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BMJ 2008; 337 doi: (Published 28 October 2008) Cite this as: BMJ 2008;337:a2294

Tesofensine works for weight loss

A phase II randomised double blind placebo controlled trial suggests that tesofensine—an inhibitor of the presynaptic uptake of noradrenaline, dopamine, and serotonin—may help people shed more weight than drugs currently approved for weight loss. Two hundred and three people (70% women) with a body mass index between 30 and 40 were randomised to receive placebo or tesofensine at doses of 0.25 mg, 0.5 mg, or 1.0 mg once a day for 24 weeks, in addition to the prescription of an energy restricted diet. One hundred and sixty one participants (79%) completed the study.

At six months, the adjusted mean weight reduction above that of placebo was 4.5% (4.5 kg, standard error 0.87, P<0.0001) for tesofensine at a dose of 0.25 mg, 9.2% (9.1 kg, 0.91, P<0.0001) at a dose of 0.5 mg, and 10.6% (10.6 kg, 0.84, P<0.0001) at a dose of 1.0 mg. Compared with placebo, the highest dose of tesofensine tripled the proportion of people who lost 5 kg or more. Also, measures of body composition and fat distribution showed that, although tesofensine caused loss of abdominal fat, lean body tissue was not lost. The most common adverse events were dry mouth, nausea, constipation, hard stools, diarrhoea, and insomnia.

However, some of the weight came back in the two months after people stopped taking placebo or tesofensine. People who had been taking placebo increased their body weight by 0.50% (standard error 0.40), compared with 0.82% (0.38) for 0.25 mg tesofensine, 2.26% (0.38) for 0.5 mg tesofensine, and 3.81% (0.43) for 1.0 mg tesofensine. The authors conclude that tesofensine could as much as double the weight loss achieved with currently available drugs, but bigger trials are needed to confirm this.

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