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April 2004 Issue

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Data Shows New Drug, Rimonabant, Helps Smokers Quit While Limiting Post-Cessation Weight Gain

Published April 2004

Researchers at the UC College of Medicine recently presented results of one of the largest smoking cessation trials ever conducted in the United States, STRATUS-US (STudies with Rimonabant And Tobacco USe). The findings show that a new drug, rimonabant, doubled the odds of quitting smoking compared with placebo, markedly reduced post-cessation weight gain at 10 weeks, and was well-tolerated.

"Smoking cessation is an enormous struggle for many people," said Robert Anthenelli, MD, one of the principal investigators in the STRATUS-US trial and an associate professor of psychiatry at the UC College of Medicine and Cincinnati Veterans Affairs Medical Center. "People who smoke are at high risk for cardiovascular disease. It is imperative to do anything and everything we can to treat tobacco dependence. Rimonabant represents a potentially promising new treatment option that can help people stop smoking while curbing post-cessation weight gain. This may be a major step forward in smoking cessation."

Rimonabant is the first in a new class of drugs called Selective CB1 Blockers. The drug works by inhibiting the CB1 receptor, one of two receptors found in the EndoCannabinoid System (or EC System), that are located in the brain and in other parts of the body. Associated with systems regulating the body's intake of food, the EC system is also involved in tobacco dependency. Chronic tobacco use over-stimulates the EC system creating an imbalance. By blocking the CB1 receptor, rimonabant helps restore balance to the EC system resulting in reduced dependence on tobacco. In addition, in other clinical trials with rimonabant, researchers discovered that CB1 receptors are also found in adipose tissue (fat cells), which is associated with lipid and glucose metabolism. Blocking CB1 receptors in the adipose tissue has shown, in a recently completed obesity clinical trial called RIO-LIPIDS, that rimonabant not only significantly induces significant weight loss, but reduces abdominal fat in overweight/obese people with untreated dyslipidemia, and also increases HDL cholesterol (good cholesterol), lowers triglycerides, and significantly improves impaired glucose and insulin levels, all contributing risk factors for cardiovascular disease.

"It is widely known that smoking is linked to respiratory diseases and lung cancer, but smokers are also at 70 percent greater risk for cardiovascular disease than non smokers," said Dr. Anthenelli. "Since these two studies show that rimonabant treats obesity and related metabolic disorders in overweight/obese patients, and also helps people to quit smoking without significant post-cessation weight gain, we may have a very promising new approach for managing two major and preventable risk factors for cardiovascular disease with one and the same drug."

The STRATUS program has enrolled over 6,500 patients in three worldwide phase III trials. The studies are designed to provide evidence supporting indications for smoking cessation and long-term abstinence as well as reduction of post-cessation weight gain. STRATUS-US is the first of the three studies to be completed. Findings of this study were presented at the American College of Cardiology Annual Scientific Session in March. STRATUS-EU is being conducted in 32 sites throughout Europe with the same protocol. STRATUS-WW is a one-year maintenance study currently underway in 54 sites worldwide. Results for STRATUS-EU and STRATUS-WW are expected in the next 12 months.

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