Risk Versus Benefit

Implications: The pooled analysis of Rimonabant trials point to a significant increase in psychiatric disorders. These studies also point to significant improvements in markers of cardiovascular risk. Risks versus benefits must be considered before the final decision is made on this class of medications.

Analysis:  The large double blind clinical trials with Rimonabant each showed a trend toward increased incidence of psychiatric disorders such as depression and anxiety. While the increased level did not reach statistical significance in any of the trials, it is not unexpected that a pooled analysis of these trials may show the increased difference being statistically significant as the recent lancet manuscript reveals.

It is however important to note that use of Rimonabant is also associated with significant decrease in weight, and increase in high density lipoprotein (the good cholesterol) as well possible retardation of type II diabetes. This medication might also have potential use in smoking cessation. These changes could potentially confer significant long term benefits from cardiovascular, pumonary, and oncologic standpoint.

As a result, while it is extremely important to figure out the safety profile of Rimonabant as well as the other encocanabiboid receptor blockers still in phase II and III research, it is also important to not lose focus of all the potential benefits of this class of agents could provide.

In the final analysis, it might behoove the potential pharmaceutical companies and the regulatory agencies to perform and demand larger and longer term trials that could more clearly;y elucidate the potential risks versus benefits of these agents.