Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?

PURPOSE OF REVIEW: Obesity continues to increase in prevalence in the USA and throughout the world. It is clearly a major contributor to morbidity and mortality. Unfortunately, effective prevention strategies are few. As a contributor to cardiovascular disease, obesity is an important treatment objective. However, before approval, all drugs must meet safety and efficacy concerns of the US Food and Drug Administration.

RECENT FINDINGS: Since July 2010, the Food and Drug Administration's Endocrine and Metabolic Advisory Committee has reviewed three new drug applications and one previously approved drug for the treatment of obesity. This review examines in detail the Advisory Committee's consideration of the risk-benefit equation of the four drugs with a concentration on sibutramine and its key study, Sibutramine Cardiovascular Outcomes Trial.

SUMMARY: Future development of drugs for the treatment of obesity will be dependent on whether they can survive review for safety and effectiveness. The Food and Drug Administration continues to be highly concerned with proposed obesity drugs increasing cardiovascular or any risks and may require changes to clinical research protocols.