Monday, May 28, 2007

Ramonabant (Acomplia) for Weight Loss - Sinner or Saint?

If you went to college in the 60's and 70's you may remember the "munchies" or voracious appetite which sometimes accompanied marijuana smoking. Little did the pot heads of that day realize that medications in the future which block the munchies would help them shed the pounds that they would gain over the next 30 or so years.

This new medication, ramonabant (affectionately known at metabolism.com as Ramona), brand name Acomplia, is presently available in Europe and may soon be available in the United States. The company which produces this medication, Sanofi-Aventis, has been in lengthy negotiations with the FDA regarding gaining the critical approval required to bring Acomplia to market in the U.S. There has been much speculation about the reasons for the lengthy delay in gaining approval from the FDA. One possible reason is that although extensive clinical trials suggest that the new drug is safe and effective for weight loss, many experts are concerned about potential side-effects of ramonabant.

Studies show that about 30-40% of obese people taking ramonabant lost more than 5% of their body weight and 10-20% of subjects lost over 10% of their body weight above what they lost on diet alone. Because Ramona acts on the liver as well it had beneficial effects on triglycerides and other fats in the blood. Blood pressure reduction has also been observed with Ramona treatment.

Ramona works by blocking an important chemical pathway in the brain known as the endocannabinoid system. Scientists speculate that our body naturally manufactures substances resembling cannabis (marijuana, pot, reefer erc.), which interact with the endocannabinoid system. The endocannabinoid system not only participates in the control of appetite but is active in many areas of the body including the gastrointestinal tract, mood regulation, bone development, muscle control, blood pressure, adaptation to stress and the reproductive system. Several experts such as University of Colorado at Colorado Springs biology professor Dr. Robert Melamede have warned that the long term use of Ramona for weight loss could result in unwanted side-effects involving these other body systems. In fact, depression is listed as one of the side-effects that may limit Ramona's tolerability occurring in about 3% of obese subjects in a weight loss study. Nausea was another important limiting side-effect.

Industry experts speculate that Acomplia may be available for U.S. consumers by this summer but no one knows for sure. Insurance companies in the U.S. will not pay for medications for weight loss. Only a drug that treats a medical illness or condition will be "covered" by an insurance company. For that reason it is thought that Sanofi-Aventis will approach the FDA for an approval to use Ramona in the treatment of diabetes. This is because many diabetics will see an improvement in their blood sugar as they lose weight and because Ramona may have a direct beneficial effect on glucose and cholesterol regulation, as well. It will then be up to the FDA to finish their analysis of the safety and efficacy of the drug for this purpose. How long this will take is anyone's guess.

In the meantime we wait and wait and wait for Ramona. At metabolism.com we have been thinking that it might help if our members wrote a song about their feelings on the matter.

We took a stab and came up with this little ditty.

(in a Calypso beat)


Lyrics by GPepper, Director Metabolism.com

Oh Ramona, Oh Ramona


Why you left me so blue?


Xenical not nearly so sweet as you.

Oh Ramon, My Ramona


Me want to shed these ugly pound


Me getting to look so soft and round

Oh Ramona, Oh Ramona


Why you left me so blue?


I'm all alone wit'a powerful taste for some yellow cheese fondu.

Oh Ramona, Oh Ramona


I don't know if you sinner or saint


You make my liver happy but the rest of me body complaint.

Please add your comments and your own song to the blog at metabolism.com. It may help you feel better.

Only you and your doctor can decide on what medical treatments are best for you. The articles on metabolism.com such as this one are meant for educational purposes only and should not be used to guide you in your medical care. Speak to your health professional before undertaking to change or initiate medical treatment plans.

Gary Pepper M.D.


Editor-in-Chief


http://metabolism.com

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