Acomplia is recommended as an addition to exercise and proper diet for obese and overweight patients who found two other weight-loss medications Reductil (orlistat) and Xenical (sibutramine) ineffective. Now Acomplia can be prescribed by doctors from the state healthcare system of the UK. However, the drug still has to wait for approval in Germany and the United States. Sanofi-Aventis the manufacturer of Acomplia sais they expect that new clinical trials in Type 2 diabetes patients will influence the approval process.

The findings of the trial showed that Acomplia not only helps people affected with Type 2 diabetes loose weight but is also instrumental in lowering the cardiovascular risk beyond the level that could be accounted for by the Weight Loss alone. Acomplia was also shown to improve blood sugar control.

Obesity is a serious condition that often requires medical treatment and can’t be overcome with healthy lifestyle and diet alone. Excessive weight increases the risk of development of type 2 diabetes and can be linked to cardiovascular disease. Almost half of Britons diagnosed with type 2 diabetes are overweight.

The 11-month trial called ARPEGIO involved 368 patients with type 2 diabetes who had been treated with standard insulin-diet-exercise therapies for an average of six years prior to the study. Presenting the results of the trial at the 68th session of the American Diabetes Association Sanofi-Aventis officials claimed that Acomplia had improved the glucose control three times as compared to insulin treatment and healthy lifestyle alone. The group of patients receiving Acomplia also experienced fewer adverse effects related to the treatment such as compared to the control group (16.8% and 19.3% respectively).

Now the manufacturer plans to submit Acomplia for approval as type 2 diabetes medication. The drug has already received approval as an obesity treatment in the European Union and is marketed in a number of countries in Europe. The US FDA, however, suspended the approval process for four years because of the possible depression risks associated with the drug.

Sanofi-Aventis said a trial of its Acomplia drug involving patients with type 2 diabetes showed a significant improvement in glucose control compared to insulin.

The company said glucose control was three times more pronounced when rimonabant - the generic name for Acomplia - was used rather than insulin and lifestyle advice alone.

Sanofi-Aventis (nyse: SNY - news - people ) said last year it aims to submit rimonabant for worldwide approval in 2009 as a treatment for type 2 diabetes.

Rimonabant has already been approved by the EU with an indication for treating obesity, and is now on sale in a number of European countries.

But in the US the company expects a four-year delay before gaining approval for the drug, for which it withdrew its new drug application after trials revealed possible risks for patients suffering from depression.

Sanofi-Aventis said in the type 2 diabetes trial, symptoms of anxiety were reported for 14 percent of patients in the rimonabant group, versus 5 percent in the control group, while 14 percent showed symptoms of depression in the rimonabant group, versus 7.5 percent in the control group.

The report projects that such an incredible market growth will be mostly driven by the expected launch of a number of therapies such as Lorcaserin manufactured by Arena Pharmaceuticals and a combination of Pramlintide and Leptin delivered by Amylin. However, the report also predicts that the cautious attitude of the FDA towards the newly developed anti-obesity medications can significantly slow down the projected growth rates. The authors of the report base their opinion on the case of Rimonabant (Acomplia) manufactured by Sanofi-Aventis and the safety concerns over similar drugs in the class such as tranabant.

An international study of Rimonabant in abdominally obese patients sponsored by Sanofi-Aventis confirmed that the diet drug can significantly reduce visceral fat and fatty liver index. 799 patients participated in the ADAGIO-LIPIDIS clinical trial. Apart form the abdominal obesity they were also diagnosed with low HDL-cholesterol dyslipimidia which can develop in atherosclerosis. The purpose of the trial was to evaluate the effect of Rimonabant on the levels of HDL (high density lipoprotein) cholesterol and TG (triglycerides) plasma in abdominally obese patients when prescribed over 1 year period together with a hypocaloric diet. The secondary objective was to asses the safety and tolerability of the patients to 20 mg of Rimonabant.

According to the leading researcher Dr Després of Université Laval (Quebec), patients receiving Rimonabant (Acomplia) had an average increase in HDL cholesterol of 9.7% while their TG plasma level decreased by 15.5%. It was the first Rimonabant trial to use Cat scanning. The results of cat scans suggest that taking the drug for 1 year results in more than 5.1% loss of subcutaneous fat as well as considerable decrease in the fatty liver index.

Manufacturer: Sanofi-Aventis

Acomplia (rimobant) is a weight-loss medicine. It is marketed under the brand names Acomplia in Europe and Zimulti in the USA. There is also a generic version of this drug called Rimonabant. Although Acomplia has been approved for marketing throughout Europe, it is still undergoing the process of approval in other countries. Therefore the best way of buying Acomplia is through online pharmacies.

What is it?

Acomplia belongs to the new class of therapeutic agents known as Cannabinoid-1 (CB1) Receptor Blockers. It is used to treat obesity, overweight and related conditions.

How does it work?

Acomplia selectively blocks CB1 receptors of brain and peripheral organs that account for glucose and fat metabolism. It switches off brain circuits that cause the feeling of hunger. By blocking CB1 receptors Acomplia slows down the activity of endocannabinoid system or EC for short. EC system regulates body weight and controls energy balance.

What is it used for?

Accomplia is used as a supplement to diet and exercise for the patients with obesity and overweight suffering from Type 2 diabetes and excessive level of fat in blood.

The manufacturer also claims that Acomplia can decrease the risk of cardiovascular disease.

Can it help to Quit smoking?

According to researches conducted by Sanofi-Aventis Company Acomplia can be used as an aid to smoking cessation but a relevant approvable letter from the FDA has yet to be issued.

What did clinical trial studies of Acomplia show?

The results of clinical studies proved that Acomplia improves a wide range of cardiometabolic risk factors and promotes sustainable Weight Loss. Nearly half of the improvements that were observed in patients receiving 20mg of Acomplia can’t be accounted for by Weight Loss alone.

What are the side-effects?

19% of patients receiving Acomplia vs 13% of those taking placebo experienced vomiting and nausea and were forced to leave the trial.

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.
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.

“We are very confident that Acomplia will grow in Europe,” Garijo told Reuters, noting that it is being reimbursed by insurance in a growing number of markets.

Source: http://www.acompliareport.com/News/news-040408.htm

Merck & Co.s experimental diet pill, developed using research on marijuana, may curb the munchies and lead to Weight Loss, a study says.Patients taking the pill, taranabant, lost an average of 6 to 12 pounds, depending on dose. Those given a placebo lost about 3 pounds during the 12-week study, published today by the journal Cell Metabolism. The research is in the second of three phases of testing needed for U.S. marketing approval.

About 31 percent of Americans over the age of 20 have abnormally high body fat, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The drug targets a receptor found in the brain and gastrointestinal tract discovered through study on marijuana, the researchers wrote.

“It’s known that when you smoke marijuana, which is a natural chemical that stimulates the receptor, the marijuana has beneficial effects on nausea,'’ said Steven Heymsfield of Merck, the study’s head researcher. The effect on the receptor, called CB1, explains why, he said.

Unlike marijuana, taranabant blocks the CB1 receptor, suppressing appetite. Side effects include anxiety, nausea, vomiting and frequent bowel movements, according to the study. All were more pronounced in the higher doses.

Larger studies will be done to determine the specific profile of the side effects, Heymsfield said. A bigger trial, the third phase of marketing tests, will end this year, he said.

The major hurdle is psychiatric,'’ Heymsfield said. We know with what we’ve seen that there are some effects of anxiety and depression related to the mechanism of the drug.'’

Shares Rise

Merck, based in Whitehouse Station, New Jersey, rose $1.74, or 3 percent, to $59.66 at 4:05 p.m. in New York Stock Exchange composite trading, the biggest increase since October. The stock has increased 35 percent in the past 12 months.

Merck said last month that it expects to file for marketing approval of taranabant by the end of 2008. Spokesman Ian McConnell declined to give a peak-sales forecast for the drug.

A similar drug, Sanofi-Aventis SA’s Zimulti, was withdrawn by the company from consideration for marketing approval after an advisory panel found that the company’s safety data were insufficient and that the weight lost in clinical trials didn’t justify the danger of psychiatric or neurological side effects. Paris-based Sanofi has said it will resubmit the pill to the U.S. Food and Drug Administration.

FDA Delay

The FDA had delayed a decision on the drug, marketed as Acomplia outside the U.S., three times because of concerns it was unsafe. U.S. regulators reviewing the company’s application found that people who took the drug were twice as likely to have thoughts of suicide as those on a placebo.

Three patients taking the drug killed themselves during clinical trials, Sanofi officials said in June 2007.

Obese patients taking Acomplia, whose chemical name is Rimonabant, were three times as likely as those taking a placebo to develop anxiety, according to a study published in November in the U.K. medical journal The Lancet.

“The balance, of course, is the efficacy and the safety, and that’s where rimonabant had questions about whether the benefits were balanced by adverse affects,'’ said Christopher P. Cannon, a doctor at Brigham and Women’s Hospital in Boston, in a telephone interview last week.

The effects demonstrated in this study are similar, though not identical, said Cannon, who has consulted for Sanofi. He said other doctors have told him that Acomplia has helped their patients lose weight and that the neurological side-effects have been manageable.

New Family

Both pills belong to a new family of drugs that block receptors in the brain and organs linked to hunger signals. The so-called CB1 receptors, when working properly, help regulate food intake and how the body uses and stores fats and sugars.

CB1 receptors were discovered by scientists attempting to understand the psychoactive components of marijuana. They found that the body produces similar chemicals of its own, called endocannabinoids. These chemicals may stimulate food intake. Acomplia and taranabant work by partially blocking the receptor so that fewer endocannabinoids can be sensed.

elopatto[@]bloomberg.net.

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