Clinical Tests of Acomplia (Rimonabant/Zimulti)

The use of Acomplia as a treatment to aid weight loss received a letter of approval from the FDA . It also has passed other testing as well. All this testing has been going on for some time, as described below. However, on February 17, 2006, the FDA declined to issue final approval in early 2006 as hoped until a number of issues were resolved.

Recent Testing Developments

Obesity is now the most common nutritional disorder in western industrialised countries. Defined as a body mass index of greater than 30, it arises from the accumulation of excess fat in the body from over consumption of fatty foods. Prevalence of obesity in the US and Europe has reached epidemic levels.

In March, 2006, compiled data from four trials that were part of the "Rimonabant (Acomplia/Zimulti) in Obesity and Related Metabolic Disorders" (RIO) program was released. Surprisingly, Acomplia's beneficial effect on blood sugars and fats went 57 percent beyond the benefit that would have been expected from weight loss alone. The drug, which affects the body's cannabinoid system, appears to reduce interrelated risks for heart and metabolic diseases.

The Rimonabant In Obesity (RIO) Study

The RIO study involved more than 6,000 patients worldwide. Results from the RIO programme demonstrated that one Acomplia 20 milligram tablet taken every day significantly decreased weight and waist circumference, HbA1c, and triglycerides and increased HDL-cholesterol levels. Importantly, the label granted by the European Commission states that an estimated 50 percent of the observed improvements in HbA1c, HDL-cholesterol and triglycerides were beyond that expected from weight loss alone.

The RIO study was conducted in several global locations. The primary focus was measuring weight loss after one year of Acomplia intake with a controlled diet. The secondary focus was on risk factors related to obesity and metabolism.

The primary objective of the trial was to assess weight loss over one year, and then to determine the ability of Acomplia to prevent regaining weight during a second year of treatment. Results were positive and researchers concluded that safety concerns were minimal.

Alcohol Use Reduction

In March, 2006, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) began recruiting participants for a test on the possible use of rimonabant to reduce alcohol consumption.

This research shows patients who took 20 mg rimonabant (Acomplia/Zimulti) for 1 year were then re-randomized to either continue on rimonabant (Acomplia/Zimulti), or to switch to placebo. Patients who stayed on rimonabant for the second year did not lose additional weight, while those switched to placebo gained weight. At the end of 2 years, patients who took rimonabant for one year and placebo for the second year had about the same amount of overall weight loss as patients who took placebo from the beginning.

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