Good news from Istanbul

By: John Scott
Submitted: 2008-05-15 10:33:16
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I am always impressed by a well-rounded acronym. It shows the research team is delighted by both science and language. In this case, we have the cumbersome An International Study of Rimonabant in Dyslipidemia with Atherogenic Risk in Abdominally Obese Patients distilled into the more convenient ADAGIO-LIPIDS. It is a shame that the team felt they had to cheat — I suppose AISRIDARAOP is not quite so catchy. Perhaps it works better in French. Two new reports based on the clinical trial of acomplia (generic name rimonabant) were presented on the 29th April in Istanbul at the 77th European Atherosclerosis Society Congress.

The first serious point to make is that ADAGIO-LIPIDS is a double-blind, randomised trial with placebo control with 799 participants run in Canada to determine whether acomplia has a beneficial effect on the level of lipids in the blood over a twelve month period. It followed on from the Rimonabant in Obesity-Lipids (RIO-LIPIDS) trial and was not intended to test whether the medication promotes weight loss. Both the test and control groups changed to a low-calorie diet before the trial began. Therefore all participants lost weight, reduced their waist measurements and increased their high-density lipoprotein (HDL) cholesterol levels before beginning their courses of medication or placebo. This allowed the trial to focus on whether acomplia changed the lipid levels of cholesterol and triglyceride in overweight patients diagnosed with atherogenic dyslipidemia ( a high-risk cardiovascular group).

After twelve months, the acomplia group’s average blood pressure was reduced, the level of HDL-cholesterol increased by 7.4% and triglycerides fell 17.9%. The acomplia group also continued to lose weight and reduce their waist measurements. However, computed tomography (CT) imaging clearly demonstrated a decrease in the total visceral and subcutaneous adipose tissue. This provides scientific confirmation of previous studies which more simply recorded a reduction in waist measurements. The fatty liver index was also improved.

There is, of course, the continuing question of psychiatric side effects. In this study, all the participants were screened and only those with no history of depression or anxiety disorders were admitted. With this precaution, there was no significant difference in reported depressed moods compared with the placebo group, and the percentage of discontinuation was significantly lower than in other studies involving acomplia. For example, in the STRADIVARIUS study, about 20% of the participants were taking antidepressants before the trial began which helps to explain the significantly higher discontinuation rate.

We are therefore left with a balanced view of acomplia. As against the placebo, it produced significant improvements in the level of lipids in the blood and of fats in the body. But the potential of psychiatric side effects remains a worry — the Food and Drug Administration in the US is waiting for further evidence on the extent of the possible problems before giving approval. The fact that acomplia can produce this side effect is now well known. Consequently, the medication should only be prescribed to high-risk patients who are unable to reduce their excess weight sufficiently by modifying their diet and introducing exercise. This is the basis of the regulatory approval in Europe. Because it has the tendency to affect mood, it should not be given to people with a history of depression. Is this a significant precondition of use? Probably not. It does not seem to be any more demanding than the condition imposed on SSRI antidepressants that they should not be given to patients at risk of suicide.

The latest studies based on ADAGIO-LIPIDS confirm the beneficial effect of acomplia. This adds to an accumulating body of data suggesting that, used with care, it should be used more widely.

Article source: Expert Articles