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.

Do patients have the right to demand experimental medications?

reposted from:http://blog.sciam.com

Do patients have the right to demand experimental medications?

In the October 2007 issue of Scientific American, we cover a controversial lawsuit that challenges the FDA's system of controlling access to drugs that are still in clinical trials. From the article:

Abigail Burroughs was only 21 when she died. If her father and his supporters get their wish, however, she will attain a kind of immortality, joining Brown, Griswold, Roe and Miranda in the band of ordinary citizens whose personal travails have permanently changed the way Americans live.

A lawsuit, Abigail Alliance for Better Access to Developmental Drugs v. Andrew von Esch en bach, contends that government regulations kept Burroughs from obtaining potentially lifesaving experimental cancer medicines that her doctor recommended, violating her constitutional right to defend her life. The U.S. Court of Appeals in the District of Columbia ruled against this claim in August, and the plaintiffs plan to appeal to the U.S.

What do you think?