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Acomslia is a diet pill and it considered as an experimental pill that offers the promise of helping people lose weight and quit smoking simultaneously.
This is the for the first time a diet pill is launched which is to have an additional function as an antismoking drug other than a weight loss drug.
The main component of Acomslia diet pill is Rimonabant. It works by blocking CB1 receptor, one of two receptors found in a newly described physiological system called the Endocannabinoid System (EC System), believed to play a critical role in the regulation of food intake and energy expenditure.
This anti smoking diet pill is aimed at blocking the CB1 receptors of the brain commonly called the ‘pleasure centre’ of the brain and interfering with the cycle of craving and satisfaction thus making hunger or cigarette pangs more manageable.
These receptors are present not only in the hypothalamus region of the brain, but also throughout the body, notably in fat cells-- which are involved in lipid and glucose metabolism. They work by reducing dependence on tobacco, suppressing appetite and restoring the balance in the system. Some analysts have also started considering Acomslia Rimonabant as a heart drug. Its medicinal implications on major cardiovascular risk factors – smoking and obesity can be considered a major medical advance for patients at risk of heart disease.
How to use
* Acomslia should be taken only on consultation with a doctor to guard against possible side effects and probable drug interactions.
* Acomslia is used complementary to diet and exercise to treat obese or overweight patients who suffer from Type 2 diabetes and abnormal levels of fat in the blood.
* The manufacturer of Acomslia is urging for the recommendation to allow the diet pill to be used as a long term drug, since initial reports have indicated a regain of the lost weight after the use of Acomslia is stopped.
* Patients with large waist circumference (102 cm in men and 88 cm in women) will mostly benefit from taking the drug.
* Obese patients treated for one year on the highest dose of 20 mg per day shed an average of 19 pounds and lost 3.5 inches of waistline, researchers showed, while 39 percent lost more than one-10th of their body weight.
Side Effects
The initial adjustment: As your body adjusts to the medication, you may experience some of the reported side effects like anxiety, vomiting, disorientation, insomnia, nausea, palpitations, headache, hallucinations, acute high blood pressure, heart and kidney damage, abnormal heart rhythm, heart attack, strokes, psychosis, a rebound effect of fatigue and hyperphagia, gastrointestinal discomfort and dizziness.
What to avoid: Acomslia may cause dizziness, and mood disorders. Therefore, use caution when driving, operating machinery, or performing other hazardous activities.
Consult a doctor: Consult your doctor if these effects persist or you experience mood disorders related to depression and psychosis while taking Acomslia .
Drug interaction
* Consult your doctor and inform about all the prescription and nonprescription drugs you use.
* Since Acomslia diet pills contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this drug.
* Therapy with Acomslia should not be initiated in patients with uncontrolled serious psychiatric illness such as a major depression.
Precautions
* It is advisable to consult a doctor before taking Acomslia and adhere to the prescribed dosage to attain the expected results.
* Do not consume Rimonabant Acomslia diet pill if you are allergic to any one of the ingredients.
* Acomslia should not be taken by pregnant woman since it may cause birth defects in an unborn baby.
* Acomslia should not also be used by lactating mothers. Though not clinically proved, there is possibility that this diet pill may be passed into breast milk. Therefore, consult your doctor for you may have to stop nursing or stop using this drug.
* Accomplia/Rimonabant is metabolized by the liver, thus caution is advised in patients with moderate hepatic impairment.
Dosage
* The usual recommended dose of Acomslia by doctors is 20mg daily before breakfast.
* Acomslia should be swallowed whole with a glass of water, and should not be chewed or crushed as it might contemplate side effects.
* In any case, Acomslia diet pills are strictly advised to be used only under medical supervision so as to prevent probable drug interaction and possible side-effects.
* The dosage for the drug varies from person to person depending upon the body metabolism.
Overdose
In case of overdose, seek emergency medical attention immediately. Never take a double dose of this medication.
Missed dose
Take the missed dose as soon as you remember. However, if it is too late or almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose.
Storage
Acomslia diet pill should be stored at room temperature in a cool and dry place. Keep away from the reach of children.
Presentation
Acomslia Tablets Blister of 10 Tablets
Despite the FDA's issuing an approvable letter in February 2006 for the obesity indication and a non-approvable letter for smoking cessation, the drug did not enter the market in the United States in 2006.[citation needed] The French pharma firm Sanofi-Aventis disclosed that a complete response to the FDA's approvable letter was submitted on October 26, 2006, triggering a Class I (two-month) or Class II (six-month) review process. On June 13, 2007, FDA's Endocrine and Metabolic Drugs Advisory Committee (EMDAC) concluded that the French manufacturer Sanofi-Aventis failed to demonstrate the safety of rimonabant and voted against recommending the anti-obesity treatment for approval.[4] Subsequently, Sanofi-Aventis announced that it was suspending the new drug application (NDA) for rimonabant and that it would resubmit an application at some point in the future.
On 21 June 2006, the European Commission approved the sale of rimonabant in the then-25-member European Union. Sanofi announced that the first country in which Acomplia will be sold is the United Kingdom as a non-prescription drug. Sales began in July 2006. Sanofi also announced that it projects that the drug will be sold shortly thereafter in Denmark, Ireland, Germany, Finland, and Norway. It is expected in Belgium[5] and Sweden in 2007. Ordinary obesity will, according to official medical recommendations, not be enough to acquire the prescription in Sweden; there are additional requirements concerning abnormal blood lipid levels.[6]
The EU's approval was not a blanket approval, nor did it approve Acomplia for non-obesity-related problems such as smoking cessation, although off-label use of the drug is still possible. The approval is in combination with diet and exercise for the treatment of obese patients (BMI greater than or equal to 30), or overweight patients (BMI greater than 27) with associated risk factors, such as type 2 diabetes or dyslipidaemia.
In October, 2008, the European Medicines Agency recommended that doctors not prescribe the drug due to the risk of serious psychiatric problems and even suicide. The drug was subsequently suspended.
Rimonabant (also known as SR141716, Acomplia, Bethin, Monaslim, Remonabent, Riobant, Slimona, Rimoslim, and Zimulti[1], Riomont) is an anorectic anti-obesity drug. It is an inverse agonist for the cannabinoid receptor CB1. Its main avenue of effect is reduction in appetite.
Rimonabant was the first selective CB1 receptor blocker to be approved for use anywhere in the world. In Europe, it was indicated for use in conjunction with diet and exercise for patients with a body mass index greater than 30 kg/m², or patients with a BMI greater than 27 kg/m² with associated risk factors, such as type 2 diabetes or dyslipidaemia. In the UK, it was available beginning in July 2006. As of 2008, the drug was available in 56 countries. On October 23, 2008, the European Medicines Agency (EMEA) released a press release stating that its Committee for Medical Products for Human Use (CHMP) had concluded that the benefits of Acomplia no longer outweighed its risks and subsequently recommended that the product be suspended from the UK market. Sanofi-Aventis later released a press statement stating that the drug had been suspended.
ABSTRACT
Background Rimonabant, a selective cannabinoid-1 receptor (CB1) blocker, has been shown to reduce body weight and improve cardiovascular risk factors in obese patients. The Rimonabant in Obesity–Lipids (RIO-Lipids) study examined the effects of rimonabant on metabolic risk factors, including adiponectin levels, in high-risk patients who are overweight or obese and have dyslipidemia.
Methods We randomly assigned 1036 overweight or obese patients (body-mass index [the weight in kilograms divided by the square of the height in meters], 27 to 40) with untreated dyslipidemia (triglyceride levels >1.69 to 7.90 mmol per liter, or a ratio of cholesterol to high-density lipoprotein [HDL] cholesterol of >4.5 among women and >5 among men) to double-blinded therapy with either placebo or rimonabant at a dose of 5 mg or 20 mg daily for 12 months in addition to a hypocaloric diet.
Results The rates of completion of the study were 62.6 percent, 60.3 percent, and 63.9 percent in the placebo group, the group receiving 5 mg of rimonabant, and the group receiving 20 mg of rimonabant, respectively. The most frequent adverse events resulting in discontinuation of the drug were depression, anxiety, and nausea. As compared with placebo, rimonabant at a dose of 20 mg was associated with a significant (P<0.001) mean weight loss (repeated-measures method, –6.7±0.5 kg, and last-observation-carried-forward analyses, –5.4±0.4 kg), reduction in waist circumference (repeated-measures method, –5.8±0.5 cm, and last-observation-carried-forward analyses, –4.7±0.5 cm), increase in HDL cholesterol (repeated-measures method, +10.0±1.6 percent, and last-observation-carried-forward analyses, +8.1±1.5 percent), and reduction in triglycerides (repeated-measures method, –13.0±3.5 percent, and last-observation-carried-forward analyses, –12.4±3.2 percent). Rimonabant at a dose of 20 mg also resulted in an increase in plasma adiponectin levels (repeated-measures method, 57.7 percent, and last-observation-carried-forward analyses, 46.2 percent; P<0.001), for a change that was partly independent of weight loss alone.
Conclusions Selective CB1-receptor blockade with rimonabant significantly reduces body weight and waist circumference and improves the profile of several metabolic risk factors in high-risk patients who are overweight or obese and have an atherogenic dyslipidemia.
Source Information
From the Quebec Heart Institute, Laval Hospital Research Center, and the Division of Kinesiology, Department of Social and Preventive Medicine, Laval University, Ste.-Foy, Que., Canada (J.-P.D.); the Service of Therapeutic Education for Chronic Diseases, University Hospital Geneva, Geneva (A.G.); and the Department of Body Composition and Metabolism, Sahlgrenska University Hospital, Göteborg, Sweden (L.S.).
The promising preclinical findings with Acomplia (rimonabant) have been confirmed in a series of clinical studies, including pivotal phase III trials involving over 6,000 obese subjects that were carried out in both the US and Europe.
Two-year data from the phase III multicentre Rimonabant In Obesity (RIO) trials, which compared rimonabant at doses of 5mg and 20mg with placebo with respect to weight reduction and prevention of weight gain, showed that the positive results seen after a year's treatment were sustained over the full two-year trial period.
Consistent with the one-year data, the results showed that overweight and obese patients taking rimonabant 20mg/d achieved significant reductions in body weight, waist circumference (an indicator of abdominal obesity) and improved lipid and glycaemic profiles compared with placebo recipients. Rimonabant also had a significant impact on metabolic CVD risk factors, greater than that expected by weight loss alone.
Efficacy and safety in long-term use is important feature of any anti-obesity drug. Some potential anti-obesity medications have proved effective in the first six months of treatment only to lose effectiveness as subjects develop resistance to treatment.
Long-term safety is also a major concern. In the US, the FDA generally requires two years of safety data before approving antiobesity drugs. Results from the phase III RIO trial programme had suggested that rimonabant was well tolerated in long-term use.
Buy Rimonabant (Acomplia), the new age weight loss drug is developed by world’s third largest French pharmaceutical Sanofi-Aventis, to help ever growing number of obese population across the world. Rimonabant is sold under brand name of Acomplia in Europe and under the name as Zimulti in USA.
Acomplia rimonabant is a new class weight loss drug manufactured by sanofi Aventis the French pharma. This drug is named as wonder drug in the world of medicines. In the clinical trials of Acomplia Rimonabant it shown the combined results of a very steady weight loss with good command on smoking cessation. Rimonabant is sold under the brand name Acomplia in Europe and as Zimulti in USA. Acomplia Rimonabant, in the clinical trials has shown very good and positive results compare to placibo.
Accomplia Remonabant has been approved for sale in europe, uk, sweden, etc since 28th June 2006, while in USA its not yet approved for sale. But still in USA rimonabant acomplia can be purchased through prescription. Rimonabant acomplia is not an Rx medication, Rimonabant acomplia is a diet pill which can be purchased only and only through prescriptions.
This drug Rimonabant Acomplia helps to lose weight quickly and safely. Acomplia Rimonabant has been a buzz in the medical world for this new wonder that helps for smoking cessation as well as obesity treatment. Sanofi Aventis has went under 3 year trials for this drug Acomplia Rimonabant or so called zimulti and which has finally been approved by European Union at end of June 2006. This drug Accomplia Rimonabant has developed a new hope for obese people or teenagers girls who are afraid to quit smoking as they may put some weight. But this diet pill Rimonabant Acomplia can easily help one to lose weight quickly with an added benefit for smoking cessation.
Acomplia Rimonabant Working.
Worldwide, the prevalence of obesity and overweight in industrialized countries and in a substantial number of developing countries is increasing at an alarming rate. Rimonabant is a selective cannabinoid-1 receptor antagonist that has been investigated for its efficacy in reducing body weight and associated risk factors in obese people. Phase III trials are now under way to test the use of rimonabant for long-term weight-loss. Given the prevalence of overweight and obesity, it is important to establish the efficacy and safety of rimonabant.
In April, when the French drug company Sanofi-Synthélabo vanquished all other players with a long-shot takeover bid for a much larger French-German rival, Aventis, many commentators focused on the role of politicians in Paris.
The French government, determined to create a national champion in pharmaceuticals, all but stage-managed the deal, which created the world's third-largest drug company, after Pfizer of the United States and GlaxoSmithKline of Britain.
But last week, with Sanofi's release of promising test results for a new drug that fights both obesity and smoking, it became clear that the $65 billion merger was about more than Gaullist bragging rights.
The drug, which is known as rimonabant and will be marketed as Acomplia, was in Sanofi's pipeline long before the merger, and the company - now called Sanofi-Aventis - says that it could become one of the industry's once-in-a-decade blockbusters. Many doctors and analysts agree. While doubters note that other promising obesity drugs have proved disappointing and that the company has not completed some crucial tests, Sanofi plans to file for regulatory approval early next year in the United States and Europe. If regulators sign off, the company hopes to put the drug on the market in 2006.
With obesity affecting 100 million people in the United States and Europe, analysts say such a drug could generate up to $6 billion a year in sales by the end of the decade. That would put Acomplia on the top shelf of the medicine cabinet, with the likes of Pfizer's Lipitor and Merck's Zocor cholesterol treatments.
"We Europeans, whenever we came to America, we always noticed the enormous number of obese people on the streets," said Jean-Pierre Bassand, a cardiologist who chaired the meeting of the European Society of Cardiology in Munich last week, where the results were presented.
"But now obesity is spreading all over the world, like wildfire," Dr. Bassand said. "Fifteen percent of French adolescents are obese. This is potentially a major breakthrough in treating this condition."
The data presented in Munich last week were based on interim results from a planned two-year study that is not yet complete. But the figures were striking - and in keeping with the outcome of an earlier trial in the United States. More than 1,500 patients treated daily for one year with a 20-milligram dose of Acomplia lost an average of 8.6 kilograms (19 pounds) and reduced their waistlines by an average of 8.5 centimeters (3.5 inches). The drug also increased levels in the blood of HDL cholesterol - the so-called good cholesterol - by an average of 27 percent.
Doctors taking part in the trial say they are particularly excited by the drug's shrinking effect on waistlines.
"We know that the deep abdominal weight in your belly is the dangerous fat that leads to heart disease and diabetes," said Luc van Gaal, a professor of medicine at the Antwerp University Hospital in Belgium.
What makes Acomplia even more tantalizing is a clinical trial in the United States indicating that the drug, taken in daily 20 milligram doses, can nearly double a patient's odds of stopping smoking. Moreover, those who did quit gained little weight afterward - avoiding a common aftereffect that has been a disincentive for smokers to give up cigarettes.
"It gives us another bullet in the gun," said Robert M. Anthenelli, an addiction psychiatrist at the University of Cincinnati and an investigator in the smoking trial. "It is totally unlike other medicines."
But if Acomplia's early promise eventually translates to a marketable drug, then selling it - especially in the huge American market - will demand a much larger sales force than Sanofi could have fielded before the takeover. Currently, for example, the company relies on Bristol-Myers Squibb to market two of Sanofi's best-selling drugs in the United States - the blood-thinner Plavix and the blood pressure pill Avapro. But the alliance has a steep price: Bristol-Myers reportedly pockets about half the drugs' American profits.
Diet pill Acomplia (Rimonabant) is a miraculous pill that helps you short out obesity as well as smoking. Acomplia diet pills work on the Endocannabinoid system, which controls appetite and energy expenditure (as well as the urge to smoke). This wonder pill selectively blocks some receptors in the Endocannabinoid system, thus creating a better balance which in turn suppresses appetite and the longing to overeat.
