Source: DGNews  |  Posted 3 years ago

NEW YORK -- October 23, 2008 -- Tesofensine can produce weight loss double that of currently approved obesity drugs, according to a study published early online and in an upcoming edition of The Lancet.

Arne Astrup, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Copenhagen, Denmark, and colleagues conducted a randomised, placebo-controlled, phase 2 study in 5 Danish obesity management centres.

The study involved 203 obese patients (body mass index [BMI] 30-40 kg/m²), weighing a mean of just over 100 kg. They were prescribed a limited-energy diet and assigned to once-daily tesofensine 0.25 mg (n = 52), 0.5 mg (n = 50), or 1.0 mg (n = 49) or placebo (n = 52) for 24 weeks. The primary outcome was percentage change in body weight.

A total of 161 patients completed the study, and mean weight loss recorded for placebo and diet was 2.2 kg. For tesofensine 0.25, 0.5, and 1.0 mg the mean weight loss was 6.7, 11.3, and 12.8 kg, respectively. For the 0.5 and 1.0 mg doses, this represented a weight loss around twice that attained using sibutramine or rimonabant.

Tesofensine increased blood pressure in the 1.0-mg group, and the most common side-effects were dry mouth, nausea, constipation, hard stools, diarrhoea, and insomnia.

The authors said that the 0.5 mg dose of tesofensine is more promising than the 1.0 mg dose because it produces a similar weight loss with fewer side-effects.

"We conclude that tesofensine 0.5 mg, once daily for 6 months, has the potential to produce twice the weight loss as currently approved drugs; however, larger phase 3 studies are needed to substantiate our findings."

SOURCE: The Lancet