New Scientist 1st November 2008: People weighing more than 100 kilograms who took the drug tesofensine (wikipedia | Daily Mail - A diet pill that makes you feel full as soon as you start eating), made by NeuroSearch of Copenhagen, Denmark, lost almost 13 kilograms (2 stone) in 6 months, on average - twice as much as with any previous diet drug (The Lancet, DOI: 10.1016/S0140-6736(08)61525-1). The drug makes people feel full early in a meal by increasing the pleasurable effects of three neurotransmitters. Tesofensine—an inhibitor of the presynaptic uptake of noradrenaline, dopamine, and serotonin. Larger trials to come will delay its approval, however.
Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial
Background
Weight-loss drugs produce an additional mean weight loss of only 3–5 kg above that of diet and placebo over 6 months, and more effective pharmacotherapy of obesity is needed. We assessed the efficacy and safety of tesofensine—an inhibitor of the presynaptic uptake of noradrenaline, dopamine, and serotonin—in patients with obesity.
Methods
We undertook a phase II, randomised, double-blind, placebo-controlled trial in five Danish obesity management centres. After a 2 week run-in phase, 203 obese patients (body-mass index 30−≤40 kg/m2) were prescribed an energy restricted diet and randomly assigned with a list of randomisation numbers to treatment with tesofensine 0·25 mg (n=52), 0·5 mg (n=50), or 1·0 mg (n=49), or placebo (n=52) once daily for 24 weeks. The primary outcome was percentage change in bodyweight.
Findings
161 (79%) participants completed the study. After 24 weeks, the mean weight loss produced by diet and placebo was 2·0% (SE 0·60). Tesofensine 0·25 mg, 0·5 mg, and 1·0 mg and diet induced a mean weight loss of 4·5% (0·87), 9·2% (0·91), and 10·6% (0·84), respectively, greater than diet and placebo (p<0·0001). p="">
Interpretation
Our results suggest that tesofensine 0·5 mg might have the potential to produce a weight loss twice that of currently approved drugs. However, these findings of efficacy and safety need confirmation in phase III trials.
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