Evidence for use of rimonabant

Animal evidence

There is evidence that the endocannabinoid system may influence in nicotine’s reward effects in the brain. Studies of the effects of rimonabant using animal models began in 2001, and data have been obtained regarding the potential utility in nicotine dependence. Cohen et al (2005) studied nicotine-seeking behavior in rats. Rats who were given rimonabant displayed decreased nicotine-conditioned behavior as demonstrated by decreasing the self-administration of nicotine and dopamine turnover in the nucleus accumbens after nicotine stimulation. Balerio et al (2006) reported that pretreatment with rimonabant in mice decreased the anxiety-reducing effects of nicotine in mice who had been previously exposed to nicotine. This study supports the link between the endocanabanoid system and nicotine’s anxiety-like behaviors.

Clinical trial evidence

Following these animal data, clinical trials in humans began in 2002. The trials evaluating the primary clinical effects of rimonabant weight loss and metabolic benefit, were presented under the acronym RIO (Rimonabant in Obesity), and consisted of 4 randomized studies in over 6,000 subjects (RIO-Lipids, RIO-Europe, RIO-North America, RIO-Diabetes). These trials demonstrated the clinical benefits of weight loss, increased HDL cholesterol, decreased triglycerides, and improved glucose metabolism in patients with type 2 diabetes. The most common side-effects in clinical trials utilizing rimonabant are summarized in Table 3.

Table 3. Side-effects of rimonabant

Another series of studies were designed to demonstrate the benefit of rimonabant for smoking cessation. These were the STRATUS (Studies with Rimonabant and Tobacco Use) trials and they enrolled concurrently with the RIO trials. These included two large multicenter phase III trials (STRATUS-United States and STRATUS-Europe), and one maintenance study (STRATUS-Worldwide). Results of these studies have not yet been published in full, and therefore, the details already in the public domain are summarized here.

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