Long-term data needed on anti-obesity drugs

[doreen T]

Long-term data needed on anti-obesity drugs

Fri Jan 5, 12:19 PM ET

NEW YORK (Reuters Health) - The long-term safety and efficacy need to be documented for Xenical, Meridia and Acomplia before doctors can be certain that the benefits of these anti-obesity drugs outweigh the risks, according to a commentary appearing in The Lancet medical journal.

Xenical (known generically as orlistat) and Meridia (sibutramine) are currently approved for long-term use, while Acomplia (rimonabant) is under review by the US Food and Drug Administration.

Orlistat reduces weight by an average of 3 kilograms, whereas sibutramine and rimonabant each reduce weight by 4 kg to 5 kg, on average, Dr. Raj S. Padwal and Dr. Sumit R. Majumdar, from the University of Alberta Hospital in Edmonton, Canada, note in their article.

However, each of the agents carry potentially important adverse effects, the authors note. Treatment with orlistat is associated with frequent gastrointestinal side effects, sibutramine may raise blood pressure and heart rate, and rimonabant may increase the risk of mood disorders.

These adverse effects are typically apparent during short-term use. The greater concern, according to the authors, is what will occur with long-term use. Padwal and Majumdar comment that research on anti-obesity agents is plagued by high drop-out rates and by a lack of data on long-term illnesses and deaths.

"In light of the lack of successful weight loss-treatments and the public-health implications of the obesity pandemic, the development of safe and effective drugs should be a priority," the researchers state.

However, they say antiobesity drug trials showing important reductions in obesity-related illness and mortality "should be required either before these drugs are approved for widespread use or as a condition of ongoing approval."

SOURCE: Lancet, January 6, 2007.


http://news.yahoo.com/s/nm/20070105/hl_nm/anti_obesity_dc_2

[SidC]

According to Wikipedia (http://en.wikipedia.org/wiki/Orlistat ), Orlistat inhibits the ability of the body to digest fat, reducing fat absorption by about one third. 1 year clinical trials with orlistat resulted in:

35 - 55% losing 5% or more of their body weight
16 to 25% losing 10% or more of their body weight


So 45% of the participants lost less than 5% of their weight over the course of a year.

Further, the Wiki article says that a "significant number" of people regained all of the weight lost after going off of the drug. Surprise. No one had changed their eating habits, is my guess. No wonder the researchers are interested in the long run effects - people would have to stay on this drug permanently in order to sustain the weight loss.

Sibutramine has to be used in combination with a reduced calorie diet, according to the NIH (Medline Plus Drug Information (http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/203725.html)), and one of its common side effects is high blood pressure.

Wikipedia reports the following additional side effects of sibutramine:
Frequently encountered side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.(http://en.wikipedia.org/wiki/Sibutramine )

That sounds like fun - increased appetite and permanent induction flu on a reduced-calorie diet...

In addition, Wikipedia includes the following safety concerns with sibutramine: Studies are ongoing into reports of sudden death, heart failure, renal failure and gastrointestinal problems.

But Atkins is bad for us.

[relliott1]

In 1999, I took Meridia for a month or two. I lost about 17 lbs without really changing my eating habits, aside from the fact that the medication seemed to make me eat less. I couldn't afford to refill the prescription and so stopped taking it, and immediately gained all the weight back. LC has been a much less expensive, more successfull, and healthier option for me!

[Demi]

BBC News
London, UK
5 January, 2007


Better data on the long-term effects of anti-obesity drugs is needed before more widespread use of the therapies, a Canadian study says.

Researchers said such drugs would become more important in the future to combat the growing obesity crisis.

But the University of Alberta Hospital said in the Lancet that data on drugs already in use was limited particularly over cardiovascular outcomes.

They said there should be better testing of anti-obesity therapies.

The team analysed articles published over the last six years on three drugs - hunger suppressant sibutramine, orlistat, which restricts the absorption of fat, and rimonabant, a relatively new drug being targeted at people with diabetes.

They said the long-term impact of the drugs was not clearly known with side effects including increased blood pressure and pulse rate for sibutramine and mood-related disorders for rimonabant reported.

The three drugs are used in the UK - where one in five adults are classed as obese - although they are restricted for clinically obese people or those at risk through conditions such as diabetes.

Doctors normally only prescribe them in tandem with exercise and dietary regimes and they are not often used for longer than a year.

But the researchers said as the obesity crisis escalates, as it is predicted to do, clinicians will have to increasingly rely on drug treatment programmes.

Pandemic

Lead researcher Raj Padwal said: "In light of successful weight-loss treatments and the public health implications of the obesity pandemic, the development of safe and effective drugs should be a priority."

But he said trails should show reductions in both weight loss and clinical outcomes "should be required either before these drugs are approved for widespread use or as a condition for on-going approval".

Dr Jim Kennedy, prescribing spokesman for the Royal College of GPs, said there was little known about the long-term impact of anti-obesity drugs.

But he added: "I think the use of drugs will be limited to certain situations.

"Obesity is a complex issue and there are many factors that need to be addressed, it is not just a question of handing out drugs.

"Doctors use these drugs carefully, there are no wonder cures, but in the right circumstances they can help.

"For example, if someone's diabetes is out of control or if they need to lose weight for an operation."


http://news.bbc.co.uk/1/hi/health/6231481.stm

[bkloots]

Just my humble opinion...

The research continues for an obesity drug simply because such a drug would be a gazillion-dollar diamond mine for the drug company who could patent it.

Many of us here know how hard it is...really, really, really hard...to embrace the lifestyle required to maintain a healthy weight. Would I prefer a miracle pill? You bet! And while you're at it, give me that miracle cream that will erase wrinkles and defy aging.

Gotta go now. Time for my two hours at the gym.

[Dodger]

J...

Gotta go now. Time for my two hours at the gym.Once they get the exercise pill perfected, you can skip the gym!