Final Acomplia (rimonabant) edited part 22

28 clinical trials promising preclinical findings

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28 Clinical Trials Promising preclinical findings have been confirmed in a series of clinical studies Pivotal phase III trials involving over 6,000 obese subjects that were carried out in both the US and Europe Two-year data from the phase III multicentre Rimonabant In Obesity (RIO) trials
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29 Clinical Trials Figure 1 Change in body weight among subjects in the Rimonabant in Obesity (RIO)-Lipids study Figure 2 Percentage of subjects achieving 10% weight loss at one year with rimonabant (solid bars) 20 mg/day versus placebo (open bars) in the first two Rimonabant in Obesity (RIO) trials among those completing the study
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30 Phase III RIO trial programme had suggested that rimonabant was well tolerated in long-term use Severe Side Effects Increased risk of psychiatric adverse events Further studies indicated an increased risk for suicidal ideation in patients - two suicides were recorded across the rimonabant clinical trial programme Side Effects
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31 Psychiatric adverse events ignored, many patients withdrew from clinical trials Despite this, In 2006, European Medicines Agency (EMEA) approved the release of Rimonabant in Europe In 2009, European Medicines Agency (EMEA) withdraws approval of Rimonabant since the disadvantages no longer outweighed advantages Withdrawal of Rimonabant
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32 Future Developments Rimonabant’s use in smoking cessation and treatment of alcohol dependence is also being researched Study the effects of CB1 receptors in the brain - Possible psychiatric and neuronal treatment Analogs of Rimonabant without side effects are being studied and reproduced
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33 Overcoming Obesity Reducing your body weight by just 5-10% can improve health significantly Changing you diet Reducing caloric intake, Increase physical activity Set up goals, for yourself to achieve, and reward yourself
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34
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35 References Kotagiri, Vijay Kumar; Suthrapu, Sashikanth; Reddy, Jambula Mukunda; Rao, Chitneni Prasad; Bollugoddu, Vijaybhaskar; Bhattacharya, Apurba; Bandichhor, Rakeshwar. An Improved Synthesis of Rimonabant : Anti-Obesity Drug. Organic Process Research & Development (2007), 11(5), 910- 912.
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