Acomplia diet drug

Rimonabant -very good news

Rimonabant- a
single drug for weight loss, smoking cessation, dyslipidemia, and metabolic
syndrome sounds almost too good to be true, but two clinical trials
presented at the American College of Cardiology

. The first in a new class of drug, Rimonabant is a cannaboid receptor
1 (CB1) antagonist that appears to be taking meeting attendees by surprise.

“Results of this trial
indicate that physicians may finally have a new tool to treat common,
classic complications that are major risk factors for cardiovascular
disease but that are too often treated in isolation, such as hypertension,
dyslipidemia, and type 2 diabetes,”

“Rimonabant
may be helpful in targeting the cause of those clustering abnormalitiesfor
example, abdominal obesityhopefully improving our ability to better
manage cardiovascular risk in an expanding proportion of our patients.”

“At a time when an estimated
50 million people may be affected by metabolic syndrome, this is good
news,” Dr Sidney Smith (University of North Carolina, Chapel
Hill) told heartwire.

Risk-factor improvement
in Rimonabant-treated patients

A
full 44% of subjects taking rimonabant for one year lost more than 20%
of their body weight, compared with only 16.3% of those taking 5-mg
rimonabant and 10.3% of placebo-treated subjects. The number of patients
with metabolic syndrome at study onset dropped by more than 50% in the
20-mg patients.

A help for those who want to
quit smoking :after 10 weeks of treatment, including a two-week run-in
period when they were allowed to continue to smoke and a final four-week
period when smoking abstinence was assessed, smokers randomized to 20
mg of rimonabant were twice as likely to quit as people randomized to
placebo.

Prolonged smoking abstinence

“Rimonabant
may have a distinctive dual effect that could prove to be critical in
helping patients to quit smoking while reducing the likelihood of weight
gain.”

In both studies, side effects
were relatively mild and transient, the most commonly cited being nausea
and dizziness. In a press conference following the late-breaking sessions,
Després likened the nausea symptoms to the feeling of having overeaten.
In addition, Rimonabant had no significant impact on blood
pressure, heart rate, or QT interval. Depression and anxiety measures
were also similar between the rimonabant- and placebo-treated patients.

The rimonabant news seemed
to catch cardiologists and other ACC attendees off-guard, many telling
heartwire that they trully believe that Rimonabant it’s
an amaizing drug with high hopes in treating many diseases.

Most of the people who work
in the field of metabolic syndrome feel that obesity is not going to
be able to be cured with one pill, that there are redundant systems
in the brain for controlling appetite. But if you hit one, you may be
able to do something positive, and it does seem like they’ve hit an
important system.

Cigarette smoking and obesity
are the leading causes of death in the US,” Dr Eric Westman
(Duke Clinical Research Center, Durham, NC) reminded . “These very
encouraging findings suggest that Rimonabant could become
a widely used medical therapy.”

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A major study released Tuesday indicates Sanofi-Aventis’ weight-loss drug candidate Acomplia can help obese adults lose weight and keep it off for at least two years.

But some experts warned that it may be premature to call Acomplia the next big thing in the weight-loss market.

Still, the findings, which appear in the Feb. 15 issue of the Journal of the American Medical Association, could help position Acomplia as a formidable competitor to weight-loss drugs already on the market, such as Abbott’s Meridia (sibutramine) and Roche’s Xenical (orlistat).

Sanofi filed a new drug application for Acomplia with the Food and Drug Administration last year. The FDA is expected to wrap up its review of the weight-loss product in the next week or so.

The study showed that Acomplia is effective and as effective, if not a little more, than the two other drugs already approved for weight loss: sibutramine and orlistat, the study’s lead author F. Xavier Pi-Sunyer, of St. Luke’s-Roosevelt Hospital Center, told United Press International.

Acomplia Rimonabant is a drug to assist obese people to lose weight and it is approved for sale Europe and UK with prescription from 28th June 2006. Since that time, this drug acomplia rimonabant is called a miracle drug for obesity treatment.

As with most drug treatment , acomplia-rimonabant/Acomplia Rimonabant does not work for everyone. Clinical trials of this drug Acomplia Rimonabant demonstrated that 70% of patients were able to lose at least 5% of their body weight over a 12 month period. Around 39% of patients who took acomplia rimonabant managed to lose at least 10% of their bodyweight over the same period. It was also noted that most of the weight loss occurred within the first nine months of this acomplia rimonabant’s treatment.

We have  good news for the drug company Sanofi Aventis that makes the weight loss medication Acomplia is that the EMEA which regulates drug sales and marketing for the European Union has allowed the company to mention the fact that Acomplia can help patients who have blood sugar problems in the form of diabetes.This was expected to happen since more and more patients reported excellent results in the test trials.

This means that from now on any Acomplia sold in the European Union will have a change on the labelling to inform patients and doctors of the positive effect that the drug can have on diabetes. At present the labeling of the Acomplia drug only mentioned that it is to be used with diet and exercise to help obese people lose weight or to help overweight people who have diabetes or other illnesses related to their weight.

Sanofi Aventis are very keen to get Acomplia known as a drug to treat diabetes and not just as a weight loss medication. This is extremely important to them because if the drug is prescribed as a diabetes medication it will be covered by most health insurance policies and this will mean that sales will rise. At present health insurance companies are not keen to reimburse patients for weight loss medication except in extreme circumstances.Early studies into Acomplia’s use to help quit smoking are encouraging, too. They suggest that Acomplia may double your chances of kicking the habit for good, without gaining excess weight (often a problem when people give up smoking).

Studies have reported an average weight loss of 10 per cent of bodyweight – with weight staying off, even up to two years later. Research has also revealed that most of the pounds are shed from the difficult to shift area around the waist.

Acomplia has also been shown to support cardiovascular health, improving cholesterol ratios and lowering triglyceride levels (bloodstream fats), and showing promise as an aid for diabetes and heart conditions.

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Abdominal fat is a Kingpin of heart disease. Acomplia Rimonabant diet pill reduces fat located in the abdominal area. A substantial drop in weight attributed to taking Acomplia Rimonabant diet pill, constituted lower triglycerides, and improved the HDL cholesterol levels, as well as Rimonabant helped desensitize insulin levels in the blood.

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SILVER SPRING, MD, 28 June 2007 — Members of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee in June agreed unanimously that rimonabant, a weight-management drug made by Sanofi Aventis, lacks adequate safety data to merit FDA approval.

“I wouldn’t in any way suggest that it be approved at the present time for use,” said committee member Jules Hirsch of Rockefeller University in New York.

Rimonabant is a selective cannabinoid-1 (CB-1)-receptor inhibitor and would have been the first in this class of drugs available in the United States. The drug inhibits the body’s endocannabinoid system, which affects appetite, energy balance, glucose and lipid metabolism, and body weight.

Rimonabant is already approved for sale in nearly 40 countries under the brand name Acomplia but would be called Zimulti in the United States, according to Sanofi Aventis.

When accompanied by a low-calorie diet, rimonabant led to significantly greater weight loss than placebo during clinical trials. Most of the weight loss occurred during the first nine months of therapy before leveling off and was accompanied by improvements in waist circumference and plasma levels of triglycerides and high-density-lipoprotein cholesterol.

Although FDA stated that the weight loss from rimonabant was clinically and statistically significant, the agency expressed concerns about rimonabant’s safety profile—in particular, the neurologic and psychiatric adverse events that were frequently reported in clinical trials of the drug.

Amy Egan, an FDA medical officer, told the panelists that adults who received a once-daily 20-mg dose of rimonabant, the amount effective for weight loss, were about twice as likely as placebo recipients to report psychiatric effects such as depression, anxiety, suicidality, and other cognitive and neurologic symptoms.

“The vast array of these events gave us a considerable sense of uneasiness,” Egan said, adding that rimonabant recipients were more than twice as likely as placebo recipients to drop out of clinical trials because of psychiatric symptoms.

Patients with a significant history of depression were excluded from clinical trials of rimonabant, even though overweight and obese people are believed to be at great risk for depression.

Egan said that 8.5% of rimonabant recipients began taking an anxiolytic or hypnotic and 4.8% began antidepressant treatment during clinical trials—roughly double the percentages who initiated these therapies while taking placebo. She noted that 88% of participants in the major rimonabant trials who reported neuropsychiatric symptoms while receiving the drug had no prior history of depressive symptoms.

Sanofi Aventis had proposed creating a risk-management program for rimonabant in the United States to prevent people with depression from taking the drug.

After the meeting, the manufacturer released a statement saying that it planned to work closely with FDA to resolve the committee members’ concerns about rimonabant.

An FDA decision on rimonabant is expected on July 27. Although FDA is not required to take the committee’s advice and reject the manufacturer’s application, the agency usually follows the recommendations of its experts.

Shannon Finks, a cardiology specialist and assistant professor at the University of Tennessee College of Pharmacy in Memphis, said the meeting’s outcome was “a big disappointment for the 60% of all Americans who are overweight or obese that could benefit from cardiometabolic risk reduction.”

“I had high hopes for this agent,” she said. But, she added, “I am certain that the advisory panel—hearing, seeing, and analyzing all data—made the right decision at this time to keep patients out of harm’s way.”

Finks, whose practice site is the Memphis Veterans Affairs Medical Center, is especially interested in the treatment of metabolic syndrome, a condition that is characterized by abdominal obesity, abnormal plasma triglyceride levels, and insulin resistance.

“Sixty percent or [more] of our patients are overweight,” Finks said. “We deal with the complications of being obese and having metabolic syndrome every single day.”

Sanofi Aventis had initially sought FDA’s approval to market rimonabant for the treatment of metabolic syndrome, according to FDA, but the agency stated that clinical data on the drug did not adequately support that indication.

Finks said that losing just a little bit of weight can improve patients’ cardiometabolic risk profiles.

“If you lose 5–10% of your body weight, we know that lipid parameters improve, we know that blood pressure decreases, we know that triglycerides decrease,” Finks said. “We know that you have an overall improvement in health.”

But Finks emphasized that neither rimonabant nor any other weight-loss drug should be the cornerstone of a program to help people lose weight.

“Lifestyle modification is the number-one treatment for metabolic syndrome and obesity,” Finks said. “Pharmacotherapy is not the answer. Pharmacotherapy can be used, though, with diet and exercise.”

Amy Franks, assistant professor at the University of Arkansas for Medical Sciences College of Pharmacy in Little Rock, emphasized that health care practitioners need to view weight management as a lifelong issue.

“We should be thinking about obesity as a chronic illness and treating it with the same vigor that we treat someone who’s hypertensive or someone who has diabetes or someone who has hyperlipidemia,” she said.

Franks, who recently completed a pilot study of a pharmacist-run program to identify and counsel adults with metabolic syndrome, said she is not a big proponent of pharmcotherapy for most patients.