[MrsJim]

Now everyone knows I'm a COMPLETE skeptic, but ya know I'll be watching how THIS develops:

One pill attacks smoking, obesity

SOUNDS ALMOST TOO GOOD TO BE TRUE

By Marilynn Marchione
Associated Press


NEW ORLEANS - An experimental pill that offers the fairy-tale promise of helping people lose weight and quit smoking has gathered even more stardust.

The biggest test yet of the drug found that it helped people not only drop pounds but also keep them off for two years -- longer than any other diet drug has been able to achieve. Cholesterol and other health measures improved, too.

The impressive results from a study of 3,040 obese people were presented at a medical conference Tuesday, capping months of anticipation about the new drug, Acomplia, made by the French pharmaceutical firm Sanofi-Aventis.

Doctors called the research exciting and the company, which funded the study, thinks the drug could have blockbuster potential similar to cholesterol-lowering statin drugs.

In a study of obese people throughout the United States and Canada, those given the higher of two doses of the drug lost more than 5 percent of their initial body weight, and a third of them lost more than 10 percent.

"They achieved and maintained a weight loss of 19 pounds as compared to 5.1 pounds in the placebo group,'' said Dr. F. Xavier Pi-Sunyer of Columbia University in New York, who led the research and presented results at the American Heart Association conference.

Those who quit taking the pill in the second year of the study regained most of what they had lost, suggesting that people might have to take the drug indefinitely to maintain a lower weight.

About two-thirds of U.S. adults are overweight or obese, raising their risk of everything from cancer and cardiovascular disease to sore joints and snoring. About a fourth of U.S. adults smoke, which brings many of the same health woes.

It has been difficult to develop effective treatments for either problem. Diet drugs in particular have a checkered history, most notably the withdrawal from the market in 1997 of the popular "fen-phen'' drug combination after users developed heart valve problems.

Drugs now on the market either are designed for short-term use or have distasteful side effects like bowel problems that make many shy away from them.

Acomplia's maker thinks it will avoid those problems by attacking obesity in a novel way, and plans to seek federal approval for it next year.

It is the first diet drug aimed at blocking the "pleasure center'' of the brain and interfering with the cycle of craving and satisfaction that drives many compulsive behaviors and addictions. This same circuitry is activated when people smoke marijuana.

Wait and see...note that the article does say the drug would have to be taken indefinitely - kind of like a birth control pill. IF IT IS SAFE AND EFFECTIVE, shoot - I wouldn't mind taking a pill every day to help lose and maintain a healthy weight! Of course, that doesn't mean I wouldn't be watching my nutrition and exercise...

[MichelleRae]

I saw that on the news yesterday!! I'm curious to hear more about it once it is actually out on the market.

[ali_cat]

Well, think logically about that, if you are taking the pill to help lose weight, odds are your subconcious is going to kick in and you are going to be doing things you wouldn't normally do to:

A: Make the process go even faster

and

B: Keep the weight off.

Kind of like when you get something new and kind of expensive, you coddle it for a while so it won't get broken without even realizing it. Many people do this, it's normal. Odds are while you're taking the drug, you're lifestyle would change to the point that if you went off the pill and gained a few pounds, it wouldn't matter, because with your new lifestyle you'd lose them again anyway. The reason they gained weight after going off the pill was probably because this was a controlled study, and they told the participants not to do anything out of the ordinary (AKA: eat differently or exercise more than they were doing).

[MrsJim]

Originally Posted by ali_cat

Well, think logically about that, if you are taking the pill to help lose weight, odds are your subconcious is going to kick in and you are going to be doing things you wouldn't normally do to:

A: Make the process go even faster

and

B: Keep the weight off.

Kind of like when you get something new and kind of expensive, you coddle it for a while so it won't get broken without even realizing it. Many people do this, it's normal. Odds are while you're taking the drug, you're lifestyle would change to the point that if you went off the pill and gained a few pounds, it wouldn't matter, because with your new lifestyle you'd lose them again anyway. The reason they gained weight after going off the pill was probably because this was a controlled study, and they told the participants not to do anything out of the ordinary (AKA: eat differently or exercise more than they were doing).

Guess we'll see what transpires. From what I've read, there has been EXTENSIVE testing and study on this drug already (I'd think that the pharmeceutical companies are being extremely cautious after the Redux/Phen-Fen debacle of the 1990's). I've found a report of one of the studies - this is the 2-year North American study of the drug, known as Acomplia.

Note that the people that gained weight after going off the pill in the second year were on a placebo - they didn't know that they were off the pill. Additionally, all participants were on a reduced-calorie diet throughout the study.

The RIO-North America Study

This North American multi-center, double-blind, placebo-controlled study enrolled 3,040 overweight or obese patients -- approximately 80 percent of them women -- from 72 medical centers in the United States and Canada.

Patients were randomized to receive for one year either a low daily, fixed dose of 5 mg of Acomplia, a higher dose of 20 mg of Acomplia, or a placebo.

After the first year, patients on either dose of Acomplia were rerandomized to receive either the same dose of Acomplia or a placebo for a second year.

Throughout the study, calorie intakes were reduced by 600 calories per day.

The primary objective of the trial was to assess weight loss over one year, and then to determine the ability of Acomplia to prevent regaining weight during a second year of treatment.

Secondary objectives included an assessment of improvement in risk factors associated with abdominal obesity (dyslipidemia), and glucose metabolism and metabolic syndrome.

Patients on the higher dose of Acomplia were far more successful in losing weight and maintaining weight loss than patients on the lower dose or in the placebo control group.

Some 62.5 percent of patients treated for the full two years with the higher dose of Acomplia lost more than 5 percent of their body weight compared to 36.7 percent of those on the low dose of Acomplia and 33.2 percent of patients in the control group.

Moreover, 32.8 percent of patients treated for the full two years with the higher dose of Acomplia lost more than 10 percent of their body weight compared to 20 percent of patients on the low dose of Acomplia and 16.4 percent of patients in the control group.

The researchers also reported that patients treated for two years with the higher dose of Acomplia reduced their waist circumference by an average of 3.1 inches compared to 1.9 inches for those on the low dose of Acomplia and 1.5 inches for patients in the control group.

The researchers also reported that those treated with the higher dose of Acomplia increased their HDL cholesterol (good cholesterol) by 24.5 percent compared to 15.6 percent for those on the low dose of Acomplia and 13.8 percent for those in the control group.

At the same time, patients treated with the higher dose of Acomplia for two years lowered their triglycerides by 9.9 percent, compared to 5.6 percent for patients on the low dose of Acomplia and 1.6 percent for those in the control group.

For those patients with metabolic syndrome at the outset of the study, approximately one third of those taking the higher dose of Acomplia for the full study period no longer had this problem at the end of the two years.

Diabetic patients were not included in the study, but researchers reported that patients on the higher Acomplia dose significantly improved their insulin sensitivity compared to those on the lower dose of Acomplia and on the placebo.

"The effect of rimonabant on HDL-cholesterol, triglycerides, fasting insulin and insulin sensitivity appeared to be twice that which would be expected from the degree of weight-loss achieved," the researchers reported.

The researchers also reported that side-effect and safety results derived from the trial were also encouraging.

"Side effects were mainly minor and short-lived," the researchers reported. They said 12.8 percent of patients taking the higher dose of Acomplia dropped out of the trial during the first year as a result of adverse events, compared to 9.4 percent taking the lower Acomplia dose and 7.2 percent of those in the control group.

They reported that the drop-out rate for those who continued treatment for a second year was 6.0 percent for those taking the higher dose of Acomplia, compared to 8.3 percent for those taking the lower dose and 6.7 percent for those in the control group.

"No differences were noted in the three groups with regards to scores measured by the Hospital Anxiety Depression scale," the researchers reported. And they said that in this trial and in two preceding studies, Acomplia was also shown to produce no significant EKG or heart rate changes.

"The results from this study data are consistent with the findings from two previous large-scale studies on rimonabant -- RIO-Lipids and RIO-Europe -- communicated earlier this year and add to the ever-growing body of evidence supporting the drug's efficacy and tolerability profile," the researchers concluded.

Dr. Xavier Pi-Sunyer, Chief of the Division of Endocrinology at Saint Luke's - Roosevelt Hospital Cente in New York and lead researcher on the study, added:

"The two-year results of the RIO-North America trial confirm that rimonabant is an innovative and promising tool for the long-term management of weight and associated cardiovascular risk factors in abdominally obese patients.

"There was no evidence that this drug in two years had something we have to worry about in regard to safety," he added.

[markgm]

As much as I think some day there will be a miracle pill, it makes you wonder. Look at all of these drugs and what they do to people. I love listening to these commercials and wondering why people even bother. Eye drops for dry eyes that can cause temporary blindness and burning. A feminine product that can cause dementia and heart attack. Heck, just look at what the research is saying high fructose corn syrup does to us. (Maybe I should cut back on the splenda!)

I guess my point is even though it takes a lot of work, I'd rather watch what I eat and exercise than take a pill which will lower heath risks of being overweight only to cause a side effect of paralysis or something.

[MrsJim]

Originally Posted by markgm

I guess my point is even though it takes a lot of work, I'd rather watch what I eat and exercise than take a pill which will lower heath risks of being overweight only to cause a side effect of paralysis or something.

I've read quite a bit now about Acomplia, and the way it works is NOT to 'lower health risks of being overweight' - what it's supposed to do is reduce or eliminate CRAVINGS for food - that dreaded HEAD HUNGER which is, IMO, the main reason 'diets don't work' for so many, and the bottom-line reason for our obesity epidemic. Many, many, MANY times in the past, I've eaten - or overeaten - not because I was hungry, but because the food was there and I was/am addicted to the taste. Of course, if this drug (as well as the promising-sounding Hoodia plant - see the sticky thread in this forum) works like it's supposed to, its function is NOT to 'melt off fat' or 'burn fat' - you STILL need to do the work of eating right and exercising, making those healthy, permanent lifestyle changes...however, taking a SAFE and EFFECTIVE drug to reduce/eliminate cravings for food (or smoking, or drug/alcohol abuse) would help tremendously. I wholeheartedly believe that sugar and fat are as addicting as tobacco, alcohol or drugs, and YUP - if there was a safe and effective pill available to help with those cravings that can be taken on a long-term basis, I would most definitely ask my doctor about it, because even though it's been 15 years since I was obese, those cravings can really do a number on me...

The spectre of Phen-Fen is always in the background...IMO, as previously stated, I believe that the pharmecutical industry learnt a valuable (and costly) lesson from that experience and will be VERY careful about both short-term and long-term safety.

But I already take a BCP and a multivitamin every day anyway. I know quite a few people on daily meds - HRT, blood pressure, heart meds, etc. To be able to take a daily medication to allieviate those killer cravings...I wouldn't have a problem with that whatsoever, as long as it's SAFE AND EFFECTIVE. We'll see what happens...

[ChickNextDoor]

This is all very interesting. I have read very little about this drug but it does show some promises. I am so afraid of medications now I doubt I would take it. I took Celebrex and now you read all this terrible stuff about it. And the weight gain was terrible. Who knew? It would be so nice to have a pill to take but realistically I'm sticking to my calorie counting.

[basic75]

I think the best thing to do it stay away from drugs to loss weight. I took phen-fen when i was 15 years old. By the time i was 17 teen i started passing out. My heart was damaged and know ever six months i have to have my heart checked to make sure theres no bleeding. I still pass out time to time. Dr. still try to give me diet pills but i want take any to scared.

[Maimers]

Hi there. Just thought I'd drop a note on this subject. My best friend was/is actually doing the testing for this drug. She works for Sanofi in Pennsylvania. From what she says and has seen, it works. It should become available in or around May 2005. They've had extremely successful results with this drug and are very excited to be offering it soon. If I hear more from her, I'll post again and give an update. All I know is that I'll be buying some stocks in Sanofi soon. Lol.

[MrsJim]

Originally Posted by Maimers

Hi there. Just thought I'd drop a note on this subject. My best friend was/is actually doing the testing for this drug. She works for Sanofi in Pennsylvania. From what she says and has seen, it works. It should become available in or around May 2005. They've had extremely successful results with this drug and are very excited to be offering it soon. If I hear more from her, I'll post again and give an update. All I know is that I'll be buying some stocks in Sanofi soon. Lol.

That's interesting!

However...3 months sounds a bit soon for a prescription drug to be put on the market. The most recent information I could find says that Sanofi is still doing clinical trials on the drug - doesn't look like it's even gotten to the FDA yet. And with the recent news regarding other prescription drugs such as Vioxx and in the past with Redux and fenfluramine, I'm sure that the FDA will be very, VERY careful in reviewing Acomplia.

Perhaps you meant 2006?

[MrsJim]

Originally Posted by Amarantha

I don't believe in miracle pills, no matter how promising or extensively studied. IMO, sooner or later, a whole lot of even the most established and respected drugs runs into a snag and they find out that people are dying from them (does Vioxx ring a bell? )

It's been my recent experience that you can pretty much eliminate a good deal (not all) of food cravings by, er, just not eating the offending food for awhile (in my case, sugar and white flour).

Many people stop smoking without any pills at all.

Many people lose weight without any pills at all.

Dunno. I just don't believe in pie in the sky ... seems like it'd be simplest to just stop smoking and just eat less and move more.

That may be true - and if you look at many of my previous posts, you'll know that I'm one of the all-time biggest skeptics as well as a fervent advocate for 'eat less/move more' (after all, that's how I lost AND how I've kept off 115 pounds over the past 15+ years). However...I think that there IS a definite need for a truly SAFE and EFFECTIVE (emphasis on SAFE) pharmeceutical weight loss aid for a variety of reasons - just off the top of my head:

* The HUGE increase in weight loss surgeries - which is supposed to be utilized as a last resort after everything else (regular diet and exercise) has failed, to me is a PRIME reason to be looking for other medical alternatives. Often it is not covered by insurance (and more and more carriers or employers are declining to cover the surgery) and it's a fairly risky procedure, with a very high price tag. IMO having a viable pharmecutical alternative to WLS would definitely be a plus.

* I remember back in the 1970's & 80's there were TONS of 'miracle hair restorer' products on the market...maybe as many or MORE than there were 'miracle weight loss' products. Then in 1988, Rogaine became the first pharmaceutical ever approved by the US Food and Drug Administration as being safe and effective for hair growth (followed in 1998 by Propecia) and the VAST majority of those 'miracle hair cures' went POOF. I can easily see that happening in the event that a truly safe and effective weight loss medication (I would rather not use the term "Magic pill") is found. If Acomplia turns out to be 'what the doctor ordered'...IMO that would be a fatal, or near-fatal, blow to many of the weight loss snake-oil hucksters out there.

(BTW I can't resist adding that when I typed the bit about hair loss, I couldn't help but visualize that Seinfeld episode where George orders the stinky hair growth potion from China... )

And if it helps smokers quit - there's ANOTHER bonus.

Of course bottom line it comes down to 'calories in calories out'/'eat less move more' - but there are MANY people who need help - I suppose, like WLS, you would call it a 'tool'.

[marbleflys]

I work in a large med. school where the Pharm. Reps. round constantly. The next time I see the Sanofi-Aventis rep. I'll ask her for some info. on approval. marketing dates. This may become popular from a cardiovascular point of view. Since Sanofi bought out Aventis I haven't seen too many of the old pharmaceutical reps, they usually shift things around.

what caught my eye was the line about "reduction in weight circumference" (I'll beg for samples of the drug if that is true!)

In my area, on one of the local cable stations, one of the bariatric surgeons actually has an infomercial......

[NewsMom]

We've all seen what can happen to a drug touted as the miracle answer, whether it's for weightloss, arthritis, diabetes, etc. Researchers find something that truly does work, but they can't know the safety record until millions of people have volunteered to be guinea pigs for them.

All drugs are poison, in some form or another. Each of us reacts differently to the poison--some of us would take Vioxx today if we could get our hands on it, because it did NOT cause us health problems. But it was deadly for others, and we only found out too late.

I'd love to think that modern medicine could come up with an appetite suppressant that wouldn't have side effects. But when this drug comes out, I will not be among its first users, no matter how tempted I am. I will wait at least a year to see if it's truly safe. Even then, I always opt for the lowest possible dosage of any drug, because one year of public testing isn't always enough.

[MichelleRae]

New Article on Acomplia.

Experimental Diet Pill Keeping Pounds Off

By MARILYNN MARCHIONE

ORLANDO, Fla. (AP) - A second study confirms that an experimental diet pill can help people lose weight and keep it off for up to two years, setting the stage for its maker to seek approval to sell it in the United States.

The drug, rimonabant, which the French company Sanofi-Aventis hopes to sell under the brand name Acomplia, trimmed nearly 16 pounds on average from people taking the optimal dose for two years, compared with 5.5 pounds for those who took dummy pills, doctors reported Tuesday at a cardiology conference.

``The majority of the weight that was lost at one year is still maintained after two years. There is only a slight increase over that second year,'' said Dr. Luc Van Gaal of University Hospital in Antwerp, Belgium, who led the company-funded study involving 1,507 severely obese people in Europe.

About two-thirds of American adults are overweight or obese; in European countries, one-third to half are. Diet drugs sold now are only for short-term use or have unpleasant side effects that make it tough to stay on them.


Acomplia works in an entirely different way, by blocking a ``pleasure center'' in the brain, leading people to eat less and acting directly on fat cells to prevent weight gain. Company studies suggest it also might help people quit smoking.


In a North American study of 3,040 obese people reported last fall, those given the higher of two doses of the drug lost about 19 pounds and kept it off for up to two years, compared with only 5 pounds for those given fake pills.


In the new study, those on the higher dose regained some weight in the second year but fared far better than those on placebo. Waistlines in the drug group were 3.4 inches smaller after one year and 3 inches after two.


The proportion of people with metabolic syndrome - a collection of unhealthy conditions such as high blood sugar and blood pressure and low amounts of ``good'' cholesterol - went from 42 percent at the start of the study to 21 percent at two years for those on the higher dose of the drug.


Dr. Sidney C. Smith, a former American Heart Association president and cardiology chief at the University of North Carolina, said this was especially important, since 47 million Americans have metabolic syndrome.


However, the drug has side effects: 13.7 percent on the optimal dose reported nausea compared with 5.5 percent taking dummy pills, though researchers said it tended to be mild and short-lived. Rates of dizziness and diarrhea were almost twice as common on the drug.


About 19 percent on the higher dose dropped out of the study because a problem occurred, but so did 13 percent in the placebo group. Depression was the reason for discontinuing for 2.8 percent on the higher dose of the drug and 1.6 percent in the placebo group.


Dr. Julius Gaardin, a cardiologist at Wayne State University who had no ties to the study or the company, called it and similar ones on the drug ``truly landmark studies in the field of obesity.''


He said ``the safety profile was quite good'' and obesity is such a serious problem that there ought to be higher tolerability of side effects than for drugs for other conditions.


Company officials say they are on track to seek Food and Drug Administration approval within a few months.


Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, said health officials would welcome an effective obesity drug if it proved safe.


``The important message is that we want men and women to focus on heart-healthy behaviors, modifications in lifestyles that promote health,'' she said.


Smith said the drug could give people ``a wonderful jump start,'' but that for long-term success, ``there have got to be some improved behavioral and diet changes going on beyond taking a pill.''

[MrsJim]

Originally Posted by NewsMom

We've all seen what can happen to a drug touted as the miracle answer, whether it's for weightloss, arthritis, diabetes, etc. Researchers find something that truly does work, but they can't know the safety record until millions of people have volunteered to be guinea pigs for them.

All drugs are poison, in some form or another. Each of us reacts differently to the poison--some of us would take Vioxx today if we could get our hands on it, because it did NOT cause us health problems. But it was deadly for others, and we only found out too late.

I'd love to think that modern medicine could come up with an appetite suppressant that wouldn't have side effects. But when this drug comes out, I will not be among its first users, no matter how tempted I am. I will wait at least a year to see if it's truly safe. Even then, I always opt for the lowest possible dosage of any drug, because one year of public testing isn't always enough.

Well, since it is estimated that 1,000 people die each year from aspirin, I guess you *could* be right in saying "all drugs are poison". BUT on the other hand...what about lives that were prolonged or SAVED due to modern medicine? Saying "All drugs are poison" is throwing the baby out with the bathwater - really no different than saying "all carbs are bad" or whatever.

As far as studies go - Acomplia has already undergone two 2-year studies - in North America and Europe - and the results (as Michelle posted) look very promising indeed.

And as far as the comparison to Vioxx and other drugs that have been withdrawn from the market - I would presume that this would cause Sanofi to be even MORE diligent in ensuring that Acomplia, or any other new drug, is tested as rigorously as possible prior to its submission for FDA approval.

Incidentally...for those of you who wish to keep track of what's happening with Acomplia - there is a website called The Acomplia Report (produced by MedicalWeek - not by Sanofi) which has been tracking the progress of the drug and is regularly updated.