Safety assessment of combination therapies in the treatment of obesity: focus on naltrexone/bupropion extended release and phentermine-topiramate extended release.

INTRODUCTION: Few studies on combination therapies for the treatment of obesity had been conducted until recently, when two fixed-dose combinations, bupropion-naltrexone ER fixed-dose combination and phentermine-topiramate ER titrated-dose combinations were evaluated in clinical studies that ultimately led to FDA approval. Areas covered: In this review, we discuss safety concerns about both combinations, the rationale and history of combination therapies for obesity (including phentermine plus fenfluramine), and possible future new combinations. Expert opinion: Combination therapies are a promising new area in obesity treatment, similar to what occurs with diabetes and hypertension. Safety assessment is highly important due to the high number of potential users on a chronic basis.

Nuevas drogas en el tratamiento de la obesidad y el sobrepeso / New drugs for the treatment of obesity and overweight / Novas drogas no tratamento da Obesidade e Sobrepeso

a obesidad y el sobrepeso se asocian con un mayor riesgo de mortalidad global y de padecer numerosas patologías crónicas, y son muy difíciles de tratar. Es por esto que la implementación de medidas farmacológicas seguras y eficaces reviste una suprema importancia. La lorcaserina y la combinación fentermina/topiramato son nuevas opciones farmacológicas aprobadas en el año 2012 por la FDA (Food and Drugs Administration de los Estados Unidos), a pesar de su compleja forma de administración, y los requerimientos de un programa de entrenamiento y de monitoreo de postmarketing. En el artículo se describen las nuevas drogas aprobadas, sus mecanismos de acción, efectos adversos, características farmacocinéticas su uso en situaciones especiales, y los inconvenientes con las drogas previamente aprobadas y que fueron retiradas del mercado.Palabras clave: obesidad, sobrepeso, topiramato, fentermina, lorcaserin

besity and overweight are associated with an increased risk of overall mortality and the development of many chronic diseases, and they are very difficult to treat. That is why the implementation of safe and effective pharmacological measures is of paramount importance. Lorcaserin and the combination of phentermine/topiramate are two new pharmacological therapies for chronic weight management. They were approved in 2012 by the U.S. Food and Drug Administration, despite concerns over its complex form of administration and the requirement of a training and post-marketing surveillance program.This article describes newly approved drugs, their mechanisms of action, side effects, pharmacokinetics, and their use in special situations, along with the drawbacks of previously approved drugs that were withdrawn from the market.

A obesidade e o sobrepeso são associados a um maiorrisco de mortalidade global e ao padecimento de numerosaspatologias crônicas, e são muito difícies de tratar. É poristo que a implementação de medidas farmaco lógicasseguras e eficazes possui uma suprema importância.A lorcaserina e a combinação fentemina/topiramato sãonovas opções farmacológicas aprovadas no ano 2012pela FDA (Food and Drugs Administration de los EstadosUnidos), apesar da sua complexa forma de administração, eos requerimentos de um programa de treinamento e demonitoramento de postmarketing. No artigo estão descritas as novas drogas aprova das,seus mecanismos de ação, efeitos adversos, característicasfarmacocinéticas, seu uso em situações especiais, e osinconvenientes com as drogas previamente aprovadas eque foram retiradas do mercado.