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Weight loss 'doubled' with diet drug

27th October 2008

An early study into a still experimental dieting drug shows it may prove to be twice as effective as currently available weight loss medications.

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If results from the Denmark-based study of tesofensine are confirmed, the drug could be marketed as an alternative to current drugs which will enable dieters to shed twice as many pounds.

Arne Astrup of the University of Copenhagen said that while researchers did not compare the drug tesofensine head-to-head with currently approved weight loss medications, the weight loss in the tesofensine study was roughly double that reported in trials of these drugs.

The study was financed by Danish biopharmaceutical company Neurosearch, which hopes to market tesofensine as a weight loss drug.

Astrup said drugs now on the market yielded at best a weight loss of 5 kilograms (11 pounds) with diet and exercise, while dieters taking tesofensine doubled that amount.

The drug is designed to target the central nervous system, affecting three different appetite regulatory centers of the brain - the neurotransmitters noradrenaline, dopamine, and serotonin.

Writing in The Lancet, researchers said the trials included 203 obese patients whose average weight was about 220 pounds.

All the participants were placed on a calorie-restricted diet and all were asked to increase their physical activity to between 30 minutes to an hour a day.

Participants were treated with either a placebo, 0.25 milligrams of tesofensine, 0.5 milligrams of the drug, or 1 milligram of the drug daily.

In the 161 participants who completed the six-month Phase II study, average weight loss ranged from around 5 pounds in the placebo group to 28 pounds among patients taking the highest doses.

However, the higher doses were also associated with higher blood pressure, they noted.

They said doses would be adjusted in phase III trials to a 0.5 milligram dose, which produced results almost as good as the higher dose in terms of weight loss in the phase II trial.

According to Neurosearch, phase III trials are now planned for both the US and Europe, and the drug could be on the market within four years.

Drug safety expert Thomas Wadden of the University of Pennsylvania School of Medicine Center for Weight and Eating Disorders, called for larger studies to confirm the findings and produce more data.

He said an extensive assessment of the psychiatric effect of medications that operate on the central nervous system was needed.

 

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