Perfil de segurança e eficácia da sibutramina e alternativas terapêuticas para o tratamento da obesidade no Brasil

Abstract

INTRODUCTION: Obesity is a chronic metabolic disease and a risk factor for some cancers and various cardiovascular and metabolic diseases. Pharmacotherapy may be useful as an adjunct in the treatment of obesity, although most pharmacological treatments have no longterm efficacy and also have risks associated with their use. In 2011, Anvisa reassessed the safety of medicines for the treatment of obesity and decided to maintain only the authorization of sibutramine in the Brazilian market. OBJECTIVES: To review the efficacy and safety profile of sibutramine and to present available therapeutic alternatives for obesity treatment in Brazil and in the world. METHODS: Descriptive literature review study on efficacy and safety data for sibutramine from 2010 to the present day, using the descriptors “sibutramine”, “sibutramine and long term”, “sibutramine and maintenance”, “sibutramine and efficacy”, “sibutramine and safety” and “sibutramine and risk” in the Medline and “BVS” databases. By using Anvisa´s systems, Notivisa and SNGPC, we also searched for adverse reaction reports related to sibutramine, received from 2008 to 2018, as well as the sales amount of sibutramine. For the literature review on therapeutic alternatives to sibutramine, we used the descriptors “obesity and pharmacotherapy”, “obesity and pharmacology” and “obesity” and “drugs” and “treatment” in the Medline database, from 2018 to 2019. RESULTS: 91% of the studies selected had favorable conclusions regarding the efficacy of sibutramine in treating obesity, and 68% of the selected studies had favorable conclusions regarding drug safety. There were only 12 reports of sibutramine adverse events to Notivisa from 2008 to 2018. Of this total, 7 reports were made after 2011 (the year Anvisa published new rules related to sibutramine control). Of these reports, 9 described at least one adverse event in the cardiovascular system. SNGPC data showed that 9,465,285 sibutramine units were sold in private pharmacies and drugstores from 2014 to 2018, with a 16% decrease in sales between 2017 and 2018. 99.95% of sibutramine prescription was performed by physicians; however, 1,696 prescriptions were performed by dentists and 3,690 by veterinarians. CONCLUSIONS: The literature review showed that sibutramine has a positive efficacy and safety profile in the treatment of obesity in the absence of cardiovascular disease. Significant underreporting of adverse events related to sibutramine use was observed, so pharmacovigilance data did not provide enough information to assess the benefit / risk profile of sibutramine. The decrease in sibutramine sales between 2017 and 2018 can be explained by the entry of new obesity treatment drugs in the Brazilian market in 2016. Sibutramine was prescribed by professionals other than doctors. Anvisa should improve Pharmacovigilance activities in order to monitor the safety of medicines registered in the Brazilian market.