Advantages of Acomplia (Rimonabant) confirmed in the two-year study – Part I
Advantages of Acomplia (Rimonabant) confirmed in the two-year study
Press releases «Sanofi-Aventis».
Results of two Phase III clinical trial in 3040 patients primeneiya Acomplia (Rimonabant) (Akomplia), the first representative of a new class of therapeutics – selective cannabinoid receptor CB1 blockers, indicate that the benefits achieved by the application of Acomplia (Rimonabant) 20 mg at the end of the first year of study, and persisted during the second years of therapy with good safety and tolerability compared with placebo. The results were submitted to the scientific community on scientific sessions of the American Heart Association in New Orleans (Louisiana), Dr. Xavier Pi-Sunyer, head of the Department of Endocrinology Hospital Center at Columbia University (New York), and principal investigator of the study.
Patients treated with Acomplia (Rimonabant) 20 mg for two years, decreased body weight and waist circumference, indicating a significant decrease in the number of abdominal fat – a key marker of cardiovascular disease. Patients were also achieved a significant increase in cholesterol high density lipoprotein, triglyceride reduction and improved insulin sensitivity.
Study RIO-North America – the largest of the studies of Acomplia (Rimonabant). His results are consistent with those of two previous large-scale studies on Acomplia (Rimonabant) – RIO-Lipids and RIO-Europe – and increase the volume of evidence demonstrating the efficacy and tolerability profile of the drug. Acomplia (Rimonabant) is designed for correction of cardiovascular risk factors, it provides a reduction of abdominal obesity, improving lipid and glucose metabolism, and promotes smoking cessation.
Obesity – the largest public health problem and one of the most frequent causes of death worldwide, mainly due to cardiovascular diseases. Obesity is usually defined by body mass index (BMI), but recent studies have shown that visceral (abdominal) obesity (the degree of its directly correlates with the size of waist circumference) is the best factor for predicting the risk of acute coronary syndrome than body weight or BMI [1 ]. 44% of U.S. adults waist circumference greater than the risk level (40 inches for men and 35 inches for women) [2]. Visceral type of obesity is associated with the causes of metabolic risk factors such as dyslipidemia or insulin resistance, which can lead to diabetes, myocardial infarction, stroke and other cardiovascular diseases. The decrease in visceral obesity is a recognized priority for preventing cardiovascular disease [3].
«Cardiovascular risk factors associated with obesity become more pronounced. Excessive amounts of abdominal fat is increasingly recognized as one of the most informative precursors of future cardiovascular events, – said Professor Pi-Sunyer. – Results of two studies RIO-North America confirm that Acomplia (Rimonabant) is an innovative and promising tool for long-term correction of obesity and associated cardiovascular risk factors in patients with abdominal obesity ».
Objectives and study design
The international, multicenter, randomized, double-blind, placebo-controlled trial of RIO-North America of the third phase, which compared the two methods of appointment to a fixed dose of Acomplia (Rimonabant) (5 and 20 mg once daily) compared with placebo during the same period – two years. The study involved 3040 patients from 72 centers in the U.S. and Canada.
Objectives of the study was to evaluate the effect of Acomplia (Rimonabant) on weight loss over one year and determine the ability of Acomplia (Rimonabant) to prevent weight gain is new in the second year of treatment, improvement of risk factors associated with abdominal obesity (measured by waist circumference) such as dyslipidemia , glucose metabolism and the metabolic syndrome, safety and tolerability of Acomplia (Rimonabant) in over two years.
After a week of screening patients received mild hypocaloric diet (by reducing daily caloric intake by 600 kcal compared to the energy needs of patients) and started to blind placebo once daily for 4 weeks. Thereafter patients were randomized to one of three treatment groups (placebo, Acomplia (Rimonabant) 5 mg and Acomplia (Rimonabant) 20 mg) for 52 weeks double-blind method with a ratio of 1:2:2 randomization.
