Weight Loss Information

Sanofi-Aventis said on April 3rd it still has high hopes for diet drug rimonabant (Acomplia / Zimulti), even though it was rejected by a U.S. FDA advisory panel last year and recent clinical trial news has been less than wildly encouraging.

Marc Cluzel, Sanofi's head of research, said in a round of interviews in London that he continues to believe Acomplia can be a winner.

Acomplia, which was to have been marketed in the United States as Zimulti, was withdrawn from FDA consideration last June after an expert panel unanimously recommended against approval out of concern over depressive and suicidal side-effects.

Data from a new clinical trial of possible use of Acomplia in slowing progression of coronary artery disease was reported this week along with news that 43.4 percent of patients who got rimonabant in this trial suffered psychiatric side effects such as anxiety and depression.

While the results of the heart trial were ambiguous at best, Cluzel put a positive face on it -- and reiterated that Sanofi intends to resubmit rimonabant to the FDA and regulators worldwide in 2009 for approval as a treatment for type 2 diabetes.

He noted that the Acomplia development program -- involving clinical trials for a variety of conditions in addition to obesity -- is only one-third completed.

"It's very difficult before 2011 to know exactly what will be the full benefits of the product," Cluzel told the news agency Reuters.

Another Sanofi executive, Belen Garijo, also expressed confidence that sales of Acomplia -- which have been disappointing to date -- will grow in Europe and other countries where it is on the market. http://www.acomplia.p5.org.uk

Cat (CT) scans of obese patients treated with Acomplia (rimonabant) have confirmed for the first time that the diet drug significantly reduces the dangerous type of abdominal obesity that often leads to type 2 diabetes, according to researchers.

In a late-breaking report presented at the annual meeting of the European Atherosclerosis Society in Istanbul, the researchers said cat scans showed that rimonabant treatment for a year resulted in significantly greater reductions in visceral fat than a placebo and also helped reduce the fatty liver index.

The results came from the ADAGIO-LIPIDS clinical trial, a study conducted in 799 patients with abdominal obesity and with the high triglyceride - low HDL-cholesterol dyslipidemia. Dyslipidemia is a condition that contributes to the development of atherosclerosis (commonly called hardening of the arteries).

The purpose of the study, according to lead researcher Dr Jean-Pierre Després of Université Laval in Quebec City, was to determine the effect of rimonabant on HDL (good) cholesterol and triglyceride levels and on the cardiometabolic profile of overweight/obese patients with dyslipidemia.

Patients treated for a year with rimonabant, Després reported, saw their HDL cholesterol increased by an average 9.7% while triglycerides were lowered 15.5%. Blood pressure was reduced 3.3 mm Hg, and inflammation levels measured by C-reactive protein (CRP) were also reduced.

But for the first time in a rimonabant trial, patients were also given cat scans to measure how much subcutaneous and visceral fat was lost on rimonabant as well as to determine whether rimonabant could reduce liver fat.

"Although we had evidence from the phase III studies conducted with rimonabant that (the drug) could induce a reduction in waist circumference (a crude marker of abdominal fat) and improve several features of the metabolic syndrome, no study had ever quantified the effect of this drug on visceral adiposity and liver fat," Després said.

The researchers reported that rimonabant therapy for a year reduced visceral adipose tissue by an average 10.1%, which was greater than the 5.1 percent loss of subcutaneous fat, and produced a "significant: decrease in the fatty liver index.

"Results of ADAGIO-LIPIDS provide support to the notion that patients with visceral obesity who are often either dyslipidemic or with type 2 diabetes (or both) represent a relevant subpopulation of overweight/obese patients who would particularly benefit from rimonabant therapy," the researchers concluded. www.acomplia.p5.org.uk 

Resources: Acompliareport.com