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Experimental drug achieves unprecedented weight loss
Date:4/10/2011

959, and topiramate, marketed under the trade name Topamax, in doses up to 400mg to treat epilepsy and prevent migraines. Patients in the study also received diet and exercise advice.

The study was funded by Vivus, which is seeking FDA approval to market the combination therapy under the trade name Qnexa. In October 2010, the FDA ruled that the New Drug Application could not be approved in its current form, and asked the company for more safety data.

In March, the FDA issued a warning regarding the use of topiramate during pregnancy stating that pregnant women who take the drug are at considerably increased risk of having babies born with cleft lip and/or cleft palate. Topiramate has also been associated with memory problems and mood changes, including depression and anxiety.

Gadde says 34 women became pregnant while in Qnexa clinical trials, and "no birth defects were reported for the babies born." Even so, Gadde says pregnant women would not be candidates for use of this drug because "there is no reason for women to use weight loss drugs while they are pregnant or trying to become pregnant."

The study used once-daily oral doses of the combined drugs. Phentermine 7.5mg plus topiramate CR 46mg achieved 7.8 percent weight loss (p<0.0001 vs placebo). Phentermine 15mg plus topiramate CR 92mg achieved 9.8 percent weight loss (p<0.0001 vs placebo). The placebo group experienced 1.2 percent weight loss.

The greatest improvement in cardiovascular disease and diabetes were seen in high risk patients among the groups given placebo, phentermine 7.5mg plus topiramate 40mg, or phentermine 15mg plus topiramate 92mg respectively:

  • Systolic blood pressure: -4.9mmHg, -6.9mmHg, -9.1mmHg
  • Diastolic blood pressure: -3.9mmHg, -5.2mmHg, -5.8mmHg
  • Total cholesterol: -4.9%, -5.7%, -7.8%
  • LDL: -3.6%, 0.7%, -4.3%
  • HDL: 2.8%, 9.5%, 10.7%
  • Triglycerides: -8.8%, -24.1%, -25.6%
  • Hemoglobin A1C in diabetics:
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Contact: Debbe Geiger
debbe.geiger@duke.edu
919-660-9461
Duke University Medical Center
Source:Eurekalert

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