High-dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes weight loss of 10.4% vs 1.8% w/placebo

By Larry Hobbs
Fatnews, Wednesday, September 09, 2009

Overweight and 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 24 pounds versus 5 pounds with placebo after one year, or 10.4 percent of body weight versus 1.8 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 : 13.2% vs 2.4%

Sixty-four percent (64 percent) of those given the high-dose Qnexa completed the entire one-year study.

The average weight loss for the “completers” was 30 pounds or 13.2 percent of body weight versus 6 pounds or 2.4 percent of those given the placebo.

Subjects

Subjects: 2487 overweight and obese patients

“The CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States” the press release notes.

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

• 979 on placebo
• 981 on Low Dose Qnexa (15 mg phentermine / 92 mg controlled release topiramate (Topamax))

Body Weight

Starting body weight: 227 lbs

The average starting body weight was 227 pounds.

BMI

Starting BMI: 36.6

The average starting body mass index (BMI) was 36.6.

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.