Tesofensine Diet Drug - average 2 stone or 13kg loss in 6 months

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.

Source: The Lancet

Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial

Prof Arne Astrup et al

Available online 22 October 2008.

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.

The yo-yo world of diet drugs

Would you take a diet drug? See our poll right.

• 01 November 2008

IN THE world of diet pills, last week was a roller coaster.
On 23 October, Sanofi-Aventis suspended European sales of its anti-obesity drug rimonabant (Acomplia), following a recommendation from the European Medicines Agency. The EMA pointed to evidence that the drug doubles the risk of psychiatric disorders and that five people in a large study committed suicide after taking it, compared to just one in a group taking a dummy drug. Concerns over side effects led the US Food and Drug Administration to refuse approval for rimonabant last year.

But it's not all bad news for dieters. People weighing more than 100 kilograms who took the drug tesofensine, made by NeuroSearch of Copenhagen, Denmark, lost almost 13 kilograms 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. Larger trials to come will delay its approval, however.

Meanwhile, orlistat, sold over the counter as Alli in the US since February 2007, should soon be approved for pharmacy-counter sales in Europe, too.

"Sense of Fullness" drugs are no quick fix for obesity

reposted from: http://www.newscientist.com/channel/health/mg20026802.800-editorial-no-quick-fix-for-obesity.html

• 29 October 2008
• From New Scientist Print Edition.

AS THE defining epidemic of a modern age notable for overconsumption and excess, obesity is hard to beat. The increased availability of high-fat, high-sugar foods, along with more sedentary lifestyles, has helped push the number of obese people worldwide to beyond 400 million, and the number of overweight to more than 1.6 billion. By 2015, those figures are likely to grow to 700 million and 2.3 billion respectively, according to the World Health Organization. Given the health implications - increased risk of heart disease, stroke, diabetes and some cancers - anything that helps people avoid piling on the pounds must be a good thing, right?

Those who agree will no doubt welcome the growing success of researchers striving to develop "diet pills" that provide a technical fix for those incapable of losing weight any other way.

Last week a study published in The Lancet showed that tesofensine, which works by inducing a sense of fullness, is twice as effective as any other drug at enabling patients to lose weight

(see "Whirlwind week for dieters").

There's no question that advances such as this are good news for those with a strong genetic predisposition to obesity. But for the rest of us it is dangerous to see treatment as a more effective solution than prevention.

There are several reasons for this. For a start, the traditional ways of maintaining a safe weight, such as limiting what you eat, increasing consumption of fruit and vegetables and taking more exercise, are beneficial for our health in many ways.

Second, overindulgence in fatty foods has implications for the entire planet. Consider the deleterious environmental effects of the rising demand for meat. As demonstrated in our special issue on economic growth (18 October, p 40), technological fixes will not compensate for excessive consumption.

Third, interfering with the brain circuits that control the desire for food can have an impact on other aspects of a person's personality and their mental and physical health.

We need two approaches: more research into the genetics of obesity to understand why some people are more susceptible, and greater efforts to help people avoid eating their way to an early death.

Cynics will say we've tried education and it hasn't worked. That is defeatist: getting people to change their behaviour takes time and effort, held back as we are by our biological tendency to eat more than we need, and by the food industry's ruthless opportunism in exploiting that.

Drugs will be the saving of a few - as a last resort. But the global obesity problem is one of lifestyle, and the solution must be too.

From issue 2680 of New Scientist magazine, 29 October 2008, page 5