Experimental diet drug keeps weight off for 2 years

NEW YORK Tue Dec 13, 2011 4:27pm EST

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NEW YORK (Reuters Health) - An experimental diet drug seems to help some obese people shed pounds, and keep them off for two years, researchers report.

The drug, which will be called Qnexa if it reaches the market, is a combination of the appetite suppressant phentermine and the anti-seizure drug topiramate.

So far, it's had a bumpy road to approval. Last year, the Food and Drug Administration (FDA) rejected Qnexa, citing safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

But last month, the FDA accepted a new application from Qnexa maker Vivus Inc., which is now seeking approval for the drug to be marketed with a warning that it shouldn't be used by women of childbearing age.

The new study, reported in the American Journal of Clinical Nutrition, is an extension of an earlier clinical trial. That one found that Qnexa, added to lifestyle changes, helped obese adults lose more weight over one year, versus placebo pills.

The current study suggests that the benefit lasts for two years, according to researchers led by Dr. W. Timothy Garvey of the University of Alabama at Birmingham.

By the end of two years, the 449 men and women randomly assigned to take Qnexa had lost about 10 percent of their starting weight, on average.

That compared with a two percent decline among 227 people given a placebo.

Qnexa users also showed a decline in obesity-related health problems. On average, their blood sugar and insulin levels dipped, and they were less likely than placebo users to develop diabetes.

Almost four percent of the placebo group developed diabetes per year. By comparison, just under two percent of people on a lower Qnexa dose developed diabetes each year, as did one percent of those on a higher dose.

Whether the diet drug will actually become available is still up in the air.

Qnexa and two other weight-loss drugs -- Arena Pharmaceuticals' lorcaserin and Orexigen Therapeutics' Contrave -- were all rejected by the FDA in the past year over potential safety concerns.

All three companies, though, are still working on addressing the FDA's concerns to try to win approval.

Drugmakers have struggled for years to develop weight-loss drugs that are both effective and safe.

Back in 1997, the infamous diet drug "fen-phen" was pulled from the market after reports of fatal heart-valve problems in some users. Another diet pill, Meridia, was pulled from the U.S. market last year after being linked to heart problems.

In this latest Qnexa trial, the most common side effects were upper respiratory infections, constipation, dry mouth and tingling sensations. Over two years, 3 percent of placebo users and about 4.5 percent of Qnexa users dropped out of the trial because of side effects.

For now, the drug options are few for obese people who fail to lose weight through diet changes and exercise alone.

The only drug approved for long-term use is orlistat (Xenical), which is also available as a lower-dose, over-the-counter version called Alli. But Xenical has its issues as well, including side effects of gas, uncontrolled bowel movements, and cases of serious liver problems.

SOURCE: bit.ly/uqZTQe American Journal of Clinical Nutrition, online December 7, 2011.

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Comments (3)
If it really works, the shakes’n fries lobby will find some way to get it banned.
Sterling Greenwood/Aspen

Dec 13, 2011 6:08pm EST  --  Report as abuse
gregbrew56 wrote:
On the contrary, the shakes ‘n fries lobby will L-O-V-E it!

Here’s a suggestion: EAT LESS, EXERCISE MORE. Works every time.

Dec 13, 2011 7:18pm EST  --  Report as abuse
MikeNP wrote:
Think about it. With this (very likely VERY expensive and not covered by insurance) drug people only lost 10% of their body weight over 2 years!! A 200 lb person would only lose 20 pounds and it would take 2 years. Eating properly, exercising, and getting adequate sleep the same person can lose that 10% in less than 2 MONTHS. Americans are looking for a pill to fix their bad habits. I have struggled with my weight for years and found the ONLY cure is to change what I put in my mouth and how much I move around. I have found I also need a support and accountability person (persons) who is not my wife. This is available to many people.

Also, wait a few years and people will likely develop serious illnesses and die from this “wonder drug.” (Anyone remember Phen-Fen??)

Dec 15, 2011 2:24pm EST  --  Report as abuse
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