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The drug has been shown to be twice as effective as current weight loss drugs such as sibutramine (Sibutral) and rimonabant (Acomplia) (the latter was withdrawn from the market in October 2008 due to psychiatric side effects).
Remember that the sale of the latter has just stopped in Europe and has never been allowed in the United States due to psychiatric side effects (depression, anxiety, aggression, suicidal tendencies).
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Tesofensin has attracted attention by causing involuntary weight loss in people with Alzheimer’s and Parkinson’s disease. This medicine reduces appetite by acting on the neurotransmitters norepinephrine, dopamine and serotonin.
The study, led by Arne Astrup of the University of Copenhagen, included 203 obese people on a low-calorie diet who were asked to get between 30 and 60 minutes of physical activity a day. They received either a placebo or a dose of 0.25 mg or 0.5 mg of tesofensin.
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Among the 161 participants who completed the six-month study, those who received the highest dose of the drug lost an average of 12.8 kilograms, compared with 6.7 kilograms for those with a lower dose and 2 kilograms for those receiving placebo. . But those who received the highest dose also had a relatively high increase in blood pressure.
For this reason, the phase III clinical trial will be performed with the lowest dose that has resulted in only a slight increase in blood pressure.
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Other side effects include dry mouth, insomnia, nausea and diarrhea. Participants also reported more anger, hostility and confusion.
Some experts believe that a more complex assessment of the psychiatric effects of drugs such as those acting on the central nervous system will be needed. And even more so when they act in this way on areas of the brain that are not involved in weight control.