High-dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes weight loss of 11% vs 1.6% w/placebo

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Wednesday, September 09, 2009 11:57 am Email this article
Morbidly obese patients given the highest dose of Qnexa, containing 15 mg of phentermine plus 92 mg of Topamax (topiramate), lost an average weight loss of roughly 28 pounds versus 6 pounds with placebo after one year, or 11 percent of body weight versus 1.6 percent with placebo according to a press release from press release from Vivus, Inc, the company developing the drug. Weight Loss for Those Who Completed the Study

Weight Loss for Those Who Completed the Study : 14.7% vs 2.5%

Fifty-nine percent (59 percent) of those given the high-dose Qnexa completed the entire one-year study.

The average weight loss for these patients was 37 pounds or 14.7 percent of body weight versus roughly 9 pounds or 2.5 percent of those given the placebo who completed the study.

Comment: I say “roughly” because I calculated the weight loss based on other figures which may not be the exact weight loss for the group.

 

Subjects

Subjects: 1267 morbidly obese patients

The study, which was called the EQUIP (OB-302) study, involved “1,267 morbidly obese patients (1,050 females and 217 males) across 93 centers in the United States” the press release notes.

The number on each dose of the drug was as follows:

• 498 on placebo
• 498 on High Dose Qnexa (15 mg phentermine / 92 mg controlled release topiramate (Topamax))

 

BMI

Starting BMI: 42

The average starting body mass index (BMI) was 42.1.

 

Dose

Dose slowly increased over one month

The dose was slowly increased (titrated) over four weeks.

 

Diet

Diet: Patients suggested to reduce calorie intake by 500 calories per day

Patients were asked to follow a diet that was reduced by 500 calories per day.

 

Conclusion

Conclusion: Weight loss with drug combination exceeds other agents

“The weight loss observed with Qnexa in these two one-year, double-blind, randomized trials far exceeds the weight loss observed for other agents reported in literature,” said Kishore Gadde, MD, director of obesity clinical trials at Duke University and a lead investigator.

REFERENCE

Vivus. Vivus announces positive results from two phase 3 studies; obese patients on qnexa achieve average weight loss up to 14.7% and significant improvements in co-morbidities. Press Release from Vivus Inc. 2009 Sept 09, http://ir.vivus.com/releasedetail.cfm?ReleaseID=407933

Articles on the same subject can be found here:

• Phentermine

• Qsymia (phentermine and topiramate) (formerly Qnexa)

• Topamax (topiramate)

• YouTube videos