Rimonabant (commercial name Accomplia) has completed the first year of its phase III drug approval trial with very promising results.
The first year results of the two-year trial Rimonabant In Obesity -- Europe (RIO-Europe), a Phase III clinical study comparing rimonabant, the first agent in a new therapeutic class known as selective cannabinoid type 1 (CB1) blockers, to placebo, were published today in The Lancet. The reported findings in overweight or obese patients taking rimonabant 20 mg once daily show a significant reduction in body weight, waist circumference -- a marker of intra-abdominal adiposity -- as well as improvements in insulin resistance and lipid and glucose profiles. The improvement in lipids (HDL-cholesterol and triglycerides) was shown to be partially independent from weight loss, suggesting a direct effect of rimonabant on these important metabolic cardiovascular risk parameters. The trial findings also revealed a decrease in the number of patients with metabolic syndrome(i) in the rimonabant 20 mg/day group.
Patients on rimonabant lost an extra 10 lbs over placebo, had higher HDL cholesterol, lower triglycerides, lower blood glucose, and lower insulin. All these are changes in healthy directions.
At one year, patients treated with rimonabant 20 mg/day lost an average of 14.55 lbs (p < 0.001 vs placebo) compared to 7.5 lbs for patients on rimonabant 5 mg/day (p = 0.002 vs placebo) and 3.97 lbs for those on placebo. Patients on rimonabant 20 mg/day also had an average decrease in their waist circumference of 2.56 inches (p < 0.001) versus 1.54 inches for those on rimonabant 5 mg (p = 0.002 vs placebo) and 0.94 inches for those on placebo.
Among patients completing the study, 67.4% of patients treated with rimonabant 20 mg/day lost more than 5% of their initial body weight (p < 0.001 vs placebo), compared to 44.2% of patients in the rimonabant 5 mg/day group (p = 0.001 vs placebo) and 30.5% in the placebo group. Moreover, 39% (p < 0.001 vs placebo) of patients on rimonabant 20 mg/day lost more than 10% of their initial body weight compared to 15.3% of those on rimonabant 5 mg/day and 12.4% of those on placebo.
The percentage of patients fulfilling the criteria for the metabolic syndrome was reduced by 54% after treatment with rimonabant 20 mg compared to 21% treated with placebo (p < 0.001). In addition to the reduction in weight and waist circumference, a statistically significant improvement in metabolic risk factors with rimonabant 20 mg vs. placebo was also observed. In patients treated for one year with rimonabant 20 mg/day, HDL-cholesterol (good cholesterol) increased by 22.3% (p < 0.001 vs placebo), compared to 16.2% (p = 0.005) in the rimonabant 5 mg/day group and 13.4% in the placebo group. Triglycerides were reduced by 6.8% in patients treated with rimonabant 20 mg (p < 0.001 vs placebo), compared to an increase of 5.7% and 8.3% in rimonabant 5 mg and placebo groups, respectively. Almost 50% of the rimonabant-induced changes in HDL-cholesterol and triglycerides were independent of the weight loss observed, suggesting a direct effect of the drug on lipid metabolism.
A significant reduction in fasting plasma glucose of 0.09 mmol/L was seen in patients treated with rimonabant 20 mg (p = 0.026 vs placebo) compared with an increase of 0.03 mmol/L in the placebo-treated group. A similar pattern was observed for insulin levels which decreased by 1.0 micron IU/mL in the rimonabant 20 mg group (p < 0.001 vs placebo) versus an increase of 1.8 micron IU/mL in the placebo-treated group. Finally, a decrease of 0.3% in HOMA-IR (a measure of insulin resistance) was seen in the rimonabant 20 mg group (p = 0.002 vs placebo) compared with an increase of 0.4% in the placebo-treated group.
Accomplia/Rimonabant may be on the market within a year.
Accomplia is made by the French pharmaceutical firm Sanofi-Aventis which is applying for licences to market it early in 2006 in Europe and the U.S. It is also known by its generic name Rimonabant.
Obesity contributes to heart disease, stroke, cancer, type II diabetes, and likely dozens of other diseases. A drug that reduces the incidence of obesity could substantially improve the long term health outlook for hundreds of millions of people. If no problems turn on Sanofi-Aventis stands to earn huge profits. But patients will receive the lion's share of the benefits from an effective and safe anti-obesity drug.
Might Rimonabant block a marijuana high?
Rimonabant acts by blocking receptors in the endocannabinoid system, one of the body's pleasure centers -- the same class of centers affected by marijuana.
Rimonabant may also make it easier to quit smoking.
The drug, which has progressed to phase III development, works by blocking endogenous cannabinoid binding to neuronal CB1 receptors. Activation of these receptors by endoegenous cannabinoids, such as anadamide, increases appetite. It is the only endocannabinoid receptor antagonist in clinical development and thus offers a unique therapeutic approach to appetite control and weight reduction. The drug also has potential as a treatment for smoking cessation because the endocannabinoid system is also involved in the body's response to tobacco dependence.
As things stand now many people who give up smoking gain weight. With this drug smokers may be able to lose weight and stop smoking at the same time. Imagine if this drug works out as advertised. Millions of people will be skinnier and healthier and gain longer life expectancies.
By Randall Parker at 2005 April 15 03:44 PM Brain Appetite | TrackBackIf CB1 antagonists are legal to treat obesity, shouldnt cannabis be legal to treat anorexia?
It is not fully understood why so many with the schizophrenic genome do not develop schizophrenia. Stress,diet(lack of fish oils),snd marijuana,seem to cause the condition to develop. I wonder if rimonabant,taken during adolescence,might prevent schizophrenia?
If rimonabant's inhibiting cannabinoid receptors makes you eat less, mustn't it make food taste worse? In that case, I wouldn't want to take it.
Rimonabant works! I know as I was in a clinical trial and was paid for it. NOTHING, repeat, nothing works for me and I've tried them all. When I began the study, the first thing I noticed was I got nauseated eating too much chocolate (namely the 2nd half of a candy bar) and I love chocolate. Then I couldn't finish my food on my plate, fast food - I left the fries and 1/2 the entree and started eating more salads, although I couldn't finish them either. It did not alter the taste of food, just made me full. My 'guilt factor', wasting money by not finishing food was diminished as well. My cholesterol levels got much better and I felt great with NO side effects. I wasn't told I was on drug, they didn't know either but I know my body and how it reacts. I never once excercised - I hate excercise, nor did I have the behavior modification I was supposed to, I just ate whatever I wanted but again, I never could finish anything! I only lost like 5lbs in the first 6 mo and then 2 lbs every visit. After 11 mo it really started kicking in and I lost 21# at the end of the first year. Then the second year began, I knew they switched me to placebo as I got ravanously hungry right away and even ate 1/2lb of See's chocolates without a problem! I begged them to put me back on the drug to no avail and the money wasn't even worth all the blood pokes and the urine samples so I quit. I gained my weight back and then some (maybe 5-8#) but ONLY because I was depressed, not because the drug stopped working (duh I wasn't on it anymore) but 21# was not enough, I needed to lose like 60-85# so a mere dent was depressing to me. It's been about 2 yrs since I've been off it and can't wait for it to be approved, I know it works, at least for me!
No, this drug can not currently be purchased either in the United States or Europe! It will not be available until some time 2006 if it even gets approved.
ARE THERE GOING TO BE ANY MORE CLINICAL TRIALS? I WOULD LIKE TO BE PART OF IT IF POSSIBLE.
Well I have just signed up for the clinical trial they are doing here in Michigan. As I am reading these post, I wonder if it is worth it. They say the average is 15 pounds a year, Well I have lost that just with exercise in less than two months. I as told it was a study for coronary problems that i have, and all I can find on the drug is that it helps you quit smoking, drugs and lose weight. well i dont drin or smoke any kind of substances.
Is there a clinical trial anywhere near Raleigh, NC for this???
Dear Sir; I was wondering if you ahve any info on clinical trials going on anywhere near Atlanta? I would so much like to be apart of this clinical trial. If you have any info that might be helpful please let me know.
Thank you,
Allison
I am in the Pittsburgh Pa. area and would like to be part of the study for accomplia. If anyone would have any info: katlee439@aol.com
Thanks!
Are any clinical trials for Acomplia going to be conducted in Asheville NC or Greenville NC? Please let me know.
Are there any Accomplia studies in the Pittsburgh area?
Are there any Accomplia studies in the Rio de Janeiro, Brazil, area?
Thanks
Are there any clinical trials in the New york city area?
I am responding to your posting below:
"Well I have just signed up for the clinical trial they are doing here in Michigan. As I am reading these post, I wonder if it is worth it. They say the average is 15 pounds a year, Well I have lost that just with exercise in less than two months. I as told it was a study for coronary problems that i have, and all I can find on the drug is that it helps you quit smoking, drugs and lose weight. well i dont drin or smoke any kind of substances."
Where in MI are clinical trials being done.
Sincerely,
Linda Lunsted
lunsted@aol.com
I am a 49 year old woman who has smoked for 30 years. I just can't seem to quit. I have tried everything with no luck. I am 5'5" tall and weigh approx. 170 lbs, I need to drop at least 30 pounds and I can't seem to accomplish that either. I am desperate to try something, anything, to stop smoking before it kills me. Do you know where I might find a trial study I could participate in? I live in Morganton, N.C. and haven't heard of anything going on near my area. I would be willing to drive anywhere in the state and try most anything to stop smoking. I've used the gum, patches, hypnosis, wellbutrin and cold turkey to no avail.
Thank you,
Peggy
looking for a clinical trial in houston texas
How do I get on a clinical trial in Boston??
Are there any clinical trials in Tucson Arizona?
philadelphia???
How do I get into the clinical trials in Michigan?
Is there a clinical trial in Chicago, Il.?
i would love to be a tester for accomplia; while not currently overweight, i am severly bulimic and have been 300 lbs in the past; am afraid of gaining it back due to frequent binges and purges (binges override the purges); am killing myself with excess sugar and bad eating habits; any chance of my participating?
ARE THERE ARE ANY CLINICAL TRIALS PENDING IN CANADA? I AM CURRENTLY 250 LBS. AND A TYPE 11 DIABETIC, AND ALSO WITH SEVERE FYBROMYALGIA. THIS DRUG SOUNDS TO GOOD TO BE TRUE!
Are there going to be more clinical trials for rimonabant if so are there any going to be in or surrounding areas of Dothan Al?
Will love to be part of a test group? Any in Ohio or southern Michigan? IF so, please respond ASAP. Thanks!
will there be any trials in Atlanta Georgia? If so how can i be a part of it.
To whom it may concern. I live in Wisconsin and I quit smoking about 22 months. I put on 30 pounds so far and I thought it would taper off and it hasn't. I am a compulsive overeater. The more I worry about gaining weight, the more I eat. I have this hand to mouth sort of a disorder and I constantly have to be eating or drinking something since I quit smoking. I want to go back to smoking because my eating habits are so out of control and I need help. I know its something in my brain telling me to eat because I'm not truly physically hungry. Could I please be part of a test group. This is putting me into a deep depression and I'm on 450 mg of wellbutrim XL and 80mg of prozac for the obsessive thinking I have.
I live in ft. lauderdale, fl. and I was wondering if there are any studies i can be part of. please respond.
Thank you
Any news on Acomplia/ Rimonabant release date? I need something now. I have tried everything. Shakes, patches, curves(got hurt),Isopreil, Xantrex 3 You name it. Please help in Al.any news is appreciated.
thanks
Looking for a study of this drug in Canada. Have been overweight all my life. It now is starting to effect my joints. Up until now I have been very active and would like to be again. I have tried everything right done to having my stomach stapled. Would like to look at this as an option please let me know of any studies that I can participate in. When is this drug going to be on the market.
Ellen
Amazing how many of us desperately want this help. Could this finally be the miracle drug we've been waiting for? Hope so, I have all of the problems this drug appears to help in trials to date. Please keep us updated on release news. Thanks
Can anyone tell me if there are going to be any clinical trials in Maine.
Much appreciated.
Seneca SC wouold like to try clinical trials close by
I AM CURRENTLY 239 LBS. WITH HIGH BLOOD PRESSURE SINCE I WAS 17 YRS OLD. ARE THERE ANY TRAILS FOR ACOMPLIA COMING TO THE DALLAS/FT.WORTH AREA IF SO I AM INTERESTED.
3/07/06
I had laproscopic surgery last year for Endometriosis and gained 30 pounds since then! I went through lots of tests and nothing showed up, so I guess it was just hormonal. My doctor said that I would be the perfect candidate for using Accomplia b/c I need to lose this weight fast. I exercise regularly and it doesn't seem to help me. I have always eaten healthy as well. I am just wondering if Accomplia would be a good choice for me b/c I don't over eat. I'd like to hear from someone else that maybe was educated about Accomplia by their doctor for similar reasons as me.
Are there any clinical trials beginning or currently being conducted in the DFW area in Texas?
are there any trials in Georiga? how would one go about it?
Are there any clinical trials being conducted in dallas/ft. worth area? What is the latest news on it's release date??
Are there any clinical trials being conducted in dallas/ft. worth area? What is the latest news on it's release date??
are there plans for any additional clinical studies in the los angeles area?
i want to know when it is on the market and how can i order it
I was part of one the clinical studies in Utah for Rimonabant last year to help me quit smoking. I am here to tell you all, "It really works" The affects only took me a about three weeks to start feeling and you continue to smoke gradually while you take it, then you stop smoking altogether from the target date you choose. I craved NO cigarettes at all. The funny thing is; it also curbed my appitite, not that I need to loose any weight, but that was a BIG concern I had, was weight gain. I did not gain any weight during the 3 1/2 month study. I even had less cravings to drink alcohol. I was really bummed out when the study was over. I even offered to pay money to continue taking Rimonabant but of course, since it was still in the study phases and not approved by the FDA, they said NO. Well, unfortunately; about three weeks after the study was over I started smoking again and have ever since. I really, really believe this is the wonder drug that will help so many people with overweight problems and smoking.
I can't wait for it to be approved. Even better, I hope my insurance company will someday pay for some of the costs.
When are the trials coming to Baton Rouge, LA?
If a clinicial trial is done in Reno, Nevada I would be very interested in participation. As a Lupus sufferer, my physician thought that this would help.
Hello,
I saw your discussion of Accomplia on 'The Early Show' this morning, November 29, 2006. I am interested in being placed in a trial. I have Asperger's Syndrome, severe Asthma, and also brain damage over my right eye, from fever spikes produced over a cracked tooth . I need to loose about 80 pounds. Weight loss projects cause me much stress, which causes anxiety attacks, which triggers my asthma, and distresses cognitive function. A low stress way to loose weight would be great for me.
I hope to hear from you soon.
Hey any trial studies for Acomplia in NJ?
How would someone find out where clinical trials well be started in the US? I am in Maine and would like to become part of the study...
Does anybody know how long it takes to notice a difference? Does it work the same day, or does it take weeks to build up? You can order it on line from England, by the way.
Steve