axokine is a modified form of a naturally occurring protein, called Ciliary Neurotrophic Factor which signals the satiety center of the brain to decrease food intake.

REFERENCE

Anon. Regeneron Announces Results of Phase III Obesity Study. Regeneron Press Release, 2003 Mar 31.

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