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Ask Bonnie
April 2007


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Question #1:

There is a lot of anticipation about the drug Acomplia for Metabolic Syndrome if it is approved. What is your opinion? 

Answer #1:

Rimonabant (Acomplia), created by Sanofi/Aventis, is a Cardio/Metabolic Syndrome/Smoking Cessation drug that may approved this year. I have been tracking this. It is to be reviewed on July 27th after two long postponements. The drug is available in Europe. Once again, it is another "blocker," in particular, CB1 blocker, so buyer beware. 

The latest published clinical trial with rimonabant, the RIO-North America study, showed that in 3040 patients treated for two years, 20 mg of rimonabant produced a significant reduction in weight, waist circumference, triglycerides, and in the percentage of patients with metabolic syndrome, as well as a significant increase in HDL levels, compared to placebo. Disturbingly, however, 50% of patients in both the Rimonabant and placebo groups (and patients did not know which group they were in) dropped out before the study was finished. Furthermore, to maintain the favorable results, chronic therapy with rimonabant - which will be a very expensive drug - appears necessary. In addition, while the weight loss and reduction in waist circumference were statistically significant as compared to placebo, they were not of impressive magnitude. The average weight loss over 2 years was about 15 pounds, and the average reduction in waist size was 2 - 4 inches. And finally, about 6% of patients on rimonabant reported anxiety, and 5% reported feeling depressed. 

Shortly after market introduction, press reports and independent studies suggested that side effects occur stronger and more commonly than shown by the manufacturer in clinical studies. Reports of severe depression are frequent. This is deemed to result from the drug being active in the central nervous system, an area of human physiology so complex that drug effects are highly difficult to determine reliably. The reported development of previously clinically silent multiple sclerosis in one patient taking Rimonabant suggests that any patients with an underlying neurological condition should not take Rimonabant, given the neuroprotective role of the cannabinoid system in many experimental paradigms of neurological disease. Simply, no long-term effects known or studied; not life-changing weight-loss; incredibly expensive; contraindications not know; no explanation for 50% dropout. Hmm.

Question #2:

Now that Zelnorm has been taken off the market, if I do not want to go on another medication for my IBS, what should I do? 

Answer #2:

Get to the root of the cause! Read my article in the March newsletter entitled "Toxic Food."

Have a happy, healthy day.


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