Much of the excitement about Acomplia / Zimulti stems from early results suggesting that it not only facilitates weight loss, but that it also helps patients significantly improve their lipid and glucose profiles.
In the RIO-Lipids trial, weight loss was accompanied by a decrease in waist size of 3.4 inches demonstrating a significant reduction in abdominal obesity, an independent marker for heart disease.
Dramatic improvements also were reported in lipid profile with a 23% increase in HDL-cholesterol (good cholesterol) and a 15% decrease in triglycerides.
Improvements in glucose tolerance and insulin levels were also reported. Approximately half of the patients diagnosed at the start of the study with metabolic syndrome, who received the higher 20 mg daily dose of Acomplia, no longer had this condition at the conclusion of the trial.
At this stage of the study process, however, uncertainties remain about side effects of Acomplia / Zimulti.
Researcher Luc Van Gaal of the University Hospital in Antwerp, Belgium, said 14.5 percent of patients participating in one of the studies underway who were on the 20 mg dose stopped taking Acomplia due to adverse side effects. The main side effect, he said, was nausea, which affected one in eight patients.
An earlier clinical trial also had a drop-out rate due to side effects of about 15 percent.
For a detailed report on Acomplia side-effects that has been approved by the European Medicines Agency (EMEA),
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