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IMAGE SOURCE: © Qnexa, made by Vivus Inc.
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A new experimental obesity drug by Vivus Inc., met key weight loss goals in two late-stage studies.
Qnexa, a combination of an older weight-loss drug and an epilepsy drug, helped patients to reduce their weight by up to 14.7 percent over a year. Patients also reported lower blood pressure and blood sugar levels.
A second study showed an average weight loss of 13 percent. In both studies, patients taking placebo lost less than 3 percent of their weight.
Onexa is a combination of phentermine which was half of the recalled fen-phen diet pill, the other half is the epilepsy drug Topamax (topiramate). Because Topamax (Johnson & Johnson) contains suicidal behavior warnings, patients were monitored for suicide risk, although no signal was found.
The trials included a total of 3,750 patients taking one of three doses of Qnexa or placebo. Researchers tracked participants for one year and found those who received Qnexa enjoyed success rates of 67 percent and 70 percent, while participants who received placebo attained 17 percent and 21 percent success. Even more impressive was the average weight loss of 14.7 percent that one group achieved.
The promising results suggest breakthrough approaches in drug design to help severely obese people to lose enough weight to improve their health may not be needed – although, how long they can keep the weight off is yet to be seen.
The findings also suggest that targeting obesity from two directions – by altering behavior and biology – can be most successful.
Researchers have tried to tackle obesity through hormones such as leptin, brain chemicals such as neuropeptide Y and stopping the body from absorbing nutrients.
One major obstacle, however, is human behavior. While drugs can speed up metabolism, suppress appetite and even prevent the body from absorbing fat, some people gorge themselves beyond being full.
The company plans to file for FDA approval at the end of 2009 and hopes to partner with a global pharmaceutical company to begin selling the drug in late 2010.
An estimated 60 percent of U.S. adults are considered overweight or obese and 9 million are morbidly obese, with a body mass index above 40.
Another study, published in the Annals of Epidemiology, suggests among the elderly, the ratio of waist size to hip size may be a better predictor of obesity than body mass index (BMI), a comparison of a person's height to weight.
The study, of 1,189 active adults in their 70s found no association between BMI or waist size alone and all-cause mortality over 12 years. #