Weight Loss Information

A report in the prestigious medical journal The Lancet linking diet drug Acomplia (rimonabant) to "severe adverse psychiatric events" is potentially the most damaging blow to efforts by Sanofi-Aventis to market the diet pill since the decision earlier this year to keep it off the market in the United States.

In a study published in the Nov. 17 edition of The Lancet, scientists at the University of Copenhagen reported on their meta-analysis of four clinical trials that in part formed the basis of approval of sale of Acomplia in the European Union but not in the United States.

"Our findings suggest that 20 mg per day rimonabant increases the risk of psychiatric adverse events -- ie, depressed mood disorders and anxiety -- despite depressed mood being an exclusion criterion in these trials," the researchers concluded.

"Taken together with the recent U.S. Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions," the researchers added.

While the European Medicines Agency (EMEA) has permitted continued sale of Acomplia in the European Union countries, Sanofi earlier this month conceded that sales have been disappointing -- and headlines generated by this Lancet study seem likely to make things worse.

Britain's Press Association, which publishes stories carried by newspapers around the UK, reported that "doctors have issued a new warning about the mental health hazards of taking weight-loss drug rimonabant. A review of trial evidence involving more than 4,000 patients found those taking the drug had a 40% higher risk of suffering 'adverse events or serious adverse events'."

The London Evening Standard ran a story headlined "Weight-loss pill taken by 40,000 'can lead to suicidal thoughts," and reported that "a weight-loss pill that has been used by 40,000 Britons may increase the risk of depression, anxiety and suicidal thoughts, scientists have warned."

The London Telegraph, in an equally alarming story, reported that "the safety of an slimming drug taken by tens of thousands of people in UK has been questioned after new research linked it to depression."

The Guardian, another UK newspaper, reported "people taking the weight-loss drug rimonabant have an increased risk of mental health problems, according to a study of more than 4,000 patients in four clinical trials."

Sanofi-aventis, developer of Acomplia, was sufficiently concerned by The Lancet report and a similar report that appeared this week in the British Medical Journal to rush out a statement on Nov. 16th responding to the stories.

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I worried about taking a new drug to market that had a completely new central nervous system mechanism: Acomplia (rimonabant). CNS makes me nervous. I used to work in the area, and I have a healthy respect for how little we know about it. So when you come in with something new, you have to be worried about what's going to happen, and whether your clinical trials are going to be enough to tell you about it.

And sure enough, the long, long delay at the FDA for the drug, which was (in theory) supposed to be approved in the first half of 2006, turned out to hinge on CNS side effects, among them "suicidal ideation". Now a meta-analysis has come out in The Lancet which suggests that patients taking the drug in Europe (one of the few places you can take it) have a much higher risk of depression.

You have to be careful with meta-analyses. But this one's noteworthy because, as the authors point out, depressed mood was an exclusionary factor for the studies concerned. Yet even after winnowing out those patients, the study patients seem to have been 2.5 times as likely to drop out of the trials due to depression as compared to the placebo groups. The studies totaled 2503 patients on the drug, and 1602 in the placebo groups. Depression showed up in 74 and 22 cases in those groups, respectively, which does seem to be a real effect, especially when you start by excluding anyone who seems depressed.

Compare that with the Avandia meta-analysis that has made much so much news (and come close to sinking the drug completely). Out of 14,000 patients, that one had 86 cardiac events in the treatment groups and 72 in the controls, and this in a population with underlying cardiovascular trouble. Depression is not as serious an outcome as a heart attack, to be sure, but it's nothing you'd sign up for, either. Sanofi-Aventis should stop being upset that they haven't gotten the drug on the market here, and start being glad that the lawyers here didn't get a chance to strip a few billion dollars off of them.

Hi friends, Anti obesity drug provide only modest weight loss according to new result shows. Most severely overweight patients taking anti-obesity drugs will realize only modest weight loss, especially if they fail to augment the medications with regular exercise and a healthy diet, say Canadian researchers after reviewing numerous studies on the agents' effectiveness.

Despite being touted in the marketplace as miracle pills that can melt away pounds, doctors say that in reality the medications are no panacea to society's growing obesity epidemic and should only be taken by certain people.

"I think the most important thing that people need to understand is these are definitely not magic pills," said Dr. Raj Padwal, an assistant professor of internal medicine at the University of Alberta and principal author of the review.

Padwal and his colleagues looked at the results of 30 clinical trials of three drugs recommended for obese patients for long-term use - orlistat, sibutramine and rimonabant - and found that they helped people shed on average less than 11 pounds.

"We found that the amount of weight loss on average with these medications ranges between three and five kilograms," Padwal, who specializes in treating hypertension and obesity, said from Edmonton.

Orlistat (Xenical) reduced patients' weight by 6.4 pounds, sibutramine (Meridia) by about nine pounds and rimonabant (Acomplia) by just over 10 pounds in the studies, which each lasted at least a year. Participants had a mean weight of 220 pounds, with a body mass index (BMI) of 35. A BMI of 25 is considered normal.

In their analysis published in Friday's issue of the British Medical Journal, the researchers showed that those given one of the drugs were significantly more likely to achieve the minimum weight loss target of five to 10 per cent than those given a dummy pill.

But although the drugs overall can be beneficial in reducing risk factors for cardiovascular disease and diabetes, they have differing side-effects that in some cases can be detrimental, Padwal pointed out.

For some people, sibutramine can significantly boost blood pressure; rimonabant - which is commonly prescribed in the U.K. and some European countries but not approved in Canada or the United States - can elevate the risk of mood disorders such as depression.

In fact, a review of studies published Friday in The Lancet shows that obese patients taking rimonabant have a 40 per cent increased risk of developing severe depression and anxiety compared to those taking a placebo. Participants were up to three times more likely to stop taking the drug because of those mood disorders.

Padwal said getting patients to stick with any of the three weight-loss drugs long-term is a challenge.

"There's a large disconnect between what patients want in terms of weight loss and what practitioners desire," he said. "So patients will often want to lose . . . about 30 to 40 per cent of their initial weight. They want to get down to the weight they were in high school, two to three decades earlier."

"And they're disappointed when they're told that's going to be difficult to achieve."

Cost is also a major factor: orlistat and sibutramine (the only ones approved in Canada) will set back patients $80 to $130 per month, he said, noting that the drugs along with rimonabant represent more than $1 billion in worldwide sales for their makers each year.

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