- Top of page
- Obesity is a Public Health Problem
- Obesity Increases the Risk of Mortality and Morbidity
- Weight Loss Improves Health Outcomes
- Drugs Currently Approved to Treat Obesity
- How much Weight Loss is Needed to Reduce Health Risks
- What Predicts Weight Loss
- How Long should We Treat Patients with Medications?
- Evaluating New Anti-Obesity Drugs – the Current Approach:
- New Directions from the FDA in Regulating Obesity Drugs
- What Might the Future for Obesity Pharmacotherapy Look Like?
Obesity is a public health problem, which increases the risk of chronic diseases and mortality. Weight loss can reduce mortality and improve most of the detrimental health consequences of obesity.
Design and Methods:
This paper was developed from two presentations to the US Food and Drug Administration (FDA), which has responsibility for reviewing and approving drugs to treat obesity.
A weight loss of 5% or more is sufficient to significantly reduce health risks in individuals with impaired glucose tolerance, hypertension, or nonalcoholic fatty liver disease. Slightly more weight loss (16% on average, achieved by surgery) reduces mortality. The goal of medicating for obesity is to help more patients achieve more weight loss. A barrier to drug approval has been the concern that weight loss medications might be used by individuals with little or no health risks, thus mandating a low side effect profile for approval of any drug. This limits the options for patients who have obesity-related health problems that could improve with weight loss. Recently the FDA signaled interest in identifying health benefits in higher risk patients that might justify medications with higher risk; however, the potential impact on a large segment of the population has led the FDA to consider requiring a cardiovascular outcome trial for all obesity medications, either prior to or after approval.
This review argues that drugs are needed for obesity because they enhance behaviorally induced weight loss and that new medications for obesity are needed in the approval process.