New hopes for obesity treatment
Anti-obesity drugs have been stigmatized for a long time. Many people are against the use of medical or even surgical treatment for this disease.
The classic clinical treatment of obesity is based on multidisciplinary programs of dietary guidelines, physical activity enhancement and behavioral change. Although this therapeutic strategy is well established as an effective treatment method for weight reduction, a large proportion of individuals are refractory to this approach and weight regain is a rule (Serdula MK et al., 1993).
In addition, these procedures have not been able to prevent the growing obesity epidemic that is out of control in many countries, including Brazil. Unfortunately, the prejudice against medication against the disease remains great. This barrier by many people should, however, be gradually transposed by the results of clinical research in this field.
The need for medication assistance for treatment and control of obesity stems from the frequent failure of classical treatment combined with a better understanding of the biological aspects of this disease, since it is a chronic and multifactorial disease, an extremely difficult treatment. These two factors resulted in the attempt to associate these two proposals with the goal of providing more effective therapy. However, in 2011, the therapeutic arsenal available for the treatment of obesity was very limited in Brazil after the withdrawal of three drugs : amfepramone, fenproporex and mazindol. Only sibutramine was maintained, and yet with stricter control, which greatly restricted the treatment of this disease, even for obese diabetics, as well as those who do not respond or do not tolerate this medicine. This made the endocrinologists very apprehensive not only about the possible increase in the prevalence of obese (including morbid) people but also the gain in weight of individuals who benefited from withdrawn medications.
Certainly , the decision to medicate an obese patient should take each individual into account in terms of the potential risks and benefits. "
However, very encouraging news has just been released. The FDA (Food and Drugs Administration), which regulates the marketing of medicines in the United States, which had not approved a new anti-obesity substance 13 years ago, has just authorized the release of two new drugs.
One of them has just been released (07/17/2012) by the FDA and has the trade name of Qsymia, from Vivus Inc. The product is composed of two substances: phentermine and topiramate. Studies have shown that Qsymia when used at the maximum recommended dose is able to promote, on average, a sustained reduction of about 9% of body weight. In addition, a 5% reduction in weight was observed in about 70% of treated patients (Garvey et al., 2012). Qsymia is expected to be available in the US market in the fourth quarter of 2012.
Phentermine, one of the compounds of the approved combination, is an agent that acts on catecholamines (adrenaline and noradrenaline) and is already available in the US market many years ago. Its side effects are very similar to those of amfepramone and fenproporex, such as: dryness of the mouth, irritability, anxiety, insomnia, tremor and imprisoned intestine (Kang et al., 2012). Topiramate (the other compound) is an anticonvulsant drug that can induce side effects such as paresthesia (tingling sensation), dizziness, taste disturbance, drowsiness and reduced appetite (Kang et al., 2012). The combination of phentermine and topiramate is especially interesting as it acts synergistically enhancing the power to decrease appetite and reduces the adverse effects of both drugs.Another anti-obesity medication, locarserin (Belviq, from Arena Pharmaceuticals) was approved by the FDA for the treatment of obese adults (BMI of 30 or over) or overweight (Body Mass Index - BMI of 27 or more), who have at least one more associated complication, such as diabetes mellitus type II, high blood pressure or high cholesterol levels. Differently from Qsymia, Belvic stimulates the serotonin receptor, ie, it is a serotonergic agent, which acts to increase satiety and, consequently, to reduce food intake.
Studies have shown good safety for the cardiovascular and pulmonary systems (BLOOM-DM). The most commonly observed side effects were headache, fatigue, dizziness, nausea and arrest. This drug was shown to promote a 3% reduction in weight more than in the placebo group after one year. This means that its efficacy is lower than that of sibutramine, orlistat and the new Qsymia (phentermine and topiramate).
Even though it is not superior to the medicines available on the market, locarserine may be a new option, especially for patients who do not tolerate the other drugs, since we have very few drugs available to treat obesity. Thus, both approved drugs can be used as adjuncts to patients who are unsuccessful through classical treatment, since they have been shown to be effective in promoting weight reduction and the benefits of their use were considered to be greater than the risks resulting from obesity, which predisposes to numerous health problems and results in a significant reduction in quality of life.
Certainly, the decision to medicate an obese patient should consider each individual in terms of the potential risks and benefits. It will be crucial that research continues at a rapid pace to improve new and increasingly effective and safe drugs, with the aim of alleviating the suffering of patients with this disease.
Finally, the FDA's position to approve these drugs demonstrates that this agency has revised its previous position, probably in the face of the results of extensive research in the field and the urgent need to contain a true obesity epidemic. But in Brazil, for now, there is no information about the possibility of approval.
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