Low-Dose Tesofensine Effective and Safe For Treating Obesity: Presented at ECO

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Title: Low-Dose Tesofensine Effective and Safe For Treating Obesity: Presented at ECO
URL: http://www.pslgroup.com/dg/221E3A.htm
Doctor's Guide
May 23, 2008

By Timothy A. O'Leary

GENEVA -- May 23, 2008 -- The experimental anti-obesity drug tesofensine produces significant weight loss at a 0.5-mg dose, with only mild and transient adverse effects, researchers stated here at the 16th European Congress on Obesity (ECO).

Their randomised, double-blind study, presented on May 16, enrolled 203 obese patients between the ages of 18 and 65 years with body mass indices between 30 and 40 kg/m².

Patients spent 2 weeks on a diet and exercise program, followed by 24 weeks of a calorie-restricted diet and regular daily doses of tesofensine (0.25, 0.50, or 1.0 mg) or placebo.

The patients in the 0.25-mg group, when adjusted for placebo, achieved an average reduction in body weight of 4.54% compared with 9.18% for the patients in the 0.50-mg group and 10.6% for those in the 1.0-mg group, noted lead author Arne V. Astrup, MD, Head, Department of Human Nutrition, The Royal Veterinary and Agricultural University, Faculty of Life Sciences, University of Copenhagen, Frederiksberg, Denmark.

The tesofensine caused blood pressure and heart rates to increase proportionate to the amount of drug administered, said Dr. Astrup. A 0.5-mg administration, for example, produced a mean increase of 1.6 mm Hg systolic blood pressure, 2.5 mm Hg diastolic blood pressure, and 7.7 bpm. At a 1.0-mg dose, the increase in blood pressure also was significant, said Dr. Astrup.

Adverse events were generally mild and transient, he noted. Twelve percent of the 0.5-mg group did not complete the study, as compared with 29% of the 1.0-mg group and 25% of the placebo group. Of the patients who dropped out of the study's 1.0-mg arm, 20.4% did so because of adverse effects, compared with a combined average of 8% in the other groups.

Dr. Astrup suggested that the optimal dose for tesofensine may be 0.5 mg. "There's no reason to pursue [a potential dose of 1.0 mg]," he noted, "because it doesn't produce much more weight loss, but [it] increases problems."

"Tesofensine may be more effective, with similar or less risk, than currently approved drugs, and warrants phase 3 trials," Dr. Astrup concluded.

Tesofensine is a serotonin-noradrenaline-dopamine reuptake inhibitor, initially developed for the treatment of Parkinson's disease and Alzheimer's disease.

This study was funded by NeuroSearch A/S. Dr. Astrup holds 425 shares in NeuroSearch A/S.

[Presentation title: The Efficacy and Safety of Tesofensine for Weight Loss in Obese Subjects. A 24-week Randomised, Double-blind, Placebo-controlled, Danish Multi-Centre Trial. Abstract T2:OS3.2]

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